Stockwinners Market Radar for April 01, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:02 EDT MediciNova 'excited' with results of SPRINT-MS Phase 2b trial subgroup analysis - MediciNova announced results from its subgroup analysis of the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis. This subgroup analysis was conducted based on recent feedback MediciNova received from the FDA that relapsing secondary progressive MS is different from non-relapsing secondary progressive MS as non-relapsing secondary progressive MS is the only type of secondary progressive MS without available therapy. The purpose of the subgroup analysis was to provide information about which types of progressive MS subjects responded best to MN-166 treatment in terms of the clinically significant endpoint of the risk of confirmed disability progression compared to placebo, as measured by EDSS. Confirmed disability progression was a secondary endpoint in this Phase 2b trial but would be considered a primary endpoint in Phase 3. Unlike the magnetic resonance imaging endpoint of whole brain atrophy, which is not a clinical endpoint, confirmed disability progression is the most important clinical endpoint and is the basis for FDA approval of progressive MS drugs. The trends for reduction in the risk of confirmed disability progression were highest for the subgroup of subjects with Secondary Progressive MS without Relapse, in which MN-166 demonstrated a 46% risk reduction compared to placebo as indicated by the hazard ratio of 0.538. Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, "We are excited with the results of our subgroup analysis. Although two drugs have recently received FDA approval for relapsing secondary progressive MS, there remains a very large unmet medical need for secondary progressive MS patients without relapses as there is still no drug approved for long-term treatment of these patients. Based on our extensive analysis of the SPRINT-MS data including this subgroup analysis, we are finalizing the optimal trial design for what we believe will be a very successful Phase 3 program and we plan to submit this trial design to the FDA shortly. With a convenient oral administration, a very favorable safety and tolerability profile, and the potential for better efficacy than other drugs for progressive MS, we believe ibudilast could become the best-in-disease drug."

18:36 EDT Fly Intel: After Hours Movers - UP AFTER EARNINGS: EDAP TMS (EDAP), up 23.4%. ALSO HIGHER: Macy's (M), up 0.5% after naming Dennis Mullahy chief supply chain officer. DOWN AFTER EARNINGS: Energy Focus (EFOI), down 26.1%. ALSO LOWER: Apyx Medical (APYX), down 36.7% after announcing it has voluntarily withdrawn its application for premarket notification 510k regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures... EVO Payments (EVOP), down 5.2% after filing to sell 5M shares of class A stock.

17:36 EDT Care.com corrects recent inaccuracies in the media regarding Its services - Care.com issued the following statement to correct inaccuracies appearing in several recent media reports about the company and its services. Since launching in 2007, Care.com has been focused on helping families find in-home care solutions that best suit their needs. Recent media coverage has reported that Care.com performs no screening on the individuals listed on its site. "To the contrary, we have been conducting various preliminary screenings on all individual caregivers on our site from the start of our service, and in mid-2009 began including as one such screening a search of certain available electronic criminal records...Over the course of 12 years, with more than 1.5M successful matches and strong repeat usage, we believe we have earned the trust of families. " With regard to the removal of unclaimed listings of childcare centers from the site: We provide a directory of childcare centers for families seeking care outside of the home. These directory listings are not our primary offering to our millions of members. However, we believe they provide an important option for families given the predominance of child care deserts and the need for more affordable care solutions. Marketing services revenue from these small and medium-sized businesses that provide childcare services represented less than 0.5% of the Company's total revenue in 2018. In the past, like many digital platforms, we used publicly available and third-party data sources to create free directory listings and provided the opportunity for these businesses to claim and enhance their listing. We have always noted on the site that we do not verify the information about childcare centers and again, encourage families to do their own due diligence to verify the information most important to them, such as licensing, references and the fit of the specific daycare for their child. We recently made the decision to remove unclaimed childcare center listings, representing 45% of the total childcare centers in our database, in order to only include profiles provided or reviewed directly by the childcare center operators."

17:21 EDT Lockheed Martin awarded $2.46B Missile Defense Agency contract modification - Lockheed Martin has been being awarded a $2.46B modification to a previously-awarded contract for the production of terminal high altitude area defense, or THAAD, interceptors and associated one-shot devices to support the U.S. government, or USG, and the Kingdom of Saudi Arabia, or KSA, foreign military sales, or FMS, case requirements. The THAAD interceptors and associated one-shot devices will be procured under fixed-price incentive contract line items. The value of this contract is increased from $1.43B to $3.89B. One offer was solicited with one offer received. The work is expected to be completed by April 1, 2026. FY19 USG procurement funds in the amount of $922.73M and KSA FMS funds in the amount of $1.53B are being obligated at time of award. The Missile Defense Agency is the contracting activity.

17:15 EDT Energy Focus trading resumes

17:06 EDT Standard Motor acquires Pollak business of Stoneridge for $40M - Standard Motor (SMP) has acquired certain assets and liabilities of the Pollak business of Stoneridge (SRI) for approximately $40M, subject to post-closing adjustments. Stoneridge's Pollak business has manufacturing and distribution facilities in Canton, Massachusetts, El Paso, Texas and Juarez, Mexico, and distributes a range of engine management products including sensors, switches and connectors. FY18 net sales volume for this business was approximately $45M. The acquisition was funded through borrowings under its revolving credit facility.

16:59 EDT Apyx Medical dives 45% after updating J-Plasma/Renuvion progress - Shares of Apyx Medical are down 44.6% or $3.10 per share to $3.85 in after- hours trading.

16:48 EDT Energy Focus retains Craig-Hallum to assist in evaluating strategic alternatives - On March 29, 2019, Energy Focus closed a strategic financing from a group of investors. The financing provided gross proceeds to the company of approximately $1.7M in exchange for subordinated convertible promissory notes that will convert into shares of the company's Series A Convertible Preferred Stock on either April 17, 2019 or the day following the company's annual meeting of stockholders, if stockholder approval is needed to allow full conversion of the notes under the Nasdaq market rules. In connection with the financing, the Board of Directors has appointed James Tu and Robert Farkas to join the Board, effective following the company's filing of its Annual Report on Form 10-K. Tu will also return to the position of Chairman, Chief Executive Officer and President and serve as its interim Chief Financial Officer effective April 2, 2019 and the company is conducting a search for a permanent or alternative interim Chief Financial Officer candidate. Prior to, and in parallel with, the discussions with the investor group, the company's Board of Directors retained Craig-Hallum Capital Group to act as its financial advisor to assist in conducting a thorough process to evaluate its strategic alternatives aimed at maximizing shareholder value, including the possible sale of some or all of the company. In connection with this process, the Board of Directors determined that the strategic financing was the most favorable option for the company and its stockholders at this time. In connection with the completion of this strategic process, the company's Chairman of the Board, Chief Executive Officer and President, Ted Tewksbury, and Jerry Turin, the company's Chief Financial Officer since May 2018, resigned from all positions, in each case, effective following the company's filing of its Annual Report on Form 10-K. Also, in connection with the completion of this process, and under the terms of the financing, current Board members, Ron Black, Marc Eisenberg and Satish Rishi resigned at the same time.

16:43 EDT Guardant Health says draft of LCD may expand Guardant360 Medicare coverage - On March 28, Guardant Health announced that Palmetto GBA, a Medicare Administrative Contractor, has posted a draft local coverage determination, LCD, that, if implemented, would expand Medicare coverage of the company's Guardant360 assay from advanced non-small cell lung cancer, NSCLC, to over a dozen advanced solid tumor cancer types with guideline-recommended genomic targets.The draft LCD would apply to advanced cancer patients who are covered by Medicare for next-generation sequencing of tumor tissue, but have insufficient or unavailable tissue samples and are candidates for FDA-approved treatment that is recommended by the guidelines of the National Comprehensive Cancer Network as category 1 or 2A. These cases may comprise a significant percentage of advanced cancers, especially those that have spread to the deep viscera, bone, or brain. Palmetto GBA is expected to finalize and implement the draft LCD after soliciting public comments. There can be no assurances that Palmetto GBA will finalize and implement the draft LCD.

16:37 EDT Marathon Oil signs definitive agreement for third-party gas in Equatorial Guinea - Marathon Oil and its partners announced they have executed the definitive agreements with the government of the Republic of Equatorial Guinea and Alen Unit owners to process Alen Unit gas through Alba Plant's liquefied petroleum gas, or LPG, processing plant and EG LNG's liquefied natural gas, or LNG, production facility, both located in Punta Europa, Equatorial Guinea. Marathon Oil, through its wholly owned subsidiaries, is the operator and majority shareholder of the integrated gas business at Punta Europa. These are proven integrated gas assets with reliability and low capital demands. First gas sales from the Alen Unit is expected in the first half of 2021 and will utilize available processing capacity not required by the Alba Field. Marathon Oil will maintain market exposure through a combination of both profit sharing and tolling. The development also supports a thriving Equatorial Guinea gas industry into the future and will create opportunities for development of Equatoguineans and local enterprise. About 80% of Marathon Oil's total current workforce in EG are national citizens, with approximately 1,250 Equatoguineans employed directly or indirectly across the Punta Europa complex.

16:34 EDT Lincoln Electric acquires Baker Industries, terms not disclosed - Lincoln Electric announced it acquired Baker Industries and related assets. Baker is a privately held Detroit, Michigan-based provider of custom tooling, parts and fixtures primarily serving automotive and aerospace markets. Lincoln Electric's automation revenue is approximately $500M in annualized sales with the addition of Baker Industries. Terms of the transaction were not disclosed.

16:32 EDT Dare Bioscience regains listing compliance on Nasdaq - Dare Bioscience, Inc. announced that it received notice from The Nasdaq Stock Market LLC indicating that the company regained compliance with the minimum bid price requirement in Nasdaq Listing Rule 5550a2 as a result of the closing bid price of the company's common stock being $1.00 per share or greater for the 10 consecutive business day period from March 18, 2019 to March 29, 2019 and that the previously reported non-compliance listing matter is now closed.

