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

updates on coronavirus vaccine/treatment candidates, there was very little for the sector to react to.” data-reactid=”19″>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:

BMY) NDA seeking approval for CC-486, its Investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukemia. (Thursday)

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.

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)

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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

ORTX): New interim data from OTL-203, an investigational gene therapy for the treatment of mucopolysaccharidosis type I (Monday)

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

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

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)

AEZS): results of the Phase 1 pediatric study of macimorelin in suspected growth hormone deficiency

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)

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

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.

AMRN) Vascepa is scheduled for Wednesday.

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