The week ended April 24 turned out to be an up-and-down one for biotech stocks, as the sector swayed along with the broader market. Two FDA approvals came through this week, with Immunomedics, Inc.'s (NASDAQ: IMMU) breast cancer drug snagging an FDA nod and Sanofi SA's (NASDAQ: SNY) meningococcal vaccine greenlighted by the regulatory agency.View more earnings on IBBFirst-quarter earnings were healthy, although the same cannot be said of the forward outlook given the uncertainty associated with the COVID-19 pandemic. Biogen Inc (NASDAQ: BIIB) came under pressure on a delay in the regulatory filing for its Alzheimer's drug.The following are key catalysts that could sway biotech stocks in the unfolding week:Conferences * American Association for Cancer Research, or AACR, 2020 Virtual Annual Meeting: April 27-28PDUFA Dates * The FDA is set to rule on Neurocrine Biosciences, Inc.'s (NASDAQ: NBIX) NDA for Opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor that is being evaluated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes. (Sunday) * The FDA will also decide on United Therapeutics Corporation's (NASDAQ: UTHR) NDA for Trevyent. Trevyent is a drug-device combination product that combines two-day, single use, disposable PatchPump technology with treprostinil, for the subcutaneous treatment of pulmonary arterial hypertension. (Monday) * Pfizer Inc. (NYSE: PFE) awaits the FDA decision on its sNDA for Braftovi in combination with Bristol-Myers Squibb Co's (NYSE: BMY) Erbitux. The Braftovi-Erbitux combo is being evaluated as a treatment option for patients with advanced BRAFV600E-mutant metastatic colorectal cancer, following one or two lines of therapy. (April schedule) * Amgen, Inc.'s (NASDAQ: AMGN) sNDA for Otezla to expand the prescribing information to include data from the Phase 3 scalp psoriasis study is under review by the FDA. The PDUFA action date is in April.See also: Some Biogen Analysts Unimpressed By Explanation For Aducanumab Filing Delay Clinical Readouts AACR Virtual Conference Presentations Monday * Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI): Data from Cohort 1 of a Phase 2 study that evaluated poziotinib in non-small cell lung cancer with exon 20 insertion mutation in EGFR or HER2 * Syndax Pharmaceuticals Inc (NASDAQ: SNDX): updated Phase 1 data for SNDX-5613 in relapsed/refractory acute leukemia. * Verastem Inc (NASDAQ: VSTM): Phase 1 data for VS-6766, its RAF/MEK inhibitor, in combination with defactinib, its FAK inhibitor, in patients with KRAS mutant advanced solid tumors. * Compugen Ltd. (NASDAQ: CGEN): Phase 1 data for COM701 and Bristol-Myers Squibb's Opdivo in solid tumors. * IMMUTEP LTD/S ADR (NASDAQ: IMMP): Initial Phase 1 results for eftilagimod alpha and Merck & Co., Inc.'s (NYSE: MRK) Keytruda in non-small cell lung cancer and head and neck cancer. * Idera Pharmaceuticals Inc (NASDAQ: IDRA): updated Phase 2 data for tilsotolimod along with Opdivo and Yervoy in squamous cell carcinoma of the head and neck. * Moderna Inc (NASDAQ: MRNA): Phase 1/2 data for mRNA-2416 and durvalumab in advanced malignancies. * GlaxoSmithKline plc (NYSE: GSK): Phase 1 data for GSK3174998 in solid tumors. * Sutro Biopharma Inc (NASDAQ: STRO): updated Phase 1 data for STRO-002 in ovarian and endometrial cancer.Tuesday * Iovance Biotherapeutics Inc (NASDAQ: IOVA): Phase 1 data for tumor-infiltrating lymphocytes in non-small cell lung cancer.The Other Readouts * Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi: initial Phase 2/3 Kevzara data (April). * Gilead Sciences, Inc. (NASDAQ: GILD): Phase 