Stockwinners Market Radar for January 06, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:01 EST Revance announces FDA accepts sBLA for DAXXIFY - Revance Therapeutics announced that the U.S. FDA has accepted for review a supplemental Biologics License Application for DAXXIFY for injection for the treatment of cervical dystonia in adults, a chronic and debilitating neurologic condition affecting the muscles of the neck. Revance was provided a Prescription Drug User Fee Act date of August 19, 2023.

17:16 EST Health Catalyst COO Paul Horstmeier to transition to senior advisor role - Health Catalyst announced that the leadership of the Church of Jesus Christ of Latter-Day Saints has called Paul Horstmeier, Health Catalyst's COO, to serve for three years as the Mission President of the Puerto Rico San Juan Mission, beginning in late June 2023. As a result, Mr. Horstmeier will transition from his full-time position as Chief Operating Officer, effective March 31, 2023, to that of a Senior Advisor. Horstmeier will continue working closely with Dan Burton, CEO of Health Catalyst, to transition his responsibilities to other senior leaders at Health Catalyst in the coming months.

16:56 EST Harmony Biosciences CEO John Jacobs stepping down - Harmony Biosciences Holdings announced that John C. Jacobs is stepping down as President and Chief Executive Officer and a member of the Board of Directors to pursue another opportunity. The Harmony Board of Directors has named Jeffrey M. Dayno, MD, Harmony's Executive Vice President and Chief Medical Officer, as interim CEO effective immediately. Jeff Aronin, Harmony's founder and Board chairman, will continue to lead the Board of Directors as well as provide counsel and guidance to the senior management team through the transition as Executive Chairman.

16:31 EST Hope Bancorp CFO Alex Ko resigns, David Malone named interim CFO - Hope Bancorp announced that Alex Ko has resigned from his position as Senior Executive Vice President and CFO of the company and Bank, effective January 6, 2023, in order to pursue other opportunities. The resignation of Ko did not result from any disagreement with the company, and Ko has agreed to serve as a consultant through March 31, 2023, to assist in the transition process. A formal search has been initiated and until such time when a new CFO is appointed, the company announced that David Malone will step in and serve as interim CFO.

16:15 EST Guardion Health Sciences announces 1-for-50 reverse stock split - Guardion Health Sciences announced that it will effect a 1-for-50 reverse split of its common stock effective as of 4:01 p.m. Eastern Time on January 6, 2023. Commencing with the opening of trading on the Nasdaq Capital Market on January 9, 2023, the company's common stock will trade on a post-split basis under the same symbol GHSI. The reverse stock split was approved by the company's stockholders at the special meeting of stockholders held on January 5, 2023, with the final ratio determined by the Company's Board of Directors. As a result of the reverse stock split, the CUSIP number for the company's common stock will be changed to 40145Q500, and every 50 shares of issued and outstanding common stock will be exchanged for 1 share of common stock, with any fractional shares being rounded up to the next higher whole share. Immediately after the reverse stock split becomes effective, the company will have approximately 1,232,016 shares of common stock issued and outstanding. The reverse stock split is primarily intended to bring the company into compliance with Nasdaq's minimum bid price requirement. However, there can be no assurances that the company will be able to remain in compliance with the minimum bid price requirement over time, or that it will be successful in maintaining compliance with any of the other Nasdaq continued listing requirements.

16:09 EST Flora Growth receives 180 day extension to regain compliance with Nasdaq - Flora Growth announced it received an extension of 180 calendar days from the Nasdaq Stock Market to regain compliance with the Nasdaq's minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550 for continued listing on the Nasdaq Capital Market, following the expiration of the initial 180 calendar days period to regain compliance on January 4, 2023.

16:03 EST Ultragenyx sees 2023 product revenue $425M-$450M - Sees 2023 Dojolvi revenue $65M-$75M. Sees 2023 total Crysvita revenue $325M-$340M.

16:02 EST NuCana receives Nasdaq notice of non-compliance - NuCana announced that it received written notification from The Nasdaq Stock Market dated January 3, 2023, indicating that, based upon a closing bid price of less than $1.00 per share for the company's American Depositary Shares for the prior 30 consecutive business day period, the company no longer satisfies Nasdaq Listing Rule 5450(a)(1). The Notification Letter has no immediate effect on the listing of the ADSs, and they will continue to trade on The Nasdaq Global Select Market under the symbol "NCNA".

15:06 EST Biogen up 7% to $290.76 after FDA approves Leqembi

14:59 EST Biogen to resume trading at 3:05 p.m. ET - Biogen (BIIB) is scheduled to resume trading at 3:05 p.m. ET, with quotation set to resume at 3:00 p.m. ET, according to Nasdaq. Shares were halted, pending news, ahead of the company and partner Eisai (ESALY) announcing that the U.S. Food and Drug Administration has approved lecanemab-irmb, U.S. brand name Leqembi, for the treatment of Alzheimer's disease.

14:39 EST Eisai announces Leqembi U.S. launch pricing at $26,500 per year - Eisai (ESALY) and Biogen (BIIB) announced that under the Accelerated Approval Pathway the U.S. Food and Drug Administration has approved lecanemab-irmb, brand name in the U.S. Leqembi, 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta for the treatment of Alzheimer's disease. Eisai stated: "Based on hhc - human health care - concept, our corporate philosophy, Eisai is committed to improve patients health outcomes and quality of life, simplify care delivery, increase health system efficiency and spur future investments in Alzheimer's disease. We consider a holistic approach in assessing value and making decisions that may affect patient access, so that our Leqembi pricing approach can maximize value for all stakeholders. This approach includes clinical outcome assessments of our medicines and the benefits we deliver to patients, their families and caregivers as the 'clinical value,' as well as the projected 'social value' that help improve patients' and caregivers' quality of life and productivity. Moreover, we assess the simulated impact of our medicines on reducing demand for health services and global burden of disease as potential 'economic value' while enhancing further innovations in AD... While we estimate the per-patient-per-year value of Leqembi treatment to the U.S. society to be $37,600, Eisai decided to price Leqembi below quantified societal value at the wholesale acquisition cost, or WAC, of $26,500 per year, which is an estimated annual price based on 10mg/kg IV biweekly for average U.S. patient weight of 75kg based on Study 201 and Clarity AD, aiming to promote broader patient access, reduce overall financial burden, and support health system sustainability. As such, the WAC for the 200mg vial is $254.81 and the WAC for the 500mg vial is $637.02. Actual annualized pricing may vary by patient. In addition, Eisai continues to pursue a less frequent maintenance dosing regimen for Leqembi, such as monthly instead of current biweekly regimen, upon significant amyloid beta clearance to prevent re-accumulation of amyloid beta biomarkers while maintaining clinical efficacy. This could further lower the yearly cost of Leqembi during the maintenance dosing phase, for example, from $26,500 to potentially about half of this figure given less amount of drugs... The price of Leqembi at a yearly cost of $26,500 is $11,100 below the projected societal value of $37,600, and a less frequent maintenance dosing regimen will further lower the yearly cost well below the projected societal value. Taking these savings as well as discounts and rebates within the U.S. healthcare system into consideration, over 10 years cumulatively, the gradual adoption of Leqembi treatment at this pricing approach could give back about 60% of the potential positive social impact of several tens of billion dollars to the U.S. society."

14:33 EST O'Reilly Automotive names Beckham, Kirby co-presidents - O'Reilly Automotive announced executive leadership promotions. Effective January 9, 2023, Brad Beckham, the company's Executive Vice President and Chief Operating Officer, and Brent Kirby, the company's Executive Vice President and Chief Supply Chain Officer, will each be promoted to Co-Presidents. Beckham and Mr. Kirby will continue to report to Greg Johnson, who currently serves as the company's President and Chief Executive Officer and will remain in his role as CEO but pass on the title and role of President to Beckham and Kirby. Johnson commented, "O'Reilly's promote from within philosophy is a pillar of our Culture and a key driver to our long-term success. We are very fortunate to have Brad and Brent's outstanding executive leadership experience in our Company, and I am extremely confident in their ability to successfully take on these new roles as Co-Presidents. During my time as CEO, Brad and Brent have both been critical members of the O'Reilly leadership team, with Brad leading our store operations and sales and Brent leading our supply chain and omnichannel initiatives. Their extensive experience and significant industry knowledge, combined with that of our long-tenured executive management team, position our Company to drive continued profitable growth long into the future."

14:31 EST Relativity Acquisition Corp trading resumes

14:10 EST FDA grants accelerated approval for Biogen and Eisai Alzheimer's drug - The U.S. Food and Drug Administration approved Leqembi via the Accelerated Approval pathway for the treatment of Alzheimer's disease. "Leqembi is the second of a new category of medications approved for Alzheimer's disease that target the fundamental pathophysiology of the disease. These medications represent an important advancement in the ongoing fight to effectively treat Alzheimer's disease," the FDA stated. "Alzheimer's disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones. This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer's, instead of only treating the symptoms of the disease," said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research. As specified in the prescribing information, Leqembi is indicated for the treatment of Alzheimer's disease. The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials. The labeling also states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations. The approval of Leqembi was granted to Eisai R&D Management.

14:00 EST Biogen trading halted, news pending

13:02 EST Baker Hughes reports U.S. rig count down 7 to 772 rigs - Baker Hughes reports that the U.S. rig count is down 7 from last week to 772 with oil rigs down 3 to 618, gas rigs down 4 to 152 and miscellaneous rigs unchanged at 2. The U.S. Rig Count is up 184 rigs from last year's count of 588 with oil rigs up 137, gas rigs up 45 and miscellaneous up 2. The U.S. Offshore Rig Count is up 1 to 16, flat year-over-year. The Canada Rig Count is up 105 from last week to 189, with oil rigs up 88 to 113, gas rigs up 17 to 76. The Canada Rig Count is up 48 rigs from last year's count of 141 with oil rigs up 35, gas rigs up 13.

12:55 EST Lightjump Acquisition Corp trading resumes

12:28 EST NetEase acquires SkyBox Labs, terms not disclosed - NetEase (NTES) announced that its game division, NetEase Games, has acquired SkyBox Labs, a Canadian-based game studio. SkyBox Labs will continue to operate independently within NetEase Games under the leadership of its three co-founders Shyang Kong, Derek MacNeil and Steven Silvester, and provide a full range of game development services to current and future partners. NetEase will support the studio with resources and execution capabilities so that SkyBox Labs can achieve faster scale while maintaining the quality of work the studio is known for. The Fly notes in addition to making its own titles, SkyBox has been a support studio for Microsoft's (MSFT) "Halo Infinite" and "Minecraft." Reference Link

12:11 EST Google Cloud forms strategic alliance with Government of Kuwait - Google Cloud announced yesterday a strategic alliance with the Government of Kuwait to roll out a comprehensive digital transformation roadmap across governmental entities and key state-owned enterprises. The alliance will enable the Government of Kuwait to leverage Google Cloud's innovative technology and expertise in data analytics, cybersecurity, and artificial intelligence (to deliver on its commitment to make digitization one of its top national priorities in the coming years. As part of the strategic alliance, Google Cloud will work with the Government of Kuwait to digitize citizen services and increase its employees' productivity. Additionally, Google Cloud and the Government of Kuwait will partner to implement a number of digital transformation initiatives in healthcare, education, disaster recovery, and smart living. In collaboration with the Kuwait Direct Investment and Promotion Authority, the Central Agency for Information Technology, and the Communication and Information Technology Regulatory Authority, Google Cloud intends to set up a local office in Kuwait and invest in opening a state-of-the-art cloud region in the country to meet broad demand. The new cloud region will support public sector organizations, businesses, and startups in their digital transformation journeys, which will contribute to realizing Kuwait's ambition to become a data-driven economy. Reference Link

12:00 EST Greenbrier falls -14.0% - Greenbrier is down -14.0%, or -$4.87 to $30.04.

12:00 EST AMTD Digital falls -17.9% - AMTD Digital is down -17.9%, or -$5.35 to $24.60.

12:00 EST JinkoSolar rises 14.8% - JinkoSolar is up 14.8%, or $5.90 to $45.87.

11:20 EST RA Medical Systems Inc trading halted, news pending

10:19 EST WWE trading resumes

10:05 EST NNN Pro Group announces separation from Marcus & Millichap - NNN Pro Group announced its separation from the national brokerage company effective January 1, 2023. Despite the departure, the two companies will continue to maintain a strong working relationship moving forward. The team was founded over 20 years ago by CEO Glen Kunofsky, and is co-managed by COO Nicoletti DePaul. To date, the team has closed on more than $30B of triple-net leased real estate across Retail, Industrial, and Office properties.

10:05 EST Bit Digital announces monthly production update for December - Bit Digital announced its unaudited bitcoin production and corporate updates for the month of December 2022. In December 2022, the company earned 130.0 bitcoins, a 10% decrease compared to the prior month. The decline in production was primarily driven by planned curtailment activities at certain hosting locations. Treasury holdings of BTC and ETH were 946.6 and 8,799.9 with a fair market value of approximately $15.7 million and $10.5 million, respectively, on December 31, 2022. The BTC equivalent of its digital asset holdings as of December 31, 2022 was approximately 1,765.8. The company had cash and cash equivalents of $32.7 million as of December 31, 2022. The company owned 38,593 bitcoin miners and 730 Ethereum miners as of December 31, 2022, with an estimated maximum total hash rate of 2.7 Exahash and 0.3 Terahash, respectively.

10:00 EST Doximity falls -11.9% - Doximity is down -11.9%, or -$3.80 to $28.21.

10:00 EST XPeng falls -16.1% - XPeng is down -16.1%, or -$1.92 to $9.98.

10:00 EST Turkcell rises 13.6% - Turkcell is up 13.6%, or 63c to $5.26.

09:54 EST WWE trading halted, news pending

09:47 EST XPeng falls -11.3% - XPeng is down -11.3%, or -$1.34 to $10.56.

09:47 EST Borr Drilling rises 7.1% - Borr Drilling is up 7.1%, or 34c to $5.13.

09:47 EST WWE rises 12.0% - WWE is up 12.0%, or $8.64 to $80.69.

09:39 EST AMTD Digital Inc - ADR trading resumes

09:29 EST First Business Financial appoints Dave Seller as president - First Business Financial announced promotions among its commercial banking team, advancing key leaders across its Midwest business banking markets. All promotions and board appointments were approved and effective January 3. Dave Seiler has been named president and COO of First Business Financial Services, following six years of service as COO. A nearly 30-year industry veteran, Seiler joined First Business Bank in 2016 and oversees all revenue generating business lines as well as various internal operations areas. Jim Hartlieb has been named president and CEO of First Business Bank and appointed as a director of the First Business bank board. A banker for nearly 30 years, Hartlieb joined First Business Bank in 2009 as senior VP and has served as President since 2015.

09:22 EST Newtek Business Services completes acquisition of National Bank of New York City - Newtek Business Services Corp. announced that on January 6, 2023, it completed its acquisition of the National Bank of New York City and converted to a financial holding company. NBNYC has been renamed Newtek Bank, National Associationvand has become a wholly owned subsidiary of the Company. In addition, Newtek has filed with the Securities and Exchange Commission its notification of withdrawal of election to be subject to the Investment Company Act of 1940, and has ceased to be a business development company as of January 6, 2023. Within the next two weeks, Newtek will change its name from Newtek Business Services Corp. to NewtekOne and will retain its trading symbol. Additionally, in the coming weeks, Newtek will finalize its rebranding initiative, and will relaunch its redesigned corporate website. The Company intends to host conference calls in the coming weeks to discuss these initiatives and financial and operational targets in greater detail.

