Stockwinners Market Radar for January 09, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:55 EST Omega Healthcare sees EBITDA declining in Q1 vs. Q4 - In an investor presentation, the company states: "At the end of 3Q22, Healthcare Homes operated 42 Omega-owned care homes in the UK. Operating performance held up quite well during the pandemic, as occupancy declines were more modest than in the US. In addition, the UK government provided financial support to the industry. However, in late 2022, due to the timing of the expiration of their prior utility contracts, energy costs increased in excess of 300%, based on October 2022 financials, which, along with continuing provisions for agency costs, impinged the operator's near-term liquidity. 1) We have agreed to allow a deferral up to 4 months of rent for Healthcare Homes -January through April 2023. In 4Q22 and FY22, Omega received cash rents from Healthcare Homes of GBP 5.0M and GBP 19.8M, respectively. 2) Healthcare Homes may choose not to defer any or all of this rent. 3) We are also providing nominal short-term financing to Healthcare Homes. This restructuring is still ongoing and therefore may be subject to change. As a result of these restructurings, we expect both EBITDA and FAD to decline from 4Q22 to 1Q23. While Agemo is scheduled to resume paying rent in 2Q23, as we continue to work through the restructuring of the operators noted above, EBITDA and FAD will continue to be negatively impacted. This will result in both our dividend payout ratio and our near-term leverage being higher than our historical range during this period of time. However, based on the expected outcomes of these restructurings, we continue to believe that both our dividend payout ratio and our leverage will return to our historical range upon resolution of these operator issues." Reference Link

20:06 EST Cathie Wood's ARK Investment bought 11.6K shares of Adobe today

18:56 EST Sotera Health settles ethylene oxide litigation in Illinois for $408M - Sotera Health announced that its subsidiaries have reached agreements to settle the more than 870 ethylene oxide cases pending against Sterigenics in the Circuit Court of Cook County, Illinois, and US District Court for the Northern District of Illinois. Under the terms of the agreements, Sterigenics will pay $408M to settle the claims, subject to substantially all of the plaintiffs providing opt-in consents to their individual settlement allocations and dismissing their claims with prejudice. The administration and completion of the settlement agreements is expected to require up to 90 - 120 days. Sterigenics and Sotera Health LLC deny any liability and the agreements explicitly provide that the settlements are not to be construed as an admission of any liability or that emissions from the Willowbrook facilities ever posed any safety hazard to the surrounding communities. Sterigenics will fund an escrow account to pay the settlement by May 1, 2023. Final payment to a qualified settlement fund will be made from the escrow account within 30 days of the final order on appeal affirming court approval of the settlement as a good-faith settlement or, if there is no appeal, within 7 days of the expiration of the deadline to file an appeal from the court's approval. The company will pursue incremental debt financing in the first half of 2023 to fund a significant portion of the settlement payment. The company will record a charge for the $408M settlement for the year ended 2022.

18:31 EST PerkinElmer to meet or exceed Q4 guidance - In a regulatory 8-K filing, the company states: "The company is updating its fourth quarter 2022 guidance as previously provided on November 8, 2022. The Company now expects its fourth quarter 2022 results to meet or exceed the guidance provided on November 8, 2022."

17:53 EST Holder of XOMA Corp BVF Partners buys ~ $421K in company shares - Beneficial Owner of XOMA Corp BVF Partners, disclosed in a regulatory filing that it had purchased 22,249 shares of company stock at $18.91 per share, between January 5 and January 6, for a total transaction amount of $420,737.

17:34 EST Columbia Banking and Umpqua announce FDIC approval of combination - Columbia Banking System (COLB), the parent company of Columbia Bank, and Umpqua Holdings (UMPQ), the parent company of Umpqua Bank, jointly announced that the Federal Deposit Insurance Corporation, FDIC, has approved the previously announced combination of the two companies. The FDIC approval was the final outstanding regulatory approval necessary to complete the combination. The merger is expected to be completed by the end of February, subject to the satisfaction or waiver of the remaining closing conditions set forth in the merger agreement governing the transaction. Columbia and Umpqua have agreed to extend the outside date under the merger agreement to March 11. Upon closing, the combined company will become one of the largest banks headquartered in the West, with over $50 billion in assets and offices in eight western states that serve customers in all 50 states. Post-closing, the holding company will operate under the Columbia Banking System, Inc. name and will be headquartered in Tacoma, Washington. The bank will operate under the Umpqua Bank name and will be headquartered in Lake Oswego, Oregon. Other major subsidiaries and divisions will include Columbia Trust Company, Columbia Wealth Advisors and Columbia Private Bank, which will operate under the umbrella of Columbia Wealth Management, as well as Financial Pacific Leasing, Inc. The combined company will trade under Columbia's ticker symbol on the Nasdaq Stock Market.

17:27 EST Lockheed Martin awarded $260.8M Navy contract modification - Lockheed Martin was awarded a $260.8M cost-plus-incentive-fee and cost-plus-fixed-fee unpriced letter contract modification to a previously awarded unpriced letter contract to provide program management, engineering development, systems integration, long lead material, and special tooling and equipment in support of missile production. Work is expected to be completed on November 9, 2026 once the contract is definitized. FY22 research, development, test, and evaluation funds in the amount of $5M; FY23 research, development, test, and evaluation funds in the amount of $5M and FY23 research, development, test, and evaluation funds in the amount of $13.54M will be obligated on this award. FY22 funds in the amount of $5M will expire at the end of the current fiscal year. This contract is being awarded to the contractor on a sole source basis under 10 U.S. Code 2304 and was previously synopsized on the System for Award Management online portal. Strategic Systems Programs, Washington, D.C., is the contracting activity.

17:23 EST Oak Street Health jumps 26% after Bloomberg reports potential acquisition by CVS - In after-hours trading, shares are up 26% to $28.55.

17:19 EST Gran Tierra: FY22 total company average production ~30,800 BOPD - Gary Guidry, President and Chief Executive Officer of Gran Tierra, commented: "We are excited to announce that our 2022 total Company average production was approximately 30,800 BOPD which was within our guidance despite several social disruptions and a delay in our Moqueta drilling program. Our Moqueta development campaign is well underway with two of the five planned wells having been spud thus far. The initial production results of the first well are encouraging with a stable average rate of 1,312 BOPD. We are very excited for what 2023 holds for the Company and expect to build off the momentum from the strong finish to 2022." During fourth quarter 2022, Gran Tierra's total average production was approximately 32,600 BOPD. December 2022 total Company average production was approximately 33,800 BOPD. Gran Tierra's total average production for the full year 2022 was approximately 30,800 BOPD which is within the Company's prescribed guidance.

17:15 EST Heska CEO buys $646K in common stock - In a regulatory filing, Heska disclosed that its CEO Kevin Wilson bought 11K shares of common stock on January 6 in a total transaction size of $646K.

17:05 EST Texas Roadhouse promotes Gina Tobin to President - Texas Roadhouse announced that its Chief Learning and Culture Officer, Gina Tobin, has been promoted to President, a post which has been held by CEO Jerry Morgan since 2021. In addition to her current duties overseeing Food, Service, Training, Research & Development, and Diversity & Inclusion, Tobin will take on more day-to-day responsibilities at all levels throughout the Support Center. "This promotion creates a clear line of succession, which the Board of Directors and I have been working on for more than a year. With Gina as President, along with our phenomenal leadership team, I will be able to spend more time in the field supporting operations for all three concepts," said Morgan.

17:01 EST FICO CFO Michael McLaughlin to step down, Steve Weber named interim CFO - FICO announced that Steve Weber has been appointed the company's interim CFO. Weber succeeds Michael McLaughlin, who has held the post since August 2019, and is leaving effective January 13 for a new professional opportunity at an enterprise software company. FICO will retain a leading global executive search firm to recruit a permanent CFO. Weber joined FICO in 2003, and currently serves as the company's vice president - treasurer, tax and investor relations. During his nearly 20-year career at FICO, he has served as head of FP&A and has led several public bond issuances, managed syndicated bank lending, stewarded due diligence and integration for mergers and acquisitions and guided strategic financial planning.

16:56 EST Enservco discloses notice of noncompliance from NYSE - Enservco "announced it has received a notice of noncompliance from the NYSE American Exchange because the Company did not hold an annual meeting in 2022 due to it having to restate its financial statements. The Company expects to hold an annual meeting in 2023, at which time it will regain compliance with the NYSE American's continued listing standards."

16:42 EST GE HealthCare to acquire IMACTIS, terms not disclosed - GE HealthCare announced it has entered into an agreement to acquire IMACTIS, an innovator in the rapidly growing field of computed tomography interventional guidance across an array of care areas. IMACTIS is a France-based company that was founded in 2009 by Stephane Lavallee and Lionel Carrat, who created CT-Navigation, an ergonomic universal solution that provides stereotactic needle guidance, enabling intuitive pre-planning and continuous control throughout a wide range of procedures, from diagnosis to treatment. "We're thrilled to take this step in strengthening our interventional guidance offering for patients and customers," said Jan Makela, President and CEO of Imaging, GE HealthCare. "The IMACTIS CT-Navigation system is designed to improve workflow for interventional radiologists and hospitals by increasing procedural accuracy, while helping to reduce procedure time and radiation dose for patients and physicians. It is an innovative navigation solution for image-guided percutaneous procedures that aims for better patient outcomes, by reducing variability for simple and complex procedures and improving reproducibility." The consummation of the transaction is subject to customary closing conditions, including review by the relevant governmental authorities in France. Financial details of the transaction have not been disclosed publicly. GE HealthCare intends to fund this transaction with cash on hand.

16:39 EST BeyondSpring regains Nasdaq minimum bid price compliance - BeyondSpring announced that on December 29 the Company received a written notification from Nasdaq that the Company has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550a2. In the Notification Letter on Compliance, the staff of Nasdaq has determined that for the 10 consecutive business days from December 14 to December 28 , the closing bid price of the Company's ordinary shares had been at $1.00 per share or greater. Accordingly, the Company has regained compliance with the Nasdaq Listing Rule 5550 a2 and the bid price deficiency matter as previously disclosed is now closed.

16:35 EST Nkarta promotes David Shook to CMO - Nkarta announced the promotion of David Shook, to the role of CMO. Shook has expertise in cell therapy development and continues to lead Nkarta's global clinical development and regulatory operations. Shook joined Nkarta in 2020 and was appointed as VP, clinical development in 2022.

16:30 EST Nkarta names David Shook chief medical officer - Nkarta announced the promotion of David R. Shook, M.D., to the role of Chief Medical Officer. Dr. Shook has extensive expertise in cell therapy development and continues to lead Nkarta's global clinical development and regulatory operations. "Dave has been a driving force behind the development and execution of Nkarta's clinical strategy using off-the-shelf NK cell therapeutics since he joined our organization," said Paul J. Hastings, President and CEO of Nkarta. "His expertise in the biology and engineering of NK cells, clinical development experience, and proven leadership will strengthen our mission to bring life-changing cell therapies to patients." An early pioneer of NK cell therapy, Dr. Shook joined Nkarta in 2020 and was appointed as Vice President, Clinical Development in 2022. Prior to joining Nkarta, he designed and led multiple first-in-human cell therapy clinical trials, including the use of CD19 CAR-NK cells, and he remains a practicing pediatric oncologist and transplant physician. He was a fellow, fellowship director and faculty member at St. Jude Children's Research Hospital, where he conducted research in the laboratory of Dario Campana, M.D., Ph.D., Nkarta's scientific founder. Dr. Campana and Dr. Shook co-developed the membrane bound form of interleukin-15 (IL-15), a key component of Nkarta's engineered NK cell platform technology. He received an M.D. from The Johns Hopkins University School of Medicine and a B.S. from Purdue University.

16:25 EST MYR Group CFO Betty Johnson to retire, Kelly Huntington to succeed - MYR Group announced that as part of a planned leadership succession process, Betty Johnson notified the board of directors of her decision to retire as senior VP and CFO of the company, effective on February 24. Johnson will be succeeded by Kelly Huntington, who will assume the role of senior VP on January 9 and the role of senior VP and CFO on February 24, following the reporting of company's FY22 earnings. Johnson will continue as senior VP with the company through May 31 to assist with an orderly transition of her duties. Johnson has more than twenty-two years of service with the company in a number of roles including eight years of service as a member of the board of directors prior to assuming the role of CFO in 2015.

16:21 EST Appeals Court upholds Thorne HealthTech's prior challenge of NR IP claim - On January 3, 2023, the U.S. Circuit Court of Appeals for the Federal Circuit in Washington, D.C., issued a final ruling rendering the previously issued U.S. Patent No. 8,383,086 ("the '086 patent") to be unpatentable and therefore invalid. The '086 patent claim covered "The pharmaceutical composition . . . wherein nicotinamide riboside is isolated from a natural or synthetic source." The effect of the '086 patent was to provide broad patent protection of the nicotinamide riboside molecule regardless of source and in any salt form such as NR chloride, NR tartrate, NR malate, etc. Thorne HealthTech had challenged the validity of the '086 patent at the U.S. Patent Trial and Appeal Board, and the PTAB had upheld Thorne's challenge, which rendered the '086 patent invalid at that time. The '086 patent is owned by Dartmouth College and is licensed to ChromaDex, of Irvine, California, for commercial use. Dartmouth College had appealed the PTAB's decision to the U.S. Circuit Court of Appeals for the Federal Circuit. However, just days ago, Dartmouth College withdrew their appeal, which leaves the initial PTAB invalidity ruling of the '086 patent intact. Thorne HealthTech intends to continue its highly successful expansion into the nutritional supplement marketplace with its nicotinamide riboside hydrogen malate suite of products. Thorne's NRM has among the highest safety profiles in the NR market and is the subject of several ongoing clinical trials related to healthy aging, cognition, and human performance.

16:21 EST DHT Holdings:Q4 time charter equivalent fleet earnings ~ $56,900 per day - DHT Holdings provides the following business update: For the fourth quarter of 2022, the Company estimates time charter equivalent earnings for its fleet at $56,900 per day, comprising of $36,100 per day for the Company's VLCCs on time-charter and $63,800 per day for the Company's VLCCs operating in the spot market. Thus far in the first quarter of 2023, 37% of the available VLCC spot days have been booked at an average rate of $70,000 per day on a discharge-to-discharge basis. 53% of the available VLCC days, spot and time-charter days combined, have been booked at an average rate of $52,000 per day.

16:20 EST E2open reports Q3 organic subscription revenue growth of 10.2% - Reports Q3 adjusted EBITDA $56.2M. Adjusted EBITDA margin was 34.1% or 32.6% on a constant currency basis versus 29.1% from the comparable year-ago period.

16:19 EST Oneok resolves Medford NGL Facility insurance claim for $930M - ONEOK announced that it has reached an agreement with its insurers to settle all claims for physical damage and business interruption related to the Medford incident that occurred in July 2022.Under the terms of the settlement agreement, ONEOK agreed to resolve its claim for total insurance payments of $930M, including $100M received to date. The outstanding settlement payment is required to be paid by the insurers within 45 days. The proceeds will serve as settlement for property damage and as a payment in lieu of future business interruption insurance claims. With the insurance claim now resolved, the company is also announcing plans to construct a new 125,000-barrel per day NGL fractionator at its Mont Belvieu, Texas, facility. Upon completion, the new fractionator, MB-6, will increase the company's total fractionation capacity in Mont Belvieu to approximately 700,000 bpd and better align ONEOK's fractionation capacity with NGL market demand in the Gulf Coast. Additionally, the MB-6 fractionator will produce purity ethane instead of an ethane/propane mix previously produced at the Medford facility. The new 125,000 bpd MB-6 fractionator would be equivalent to approximately 185,000 bpd of capacity at the Medford facility. The demand for E/P mix has decreased while the demand for purity ethane has increased in the Gulf Coast, causing much of the Medford E/P mix to be transported south and split into purity ethane and propane consuming capacity at ONEOK's existing Mont Belvieu facilities. ONEOK's E/P mix output from the remaining Mid-Continent fractionation facilities at Bushton, Hutchinson and Conway is expected to be enough to meet market demand. Construction of MB-6 is expected to be completed in approximately 24 months at a total cost of approximately $550M and has a more favorable completion schedule when compared with rebuilding at Medford.

16:17 EST Valmont secures $85M order for irrigation products and technology solutions - Valmont Industries announced it has entered into a supply agreement to provide mechanized irrigation equipment and innovative technology for multiple agricultural development projects in Africa. The agreement will harness the market-leading solutions of Valley Irrigation, a Valmont company, to help meet the escalating global demand for more efficient and reliable food production, and support national investments in agriculture to feed growing populations and address ongoing food security concerns. "This new engagement is a testament to our technology leadership and ability to secure large-scale projects that address the critical need by many countries to increase food production while decreasing dependence on grain imports," said Josh Dixon, Valley Irrigation President. "Our successful execution of several projects within the region has demonstrated the value of our technologically-advanced irrigation products and dealer network, giving customers confidence in our ability to consistently deliver results. This supply agreement validates the continuing strength of our international project pipeline, and we are very excited about the momentum this opportunity provides heading into 2023." Utilizing Valley's market-leading, proprietary technology solutions, this project will become one of the largest installations of connected pivots. With remote monitoring and controls, this project will maximize crop yields and minimize inputs, while conserving approximately half the water used by traditional irrigation methods. Project shipments are expected to begin in second quarter of 2023.

16:16 EST Churchill Downs enters multi-year agreement with bet365 in Pennsylvania - Churchill Downs announced that Presque Isle Downs & Casino, the company's wholly-owned subsidiary, has entered into a multi-year agreement with a wholly-owned U.S. subsidiary of bet365 Group for online sports betting and iGaming market access in Pennsylvania, subject to necessary regulatory approvals. The bet365 agreement is consistent with CDI's strategy to exit the online sports and casino business, monetize the company's online sports and iGaming market access rights and remain focused on growing the TwinSpires online horseracing wagering business.

16:12 EST Udemy CEO and chairman Gregg Coccari to retire, Greg Brown to succeed - Udemy announced Gregg Coccari will retire from his position as CEO and chairman of the Board, effective February 28, 2023. Additionally, Greg Brown, president of Udemy Business, will succeed Coccari as CEO and join the Udemy board of directors, and Stephanie Stapleton Sudbury, senior VP of customer success for Udemy Business, will be promoted to president of Udemy Business, effective March 1. In conjunction with these transitions, Udemy's board will separate the chair and CEO roles, further strengthening Udemy's corporate governance. Udemy's lead independent director Jeff Lieberman will be appointed Interim chairman of the board upon Coccari's departure. A search for a permanent chairperson is underway.

16:07 EST Terreno Realty reports Q4 occupancy of 98.6% vs. 98.4% q/q and 95.5% y/y - The company states: "Terreno Realty announced today its operating, investment and capital markets activity for the fourth quarter of 2022. The operating portfolio, excluding one property under redevelopment, was 98.6% leased at December 31, 2022 to 569 tenants as compared to 98.4% at September 30, 2022 and 95.5% at December 31, 2021; The same-store portfolio of approximately 12.1 million square feet was 99.5% leased at December 31, 2022 as compared to 98.9% at September 30, 2022 and 98.1% at December 31, 2021; The improved land portfolio of 46 parcels, excluding two parcels under redevelopment, totaling approximately 161.4 acres was 92.5% leased at December 31, 2022 as compared to 91.6% at September 30, 2022 and 94.8% at December 31, 2021. Occupancy at December 31, 2022 included acquired vacancy of 6.7 acres which is pre-leased and expected to commence February 1, 2023; Cash rents on new and renewed leases totaling approximately 0.3 million square feet and 2.6 acres of improved land commencing during the fourth quarter increased approximately 45.2% with a tenant retention ratio of 80.6% for the operating portfolio and 0.0% for the improved land portfolio. Cash rents on new and renewed leases totaling approximately 2.2 million square feet and 19.1 acres of improved land commencing during the year ended December 31, 2022 increased approximately 49.5% with a tenant retention ratio of 56.6% for the operating portfolio and 65.0% for the improved land portfolio; Executed a lease renewal for 66,000 square feet in Rancho Dominguez, California with a provider of third-party logistics in the Southwestern U.S. and Mexico. The lease, which was to expire in April 2023, will now expire May 2026; Executed a lease renewal for 63,000 square feet in Jamaica Queens, New York with a global freight forwarding provider. The lease, which was to expire in December 2022, will now expire December 2027; Executed a lease renewal for 110,000 square feet in Commerce, California with a provider of third-party logistics. The lease, which was to expire in March 2023, will now expire April 2028; Executed a lease for 6.7 acres of improved land in Medley, Florida with a North American provider of equipment rentals. The lease will commence February 1, 2023 and expire March 2033."

