The Week Ahead In Biotech (Aug. 30- Sept. 5): Bristol-Myers Squibb FDA Decision, Adcom Review For Glaxo, Amarin Vascepa Hearing

Biotech stocks went about a consolidation move in the week ended August 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 are the key catalysts for the unfolding week:

Conferences

  • European Society of Cardiology, ESC, Congress 2020: August 29 – September 1.
  • 46th Annual Meeting of the European Society for Blood and Marrow Transplantation, or EBMT: August 29 – September 1.
  • eCongress of European Congress of Endocrinology, or ECE: September 5-9.

PDUFA Dates

The FDA is scheduled on Thursday, September 3 to rule on Bristol-Myers Squibb Co. (BMY)'s NDA seeking approval for CC-486, its Investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukemia.

Adcom Meetings

FDA's Pulmonary-Allergy Drugs Advisory Committee is scheduled to discuss GlaxoSmithKline plc. (GSK)'s 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.

Standalone releases

Cue Biopharma Inc. (CUE) is scheduled on Monday, August 31 at 4:30 p.m. ET 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.

Acasti Pharma Inc. (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.

EBMT Presentations

Incyte Corporation (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 disease.

Orchard Therapeutics PLC – ADR (ORTX): New interim data from OTL-203, an investigational gene therapy for the treatment of mucopolysaccharidosis type I presenting Monday, August 31.

ESC Presentations

Arrowhead Pharmaceuticals Inc. (ARWR): RNA interference targeting apolipoprotein C-3 with ARO-APOC3 in Familial chylomicronemia syndrome / Hypertriglyceridemia is scheduled to be presented Monday, August 31.

AstraZeneca plc. (AZN): detailed results from the Phase 3 DAPA-CKD trial of Farxiga in chronic kidney disease is scheduled to be presented Monday, August 31.

Novartis AG (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 is scheduled to be presented Monday, August 31.

ECE Presentations

AEterna Zentaris Inc. (AEZS): results of the Phase 1 pediatric study of macimorelin in suspected growth hormone deficiency.

Earnings

  • Catalent Inc. (CTLT) (Monday, before the market open).
  • I-Mab ADR (IMAB) (Monday, before the market open).
  • Avid Bioservices Inc. (CDMO) (Tuesday, after the close).
  • Misonix Inc. (MSON) (Thursday, after the close).
  • Cooper Companies Inc. (COO) (Thursday, after the close).

IPO Quiet Period Expiry

  • Acutus Medical Inc. (AFIB).
  • Checkmate Pharmaceuticals Inc. (CMPI).
  • Freeline Therapeutics Holdings PLC. (FRLN).

Other Key Events

Castle Biosciences Inc. (CSTL) is scheduled to host a conference call September 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.

A Federal Circuit appellate hearing related to a patent on Amarin Corporation plc's (AMRN) Vascepa is scheduled for Wednesday, September 2.

© 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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William K. 3 years ago Member's comment

Thanks for the interesting and educational article!