The Week Ahead In Biotech: Bristol-Myers Squibb FDA Decision, Adcom Review For Glaxo, Amarin Vascepa Hearing

The Week Ahead In Biotech: Bristol-Myers Squibb FDA Decision, Adcom Review For Glaxo, Amarin Vascepa HearingBiotech stocks went about a consolidation move in the week ended Aug. 28 amid thin news flow. Barring updates on coronavirus vaccine/treatment candidates, there was very little for the sector to react to.The second half of the week saw the Liver Congress kicking in, with a slew of updates coming from companies working on liver-related ailments.Here're the key catalysts for the unfolding week:ConferencesEuropean Society of Cardiology, ESC, Congress 2020: Aug. 29 – Sept. 1 46th Annual Meeting of the European Society for Blood and Marrow Transplantation, or EBMT: Aug. 29 – Sept. 1 eCongress of European Congress of Endocrinology, or ECE: Sept. 5-9PDUFA DatesFDA is scheduled to rule on Bristol-Myers Squibb Co's (NYSE: BMY) NDA seeking approval for CC-486, its Investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukemia. (Thursday)Adcom MeetingsFDA's Pulmonary-Allergy Drugs Advisory Committee is scheduled to discuss GlaxoSmithKline plc's (NYSE: GSK) sNDA for Trelegy Ellipta, a fixed-dose combination of fluticasone furoate, umeclidinium, and vilanterol inhalation powder oral inhalation, for use in patients with chronic obstructive pulmonary disease.Clinical ReadoutsStandalone releases Cue Biopharma Inc (NASDAQ: CUE) is scheduled to provide an update on its ongoing Phase 1 clinical trial of CUE-101 for the treatment of HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma. (Monday at 4:30 pm ET)Acasti Pharma Inc (NASDAQ: ACST is due to release topline results from the Phase 3 TRILOGY 2 study on or about August 31. The study is evaluating CaPre, a highly purified omega-3 phospholipid concentrate derived from krill oil that is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis.See also: 2 Moderna Analysts On Chances Of COVID-19 Vaccine Approval, Upcoming Catalysts EBMT Presentations View more earnings on IBBIncyte Corporation (NASDAQ: INCY): oral presentation of already-released Phase 3 REACH2 data that demonstrated Jakafi improved outcomes across a range of efficacy measures in patients with steroid-refractory acute graft-versus-host diseaseOrchard Therapeutics PLC – ADR (NASDAQ: ORTX): New interim data from OTL-203, an investigational gene therapy for the treatment of mucopolysaccharidosis type I (Monday)ESC Presentations Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR): RNA interference targeting apolipoprotein C-3 with ARO-APOC3 in Familial chylomicronemia syndrome / Hypertriglyceridemia (Monday)AstraZeneca plc (NYSE: AZN): detailed results from the Phase 3 DAPA-CKD trial of Farxiga in chronic kidney disease (Monday)Novartis AG (NYSE: NVS): Entresto late-breaking data of Phase 3 Parallax-HF trial in chronic heart failure patients with preserved ejection fraction, with endpoints on biomarkers, symptoms and functional measures (Monday)ECE Presentations AEterna Zentaris Inc. (NASDAQ: AEZS): results of the Phase 1 pediatric study of macimorelin in suspected growth hormone deficiencyEarningsCatalent Inc (NYSE: CTLT) (Monday, before the market open) I-Mab ADR (NASDAQ: IMAB) (Monday, before the market open) Avid Bioservices Inc (NASDAQ: CDMO) (Tuesday, after the close) Misonix Inc (NASDAQ: MSON) (Thursday, after the close) Cooper Companies Inc (NYSE: COO) (Thursday, after the close)IPO Quiet Period ExpiryAcutus Medical Inc (NASDAQ: AFIB) Checkmate Pharmaceuticals Inc (NASDAQ: CMPI) Freeline Therapeutics Holdings PLC (NASDAQ: FRLN)Other Key EventsCastle Biosciences Inc (NASDAQ: CSTL) is scheduled to host a conference call Sept. 2 at 4:30 p.m. ET, to highlight the planned commercial launch of DecisionDx-SCC, its prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma.Federal Circuit appellate hearing related to a patent on Amarin Corporation plc's (NASDAQ: AMRN) Vascepa is scheduled for Wednesday.Related Link: COVID-19 Testing Stocks Move Lower After Abbott Receives EUA For 15-Minute Test See more from Benzinga * The Daily Biotech Pulse: Moderna Japanese Vaccine Deal Talk, Lipocine FDA Decision, Liver Congress Presentations * The Daily Biotech Pulse: Liver Congress Underway, FDA Approves Companion Diagnostic Test For Clovis Cancer Drug, EUA For Abbott's , 15-Minute COVID-19 Test * The Daily Biotech Pulse: Altimmune Reports Positive Preclinical Data For Intranasal COVID-19 Vaccine, AbbVie Licenses Morphic's Drug, Viveve Clinical Readout(C) 2020 Benzinga does not provide investment advice. All rights reserved.

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