16:05 EST VYNE Therapeutics says 1st patient dosed in Phase 1a/b clinical trial of VYN201 - VYNE Therapeutics announced that the first vitiligo patient has been dosed in a Phase 1a/b clinical trial of VYN201. VYN201 is a locally administered, small molecule, pan-bromodomain and extra-terminal domain BET inhibitor that is being developed for the treatment of immuno-inflammatory diseases. The clinical trial is a first-in-human study designed to generate safety and pharmacokinetic data in healthy volunteers, ,Phase 1a, as well as provide early clinical proof-of-concept data in vitiligo patients, Phase 1b . "Dosing the first vitiligo patient in our Phase 1a/b clinical trial represents a significant clinical milestone for VYNE and our novel InhiBET BET inhibitor platform," said David Domzalski, President and Chief Executive Officer of VYNE. "I'm pleased with the progress our team has made to advance this critical program, and we look forward to reporting topline data for both the Phase 1a and Phase 1b portions of the study in the first half of 2023."In the Phase 1b portion, up to 30 patients with a clinical diagnosis of non-segmental vitiligo will receive VYN201 once daily in up to three dose cohorts. The primary objective of the Phase 1b portion of the study will be to evaluate the safety and pharmacokinetics of VYN201. Exploratory efficacy of VYN201 in non-segmental vitiligo patients will also be evaluated, including pharmacodynamic biomarkers and photography.

16:02 EST Rocket Pharmaceuticals adds RP-A601, PKP2-ACM to gene therapy portfolio - Rocket Pharmaceuticals announced the addition of RP-A601 to Rocket's cardiac gene therapy portfolio as well as anticipated highlights for the year ahead across the Company's world-class pipeline of lentiviral and AAV gene therapy programs targeting rare hematologic and cardiovascular diseases. These announcements and anticipated highlights will be presented at the 41st Annual J.P. Morgan Healthcare Conference today at 2:15 p.m. PT by Gaurav Shah, M.D., Chief Executive Officer, Rocket Pharma. "I am extremely excited to build on our significant progress in 2022 as we advance six programs with compelling clinical and/or preclinical proof of concept, including the addition of RP-A601 for the treatment of arrhythmogenic cardiomyopathy due to plakophilin 2 pathogenic variants (PKP2-ACM), expanding our industry-leading cardiovascular AAV gene therapy portfolio. Equally, we look forward to submitting our first regulatory filings, for Fanconi Anemia and Leukocyte Adhesion Deficiency (LAD-I), this year," said Dr. Shah. "RP-A601 for ACM aims to address the unmet needs of approximately 50,000 adults and children in the U.S. and EU who face this devastating genetic heart disease marked by arrhythmias and heart failure that often results in sudden cardiac death. We are moving this program forward into the clinic having demonstrated robust preclinical proof of concept using an rh74 serotype that has been associated with a favorable safety profile in the clinic for other diseases. We anticipate being first to clinic with a submission of an IND for RP-A601 in the second quarter of 2023 for a multi-center, dose-escalation study for the treatment of PKP2-ACM." Dr. Shah continued, "Additionally, positive data updates today in Danon Disease include several months of additional Phase 1 results that demonstrate further robust improvements in all biomarkers, and in how both adult and pediatric patients function and feel, that diverge meaningfully from natural history patients of similar age and disease characteristics. We have shared these updates with the FDA as part of our pivotal Phase 2 study design discussions. Additionally, we have successfully produced two Danon AAV cGMP batches at our Cranbury, N.J. facility with improved product specifications versus Phase 1 thus taking another essential step towards commercial readiness." "Clinical programs from our hematology portfolio, represented by our Phase 2 pivotal studies in Fanconi Anemia and LAD-I, remain on track. We are laser focused on regulatory submissions, with BLA filings anticipated for LAD-I and FA in the second quarter and fourth quarter of 2023, respectively," said Dr. Shah. "Lastly, I am pleased to note an extension of our cash runway, which we expect to fund operations through 2024. I am incredibly pleased with our progress, and excited about the catalyst-rich year ahead as we continue on our path to becoming a fully integrated rare disease and gene therapy company with capabilities extending from discovery through manufacturing and commercialization."

15:56 EST Qualcomm down 1% after Bloomberg report on Apple taking modem in-house - Shares of Qualcomm (QCOM) are down about 1% heading into the close following Bloomberg's report on Apple's (AAPL) in-house chip efforts.

15:21 EST Four Seasons Edu (Cayman) Inc ADR trading resumes

15:10 EST Meta Platforms issues update on ads fairness efforts - Roy Austin Jr, Vice President of Civil Rights and Deputy General Counsel at Meta, issued an update that stated in part: "As a part of our settlement with the Department of Justice, or DOJ, representing the US Department of Housing and Urban Development, or HUD, we announced our plan to create the Variance Reduction System, or VRS, to help advance the equitable distribution of ads on Meta technologies. After more than a year of collaboration with the DOJ, we have now launched the VRS in the United States for housing ads. Over the coming year, we will extend its use to US employment and credit ads. Additionally, we discontinued the use of Special Ad Audiences, an additional commitment in the settlement... The VRS builds on our longstanding efforts to help protect against discrimination. This includes restricting certain targeting options for campaigns that advertise housing, employment or credit ads... Across the industry, approaches to algorithmic fairness are still evolving, particularly as it relates to digital advertising. But we know we cannot wait for consensus to make progress in addressing important concerns about the potential for discrimination - especially when it comes to housing, employment, and credit ads, where the enduring effects of historically unequal treatment still have the tendency to shape economic opportunities. We will continue to make this work a priority as we collaborate with stakeholders to support important industry-wide discussions around how to make progress toward more fair and equitable digital advertising." Reference Link

14:17 EST Denny's announces appointment of Sherri Landry as CMO - Denny's announced the appointment of Sherri Landry as Senior Vice President, Chief Marketing Officer, or CMO. Landry will lead the marketing team and report to President of Denny's Inc., John Dillon, the company stated.

13:02 EST ADT Inc. appoints Wayne Thorsen as CBO - ADT (ADT) announced the appointment of Wayne Thorsen to the newly created role of Executive Vice President and Chief Business Officer, effective immediately. Thorsen will be responsible for leading ADT's product, innovation and new business development teams. Thorsen joins ADT from Google (GOOG, GOOGL), where he served as Vice President, Devices and Services Business Development. Throughout his career, Thorsen held leadership roles at SoFi, Viacom, Telefonica Digital and Microsoft.

12:24 EST NuZee trading resumes

12:19 EST NuZee trading halted, volatility trading pause

12:12 EST Jack in the Box says Q1 SSS accelerated to mid- to high-single digits - Jack in the Box, in conference presentation slides, said its same-store-sales have accelerated during Q1 and are now at mid- to high-single digits. The company reports Q1 results on February 22.

12:00 EST ProShares UltraShort Bloomberg Natural Gas falls -14.8% - ProShares UltraShort Bloomberg Natural Gas is down -14.8%, or -$5.40 to $31.20.

12:00 EST AMTD Digital falls -26.9% - AMTD Digital is down -26.9%, or -$6.17 to $16.77.

12:00 EST F45 Training rises 14.2% - F45 Training is up 14.2%, or 38c to $3.07.

11:45 EST Moderna expects minimum Covid-19 vaccine sales of $5B in 2023 - Earlier, Moderna reiterated 2023 expected minimum COVID-19 vaccines sales of approximately $5B from confirmed Advance Purchase Agreements and 2022 contract deferrals. In other news, Moderna said the mRNA-1010 Southern Hemisphere immunogenicity study in adults is fully enrolled, with a data readout expected in 1Q23, and the mRNA-1010 Northern Hemisphere efficacy study in older adults is fully enrolled, with the data readout that could occur this winter depending upon cases accrued in the study and vaccine efficacy. Moderna also said that the Phase 3 RSV study of has now accrued the cases required to complete the first interim efficacy analysis.

11:23 EST SINTX Technologies Inc trading halted, volatility trading pause

11:04 EST SEC charges McDonald's former CEO for misrepresentations about termination - The Securities and Exchange Commission has charged Stephen J. Easterbrook, former CEO of McDonald's Corporation, with making false and misleading statements to investors about the circumstances leading to his termination in November 2019. McDonald's also was charged for shortcomings in its public disclosures related to Easterbrook's separation agreement. According to the SEC's order, "McDonald's terminated Easterbrook for exercising poor judgment and engaging in an inappropriate personal relationship with a McDonald's employee in violation of company policy. However, McDonald's and Easterbrook entered into a separation agreement that concluded his termination was without cause, which allowed him to retain substantial equity compensation that otherwise would have been forfeited. In making this conclusion, McDonald's exercised discretion that was not disclosed to investors. Subsequently, in July 2020, McDonald's discovered through an internal investigation that Easterbrook had engaged in other undisclosed, improper relationships with additional McDonald's employees." According to the SEC's order, "Easterbrook knew or was reckless in not knowing that his failure to disclose these additional violations of company policy prior to his termination would influence McDonald's disclosures to investors related to his departure and compensation." The SEC's order finds that Easterbrook violated the anti-fraud provisions of the Securities Act of 1933 and the Securities Exchange Act of 1934. Without admitting or denying its findings, Easterbrook has consented to entry of the SEC's cease-and-desist order, which imposes a five-year officer and director bar and a $400,000 civil penalty. The SEC's order also finds that McDonald's violated Section 14(a) of the Exchange Act and Exchange Act Rule 14a-3. Without admitting or denying its findings, McDonald's has consented to the SEC's cease-and-desist order. The Commission determined not to impose a financial penalty on McDonald's in light of the substantial cooperation it provided to SEC staff during the course of its investigation, including voluntarily providing information not otherwise required to be produced in response to the staff's requests, as well as the remedial measures undertaken by McDonald's, including seeking and ultimately recovering the compensation Easterbrook received pursuant to the separation agreement. Reference Link

10:59 EST Canada confirms procurement of Lockheed Martin's F-35 Lightning II aircraft - The Government of Canada confirmed that it is procuring Lockheed Martin's 5th Generation F-35 Lightning II aircraft as a result of the Future Fighter Capability Project competition. The Royal Canadian Air Force will receive 88 F-35A multirole stealth fighters. "Canada is our friend and a close ally. Their decision to procure almost 90 jets underscores the value of the incredible F-35 Lightning II," said U.S. Air Force Lt. Gen. Mike Schmidt, program executive officer, F-35 Joint Program Office.

10:36 EST First Light Acquisition Group announces merger agreement with Calidi - Calidi Biotherapeutics, a clinical-stage biotechnology company, and First Light Acquisition Group, a special purpose acquisition company organized to acquire or merge with one or more businesses, announced they have entered into a definitive merger agreement to create a public company focused on developing oncolytic viral therapies with stem cell-based delivery platforms to treat a wide range of cancers with significant unmet needs. Upon closing of the transaction, anticipated to occur in the second quarter of 2023, the combined company will be named Calidi Biotherapeutics, Inc. and led by Allan Camaisa, CEO and Chairman of the Board. In addition, the combined company's common stock intends to list on the NYSE American under the ticker "CLDI." "We are excited to partner with FLAG which we believe will accelerate our ability to bring life-changing therapies to patients, pairing our first-in-class, allogeneic stem cell-based technology with strategic partnering opportunities, to advance our goal of revolutionizing cancer treatment," said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. The transaction includes gross proceeds of up to $42M in trust with FLAG. The parties will attempt to arrange a PIPE Investment from institutional investors of up to $40M. Net proceeds from the transaction are expected to provide Calidi with capital into the first half of 2025 to advance its pipeline of therapeutic candidates through multiple clinical milestones, including:

10:28 EST Mattel's Fisher-Price re-announces recall of 4.7M Rock 'n Play Sleepers - Mattel's (MAT) Fisher-Price has re-announced the recall of 4.7M Rock 'n Play Sleepers. On April 12, 2019, at the time the original recall was announced, over 30 fatalities were reported to have occurred in the Rock 'n Play Sleepers after the infants rolled from their back to their stomach or side while unrestrained, or under other circumstances. Since the recall, approximately 70 additional fatalities have been reported, which includes at least 8 fatalities that were reported to have occurred after the initial recall announcement. Approximately 100 deaths have reportedly occurred while infants were in the products. Fisher-Price notes that in some of the reports, it has been unable to confirm the circumstances of the incidents or that the product was a Rock 'n Play Sleeper. Major stores nationwide including Walmart (WMT), Target (TGT), and online at Amazon (AMZN) from September 2009 through April 2019 for between $40 and $149.Reference Link

10:23 EST Wolters Kluwer acquires NurseTim, terms not disclosed - Wolters Kluwer Health announced it has signed and completed an agreement to acquire NurseTim, a US-based provider of nursing education solutions. NurseTim will become part of Wolters Kluwer's Health Learning, Research & Practice business, which includes nursing education and practice solutions that help ensure students are ready for practice and nurses are prepared to deliver better patient care and outcomes. NurseTim's NurseThink provides a set of test preparation tools for faculty and students to prepare candidates for the Next Generation National Council Licensure Examination in the U.S. In addition, the company provides hands-on nurse faculty training through conferences and webinars. NurseTim, founded in 2008, is based in Minneapolis MN and employs 48 professionals. Wolters Kluwer expects the investment to deliver a return on invested capital above its weighted average cost of capital within 3-5 years and expects the transaction to have an immaterial impact on adjusted earnings.

10:12 EST Live Nation down 1% after launching $850M convertible senior notes offering - Shares of Live Nation are down $1.04, or about 1%, to $71.34 in early trading after the company announced earlier that it intends to offer, subject to market and other conditions, $850M in aggregate principal amount of convertible senior notes due 2029. The company intends to use a portion of the net proceeds from the convertible notes offering to fund the cost of entering into capped call transactions. The company intends to use the remainder of the net proceeds from the convertible notes offering to effect the repurchase of a portion of its 2.5% convertible senior notes due 2023 in one or more separate and individually negotiated transactions with one or more holders of the existing convertible notes, to pay related fees and expenses and for general corporate purposes, which may include the repayment or repurchase of certain of its outstanding indebtedness.

10:06 EST Unum appoints Valoria Armstrong as chief global inclusion, diversity officer - Unum Group has named Valoria Armstrong to lead the company's office of inclusion and diversity. Armstrong will continue to develop the company's I&D strategy to further foster a culture of belonging. Prior to joining Unum, Armstrong served as chief inclusion officer and vice president, External Affairs, for American Water.

10:01 EST Cartesian Growth Corp trading resumes

10:00 EST Macy's falls -9.0% - Macy's is down -9.0%, or -$1.99 to $20.14.

10:00 EST Riskified rises 10.0% - Riskified is up 10.0%, or 44c to $4.85.

10:00 EST Gaotu Techedu rises 10.2% - Gaotu Techedu is up 10.2%, or 36c to $3.89.

09:51 EST Lightjump Acquisition Corp trading resumes

09:47 EST Paymentus falls -8.5% - Paymentus is down -8.5%, or -68c to $7.30.

09:47 EST Teladoc rises 8.3% - Teladoc is up 8.3%, or $1.85 to $24.14.

09:47 EST TAL Education rises 9.5% - TAL Education is up 9.5%, or 81c to $9.35.

09:41 EST Lightjump Acquisition Corp trading halted, volatility trading pause

09:37 EST Raven SR, Hyzon Motors and Chevron to collaborate on waste-to-hydrogen facility - Raven SR, Chevron New Energies, a division of Chevron (CVX) and Hyzon Motors (HYZN) announced they are collaborating to commercialize operations of a green waste-to-hydrogen production facility in Richmond intended to supply hydrogen fuel to transportation markets in Northern California. The facility will be owned by a newly formed company, Raven SR S1. Raven SR will be the operator of the facility, which is targeted to come online in the first quarter of 2024. Chevron holds a 50% equity stake in Raven SR 1. Raven SR holds a 30% stake and Hyzon owns the remaining 20%. To produce the hydrogen, the project is expected to divert up to 99 wet tons of green and food waste per day from Republic Services' West Contra Costa Sanitary Landfill into its non-combustion Steam/CO2 Reforming process, producing up to 2,400 metric-tons per year of renewable hydrogen. Diversion of this organic waste will help fulfill SB 1383 mandates, and will potentially avoid up to 7,200 metric-tons per year of CO2 emissions from the landfill. In addition, Raven's technology uses no fresh water, an important element given drought risks in California, and uses less electricity to power its units than competing processes. The project is expected to produce at least 60% of its own electricity by upgrading the currently permitted and zoned landfill gas electric generators at the landfill, further reducing both the current air emissions and the need for grid power for its non-combustion process. Chevron plans to market its share of the hydrogen in Bay Area and Northern California fueling stations, enabling the energy transition to zero emission vehicles. Hyzon, a global supplier of fuel cell electric commercial vehicles, plans to provide refueling for hydrogen fuel cell trucks at a hydrogen hub in Richmond.

09:36 EST Aptevo Therapeutics files provisional patentfor APVO711 - Aptevo Therapeutics announced that the Company has filed a provisional patent with the U.S. Patent and Trademark Office pertaining to an anti-PD-L1 x anti-CD40 compound, APVO711, with the potential to fight a range of solid malignancies such as head and neck squamous cell carcinoma, melanoma, and carcinomas of the lung, gastrointestinal tract and colon. The Company plans to initiate pre-clinical studies this year.

09:33 EST Kellogg announces Vitamin D petition accepted by FDA - Following a petition from Kellogg Company, the U.S. Food and Drug Administration recently announced increases to the fortification levels of Vitamin D allowed within the cereal category and now allows fortification of Vitamin D in grain-based bars, the company announced. Nigel Hughes, Kellogg Company's SVP, Global R&D and Innovation, said: "Now, everyday foods, like cereal and grain-based bars, can go even further toward helping people access and consume Vitamin D, creating better days for 3 billion people by the end of 2030."

09:30 EST Royalty Pharma provides business update, outlook - Royalty Pharma provided an update on its business performance, including recent key accomplishments and the full year 2022 outlook for Net cash provided by operating activities and Adjusted Cash Receipts. "Royalty Pharma delivered outstanding performance in 2022," said Pablo Legorreta, Royalty Pharma's founder and Chief Executive Officer. "We deployed substantial capital and added royalties on six new therapies, ranging from an approved, growing blockbuster to exciting development-stage therapies in areas of high unmet patient need. Further, we hosted our inaugural Investor Day, highlighting our talented team, the unique strength of our business model, and our strategy to drive long-term, compounding growth. Lastly, we expect to achieve the upper end of our 2022 financial guidance, putting us in a strong position to accelerate innovation in life sciences and transform patient lives globally." Strong 2022 Financial Performance. Based on preliminary unaudited fourth quarter 2022 results, Royalty Pharma expects Net cash provided by operating activities to be approximately $2.140B to $2.150B for full year 2022. Additionally, Royalty Pharma now expects to deliver Adjusted Cash Receipts for full year 2022 of approximately $2.785B to $2.790B, which is towards the upper end of its guidance range of $2.750B to $2.800B and represents growth of 31% year-over-year. This strong double-digit growth in Adjusted Cash Receipts reflects the strong performance of Royalty Pharma's diversified royalty portfolio as well as the acceleration of payments related to Pfizer's acquisition of Biohaven. Importantly, the growth in Adjusted Cash Receipts was achieved despite a significant decline in two of Royalty Pharma's largest royalties in previous years, the HIV and DPP-IV franchises, highlighting the resilience of the business model with a unique ability to grow through royalty expirations.

09:28 EST XS Financial provides $50M capex lease facility to Curaleaf - XS Financial announced that it has entered into a new lease agreement with Curaleaf Holdings, which currently operates in 21 states with 145 dispensaries and 29 cultivation sites. All amounts are in U.S. dollars. Curaleaf has been approved for a $50M CAPEX lease facility, with an immediate drawdown of ~$10M to purchase equipment with up to 60-month terms.

