Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs March 4) AtriCure, Inc. (NASDAQ: ATRC) Five Prime Therapeutics, Inc. (NASDAQ: FPRX) - announced a deal to be bought by Amgen Inc. (NASDAQ: AMGN) for $1.9 billion Down In The Dumps (Biotech Stocks Hitting 52-week Lows March 4) AbCellera Biologics Inc. (NASDAQ: ABCL) Acutus Medical, Inc. (NASDAQ: AFIB) ADC Therapeutics SA (NYSE: ADCT) Aptose Biosciences Inc. (NASDAQ: APTO) Assembly Biosciences, Inc. (NASDAQ: ASMB) Athenex, Inc. (NASDAQ: ATNX) Biophytis SA (NASDAQ: BPTS) Bioventus Inc. (NASDAQ: BVS) Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) BriaCell Therapeutics Corp. (NASDAQ: BCTX) Decibel Therapeutics, Inc. (NASDAQ: DBTX) Dyne Therapeutics, Inc. (NASDAQ: DYN) (reacted to fourth-quarter results) Epizyme, Inc. (NASDAQ: EPZM) Freeline Therapeutics Holdings plc (NASDAQ: FRLN) Galecto, Inc. (NASDAQ: GLTO) Inhibikase Therapeutics, Inc. (NASDAQ: IKT) Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) Karyopharm Therapeutics Inc (NASDAQ: KPTI) Legend Biotech Corporation (NASDAQ: LEGN) Liquidia Corporation (NASDAQ: LQDA) Lucira Health Inc (NASDAQ: LHDX) Nabriva Therapeutics plc (NASDAQ: NBRV) Nanobiotix S.A. (NASDAQ: NBTX) NeuroBo Pharmaceuticals, Inc. (NASDAQ: NRBO) NexImmune, Inc. (NASDAQ: NEXI) NLS Pharmaceutics AG (NASDAQ: NLSP) Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) Oncorus, Inc. (NASDAQ: ONCR) Protara Therapeutics, Inc. (NASDAQ: TARA) Qualigen Therapeutics, Inc. (NASDAQ: QLGN) Repro Med Systems, Inc. (NASDAQ: KRMD) Sana Biotechnology, Inc. (NASDAQ: SANA) Sensei Biotherapeutics, Inc. (NASDAQ: SNSE) Sigilon Therapeutics, Inc. (NASDAQ: SGTX) Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) Talis Biomedical Corporation (NASDAQ: TLIS) uniQure N.V. (NASDAQ: QURE) Vallon Pharmaceuticals, Inc. (NASDAQ: VLON) Virios Therapeutics, LLC (NASDAQ: VIRI) Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX) Viveve Medical, Inc. (NASDAQ: VIVE) Voyager Therapeutics, Inc. (NASDAQ: VYGR) Yumanity Therapeutics, Inc. (NASDAQ: YMTX) Stocks In Focus Moderna's Japanese Partner Takeda Submits New Drug Application For Coronavirus Vaccine In Japan Moderna, Inc. (NASDAQ: MRNA) said its Japanese partner Takeda Pharmaceutical Company Limited (NYSE: TAK) submitted a new drug application to Japan's Ministry of Health, Labour and Welfare to import and distribute Moderna's vaccine candidate against COVID-19 in Japan. Takeda is conducting a placebo-controlled Phase 1/2 study designed to evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 at the 100 μg dose level given 28 days apart in 200 participants aged 20 years and above in Japan. In October, the two companies entered into a pact under which Moderna will supply 50 million doses of its vaccine to Takeda for distribution in Japan. Moderna shares were down 1.81% to $130.49 in premarket trading Friday. Roche's Biologics Products Gets FDA Nod For Lung Disease Roche Holding AG (OTC: RHHBY) said the FDA approved Actemra/RoActemra subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease, a debilitating condition with limited treatment options. Actemra/RoActemra is the first biologic therapy approved by the FDA for the treatment of the disease. Sigilon's SIG-007 Gets Orphan Drug Designation For Fabry Disease Sigilon said the FDA has granted orphan drug designation to SIG-007 for the treatment of Fabry disease, a progressive, life-threatening lysosomal disease. Related Link: The Week Ahead In Biotech (Feb. 28-March 6): KemPharm, Gilead FDA Decisions and More Earnings ALX Oncology to Collaborate With Tallac For Developing Cancer Immunotherapies ALX Oncology Holdings Inc. (NASDAQ: ALXO) announced a collaboration with privately held Tallac Therapeutics to jointly develop, manufacture, and commercialize a novel class of cancer immunotherapeutics. Under the terms of the agreement, ALX Oncology and Tallac will share equally in the cost of R&D and any profits or losses incurred. The