Supernus Pharmaceuticals Inc (NASDAQ:SUPN) received FDA’s complete response letter (CRL) for the SPN-830 marketing application. SPN-830 is an investigational apomorphine infusion…
Most FDA decisions scheduled for September yielded positive results, but there were stray disappointments as well. Seven new molecular entities, or NMEs, were approved during the month, taking the total NME approvals for the year to 24. This is far less than the 40 approvals received by the same time last year.
The month of April was a mixed one for regulatory approvals. The Food and Drug Administration delayed approvals for at least three treatment candidates. New molecular entity, or NME, approvals, a measure of innovation in drug research, tapered to merely one for the month.
Biotech stocks extended their loses in the week ending April 22. The sector took cues from the broader market, which reacted to the lackluster start of the first-quarter reporting season and lingering rate hike fears.
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.