09:25 EST Muscle Maker's Sadot crossed $150M revenue milestone in first 60 days - Muscle Maker announced its new wholly owned subsidiary, Sadot, has crossed the $150M revenue milestone in its first 60 days of operation. Sadot generated $54.19M in revenue in November and an additional $96.39M in top line sales for the full month of December. Sadot, in its first two months of operation, has now generated $150.58M in total revenue. Total company year-to-date revenue increased by 1,836% to $159.25M since the end of Q3, 2022. Sadot currently focuses on international shipping of physical food commodity items such as wheat, soybean meal, corn, etc. Shipments are via cargo ships that can range between 25,000 to 75,000 metric tons. Michael Roper, CEO of Muscle Maker, stated "it has been our belief that the creation of the new Sadot subsidiary and the diversification of Muscle Maker into additional lines of business could change the landscape for Muscle Maker overall. While Pokemoto and growing our franchising footprint will be a critical part of the restaurant division moving forward, the launch of Sadot and our agreement with AGGIA has made an immediate, significant impact to our top line revenue. Total company revenue through Q3, 2022 was $8.67 million. Sadot has generated $150.58 million in revenue in Q4, its first two months of operation, pushing the total company revenue for the entire 2022 year-to-date upwards of 1,836% to over $159.25 million in just 60 days. These numbers exclude Q4 revenue generated by our restaurant, meal prep, franchising and other divisions."

09:24 EST Royalty, Ionis enter into royalty agreement for up to $1.1B - Royalty Pharma (RPRX) and Ionis Pharmaceuticals (IONS) announced that Royalty Pharma has acquired an interest in Ionis' royalty in Biogen's SPINRAZA and Novartis' pelacarsen for up to $1.125B, including an upfront payment of $500M and up to $625M in additional pelacarsen milestone payments. "This transaction provides us with significant capital to reach our strategic objectives, the first of which is to achieve commercial readiness for our late-stage programs eplontersen, olezarsen and donidalorsen. It also enables us to further advance our deep and innovative pipeline so that we can continue to deliver a steady cadence of new genetic medicines to the market," said Brett Monia, Ph.D., Chief Executive Officer of Ionis. "Royalty Pharma's investment underscores their confidence in SPINRAZA's resilience as an important therapy for the treatment of SMA. It also demonstrates their belief in pelacarsen's potential to be a first-in-class treatment for Lp(a)-driven cardiovascular disease, representing a multibillion-dollar commercial opportunity. Furthermore, because Ionis retains a majority interest in SPINRAZA and pelacarsen royalties, we maintain our ability to benefit significantly from the potential commercial upside of both products." Under the terms of the monetization transaction, Royalty Pharma will receive: 25% of Ionis' SPINRAZA royalty payments through 2027, increasing to 45% of royalty payments in 2028, on up to $1.5 billion in annual sales. Royalty Pharma's royalty interest in SPINRAZA will revert to Ionis after total SPINRAZA royalty payments reach either $475 million or $550 million, depending on the timing and occurrence of certain events; and 25% of Ionis' pelacarsen royalty payments. Under the terms of Ionis' exclusive licensing agreement with Biogen, Ionis is entitled to tiered royalties up to the mid-teens on annual worldwide net sales of SPINRAZA. Ionis' exclusive license agreement with Novartis entitles Ionis to receive tiered royalties in the mid-teens to low 20% range on net sales of pelacarsen. Ionis also retains all rights to $650 million in pelacarsen development, regulatory and commercial milestones from Novartis.

09:22 EST Athersys provides MultiStem clinical update - Athersys provided an update on ongoing clinical trials with MultiStem for the treatment of patients following hemorrhagic trauma and for the treatment of ischemic stroke . MultiStem is a proprietary off-the-shelf stem cell product in late-stage clinical trials for acute ischemic stroke, as well as trauma and other inflammatory conditions. MATRICS-1 is an investigator-initiated Phase 1/2 randomized, double-blind, placebo-controlled trial evaluating MultiStem in patients following resuscitation from hemorrhagic trauma that is underway at the University of Texas-Houston and the Memorial Hermann Hospital, the busiest Level 1 Trauma Center in the U.S. Athersys announces that complete enrollment has been reached in the second cohort in which patients were dosed with MultiStem cells manufactured under Athersys' new 3D manufacturing process. This will provide Athersys with safety data for 3D-treated patients and comparability against 2D-treated patients in the first cohort. This trial aims to enroll 156 patients in total, and enrollment in the third and final cohort is expected to begin later in 2023. This trial is being supported in part by MTEC in partnership with the Department of Defense.

09:21 EST NGM Biopharmaceuticals outlines 2023 corporate priorities - NGM Biopharmaceuticals is providing an overview of highlights from 2022 and outlining its 2023 corporate priorities. "In 2022, NGM Bio sharpened its focus on oncology solid-tumor clinical development. We reported promising preliminary data from our first myeloid checkpoint inhibitor program, NGM707, and advanced our additional myeloid checkpoint inhibitor programs, NGM438 and NGM831, into the clinic," said David Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. Dr. Woodhouse continued, "Our strategy in 2023 is to focus our clinical development efforts on our portfolio of four clinical-stage oncology programs while operating our prolific drug discovery engine to generate next-generation biologic therapeutics. For our programs outside this area of focus, in retinal disease and NASH, we will seek development partners with relevant domain expertise. We're committed to developing transformative therapeutics for patients and energized by the opportunities we see in this next chapter of the NGM Bio story." 2023 Strategic Priorities: Oncology: Advance the ongoing Phase 1/2 signal-seeking trial of NGM707 and the ongoing Phase 1 signal-seeking trials of NGM831 and NGM438, all being studied in patients with advanced solid tumors. NASH: Read out topline data from ALPINE 4, the Phase 2b trial of aldafermin in patients with F4 NASH, in Q2 2023. Business Development: Consistent with NGM Bio's business model since inception, business development will remain a key priority to allow the company to focus development and financial resources on oncology clinical development and new molecule generation. NGM Bio will seek partners for the following programs: Aldafermin; NGM621; NGM936

09:20 EST ManTech wins $57M contract from the Navy - ManTech has been awarded a five-year $57 million contract by Naval Surface Warfare Center Crane to develop world-class technology solutions that support advanced expeditionary weapon systems for U.S. Special Operations Command. ManTech won this contract under the Department of Defense Information Analysis Center's multiple-award contrac vehicle. NSWC Crane manages the research, development, prototyping, acquisition, test, evaluation and delivery of expeditionary weapon systems for SOCOM Program Manager-Special Operations Force Lethality.

09:20 EST 4D Molecular announces updates on clinical pipeline - 4D Molecular Therapeutics announced product pipeline portfolio updates and preclinical product candidate additions for its large market ophthalmology and pulmonology programs, as well as clinical data and program updates for its 4D-310 Fabry disease program. Ophthalmology Product Candidate Portfolio: 4D-150 for the Intravitreal Treatment of Patients with Wet Age-Related Macular Degeneration and Patients with Diabetic Macular Edema, DME. Filed IND Application for Phase 2 SPECTRA Clinical Trial with Intravitreal 4D-150 in Patients with DME: 4DMT filed an Investigational New Drug Application for 4D-150 in patients with DME in December 2022, following pre-IND correspondence and alignment with the FDA. expects to initiate enrollment in the third quarter of 2023. Initiated Randomized Phase 2 of PRISM Clinical Trial of Intravitreal 4D-150 in Patients with Wet AMD: This Phase 2 stage of the trial was initiated in January 2023. Expanded Portfolio with Preclinical Product Candidate 4D-175 for Geographic Atrophy: Preclinical development was initiated for a new product candidate designed for single dose intravitreal treatment of patients with GA; the product candidate will utilize 4DMT's proprietary R100 intravitreal vector currently used in the wet AMD and DME programs, and a transgene payload that addresses a complement pathway target. Program Updates on Rare Disease Product Candidates 4D-125 for XLRP and 4D-110 for Choroideremia: Enrollment on the Phase 1/2 clinical trials for 4D-125 and 4D-110 was completed in the fourth quarter of 2022: 14 patients have been treated with 4D-125, and 13 with 4D-110. Anticipates providing program and clinical data updates in 2024. Pulmonology Product Portfolio: 4D-710 for the Aerosol Treatment of Patients with Cystic Fibrosis Lung Disease: Treated First Patient in High Dose Cohort on Phase 1/2 Clinical Trial with Aerosol Delivered 4D-710 in Patients with Cystic Fibrosis Lung Disease that is Not Amenable to Treatment with CFTR Modulator Therapy.

09:19 EST Mitek Systems reports resignation of CFO - In a regulatory filing, Mitek Systems reported that on January 4, Frank Teruel, the Chief Financial Officer, principal financial and accounting officer, of the company tendered his resignation, effective as of February 1, to pursue another career opportunity. "Teruel's resignation was not due to any disagreement with the company on any matter relating to the company's operations, policies or practices," Mitek stated.

09:18 EST Acacia Research CFO Richard Rosenstein to step down - Acacia Research announced that Richard Rosenstein, the company's CFO, will step down from his position, effective at the close of business on January 27, 2023, to pursue another professional opportunity. The board has commenced a search for a new CFO. The process will be supported by an executive search firm.

09:17 EST Baker Hughes appoints Ganesh Ramaswamy as EVP, IET business - Baker Hughesannounced Ganesh Ramaswamy as executive vice president of the Industrial & Energy Technology business segment effective Jan. 16. Ramaswamy's appointment is another step in the Company's strategic transformation - announced in September 2022 - to simplify its operations, enhance profitability, and drive growth in the rapidly evolving energy and industrial markets. Ramaswamy brings more than 25 years of diversified experience across industrial sectors. He most recently served as president of Global Services for Johnson Controls, where he led the multinational conglomerate's transformation in digital services and drove significant year-over-year growth in services and sustainability solutions. Ramaswamy previously held multiple business leadership roles in Danaher, a diversified manufacturer of industrial products and services, as well as holding product and general management roles for multiple international companies. With Ramaswamy's appointment, Rod Christie, EVP of IET, will be moving to a strategic adviser role before departing the Company in the second quarter of 2023.

09:14 EST Diana Shipping announces time charter contract for m/v G. P. Zafirakis - Diana Shipping announced that, through a separate wholly-owned subsidiary, it has entered into a time charter contract with Solebay Shipping Cape Company Limited, Hong Kong, for one of its Capesize dry bulk vessels, the m/v G. P. Zafirakis. The gross charter rate is $17,000 per day, minus a 5% commission paid to third parties, for a period until minimum June 15, 2024 up to maximum August 15, 2024. The charter is expected to commence on January 10, 2023. The "G. P. Zafirakis" is a 179,492 dwt Capesize dry bulk vessel built in 2014. The employment of "G. P. Zafirakis" is anticipated to generate approximately $8.76 million of gross revenue for the minimum scheduled period of the time charter.

09:11 EST LPL Financial: David Dobrusin joins broker-dealer, RIA, custodial platforms - LPL Financial announced that financial advisor David J. Dobrusin has joined LPL Financial's broker-dealer, RIA and custodial platforms. Having served approximately $200 million in advisory, brokerage and retirement plan assets, Dobrusin joins LPL from Cambridge Investment Research. Based in Arizona, Dobrusin is a Certified Public Accountant and Certified Financial Planner, having founded a tax and accounting firm prior to joining the investment industry. Dobrusin brings a practical combination of tax planning and financial management to help clients maximize investment goals and minimize tax liability.

09:10 EST Dominari Holdings purchased 5,000 shares of common stock on January 6 - The company reported that on January 6, the company purchased 5,000 shares of common stock at $3.5081 per share.

09:09 EST Sorrento Therapeutics releases Phase 1b data of OVYDSO - Sorrento Therapeutics released unblinded Phase 1b study data of its oral main viral protease inhibitor, OVYDSO in COVID patients. This Phase 1b safety, PK and efficacy study in healthy volunteers and COVID patients was conducted in China. The study is entitled: "A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Single and Multiple Oral Doses of STI-1558 in Healthy Volunteers and COVID Patients". In the SAD portion of the study, four dose-escalation cohorts were conducted with eight subjects in each cohort - randomized 3:1. In the MAD portion of the study, three dose-escalation cohorts with daily dose of 300 mg BID, 600 mg BID or 800 mg BID for consecutive 7.5 days were conducted with eight participants infected with SARS-CoV-2 in each dose cohort - randomized 3:1, and in the 600 mg BID dose cohort, an additional 16 participants infected with SARS-CoV-2 were added as a cohort extension. The topline safety, PK and efficacy data from the SAD and MAD portions of the study are now available. Overall, STI-1558 was well-tolerated at these doses, with most subjects in both the SAD and MAD portions of the study reporting no AEs. There was no dose limiting toxicity during the study. There were no severe or serious AEs, no premature discontinuations of STI-1558 due to an AE, and no deaths. Most AEs were mild, transient, unrelated and required no medical treatment. A total of 12 subjects reported an AE in the SAD portion of the study, with one AE of elevated blood thyroid-stimulating hormone deemed related to STI-1558 in the 2000 mg cohort. In the MAD portion of the study in COVID-19 patients, 20 subjects from a total of 46 subjects reported AEs, with only four subjects experiencing STI-1558-related events. Antiviral activity was evaluated in the MAD portion of the study in participants infected with SARS-CoV2. The viral RNA load in participants infected with SARS-CoV2 was measured by quantitative PCR. The viral RNA load was significantly reduced in COVID-19 patients treated with STI-1558 on Days 2, 4 and 6 post-treatment in comparison with placebo, indicating the strong antiviral activity of STI-1558 in COVID-19 patients. After communication with the regulatory agency, a Phase 3 protocol was submitted to China NMPA. The Phase 3 trial is entitled: "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy and Safety of STI-1558 for Treatment of Mild and Moderate Symptomatic Adults Infected with SARS-CoV-2". Once cleared by NMPA, the study, which plans to enroll 1200 COVID-19 patients, will be subsequently commenced.

09:07 EST Ionis Pharmaceuticals, Royalty Pharma enter $1.1B royalty agreement - Ionis Pharmaceuticals (IONS) and Royalty Pharma (RPRX) announced that Royalty Pharma has acquired an interest in Ionis' royalty in Biogen's SPINRAZA and Novartis' (NVS) pelacarsen for up to $1.125B, including an upfront payment of $500M and up to $625M in additional pelacarsen milestone payments. Under the terms of the monetization transaction, Royalty Pharma will receive: 25% of Ionis' SPINRAZA royalty payments through 2027, increasing to 45% of royalty payments in 2028, on up to $1.5B in annual sales. Royalty Pharma's royalty interest in SPINRAZA will revert to Ionis after total SPINRAZA royalty payments reach either $475M or $550M, depending on the timing and occurrence of certain events; and 25% of Ionis' pelacarsen royalty payments. Under the terms of Ionis' exclusive licensing agreement with Biogen (BIIB), Ionis is entitled to tiered royalties up to the mid-teens on annual worldwide net sales of SPINRAZA. Ionis' exclusive license agreement with Novartis entitles Ionis to receive tiered royalties in the mid-teens to low 20% range on net sales of pelacarsen. Ionis also retains all rights to $650M in pelacarsen development, regulatory and commercial milestones from Novartis.

09:06 EST Biora Therapeutics announces 2023 anticipated milestones - Key 2023 Milestones: Present the first detailed results from the Targeted Therapeutics program device performance study indicating successful device function when administered with food, which could potentially enable non-fasted administration in patients, at the Crohn's & Colitis Congress on January 19, 2023. File an IND for Targeted Therapeutics PGN-600 and enter the clinic in the first half of 2023. Generate key Targeted Therapeutics PGN-600 data by Q3. Complete Systemic Therapeutics preclinical data generation with the next generation device in Q1 and Q2. Initiate next-phase pharma partnerships for Systemic Therapeutics program in 2023. Biora also remains committed to efficient use of resources by maintaining its target monthly cash burn rate while rapidly progressing development.

09:05 EST Biora Therapeutics remains on track for IND filing for PGN-600 - Biora Therapeutics announced feedback from the United States Food and Drug Administrationon its clinical development plans for its PGN-600 program, and provided program updates. For Biora's Targeted Therapeutics Platform, which is focused on treatment of ulcerative colitis, the company remains on track for an IND filing for its PGN-600 program followed by clinical trial initiation. During Q4 2022, Biora continued its engagement with the FDA with a pre-IND supplemental Type C filing requesting agency feedback on its proposed PGN-600 clinical development plans, including the company's proposed approach to toxicity studies and other aspects of its clinical plan. "The recent Type C response from the FDA further strengthens our confidence in our plans to enter the clinic during the first half of 2023 with IND filing followed by trial initiation in Q2, and data readouts anticipated in Q3," said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. "Based on previous studies, we know that achieving the appropriate concentration of tofacitinib in the tissue of the large intestine is correlated with endoscopic improvement, and we believe that reducing systemic exposure to tofacitinib could be a paradigm shift in the ability to help a substantial percentage of patients. Our planned clinical trial should provide insights on these very important tissue and plasma levels, along with the safety of our approach. With this critical data anticipated during the phase 1 trial, we look forward to progressing a program that could have significant impact on patient care for ulcerative colitis." For Biora's Systemic Therapeutics program, the company has been transitioning from early concept to a clinical-ready device. With several of the key device upgrades implemented, the company expects to report data from preclinical studies on its next-generation device during Q1 and Q2 of 2023.

09:03 EST Eledon to prioritize resources on tegoprubart in kidney transplantation - Eledon Pharmaceuticals announced a business update aimed at maximizing shareholder value by prioritizing resources on its ongoing clinical development efforts in kidney transplantation. Every year more than 24,000 people undergo a kidney transplant in the United States, and over 240,000 Americans are living with a functioning transplanted kidney. Eledon's investigational drug candidate, tegoprubart, seeks to address the challenges associated with current immunosuppressive transplantation regimens, such as those that administer calcineurin inhibitors. The ability to prevent acute and chronic transplant rejection without the need for CNIs has the potential to transform the clinical management of transplantation by mitigating the nephrotoxicity and other side effects associated with CNIs, and potentially increasing the functional life of transplanted organs. Kidney Transplantation: The Company received regulatory clearance to initiate a Phase 1b open-label trial in Canada, the United Kingdom and Australia, for up to twelve patients, evaluating tegoprubart as a replacement for tacrolimus as a component of an immunosuppressive regimen in patients undergoing kidney transplantation. Enrollment is currently ongoing, with three patients dosed in the second half of 2022. The Company received Investigational New Drug application clearance from the U.S. Food and Drug Administration for BESTOW, a Phase 2 trial of tegoprubart for the prevention of transplant rejection in persons receiving a kidney allograft. BESTOW will be a multicenter, open-label, active control, trial to assess the safety and efficacy of tegoprubart compared with tacrolimus in the preservation of allograft function after kidney transplantation. The trial's primary endpoint is mean eGFR at one year post-transplantation. Secondary objectives include safety, incidence of new onset diabetes, biopsy-proven rejection, and graft survival. The trial will enroll approximately 120 participants undergoing kidney transplant and will run in parallel to the ongoing Phase 1b clinical trial of tegoprubart in kidney transplantation. BESTOW includes an open-label extension trial allowing for the collection of long-term efficacy and safety from both this Phase 2 as well as the ongoing Phase 1b trial. The Company announced a collaboration agreement with eGenesis for the use of tegoprubart in preclinical xenotransplantation studies. Anti-CD40L costimulatory blockade has been demonstrated as a key component of effective immunosuppressive regimens to suppress xenograft rejection in non-human primate models of organ transplantation. IgAN: The Company received IND application clearance from the FDA to evaluate tegoprubart for the treatment of IgAN. This global clinical trial is a 96-week open-label clinical trial that may include up to 42 total participants, equally split between an initial high dose and a potential subsequent low dose cohort. Ten patients have been dosed to date in the high dose cohort. Amyotrophic Lateral Sclerosis: In mid-2022, the Company announced positive topline results from a Phase 2a trial of tegoprubart in patients with ALS. Tegoprubart successfully met the primary endpoints of safety and tolerability, with no drug-related serious adverse events. Tegoprubart treatment was associated with dose dependent target engagement and a reduction in pro-inflammatory biomarkers in circulation. The Company continues to work closely with key stakeholders on potential next steps, as well as evaluating a range of approaches to fund a potential future trial. Anticipated 2023 Milestones: 1Q 2023: initial three and six-month open-label data from the Phase 1b trial of tegoprubart in kidney transplantation. 1Q 2023: initial open-label safety data from the Phase 2a trial of tegoprubart in IgAN. Mid-2023: initiate Phase 2 BESTOW trial of tegoprubart in kidney transplantation. 2H 2023: complete enrollment in Phase 1b trial of tegoprubart in kidney transplantation.