companies said they will leverage their respective scientific and technical expertise to advance an anti-SIRPα antibody conjugated to a Toll-like receptor 9 agonist for targeted activation of both the innate and adaptive immune systems. Apellis Shelves Study Of APL-9 In Severe COVID-19 Patients Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) said it will not pursue additional development of APL-9, an investigational targeted C3 therapy designed for acute interventions, for the treatment of severe COVID-19. The decision followed an interim review of mortality data from the Phase 1/2 study by an independent data monitoring committee, which found no meaningful reduction in the overall mortality rate in patients treated with APL-9 in combination with standard of care therapy compared to standard of care alone. No safety signals were observed by the DMC. The stock fell 1.42% to $45 in after-hours trading. Ocular Therapeutix Application For Dextenza Label Expansion Accepted For Review Ocular Therapeutix, Inc. (NASDAQ: OCUL) announced the supplemental new drug application for Dextenza 0.4 mg for intracanalicular use, has been accepted for review by the FDA. The FDA has set an action date under the Prescription Drug User Fee Act of no later than Oct. 18. If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of Dextenza. View more earnings on IBB The stock rose 2.42% to $17.75 in after-hours trading. Earnings Fulgent Genetics, Inc. (NASDAQ: FLGT) reported fourth-quarter revenues of $295 million, up over 3,400% year-over-year. The non-GAAP net income came in at $6.20 per share, ahead of the $4.02 per share estimated by analysts. The stock jumped 34.46% to $115 in after-hours trading. Acorda Therapeutics Inc (NASDAQ: ACOR) reported fiscal-year 2020 fourth-quarter revenues of $38.16 million, down from $50.50 million a year-ago. The company reversed to a loss per share of $9.82 from a profit of $8.26 per share. The stock slipped 11.5% to $6 in after-hours trading. Opiant Pharmaceuticals Inc's (NASDAQ: OPNT) fourth-quarter revenues climbed from $7.67 million in 2019 to $9.924 million in 2020. The company reversed to a loss of 16 cents per share from a profit of 20 cents per share. The consensus estimates had called for a profit of 7 cents per share on revenues of $9.92 million. In after-hours trading, the stock rose 5.34% to $14. DermTech Inc (NASDAQ: DMTK) said its fourth-quarter revenues increased 33% year-over-year to $2.1 million. The net loss per share widened from 48 cents to 43 cents. The company said it estimates that first-quarter assay revenue will be between $1.6 and $1.9 million. The stock moved down 7.95% to $48.77 in after-hours trading. On The Radar PDUFA Dates The FDA will decide on the approvability of Gilead Sciences, Inc.'s (NASDAQ: GILD) Yescarta, or axicabtagene ciloleucel, which is being evaluated for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy. Yescarta is a CAR T-cell therapy that came into Gilead's stable through its Kite purchase. Earnings IMARA Inc. (NASDAQ: IMRA) (before the market open) Oncolytics Biotech Inc. (NASDAQ: ONCY) (before the market open) Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates See more from BenzingaClick here for options trades from BenzingaThe Daily Biotech Pulse: FDA Nod For Pfizer, Kiniksa Rises On Commercialization Pact With Regeneron, Bio-Techne To Buy Diagnostic CompanyThe Daily Biotech Pulse: KemPharm ADHD Drug Gets The Nod, MediciNova Shelves Vaccine Study© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Ocular Therapeutix, Inc. (Nasdaq: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the supplemental New Drug Application (sNDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set an action date under the Prescription Drug User Fee Act (PDUFA) of no later than October 18, 2021. If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.
Ocular Therapeutix (OCUL) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.