09:19 EST ODP Corporation, HCLTech enter IT agreement - HCLTech announced that ODP Corporation has selected the company as its primary IT partner. HCLTech will be the IT partner for ODP for end-to-end IT operations and enterprise-wide digital transformation to support ODP's business strategy in its Office Depot, ODP Business Solutions and Veyer business units. As part of this agreement, HCLTech will leverage its automation and artificial intelligence, or AI, capabilities to enable efficient IT operations with personalized and intuitive IT services. ODP will also benefit from HCLTech's vast experience in application modernization and operating model transformation to further evolve as an agile, product-centric IT organization.

09:16 EST Comcast promotes Jason Armstrong to CFO - Comcast announced Jason Armstrong has been promoted to CFO. Armstrong elevates to the position after serving nine years in several financial leadership positions at Comcast, including most recently as deputy CFO and treasurer. He succeeds Mike Cavanagh who was named president of the company in October. As deputy CFO, Armstrong oversaw the treasury and finance functions at Comcast and managed the corporation's capital formation, capital allocation, credit-related matters, and investment management activities, working closely with the management teams across Comcast Cable, NBCUniversal, and Sky. Before that, he served as treasurer of Comcast, as CFO at Sky, and as head of investor relations and finance at Comcast.

09:05 EST Occidental Petroleum's 1PointFive announces agreement with Houston Texans - 1PointFive, a subsidiary of Occidental's Low Carbon Ventures business, announced an agreement and sponsorship with the Houston Texans whereby the Texans have agreed to purchase carbon dioxide removal credits from 1PointFive's first Direct Air Capture plant, which is expected to be operational in late 2024. The CO2 removal credits would allow the Texans to offset the estimated carbon emissions for the team's future air travel to regular season away games for three seasons. "We are excited to work with the Houston Texans and for their purchase of carbon removal credits enabled by Direct Air Capture," said Michael Avery, President and General Manager of 1PointFive. "We believe Direct Air Capture is an efficient way to help reduce an organization's carbon footprint and provides a solution that is particularly well-suited to addressing carbon emissions associated with air travel."

09:04 EST Rumble launches new interface for desktop, mobile web - Rumble announced the launch of its new desktop and mobile web user interface and user experience. The update, which will be rolled out over the next week, improves the look and feel of the Rumble.com website and also features several improvements.

09:03 EST Texas Roadhouse CFO Tonya Robinson retires, Keith Humpich named interim CFO - Texas Roadhouse announced that after more than two decades at the Company, its CFO Tonya Robinson, has retired effective January 4, 2023. The Company's Board of Directors has appointed Keith Humpich, Vice President of Finance, as interim CFO until a permanent successor has been identified. The Company has retained an executive search firm to assist in a formal search for a permanent successor.

09:01 EST Sintx Technologies regains compliance with Nasdaq minimum bid pricing rule - SINTX Technologies announced that it has received notification from the NASDAQ Listing Qualifications Staff notifying the Company that it has regained compliance with NASDAQ's minimum bid price requirements for continued listing on the Nasdaq Capital Market. The notification indicated that because the closing bid price of the Company's common stock having been at $1.00 per share or greater for at least ten consecutive business days, from December 20, 2022 to January 4, 2023, the Company has regained compliance with Listing Rule 5550(a)(2) and the matter is now closed.

08:57 EST iCoreConnect to uplist through FG Merger Corp. combination - iCoreConnect and FG Merger Corp. (FGMC) announced they have entered into a business combination agreement for a business combination that would result in iCoreConnect uplisting from the over the counter, or OTC, market to the Nasdaq, and expecting to trade under the ticker (ICCT). The transaction is expected to deliver up to $82.5M of gross proceeds to the combined company from the FGMC trust account from its initial public offering in February 2022, assuming no redemptions. All references to available cash from the trust account and retained transaction proceeds are subject to any redemptions by the public stockholders of FGMC and payment of transaction expenses. Existing FGMC shareholders who choose not to exercise their redemption rights in connection with the business combination will have 100% of their equity converted into preferred stock of the combined company. The preferred stock will have a 12% coupon payable in cash or paid-in-kind for the first 24 months after the close of the transaction and cash thereafter. The initial conversion price from common stock to preferred stock will be at a conversion price of $10.00 per share. A reset to the holder of $10.00 or 20% above the simple average volume weighted average price will occur 12 months after the closing of the transaction. The reset price can be no greater than $10.00 per share, and no less than $2.00 per share. iCoreConnect common stockholders will receive common stock in the combined company. The transaction has no minimum cash condition, however if the closing cash is less than $20,000,000 then the Sponsor will forfeit any and all dividends accrued on any shares of preferred stock owned by the Sponsor. The transaction, which has been unanimously approved by FGMC's board of directors and the members of iCoreConnect's board, is expected to close in the second quarter of 2023, and is subject to approval by FGMC's stockholders and iCoreConnect's stockholders as well as other customary closing conditions.

08:39 EST Montrose Environmental buys Frontier Analytical Laboratories, terms undisclosed - Montrose Environmental announced the acquisition of Frontier Analytical Laboratories, an environmental laboratory specializing in high-resolution gas chromatography mass spectrometry analysis of Dioxins/Furans, Polychlorinated Biphenyls, and other Persistent Organic Pollutants, or POPs. Frontier's leadership, including VPs Bradley Silverbush and Tom Crabtree, will join Montrose. The business will be integrated into the company's measurement and analysis Segment and operate as part of Enthalpy Analytical, a subsidiary of Montrose. Terms of the transaction were not disclosed. Frontier, formed in 2001, is comprised of a group of chemists/analysts who offer more than 80 years of combined experience in providing mass spectrometry identification and quantification of trace level organic pollutants from a wide array of matrices. Based in El Dorado Hills, California, the Frontier team will now begin working out of Montrose's neighboring Enthalpy laboratory.

08:34 EST Compass announces first patient dosed in Phase 2 U.S. study of CTX-009 - Compass Therapeutics announced that the first patient has been dosed in the Phase 2 U.S. study of CTX-009 in patients with metastatic colorectal cancer who are being treated in the third- and fourth-line setting. "We are very pleased to begin dosing patients with colorectal cancer in the United States. We have previously seen 2 confirmed responses among 6 patients dosed at the projected efficacious doses in a Phase 1 monotherapy study" said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer and Scientific Founder of Compass. "Colorectal cancer patients in whom two of more lines of therapy have failed face very limited treatment options, and we look forward to assessing the potential of CTX-009 in those patients." Preliminary results from this study may become available in mid-2023.

