Otonomy, Inc. (NASDAQ:OTIC) announced its Phase 3 clinical trial of Otividex in patients with Ménière's disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for vs. placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model. Shares slumped to close down 44% to $3.00.
BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) shares closed down 34% to $4.58 on news the FDA has advised the company that data from its Phase 3 trial of NurOwn in patients with Amyotrophic lateral sclerosis does not provide the threshold of substantial evidence to support a Biologics License Application (BLA). The FDA advised that this recommendation does not preclude Brainstorm from proceeding with a BLA submission. The company announced in November 2020 that the trial did not meet the primary endpoint.
Celsion Corporation(NASDAQ:CLSN) shares closed up 48% to $2.81 following its announcement that it received Fast Track designation from the FDA for GEN-1, currently in Phase 2 development for the treatment of advanced ovarian cancer. Fast Track Designation (FTD) is designed to expedite development of pharmaceutical products which demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.
Viatris Inc. (NASDAQ:VTRS) shares closed down 15% following its announcement of revenue guidance below analyst expectations, noting that it expects 2021 to be their trough year in terms of revenue. The company was formed in 2020 following the merger between Mylan and Pfizer’s Upjohn business.
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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:
ADVANCERS:
Corvus Pharmaceuticals, Inc. (CRVS): $4.57; +22%.
Annovis Bio, Inc. (ANVS): $33.17; +15%.
Aridis Pharmaceuticals, Inc. (ARDS): $7.25; +12%.
Longeveron Inc. (LGVN): $6.80; +10%.
Athira Pharma, Inc. (ATHA): $23.69; +10%.
DECLINERS:
GeoVax Labs, Inc. (GOVX): $5.51; -19%.
Immunome, Inc. (IMNM): $31.20; -18%.
Altimmune, Inc. (ALT): $19.56; -15%.
VistaGen Therapeutics, Inc. (VTGN): $2.55; -14%.
Ovid Therapeutics Inc. (OVID): $2.99; -14%.
Pipeline updates below: