Biotech week ahead, Aug. 31

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 0.24% 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 0.39% 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 0.45% 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.

EBMT Presentations

Incyte Corporation INCY 0.42%: 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 18.57%: New interim data from OTL-203, an investigational gene therapy for the treatment of mucopolysaccharidosis type I (Monday)

ESC Presentations

Arrowhead Pharmaceuticals Inc ARWR 0.31%: RNA interference targeting apolipoprotein C-3 with ARO-APOC3 in Familial chylomicronemia syndrome / Hypertriglyceridemia (Monday)

AstraZeneca plc AZN 0.74%: detailed results from the Phase 3 DAPA-CKD trial of Farxiga in chronic kidney disease (Monday)

Novartis AG NVS 0.44%: 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 1.06%: results of the Phase 1 pediatric study of macimorelin in suspected growth hormone deficiency

Earnings

Catalent Inc CTLT 0.02% (Monday, before the market open)
I-Mab ADR IMAB 0.77% (Monday, before the market open)
Avid Bioservices Inc CDMO 0.12% (Tuesday, after the close)
Misonix Inc MSON 1.62% (Thursday, after the close)
Cooper Companies Inc COO 1.11% (Thursday, after the close)

IPO Quiet Period Expiry

Acutus Medical Inc AFIB 3.2%
Checkmate Pharmaceuticals Inc CMPI 1.42%
Freeline Therapeutics Holdings PLC FRLN 2.06%

Other Key Events

Castle Biosciences Inc CSTL 0.52% 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 3.66% Vascepa is scheduled for Wednesday.

https://www.benzinga.com/general/biotech/20/08/17298263/the-week-ahead-in-biotech-bristol-myers-squibb-fda-decision-adcom-review-for-glaxo-amarin-vascepa