09:02 EST Novavax names John Jacobs as new CEO, succeeding Stanley Erck - Novavax (NVAX) announced that John Jacobs will succeed Stanley Erck as President and CEO and a member of the Board of Directors. The transition will be effective as of January 23. Erck will serve as an advisor to the company for the next fifteen months to enable a smooth transition. Jacobs brings more than 25 years of commercial, operations, business and leadership experience across multiple therapeutic areas. He will join Novavax from Harmony Biosciences (HRMY), where he has served as President and CEO and a member of the Board of Directors since June 2018, and Executive Vice President and Chief Commercial Officer from October 2017 to June 2018.

09:00 EST Omniq awarded multi-year supply contract from Clalit - omniQ announced its subsidiary Dangot Computers Ltd, has received a multi-year, supply and maintenance contract from Clalit. The kiosks will be utilized in 14 Hospitals and 2,000 plus clinics serving over 50% of the Israeli population. Estimated value of the contract is $3M.

08:59 EST Medigus says Eventer signs agreement for reverse merger to become public - Medigus announced that its 46.21% owned subsidiary, Eventer Technologies signed a definitive agreement for a planned securities exchange with AI Conversation Systems. According to the Agreement, Eventer will become a wholly owned subsidiary of AI Conversation Systems, and in exchange, Eventer shareholders will receive 74.99% of the issued and outstanding share capital of AI Conversation Systems. The securities exchange agreement will be subject to certain closing conditions, including the completion of mutual due diligence; Eventer having at least $700,000 in cash; AI Conversation Systems accruing no debt; and other customary closing conditions. The transaction will only be completed if Eventer is valued at a minimum of $5.7 million, as determined by an independent appraiser.

08:54 EST Agilent invests $725M for manufacturing of therapeutic nucleic acids - Agilent Technologies announced it is investing approximately $725M to double manufacturing capacity of therapeutic nucleic acids in response to rapid growth of the $1B market and strong demand for the company's high-quality active pharmaceutical ingredients. Therapeutic nucleic acids, also called therapeutic oligonucleotides or oligos, are short DNA and RNA molecules that serve as the API for drugs targeting a growing number of diseases, including cancer, cardiovascular disease, and rare and infectious diseases. "This investment reflects not only the strong demand for therapeutic oligos, but also for the unmatched quality and service of our therapeutic oligo contract development and manufacturing organization " said Mike McMullen, Agilent president and CEO. "It's yet another example of our focus on investing in high-growth markets while also delivering on Agilent's mission of improving the quality of life."

08:52 EST Sema4 Holdings announces name change to GeneDx - Sema4 announced it has changed its name from Sema4 Holdings Corp. to GeneDx Holdings Corp. GeneDx, a leader in delivering improved health outcomes through genomic and clinical insights, is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx's industry-leading exome and genome testing is enhanced by Centrellis, its innovative health information platform. Powered by one of the world's largest rare-disease datasets and millions of medical records, Centrellis integrates digital tools with artificial intelligence to ingest and synthesize clinical and genomic data. GeneDx is developing a more complete understanding of complex disease than ever before, which translates to faster diagnoses, more effective treatment plans and enhanced drug discovery. "For more than 20 years, GeneDx has earned the constant trust of the world's genetics experts, while pioneering and increasing the use of its clinically actionable exome and genome analysis. By combining the best of GeneDx and Sema4 to continue our growth, we sit at the intersection of diagnostics and data science, pairing decades of genomic interpretation expertise with an unmatched ability to analyze clinical data at scale. GeneDx now has the capability to combine the power of genomic insights with clinical data to improve health care for people and populations," said Katherine Stueland, President and CEO of GeneDx. In conjunction with the name change, GeneDx's shares of Class A common stock will trade under the new ticker symbol "WGS," in recognition of the Company's role in pioneering whole genome sequencing. The company expects its shares of Class A common stock will begin trading on the NASDAQ Stock Market under the new name and stock ticker symbol on January 10, 2023.

08:51 EST Centogene, Denali extend observational study on Parkinson's disease genetics - Centogene (CNTG) announced that it has extended the Rostock International Parkinson's Disease, ROPAD, Study to recruit and genetically test additional patients over the next few years. Based on initial findings of the more than 12,500 participants already recruited and genetically tested, the study will now focus its efforts on 48 sites across 10 countries, consisting of Argentina, Belgium, Brazil, Germany, Israel, Italy, Portugal, Spain, the U.K., and the U.S. In 2018, CENTOGENE entered a strategic collaboration with Denali Therapeutics (DNLI) for the targeted global identification of PD patients with genetic variations in the LRRK2 gene. The LRRK2 gene is one of the most common mutated genes in familial PD. Patients enrolled in ROPAD and identified with LRRK2 genetic variations may be eligible for participation in ongoing interventional clinical studies. CENTOGENE conducts clinical studies with pharma partners around the world, such as Denali Therapeutics. "Parkinson's disease is a devastating neurodegenerative disease - affecting over 10 million people worldwide from all walks of life. There is an urgent medical need to unveil multidimensional data," said Kim Stratton, Chief Executive Officer at CENTOGENE. "At CENTOGENE, we find it truly essential to establish a more inclusive and comprehensive approach from diagnostics to drug discovery, development, and commercialization. By extending this study alongside Denali, we are generating multi-ethnic insights into the genetic causes - accelerating potentially disease-modifying therapeutics for PD patients around the world."

08:49 EST iRhythm shares preliminary Q4 highlights, business update - Preliminary Fourth Quarter 2022 Operational Highlights: Patient registration growth of more than 20% compared to the fourth quarter 2021; Sequential improvement in Zio XT returned device rate; Record new account openings for Zio XT in the United States; CMS Medicare Physician Fee Schedule Final Rule for Calendar Year 2023 released, which contained national rates for CPT codes that iRhythm uses to seek reimbursement for its Zio XT service. "Despite challenges during 2022, we have made significant progress to advance our mission while investing in strategic and operational initiatives to set the Company up to best realize expected strong growth in the years to come," said Quentin Blackford, iRhythm's President and CEO. "We made nice progress in the fourth quarter addressing the near-term challenges that we had realized exiting the third quarter. Strong momentum in patient registrations continued, growing in excess of 20% in the fourth quarter and in line with expectations. We also made good progress with returned devices rates, which are trending back towards historical levels, and we made the necessary updates to our Zio AT Clinical Reference Manual and Important Information pamphlet. For the second time in the last three quarters, we realized another record quarter of new account openings for Zio XT, demonstrating the continued strong demand of our Zio product platform. Finally, we are proud of our teams working collaboratively to finalize a CMS national rate which positions us well to focus on further market penetration and providing our technology to all patients who may benefit. As we enter 2023, we are poised to continue executing upon our strategic initiatives to position the Company to drive sustainable growth for years to come. We are excited by the progress we are making to open the primary care channel, recently establishing relationships with some of the most significant players in the space within the United States. Further, we are excited by the upcoming product launch of our next-generation biosensor platform and believe that efforts underway will yield additional high-quality clinical and economic data to support Zio's value proposition with iRhythm's customers and payers."

08:48 EST Atreca appoints Philippe Bishop as Chief Medical Officer - Atreca announced the appointment of Philippe Bishop, MD, as Chief Medical Officer, or CMO, effective immediately. Dr. Bishop joins Atreca from Clover Biopharmaceuticals, a biotech company focused on the development of vaccines and biologics, where he served as CMO. "I believe that ATRC-101 has generated compelling data in the ongoing clinical study, validating the ability of Atreca's discovery platform to identify active tumor targeting antibodies. I'm excited to join a highly talented and dedicated team as we continue to develop ATRC-101 and begin to advance additional novel antibodies into the clinic.," said Dr. Bishop.

08:47 EST Rani Therapeutics, Celltrion partner for development of RT-111 - Rani Therapeutics announced that it has partnered with Celltrion for the development of RT-111, an orally administered ustekinumab biosimilar. Under a license and supply agreement, Celltrion will exclusively supply to Rani the ustekinumab biosimilar drug substance required for RT-111. Rani is granted an exclusive license to use CT-P43 in the development and commercialization of RT-111, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-111 following a Phase 1 clinical trial. Rani has developed an oral delivery technology known as the RaniPill capsule, which is intended to replace subcutaneous or intravenous injection of biologics and drugs with oral dosing. The RaniPill capsule is designed to administer biologics and drugs with bioavailability comparable to subcutaneous injection. "We are delighted to be partnering with Celltrion, a leader in biosimilars and biologics manufacturing, on RT-111. This agreement is a validation of our RaniPill oral drug delivery technology, which has already performed well in two separate Phase 1 trials of RT-101 and RT-102, respectively," said Talat Imran, CEO of Rani. "We value Celltrion as the exclusive provider of ustekinumab biosimilar for our RT-111 program and look forward to sharing the results of our study in due course, and potentially broadening our partnership with Celltrion."

08:45 EST Independent Bank appoints Jeffrey Tengel CEO - Rockland Trust Company and its bank holding company parent Independent Bank announced the appointment of Jeffrey Tengel as the successor to current Chief Executive Officer, Christopher Oddleifson, effective on or about February 6 . Jeffrey J. Tengel Oddleifson has served as the Bank's CEO since 2003. Under his leadership, Rockland Trust has grown total assets from just over $2B to nearly $20B and expanded from its southeastern Massachusetts roots to a bank with over 120 retail branches, commercial and residential lending centers, and investment management offices.

08:44 EST ToughBuilt announces 2022 Amazon sales $15.91M - ToughBuilt Industries announced that gross global Amazon sales for 2022 through Amazon.com were approximately $15.91 million. This represents an approximate 25% increase from 11.87 million in Amazon sales in 2021. Throughout 2022, ToughBuilt introduced sales to new Amazon portals around the globe, including Brazil, France, Germany, Italy, Spain, and the United Kingdom, while continuing to foster sales in leading regional channels such as the United States and Canada. Michael Panosian, ToughBuilt's Chief Executive Officer, and Chairman, commented, "Our growth and brand expansion through Amazon sales remains a driver of ToughBuilt's success. As we continue expanding into new international marketplaces and introducing ToughBuilt products to new regions through, we believe our global online sales will contribute to overall long-term revenue growth. We look forward to extending and further diversifying our reach to promote new opportunities for continued revenue success."

08:42 EST SeaStar Medical submits IDE application to FDA to study SCD - SeaStar Medical has submitted an investigational device exemption application to the U.S. Food and Drug Administration requesting approval to initiate a pivotal study to evaluate the effectiveness of the Company's Selective Cytopheretic Device in reducing hyperinflammation in adults with acute kidney injury requiring continuous kidney replacement therapy. The randomized, controlled study is expected to enroll 200 subjects, with a primary endpoint of a composite of 90-day mortality and dialysis dependency of SCD patients compared to the control group. Details of the study design will be provided upon IDE approval by the FDA. The study is anticipated to begin in the first quarter of 2023 with interim results expected in the fourth quarter of 2023 and topline results and submission for Pre-market Approval in the third quarter of 2024.

08:39 EST AIM broadens patent portfolio with new Netherlands utility patent on Ampligen - AIM ImmunoTech announced that the Netherlands Patent Office has granted a utility patent covering rugged dsRNA, a double-stranded RNA product related to Ampligen, which claims cover, among other aspects, compositions and compositions for use in the prevention or treatment of COVID-19. The new patent broadens AIM's existing portfolio for COVID-19 treatments to include rugged dsRNA. Ampligen is AIM's RNA product candidate designed to modulate the immune system. Data from in vitro, pre-clinical and clinical experiments strongly suggest that Ampligen has a broad-spectrum early-onset antiviral effect by stimulating a powerful innate immune response. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication.

08:38 EST Anebulo Pharmaceuticals completes dosing in ANEB-001 study for ACI treatment - Anebulo Pharmaceuticals announced completion of dosing in its randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating ANEB-001 as a potential treatment for ACI in healthy subjects challenged with oral THC...Based on preliminary pharmacodynamic data for Part B of the study, a single low oral dose of ANEB-001 administered 1 hour after THC appeared to rapidly reverse key psychotropic effects of THC doses as high as 30 mg, including reduction in feeling high and improvement in alertness and body sway. ANEB-001 also appeared to reduce the time required for effects to normalize back to baseline. Only 5 subjects were challenged with 40 mg THC due to poor THC tolerability. Final analyses await the unblinded data expected by end of 1Q2023. "Completing the dosing in this Phase 2 trial represents an important milestone for the company. Preliminary data showed that a single 10 mg dose of ANEB-001 reduced key symptoms of ACI induced with 30 mg of THC," said Simon Allen, Chief Executive Officer of Anebulo. "Further, we successfully demonstrated rapid reversal of key ACI symptoms even after a one-hour delay between the THC challenge and ANEB-001 dosing. We believe the final data from this study, together with data from our planned observational study in ACI subjects, will provide support for the design of a registrational trial. We anticipate discussing the final data from this study with FDA at an End of Phase 2A meeting in the first half of this year."

08:36 EST Progyny to discuss expectations for quarter, year at conference - Progyny announced that the Company is participating in the 41st Annual JP Morgan Healthcare Conference, where it expects to discuss its expectations for the quarter and year ended December 31, 2022. "We're extremely pleased to see 2022 concluding on a strong note, with healthy utilization across our book of business, including those clients who launched their Progyny benefit in the latter part of the year. Accordingly, we now expect that our fourth quarter and full year 2022 revenue, net income and Adjusted EBITDA will be at or near the high-end of the financial guidance that we provided in our press release on November 28, 2022. In addition, we also expect to report record fourth quarter operating cash flow of approximately $50 million, or approximately $79 million for the full year, reflecting the high capital efficiency in our model," said Pete Anevski, Progyny's Chief Executive Officer. "As we look into 2023, substantially all of the new clients and covered lives that we expect for this year have now already launched, and we continue to expect that our more than 370 clients will reflect 5.4 million covered lives. We also expect that our 2023 selling season activities will begin, as usual, around March, but the early activity we're seeing from prospective clients is very encouraging and maintains our momentum from the 2022 season, where we won a record number of new clients and more than a quarter of our existing clients made the decision to expand their relationship with Progyny, even against the backdrop of the current macroeconomic environment. Taken together, we believe this reinforces our strong conviction that family building benefits continue to be a top priority for employers in 2023, and that Progyny is the brand of choice for employers looking to provide these benefits."

08:35 EST Denali Therapeutics announces 2023 milestones - Denali Therapeutics announced program progress and expected milestones for 2023, which Chief Executive Officer, Ryan Watts, Ph.D., will highlight during a corporate presentation at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10th, at 10:30 a.m. Pacific Time. "We are excited to kick off 2023 with a broad and diversified therapeutic portfolio of seven programs in clinical development, anticipated progression and expansion of our TV blood-brain barrier platform technology, and a highly productive discovery organization working to capture and translate the potential of new scientific insights in neurodegeneration biology," said Dr. Watts. "With four programs expected to be in late-stage development this year, we continue to build commercial capabilities and expand our global footprint to ultimately deliver effective medicines to people living with neurodegenerative and lysosomal storage diseases." Denali's therapeutic portfolio includes small molecules designed to cross the BBB and biotherapeutics that are enabled to cross the BBB using Denali's TV technology.

08:35 EST Selecta Biosciences provides 2023 anticipated milestones - Selecta Biosciences provided a corporate update, including its roadmap for 2023. Key 2023 Anticipated Milestones: Report top-line data from Phase 3 DISSOLVE I & II programs of SEL-212 in chronic refractory gout in Q1 2023; Preliminary Phase 1 SEL-302 data in gene therapy for MMA; Initiate IND enabling studies with the selected IL-2 candidate to further advance and expand the immune tolerance platform in autoimmune disease; Begin IND enabling studies with the selected IgA protease candidate from IGAN Biosciences. "In 2022, we delivered on key milestones that further validated the value and breadth of our innovative ImmTOR and ImmTOR-IL immune tolerance platforms, continued to advance our diversified clinical pipeline and established strategic collaborations that will propel our next-generation programs toward multiple IND filings," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. "Building on the momentum of our recently announced deal with Astellas Gene Therapies' for Xork in Pompe disease, the initiation of the Phase 1/2 trial in methylmalonic acidemia, the identification of an IL-2 candidate and selection of an IgA protease candidate, we also expect joint topline data from the Phase 3 DISSOLVE clinical program investigating SEL-212 in chronic refractory gout in Q1 2023. We are at a pivotal moment in the Company's growth trajectory and as we look ahead, we believe we are well positioned to take a potentially generational leap forward for our precision immune tolerance platform, advance our pipeline in autoimmune disease and continue to explore additional collaborations to maximize the value of our ImmTOR platform and pipeline."

08:34 EST Capstone Green Energy receives new orders - Capstone Green Energy announced that E-quad Power Systems GmbH, Capstone's long-time distributor for Belgium, Denmark, Germany, and the Netherlands, has secured two new orders. The first is an order for a C200S microturbine-based combined heat and power system for a leading textile finishing company. The second order is for four 65kW high-pressure natural gas , dual mode , high humidity offshore systems for an offshore gas production company with assets in the North Sea that is a loyal Capstone customer. The C200S microturbine-based CHP system is for leading textile finishing company Gerhard van Clewe GmbH & Co.KG, based in Hamminkeln, Germany. The system is expected to be commissioned in May 2023 and will be fueled by high-pressure natural gas. The C200S will provide up to 200kW of electricity to the plant, while the exhaust produced by the microturbine will be captured for use in the material drying process as well as the production of warm water for the facility. The company first considered microturbine technology due to rising electricity costs compared to the low cost of natural gas. As a company with a sustainability mission, they also valued the high efficiency and emissions reduction that a CHP system delivers. "Between the cost savings and environmental benefits, we are especially excited to be a development partner in this first-of-its-kind application," said Ansgar van Clewe, Principle at Gerhard van Clewe. "Given the technology's ready availability and Capstone's good reputation in the space, we felt comfortable working with their distributor E-quad Power Systems."

08:34 EST Denny's backs Q4 SSS outlook of up 1%-3% - Backs Q4 adjusted EBITDA view of $21M-$23M. Kelli Valade, CEO, stated, "We were pleased to conclude 2022 with another solid quarter of same-restaurant** sales performance in a challenging environment. We remain focused on increasing staffing levels, extending operating hours, and upholding our commitment to everyday value in the near-term while we move forward with exciting revitalization strategies to further propel our business into the future."

08:34 EST Calithera Biosciences announces board approval for liquidation, dissolution - Calithera Biosciences announced that its Board of Directors has determined, after extensive consideration of potential strategic alternatives, that it is in the best interests of its shareholders to dissolve the Company and liquidate its assets, following an orderly wind down of the company's operations. In order to reduce costs and in connection with the planned dissolution, Calithera is discontinuing all clinical development programs and reducing its workforce, including the termination of most employees by the end of the first quarter. The Board of Directors has unanimously approved the dissolution and liquidation of the Company, subject to shareholder approval, pursuant to a Plan of Complete Liquidation and Dissolution. The Company intends to call a special meeting of its shareholders in the first calendar quarter of 2023 to seek approval of the Plan of Dissolution and will file proxy materials relating to the special meeting with the Securities and Exchange Commission as soon as practical. The Plan of Dissolution contemplates an orderly wind down of the Company's business and operations. If the Company's shareholders approve the Plan of Dissolution, the Company intends to file a certificate of dissolution, delist its shares of common stock from The Nasdaq Global Select Market, satisfy or resolve its remaining liabilities and obligations, including but not limited to contingent liabilities and claims and costs associated with the dissolution and liquidation, make reasonable provisions for unknown claims and liabilities, and attempt to convert all of its remaining assets into cash or cash equivalents. Upon the filing of the certificate of dissolution, the Company intends to cease trading in its common stock, close its stock transfer books and discontinue recording transfers of shares of its capital stock, in accordance with applicable law. The Company will establish a reserve, which will be used to pay all expenses and other known, non-contingent liabilities and obligations, and will include reasonable provision for future expenses of liquidation and contingent and unknown liabilities as required by Delaware law. The Company currently expects that its existing capital resources together with the anticipated net proceeds from the sale of certain clinical assets will enable it to meet its remaining liabilities and obligations with sufficient reserves. However, in light of the liquidation preference held by the holder of its Series A convertible preferred stock, even if all of the Company's assets are converted to cash or cash equivalents, the Company does not anticipate that the liquidation preference will be satisfied and therefore no liquidating distributions are expected to be made to the holders of its common stock. The Company will provide an estimate of any such amount that may be distributed to the holder of its Series A convertible preferred stock in the proxy materials to be filed with the SEC. The amount actually distributable, however, may vary substantially from any estimate provided by the Company based on a number of factors.

