Omeros stock craters as FDA cites deficiencies in application for HSCT-TMA drug
Omeros’ stock price fell by more than 40% in early trading Friday as the company disclosed that the FDA has found deficiencies in its application for narsoplimab as a treatment of the rare but serious blood clotting disease known as hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
“FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time,” Omeros said in a statement. And although the FDA stated that the notification does not reflect a final decision on the information under review, these types of notifications from the FDA typically lead to CRLs.
While the agency “did not provide specific details of the deficiencies in its notification,” according to Omeros, in a meeting between the company and FDA on Thursday, FDA “expressed its intention to work with Omeros to resolve any issues as expeditiously as possible,” the company said, although that collaboration likely will not occur by narsoplimab’s PDUFA date of Oct. 17.
Pivotal data in narsoplimab’s application, submitted under priority review, proved positive, though shrouded in some mystery as the company declined to publicly explain its response criteria due to “competitive business reasons.” This is the first drug candidate submitted to FDA for approval in HSCT-TMA. It’s nabbed both breakthrough therapy and orphan designations in both HSCT-TMA and IgA nephropathy.