Checkpoint Therapeutics Announces Biologics License Application Resubmission for Cosibelimab [Yahoo! Finance]
Fortress Biotech, Inc. (FBIO)
Last fortress biotech, inc. earnings: 11/12 07:30 am
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Source: Yahoo! Finance
targeted oncology company, today announced it has completed the resubmission of its Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or curative radiation. The BLA resubmission follows Checkpoint recently reaching alignment with the FDA on its BLA resubmission strategy to potentially address all approvability deficiencies outlined in the complete response letter (“CRL”) received last December, in which FDA only cited findings that arose during a multi-sponsor inspection of Checkpoint's third-party contract manufacturing organization (“CMO”) as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosi
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FBIO
News
- Fortress Biotech, Inc. (NASDAQ: FBIO) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Checkpoint Therapeutics Announces Alignment with FDA Enabling Upcoming Cosibelimab BLA Resubmission [Yahoo! Finance]Yahoo! Finance
- Fortress Biotech, Inc. (NASDAQ: FBIO) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald.MarketBeat
- Fortress Biotech, Inc. (NASDAQ: FBIO) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Fortress Biotech, Inc. (NASDAQ: FBIO) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
FBIO
Earnings
- 5/15/24 - Beat
FBIO
Sec Filings
- 7/1/24 - Form 4
- 6/28/24 - Form 8-K
- 6/28/24 - Form EFFECT
- FBIO's page on the SEC website