16:31 EDT Jason Industries acquires Acquires Schaffner Manufacturing Company for $11M - Jason Industries announced that it has acquired Schaffner Manufacturing Company, a North American manufacturer of high-quality polishing and finishing products, in an all cash transaction valued at $11M. Founded more than 70 years ago, Schaffner develops products for specialized applications including flap wheels, buffing wheels, and buffing compounds, serving a range of industries with annual sales of approximately $20M. It currently operates four manufacturing facilities in Pennsylvania, Michigan, and Mississippi.

16:22 EDT Select Interior Concepts confirms receipt of ADW Capital letter - Select Interior Concepts, Inc. said it received a letter last week addressed to the board of directors from Adam D. Wyden, Managing Member of ADW Capital Partners, L.P. "Consistent with SIC's practice of engaging with our shareholders on a regular basis, members of the Company's Board of Directors and management have had several discussions with ADW Capital Management in recent months to discuss its perspectives," the company said. "The SIC Board of Directors and management team remain confident in the Company's strategic plan to capitalize on its attractive growth opportunities and remain committed to acting in the best interests of the Company to create value over the long-term for all of its shareholders."

16:20 EDT Atara Biotherapeutics presents allogeneic CAR T platform results at AACR - Atara Biotherapeutics presented off-the-shelf, allogeneic CAR T platform preclinical proof-of-concept results at the American Association of Cancer Research, or AACR. Atara engineered EBV-specific T cells to express second-generation CD19 CARs, or EBV.CD19.CAR T, utilizing CD28 or 4-1BB co-stimulatory domains, resulting in high expression of both the CD19 CAR and EBV T cell receptor, or TCR. EBV.CD19.CAR T cells exerted potent and specific cytotoxicity against CD19 or EBV-positive cells and had limited activity against CD19-negative cells, while also depleting alloreactive activity. EBV.CD19.CAR T cells also demonstrated a central memory phenotype that balances expansion with effector function and is associated with persistence. EBV.CD19.CAR T anti-tumor activity was evaluated in vivo in a mouse model of aggressive lymphoma. Following a period of tumor establishment, a single injection of EBV.CD19.CAR T cells significantly inhibited tumor growth.

16:19 EDT Macy's names Dennis Mullahy chief supply chain officer - Macy's announced that Dennis Mullahy has been named chief supply chain officer of the Macy's brand, effective April 8, 2019. In this newly created role, Mullahy will oversee the entire product journey, including global sourcing, inventory management, store and ecommerce distribution, transportation, indirect procurement, supply chain systems, sustainability and supplier diversity. Mullahy will report to Hal Lawton, president of Macy's. Most recently, Mullahy was executive vice president, supply chain and IT at Michaels Stores, Inc., where he was responsible for leading supply chain, information technology and manufacturing.

16:18 EDT FAA expects to receive Boeing's final software fix package in 'coming weeks' - The FAA announced that it expects to receive Boeing's final package of its software enhancement over the coming weeks for FAA approval. "Time is needed for additional work by Boeing as the result of an ongoing review of the 737 MAX Flight Control System to ensure that Boeing has identified and appropriately addressed all pertinent issues. Upon receipt, the FAA will subject Boeing's completed submission to a rigorous safety review. The FAA will not approve the software for installation until the agency is satisfied with the submission," the agency said in an updated statement posted to its website.

16:17 EDT FB Financial announces exit of wholesale mortgage channels - FB Financial Corporation announced that it is restructuring its Mortgage segment through the exit of its wholesale mortgage origination operations. FirstBank has signed an agreement to sell its third party origination channel to Renasant Bank. Upon closing of the transaction, Renasant Bank will assume substantially all of the assets and personnel related to the channel. The agreement is subject to customary closing conditions, including the receipt of any required third party and regulatory approvals. FB Financial expects the transaction to close in the second quarter of 2019. Additionally, FirstBank has entered into a non-binding indication of interest to sell its correspondent channel to a separate unrelated third party. Assuming completion of the transaction, the third party will assume substantially all of the assets and personnel related to the channel. The proposed transaction is subject to, among other things, the potential buyer's additional review of the assets to be purchased, as well as the negotiation and execution of a definitive agreement with respect to the transaction, which will include certain terms and conditions, including customary representations and warranties. Subject to signing of an agreement and final diligence, FB Financial expects the transaction to close in the second quarter of 2019. FB Financial expects to record a restructuring charge of up to $2.5M to cover deal related expenses, severance and other items related to its mortgage operations. Additionally, FB Financial expects its total mortgage operations to record a small pre-tax contribution for the first quarter of 2019, excluding the impact of the aforementioned mortgage restructuring charges, compared to total mortgage operations pre-tax loss of $1.8M in the fourth quarter of 2018.

16:16 EDT C.H. Robinson names Scott Hagen interim CFO, announces segment reporting changes - C.H. Robinson Worldwide, Inc. announced that Scott Hagen, Corporate Controller, will also serve as Interim Chief Financial Officer, effective immediately, while the company completes its search for a permanent CFO. Scott has led C.H. Robinson's accounting and financial reporting teams since 2008. C.H. Robinson also announced that the company has reorganized its enterprise transportation services structure in the first quarter of 2019 to combine its North American Surface Transportation and Robinson Fresh transportation networks. The newly combined transportation network will be managed by and reported under the NAST segment. With this structure change, first quarter 2019 operating results will be based on two reportable segments: NAST and Global Forwarding. Robinson Fresh results will be combined with the Managed Services and Other Surface Transportation segments in the "All Other and Corporate" category. To provide a basis for comparison, the company has provided certain historical segment information under the new segment organization.

16:13 EDT Financial Institutions appoints Justin Bigham CFO - Financial Institutions announced that Justin Bigham was named executive VP, CFO and Treasurer. Kevin Klotzbach, former CFO and Treasurer for the company, was named executive VP, Senior Financial Advisor. Klotzbach will remain with the company through December 31 to ensure a successful transition.

16:10 EDT RA Pharmaceuticals says Phase 2 zilucoplan trial data selected for presentation - Ra Pharmaceuticals, Inc. announced that data from its Phase 2 clinical trial of zilucoplan for the treatment of generalized myasthenia gravis have been selected for an Emerging Science dual oral and poster presentation at the 2019 American Academy of Neurology Annual Meeting in Philadelphia, PA, from May 4 to 10, 2019. The presentation will feature data from the Phase 2, randomized, double-blind, placebo-controlled clinical trial, as well as data from the open-label, long-term extension study.

16:09 EDT Apyx withdraws application for premarket notification 510k submission to FDA - Apyx Medical Corporation announced it has voluntarily withdrawn its application for premarket notification 510k regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures. The company will continue to work with the U.S. Food and Drug Administration relative to the development of a new 510k submission. At the present time, the company cannot provide a timeline for resubmission but intends to do so after further discussions with the Agency.

16:08 EDT Sierra Oncology reports preclinical data for SRA737 - Sierra Oncology announced that preclinical data for SRA737+LDG, its Chk1 inhibitor plus non-cytotoxic low dose gemcitabine, in combination with immunotherapy, are being reported today in a late-breaking oral presentation at the American Association of Cancer Research Annual Meeting 2019 being held in Atlanta, Georgia. "Given the limited response rates for anti-PD-L1 drugs in patients with small cell lung cancer, better treatment options are sorely needed. Our data, showing durable tumor regressions when combining SRA737+LDG with anti-PD-L1 in a mouse model, warrant further clinical studies to investigate the potential of this approach as a strategy to improve outcomes in our patients," said senior researcher Lauren Averett Byers, M.D., Associate Professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, Texas. In the study, SRA737+LDG demonstrated significant anti-tumor activity when combined with anti-PD-L1 in a mouse model of SCLC, resulting in durable tumor regressions. These results were accompanied by an induction of anti-tumor cytotoxic T-cells and M1 macrophages and a corresponding reduction in several pro-tumorigenic cell types in the tumors of drug-treated animals. "The unique replication stress-inducing properties of SRA737 as potentiated by non-cytotoxic low dose gemcitabine have been previously demonstrated to result in intrinsic anti-tumor activity in multiple preclinical models. These striking new data provide evidence for SRA737+LDG's activation of innate immune signaling and the establishment of an anti-tumor immune microenvironment that synergizes with immune checkpoint inhibitors," said Dr. Christian Hassig, Chief Scientific Officer, Sierra Oncology. "These findings provide a mechanistic basis for the growing body of evidence highlighting a synergistic interplay between replication stress and anti-tumor immune responses and afford a compelling rationale for evaluating SRA737+LDG with immunotherapy in the clinic."

16:07 EDT Aveo, Biodesix report 'positive' results from ficlatuzumab-cytarabine trial - AVEO Oncology and Biodesix, Inc. announced results from an investigator-sponsored Phase Ib expansion cohort of ficlatuzumab, AVEO's potent hepatocyte growth factor inhibitory antibody product candidate, in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia. The results were presented in a poster session at the American Association for Cancer Research 2019 Annual Meeting. The presentation, titled, "CyFi: Results from a phase Ib expansion cohort of ficlatuzumab combined with high-dose cytarabine in patients with high risk relapsed or refractory acute myeloid leukemia" is available in the Publications & Presentations section of AVEO's website. Elevated serum HGF level is an adverse prognostic factor associated with worse survival in AML and other cancers. Pre-clinical models have shown that myeloid blasts produce HGF and that blocking the HGF/c-Met pathway sensitizes blasts to cell death. The Phase Ib trial, which was funded by Gateway for Cancer Research and is being conducted at the UCSF Medical Center under the direction of Charalambos Andreadis, M.D., Associate Professor of Clinical Medicine, Director, Clinical Research Support Office, UCSF Helen Diller Family Comprehensive Cancer Center, was designed to assess the safety, tolerability and preliminary efficacy of ficlatuzumab with cytarabine in AML patients who are refractory to first line therapy or have relapsed within one year of induction, a population known to have poor outcomes. The maximally tolerated dose was 20 mg/kg of ficlatuzumab on day 1 followed by 2 g/m2 cytarabine daily on days 2-7. Of 12 patients who received ficlatuzumab and cytarabine at the maximally tolerated dose, one of whom was non-evaluable, 6 achieved a complete response. Of 18 patients enrolled in the study, 17 were evaluable and 9 achieved a CR. The most frequent grade 3/4 treatment emergent adverse events observed were febrile neutropenia, LFT abnormalities, and electrolyte disturbance. There was one death from sepsis and multi-organ failure that was determined to be disease related, and one patient withdrew from the study due to grade 4 gastrointestinal bleed, determined to be likely ficlatuzumab related. scRNA sequencing identified a TNF alpha and IFN gamma inflammatory signature that correlated with response to ficlatuzumab at count recovery.