08:33 EST Longeveron provides corporate update, 2023 strategic priorities - Longeveron provided a corporate update highlighting the Company's strategic priorities and anticipated milestones for 2023. 2023 Pipeline Updates and Anticipated Milestones: Hypoplastic Left Heart Syndrome: The ELPIS II trial continues to enroll at 7 clinical sites. ELPIS II is a Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial injection of Lomecel-B in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery. Lomecel-B for HLHS has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration. Longeveron expects to publish the full data from the Phase 1 ELPIS I trial in a peer-reviewed publication in 1Q23. Top-line data from ELPIS I were previously announced in 2021. Aging-Related Frailty: Longeveron expects to enroll the first patient in the Company's Phase 2 clinical trial of Lomecel-B for Aging-Related Frailty in Japan. The Phase 2 clinical trial is a 3-arm, parallel design, randomized, placebo-controlled, double-blind single-infusion study of two different dose levels of Lomecel- B. The primary objective of the study is to evaluate the safety of Lomecel-B(TM) as a treatment for Aging-Related Frailty. The trial is expected to enroll 45 patients. The Phase 2 trial is being conducted in partnership with the National Center for Geriatrics & Gerontology and Juntendo University Hospital and the clinical sites have been activated and patients are being screened for participation. After consultation with the United States Food and Drug Administration, Longeveron may advance a parallel program in the United States. In the near-term, Longeveron is focusing its Aging-Related Frailty resources on clinical development in Japan. Alzheimer's Disease: In November 2022, Longeveron announced the completion of enrollment in a Phase 2a trial of Lomecel-B in patients with mild Alzheimer's Disease. Longeveron expects to release topline data from the Phase 2a trial in early 2024. The Phase 2a trial is a clinical trial of Lomecel-B designed to evaluate the safety of single and multiple infusions of two different dose levels compared to placebo in patients with mild AD.

08:32 EST Astec CEO Barry Ruffalo steps down, Jaco van der Merwe to succeed - Astec Industries announced Barry Ruffalo has stepped down as President and CEO and as a member of the Board of Directors, effective immediately. The Board has appointed Jaco van der Merwe to serve as President and CEO and as a member of the Astec Industries Board of Directors. Mr. van der Merwe joined Astec in 2016 as Group President and currently serves as Group President - Infrastructure Solutions, a role he assumed in 2019.

08:21 EST Ocular Therapeutix provides 2022 update, reviews 2023 milestones - DEXTENZA 0.4mg: Net product revenue of DEXTENZA for the fourth quarter of 2022 is estimated to be $13.6 million, which would represent growth of approximately 14% over the previous quarter and approximately 11% over the fourth quarter of 2021. DEXTENZA net product revenue for the year is estimated to be $50.2 million, which would represent growth of 20% over 2021. The Company believes DEXTENZA remains poised for continued growth in 2023 with continued drug payment in the ambulatory surgery center setting through the non-opioid pain provision and with a focus on the growing ophthalmic surgery market, more than offsetting the loss of reimbursement in the hospital outpatient department setting. OTX-TKI for wet AMD and other retinal vascular diseases: The Company presented positive interim 6- and 7-month data from its U.S.-based Phase 1 trial of OTX-TKI for the treatment of wet AMD at the American Academy of Ophthalmology 2022 Annual Meeting.Interim data showed a single OTX-TKI implant was generally well tolerated with no drug-related ocular or systemic serious adverse events. 80% of subjects in the OTX-TKI arm were rescue-free up to 6 months and 73% of subjects in the OTX-TKI arm were rescue-free up to 7 months. Subjects treated with a single OTX-TKI implant demonstrated stable and sustained best corrected visual acuity and central subfield foveal thickness at 7 months, which was comparable with the aflibercept arm dosed every 8 weeks. The Company intends to present 9-and 10-month interim data at the upcoming Angiogenesis, Exudation, and Degeneration 2023 Meeting at 8:10 am on Saturday, February 11th, 2023, and plans to follow subjects at least until their respective one-year anniversaries of initial dosing, in accordance with the clinical trial protocol. The Company plans to meet with the FDA in early 2023 to discuss potential future clinical trial requirements with the goal of being in position to initiate a Phase 2/3 clinical trial for the treatment of wet AMD as early as Q3 2023, subject to obtaining additional funding for the trial from external sources, including potentially a strategic alliance. OTX-TKI for the potential treatment of Diabetic Retinopathy: The Company believes that the interim 7-month data from the U.S.-based Phase 1 clinical trial evaluating OTX-TKI for the treatment of wet AMD, as well as the product's mechanism of action, support proof of concept for the potential treatment of VEGF-mediated retinal vascular diseases, including diabetic retinopathy. The Company initiated a U.S.-based Phase 1 clinical trial for the treatment of DR in December 2022. This trial will include approximately 10 sites and is designed to include approximately 21 patients randomized 2:1 to either a 600 microgram OTX-TKI single implant containing axitinib or sham control. Subject to the results of this trial, discussions with the FDA and additional financing to fund the trial, the Company believes it could be well-positioned to initiate its first Phase 3 pivotal trial for the treatment of DR as early as Q1 2024. OTX-TIC for the treatment of patients with primary open-angle glaucoma or ocular hypertension: The Company continues to enroll its U.S.-based Phase 2 prospective, multi-center, randomized, controlled clinical trial evaluating the safety, tolerability, and efficacy of OTX-TIC for the treatment of patients with primary open-angle glaucoma or ocular hypertension. The trial is designed to evaluate whether OTX-TIC can demonstrate a clinically meaningful decrease in intraocular pressure while preserving endothelial cell health while enabling repeat dosing. Due to observed elevations in intraocular pressure in the OTX-TIC 5 microgram arm of the trial, the Company has decided to terminate enrollment in the 5 microgram arm of the trial and continue forward with the OTX-TIC 26 microgram and Durysta arms of the trial. The Company expects that the Phase 2 clinical trial will consist of approximately 86 patients: approximately 35 patients in the OTX-TIC 26 microgram treatment arm, 35 patients in the Durysta arm and 16 patients that were previously enrolled in the OTX-TIC 5 microgram treatment arm. The Company plans to provide top-line data from the trial in Q4 2023. OTX-DED: The Company continues to advance both dry eye programs and plans to launch a small study in the first half of 2023 to evaluate the performance of OTX-DED versus fast-dissolving collagen plugs and no inserts at all in order to identify a proper placebo control for any future trials of these product candidates. The Company plans to use the results of this study to inform the next steps for both OTX-DED and OTX-CSI.

08:17 EST DMG Blockchain Solutions mines 104.6 bitcoin in December - DMG Blockchain Solutions announces December 2022 preliminary mining results: DMG mined 104.6 bitcoin with 0.91 EH/s realized hashrate. DMG's bitcoin balance as of December 31, 2022 was 454 bitcoin. DMG nearly reached its bitcoin mining computational capacity goal of 1 EH/s at the end of calendar 2022. As an update on its longer-term mining goals, DMG still plans to implement immersion cooling, from which it expects to achieve up to a 40% hashrate increase. However, the time frame for deployment will likely extend beyond DMG's prior guidance for mid-calendar 2023.