08:32 EST Ballard Power names Mark Biznek as COO, effective immediately - Ballard Power Systems announced the appointment of Mark Biznek, MEng, as COO, effective immediately. During the past 10 years, Mark served in various leadership roles for Kohler Power Systems, including as General Manager of Marine & Power Solutions, as Vice President of Global Operations & Supply Chain, and as Vice President of Operations & Engine Development.

08:31 EST Surge Copper completes assay results for 3 holes at Ootsa property - Surge Copper announced complete assay results for 3 holes from the Company's 100% owned Ootsa Property in British Columbia. Included are results from one hole testing a regional exploration target and two holes drilled along the northern margins of the Seel Breccia East zone where the Company is expanding high-grade breccia-style mineralization. These two holes encountered greater than 100 metre intervals of copper-gold porphyry-style mineralization within the upper portions of the holes, coincident with IP chargeability and resistivity anomalies which extend to the north and at depth. These results open a new exploration target for near-surface copper-gold porphyry mineralization similar to the East Seel deposit. Highlights: 2022 drilling has intersected near-surface copper-gold porphyry-style mineralization immediately north of the new Seel Breccia East zone; Hole S22-330 returned 100 metres grading 0.42% copper equivalent from 40 metres depth opening up expansion potential to the north: Induced polarization geophysical data show a 200 by 400 metre zone immediately north of Hole S22-330 with good discovery potential; Results for 27 drill holes from the Ootsa & Berg regional exploration program are pending. Leif Nilsson, Chief Executive Officer, commented: "These results are significant for two reasons. Firstly, the copper-gold porphyry intervals were seen in the upper portions of holes angled to the southeast, and combined with the interpretation of geophysical data in the area, suggests these holes may have just grazed the margins of a much larger area extending to the north which looks prospective for this type of mineralization. Secondly, the East Seel portion of the Seel deposit contains some of the nearest-to-surface, highest-grade material at Ootsa, with simple metallurgy nearly devoid of molybdenum; any opportunity to build tonnage with these types of characteristics would likely translate into material that would be sequenced early on in any future mining scenario."

08:29 EST Krystal Biotech announces FDA 3-month extension of BLA PDUFA date - Krystal Biotech announced that on January 5, 2023, the U.S. Food and Drug Administration notified the Company that based on manufacturing information submitted to the Agency on December 20, 2022, in response to an information request, the PDUFA date has been revised to May 19, 2023, and proposed labeling discussions to no later than April 20, 2023. The manufacturing information submitted by the Company included additional information about a replaced hardware unit in the concentration step of the manufacturing process and comparability data supporting the use of the unit. The unit did not affect processing parameters or product contact materials. The FDA considered this new information as a major amendment to the application that will require additional time for review. The BLA late-cycle review meeting was completed on December 15, 2022. During this meeting, the FDA indicated that there will be no Advisory Committee meeting for B-VEC and a Risk Evaluation and Mitigation Strategies program is not needed for the B-VEC application. All pre-approval inspections of clinical sites and internal manufacturing and testing facilities have been successfully completed."While we are disappointed that this change was viewed as a major amendment, we are committed to working with the FDA as it completes its review of the B-VEC application," said Krish S. Krishnan, Chairman & CEO at Krystal Biotech. "We will continue our commercial readiness efforts and upon approval bring this important treatment to DEB patients as soon as possible." The Company submitted the B-VEC BLA to the FDA in June 2022. The FDA accepted the BLA in August 2022 and granted Priority Review.

08:27 EST Achieve Life Sciences announces last subject dosed in Phase 3 ORCA-3 trial - Achieve Life Sciences announced that the final subject of the Company's Phase 3 ORCA-3 trial has completed treatment in the study. Similar to the previously reported ORCA-2 trial, ORCA-3 is evaluating the smoking cessation efficacy, safety, and tolerability of 3 mg cytisinicline dosed three times daily for either 6 or 12 weeks compared with placebo. "With the milestone achieved of last ORCA-3 subject completing study treatment, we are pleased to remain on schedule for announcing data results as expected in the second quarter," stated John Bencich, Chief Executive Officer of Achieve. "It will be a busy and exciting year ahead with the completion of both ORCA-3 and ORCA-V1, evaluating cytisinicline for e-cigarette cessation, and the preparation for FDA filing in the U.S., which is already underway." The ORCA-3 trial randomized 792 subjects in total across 20 clinical trial locations in the United States. Participants are being monitored through 24 weeks post randomization and will receive standard behavioral support for the duration of the trial. The ORCA-3 primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment.

08:26 EST SAB Biotherapeutics CMO to present on biologics in immunology - SAB Biotherapeutics announced that Alexandra Kropotova, MD, Executive Vice President and Chief Medical Officer, will deliver a presentation at the Biotech Showcase in San Francisco on Tuesday, Jan. 10 at 2:30 p.m. PST. Dr. Kropotova's presentation, titled: Next Generation Biologics in Immunology: Solution for Complex Diseases, will discuss the latest innovations and treatment pathways in immunology, including an overview of SAB's novel DiversitAb platform. DiversitAb is the only platform in the world that produces fully-human, broadly neutralizing, polyclonal antibodies utilizing transchromosomic cows. Dr. Kropotova will also present data from completed clinical trials that indicate SAB's polyclonal antibody therapies can provide long-lasting efficacy against numerous highly mutating pathogens or multiple targets or pathways at once.

08:25 EST Infinera, Beyond Technology partner to deploy multi-terabit network - Beyond Technology and Infinera successfully deployed a 3.6-terabit network for a leading Middle East network operator to support the upsurge in global and local demand for the 2022 FIFA World Cup. Leveraging Infinera's industry-leading ICE6 800G technology and installed in record time ahead of the world's largest sports tournament in support of one of the world's largest streaming platforms, the deployment ensured fast, seamless, high-quality, and nonstop connectivity for sports fans globally.

08:24 EST Sensus Healthcare announces senior managment appointments - Sensus Healthcare is pleased to announce the following promotions and appointments to its management team: Maggie Martinez has been promoted to Chief Operating Officer; Emiliano Sosa has been promoted to Chief Technical Officer; Stephanie Tipton has been promoted to Vice President of Marketing; Sean Delaney has been appointed Vice President of Regulatory and Quality Assurance; Wayne Lura has been appointed Vice President of Aesthetic Sales; Ms. Martinez joined Sensus nine years ago and subsequently held positions of increasing responsibility. Most recently she served as Vice President of Operations, and in her new role as COO she will be responsible for all aspects of customer support and satisfaction, vendor relations, intra-company communication and processes.

08:22 EST Five Below up 3% at $181.51 after guiding FY22 near high end of prior range

08:21 EST Xtant appoints Mark Schallenberger as COO - Xtant Medical Holding announced the appointment of Mark Schallenberger as Chief Operations Officer, effective January 16, 2023. Schallenberger has more than 12 years of orthobiologics experience focused on product development and scientific affairs, having most recently served as Chief Operations Officer at Surgenex, a medical technology manufacturer, since June 2019.

08:19 EST Global Crossing Airlines announces Glen Gates as VP, A321 Freighter Programs - Global Crossing Airlines Group is pleased to announce the appointment of Mr. Glen Gates as Vice President - A321 Freighter Programs. Mr. Gates brings over 38 years of creating and managing profitable freighter revenue programs.

08:18 EST Quantum-Si, Biovista team to provide AI-driven deep proteomic insights - Quantum-Si Incorporated announced that it entered into a partnership and license agreement with Biovista to provide customers greater proteomic insights beyond their protein sequence output. Biovista leverages AI in multiple formats to analyze massive data repositories and visualize non-obvious networks and associations between proteins, diseases, and drug mechanisms-of-action. The partnership enhances Quantium-Si's offering by making proteomic-to-drug workflows more efficient for researchers.

08:17 EST TFF Pharmaceuticals names Zamaneh Mikhak as chief medical officer - TFF Pharmaceuticals announced the appointment of Zamaneh Mikhak, M.D. as Chief Medical Officer. Mikhak will be responsible for the clinical development of the company's pipeline candidates, including the Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder clinical programs. "We are pleased to welcome Dr. Mikhak to TFF Pharmaceuticals as our Chief Medical Officer," said Dr. Harlan Weisman, Interim CEO of TFF Pharmaceuticals. "Dr. Mikhak brings to TFF an extraordinary depth of industry and clinical experience that will be instrumental in helping us advance our clinical-stage pipeline candidates and expand our pipeline. This appointment also signals the natural evolution of our Company, as we seek to further expand the clinical applications of Thin Film Freezing to help realize the full potential of our technology platform." Mikhak most recently served as Senior Vice President, Head of Clinical Development for Cogent Biosciences.

08:17 EST Centogene, Premier Research announce strategic partnership - Premier Research and Centogene have announced a strategic partnership to provide end-to-end support in rare disease clinical trials. The collaboration aims to improve patient identification, stratification, recruitment, and enrollment, thereby increasing the likelihood of study success.

08:16 EST Relmada Therapeutics names Cedric O'Gorman MD as Chief Medical Officer - Relmada Therapeutics announced the appointment of Cedric O'Gorman MD as the company's Chief Medical Officer. Dr. O'Gorman will lead medical, clinical and regulatory functions in support of the company's late-stage REL-1017 development program. Dr. O'Gorman brings to Relmada more than two decades of life sciences experience in clinical development, medical affairs and medical strategy, with significant expertise in the CNS therapeutics field. Most recently, he served as Chief Medical Officer at Alpha Cognition, where he led clinical development programs for the company's Alzheimer's disease targets.

08:15 EST Apptio acquires Cloudwiry, terms not disclosed - Apptio announced that it has acquired Cloudwiry, a multi-cloud savings automation and FinOps company. Founded in 2016, Cloudwiry automates commitment management and optimization on behalf of its enterprise customers, maximizing savings, reducing risk, and increasing flexibility. This transaction closed on December 22, 2022. Cloudwiry will no longer operate as an independent company but will now be integrated into Apptio.

08:13 EST Biomea Fusion highlights 2023 corporate milestones - ONCOLOGY: COVALENT-101: Presented robust anti-tumor activity of covalent menin small molecule inhibitor, BMF-219, as a single agent and mechanistic evidence for novel inhibition of the menin protein in preclinical models of diffuse large B-cell lymphoma, multiple myeloma, and chronic lymphocytic leukemia. BMF-219 displayed single agent potency, surpassing greater than 90% cell killing at clinically relevant exposures in DLBCL, MM and CLL cell lines and patient-derived samples. BMF-219 is the first investigational menin inhibitor in clinical development to show potential as a therapeutic agent in hematologic malignancies outside of MLLr and NPM1 mutated acute myeloid leukemia/acute lymphoblastic leukemia patients, specifically in subsets of DLBCL, MM and CLL patients. Biomea continued site activation and patient enrollment for the dosing of BMF-219 across four liquid tumor cohorts in the COVALENT-101 study, including patients with AML/ALL, DLBCL, MM and CLL. Next Anticipated Milestone: On track to present initial clinical data of AML/ALL patients dosed in the COVALENT-101 study in the first half of 2023. COVALENT-102: Presented strong and highly specific pan-KRAS anti-cancer activity of BMF-219 as a single agent across KRAS G12C, G12D, G12V and G13D mutant cell lines including in non-small cell lung cancer, colorectal cancer and the most prevalent type of pancreatic cancer, PDAC. BMF-219 is the first investigational menin inhibitor in development to enter clinical trials for the treatment of solid tumors. A targeted pan-KRAS inhibitor could have the potential to treat 25-35% of NSCLC, 35-45% of CRC, and approximately 90% of PDAC patients. Biomea received FDA clearance of its IND in the fourth quarter of 2022 and has since initiated a Phase I/Ib clinical trial of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic NSCLC, CRC or PDAC with an activating KRAS mutation. Next Anticipated Milestone: On track to dose first patient in COVALENT-102 study in January 2023. COVALENT-103: Presented data showing multi-fold higher potency and increased cytotoxicity of Biomea's covalent FLT3 small-molecule inhibitor BMF-500 compared to the commercially available reversible, non-covalent FLT3 inhibitor gilteritinib, and complete, sustained tumor regression in mouse models of FLT3-ITD AML with maintenance of effect after cessation of therapy. Next Anticipated Milestone:On track to file IND for BMF-500 in the first half of 2023 to initiate COVALENT-103 study of the covalent FLT3 inhibitor in patients with acute leukemia. DIABETES; COVALENT-111: Presented preclinical data highlighting the ability of BMF-219 in a Type 2 diabetes rat model to restore normal HOMA-B, a measure of pancreatic beta cell function, following only 4-weeks of treatment and to significantly lower HbA1c compared to active control, liraglutide, -3.5% vs -1.7%, respectively. BMF-219 is the first investigational menin inhibitor in development to enter clinical trials for the improvement of glycemic control and insulin sensitivity in Type 2 diabetes patients. Biomea completed the healthy volunteer portion of the Phase I/II COVALENT-111 study of BMF-219 in Canada. BMF-219 was well tolerated with an encouraging pharmacokinetic and pharmacodynamic profile in healthy volunteers and with no safety signals detected.Biomea received FDA clearance in December 2022 to expand the Phase II portion of COVALENT-111 to sites in the U.S. and in January 2023 announced dosing of the first U.S. patient with Type 2 diabetes. The company continues to enroll Type 2 diabetes patients in the Phase II portion of the study in Canada as well. Next Anticipated Milestones: On track to present initial clinical data from the first two cohorts of the Phase II portion of the study by the end of Q1 2023, and to present details of the healthy volunteer portion of the study at a scientific medical meeting in 2023. FUSION SYSTEM DISCOVERY PLATFORM: Developed two covalently binding small molecules, each within 18 months from target identification to IND candidate, leveraging the proprietary FUSION System Discovery Platform and showing excellent preclinical profiles. Next Anticipated Milestone: On track to announce a third development candidate from the FUSION platform in the first half of 2023.

08:12 EST Anebulo Pharmaceuticals completes dosing in ANEB-001 trial - Anebulo Pharmaceuticals announced completion of dosing in its randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating ANEB-001 as a potential treatment for ACI in healthy subjects challenged with oral THC. Part B of the Phase 2 trial was an adaptive design that included six cohorts of up to 15 healthy adults to examine different doses of THC and ANEB-001, and the impact of delayed dosing of ANEB-001 or placebo. In total, Parts A and B of the Phase 2 study enrolled 134 healthy subjects.

08:10 EST authID deploys verified Human Factor Authentication service with Tax Status - authID announced that Tax Status has launched the full suite of authID's identity authentication services. Tax Status implemented authID's Human Factor Authentication services, HFA, to help its enterprise partners in wealth management, lending, accounting, and other financial service providers protect highly sensitive tax data, defend against password compromise, and seamlessly secure account onboarding of their consumers. authID's HFA secures customer journeys with strong identity and document authentication that weeds out fraud during online customer onboarding. HFA also eliminates the risks and costs of passwords with strong FIDO2 passwordless authentication that offers seamless login across any mobile or desktop device. "Consumers who provide highly sensitive personal data to third parties deserve an identity solution that preserves their privacy and keeps their information completely secure from fraud and theft," said authID CEO Tom Thimot. "Our next-gen Verified platform, which prioritizes ethical, consent-based biometrics, provides Tax Status and their clients with a comprehensive fraud prevention solution and 'unphishable' authentication that is more secure than legacy MFA. We are proud to support Tax Status in its efforts to protect U.S. taxpayers from cybercrime, and to further empower a financial system that prioritizes data privacy and consent in identity authentication."

08:10 EST Voip-Pal.com says received favorable claim in patent case against Samsung - VoIP-Pal.com announced the Company has received a favorable result in the Claim Construction Hearing that was held on January 4, 2023, in the U.S. District Court for the Western District of Texas in VoIP-Pal's cases versus Samsung Electronics Co., Ltd et al 6:21-cv-01246-ADA-JTG. Judge Derek T. Gilliland adopted VoIP-Pal's proposed constructions, either partially or in their entirety, for all of the terms in dispute in the litigation. The Court's order has been posted on the Company's website www.voip-pal.com and can be accessed here. The Court plans to issue a more-detailed Order explaining its analysis in due course. VoIP-Pal's lawsuit against Samsung is in the discovery phase and is moving towards an expected jury trial in approximately seven months according to the current schedule.

08:08 EST Transocean announces proposed private offering of $500M - Transocean announced that Transocean Titan Financing, a wholly-owned indirect subsidiary of Transocean Ltd., commenced a private offering of U.S. $500 million in aggregate principal amount of senior secured notes due 2028 to eligible purchasers pursuant to Rule 144A/Regulation S. The Notes will be guaranteed by Transocean Ltd., Transocean Inc., and a wholly-owned indirect subsidiary that owns and initially will operate the Deepwater Titan and will be secured by a lien on the Deepwater Titan and certain other assets related to the rig. The timing of pricing and terms of the Notes are subject to market conditions and other factors. The net proceeds from the Notes will be used to partially finance the construction, acquisition, improvement, or alteration of the Deepwater Titan and to fund the initial debt service reserve.

08:07 EST Teva announces nationwide opioids settlement after receiving state support - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, confirmed a sufficient level of participation to move forward with its nationwide settlement agreement to resolve opioid-related claims and litigation by states, cities, counties, and other subdivisions in the United States. Teva has either already settled with or confirmed participation from 48 of the 50 states and will continue to pursue participation by those states that have yet to join. The sign-on process for the states' subdivisions will now begin. Given the very positive response from states, the Company remains optimistic that the nationwide settlement will garner similar support from the states' subdivisions. As previously announced, Teva has reached an agreement with the working group of States' Attorneys General and plaintiffs' lawyers representing the states and subdivisions, on the nationwide opioids settlement. While the agreement will include no admission of wrongdoing, it remains in the Company's best interest - and in the interest of those impacted by the opioid crisis - to settle these cases and to continue to focus on the patients Teva serves every day.

08:06 EST Five Below CEO Joel Anderson says entering 2023 with momentum - CEO Joel Anderson stated: "We are pleased with our holiday performance, with results in the upper end of our fourth quarter sales guidance range. We believe our diverse eight worlds and WOW merchandise offering along with increased and more targeted marketing effectively highlighted the tremendous value for our customers. Given this holiday performance, we now expect to finish the fourth quarter and full year near the high end of our previously provided guidance ranges. We are entering fiscal year 2023 with momentum and excited to be executing our Triple-Double strategy, including opening 200+ new stores for the first time in our history and converting over 400 stores to the new Five Beyond format. We look forward to discussing Five Below's full year 2022 results and outlook for fiscal 2023 on our fourth quarter earnings call in March."

08:05 EST Zai Lab appoints Michel Vounatsos to board of directrs - Zai Lab announced that Michel Vounatsos has been appointed to its Board of Directors, effective January 7, 2023. Mr. Vounatsos brings to the Board extensive global leadership and management experience in the biopharmaceutical industry, including more than 25 years of service at leading companies. His expertise includes significant commercial experience in China and worldwide in the areas of primary care and neuroscience.

08:04 EST American Eagle reports quarter-to-date brand revenue down 3% - American Eagle announced that fourth quarter-to-date brand revenue, through Saturday, January 7, is down approximately 3%, on the higher end of expectations, with American Eagle tracking slightly ahead and Aerie in line with expectations. Quiet Logistics is expected to add two percentage points to fourth quarter brand revenue. Gross margins are now expected to be on the high end of the company's guidance of 32%-33%, reflecting controlled promotions fueled by strong inventory management. Current inventory is well-positioned with quarter-end inventories expected to be down compared to last year, in-line with prior guidance.

