Biopharma stocks are sensitive to a key binary event called the PDUFA date, the date by which the Food and Drug Administration is required to give its verdict on a regulatory application filed with it.
The month of March saw several approvals coming through, while outright rejection and postponements were few and far between. Three new molecular entities, or NMEs, were approved during the month. NMEs are drugs that contain active moieties that haven't been previously approved by the FDA. It's, therefore, an indicator of innovation in drug research.
Marinus Pharmaceuticals, Inc.'s (NASDAQ: MRNS) Ztalmy, indicated to treat seizures associated with a rare genetic condition known as CDKL-5 deficiency disorder (CDD), was among the NMEs that scored win the FDA in March. H.C. Wainwright analyst Douglas Tsao expects peak U.S. sales potential of $92 million for Ztalmy, given CDD is a relatively small market.
Other NMEs approved during the month included Bristol-Myers Squibb Company's (NYSE: BMY) melanoma combo therapy Opdualag and Novartis AG's (NYSE: NVS) Pluvicto for treating a certain type of advanced, castration-resistant prostate cancer.
On the flip side, Akebia Therapeutics, Inc.'s (NASDAQ: AKBA) vadadustat was rejected by the FDA as a treatment option for anemia in chronic kidney disease patients.
Here are the key PDUFA dates scheduled for April.
Click here to access Benzinga's FDA Calendar
Can BioXCel Push Psychiatric Disorder-Associated Agitation Drug Past Finish Line?
Company: BioXcel Therapeutics, Inc. (NASDAQ: BTAI)
Type of Application: new drug application
Candidate: dexmedetomidine (BXCL501)
Indication: agitation associated with schizophrenia and bipolar disorders I and II.
Date: April 5
BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders. The original PDUFA date of Jan. 5, 2022 was pushed back by three months, with BoXcel communicating that the FDA needed three more months to review data pertaining to analyses of clinical data submitted by the company upon the regulator's information request.
Regeneron Awaits Approval Of Antibody Cocktail For Prophylactic Treatment Of COVID-19
Company: Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
Type of Application: BLA
Candidate: REGEN-COV
Indication: prophylactic treatment of COVID-19
Date: April 13
Regeneron's REGEN-COV is a cocktail of two monoclonal antibodies, namely casirivimab and ...
Benzinga