16:05 EDT Partner Fund Management reports 6% passive stake in Voyager Therapeutics - In a regulatory filing, Partner Fund Management disclosed a 6% stake in Voyager Therapeutics, which represents about 1.96M shares. The filing does not allow for activism.

16:04 EDT Adverum appoints Aaron Osborne MBBS MRCOphth as Chief Medical Officer - Adverum Biotechnologies announced the appointment of Aaron Osborne, MBBS MRCOphth as chief medical officer, effective immediately. Dr. Osborne will serve as a member of the Adverum leadership team and will report to Leone Patterson, chief executive officer of Adverum."Aaron brings to Adverum extensive experience in clinical practice, drug development and global medical affairs. He has been at the forefront of many exciting therapeutic developments for patients in the field of ophthalmology," said Leone Patterson, chief executive officer of Adverum Biotechnologies. "His expertise will be very valuable as we advance ADVM-022, our unique intravitreally delivered gene therapy, in an ongoing clinical trial for wet AMD and extend our clinical development plans into additional ocular VEGF-related indications. We are delighted to have him join the team."

16:02 EDT Bank OZK increases quarterly dividend 4.55% - Bank OZK announced its board has approved a regular quarterly cash dividend of 23c per common share payable April 22 to shareholders of record as of April 15. The dividend of 23c per common share represents an increase of 1c per common share, or 4.55%, over the dividend paid in the previous quarter. Bank OZK has increased its quarterly cash dividend in each of the last thirty-five quarters.

16:00 EDT Energy Focus trading halted, news pending

15:56 EDT Kroger dips after Amazon announces plans for added Whole Foods price cuts - Heading into the close, shares of Kroger (KR) have turned negative after Amazon (AMZN) and Whole Foods Market announce what they called "a third round of price cuts" to begin Wednesday. Amazon's Whole Foods unit, which competes with Kroger, said customers will save an average of 20% on new reduced priced items.

15:43 EDT McDonald's announces investment in mobile engagement software maker Plexure - McDonald's announced an investment in New Zealand-based mobile engagement software maker Plexure, which it said "has played an important role in McDonald's focus on digital transformation, powering a version of McDonald's Global Mobile App in 48 countries outside the U.S. and other markets, including Italy and Japan." The transaction "marks McDonald's first-ever investment in a mobile app vendor and follows its recent announcement to acquire Dynamic Yield, a decision-engine and personalization company," McDonald's added. The investment coincides with an amendment to the existing software service agreement between the two companies, which will extend McDonald's usage of Plexure's technology and set new specifications for service levels and pricing. As part of this agreement, Plexure will not provide similar services to a defined list of competitors in the QSR space, based on certain terms and conditions. Under the terms of the subscription agreement, McDonald's, through an indirect wholly-owned subsidiary, will purchase 13,795,311 shares of Plexure, facilitated through a cash transaction at an issue price of NZ$0.3905, representing a 15% premium over the volume-weighted average price of Plexure shares during March 2019. The cash investment from McDonald's will result in a 9.9% minority stake, of which funds will be used for Plexure's growth and expansion purposes.

15:16 EDT ThornTree Capital reports 6.4% passive stake in Eventbrite - In a regulatory filing, ThornTree Capital disclosed a 6.4% stake in Eventbrite, which represents 738,849 common shares. The filing does not allow for activism.

15:02 EDT CareDx CEO says focus on improving long-term outcomes - In an exclusive interview with The Fly, CareDx (CDNA) CEO Peter Maag talked about the molecular diagnostics company's future: "I think the one area where CareDx is probably going to in the future is the longitudinal data management, with the focus on improving long-term outcomes in patients. Maybe today people see us as a diagnostic company, but going forward it will be very important for us to allow individual and personalized medicine to this very high-cost, high-value patient population. Nobody else cares for the long-term outcome in these patients. The U.S. Healthcare system focuses very much on procedures, where we as a company try to bring this long-term view to patient outcomes." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.

14:31 EDT CareDx CEO says company preparing for more competition - CareDx (CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of diagnostic solutions for transplant recipients, joined The Fly for an exclusive interview. In the interview, CareDx CEO Peter Maag discussed competition and the company's lawsuit against Natera (NTRA): "Natera is trying to cut corners in bringing their solution to the market. We have worked for 7/8 years to build and make this technology available to transplant patients. And now, I think they're trying to adopt a fast follower strategy. I think it's very important to realize that CareDx has relevant IP in the state and that we have established relationships with transplant centers. We're making sure that we are linking ourselves with these 250 transplant centers in the country, being part of their workflow and caring for patients versus being a company that says, 'oh I have one more test and I can do that as well.' This is very critical as we are preparing for more competition in a market, in heart transplant, where we used to be the only company and now there might be other companies coming in the future. So, we are embracing competition." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.

14:17 EDT Apple reports issues with some iCloud services - In notices posted to its System Status page, Apple indicated that some users are being affected by issues with iCloud Drive, iCloud Backup, iWork for iCloud, Photos and iCloud Web Apps. Reference Link

14:03 EDT Piedmont Natural Gas requests general rate review in North Carolina - Piedmont Natural Gas filed a request with the North Carolina Utilities Commission to raise its base rates. Piedmont seeks to recover costs related to system growth, pipeline integrity management, infrastructure investments, and safety and security upgrades. "Customer growth and our commitment to operating a natural gas pipeline system that meets the highest safety and reliability standards required critical investment over the past six years," said Frank Yoho, executive vice president and president, Piedmont Natural Gas. "Upholding these standards is the very foundation of our commitment to our customers and the communities we serve." Piedmont's proposed rate increase of approximately 9%applies to residential, commercial and industrial customers. As a result, Piedmont's average residential customer could expect a monthly bill increase of about $6. If approved, the increase will be less than the rate of inflation since 2013, and monthly bills for the average residential customer will be less than those in 2008 due to the continued low price of natural gas, the company said. Some of this investment is required by the U.S. Department of Transportation and the Pipeline and Hazardous Materials Safety Administration as part of broad pipeline regulations. The remaining investment is related to an increase in Piedmont's customer base and upgrades to the system to help our state and communities continue to grow. Piedmont Natural Gas is a subsidiary of Duke Energy.

13:43 EDT CareDx CEO sees 'measured opportunity' in lung transplant - In an exclusive interview with The Fly, CareDx (CDNA) CEO Peter Maag discussed the company's opportunity in lung transplant: "This is a $50M-$100M revenue opportunity. If you contrast this with a $2B opportunity in kidney transplantation, it's somewhat a measured opportunity, but it is an opportunity to establish this technology also in lung transplantation." CareDx is a molecular diagnostics company focused on the discovery, development and commercialization of diagnostic solutions for transplant recipients. "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.

13:31 EDT Beacon Roofing names Thomas Schmitz as chief accounting officer - Beacon Roofing Supply announced that ThomasSchmitz was appointed its VP and Chief Accounting Officer, effective April 15. Schmitz assumes leadership of Beacon's accounting organization and will oversee all the company's accounting operations. In January, Schmitz was named Beacon's Corporate Controller, assuming responsibility for all the company's regional accounting functions.

13:23 EDT CareDX CEO sees 'much bigger' opportunity in kidney transplant market - CareDx (CDNA) is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant recipients. In an exclusive interview with The Fly, CareDx CEO Peter Maag talked about the company's two commercialized tests that serve an unmet need for non-invasive detection of heart and kidney post-transplant rejection: "Right now, this is a $2B market. We are only 3% penetrated in the kidney transplant market because we only launched maybe 14-15 months ago. We have that product on the market since October 2017 and it's making a huge difference in many 'transplantations lives.' So, 3% penetration is good for a launch and I think that's a very, very strong launch, but there's obviously a much bigger opportunity out there. In our heart transplant product, we have 30% penetration. AlloSure as a level of AlloMap, of our heart product, would be a $600M revenue opportunity which in Diagnostics is a very, very strong product." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.

13:11 EDT Trovagene jumps after reporting results from Acute Myeloid Leukemia trial - Shares of TrovaGene are up 86c, or 23%, to $4.61 following the company's report of new data from its ongoing Phase 1b/2 study evaluating onvansertib in combination with standard-of-care chemotherapy in Acute Myeloid Leukemia, or AML. Objective response rate has been observed at last 3 highest dose levels of onvansertib with 5 of 19 evaluable patients achieving a complete response, the company reported.

13:08 EDT Autolus reports initial results from ALLCAR19 Phase 1/2 trial - Autolus Therapeutics announced that Claire Roddie MB, PhD, FRCPath, honorary senior lecturer, Cancer Institute, University College London, presented initial data from the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult acute lymphoblastic B cell leukemia as a late-breaking poster presentation at the American Association for Cancer Research Annual Meeting. As of the data cutoff date of March 18, 2019 in the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult ALL patients, 13 patients were leukapheresed, and products for 12 patients were manufactured, including 7 with Autolus' semi-automated, fully enclosed manufacturing process. Two patients are pending infusion. Among the 10 infused patients to date, the median age is 41 and 70% were male, with median lines of treatment of 4. Five of the ten treated patients had greater than or equal to 50% BM blasts and were considered to be high-risk for severe CRS. Patients received a split dose based on disease burden for a total dose of up to 410 million cells. Using the Lee criteria, there were no patients with severe CRS, and 2 of 10 patients with Grade 2 CRS. Tocilizumab was used in 2 of 10 patients. None of the patients were admitted to intensive care due to CRS. One patient developed delayed Grade 3 neurotoxicity following high levels of CAR T expansion, which was quickly reversed with steroids. Four patients died while enrolled in the trial, two due to progression of leukemia and two due to sepsis, a common complication of advanced ALL.