08:03 EST Cogent Biosciences announces planned milestones for 2023 - Cogent Biosciences highlighted the company's key 2023 milestones ahead of its presentation at J.P. Morgan's 41st annual healthcare conference this week. In 2023, the Company plans to achieve the following milestones: Bezuclastinib - Systemic Mastocytosis: Phase 2 APEX trial - announce results from planned Part 1 analysis including approximately 25-30 AdvSM patients in mid-2023, enabling dose selection for Part 2 trial expansion. Phase 2 SUMMIT trial - present initial clinical data in patients with NonAdvSM in the second half of 2023. Clinical results will include safety/tolerability, pharmacokinetics and measures of clinical activity. Initiate clinical investigation of bezuclastinib in SM patients with associated hematologic neoplasms, allowing for concomitant use of AHN-directed therapies. Bezuclastinib - Gastrointestinal Stromal Tumors: Present updated clinical results from refractory GIST patients in the lead-in cohort of the Phase 3 PEAK trial of the pan-KIT mutant regimen, bezuclastinib plus sunitinib, during the first half of 2023. Enrollment in the Phase 3 PEAK trial for 2nd-line GIST patients remains on track, with expansion to over 100 global clinical sites expected before the end of this year. Preclinical Pipeline: Select FGFR2-mutant selective clinical candidate and initiate IND-enabling GLP toxicology studies in the first half of 2023. This program is designed as a potential best-in-class, reversible, FGFR1-sparing, potent pan-FGFR2 mutant inhibitor that includes coverage of both key gatekeeper and molecular brake mutations. Select ErbB2-mutant selective clinical candidate in the second half of 2023. This program is designed as an EGFR-sparing, CNS-penetrant ErbB2 inhibitor that includes coverage of key mutations inadequately addressed by currently approved therapies. Present initial preclinical data on two additional novel target programs with best-in-class potential out of the Cogent Research Team's labs during 2023.

08:01 EST IGM Biosciences announces update on IGM-8444 Phase 1 trial - IGM Biosciences announced an update on its clinical development program for IGM-8444, a novel multivalent DR5 agonist, and announced plans for a new randomized combination trial in patients with metastatic colorectal cancer. Initial Phase 1 data reported from a cohort of patients with combination treatment of IGM-8444 and FOLFIRI showed an encouraging safety profile which was broadly comparable to that expected from chemotherapy alone in this setting. Specifically, there was no drug related clinically significant hepatotoxicity, with only grade 1 and grade 2 transient liver enzyme elevations observed. In patients with metastatic colorectal cancer, the combination of IGM-8444 and FOLFIRI showed promising activity, with multiple confirmed responses observed even in patients who had previously progressed on FOLFIRI. In 13 metastatic patients treated with doses of IGM-8444 from 1 to 10 mg/kg plus standard doses of FOLFIRI chemotherapy, there were four responses observed, and one additional patient had substantial tumor shrinkage allowing for subsequent complete surgical resection. Responses occurred in patients with KRAS wild type and mutated tumors and in patients with or without liver metastases. The majority of patients were on their third line of treatment or beyond and 10 of the 13 patients had previously been treated with FOLFIRI chemotherapy. Median progression free survival among nine 3L+ patients was 5.5 months, with the longest observed PFS extending beyond 12 months. Based on these results, the Company is initiating a randomized trial in second line patients with metastatic colorectal cancer to assess the additional benefit of IGM-8444 combined with the current standard of care regimen of FOLFIRI and bevacizumab. This open label trial is planned to begin in Q1 2023. "These initial IGM-8444 clinical results represent an important step in demonstrating the potential of our IgM antibody platform to overcome the long history of failure with conventional IgG antibodies targeting DR5," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We believe these results also help support the potential for IgM antibodies as agonists against the broader TNF receptor super family, and we look forward to accelerating our company-wide efforts to develop a new class of agonist antibody medicines, including through our collaboration with Sanofi."

07:59 EST Jushi Holdings sees 17% reduction in headcount - In addition, over the past 12 months, Jushi's executive leadership has conducted an extensive review of management and administrative roles within the organization which is expected to result in an approximate 17% reduction in total corporate headcount, from 172 to 143. The Company has worked to right-size its retail-level labor model to match current market conditions, which resulted in an approximate 19% reduction of in-store salaried and hourly staff, from an average of 28.7 employees per store to an average of 23.3 employees per store, and will continue to monitor staffing levels across its retail network. For the grower processors, in the state of Nevada, management and labor were optimized following the NuLeaf acquisition of two sites, resulting in 7 reductions. In Ohio, management, administrative support, and facility labor were reduced by 27 in connection with the temporary closure of the Columbus facility. In December of 2022, Jushi's management identified additional labor efficiencies to be implemented this year.

07:58 EST GH Research provides business updates, key upcoming milestones - GH Research provided updates on its business and highlighted key upcoming milestones. GH001 for the treatment of TRD: "GH001 is our proprietary inhalable mebufotenin product candidate. We have recently received initial regulatory and ethical approvals for our planned multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression. We continue to expect initiation of this trial in several European countries in the first quarter of 2023," the company said. Proprietary aerosol delivery device for GH001: "In 2021, we initiated the development of a proprietary aerosol delivery device for GH001 for use in our pivotal clinical trial program and for commercial use. Based on recent development progress, we now expect to submit an IND for GH001, delivered with this proprietary device, in the third quarter of 2023. The IND-opening study will be a Phase 1 clinical pharmacology trial in healthy volunteers, designed to support bridging to the clinical data generated with the third-party device we currently use in our clinical trials. Due to the progress with our proprietary aerosol delivery device, we no longer plan to submit an IND with this third-party device," the company said. GH002: "GH002 is our mebufotenin product candidate formulated for administration via a proprietary injectable approach. The previously announced randomized, double-blind, placebo-controlled, dose-ranging clinical pharmacology trial of GH002 in healthy volunteers has recently been initiated. We expect to complete this trial in the fourth quarter of 2023," the company said. Intellectual property: "We have recently filed a new device-related patent application, expanding our patent portfolio to 11 patent families, that relate to various aspects of mebufotenin use in a therapeutic context, including but not limited to the use of mebufotenin for treatment of various disorders when administered by inhalation, or by nasal, buccal, sublingual, intravenous, intramuscular or subcutaneous routes," the company said. Other updates: "We are pleased to announce the selection of mebufotenin as the International Nonproprietary Name for 5-MeO-DMT by the World Health Organization Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. From this point forward, we will introduce the nomenclature mebufotenin into our communications."

07:56 EST Monte Rosa Therapeutics outlines anticipated 2023 milestones - Monte Rosa Therapeutics outlined anticipated 2023 milestones ahead of its participation at the 41st Annual J.P. Morgan Healthcare Conference. The company's presentation will focus on strategic priorities for 2023, including its plans to report initial data from the Phase 1 arm of its ongoing Phase 1/2 clinical trial for MRT-2359. "In 2022, we made significant progress across our portfolio of highly selective molecular glue degraders, culminating in the initiation of our Phase 1/2 trial of MRT-2359 in MYC-driven tumors," said Markus Warmuth, M.D., CEO of Monte Rosa. "As we look ahead to 2023, with our lead program in the clinic, a rich pipeline of wholly owned preclinical programs, and backed by a strong cash position, we believe we are well positioned for success. We expect our programs to achieve important catalysts in 2023 that will bring us closer to fulfilling our vision of developing a new generation of MGD-based precision medicines for patients living with serious diseases." 2023 Key Milestones and Catalysts: The U.S. Food and Drug Administration has granted Fast Track designation to MRT-2359 for the treatment of patients with previously treated, metastatic NSCLC with L-MYC or N-MYC expression; The company anticipates disclosing initial data from the Phase 1 arm of the ongoing Phase 1/2 clinical trial evaluating MRT-2359 in the second half of 2023; The company anticipates the nomination of multiple development candidates in 2023 for its programs oncology, autoimmune and inflammatory diseases

07:54 EST Revival Gold reports drilling results at Beartrack-Arnett - Revival Gold announced results from the first twelve of eighteen core holes drilled in the Haidee deposit area during the Company's 2022 exploration program at the Beartrack-Arnett Gold Project located in Idaho, USA. Each of the twelve holes released today intersected above cut-off grade, near-surface oxidized gold mineralization. Highlights: 1.12 g/t gold over 18.0 meters1 and 0.36 g/t gold over 32.8 meters1 in AC22-097D; 0.81 g/t gold over 30.1 meters1 and 0.53 g/t gold over 16.9 meters1 in AC22-100D; 0.76 g/t gold over 19.8 meters1 in AC22-092D; 0.53 g/t gold over 35.8 meters1, 0.53 g/t gold over 29.3 meters1 and 0.40 g/t gold over 14.7 meters1 in AC22-095D. The 2022 drilling program at Haidee was designed to upgrade and expand the deposit's current Inferred heap leachable Mineral Resource. A total of 18 holes were completed for approximately 2,900 meters. Results to-date from the 2022 drilling program are consistent with those from previous drilling. They will help support this year's Preliminary Feasibility Study on the first phase re-start of heap leach operations at Beartrack-Arnett and they further validate the potential for future up-dip and down-dip additions to the current Mineral Resource. Results for the remaining six core holes from the 2022 program at Haidee are expected by the end of January. "Today's results build on Revival Gold's prior exploration success in the Haidee deposit area with each hole having intersected above cut-off grade gold mineralization in oxide material, all within 150 meters of surface. The results have increased our confidence in the integrity of the Haidee deposit ahead of this year's PFS on the first phase re-start of heap leach operations at Beartrack-Arnett and they point to the potential for further expansion, both up-dip and down-dip of the current Mineral Resource", said Hugh Agro, President and CEO.

07:52 EST Rail Vision demos AI-based obstacle detection technology - Rail Vision announced the successful demonstration of the field applicability of its innovative Switch Yard System for a Class 1 North American railroad. The demonstration showcased Rail Vision's technology on an SD40 locomotive equipped with autonomous driving technology and an advanced electronic air brake system. In wet and foggy weather, Rail Vision's obstacle detection system enabled the locomotive to efficiently navigate numerous challenging obstacles during both conventional and autonomous operations, identifying and providing the distance to people, cars, and rail equipment, as well as determining the alignment of switch points. The demonstration achieved GoA4 status. GoA4, which requires no on-train staff, is the highest level of automated train operations.

07:51 EST Parsons' Xator selected for task orders up to $79.5M supporting USAF IBDSS - Parsons won prime and major subcontractor positions on the United States Air Force, USAF, Integrated Base Defense Security System, IBDSS, task order contract, which will deliver modernization and sustainment solutions for the USAF through 2027. Xator is eligible to receive up to $79.5M of task order work that expands on the company's existing Force Protection Site Security System Solutions contract to provide foundational and integrated security solutions to the Air Force's global operations. "We remain focused on delivering security solutions that integrate personnel and technology into a seamless defense architecture, providing a collective view of the battlespace, securing Air Force assets, and protecting the warfighter," said Hal Smith, president, Xator, LLC. "Today's threat environment requires complex solutions that enable seamless physical to digital layered defense. Xator's support continues and expands our commitment to provide the warfighter with systems designed to enable more rapid and informed decision-making in response to evolving threats."

07:49 EST GreenLight Bioscences, Epivax signs exclusive collaboration agreement - GreenLight Biosciences and EpiVax Therapeutics announced that they have signed an exclusive collaboration agreement to jointly develop and commercialize personalized mRNA-based vaccine candidates for cancers. Under this collaboration, the companies will design and develop new personalized mRNA cancer vaccine candidates using GreenLight and EpiVax Therapeutics technology platforms. EpiVax Therapeutics has developed a proprietary computational tool for precision immunotherapy, Ancer, an end-to-end, automated platform that integrates multiple advanced algorithms into a single pipeline to rapidly design custom therapies for individual cancer patients using each patient's own tumor genome sequence as the starting point for the vaccine design. EpiVax Therapeutics' pipeline currently includes vaccine design capacity for bladder cancers and other solid tumors. GreenLight's mRNA design, formulation and manufacturing expertise is currently applied to research and develop mRNA vaccine candidates, including a collaboration with the NIH to develop a next generation Covid vaccine, and a multi-target license agreement with Serum Institute of India, which includes developing a shingles vaccine candidate. "We are delighted to partner with EpiVax Therapeutics, to expedite development of personalized cancer vaccine candidates using GreenLight's RNA platform," said Andrey Zarur, CEO of GreenLight. "We are excited to combine our mRNA design and manufacturing expertise with EpiVax Therapeutics' neoantigen discovery platform and oncology expertise to build towards a future of accessible and timely oncology vaccines."

07:48 EST Chico's falls 12% to $4.60 after lowering Q4 outlook

07:46 EST BioCryst sees Q4 ORLADEYO net revenue $70.7M - "In our second year on the market we more than doubled our first year ORLADEYO sales and are more than a quarter of the way towards $1 billion in peak sales. This continues to be an exceptional launch of an oral rare disease drug and we expect this success to continue creating real value for patients and for shareholders this year and for many years to come," said Jon Stonehouse, president and chief executive officer of BioCryst. Preliminary, unaudited ORLADEYO net revenue in the fourth quarter of 2022 was $70.7 million. Preliminary, unaudited ORLADEYO net revenue for full year 2022 was $251.6 million.

07:45 EST Glencore Canada to acquire Noranda Income Fund priority units - Noranda Income Fund announced that it has entered into an arrangement agreement with Glencore Canada Corporation by which Glencore will acquire all of the issued and outstanding priority units of the Fund for C$1.42 per unit, by way of a court approved plan of arrangement, for total consideration of approximately C$53.2 million. The purchase price of C$1.42 per unit represents a 45% premium on the closing price on the Toronto Stock Exchange on January 6, 2023, the last trading day prior to announcement, and a 62% premium on the 20-day volume weighted average price per priority unit on the TSX for the period ending on January 6, 2023. Glencore currently holds 100% of the Fund's special fund units, representing 25% of all issued and outstanding units of the Fund. The Arrangement Agreement was unanimously approved by the Board of Trustees of Noranda Operating Trust with those members of the Board who are related to Glencore abstaining from voting, upon recommendation from the Independent Committee of the Board, after arm's-length negotiations yielded an attractive offer for the Fund's priority unitholders.

07:44 EST Takeda Pharmaceutical, Arrowhead announce topline results from SEQUOIA study - Takeda (TAK) and Arrowhead (ARWR) announced topline results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran for the treatment of liver disease associated with alpha-1 antitrypsin deficiency, or AATD-LD. The companies also provided an outline of a Phase 3 study that was co-developed by Takeda and Arrowhead and will be conducted by Takeda. Additional SEQUOIA study results are planned to be presented at a future medical meeting and submitted for publication. Arrowhead will host a webcast call for investors at 8:30 a.m. ET to review the Phase 2 data. Patients receiving 25 mg, 100 mg, or 200 mg of fazirsiran who had baseline fibrosis demonstrated a dose dependent mean reduction in serum mutant alpha-1 antitrypsin protein, or Z-AAT, concentration at week 48 of 74%, 89%, and 94%, respectively. All three doses led to a dramatic reduction in total liver Z-AAT with a median reduction of 94% at the postbaseline liver biopsy visit. In addition, PAS-D globule burden, a histological measure of Z-AAT accumulation, was reduced from a baseline mean of 5.9 to a post baseline mean of 2.3 at the postbaseline liver biopsy visit. Improvement in portal inflammation was observed in 42% of patients while only 7% showed worsening. Lastly, 50% of patients achieved an improvement in fibrosis of at least one point by METAVIR stage. In contrast, by week 48 patients receiving placebo who had baseline fibrosis saw no meaningful changes from baseline in serum Z-AAT, a 26% increase in liver Z-AAT, no meaningful change in PAS-D globule burden, no placebo patients experienced an improvement in portal inflammation while 44% experienced worsening, and 22% of placebo patients experienced worsening while 38% experienced an improvement in fibrosis at the postbaseline liver biopsy visit. This finding highlights the known variability on histologic fibrosis assessment. With a larger sample size, like in the planned Phase 3 study, the rate of improvement in patients receiving placebo may more closely approximate results from natural history studies of untreated patients with AATD-LD. Fazirsiran has been well tolerated with treatment emergent adverse events reported to date generally well balanced between fazirsiran and placebo groups. There were no treatment-emergent adverse events leading to drug discontinuation, dose interruptions, or premature study withdrawals in any study group. Compared with placebo, no dose-dependent or clinically meaningful changes were observed in pulmonary function tests over 1 year with fazirsiran. These data are consistent with results from the Phase 2 AROAAT-2002 open-label study that were previously published in The New England Journal of Medicine. Additional details on the SEQUOIA study will be provided at a future scientific meeting.

07:43 EST Apollo Silver reports further assay results from Phase 2 drilling - Apollo Silver Corp is pleased to report further assay results from the recently completed Phase 2 of the 2022 Drill Program at the Calico Silver Project located in San Bernardino County, California. Resource infill drilling results continue to deliver exceptional silver intercepts such as 109 grams per tonneAg over 109.0 metres from surface. Latest results continue to expand silver mineralization below the base of the current mineral resource estimate. The oxide gold horizon continues to be defined, with 0.262 g/t Au over 19.5 m from 134.5 m depth down hole in drill hole W22-RC-045. Results reported below are from 10 holes, bringing the total number of holes with assays released for Phase 2 drilling to 16 out of 44 completed. New significant intercepts include: SILVER: 109 g/t Ag over 109.0 m from surface, including; 267 g/t Ag over 1.5 m from 25.0 m depth down hole; 456 g/t Ag over 1.5 m from 29.5 m depth down hole; and 307 g/t Ag over 1.5 m from 55.0 m depth down hole; 106 g/t Ag over 45.0 m from 11.5 m depth down hole; 169 g/t Ag over 64.5 m from 1.0 m depth down hole, including 260 g/t Ag over 6.0 m from 13.0 m depth down hole; and 261 g/t Ag over 15.0 m from 26.5 m depth down hole; 101 g/t Ag over 67.0 m from surface, including; 268 g/t Ag over 4.0 m from surface. GOLD: 0.262 g/t Au over 19.5 m from 134.5 m depth down hole, including; 0.921 g/t Au over 3.0 m from 140.5 m depth down hole; and 1.220 g/t Au over 1.5 m from 140.5 m depth down hole; 0.160 g/t Au over 21.0 m from 134.5 m depth down hole; 0.327 g/t Au over 18.0 m from 86.5 m depth down hole, including; 0.806 g/t Au over 1.5 m from 95.5 m depth down hole; and 0.774 g/t Au over 1.5 m from 101.5 m depth down hole.

07:40 EST Red Robin releases 'North Star' five-point plan - Red Robin released its "North Star" five-point plan to drive long-term shareholder value. The company also reported preliminary, unaudited revenue results for the fourth quarter ended December 25 and announced it is evaluating a Sale-Leaseback transaction. G.J. Hart, Red Robin's president and CEO said, "We are excited to release our 'North Star' five-point plan, designed to drive long-term shareholder value and enhance Red Robin's competitive positioning. With our menu of gourmet burgers and American favorites, attractive atmosphere, and playful environment that connects friends and family, the brand not only carries great memories for our most loyal guests but also appeals to a broad demographic. While the business has faced challenges in recent years due to the impact of COVID and at times execution that has not met our standards, we are committed to taking bold action through new executive leadership to deliver long term sustainable growth. We are thankful to have an excellent team of dedicated General Managers and team members and are committed to providing them with the resources necessary to ensure a great experience for guests and strong business results for their restaurants. We have identified multiple levers to build sales and increase profitability and are now moving to aggressive implementation to drive our success in 2023 and beyond."

07:40 EST Travere Therapeutics provides 2023 anticipated milestones - In 2023, the Company anticipates the first regulatory approvals in the U.S. and Europe for sparsentan, the first and only Dual Endothelin Angiotensin Receptor Antagonist in development for rare kidney disorders. If approved, sparsentan would also become the only non-immunosuppressive treatment indicated for IgAN. Sparsentan - IgAN: The U.S. Food and Drug Administration is reviewing a New Drug Application under Subpart H for accelerated approval of sparsentan for the treatment of IgAN. The FDA has assigned a Prescription Drug User Fee Act target action date of February 17, 2023, and if approved, the Company is well-positioned for commercial launch in the first quarter of 2023. In the second half of 2023, the Company together with its collaborator CSL Vifor, anticipates a review decision by the European Medicines Agency on the potential approval of the Conditional Marketing Authorization application for sparsentan for the treatment of IgAN in Europe. If approved, sparsentan would receive CMA in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. In the fourth quarter of 2023, the Company expects to report topline results from the two-year confirmatory endpoints in the ongoing Phase 3 PROTECT Study, which are designed to support traditional approval of sparsentan in IgAN. In 2023, the Company plans to expand data generation through a sub study in the open-label extension of the ongoing PROTECT Study, as well as an open-label clinical study to investigate the safety and efficacy of sparsentan in combination with sodium glucose cotransporter-2 inhibitors for the treatment of IgAN. Sparsentan - FSGS In the second quarter of 2023, the Company expects to report topline results from the two-year confirmatory endpoints in the ongoing Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis. Pending data supportive of approval, the Company anticipates submitting a supplemental NDA for traditional approval for FSGS in the second half of 2023. Pending completion of the DUPLEX Study of sparsentan in FSGS and data supportive of approval, a subsequent variation to the CMA of sparsentan for the treatment of FSGS in Europe is targeted for submission by the end of 2023. Pegtibatinase - HCU The Company continues to advance pegtibatinase, a novel investigational enzyme replacement therapy with the potential to become the first disease-modifying therapy for people living with classical homocystinuria. Following positive results from the first five cohorts of the ongoing Phase 1/2 COMPOSE Study, the Company is evaluating pegtibatinase in a final cohort in the COMPOSE Study to further inform its potential pivotal development program. In the fourth quarter of 2022, enrollment completed in the sixth and final cohort of the ongoing Phase 1/2 COMPOSE Study. The Company anticipates reporting additional data from COMPOSE in mid-2023. In parallel with completing the final cohort in the COMPOSE Study, the Company is preparing for the initiation of a pivotal Phase 3 clinical trial of pegtibatinase in patients with HCU in the second half of 2023. CDCA - CTX: The Company's chenodeoxycholic acid program includes Chenodal (chenodiol), a commercially available product that is under clinical evaluation to include an indication for cerebrotendinous xanthomatosis, a rare, progressive, and underdiagnosed bile acid synthesis disorder, to its label. During 2023, the Company expects to complete the ongoing Phase 3 RESTORE Study in CTX. Pending supportive data, the Company anticipates being in position to subsequently submit an NDA for a CTX indication.

