AMGN

Amgen Inc.

223.4800
USD
0.20%
223.4800
USD
0.20%
166.3000 244.9900
52 weeks
52 weeks

Mkt Cap 136.31B

Shares Out 609.94M

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Correvio CORV shares fall on Advisory Committee notes - meeting Tuesday; Acceleron XLRN Advisory Committee cancelled

Price and Volume Movers

Amgen (NASDAQ:AMGN) announced that the FDA has approved Avsola (infliximab-axxq) as a biosimilar to al approved indications of Remicade (infliximab): rheumatoid arthritis (RA), Crohn's Disease (CD), ulcerative colitis (UC), plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

Bristol-Myers Squibb Company (NYSE:BMY) and Acceleron Pharma Inc. (NASDAQ:XLRN) announced that the FDA will no longer hold an Advisory Committee meeting scheduled for December 18, 2019, for their Biologics License Application (sBLA) for Reblozyl. The PDUFA date of April 4, 2020 remains in place.

Correvio Pharma Corp (NASDAQ: CORV) shares closed down 40% to $1.30 following the release of briefing documents for its upcoming Advisory Committee meeting to be held on Tuesday December 10, where an expert panel will discuss the regulatory application to market Brinavess (vernakalant) for the rapid conversion of recent onset atrial fibrillation (AFib) to sinus rhythm (SR). Sufficient evidence of benefit of the treatment were noted but safety concerns led the FDA to ‘not believe that the benefit proffered by vernakalant, conversion of AFib to SR, outweighs the serious risks associated with its use.’ Shares will likely be halted during Tuesday’s meeting.

ObsEva SA (NASDAQ: OBSV) announced that it will release results from the Phase 3 PRIMROSE 2 clinical trial of linzagolix for the treatment of heavy menstrual bleeding due to uterine fibroids, on Monday December 9, 2019. A conference call will be held at 8am EST.

Bristol-Myers Squibb Company (NYSE:BMY) and bluebird bio, Inc. (NASDAQ:BLUE) announced after hours that their Phase 2 open label trial, KarMMa, of idecabtagene vicleucel (bb2121), in patients with relapsed and refractory multiple myeloma, met its primary endpoint and key secondary endpoint. Across all doses, an overall response rate of 73.4% was noted, together with a complete response rate of 31% and median duration of response of 10.6 months.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume

ADVANCERS:

Matinas BioPharma Holdings, Inc. (MTNB): $1.93; +24%.

Epizyme, Inc. (EPZM): $18.22; +19%.

Cerecor Inc. (CERC): $4.00; +19%.

Stoke Therapeutics, Inc. (STOK): $28.98; +16%.

Lexicon Pharmaceuticals, Inc. (LXRX): $4.87; +15%.

DECLINERS:

Axcella Health Inc. (AXLA): $3.59; -20%.

Capricor Therapeutics, Inc. (CAPR): $1.33; -15%.

Cortexyme, Inc. (CRTX): $28.31; -17%.

Kaleido BioSciences, Inc. (KLDO): $5.36; -17%.

Cabaletta Bio, Inc. (CABA): $10.21; -16%.

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