08:14 EST Aquestive Therapeutics provides business update, 2023 objectives - Aquestive Therapeutics provided an update on recent business developments and outlined key 2023 objectives. "In 2023, we plan to focus our resources on the following key initiatives: advancing AQST-109 into a pivotal PK study, continuing to work with the FDA to potentially accelerate the market access for Libervant, exploring new capabilities for our manufacturing business,continuing to expand our base of strategic collaborations with other companies, and strengthening our balance sheet," remarked CEO Daniel Barber. "We are thankful for the collaborations that we have forged with a variety of global companies, including Indivior Inc., Zambon S.p.A., Otter Pharmaceuticals, Mitsubishi Tanabe Pharma America, Inc., Atnahs Pharma UK, Haisco Pharmaceutical Group Co., Ltd., and Hypera S.A. It is worth highlighting that the majority of these collaborations were entered into over the last 24 months. We look forward to securing possible additional collaborations in 2023 as we continue to prioritize our alliance strategies to bringing innovative and, in some cases, life-saving medications to patients." AQST-109: In late December 2022, Aquestive received the final minutes from the End-of-Phase 2 meeting with the United States Food and Drug Administration for AQST-109 for the treatment of severe allergic reactions including anaphylaxis, which provided clarity as to the FDA's expectations regarding key program areas. Aquestive is conducting additional analysis regarding the bracketing of PK performance of approved epinephrine products and plans to finalize its protocol for the pivotal PK trial in the first half of 2023. Aquestive anticipates conducting the pivotal PK study in the second half of 2023, and continues to plan for a potential launch in 2025, if approved by the FDA. Libervant: The Company continues to actively pursue U.S. market access for Libervant Buccal Film. Libervant was tentatively approved by the FDA in August 2022, subject to an Orphan Drug Exclusivity block until January 2027 based on a competing product. The Company provided the FDA with additional clinical data in September 2022 and has been informed that the FDA is reviewing this data. Furthermore, in October 2022, the Company provided the FDA with a draft protocol for a head-to-head comparative PK study of Libervant versus the competing product. This was followed by a publication of a crossover food effect PK study of diazepam nasal spray in the peer-reviewed scientific journal Epilepsia in late November 2022. Commercial Collaborations and Manufacturing: The Company continues to anticipate strong order demand for the manufacture of Indivior's Suboxone Sublingual Film in 2023. In addition, the Company is prepared to support the continued growth of Hypera's Ondif Oral Film in Brazil, Zambon's upcoming launch of riluzole oral film in Europe, and the ongoing marketing efforts of Assertio with Sympazan Oral Film. Furthermore, the Company is currently exploring possible out-licensing opportunities for Libervant in several markets, including the U.S., China, and South America. The Company plans on exploring possible out-licensing opportunities for AQST-109 outside of the United States in 2023. In 2022, the Company completed work to expand its manufacturing capabilities to include serialization and secondary packaging. This expansion allows the Company to support its existing and possible future business collaborations more broadly. With over 90,000 square feet of GMP facilities in Indiana, the Company will continue to explore possible additional manufacturing capabilities in 2023.

08:11 EST OrthoPediatrics establishes direct sales organization in Germany - OrthoPediatrics announced the establishment of its direct sales organization in Germany. OrthoPediatrics GmbH, commencing operations on January 1, 2023. OrthoPediatrics' first direct international organization represents an expanding commitment to support pediatric orthopedics in international markets. "We are proud to establish OrthoPediatrics GmbH, which demonstrates our commitment to helping children across the globe," said Mark Karshner, Senior Vice President of International Sales at OrthoPediatrics. "Having a direct organization in Germany will provide better insights on the unique needs of the pediatric community there, along with additional resources to meet the needs of our expanding customer base. With our growing presence we aim to enhance surgeon relationships and provide a deeper level of service that we believe will ultimately lead to better patient outcomes." With this new direct organization, OrthoPediatrics will be able to establish a deeper connection to the German pediatric orthopedic community, which represents one of the largest orthopedic markets in Europe. OrthoPediatrics GmbH will continue to support the Vereinigung fur Kinderorthopadie through workshops and grants focused on the education of pediatric orthopedic surgeons.

08:10 EST Elys Game Technology completes formal license approval process in Ohio - Elys Game Technology announced that on December 31st the Company's wholly owned subsidiary Elys Gameboard Technologies received approval for Type C sports gaming proprietor licensure from the Ohio Casino Control Commission, OCCC, for a period of 5 years effective January 1, 2023. The commencement of betting transactions in Ohio remains subject to ongoing proprietor suitability and continuous maintenance of compliance requirements of the Ohio Lottery as well as any additional required compliance and certifications for the duration of the license. As previously announced, the Company has commenced programming of its technology platform to comply with betting compliance specifications of the Ohio Lottery and while actively pursuing as many as up to 3,000 potentially approved host locations available, plans to launch the currently signed 100 plus host locations in phases commencing in the first half of 2023 and in time for ensuing major league sports season in mid-August.

08:09 EST Icosavax highlights anticipated milestones for 2023 - Icosavax provided a corporate update and highlighted anticipated milestones for 2023. "We enter 2023 energized by the recent six-month immunogenicity data from our IVX-121 Phase 1/1b study, which we believe provides the first clinical evidence of potential differentiation on durability using Icosavax's VLP platform technology," said Adam Simpson, Chief Executive Officer of Icosavax. "With the Phase 1 trial of IVX-A12 -- our differentiated, bivalent vaccine combination of IVX-121 for RSV and IVX-241 for hMPV -- on track to report topline results in mid-2023, and with our plans to initiate a Phase 2 study of IVX-A12 in the second half of the year, I believe we are poised to make further strides towards our vision of creating pan-respiratory vaccines for older adults." Near-Term Milestone Expectations: IVX-121 Phase 1b extension, 12-month immunogenicity data expected in mid-2023; IVX-A12 Phase 1 topline interim data expected in mid-2023; IVX-A12 Phase 2 initiation expected in 2H 2023; Flu program candidate selection expected in 2023; COVID-19 bivalent candidate selection expected in 2023.

08:08 EST Hurco Companies remains 'committed to evaluating future acquisitions' - CEO Greg Volovic stated, "It is critical that we continue to have a balanced capital allocation strategy that prioritizes a strong balance sheet and optimal liquidity while recognizing the importance of accretive growth and shareholder value We have implemented a two-year stock repurchase plan that we believe will enhance shareholder value and continue to allow us to invest in capital expenditures, make new investments in emerging technologies and research and development, and pay dividends. While we evaluated potential strategic acquisitions during fiscal year 2022, the volatile macroeconomic environment was not conducive to transacting. We remain committed to evaluating future acquisitions and believe that economic downturns will present opportunities to acquire businesses accretive to ours. The ability to return value to shareholders, even during periods of economic uncertainty, is a testament to the company's fiscally responsible culture and long-term growth perspective."

08:07 EST Insmed expects to report 30% global revenue growth for ARIKAYCE in 2022 - Insmed continues to expect full-year 2022 global revenues for ARIKAYCE to increase 30% year over year from 2021. For the full year 2023, Insmed anticipates ARIKAYCE global revenues will be between $285M-$300M. Insmed is advancing the development of ARIKAYCE in a frontline setting of patients newly diagnosed with MAC lung disease, consisting of the postmarketing confirmatory ARISE and ENCORE trials. Enrollment is complete in ARISE and Insmed anticipates sharing topline efficacy and safety data from the study in the third quarter of 2023. The company reported a treatment discontinuation rate in ARISE of 15%, which is less than half the discontinuation rate observed in the pivotal CONVERT trial of ARIKAYCE in patients with refractory MAC lung disease. The company continues to anticipate completing enrollment in ENCORE by the end of 2023.

08:04 EST AirSculpt Technologies announces Rollins to become Executive Chairman - AirSculpt Technologies announced that AirSculpt Founder and current Chief Executive Officer, Dr. Aaron Rollins, will become Executive Chairman of the Board of Directors. Dr. Rollins will be primarily focused on leading the Company's overall vision and providing strategic guidance. In addition, the Company announced today that Todd Magazine has been appointed Chief Executive Officer. Magazine will work closely with Dr. Rollins to develop and execute the company's growth strategy. He will assume CEO responsibilities at the end of January.

08:04 EST Braemar Hotels & Resorts sees Q4 occupancy of 64%, RevPAR of $301 - Braemar Hotels & Resorts reported that the company expects to report occupancy of approximately 64% for the fourth quarter of 2022 with an average daily rate of approximately $469 resulting in RevPAR of approximately $301. This RevPAR reflects an approximate increase of 8% compared to the fourth quarter of 2021 and an approximate increase of 20% compared to the fourth quarter of 2019. Additionally, for the month of December 2022, RevPAR increased approximately 26% versus December 2019. For the month of November 2022, RevPAR increased approximately 15% versus November 2019. For the month of October 2022, RevPAR increased approximately 14% versus October 2019. The preliminary operating information discussed above assumes the 16 hotel properties owned and included in the company's operations at December 31, 2022, were owned as of the beginning of 2019.