07:38 EST Voyager, Neurocrine enter collaboration to advance multiple gene therapies - Neurocrine Biosciences (NBIX) and Voyager Therapeutics (VYGR) announced the formation of a new strategic collaboration to advance multiple gene therapies for the treatment of neurological diseases. The collaboration builds upon the long-standing strategic partnership between Neurocrine Biosciences and Voyager and continues to combine Voyager's expertise in novel capsid discovery, payload design, and neuropharmacology with Neurocrine Biosciences' expertise in neuroscience and the clinical and commercial development of therapies for patients suffering from serious neurological diseases. Collaboration Details and Financial Terms: Under the terms of the agreement, Neurocrine Biosciences has agreed to pay Voyager $175M up front, of which Neurocrine Biosciences has agreed to pay approximately $136M in cash and to purchase approximately $39M of newly issued equity in Voyager at a price of $8.88 per share, which represents a 50% premium to the average daily volume-weighted average price of Voyager's stock over the 30 trading days prior to the execution of the transaction. In addition, Neurocrine Biosciences has agreed to fund all costs incurred under the collaboration, subject to the cost- and profit-sharing option terms below. Regarding the GBA1 gene therapy program, Neurocrine Biosciences has agreed to fund development through the completion of a first Phase 1 trial. Following the data readout from such trial, Voyager has the right, but not the obligation, to elect to co-develop and co-commercialize the GBA1 program with Neurocrine Biosciences in the U.S. under a 50/50 cost- and profit-sharing arrangement in lieu of receiving further U.S. milestone-based payments and royalties or alternatively be eligible for U.S.-based development, regulatory, and commercial milestone payments and tiered royalties, with Neurocrine Biosciences maintaining responsibility for all development and commercialization expenses. If Voyager declines its option for cost and profit sharing on the GBA1 program, under the terms of the collaboration agreement, Voyager will be eligible for up to $985 million in total development milestone payments plus substantial potential commercial milestone payments, and tiered royalties ranging from low double-digit to twenty percent on U.S. net sales. Irrespective of Voyager's election on its cost- and profit-sharing option, Voyager shall be eligible for potential ex-U.S.-based regulatory and commercial milestone payments, as well as royalties ranging from high-single-digits to mid-teens on ex-U.S. net sales. Regarding the three new gene therapy programs under the collaboration, Voyager is eligible to earn up to $175M in development milestone payments plus substantial potential commercial milestone payments for each program, and tiered high single-digit to mid-teens royalties on U.S. net sales and mid-single-digit to low double-digit royalties on ex-U.S. net sales. Neurocrine Biosciences has agreed to fully fund the development of the three new programs. Neurocrine Biosciences and Voyager have agreed that, following the completion of the transaction, Jude Onyia, Ph.D., Chief Scientific Officer at Neurocrine Biosciences, will join Voyager's Board of Directors.

07:36 EST AlloVir plans completion of enrollment in posoleucel studies in 2023 - AlloVir announced the company's 2023 priorities and anticipated future milestones across its pipeline of virus-specific T cell therapies, including its lead investigational therapy posoleucel. These updates will be the focus of a corporate presentation by Chief Executive Officer Diana Brainard, M.D., at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10. A live webcast and archived replay of the presentation will be available in the Investors & Press section of the AlloVir website at https://ir.allovir.com. "The positive posoleucel Phase 2 data we reported in 2022 and the enthusiasm we are seeing from transplant centers give us further confidence in our Phase 3 strategy for posoleucel and our ability to execute on our trials in 2023," said Dr. Brainard. "Our Phase 2 multi-virus prevention study data underscore the potential for posoleucel to be transformative for allo-HCT patients by substantially reducing clinically significant infections from six viruses that are devastating for this vulnerable population. Viral infections are a leading cause of non-relapse mortality, generate substantial healthcare expenditures, exact a significant emotional burden on patients and their caregivers, and unfortunately most viruses targeted by posoleucel currently have no preventive therapies."

07:35 EST Orchard Therapeutics provides FY23 key milestones - Orchard Therapeutics announced recent commercial and regulatory accomplishments and outlined key 2023 milestones. Key 2023 Priorities: Orchard has outlined the following key milestones expected for 2023: Libmeldy: Secure reimbursement agreements in at least two additional markets in Europe and establish qualified treatment centers in Sweden, Spain and Saudi Arabia. Expand newborn screening activities throughout Europe, the U.S. and the Middle East. OTL-200 for metachromatic leukodystrophy: Conduct a clinical Type B meeting with the U.S. Food and Drug Administration in early 2023 in advance of an anticipated BLA submission. OTL-203 for mucopolysaccharidosis type I Hurler's: Initiate a global, registrational trial in the second half of 2023. OTL-201 for mucopolysaccharidosis type IIIA: Report additional biochemical and clinical data from the ongoing proof-of-concept study. OTL-104 for NOD2-Crohn's disease: Report pre-clinical PoC data in the first half of 2023 and initiate IND-enabling activities in advance of a planned 2024 filing. Advance the company's other preclinical programs, which includes a program partnered with and funded by Pharming in hereditary angioedema, OTL-105.

07:34 EST Selecta Biosciences, Astellas Pharma enter licensing agreement for IdeXork - Selecta Biosciences (SELB), and Astellas Pharma (ALPMY) announced an exclusive licensing and development agreement for IdeXork. Xork is being studied as a potential next generation immunoglobulin G protease that will be developed by Astellas for use with AT845, an investigational, adeno-associated virus-based treatment for Late-Onset Pompe disease in adults. Under the terms of the agreement, Selecta will receive a $10M upfront payment and is eligible to receive up to $340M for certain additional development and commercial milestones plus royalties on any potential commercial sales where Xork is used as a pre-treatment for AT845. Selecta is responsible for the development and manufacturing of Xork and will maintain the rights for the development of additional indications beyond Pompe disease. Astellas would have the sole and exclusive right to commercialize Xork for use in Pompe disease with an Astellas gene therapy investigational or authorized product, with a current focus on AT845.

07:34 EST Potbelly raises FY22 same-store sales view to 18.4%-18.5% from 16%-18% - Raises FY22 AUVs view to $1.16M - $1.17M from $1.14M - $1.16M; Raises FY22 Same-store sales to 18.4% - 18.5% from 16% - 18%; Raises FY22 Shop-level margins to 10.2% - 10.4% from ~10%

07:32 EST Avantor, Catalent enter multi-year supply agreement - Avantor (AVTR) announced that it has entered into a multi-year supply and services agreement with Catalent (CTLT). Under the terms of the agreement, Avantor will be the primary supplier of a broad range of laboratory supplies, clinical and production materials, and services to Catalent, expanding the companies' existing relationship.

07:29 EST Kirby conclude review of alternatives for distribution, services business - Kirby Corporation announced its Board of Directors has concluded the Company's review of strategic alternatives for its Distribution and Services business, which was initiated in early 2022. The Kirby Board of Directors, with the support of its independent financial and legal advisors, reviewed a range of alternatives, including a sale or spin-off of the Company's Distribution and Services business, and held discussions with a number of potential strategic and financial counterparties. Following this process, the Board concluded that, under current financial market conditions, the best path for Kirby is to continue to execute its strategic plan for both its Marine Transportation and Distribution and Services businesses. The Board and management team remain open to reviewing any and all opportunities that may maximize value for shareholders. "Following a thorough review of strategic alternatives, the Kirby Board determined that the best way to enhance shareholder value is to continue to execute on the strategic plan for both the Marine Transportation and Distribution and Services businesses at this time," said Joseph Pyne, Kirby's Chairman of the Board. "The M&A market continues to be constrained by macroeconomic headwinds, including a challenging financing environment. The Board remains committed to maximizing value and will continue to evaluate all opportunities to do so, consistent with its fiduciary duty to shareholders." Looking ahead, Kirby expects that favorable conditions for inland marine transportation and oil and gas markets will support continued growth in demand for the Company's products and services. For Kirby's Distribution and Services segment, the Company expects demand for its new products that have been developed as part of its electrification growth strategy, especially for its environmentally friendly pressure pumping and e-frac power generation equipment, to remain strong with growing backlog of new orders and increased deliveries of new equipment into 2023. Kirby continues to expect its businesses to deliver improved financial results throughout 2023 as it maintains a relentless focus on cost and capital management, while capitalizing on growth opportunities and continuing to ensure safe, efficient, and reliable operations.

07:28 EST iTeos Therapeutics expects cash to provide runway into 2026 - The company's cash and cash equivalent position was $752.2 million as of September 30, 2022. The company continues to expect its cash balance to provide runway into 2026 to support differentiated clinical programs for EOS-448 and inupadenant as well as advance preclinical programs targeting immunosuppression pathways.

07:27 EST Twist in research pact with with Astellas, eligible for milestone payments - Twist Bioscience (TWST) announced a research collaboration with Astellas Pharma (ALPMF) to discover antibodies against multiple targets of interest to develop curative therapies for patients suffering from diseases that lack treatment options. "This second collaboration with Astellas demonstrates the power of our antibody discovery capabilities. The depth and breadth of our Library of Libraries enables highly potent antibodies, often missed using other technologies, to be identified across multiple potential therapeutic areas," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We are looking forward to continuing our working relationship with Astellas and building on the progress made to date in our first collaboration." Under the terms of the agreement, Twist will conduct antibody discovery activities against multiple targets identified by Astellas. In addition to an upfront payment and project specific research fees, Twist will be eligible to receive up to $11M per product through payments associated with specific clinical and commercial milestones. Twist will also be eligible to receive royalty payments on product sales. Astellas will be responsible for the development, manufacturing and commercialization of any such products.

07:25 EST C4 Therapeutics expects cash to fund operations to end of 2024 - The company expects that its cash, cash equivalents and marketable securities as of September 30, 2022, together with anticipated collaboration expense reimbursements, but excluding any collaboration option or milestone payments, will enable the company to fund its operating plan to the end of 2024.

07:23 EST Algernon plans Phase 2b chronic cough study of ifenprodil - Algernon Pharmaceuticals is planning a 180 patient, 90-day Phase 2b clinical study of NP-120 for chronic cough to begin in Q3 of 2023. Ifenprodil is an N-methyl-D-aspartate receptor antagonist specifically targeting the NMDA-type subunit 2B, which prevents glutamate signaling. Ifenprodil represents a novel first-in-class potential treatment for chronic cough and is thought to interfere with central signalling in the brain, suppressing the urge to cough. In addition to being Algernon's lead chronic cough advisor, Dr. Smith is also a consultant to Merck & Co. and Bellus Health, both of which are pursuing a drug for the indication of chronic cough. The decision to advance the study is based on positive data previously reported on July 28, 2022, from the Company's Phase 2a study of Idiopathic Pulmonary Fibrosis and chronic cough, where Ifenprodil showed a significant improvement in mean objective 24-hour and waking cough counts in patients after 4 and 12 weeks. Patients with IPF are usually excluded from trials in refractory chronic cough, and cough in this population is regarded as extremely difficult to treat. The analysis showed that: The geometric mean 24-hour cough counts were reduced by 32.0% at 4 weeks and 39.5% at 12 weeks compared to baseline The geometric mean awake cough counts were reduced by 30.2% at 4 weeks and 37.4% at 12 weeks compared to baseline. Algernon previously announced on January 14, 2022, that it had received positive feedback from the U.S. Food and Drug Administration (U.S. FDA) at its pre-Investigational New Drug meeting for its investigation of Ifenprodil solely for the treatment of chronic cough. The Company has since engaged in further discussions with the U.S. FDA, and plans to file an investigational new drug application shortly. While the Company originally planned to focus on IPF in a Phase 2b study, Algernon has now decided to pursue a chronic cough study first, and to delay planning its IPF Phase 2b study for Ifenprodil until a later date. The planned study design will include the following elements: Multinational, three-arm, randomized, double-blind, placebo-controlled trial to evaluate NP-120 in approximately 180 patients. Patients will be randomized 1:1:1 to receive NP-120 or NP-120, or placebo for 12 weeks. The primary endpoint will be the reduction in geometric mean 24-hr cough count over 12 weeks compared to placebo. Secondary endpoints will include safety, tolerability and patient-reported quality-of-life measures.

07:20 EST Adagene announces interim data on its ADG126 - Adagene announced data for its masked anti-CTLA-4 SAFEbody, ADG126, in combination with anti-PD-1 therapy in patients with advanced/metastatic solid tumors. The results in 14 heavily pre-treated patients demonstrate the safety and initial efficacy profiles of ADG126 in combination with anti-PD-1 treatment. Adagene plans to present the detailed dose escalation data at an upcoming medical conference in the first half of 2023. Key findings include: Compelling Safety Profile in Combination with Anti-PD-1: ADG126 has been administered at escalating doses up to 10 mg/kg every three weeks in combination with a fixed dose of anti-PD-1 therapy, including repeat dosing cycles. The combination was well tolerated, with no dose-limiting toxicities observed, or maximum tolerated dose yet reached. As of January 6, 2023, an additional 10 patients are being evaluated with the combination of ADG126 and pembrolizumab in a separate clinical trial. Dose Optimization following FDA Project Optimus Initiative: Following completion of the dose escalation cohorts, two separate doses of ADG126 are proceeding in expansion cohorts to address different tumor types and follow the goal of the Food and Drug Administration's 'Project Optimus' initiative to reform the dose optimization and dose selection paradigm in oncology drug development. Confirmed Clinical Responses & Antitumor Activity: Adagene also confirmed several partial responses were observed in multiple tumor types during combination dose escalation. Furthermore, continuous tumor shrinkage has been observed in cold tumors and immune-oncology-resistant patients with difficult-to-treat tumor types, consistent with the depletion of T regulatory cells by ADG126 and its parental antibody, ADG116, as well as other next-generation anti-CTLA-4 therapies with strong Treg depletion.

07:18 EST GoldMining appoints David Garofalo as co-chair - GoldMining announced the appointment of David Garofalo as a director and co-chair of the company. Garofalo has worked in various leadership capacities in the natural resources sector over the last 30 years. He has served as chairman and CEO of Gold Royalty Corp since August 2020, president and CEO of Goldcorp Inc. from 2016 to 2019, president and CEO.

07:17 EST Instil Bio resumes clinical trial of ITIL-306 in lung, ovarian, renal cancer - Instil Bio announced the resumption of its Phase 1 clinical trial of ITIL-306 for the treatment of non-small cell lung cancer, ovarian cancer, and renal cell carcinoma. With the resumption of the ITIL-306 Phase 1 study, the Company expects to release initial safety, translational, and efficacy data from dose escalation cohorts at a medical conference in 2023. The trial was resumed after the implementation of additional quality safeguards designed to further protect the manufacturing process from potential contaminants.

07:16 EST Tenaya Therapeutics announces TN-201 FDA IND clearance - Tenaya Therapeutics announced that the U.S. Food and Drug Administration, FDA, has provided clearance of its Investigational New Drug, IND, application to initiate clinical testing of TN-201. In addition, Tenaya shared anticipated 2023 program milestones and updated cash runway guidance. "Tenaya had a momentous year in 2022 in which we filed two INDs, transitioned into a clinical-stage company, launched operations of our Genetic Medicines Manufacturing Center - where we successfully produced clinical drug supply for TN-201 - and significantly extended our cash runway," said Faraz Ali, Chief Executive Officer of Tenaya. "We are pleased to start 2023 with clearance of the IND for our TN-201 gene therapy program and look forward to dosing patients with MYBPC3-associated HCM in our Phase 1b study in the coming months. We are also starting 2023 with confirmation of target engagement in our TN-301 Phase 1 study and look forward to reporting clinical data for this program later this year. We are enrolling patients across three non-interventional studies for our gene therapy programs and plan to file an IND for TN-401. Taken altogether, we are making tremendous strides on our mission and are solidifying our leadership position in the field of precision medicine therapies for heart disease."

07:15 EST Tenaya Therapeutics announces anticipated 2023 milestones - 2023 Anticipated Milestones and Recent Progress: TN-201 - MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy: Tenaya anticipates dosing the first patient in the Phase 1b clinical trial of TN-201 in the third quarter 2023, Initial data from the TN-201 Phase 1b clinical trial is anticipated in 2024. TN-301 - Small Molecule HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction: The company expects to commence dosing in the multiple-ascending dose stage of the Phase 1 trial in the first quarter 2023. Tenaya plans to present clinical data from both the SAD and MAD stages of the Phase 1 clinical trial in the second half 2023. The company expects to also present additional preclinical data supporting the efficacy of TN-301, the mechanism of action of HDAC6 inhibition, and comparisons with SGLT2 inhibitors at major conferences in 2023. TN-401 - PKP2 Gene Therapy Program for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy: Tenaya plans to submit an IND application to the FDA in the second half 2023 to enable clinical development of TN-401. Clinical supply of TN-401 will be produced at Tenaya's cGMP Genetic Medicines Manufacturing Center to support the IND filing. These efforts leverage significant learnings from related nonclinical, regulatory, clinical and manufacturing efforts for TN-201. Early-stage Research Efforts: Tenaya plans to present and publish new preclinical data related to its research on new targets, novel AAV capsid engineering efforts and manufacturing process improvements throughout 2023.

07:14 EST Prime Medicine announces 2023 anticipated upcoming milestones - Prime Medicine expects the following activities and next steps to drive the Prime Editing platform forward: Pipeline Nominate first development candidate for CGD in 1Q 2023. Initiate investigational new drug-enabling studies in CGD in 2023. Expand preclinical proof-of-concept in vivo, including sharing data from in vivo rodent studies and large animal studies in several programs in 2H 2023. Share in vitro preclinical data in additional liver, eye and neuromuscular programs. First IND filing expected as early as 2024 and additional IND filings anticipated in 2025. Platform: Continue to develop and optimize non-viral and viral delivery systems and share additional proof-of-concept data from in vivo rodent and large animal studies in 2H 2023. Further demonstrate superior "off-target" profiles for Prime Editing programs. Expand Prime Editing using proprietary recombinase and/or retrotransposon technologies for new and existing programs.

07:13 EST Viking Therapeutics completes enrollment in Phase 2b VOYAGE study of VK2809 - Viking Therapeutics announced the completion of patient enrollment in its Phase 2b clinical trial of VK2809, the company's novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis. The company expects to report data for the study's primary endpoint in the first half of 2023.

07:13 EST Trevena enrolls first subject in TRV045 proof-of-concept trial - Trevena announced the enrollment of the first subject in a Phase 1 proof-of-concept study of TRV045, a novel sphingosine-1-phosphate receptor modulator selective for the S1P receptor subtype 1. The Phase 1 clinical study is a randomized, double-blind, placebo-controlled, four-way cross-over study designed to test the mechanism of action and measure evidence of target engagement for TRV045. The study will use a validated set of analgesic tests to evaluate potential central and peripheral nervous system effects and to provide insight into the potential anti-inflammatory actions of TRV045. Twenty-four healthy volunteers will be enrolled and each subject will receive three different single doses of TRV045 and placebo on four separate visits across the study duration. Doses for this study were selected based on the PK exposure determined in the recently completed Phase 1 single and multiple dose ranging study, and bracket the expected targeted efficacy exposure range. Subjects will be enrolled at sites outside of the United States and the study is not being conducted under the Investigational New Drug Application for TRV045. The first subject in the trial was dosed in December 2022 and the study is expected to complete enrollment by mid-2023.

