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

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 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 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 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

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 (Monday)

ESC Presentations

Arrowhead Pharmaceuticals Inc ARWR: RNA interference targeting apolipoprotein C-3 with ARO-APOC3 in Familial chylomicronemia syndrome / Hypertriglyceridemia (Monday)

AstraZeneca plc AZN: detailed results from the Phase 3 DAPA-CKD trial of Farxiga in chronic kidney disease (Monday)

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 (Monday)

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 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 AMRN Vascepa is scheduled for Wednesday.

Related Link: COVID-19 Testing Stocks Move Lower After Abbott Receives EUA For 15-Minute Test