13:04 EDT Celldex presents data from its bispecific and TAM receptor programs at AACR - Celldex Therapeutics presented promising data from the company's growing bispecific and TAM receptor programs during poster sessions at the American Association for Cancer Research, AACR, Annual Meeting 2019. "Our research and discovery efforts have yielded multiple promising candidates that address important needs in cancer immunotherapy and complement our pipeline," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "CDX-527 joins two powerful pathways in the immune system, PD-1 blockade and CD27 costimulation. The data we presented at AACR demonstrate that this bispecific antibody candidate has greater activity than the combination of the two individual antibodies and support advancing the program into IND-enabling studies. In addition, we also presented data on our lead candidate antibodies targeting the TAM receptors, which act as checkpoints on myeloid cells. We have uncovered a unique mechanism for antibody-mediated activation of dendritic cells and macrophages and demonstrated that a surrogate MerTK mAb promotes anti-tumor immunity alone and enhances the activity of PD-1 blockade. We look forward to continuing to progress both CDX-527 and our TAM program over the course of the year," concluded Keler.

13:01 EDT Trovagene presents new data from ongoing Phase 1b/2 study of onvansertib

13:00 EDT Natera 'trying to cut corners,' CareDX CEO says

13:00 EDT CareDX CEO sees 'much bigger' opportunity in kidney transplant market

12:57 EDT Vale says 13 structures did not receive DCE renewal - Vale said that 80 Stability Condition Declarations of its operational structures that were to expire on March 31st, 2019 have been renewed. The inactive upstream structures, which emergency levels had already been reevaluated and which Self-Rescue Zones had already been evacuated, did not have their DCEs renewed: Sul Superior Dam of Gongo Soco Mine; B3/B4 dams of Mar Azul Mine; Vargem Grande Dam of Vargem Grande Complex; Forquilha I, Forquilha II, Forquilha III and Grupo dams of Fabrica Complex. Additionally, other structures, with ongoing complementary studies and with the planning of reinforcement works already being carried out, did not have their DCE renewed: Auxiliary Dike of Dam 5 of Aguas Claras Mine; Dike B and Capitao do Mato Dam of Capitao do Mato Mine; Maravilhas II Dam of Vargem Grande Complex; Taquaras Dike of Mar Azul Mine; Mares II Dam of Fabrica Complex; Campo Grande Dam of Alegria Mine; Doutor Dam of Timbopeba Mine; Dike 02 of the Pontal dams system of Itabira Complex; and Dam VI of Corrego do Feijao Mine. These structures were halted and had their emergency levels raised to 1, which does not require the ZAS evacuation. The external auditors reevaluated all available data from the structures and considered new interpretations for calculating safety factors in their analyses, with the adoption of new constitutive models and more conservative resistance parameters. To secure the stability of the structures considering the new auditing parameters and following guidelines from authorities, primarily the ones given by the National Mining Agency, Vale is working with its technicians and international experts to conclude complementary assessments to guarantee that the model used by external auditors is adequate, while planning reinforcement measures to increase these structures safety factor, the company said.

12:52 EDT India based Tata Motors jumps 9% after reporting vehicle sales up 16% in FY19 - Mumbai-based manufacturer of automotive vehicles said that commercial and passenger vehicles business sales in the domestic market for FY19 grew by 16% with 678,486 units as compared to 586,507 units over the same period last year. In March 2019, the Company witnessed its sales drop by 1% to 68,709 units as against 69,409 units sold in March 2018, as weak consumer sentiments continued. Tata Motors commercial vehicles business sales in the domestic market for FY19, recorded a growth of 17% with 468,692 units compared to 399,317 units sold during the same period last year. The CV domestic sales in March 2019, grew by 4% at 50,917 units, compared to 49,174 units sold last year. The market however, continues to exhibit subdued demand on back of lingering effects of liquidity crisis, lag effect of the implementation of revised axle load norms, slowing economy and weak IIP growth index. The base effect is also playing a role in the muted growth of CV industry w.r.t. H2 FY 18. Shares of Tata Motors are up 9% or $1.12 to $13.68 in afternoon trading.

12:49 EDT Catalyst Biosciences receives orphan drug desgination for MarzAA in EU - Catalyst Biosciences announced that the European Commission has awarded orphan designation of its Factor VIIa variant marzeptacog alfa, or MarzAA, for the treatment of haemophilia B. Catalyst has also completed dosing in the Phase 2 portion of the Phase 2/3 subcutaneous trial of MarzAA for the treatment of hemophilia A or B with inhibitors. Nine subjects successfully completed dosing and top-line results will be presented in the third quarter of 2019. "Orphan designation is another important acknowledgement of the significant benefits of subcutaneous MarzAA and will complement our orphan drug designation already granted in the U.S. by the Food and Drug Administration," said Nassim Usman, Ph.D., CEO of Catalyst. "We have completed dosing in the Phase 2 portion of the Phase 2/3 trial for the treatment of hemophilia A or B with inhibitors and have clearly demonstrated efficacy as measured by greater than 90% reduction in annualized bleed rate, as well as bleeding density. We expect to present top-line results from the study in the third quarter of 2019. We also plan to initiate a Phase 3 MarzAA registrational study in 2020 and believe that subcutaneous MarzAA has significant commercial potential in the $2.2B hemophilia inhibitor market."

12:45 EDT Celcuity Inc trading halted, volatility trading pause

12:02 EDT Facebook seeking input on Oversight Board initiative - In a post on Facebook's (FB) Newsroom, Brent Harris, Director of Governance and Oversight Board, wrote, "Every day, teams at Facebook make difficult decisions about what content should stay up and what should come down based on our Community Standards. But given the size of our community -- and the reach of our platform -- we don't think we should be making all of these decisions on our own... Today, we're opening a public consultation process to help us answer questions around the design for this Oversight Board... We're partnering with a team from the firm Baker McKenzie, who are providing project management support for this effort and will review each submission. In June, we'll publish a report summarizing what we've learned through these submissions and in the broader conversations we're having." Reference Link

12:00 EDT Laix rises 14.3% - Laix is up 14.3%, or $1.35 to $10.79.

11:36 EDT Cboe sees Lyft options trading beginning on April 4 - Cboe Global Markets (CBOE) announced it plans to list options on Lyft (LYFT). Cboe anticipates trading in options on Lyft will begin on Thursday, April 4, once the underlying stock has been certified as meeting all of Cboe's applicable exchanges' listing criteria. The company plans to list Lyft options on its four options exchanges - Cboe Options Exchange, Cboe C2 Options Exchange, Cboe BZX Options Exchange and Cboe EDGX Options Exchange.

11:12 EDT Preformed Line Products Co to acquire MICOS TELCOM s.r.o., terms not disclosed - Preformed Line Products announced that it has signed an agreement to acquire MICOS TELCOM s.r.o., a manufacturer of passive components for high-speed telecommunications networks. The acquisition will complement Preformed Line Products' existing portfolio of fiber-optic connectivity devices, including the COYOTE brand of fiber-optic closures and accessories. With MICOS' current concentration on fiber-to-the-home, optical distribution, and datacenter products, the new combined product range will provide a comprehensive line of solutions to support emerging industry technologies like 5G, network densification, and metro fiber rings.

10:36 EDT Syndax updates findings from melanoma, NSCLC cohorts of ENCORE 601 trial - Syndax Pharmaceuticals (SNDX) announced the presentation of updated findings from the melanoma and non-small cell lung cancer, or NSCLC, cohorts of ENCORE 601, the company's Phase 1b/2 trial evaluating the efficacy and safety of entinostat, its once-weekly, oral, small molecule, class I HDAC inhibitor, in combination with Keytruda, Merck's (MRK) anti-PD-1 therapy. The data were presented during oral presentations at the American Association of Cancer Research Annual Meeting. The company presented results from the ENCORE 601 melanoma cohort that enrolled patients whose disease had progressed on or after anti-PD-1 therapy. Of 53 patients treated, a confirmed objective response was observed in 19% of patients per irRECIST criteria, with a clinical benefit rate of 36%. Median duration of response is 13 months. Four responders, all of whom have been on study therapy for over a year, currently remain on treatment. Efficacy results in patients who also received prior Yervoy therapy were consistent with the overall population. The entinostat-pembrolizumab combination was well tolerated with a manageable toxicity profile. Briggs Morrison, M.D., CEO of Syndax, said, "Both indications represent areas of high unmet need and we believe that available data warrant consideration to move the entinostat-pembrolizumab combination into one or more registration trials. As previously communicated, we look forward to determining next steps for the combination program following availability of overall survival results from E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, the next interim readout of which is expected in the second quarter of this year."

10:04 EDT AIG names Rich Baich as chief information security officer - American International Group (AIG) announced that Rich Baich will join the company as SVP, chief information security officer, effective April 22, 2019. In this role, he will lead the firm's global cybersecurity risk management program. He will work closely with AIG's Executive Leadership Team to drive information security strategy for the company. His responsibilities will include defining information security requirements, implementing industry-leading technology solutions and providing oversight on information security risks associated with the roll-out of new technology platforms and systems. He will report to John Repko, AIG's CIO. Baich is joining AIG from Wells Fargo (WFC), where he has served as chief information security officer since 2012.

10:00 EDT Ferro falls -5.0% - Ferro is down -5.0%, or -95c to $17.98.

10:00 EDT ION Geophysical rises 8.6% - ION Geophysical is up 8.6%, or $1.24 to $15.68.

10:00 EDT Laix rises 13.8% - Laix is up 13.8%, or $1.30 to $10.74.

