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

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Biotech 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:

Conferences

European 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. 5-9

PDUFA Dates

FDA 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 Meetings

FDA'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 Readouts

Standalone 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 IBB

Incyte 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 disease

Orchard 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)