07:12 EST Atea Pharmaceuticals announces 2023 strategic priorities - Atea Pharmaceuticals provided an update on the company's clinical development programs for 2023, including its strategic priorities and expectations for achievement of a variety of milestones. Bemnifosbuvir for COVID-19: SUNRISE-3 Global Phase 3 Registrational Study of Bemnifosbuvir in High-Risk Non-Hospitalized Patients with COVID-19: Patient enrollment continues in the randomized, double-blind, placebo-controlled, global Phase 3 SUNRISE-3 study evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care. The study is designed to enroll at least 1,500 high-risk, non-hospitalized patients with mild or moderate COVID-19, with an expected global footprint of approximately 300 clinical trial sites in the United States, Europe, Japan and rest of the world. Patients will be randomized 1:1 to receive either bemnifosbuvir 550 mg twice-daily plus locally available SOC or placebo BID plus locally available SOC for five days. An interim analysis is expected to be conducted in the second half of 2023. This trial is comprised of two patient population cohorts derived from the type of SOC received. These are 1) "Supportive Care Population" and bemnifosbuvir is evaluated as monotherapy and 2) "Combination Antiviral Population" which will assess combination therapy being bemnifosbuvir plus SOC if the SOC includes treatment with other COVID-19 antivirals. The primary endpoint of the study is all-cause hospitalization or death through Day 29 in the supportive care population in at least 1,300 patients. Secondary endpoints in each cohort include: COVID-19 complications, medically attended visits, symptom rebound / relapse and viral load rebound. The patient population will consist of those at the highest risk for disease progression, including patients greater than or equal to 80 years old, patients greater than or equal to 65 years old with greater than or equal to one major risk factor, and immunocompromised patients greater than or equal to 18 years old, all regardless of COVID-19 vaccination status. COVID-19 Program for Second Generation Protease Inhibitors: As part of a multipronged approach against COVID-19, Atea is advancing an internal program focused on the discovery of second-generation protease inhibitors that have clinical profiles appropriate for combination with bemnifosbuvir for the treatment of COVID-19. Atea's target profile for a protease inhibitor is a compound that is highly potent, has a favorable safety profile with limited drug-drug interactions and does not require a pharmacokinetic booster. The lead optimization of compounds is ongoing for the selection of a candidate that will next enter preclinical toxicology studies. Atea's goal for this program is to file an investigational new drug application / clinical trial application for a lead compound at the end of 2023. The combination of bemnifosbuvir with the protease inhibitor nirmatrelvir was examined in vitro in an HCoV-229E surrogate model and results indicated an additive antiviral effect. These data support the potential benefit of the combination of bemnifosbuvir and a protease inhibitor for the treatment of SARS-CoV-2 infection. AT-752 Program Update for DengueGlobal Phase 2 Dengue Study and Human Challenge Trial: Patient enrollment has been completed for the first cohort in the global Phase 2 DEFEND-2 trial of AT-752 for the treatment of dengue. The randomized, double-blind, placebo-controlled study is designed to evaluate multiple doses of AT-752 in three distinct cohorts and may enroll up to 60 adult patients infected with dengue. The primary objective of the study is to assess antiviral activity, with change from baseline dengue virus viral load as the primary endpoint. In addition, patient enrollment has been completed for the dengue human challenge model. This trial is designed to evaluate the effect of AT-752 in healthy volunteers who were challenged with an attenuated DENV-1 virus strain after receiving AT-752 or placebo. Analysis of data from both studies is underway and proof-of-concept results are expected in the first quarter of 2023. Hepatitis C Virus Program Update: Phase 2 HCV Combination Program: Regulatory submissions for the Phase 2 combination study of bemnifosbuvir and ruzasvir are ongoing. Atea expects to initiate patient dosing of the Phase 2 study during the second quarter of 2023 with initial data anticipated in the fourth quarter of 2023. This study will enroll approximately 280 HCV-infected, direct-acting antiviral naive patients across all genotypes, including a lead-in cohort of approximately 60 patients.Patients will be administered 550 mg bemnifosbuvir in combination with180 mg ruzasvir once-daily for eight weeks. The primary endpoints of the study are safety and sustained virologic response at Week 12 post-treatment. Other virologic endpoints include virologic failure, SVR at Week 24 post-treatment and resistance. Studies conducted by Atea have shown in vitro synergy from the combination of bemnifosbuvir and RZR in inhibiting HCV replication. In January 2022, Atea announced that it had obtained exclusive worldwide rights to develop, manufacture and commercialize RZR, an oral NS5A inhibitor, through a license agreement with Merck.

07:10 EST Emergent BioSolutions announces organizational changes, workforce reductions - Emergent BioSolutions announced a sharpened strategic focus on protecting and enhancing life through its core businesses, consisting of medical countermeasures and commercial products, including NARCAN Nasal Spray, as well as contract development and manufacturing services. Strategic developments include: The appointment of Paul Williams, Emergent's current SVP government/MCM business, as Senior Vice President, Products Business to lead the company's MCM and commercial products business, including NARCAN Nasal Spray. Newly created Science and Development function that unites research, product development, and clinical teams. The S&D function will be led by Kelly Warfield, Senior Vice President, Science and Development, and reporting to Adam Havey, Chief Operating Officer. Elimination of 132 roles related to the S&D consolidation and other organizational changes representing approximately 5% of the current corporate workforce. Due to the realignment of these functions and the sharper focus on our core businesses, the following changes to the executive management team: Departure of Atul Saran, EVP and Chief Strategy and Development Officer, effective March 17. Strategy and Development teams will report to Stephanie Duatschek, Chief Strategy and Transformation Officer. Departure of Katy Strei, EVP and Chief Human Resource Officer, effective March 17. Michelle Pepin is being promoted to Senior Vice President and Chief Human Resource Officer, effective immediately. These actions, in combination with other cost reduction initiatives, are expected to result in annualized savings of over $60 million when fully implemented. The costs associated with these actions are estimated to be approximately $9 million - $11 million and are expected to be incurred in the first quarter of 2023.

07:09 EST Becton Dickinson, CerTest Biotec announce EUA for molecular PCR assay for Mpox - Becton Dickinson and CerTest Biotec have announced Emergency Use Authorization, or EUA, from the FDA for a molecular polymerase chain reaction, or PCR, assay for Mpox virus detection.

07:08 EST Ritchie Bros. acquires controlling stake in VeriTread, terms not disclosed - Ritchie Bros. is excited to announce that it has acquired a controlling stake in VeriTread, a transportation technology and services company. This acquisition will accelerate Ritchie Bros.' marketplace strategy, which brings services, insights, and transaction solutions together to improve the overall customer experience. VeriTread, founded in 2013, brings a legacy of experience in building heavy haul transportation platforms and solutions for industrial equipment, vehicles, and other assets.

07:08 EST Emergent BioSolutions: Chief Strategy & Development Officer Atul Saran to leave

07:07 EST Emergent BioSolutions: Chief Human Resource Officer Katy Strei to leave

07:07 EST Emergent BioSolutions eliminating 132 jobs, or about 5% of corporate workforce

07:02 EST Atai Life Sciences reports 'positive' results from Phase 1 trial of GRX-917 - Atai Life Sciences and its subsidiary GABA Therapeutics, announced final positive results from a Phase 1 clinical trial of GRX-917 that were previously announced as preliminary results during atai's R&D day. The randomized, double-blind, placebo-controlled trial was designed to evaluate the safety, tolerability, and pharmacokinetic profile of single and multiple ascending doses of orally administered GRX-917. Overall, compared to placebo, GRX-917 was well-tolerated and neither dose-related nor dose-limiting adverse events were observed. There were no serious adverse events reported nor discontinuations due to drug administration. Furthermore, in contrast to current first-line anxiety disorder treatments such as benzodiazepines, sedation was found to be comparable to placebo. Dose-dependent increases in qEEG beta power, a biomarker for GABA receptor activation, was demonstrated in subjects who received GRX-917 but not with those who received a placebo, providing evidence of target engagement consistent with GRX-917's putative mechanism of action.

06:57 EST RVL Pharmaceuticals sees Q4 net sales of UPNEEQ about $12.1M - RVL Pharmaceuticals announced preliminary fourth quarter and full year 2022 net product sales of UPNEEQ of approximately $12.1M and $36.5M, respectively. The preliminary fourth quarter 2022 net product sales of UPNEEQ represent a sequential increase of 21% from the third quarter 2022. The company also announced that from February through year-end 2022 it had received orders from approximately 4,300 cumulative unique medical aesthetics practices. "We are proud of our progress in the fourth quarter, notably the continued upward trajectory of net product sales for UPNEEQ. On a full-year basis, we expect our UPNEEQ revenues to exceed $36 million, representing nearly 400% growth over 2021. We are similarly pleased with the continued management of our operating expense base as we have streamlined and simplified our business this past year while driving significant topline growth. This momentum supports our continued enthusiasm about the high growth potential of UPNEEQ. Looking ahead, as our sales team continues to make inroads in establishing the product as a non-invasive part of the daily routine of people with ptosis or droopy eye lids, we expect the rollout of our new eCommerce platform along with the expansion into telemedicine, to further enhance access and awareness for UPNEEQ," stated Brian Markison, CEO of RVL.

06:54 EST Nuvei to aquire Paya Holdings for $9.75 per share in cash, or $1.3 - Nuvei (NVEI) and Paya Holdings (PAYA) announced that they have entered into a definitive agreement whereby Nuvei will acquire Paya in an all-cash transaction at $9.75 per share for total consideration of approximately $1.3B. The transaction has been unanimously approved by each party's Board of Directors, and the Board of Directors of Paya intends to recommend the transaction to Paya's stockholders. Pursuant to the terms of the agreement, Nuvei will commence a tender offer to acquire all outstanding shares of Paya for $9.75 per share in cash (approximately $1.3B of enterprise value. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Paya's outstanding shares, the expiration or termination of the antitrust waiting period, and other customary conditions. Following the successful completion of the tender offer, Nuvei will acquire all remaining shares not tendered in the tender offer through a second-step merger at the same price. The transaction is expected to close by the end of the first quarter of 2023. Nuvei expects to finance the acquisition with a combination of cash on hand, an existing credit facility and a new committed $600M first lien secured credit facility. The proposed transaction is expected to deliver up to $21 million of estimated run-rate cost synergies within 24 months, as well as provide attractive revenue synergy upside potential by bringing Nuvei's global capabilities as additional offerings to Paya's partners and customers. The transaction is expected to be accretive to adjusted EPS in 2023. An investment fund affiliated with GTCR LLC has entered into a tender and support agreement pursuant to which it has agreed, among other things, to tender its Paya shares pursuant to the tender offer, subject to certain conditions. This stockholder currently represents approximately 34% of the outstanding shares of Paya's common stock. The Merger Agreement also includes customary termination provisions for both Nuvei and Paya, and provides that, in connection with the termination of the Merger Agreement under specified circumstances, including termination by Paya to accept and enter into an agreement with respect to a superior proposal, Paya will pay Nuvei a termination fee of approximately $38M.

06:50 EST Liquidia enters Revenue Interest Financing Agreement with HealthCare Royalty - Liquidia announced that it has entered into a Revenue Interest Financing Agreement with HealthCare Royalty for a total investment amount of up to $100 million. Liquidia intends to use the proceeds from the financing to fund the potential launch of YUTREPIA inhalation powder upon final regulatory approval by the U.S. FDA, to support the continued clinical development of YUTREPIA, to provide capital for business development activities directed towards expanding Liquidia's product pipeline and for general corporate purposes.Under the terms of the agreement, Liquidia will receive $32.5 million from HCRx at closing, with the potential to receive three additional tranches of funding: $7.5 million at Liquidia's discretion to support any acquisition of rights to a clinical stage or commercial stage biopharmaceutical product to diagnose, prevent, or treat pulmonary hypertension; $35 million upon a favorable resolution of the ongoing patent litigation with United Therapeutics Corporation or upon earlier, mutual agreement of the parties; and $25 million to be drawn upon the mutual agreement of the parties. Upon closing, Liquidia intends to use approximately $22.3 million from the initial $32.5 million to retire the company's existing term debt with Silicon Valley Bank.

06:44 EST KemPharm names Richard Pascoe as CEO - KemPharm announced changes to its Board of Directors and executive leadership team as part of the company's ongoing business transformation initiatives. Effective immediately, Matthew Plooster, who has been serving as an independent member of the Board of Directors, has been appointed to serve as Chairman of the Board of Directors. Richard Pascoe, who has been serving as Executive Chairman, will transition into the role of CEO and remains a member of the Board of Directors. Travis Mickle, Ph.D., who is co-founder and has been serving as President and CEO, will transition to the role of President and will also remain a member of the Board of Directors until the company's 2023 Annual Meeting of Stockholders. Thereafter, Dr. Mickle will continue to support the Company's pipeline build and the planned resubmission of the arimoclomol New Drug Application as a scientific advisor. Additionally, Joshua Schafer has been appointed to the newly created role of Chief Commercial Officer and Executive Vice President of Business Development.

06:33 EST G. Willi-Food receives noncompliance notification from Nasdaq - G. Willi-Food announced that it received a letter from Nasdaq notifying the company that it is no longer in compliance with Nasdaq Listing Rules 5620(a) and 5620(c) because it did not hold an annual meeting of shareholders within twelve months of the end of the Company's fiscal year-ended December 21, 2021.

06:21 EST High Tide opens first Canna Cabana store in Kamloops, British Columbia - High Tide announced that its Canna Cabana retail cannabis store located at 1055 Hillside Dr, Kamloops, British Columbia has begun selling recreational cannabis products and consumption accessories for adult use. This brings High Tide's total number of branded Canna Cabana locations across Canada to 151, including 7 in British Columbia. This new store represents the first Canna Cabana in the city of Kamloops and is a 15-minute walk from Thompson Rivers University, with an on-campus student population of over 13,000 and a scenic 250-acre campus. The store is also at the base of several hiking trails, and it is located in a shopping complex anchored by a major discount grocer and retailer. Finally, this bricks-and-mortar location is a short drive from Aberdeen Mall, a hub of retail activity in Kamloops.

06:19 EST Ideaya Biosciences announces FDA conclusion that its IDE161 trial may proceed - Ideaya Biosciences, announced that the FDA has completed its safety review of the investigational new drug, or IND, application and concluded that Ideaya s proposed clinical study may proceed to evaluate IDE161 in solid tumors.

06:17 EST Geo Group announces contract in Australia worth about $33M - The GEO Group announced that its Australian subsidiary, GEO Australia, has entered into a contract with the Department of Justice and Community Safety in the State of Victoria for the delivery of primary health services across 13 public prisons. The contract will commence on July 1, 2023, and is expected to generate approximately $33M in incremental annualized revenue for GEO.

06:07 EST Acutus Medical names Takeo Mukai as CFO - The company announced the appointment of Takeo Mukai as Senior Vice President and CFO, effective January 9, 2023. Mukai joined Acutus (AFIB) in July of 2021 as Vice President, Finance, and has progressively expanded his responsibilities over the past 18 months, most recently serving as interim CFO. Prior to joining Acutus, Mukai held roles of increasing responsibility over a 14-year career at Medtronic (MDT).

06:04 EST Ocugen reports 'positive' data from Phase 2/3 trial of COVAXIN - Ocugen announced positive results from the Phase 2/3, observer-blind, immuno-bridging and broadening study of its COVID-19 vaccine candidate, COVAXIN, a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades. COVAXIN, an inactivated virus vaccine adjuvanted with TLR7/8 agonist, has been demonstrated in clinical trials to generate a broader immune response against the whole virus covering important antigens such as S-protein, RBD, and N-protein; whereas currently approved vaccines in the U.S. target only S-protein antigen. Additionally, in contrast to other inactivated vaccines, clinical trials have demonstrated that TLR7/8 agonist adjuvant in COVAXIN generates a Th1-biased immune response that induces robust long-term memory B- and T-cell responses. This study enrolled 419 U.S. adult participants that were randomized 1:1 to receive two doses of COVAXIN or placebo, 28 days apart. Blinded safety results and preliminary unblinded immunogenicity results are available through Day 56, one month following the second vaccination. Immunogenicity results from COVAXIN-vaccinated participants in the U.S. were compared with results in COVAXIN-vaccinated participants in the Bharat Biotech International Limited-sponsored Phase 3 study in India . Approximately 24% of tested participants in the U.S. were vaccine-naive while all participants in the Bharat Biotech Phase 3 study were vaccine-naive. Immune responses were adjusted for differences between the U.S. and Indian cohorts in baseline neutralizing antibody, body mass index, gender, and age. Both co-primary immunogenicity endpoints were met, with the 95% confidence interval for the propensity score-adjusted geometric mean titer ratio well above the non-inferiority limit of 0.667 and the 95% CI for the propensity score-adjusted difference in seroconversion rates well above the non-inferiority limit of -10%. Blinded safety data are also available for one month following vaccination. There were no deaths, related potential immune mediated medical conditions, or related adverse events of special interest. There were also no cases of myocarditis, pericarditis, thrombotic events, or Guillain-Barre syndrome. Thirty medically attended adverse events in 18 subjects and two serious adverse events in one subject were reported, and all were considered unrelated to vaccination.

05:53 EST AstraZeneca to acquire CinCor Pharma for at least $1.3B - AstraZeneca (AZN) has entered into a definitive agreement to acquire CinCor Pharma, Inc. (CINC), a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension as well as chronic kidney disease. The acquisition will bolster AstraZeneca's cardiorenal pipeline by adding CinCor's candidate drug, baxdrostat, an aldosterone synthase inhibitor for blood pressure lowering in treatment-resistant hypertension, AstraZeneca said. Mene Pangalos, Executive Vice President BioPharmaceuticals R&D, AstraZeneca, said: "Acquiring CinCor supports our commitment to cardiorenal disease and further strengthens our pipeline with baxdrostat. Excess levels of aldosterone are associated with hypertension and several cardiorenal diseases, including chronic kidney disease and coronary artery disease and being able to effectively reduce this would offer a much-needed treatment option for these patients." Under the terms of the agreement, AstraZeneca will initiate a tender offer to acquire all of CinCor's outstanding shares for a price of $26 per share in cash at closing, plus a non-tradable contingent value right of $10 per share in cash payable upon a specified regulatory submission of a baxdrostat product. The upfront cash portion of the consideration represents a transaction value of approximately $1.3B and a 121% premium over CinCor's closing market price on 06 January 2023. Combined, the upfront and maximum potential contingent value payments represent, if achieved, a transaction value of approximately $1.8B and a 206% premium over CinCor's closing market price on 6 January 2023. As part of the transaction, AstraZeneca will acquire the cash and marketable securities on CinCor's balance sheet, which totalled approximately $522M as of 30 September 2022.

05:20 EST PowerSchool to open first MEA office in Dubai - PowerSchool announced its accelerated international expansion plans to open its first Middle East & Africa, or MEA, Office in Dubai, United Arab Emirates, or UAE. The UAE office will serve PowerSchool's customer base in the MEA region, as well as support the company's expanding customer relationships in surrounding markets. Additionally, the new office will provide a focal point to help broaden PowerSchool's channel partnerships across MEA markets.

05:11 EST Argenx reports preliminary Q4 Vyvgart revenue $175M - Argenx also announced preliminary global net Vyvgart revenues for the fourth quarter and full-year 2022 of approximately $175M and $402M, respectively. As of December 31, 2022, argenx had approximately $2.2B in cash, cash equivalents and current financial assets*. Based on its current operating plans and a projected 2023 cash burn of approximately $500M, Argenx expects its existing cash, cash equivalents and current financial assets, together with anticipated future product revenues, to fund the company to profitability.

05:05 EST Hyatt opens Hyatt Regency Izmir IstinyePark in Turkey - Hyatt announced the opening of Hyatt Regency Izmir IstinyePark, located in Balcova, a charming district of Izmir and one of the oldest cities in the Mediterranean. Marking the sixth Hyatt branded property in Turkey, and the second Hyatt Regency hotel in the country, its opening demonstrates Hyatt's intentional brand growth in destinations that matter most to its guests and World of Hyatt members.