09:47 EDT Daily S&P Biotech Bear 3x Shares falls -3.2% - Daily S&P Biotech Bear 3x Shares is down -3.2%, or -59c to $17.80.

09:47 EDT CSN rises 6.3% - CSN is up 6.3%, or 26c to $4.37.

09:47 EDT Lithium Americas rises 9.0% - Lithium Americas is up 9.0%, or 34c to $4.12.

09:39 EDT Lyft down nearly 9% in early trade to fall below $72 per share IPO price - In early trading on its second day being public, Lyft (LYFT) is down $6.78, or 8.7%, to $71.51. Friday's IPO for the ride-sharing service was priced at $72 per share.

09:37 EDT Aptorum Group appoints Angel Ng as COO - Aptorum Group announced the appointment of Thomas Wai-yip Lee as head of research and development and Angel Siu-yan Ng as COO of Aptorum, effective on April 1, 2019. Lee joined Aptorum in January 2018 as the CEO and CSO of Aptorum Therapeutics Limited, a wholly-owned subsidiary of Aptorum. Ng joined Aptorum in September 2017 as COO of Aptorum Therapeutics Limited. Keith Kwei-hang Chan, CSO of Aptorum, will transition to serve as a key member of the newly formed Scientific Advisory Board, effective on April 1, 2019.

09:25 EDT Navios Acquisition sells C. Dream vessel for $21.75M - Navios Acquisition announced that is has sold the oldest vessel of its fleet, the C. Dream, a 2000-bult VLCC for $21.75M.

09:18 EDT Kratos Defense announces Australian Defence Force acceptance of CH-47F CAT - Kratos Defense (KTOS) announced that the Australian Defence Force has completed all evaluation testing of Kratos' CH-47F Chinook Avionics Trainer, or CAT. The CAT is part of a $9.4M contract by Boeing (BA) Defence Australia in support of the Australian Defence Force that also included two Kratos maintenance blended reconfigurable aviation trainers, or MBRATs, spares packages and lifecycle support services. The Kratos training systems are stationed at The Army Aviation Training Centre in Oakey, Queensland. The CAT and MBRATs at Oakey will, for the first time, establish a local CH-47F Chinook maintenance training capability presence for the Australian military, an activity traditionally conducted in the United States. Kratos will provide on-site and post-delivery support to both the CAT and MBRAT training systems. Both systems provide high fidelity hands-on, full-task and virtual training through simulation of related CH-47F Chinook avionics systems.

09:17 EDT Terreno Realty acquires in Kearny, NJ for $14.1M - Terreno Realty acquired an industrial property in Kearny, New Jersey on March 29, for a purchase price of approximately $14.1M. The property was acquired as partial repayment of the $55M senior secured loan that Terreno Realty Corporation made in 2018, reducing the outstanding loan balance to approximately $16M.

09:09 EDT Eros Now enters into content partnership with Veriown Global - Eros Now announced it entered into a partnership with Veriown. Through this alliance, Eros Now powers Films, Originals and other content on 'The Connect' a product designed and conceptualized by Veriown. The pilot phase for this initiative is expected to begin 2Q19 and will see the markets of Uttar Pradesh and Rajasthan benefitting from clean, affordable and reliable electricity. Soon the product will also be made available to other remote villages across India and overseas.

09:07 EDT China XD Plastics files extension for Annual Report on Form 10-K - China XD Plastics announced that it has filed a Form 12b-25 with the SEC indicating that it will not be in a position to file its Quarterly Report on Form 10-K for the year ended December 31, 2018 within the 15-day extension period provided in Rule 12b-25(b) under the Securities Exchange Act of 1934. The company is in the process of preparing and reviewing the financial information and compiling and disseminating the information to be included in the Form 10-K for the period ended December 31, 2018, as well as the completion of the required review of the company's financial information, none of which could be complete by the date required without incurring undue hardship and expenses. The company expects to file the Annual Report on Form 10-K within the fifteen-day following extension period provided by this Form 12b-25 and new earnings conference call coordinates will be forthcoming and provided in a separate press release prior to the Form 10-K filing.

09:05 EDT Pulmatrix enters term sheet with Cipla Technologies for development of Pulmazole - Pulmatrix announced its entry into a Binding Term Sheet with Cipla Technologies, a subsidiary of Cipla for the co-development and commercialization of Pulmazole - an inhaled iSPERSE formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in patients with asthma. The Binding Term Sheet lays the groundwork for entry into a definitive agreement with Cip Tec during the second quarter. Per the Binding Term Sheet, subject to entry into the definitive agreement, Cip Tec will make an upfront payment of $22M to Pulmatrix in exchange for an assignment of all rights to Pulmazole to Cip Tec. However, following this assigning, Pulmatrix will retain the right to receive 50% of the free cash flow from future sales of Pulmazole. In addition, Pulmatrix will remain primarily responsible for the implementation of the clinical development of Pulmazole and Cip Tec will be responsible for implementation of the commercialization of the product. Entry into a definitive agreement is contingent upon, Pulmatrix having at least $15M in unencumbered funds.

09:01 EDT GlobalSCAPE announces unexpected passing of CEO Matthew Goulet - The Board of Directors of GlobalSCAPE announced with deep sadness, the unexpected death of its President and CEO, Matthew Goulet. GlobalSCAPE's Board of Directors has named Robert Alpert, Chairman of the Board, as Interim CEO while the search for a permanent replacement begins.

08:52 EDT Kellogg to sell Keebler Cookies, related businesses to Ferrero for $1.3B cash - Kellogg announced that it has reached a definitive agreement to sell selected cookies, fruit and fruit-flavored snacks, pie crusts, and ice cream cones businesses to the Ferrero Group and its related companies. The cash transaction is valued at $1.3B and includes brands and assets primarily related to these businesses. Subject to customary closing conditions, including any applicable regulatory approvals, the transaction is expected to close by the end of July. In 2018, these businesses recorded net sales of nearly $900M and operating profit of approximately $75M, including estimated indirect corporate expenses. Assuming the cash proceeds are used only to reduce outstanding debt, the transaction is expected to be less than 5% dilutive to Kellogg's projected 2019 currency-neutral adjusted earnings per share. Kellogg will retain the rest of its North America snacking businesses, including its crackers, salty snacks, wholesome snacks, and toaster pastries brands.

08:46 EDT Scientific Games, Danske Spil extend contract - Scientific Games has strengthened its relationship with Danske Spil, Denmark's national lottery and largest operator, signing an agreement that will see the operator enhance their sportsbook offering for their players. The extension will see SG Digital continue to play an integral role in the delivery of Danske Spil's sports betting offering, having been a trusted partner to the leading Danish operator since 2012. SG Digital has provided Danske Spil with a proven product set, and this extension will see further enhancements to the sportsbook platform to create unrivalled player experiences for Danish sports bettors. The five-year renewal will see Danske Spil benefit from SG Digital's enhanced sportsbook solutions, including a brand new front-end digital user experience with a roadmap of new innovative features. As part of the new revenue share commercial model, Danske Spil will be able to deploy all new product features from SG Digital's roadmap as they're released.

08:41 EDT Future FinTech enters securities purchase agreement with Iliad - Future FinTech announced it has entered into a Securities Purchase Agreement with Iliad Research and Trading on March 26. Pursuant to the Purchase Agreement, the company sold and issued to the Purchaser a Secured Convertible Promissory Note in the principal amount of $1,070,000. The Purchaser purchased the Note with an original issue discount of $50,000, and the company agreed to pay to the Purchaser $20,000 for fees and costs incurred by Purchaser in connection with the consummation of the Purchase Agreement. The Note was sold to the Purchaser pursuant to an exemption from registration under Regulation D, promulgated under the Securities Act of 1933, as amended. The purchase price for the Note will be paid by the Purchaser through an initial cash payment of $500,000 and the issuance of an Investor note to the company with a one-year term and an interest rate of 8%, which the Purchaser agrees to prepay in full upon the satisfaction of certain conditions for pledged shares and transfer agent instruction letter pursuant to the Investor Note and Purchase Agreement.

08:35 EDT Heron Therapeutics: MAA for HTX-011 validated by European Medicines Agency - Heron Therapeutics announced that the Marketing Authorisation Application for its investigational agent, HTX-011, for postoperative pain, was validated by the European Medicines Agency. Validation of the MAA confirms that the submission is complete and starts the EMA's Centralised Procedure. The EMA granted eligibility to the Centralised Procedure for HTX-011 based on it meeting the criteria of a medicinal product constituting a significant scientific innovation. The Centralised Procedure allows applicants to receive a marketing authorisation that is valid throughout the European Union. With the validation of the MAA, an opinion from the EMA Committee for Medicinal Products for Human Use would be anticipated in the first half of 2020.

08:33 EDT Neurotrope appoints Dr. Michael Ciraolo as COO - Neurotrope (NTRP) announced that Michael Ciraolo, J.D., Ph.D., is joining the company as general counsel and COO. Dr. Ciraolo was most recently at Ovid Therapeutics (OVID), where he served as senior vice president, chief intellectual property counsel.

08:32 EDT Amneal Pharmaceuticals enters agreement with Zentiva to divest Creo Pharma - Amneal Pharmaceuticals announced that it has entered into an agreement with Zentiva Group, under which Zentiva has acquired Creo Pharmaceuticals, a subsidiary of Amneal that operates the company's commercial operations in the United Kingdom.

08:20 EDT Outlook Therapeutics announces FDA acceptance of ONS-5010 IND - Outlook Therapeutics announced the FDA acceptance and activation of the investigational new drug, or IND, application for the company's lead product candidate, ONS-5010, an innovative monoclonal antibody, or mAb, therapeutic product candidate being developed for wet age related macular degeneration, diabetic macular edema and branch retinal vein occlusion. The company is now able to begin enrolling patients with wet AMD in the U.S. portion of its ONS-5010-002 Phase 3 clinical trial.