08:03 EST Madrigal announces additional results from Phase 2 MAESTRO-NASH trial - Madrigal Pharmaceuticals announced additional results from the pivotal Phase 3 MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. The new MAESTRO-NASH data are being presented at the NASH-TAG Conference, taking place from January 5-7, 2023 in Park City, Utah. In December 2022, Madrigal announced that MAESTRO-NASH achieved both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment NASH with liver fibrosis including: 1- NASH resolution, 2- greater than or equal to 1-stage reduction in fibrosis with no worsening of NAS. New data to be presented at NASH-TAG using a supportive analysis, a "consensus read" by the central pathologists of digitized biopsy images, supplement the positive topline findings and reinforce the strength of results observed in the primary analysis. Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, "In addition to supporting our regulatory filings in the U.S. and Europe, we believe MAESTRO-NASH and the broader MAESTRO Phase 3 program will provide important learnings to advance NASH drug development and gain insight into the NASH patient population. Importantly, the wealth of biomarker and imaging data from the MAESTRO studies will help identify NASH patients in the real world and provide foundation for monitoring treatment response to resmetirom, if approved."

08:01 EST AbbVie, Immunome announce strategic collaboration - AbbVie (ABBV) and Immunome (IMNM) announced a worldwide collaboration and option agreement directed to the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome's Discovery Engine. Under the terms of the agreement, Immunome will grant AbbVie the option to purchase worldwide rights for up to 10 novel target-antibody pairs arising from the selected tumors. Immunome will receive an upfront payment of $30M and will be eligible to receive additional platform access payments in the aggregate amount of up to $70M based on AbbVie's election for Immunome to continue research using its Discovery Engine. Immunome is also eligible to receive development and first commercial sale milestones of up to $120M per target with respect to certain products derived from target-antibody pairs that AbbVie elects to purchase, with potential for further sales-based milestones as well as tiered royalties on global sales.

07:48 EST Fusion Pharmaceuticals reports progress across its pipeline of TATs - Fusion Pharmaceuticals reported continued progress across its pipeline of target alpha therapies and provided recent corporate highlights. Fusion CEO John Valliant, Ph.D., commented, "With three Phase 1 clinical programs developing TATs as next-generation radiopharmaceuticals, Fusion is leading a wave of excitement in the radiopharmaceutical sector. Fusion is poised for an exciting year, with data from the Phase 1 study of FPI-1434 in solid tumors expressing IGF-1R expected in the second quarter. Additionally, we expect to file an investigational new drug application for FPI-2068, our first novel TAT being developed in collaboration with AstraZeneca, in the first quarter of 2023. While advancing our clinical programs, we've continued to focus on ensuring adequate actinium supply, and recently announced a new partnership with established global medical isotope supplier BWXT Medical. We are well positioned to execute on our clinical programs and continue to advance a diversified pipeline of cancer therapies generated through Fusion's internal R&D capabilities and technologies." Highlights: FPI-2068 IND expected to be submitted in the first quarter of 2023. FPI-1434 Phase 1 data expected in the second quarter of 2023. FPI-1966 Phase 1 study open and enrolling patients; Company expects to provide clinical data update in 2024. New actinium-225 partnership with BWXT Medical, a global leader in medical isotope supply, supports growing pipeline opportunities.

07:33 EST Phillips 66 to acquire public common units of DCP Midstream for $41.75 per unit - Phillips 66 (PSX) and DCP Midstream (DCP) announced that they have entered into a definitive agreement pursuant to which Phillips 66 will acquire all of the publicly held common units representing limited partner interests in DCP Midstream for cash consideration of $41.75 per common unit, increasing its economic interest in DCP Midstream to 86.8%. In combination with the previously announced realignment of Phillips 66's economic and governance interests in DCP Midstream, the transaction is expected to generate an incremental $1B of adjusted EBITDA for Phillips 66. In addition, Phillips 66 expects to capture operational and commercial synergies of at least $300M by integrating DCP Midstream into its existing midstream business. Phillips 66 plans to fund the approximately $3.8B cash consideration through a combination of cash and debt while maintaining its current investment grade credit ratings. The transaction is expected to close in the second quarter of 2023, subject to customary closing conditions. The transaction was unanimously approved by the board of directors of DCP Midstream GP, LLC, the general partner of DCP Midstream GP, LP, the general partner of DCP Midstream, based on the unanimous approval and recommendation of a special committee comprised entirely of independent directors after evaluation of the transaction by the special committee in consultation with independent financial and legal advisors. Affiliates of Phillips 66, as the holders of a majority of the outstanding DCP Midstream common units, have delivered their consent to approve the transaction. As a result, DCP Midstream has not solicited and is not soliciting approval of the transaction by any other holders of DCP Midstream common units.

07:27 EST Alterity Therapeutics announces 1-for-10 reverse ADS split - Alterity Therapeutics announced that its Board of Directors approved a ratio change of its American Depository Shares to Ordinary Shares from the current ADS Ratio of 1 ADS representing 60 Ordinary Shares to 1 ADS representing 600 Ordinary Shares. The ADS Ratio Change will be effective on January 9, 2023. Beginning with the opening of trading on Monday, January 9, 2023, Alterity's ADS will continue to trade on the Nasdaq Capital Market under the symbol "ATHE," but will trade on a split-adjusted basis under a new CUSIP number 02155X205.

07:26 EST Enghouse Systems commences 90c per share offer for Qumu - Enghouse Systems announced that its indirect wholly-owned subsidiary, Cosmos Merger Sub, Inc., has commenced its previously announced tender offer for all outstanding shares of common stock of Qumu (QUMU) at a price of 90c per share in cash, for a total equity value of approximately $18M. The tender offer is being made in connection with the Agreement and Plan of Merger, dated as of December 17, 2022, by and among Enghouse Interactive, Inc., Cosmos Merger Sub, Inc. and Qumu, which Enghouse and Qumu announced on December 19, 2022. The Qumu board of directors has unanimously determined that the offer is fair to and in the best interests of Qumu's shareholders and unanimously recommends that the Qumu shareholders accept the offer and tender their shares. The tender offer is scheduled to expire at one minute following 11:59 p.m., New York City time, on February 6, 2023. Certain shareholders, including the directors and executive officers of Qumu, have entered into tender and support agreements with Enghouse committing to tender all of their Qumu shares in the tender offer.

07:22 EST Broadmark Realty Capital receives letter from NYSE regarding warrants - Broadmark Realty Capital announced that it had received a letter from NYSE Regulation indicating that NYSE Regulation has determined to commence proceedings to delist the company's warrants from the NYSE American exchange and that trading in the warrants has been suspended. Specifically, the letter stated that the warrants are no longer suitable for listing based on low selling price levels, pursuant to Section 1001 of the NYSE American Company Guide. The notification letter confirms that the Company's common stock will continue to be traded on the New York Stock Exchange.

07:17 EST Ceva's AFE solution now Alexa Voice Service qualified - Ceva (CEVA) announced that its audio front end software solution has become Alexa Voice Service qualified. The solution, which combines CEVA's ClearVox far-field noise reduction and voice processing software together with WhisPro, voice user interface neural network based keyword spotting software, is a robust, ultra-low power software package ready for integration with AVS-enabled devices such as smart speakers, soundbars and more. AVS is Amazon's (AMZN) cloud-based service that allows device makers to integrate an ever-increasing set of Alexa features and functions into compatible devices. By garnering an AVS qualification for its audio front end software solution, Ceva's semiconductor, ODM and OEM customers can utilize this software solution to seamlessly add Alexa-enabled services to their target device.

