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

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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 (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

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)

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 deficiency

Earnings

Catalent 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 Expiry

Acutus Medical Inc (NASDAQ: AFIB)
Checkmate Pharmaceuticals Inc (NASDAQ: CMPI)
Freeline Therapeutics Holdings PLC (NASDAQ: FRLN)

Other Key Events

Castle 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

 

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