08:16 EDT Teva receives EU marketing authorization for AJOVY - Teva Pharmaceutical Industries announced that the European Commission has granted the Marketing Authorization for AJOVY 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. AJOVY is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor. AJOVY was evaluated in two pivotal Phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylactic treatment for migraine in adults. In these trials, patients treated with fremanezumab had a significantly greater reduction in migraine days compared to placebo. Adverse drug reactions observed with fremanezumab were mostly mild to moderate, short-lasting skin reactions around the injection area: pain, hardening, redness, itching and rash at the injection site. The EC decision is applicable to all 28 EU member states plus Iceland, Norway and Liechtenstein after transposition into legally binding acts in these countries. AJOVY received U.S. FDA approval for the preventive treatment of migraine in adults on 14 September 2018. Additional regulatory filings are underway with other health authorities worldwide.

08:12 EDT Altair acquires SEAM software from Cambridge Collaborative - Altair announced the acquisition of Cambridge Collaborative's SEAM software. The addition of SEAM software to Altair's portfolio of simulation and solver solutions creates a more expansive portfolio for solving engineering problems.

08:09 EDT Transition Networks announces strategic partnership with Verint - Transition Networks announced a strategic partnership with Verint Systems to seamlessly integrate its device management software with Verint's video software management platform for improved control and management of security cameras and other connected devices.

08:08 EDT PolarityTE enrolls patients in trials evaluating SkinTE - PolarityTE announced that patient enrollment has begun for two new randomized controlled trials evaluating SkinTE for the treatment of chronic wounds, specifically diabetic foot ulcers and venous leg ulcers. SkinTE is commercially available through a regional market release and is a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for skin repair, reconstruction and replacement.

08:07 EDT Fate Therapeutics presents data on clonal master engineered iPSC lines - Fate Therapeutics presented late-breaking preclinical data highlighting the company's "unmatched ability to mass produce uniformly engineered chimeric antigen receptor T cells for off-the-shelf cancer immunotherapy" at the American Association of Cancer Research Annual Meeting 2019 in Atlanta, Georgia. New preclinical data presented at AACR for FT819, the company's universal, off-the-shelf CAR19 T-cell product candidate being developed under a collaboration with Memorial Sloan Kettering Cancer Center led by Michel Sadelain, M.D., Ph.D., demonstrate the production of clonal master engineered iPSC lines having complete elimination of T-cell receptor expression and insertion of a novel 1XX CAR signaling domain into the T-cell receptor alpha locus. These synthetic features are intended to mitigate the risk of graft-versus-host disease, a severe life-threatening condition that occurs when donor T cells attack a patient's healthy tissue, and to regulate CAR expression to enhance the therapeutic profile of CAR T cells.

08:05 EDT Iovance Biotherapeutics presents data on T-cell diversity at AACR meeting - Iovance Biotherapeutics announced data from an investigation of the persistence and diversity of circulating T cells from metastatic melanoma patients from the innovaTIL-01 study receiving lifileucel TIL therapy. Results from an analysis of the persisting T cell clones circulating 42 days following infusion, as compared to the initial TIL product, demonstrated two phenomena: first, that TIL product from 100 percent of the evaluated patients in Cohort 2 of the innovaTIL-01 trial are persisting in circulation at 42 days post-infusion, and second, that each patient has a unique TIL product with almost no overlap between patients for expanding clones in the human body observed post-infusion. Furthermore, the small number of overlapping clones between a few patients were not associated with a clinical response. The uniqueness of the clonal profiles associated with response highlights the challenge of identifying a few T cell receptors as mediators of activity and supports using a polyclonal product such as the Iovance bulk TIL to treat high mutational load solid tumors.

08:05 EDT On Track Innovations receives order for 6,000 advanced payment systems in Russia - On Track Innovations announced that it had received a significant order for more than 6,000 advanced payment systems for use in Russian rail ticketing systems. The systems are due to be delivered primarily in the second quarter. This is an additional large-scale order from the Russian market following OTI's successful acceptance of the mandatory MIR certification in the ever-growing Russian self-service market. OTI delivered 11,000 cashless payment systems to Russia in 2018 and expects a higher rate of deliveries in 2019.

08:03 EDT Encompass Health to acquire Alacare Home Health & Hospice, terms not disclosed - Encompass Health announced it has entered into a definitive agreement to purchase substantially all of the assets of privately owned Alacare Home Health & Hospice. Birmingham, Alabama-based Alacare operates 23 home health locations and 23 hospice locations in Alabama and generated revenues of approximately $117M in 2018. The transaction is expected to close in the second quarter of 2019, subject to certain customary closing conditions and regulatory approvals. Encompass Health will fund the purchase with cash on hand and borrowings under its revolving credit facility.

07:59 EDT Lithium Americas updates Cauchari-Olaroz resource to 17.9M tons of LCE - Lithium Americas has announced it entered into a definitive transaction agreement whereby Ganfeng has agreed to subscribe, through a wholly-owned subsidiary, for 141M newly issued shares of Minera Exar, the holding company for the Cauchari-Olaroz lithium brine project, for cash consideration of $160M. As a result of the project investment, Ganfeng will increase its direct and indirect interest in the Cauchari-Olaroz project from 37.5% to 50%, with Lithium Americas holding the remaining 50% interest. Closing of the transaction remains subject to Ganfeng shareholder and regulatory approvals, the consent of BCP Innovation in its capacity as lender pursuant to the company's senior credit facility, the company's shareholder approval and other customary closing conditions. Concurrently herewith, the company updated the measured and indicated mineral resource at its Cauchari-Olaroz project to 17.9M tons of lithium carbonate equivalent, or LCE, at 581 mg/L average grade and the inferred mineral resource to 5.1M tonnes of LCE at 602 mg/L. The updated measured and indicated mineral resource has not been used to update the assumptions in the company's detailed feasibility study. The updated NI 43-101 resource report discloses an approximate 53% increase in the measured and indicated mineral resource from the company's 2018 resource estimate. As part of the transaction, Minera Exar repaid $25M of its outstanding indebtedness to the company.

07:41 EDT Xunlei collaborates with CPCC to build blockchain-powered DCI system - Xunlei announced that the company has cooperated with the Copyright Protection Center of China, or CPCC, to build a blockchain-powered digital copyright identifier, or DCI, system. CPCC is the national copyright public service institution supervised directly by the State Administration of Press, Publication, Radio, Film and Television of the People's Republic of China. CPCC has a DCI system, which plays a significant role in the core infrastructure of the national internet copyright public services. In accordance with the technological cooperation, Xunlei, as a blockchain services provider, will leverage its blockchain technology capabilities to support the operations of CPCC's DCI system, particularly in the area of the copyright registration of fine arts and photographic works.

07:36 EDT Primoris appoints John Moreno as COO - Primoris announced that John Moreno has been hired as its COO. Moreno will take over the role from Tom McCormick, who has been promoted to president of Primoris. David King will continue in the position of CEO. Moreno has over twenty-five years' experience in the engineering and construction industry and has experience in energy-related markets. Since 2000, he has worked at PCL Industrial. He began his tenure at PCL in project services, being steadily elevated to operations manager, general manager, and then promoted to president in 2010.

07:32 EDT Biohaven Pharmaceutical enrolls first patient in Phase 2/3 Trial of BHV-3500 - Biohaven Pharmaceutical announced that it enrolled the first patient in a Phase 2/3, double-blind, randomized, placebo-controlled, dose-ranging trial of intranasally administered BHV-3500 for the acute treatment of migraine. BHV-3500 is a novel, structurally distinct, third-generation calcitonin gene-related peptide receptor antagonist being developed by Biohaven. Topline efficacy and safety results are expected in the fourth quarter.

07:23 EDT Orchids Paper enters option for asset purchase with Orchids Investment - Orchids Paper announced it has entered into an option agreement with Orchids Investment. The Option gives the company the right to execute an asset purchase agreement with OI, through which, should the company exercise the Option, OI would acquire substantially all of the company's assets in exchange for a credit bid of approximately $175M against the company's obligations under its pre-petition secured credit facility plus other consideration. OI is indirectly owned by a fund affiliated with Black Diamond Capital Management, L.L.C. and Brant Paper Investment Company. To facilitate the potential sale and address its debt obligations, the company has initiated proceedings under chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware. The company has filed a bid procedures and sale motion with the Court, and the Purchase Agreement will be subject to an auction at which higher and better offers may be made and will require Court approval. The bid by OI comprises the initial stalking horse bid in the auction process. Subject to the results at auction, the closing of the transaction is subject to the satisfaction of usual and customary conditions, but the company anticipates the transaction will move swiftly and aims to complete the process no later than August 2019.

07:17 EDT Macellum issues letter to Citi Trends shareholders urging change to board - Macellum SPV III, LP, Macellum Advisors GP, LLC, and certain of their affiliates, which own approximately 3.8% of the common Stock of Citi Trends, issued a letter to its fellow stockholders highlighting the urgent need for immediate and significant change to the composition of the board of directors of the company and addressing recent statements made by certain members of Citi Trends' management and Board in the company's March 28th letter.

07:11 EDT Village Farms' Pure Sunfarms doubles targeted annual production - Village Farms announced that its 50%-owned joint venture for large-scale, low-cost, high-quality cannabis production, Pure Sunfarms, has exercised its option on the existing 1.1M square foot Delta 2 greenhouse facility currently owned by Village Farms in Delta, British Columbia. The Delta 2 facility is a newer, nearly identical "sister" facility immediately adjacent to the 1.1 million square foot Delta 3 greenhouse facility, which is already one of the largest cannabis production operations in the world. The addition of the Delta 2 greenhouse operation doubles Pure Sunfarms' total production area to 2.2M square feet and, with conservatively targeted annual production of approximately 75,000 kilograms of dried cannabis, doubles its annual cannabis production potential to approximately 150,000 kilograms. Pure Sunfarms also expects to benefit from further economies of scale resulting from the concentration of 2.2M square feet of production area at a single location, which will further support the company's goal to be the high-quality, low-cost cannabis producer in Canada. The existing automated propagation operation in the Delta 3 facility will provide propagation for the Delta 2 facility, enabling more of the footprint of the Delta 2 facility to be devoted to flower rooms than in Delta 3, which is expected to generate further cost efficiencies. Village Farms also announced that Pure Sunfarms has entered into a subsequent supply agreement with Emerald, which will commence upon the expiry of the current supply agreement at the end of 2019. Under the new supply agreement, Emerald will purchase up to 25% of Pure Sunfarms' production in 2020, 2021 and 2022 at prevailing wholesale market prices.