3 data for remdesivir in COVID-19 severe patients (late-April). * Ovid Therapeutics Inc (NASDAQ: OVID): Phase 2 top-line data for OV101 in Fragile X syndrome (Early Q2). * Iterum Therapeutics PLC (NASDAQ: ITRM): Phase 3 data for Sulopenem in uncomplicated and complicated urinary tract infections (Early Q2). * Atossa Therapeutics Inc (NASDAQ: ATOS) will meet with the FDA Thursday to discuss the clinical development of oral Endoxifen to reduce mammographic breast density.Earnings Monday * Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) (before the market open)Tuesday * Merck & Co., Inc. (NYSE: MRK) (before the market open) * Pfizer Inc. (NYSE: PFE) (before the market open) * NeoGenomics, Inc. (NASDAQ: NEO) (before the market open) * Masimo Corporation (NASDAQ: MASI) (after the close) * Medpace Holdings Inc (NASDAQ: MEDP) (after the close) * DexCom, Inc. (NASDAQ: DXCM) (after the close)Wednesday * Alkermes Plc (NASDAQ: ALKS) (before the market open) * Boston Scientific Corporation (NYSE: BSX) (before the market open) * United Therapeutics Corporation (NASDAQ: UTHR) (before the market open) * Alimera Sciences Inc (NASDAQ: ALIM) (after the close) * AtriCure Inc. (NASDAQ: ATRC) (after the close) * BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after the close) * Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close) * SurModics, Inc. (NASDAQ: SRDX) (after the close) * Hologic, Inc. (NASDAQ: HOLX) (after the close)Thursday * Agios Pharmaceuticals Inc (NASDAQ: AGIO) (before the market open) * ABIOMED, Inc. (NASDAQ: ABMD) (before the market open) * BIO-TECHNE Corp (NASDAQ: TECH) (before the market open) * Syneos Health Inc (NASDAQ: SYNH) (before the market open) * PRA Health Sciences Inc (NASDAQ: PRAH) (before the market open) * Lantheus Holdings Inc (NASDAQ: LNTH) (before the market open) * Iradimed Corp (NASDAQ: IRMD) (before the market open) * Concert Pharmaceuticals Inc (NASDAQ: CNCE) (before the market open) * Amgen, Inc. (NASDAQ: AMGN) (after the close) * Emergent Biosolutions Inc (NYSE: EBS) (after the close) * Insmed Incorporated (NASDAQ: INSM) (after the close) * Gilead Sciences, Inc. (NASDAQ: GILD) (after the close) * Seattle Genetics, Inc. (NASDAQ: SGEN) (after the close) * Natus Medical Inc (NASDAQ: NTUS) (after the close) * Illumina, Inc. (NASDAQ: ILMN) (after the close) * PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close) * LeMaitre Vascular Inc (NASDAQ: LMAT) (after the close) * ResMed Inc. (NYSE: RMD) (after the close) * Viking Therapeutics Inc (NASDAQ: VKTX) (after the close) * Silk Road Medical Inc (NASDAQ: SILK) (after the close) * Corvus Pharmaceuticals Inc (NASDAQ: CRVS) (after the close) * CareDx Inc (NASDAQ: CDNA) (after the close) * Tandem Diabetes Care Inc (NASDAQ: TNDM) (after the close)Friday * AbbVie Inc (NYSE: ABBV) (before the market open) * GlycoMimetics Inc (NASDAQ: GLYC) (before the market open) * ImmunoGen, Inc. (NASDAQ: IMGN) (before the market open)IPO Quiet Period Expiry * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)Related Link: BioNTech, Immunic Soar On COVID-19 Developmental Updates See more from Benzinga * The Daily Biotech Pulse: FDA Approves Sanofi's Meningococcal Vaccine, Pluristem Secures M In Funding For COVID-19 Treatment, Oric Pharma Prices IPO * The Daily Biotech Pulse: FDA Nod For Immunomedics, Lilly's Solid Q1 Beat, Predictive Oncology Restructures Debt * The Daily Biotech Pulse: Immunic To Develop COVID Treatment, Gilead Strikes IO Partnership(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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