07:12 EST Ginkgo Bioworks expands R&D facilities - Ginkgo Bioworks announced the opening of Bioworks7, the latest expansion of its biological engineering foundry. With this new space, Ginkgo increases its capacity and capabilities to serve its partners in the spaces of cell and gene therapy, biomanufacturing and general mammalian programming for therapeutic applications and new biopharmaceutical modalities. Ginkgo's foundry automates and scales the process of organism engineering, allowing engineers to prototype thousands of biological designs. This evolving platform equips companies and labs from startups to large pharmaceutical companies with access to robust technology, without the need to invest in costly lab and R&D infrastructure in-house and aims to drive down the cost per design.

07:11 EST Ceva: Sino Wealth licenses, deploys CEVA's Bluetooth connectivity platform - Ceva announced that Sino Wealth Electronic has licensed and deployed CEVA's Bluetooth connectivity platform - RivieraWaves Bluetooth Low Energy 5 IP in its latest SH87F881X family of connectivity MCUs targeting white goods and the broader Industrial IoT markets.

07:09 EST Aeglea BioTherapeutics announces 15% workforce reduction, COO departure - Aeglea BioTherapeutics announced an update to its corporate structure. These changes are in addition to the restructuring process that was initiated in August 2022 and are intended to further streamline the organization, create operational efficiencies to support near- and long-term objectives and maximize the value of the company's two clinical programs. As part of these additional changes, the workforce of the company has been further reduced by approximately 15%. Aeglea is also halting the preclinical work on the Cystinuria and other unnamed pipeline programs. The company will evaluate potential strategic options for these programs in order to maximize value. In conjunction with these announcements, Cortney Caudill has been promoted from senior vice president of technical operations to chief product officer, effective January 6, 2023. In this expanded role, Caudill will be a strategic leader, team supervisor, and internal advocate for Aeglea's clinical programs, helping the company focus on key deliverables and resource allocation for both Homocystinuria and Arginase 1 Deficiency programs. In addition, Leslie Sloan, Ph.D., will be departing from her role as COO.

07:08 EST Nabriva to focus on preserving cash to fund wind down of operations - Nabriva Therapeutics announced that, after an assessment of strategic options, its Board of Directors approved a plan to preserve cash in order to adequately fund an orderly wind down of the Company's operations. As previously disclosed, the Company engaged Torreya Capital to facilitate the exploration of a range of strategic options, including potential in-licensing or out-licensing of commercial stage assets. While the Company continues to work with Torreya Capital on identifying and evaluating potential strategic options with the goal of maximizing shareholder value, the Company is currently focused on the sale of its existing assets, including Lefamulin and IV Fosfomycin. To preserve cash in order to adequately fund an orderly wind down and enable a sale of its assets, Nabriva plans to terminate all employees, including officers of the Company, not deemed necessary to execute an orderly wind-down of the Company. Nabriva estimates that it will incur approximately $6.0 million for severance and other employee termination-related costs in the first quarter of 2023. The Company also has terminated its agreement with Amplity Health, the contract sales organization responsible for promoting SIVEXTRO and XENLETA, to preserve cash, but will continue to make both products commercially available. The Company expects to transition responsibility for the promotion and distribution of SIVEXTRO back to Merck & Co. Inc. and terminate that agreement over the coming months. In addition, on January 5, 2023, the Company repaid $4.5 million to Hercules Capital, including principal, accrued and unpaid interest, fees and other expenses, under its loan agreement. Effective at the time of repayment, the Hercules loan agreement was terminated, and Hercules released all security interests held on the assets of the Company and its subsidiaries. Nabriva's Board of Directors continues to evaluate alternatives to maximize shareholder value. In the event that the Board of Directors determines that a liquidation and dissolution of the Company pursuant to a Plan of Dissolution to be approved by shareholders is the best method to maximize shareholder value, the Company would file proxy materials with the Securities and Exchange Commission and schedule an extraordinary meeting of its shareholders to seek approval of such a Plan of Dissolution as required.

07:07 EST Aclaris Therapeutics provides corporate outlook for 2023 - Aclaris Therapeutics is providing a corporate outlook for 2023. Clinical Development Programs: Zunsemetinib, an investigational oral small molecule MK2 inhibitor: Rheumatoid Arthritis: This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis is ongoing. Aclaris expects topline data in the second half of 2023. Hidradenitis Suppurativa: This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib over 12 weeks in subjects with moderate to severe hidradenitis suppurativa has completed enrollment with 95 patients randomized and is ongoing. Aclaris expects topline data in mid-first half of 2023. Psoriatic Arthritis: This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib in subjects with moderate to severe psoriatic arthritis (PsA) is ongoing. Aclaris expects topline data by year end 2023. ATI-1777, an investigational topical "soft" Janus kinase 1/3 inhibitor: Atopic Dermatitis: This Phase 2b trial to determine the efficacy, safety, tolerability, and PK of multiple doses and application regimens of ATI-1777 in subjects with moderate to severe AD is ongoing. Aclaris expects topline data mid-year 2023. ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor: Aclaris has selected ulcerative colitis as the intended first clinical development target for ATI-2138. Aclaris is also exploring additional indications that are relevant to the mechanism of action. Aclaris initiated a Phase 1 MAD trial of ATI-2138 in healthy volunteers in December of 2022. Aclaris expects topline data from the MAD trial in the second half of 2023. Preclinical development: ATI-2231, an investigational oral MK2 inhibitor compound: Second MK2 inhibitor generated from Aclaris' proprietary KINect drug discovery platform and designed to have a long plasma half-life. Aclaris expects an IND to be submitted in 2023.

07:05 EST Atlas awarded $15M contract to support GDOT's railroad safety program - Atlas Technical Consultants announced that it was selected by the Georgia Department of Transportation's, GDOT, Railroad Safety Program to provide Engineering & Design and Environmental services related to rail crossings owned by one of the largest Class 1 rail operators in the state. The contract has a maximum value of $15M with an initial term of three years, and an option for a two-year extension. Under the contract, Atlas' technical staff will conduct field inventory of railroad crossings, provide concept, preliminary, and final design plans for prioritized projects, as well as prepare National Environmental Policy Act studies. "Atlas has partnered with GDOT for over 16 years, providing our full portfolio of services to various transit-related markets throughout the state," said Atlas CEO, L. Joe Boyer. "We are excited to continue our work under GDOT's railroad safety program and with major rail operators in our shared efforts to improve the safety and efficiency of Georgia's transportation infrastructure."

07:04 EST Mersana Therapeutics provides business update, expected milestones - Mersana Therapeutics provided a business update and announced strategic objectives and expected milestones for 2023. "Following a year of tremendous accomplishment in 2022, we are now approaching top-line data from our first registrational trial of UpRi, which we believe will provide an opportunity to further demonstrate Mersana's increasing role as an ADC leader," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "The data we expect to report from our UPLIFT clinical trial in mid-2023 will represent the most significant milestone to date in our effort to establish UpRi as a foundational medicine for patients with ovarian cancer. Assuming positive data, we plan to target the submission of a BLA around the end of 2023 and prepare for a potential U.S. commercial launch in 2024. We will also continue to advance our UP-NEXT and UPGRADE-A trials of UpRi in earlier lines of treatment." Strategic Objective: Establish UpRi as a Foundational Medicine in Ovarian Cancer - Expected Milestones: Report top-line data from UPLIFT in mid-2023; Assuming positive data, submit a biologics license application to the U.S. Food and Drug Administration around the end of 2023; Prepare for potential U.S. accelerated approval and commercial launch in 2024; Significantly advance enrollment of UP-NEXT in 2023; and Initiate dose expansion portion of UPGRADE-A in the first quarter of 2023 and report interim data from UPGRADE-A in the second half of 2023. Strategic Objective: Advance Clinical-Stage Pipeline - expected Milestones: XMT-1660: Complete dose escalation portion of Phase 1 clinical trial in 2023; XMT-2056: Initiate Phase 1 clinical trial in the first quarter of 2023. Strategic Objective: Position Mersana as the ADC Partner-of-Choice - Expected Milestones: Pursue impactful new collaborations; Execute against existing collaboration agreements;.