07:08 EDT Diodes completes acquisition of Texas Instruments' wafer fabrication facility - Diodes Incorporated (DIOD) announced it has completed the transaction to acquire Texas Instruments' (TXN) wafer fabrication facility and operation located in Greenock, Scotland. As previously announced, Diodes will integrate the Greenock facility and fab operations, including the transfer of all GFAB employees to Diodes. In addition, Diodes is extending offers for permanent employment to 18 contractors who have been supporting the GFAB operation. As part of a multi-year wafer supply agreement, Diodes will continue to manufacture TI's Analog products from GFAB as TI transfers into its other wafer fabs. The 318,782 square-foot facility has a potential capacity of up to 21,666 wafer starts or 256,000 8" equivalent layers per month, depending on product mix.

07:07 EDT Maxar Technologies' MDA signs C$4M contract with Lockheed Martin - MDA, a Maxar (MAXR) company, announced that it has signed a C$4M contract with Lockheed Martin Canada (LMT) for the initial phase of design work for the Canadian Surface Combatant ship's Electronic Warfare system. Lockheed Martin Canada was selected as the winning bidder for the CSC program by Irving Shipbuilding. Irving Shipbuilding is the CSC Prime Contractor and will build 15 ships at Halifax Shipyard. This design work is expected to become the basis for the manufacture, integration, installation and commissioning of the Electronic Warfare equipment on the Royal Canadian Navy's next-generation CSC ships.

07:05 EDT Salix Pharmaceuticals enters license agreement with University Of California - Salix Pharmaceuticals announced its affiliate has entered into a license agreement with the University of California via UCLA's Technology Development Group for certain intellectual property relating to an investigational compound targeting the pituitary adenylate cyclase receptor 1 in non-alcoholic fatty liver disease, non-alcoholic steatohepatitis and various other gastrointestinal and liver diseases.

07:04 EDT Pacific City Financial announces $6.5M stock repurchase plan - Pacific City Financial, the bank holding company for Pacific City Bank, announced that on March 28, 2019, its board approved the repurchase of up to $6.5M of the company's common stock through March 27, 2020. Under the stock repurchase program, the company may purchase shares of its common stock through various means such as open market transactions, including block purchases, and privately negotiated transactions As part of the stock repurchase program, the company is entering into a trading plan adopted in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended. The 10b5-1 trading plan would permit common stock to be repurchased at a time that the company might otherwise be precluded from doing so under insider trading laws or self-imposed trading restrictions. The 10b5-1 trading plan is administered by an independent broker and is subject to price, market volume and timing restrictions.

06:58 EDT VF Corp. files Form 10 registration statement for separation of Kontoor Brands - VF Corporation announced the public filing of a Form 10 Registration Statement with the U.S. SEC in connection with the previously announced separation of VF's Jeanswear organization into an independent, publicly traded company. The new company, named Kontoor Brands, will include the Wrangler, Lee and Rock & Republic brands, and the VF Outlet business. The filing provides detailed information on Kontoor Brands' business, strategy and historical financial results. The separation is on track to be completed in May, subject to final approval by VF's Board of Directors, customary regulatory approvals, and tax and legal considerations.

06:56 EDT Discovery to take full ownership of UKTV's lifestyle channels - Under the terms of the UKTV deal, which is expected to complete in late Spring 2019, Discovery takes full control of lifestyle channels Good Food, Home and Really, in line with its editorial strategy and further strengthening its global leadership position in factual entertainment. Discovery has an existing portfolio of 16 channels in the UK including Discovery Channel, TLC, ID, Animal Planet, Eurosport, Quest and Quest Red and the Quest OD video-on-demand service. Following completion, James Gibbons, EVP, GM, UK/IRL/ANZ and Commercial Development, Discovery EMEA, will manage the lifestyle channels as part of Discovery's UK portfolio. BBC Studios acquires the remaining seven channels - Alibi, Dave, Drama, Eden, Gold, Yesterday and W - along with digital player UKTV Play, and the UKTV brand. These channels are the most closely aligned to its own content strategy and supply, with BBC programmes currently delivering around half the viewing for these seven channels, and accounting for around 95% of BBC Studios' content on UKTV. Following these changes, the entertainment channels will continue to operate under the UKTV brand out of UKTV's offices and BBC Studios will look to grow investment into UK programming, including original content, for the channels it will own. Following completion, Marcus Arthur, President, UK, Ireland and ANZ, BBC Studios Distribution, will also assume the role of CEO, UKTV. Marcus Arthur, who joined BBC Worldwide in 1991, has previously held the roles of Managing Director, BBC Magazines and MD, Global Brands and New Ventures, and sits on the UKTV Board. As part of the UKTV agreement, BBC Studios will make payments totalling GBP173M to Discovery. This includes a balancing payment in relation to the channels acquisition and the assumption of GBP70M of debt, currently financed by Discovery. This will be financed through existing borrowing facilities. Discovery will also receive at least an additional GBP10M from UKTV, as the parties will share the existing cash on the company's balance sheet, reflecting outstanding dividend, and other ancillary value transfers to Discovery through the transaction. BBC Studios and Discovery have also agreed a short-term Programme Licensing Agreement for the supply of BBC Studios lifestyle content to Discovery's UKTV channels in the UK.

06:53 EDT Discovery, BBC sign major global content partnership - Discovery (DISCA, DISCB) and BBC Studios jointly announce a series of agreements, reigniting their relationship with a significant multi-million pound global content partnership spanning a library of premium factual series to power a new global streaming service, and a bespoke development deal for BBC Studios' iconic genres of natural history, animals, adventure, science, travel, space, history and civilization documentaries. Additionally, the two companies have concluded the future of UKTV's channels business in the UK with a structured split that complements the strategic focus and commercial business of both organizations. The new ten-year content partnership, effective in all territories outside the UK, Ireland and Greater China, will make Discovery the exclusive global home of BBC landmark natural history programmes in SVOD, including the Planet Earth, Blue Planet and Life collection of titles, the recently lauded Dynasties and others, as well as future BBC-commissioned landmark series from BBC Studios, following their linear transmission. Discovery also acquires SVOD rights to hundreds of hours of BBC programming across factual genres. All of this iconic content will form one of the pillars of a new global streaming service, which will also include some of the best of Discovery's programming library, original content created for the service, and experiences and offerings that go well beyond video. The service will launch by 2020 and will form a key part of Discovery's unique and growing portfolio of direct-to-consumer services that will enable fans to 'view and do.' These services will also be made available to distribution partners for retail. Discovery and BBC Studios have also signed a bespoke development deal to create new landmark factual content for Discovery that furthers audiences' discovery of the world for both linear and digital distribution. This deal reunites the two media and entertainment brands that worked together on unrivalled natural history series such as Planet Earth, Walking with Dinosaurs, Life and Blue Planet. The two companies will co-fund a dedicated development team within BBC Studios. m

06:51 EDT NovaBay announces investments of $5M to support U.S. Avenova strategy - NovaBay announces investments totaling $5M to support the recent strategic shift in its U.S. commercialization strategy aimed at driving growth in Avenova sales while maintaining cost effectiveness. The investments include a convertible loan of $2M from Ascendiant Capital Markets and Chicago Venture Partners. Additionally, Triton Funds LP has committed to making an equity investment of up to $3M.

06:44 EDT Orchids Paper trading halted, news pending

06:42 EDT Cal-Maine Foods CEO says 'market prices for shell eggs have been volatile' - Dolph Baker, chairman and CEO of Cal-Maine Foods stated, "Cal-Maine Foods had a solid financial and operating performance for the third quarter of fiscal 2019, supported by favorable demand trends and continued growth of our specialty egg business. The decline in net sales compared to the prior-year quarter reflects lower average market prices and the timing of the Easter holiday. In fiscal 2018, the Easter holiday occurred three weeks earlier and was preceded by a strong pre-holiday sales bump in our third quarter. Market prices for shell eggs have been volatile, with the Southeast large market average price down 19.5 percent in the third quarter compared with the prior-year quarter. At the same time, our average customer selling price for the quarter, due to the strength of our specialty egg business, was down 11.1 percent. While demand trends have been strong throughout fiscal 2019, with near record per capita U.S. egg consumption, we believe future supply concerns are affecting market prices. Actual hen numbers from the March 2019 USDA report are 336.1 million, up 1.7 percent over last year. These numbers continue to trend upwards and could negatively affect market prices for our fourth fiscal quarter and on through calendar 2019. Specialty eggs, excluding co-pack sales, accounted for 24.7 percent of our sales volumes for the third quarter, compared with 24.3 percent a year ago. Specialty egg revenue was 35.0 percent of total shell egg revenue, compared with 30.2 percent for the third quarter of fiscal 2018, reflecting slightly higher volumes and a 2.1 cent per dozen increase in average selling price for specialty eggs compared with the prior-year period. Specialty eggs remain a primary focus of our growth strategy, and we strive to offer a favorable product mix that reflects current demand trends. As the egg industry prepares for the expected continued increase in demand for cage-free eggs, we are working closely with our customers to ensure their needs are met through this transition."

06:40 EDT Air Lease delivers first of five new Boeing 787-9 aircraft to China Southern - Air Lease (AL) announced the delivery of one new Boeing (BA) 787-9 aircraft on long-term lease to China Southern Airlines. Featuring GEnx-1B76A engines, this aircraft is the first of five 787-9 Dreamliner aircraft scheduled to deliver to China Southern Airlines through 2020 from ALC's order book with Boeing.

06:37 EDT Owens-Illinois to acquire Nueva Fanal from Grupo Modelo for about $188M - Owens-Illinois (OI) announced it has entered into a definitive agreement to acquire Nueva Fabrica Nacional de Vidrio, S. de R.L. de C.V. from Grupo Modelo, a wholly owned affiliate of Anheuser-Busch InBev (BUD). The Nueva Fanal facility is located near Mexico City, Mexico. Currently, this plant has four furnaces to produce and supply approximately 300,000 tons of glass containers annually for Grupo Modelo brands, which include Corona, Modelo Especial and Pacifico. The acquisition is a cash transaction valued at approximately $188M, subject to customary closing conditions, including competition authority approval, and is expected to close during 2019. O-I expects the business to contribute approximately $140M of revenue and $40M EBITDA on an annual basis. Incremental synergies are anticipated. Further, O-I will enter into a long-term glass supply agreement to continue to supply Grupo Modelo.

06:32 EDT Cable ONE to acquire Fidelity Communications for $525.9M in cash - Cable One announced it has entered into a definitive agreement with Fidelity Communications Co. to acquire Fidelity's data, video and voice business and certain related assets for $525.9M in cash, subject to customary post-closing adjustments. Fidelity Communications Co. is a family-owned cable operator that has been providing residential and business services to customers throughout greater Arkansas, Illinois, Louisiana, Missouri, Oklahoma and Texas for nearly 80 years. Fidelity's network passes approximately 190,000 homes and it has approximately 114,000 residential primary service units and 20,000 business PSUs. Fidelity is headquartered in Sullivan, Missouri. The all-cash transaction is expected to be funded through a combination of cash on hand, revolving credit facility capacity and the proceeds of new indebtedness. The transaction is subject to certain regulatory approvals and other customary closing conditions and is expected to be completed during the fourth quarter.

06:14 EDT Energy Fuels provides update on ongoing vanadium production programs - Energy Fuels provided an update on the company's ongoing vanadium production programs. Energy Fuels is currently producing vanadium product at commercial rates from the pond solutions at its 100%-owned White Mesa Mill. The mill has produced about 45M pounds of vanadium pentoxide, or V2O5, during its nearly 40-year operating history. As a result of facility upgrades and improved procedures put in place in 2018, the mill is currently producing the highest-purity V2O5 in its history. The company is currently selling this vanadium into the steel industry and it continues to pursue opportunities to sell portions of this material into specialty chemical and aerospace markets, potentially at a premium to reported spot prices. The company has implemented this method of producing vanadium at the mill with little capital exposure. The company estimates that a total of up to 4M pounds of recoverable V2O5 could reside in the mill's pond solutions. This vanadium is currently being recovered at commercial rates of approximately 150,000-160,000 pounds of V2O5 per month, and as a result of expected seasonal influences, could increase to approximately 200,000-225,000 pounds per month in the warmer, dryer months of the year, settling back to current production rates in the winter months. Average production rates, taking into account these expected seasonal influences, are expected to be approximately 160,000-200,000 pounds per month on an annualized basis, which would exceed the average annualized production rates during the last five full conventional vanadium ore runs at the mill since 2008, without having to mine a single ton of ore. Conservatively allowing for the uncertainties associated with a new project of this nature and the impacts of seasonal influences as they unfold over the first full year of production, this is expected to result in a total recovery over the life of the project of approximately 2.5M-4M pounds of V2O5, subject to continued successful recovery and supportive market conditions. The company also announced that it is able to achieve these results at a production cost per pound of recovered V2O5 at current production rates that is less than originally budgeted, which is resulting in margins that exceed original expectations, even at V2O5 prices of approximately $13.88 per pound. If production rates increase as expected, the production costs per pound would be expected to decrease, resulting in even more attractive margins. In addition, of course, if vanadium prices increase to recent levels, the margins would also improve. This new source of vanadium recovery is also flexible. The company is able to turn production on and off within a matter of days, at little to no cost, in response to any changes in vanadium market conditions. If the company decides to defer or slow down production, either due to a significant decline in the price of V2O5, or if it decides to retain its vanadium pond inventory for recovery and sale in potentially improved market conditions, it has the flexibility to make those decisions. If vanadium prices increase, production can then be resumed quickly in response. Energy Fuels also provided the following update on activities at the company's 100%-owned La Sal Complex of uranium/vanadium mines. Over the past several months, the company has been engaged in a limited conventional vanadium test-mining program at the La Sal and Pandora mines, two connected mines within the La Sal Complex, located in southeast Utah. In October 2018, the company announced the initial results of the test-mining program, including vanadium grades averaging 1.67% V2O5 and uranium grades averaging 0.10% U3O8 over about 420 tons of mineralized material. The company announced that, to date, it has mined approximately 5,200 tons of mineralized material under this test-mining program and the grades observed early in the campaign have held since that time, averaging approximately 1.60% V2O5 and 0.19% U3O8. While these numbers are not intended to represent the basis of a new resource or reserve estimate of any kind, the company believes that the new mining methods being tested are likely to result in reduced costs, higher grades and higher value for mined material due to significantly improved grade control at the mine site. Furthermore, vanadium recoveries at the Mill increase as feed grade increases. Therefore, the company believes there is a good chance that the Mill can increase average vanadium recoveries from mined ores as compared to historic performance, as a result of this improved grade control. The company expects to deploy these new mining techniques at full production rates once the company makes the decision to go back into full production at the La Sal Complex and other company-owned uranium/vanadium mines on the Colorado Plateau, as market conditions warrant. Through the test-mining campaign, the company refurbished the Pandora and La Sal mines, so they are now ready to enter full production shortly following a positive commercial production decision. Due to the inherent volatility of vanadium prices, the economics of these mines are expected to be supported primarily by uranium sales contracts at prices higher than the spot price, which may result from generally improved global uranium market conditions, or the ongoing government investigation into uranium imports into the U.S. Once uranium prices improve sufficiently, the company expects to be able to produce significant quantities of vanadium from these mines at costs competitively. Prices for vanadium have been highly volatile. The mid-point spot price of V2O5 in Europe began 2018 at $9.75 per pound, reached a high of $28.83 per pound in November 2018, and ended 2018 at $15.50 per pound. Spot prices rose through January, reaching a high of $17.38 per pound in February and early-March. At the current time, the spot price of V2O5 in Europe has dropped to $13.88 per pound. The global market for vanadium is currently primarily guided by market fundamentals and government policies in China. China is continuing to enforce new environmental standards, which are having the effect of restricting supply of vanadium. In addition, China is continuing to enforce new rebar standards, which require the use of more vanadium and have the effect of increasing demand. There is also a chance that China will pursue new infrastructure spending to spur economic growth, which would likely have the effect of increasing demand for steel and rebar containing vanadium. For these reasons, the company believes there is a good chance vanadium prices will strengthen in the coming months, reaching or surpassing the higher levels seen earlier this year. The company intends to continue to produce V2O5 from its mill pond solutions, which supports attractive margins for the company.

06:08 EDT AngioDynamics granted FDA approval to initiate NanoKnife DIRECT study - AngioDynamics announced that the United States FDA approved the company's investigational device exemption application for its NanoKnife Irreversible Electroporation "Direct IRE Cancer Treatment" clinical study. The DIRECT Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer. In January 2018, the FDA granted the company's NanoKnife System a Breakthrough Device Designation under the 21st Century Cures Act.

06:05 EDT MannKind receives $12.5M milestone payment from United Therapeutics - MannKind (MNKD) announced that it achieved the first of several specified development milestones under its licensing and collaboration agreement with United Therapeutics (UTHR) for the development and commercialization of a dry powder formulation of treprostinil. Treprostinil Technosphere is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension. Pursuant to the agreement, MannKind is eligible to earn additional payments up to $37.5M upon the achievement of other defined development milestones. MannKind will also be entitled to receive low double-digit royalties on net sales of TreT. MannKind also announced that it filed a new shelf registration statement on Form S-3 with the SEC on March 29, which, when effective, will replace the existing shelf registration statement that expires on April 27.

05:48 EDT Finjan Holdings says USPTO PTAB denies IPR to Juniper - Finjan Holdings (FNJN), and its subsidiary Finjan, Inc., announced that on March 25, the United States Patent & Trademark Office's, or USPTO, Patent Trial and Appeal Board, or PTAB, entered a Decision Denying Institution of Inter Partes Review, or IPR, against Juniper Networks (JNPR). In its petition, Case IPR2019-00031, Juniper sought to invalidate Claim 1 of Finjan's U.S. Patent No. 8,141,154. In denying institution of the IPR under 35 U.S.C Section 314(a), the PTAB relied on its, and the Court of Appeals for the Federal Circuit's, prior claim construction, and determined that Juniper failed to establish a reasonable likelihood that Claim 1 is unpatentable in light of asserted prior art.

05:33 EDT Novartis acquires IFM Tre - Novartis announced that it is adding to its broad portfolio of immunomodulatory medicines with the planned acquisition of IFM Tre, a subsidiary of IFM Therapeutics LLC focused on developing anti-inflammatory medicines targeting the NLRP3 inflammasome. The acquisition will give Novartis full rights to IFM Tre's portfolio of NLRP3 inhibitors. Under the terms of the agreement, Novartis will acquire all of the outstanding capital stock of IFM Tre. In addition, IFM Tre will receive an upfront payment and will be eligible for downstream milestone payments.

05:17 EDT comScore CEO steps down, Dale Fuller appointed interim CEO - Comscore announced the appointment of Irwin Gotlieb, Joanne Bradford and Kathi Love to its board. Dale Fuller, currently a director, was named interim CEO following the resignation of Bryan Wiener, who is also stepping down from the board effective March 31. Comscore's nominating and governance committee has initiated a search to identify a permanent CEO and will consider external and internal candidates. Dale Fuller has served as a director since March 2018 and as chair of Comscore's audit committee since April of the same year. The board also announced that Sarah Hofstetter, president, will be resigning from the company. The company has no immediate plans to fill her position.