07:02 EST Descartes Systems acquires Supply Vision for $12M - Descartes Systems Group announced that it has acquired Supply Vision, a provider of shipment management solutions for North American Logistics Services Providers, LSPs. "The Supply Vision acquisition complements our recent investments in QuestaWeb, Kontainers and Portrix, as we look to broaden our footprint for LSPs," said Edward Ryan, Descartes' CEO. "We're looking forward to working with the Supply Vision customers, partners and team of domain experts to continue to help LSPs digitize their operations and manage the lifecycle of shipments in a secure, efficient and sustainable manner." Supply Vision is headquartered in Phoenix, Arizona. Descartes acquired Supply Vision for up-front consideration of approximately $12M satisfied with cash on hand, plus potential performance-based consideration. The maximum amount payable under the all-cash performance-based earn-out is $3M, based on Supply Vision achieving revenue-based targets in each of the first two years post-acquisition. Any earn-out is expected to be paid in fiscal 2025 and fiscal 2026.

07:02 EST Casi Pharma, Cleave Therapeutics: Trial application for CB-5339 approved - Casi Pharmaceuticals announces that the China National Medical Products Administration has approved the company's Clinical Trial Application for CB-5339, a first-in-class VCP/p97 inhibitor from Cleave Therapeutics. CASI is planning a Phase 1 development program in China of CB-5339 as a single agent to evaluate the PK/safety profile, select the Recommended Phase 2 Dose, and assess early signs of clinical efficacy. The Phase 1 development program is expected to start in 2023.

06:53 EST Pfizer: FDA accepts for priority review sBLA for 20vPnC - Pfizer announced that the U.S. FDA accepted for priority review a supplemental Biologics License Application for its 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae serotypes contained in the vaccine in infants and children 6 weeks through 17 years of age, and for the prevention of otitis media caused by seven of the 20 Streptococcus pneumoniae serotypes contained in the vaccine. Priority Review designation by the FDA reduces the standard sBLA review period by four months. The Prescription Drug User Fee Act goal date for a decision by the FDA on the 20vPnC vaccine application is anticipated in April 2023. The FDA previously granted Pfizer's 20vPnC Fast Track Designation in May 2017 and Breakthrough Therapy Designation in August 2020 for the pediatric indication for IPD.

06:46 EST Trinity Industries acquires Holden America for $70M - Trinity Industries announced the acquisition of Holden America for an initial purchase price of $70M with an additional minimum of $5M per year for the next two years. This acquisition of Holden, a manufacturer of market-leading multi-level vehicle securement and protection systems, gravity-outlet gates, and gate accessories for freight rail in North America, provides Trinity a market-leading bi-level chock system. Along with Trinity's existing tri-level chock system, this acquisition strengthens Trinity's position as the leading manufacturer of autoracks in North America and allows the company to take advantage of an improving automobile end market. The acquisition closed on December 30, 2022 and is not expected to be material to Trinity's results. Trinity will retain all of the employees of Holden as part of the transaction.

06:43 EST Southwest canceled more than 16,700 flights from December 21-December 31

06:42 EST Southwest expects to report net loss in Q4

06:31 EST Annexon names Dr. Rick Artis as Chief Scientific Officer - Annexon announced that Dean "Rick" Artis, Ph.D., has been appointed as chief scientific officer, succeeding Larry Mattheakis, Ph.D. Dr. Artis most recently served as CSO at Octant Bio and earlier, led efforts at Annexon for the discovery of the company's small molecule classical complement inhibitors, including ANX1502. As CSO of Annexon, Dr. Artis will be responsible for leading all research efforts, with a particular emphasis on the expansion of small molecule research and the further building of the company's robust pipeline.

05:48 EST Shell says natural gas profit to be 'significantly higher' in Q4 vs. Q3 - In a trading update ahead of Q4 earnings, Shell said it expects its Q4 natural gas profit was "significantly higher" than in Q3. The company said it it experienced higher refining margins in its chemicals and fuels business in the last three months of 2022, but that trading profit from refined products will be lower than Q3. Shell said Friday it expects to pay around $2B more in European Union and U.K. energy-profit levies, which won't impact its Q4 adjusted earnings or cash position.

05:19 EST Gaotu Techedu regains compliance with NYSE - Gaotu Techedu announced that the company has received a letter from the New York Stock Exchange, notifying that the Company has regained compliance with the NYSE's continued listing criterion that requires a minimum average stock price of $1.00 per share over a consecutive 30 trading-day period as set forth in Section 802.01C of the NYSE Listed Company Manual.

05:14 EST Enviva issues statement regarding Dutch Parliament motion on biomass - Enviva issued the following statement regarding the Dutch Parliament's motion on sustainably sourced biomass: "Enviva fully supports the principle that financial assistance should only be provided for woody biomass that is sourced sustainably. As a U.S. producer and exporter of wood pellets, complying with all applicable rules and regulations in the markets we operate in is critical to our business. The Netherlands is no exception. The motion passed in Dutch Parliament in mid-December 2022 requests that the Dutch government ensure that subsidies are not awarded to parties that do not comply with sustainability criteria through proper certification. Enviva is in full compliance with the sustainability criteria, which requires extensive independent auditing and certification. Therefore, we do not expect any adverse economic impact on Enviva. We have the utmost confidence that the wood pellets we deliver into the Netherlands meet the Dutch sustainability criteria," said Thomas Meth, President and Chief Executive Officer of Enviva. "Enviva's production is certified by the Sustainable Biomass Program (SBP), annually audited, and has always complied with the Dutch Ministry of Climate's sustainability criteria. On the domestic front, President Biden recently signed into law a $1.7 trillion omnibus spending bill that recognizes forest bioenergy as a renewable energy source, declares it carbon neutral provided the use of forest biomass for energy production does not cause conversion of forests to non-forest use, and directs federal agencies to "recognize the full benefits of the use of forest biomass for energy, conservation, and responsible forest management." The legislation further complements the U.S. government's investment in and support for energy security and climate change resources, as previously seen in the passage of the 2022 Inflation Reduction Act, which utilizes investments and tax credits to incentivize the deployment of wind, solar, and other renewable power sources, including sustainably sourced biomass. As expressed by a spokesperson for Senate Appropriations Committee member Sen. Susan Collins, "Recognizing the carbon neutrality of biomass not only aligns with the science, but also encourages investments in working forests, harvesting operations, bioenergy, wood products, and paper manufacturing."

05:08 EST Virgin Orbit announces LauncherOne system completes end-to-end launch rehearsal - Partners for the United Kingdom's first orbital launch announced that the initial window for the Start Me Up mission will officially open on Monday, January 9 with additional back-up dates continuing into mid and late January. Start Me Up is a collaborative effort between the United Kingdom Space Agency, or UKSA, Cornwall Council, the Royal Air Force, and Virgin Orbit. The Start Me Up mission will carry satellites from seven customers to space, including commercial and government payloads from several nations and a collaborative US-UK mission. The LauncherOne system that will conduct the mission is now mated to its carrier aircraft, a Boeing 747 dubbed Cosmic Girl, at Spaceport Cornwall. Yesterday morning, Virgin Orbit's LauncherOne system successfully completed an end-to-end launch rehearsal, taking the integrated system through to the loading of propellants and proceeding through terminal count, resulting in the verification of the health of the system and readiness of the team.