BTIG downgraded Zosano Pharma (NASDAQ:ZSAN) to “neutral” from “buy” and removed its price target after the FDA refused to accept the company’s NDA resubmission for M207 to treat acute migraine.
Shares of Zosano, which fell 8 cents to close at 13 cents on Feb. 22, traded as high as $1.57 in March 2021.
The FDA is requesting additional pharmacokinetic bridging data by FDA, as Zosano’s strategy to refer M207 to the reference product – Zomig nasal spray- was not acceptable, writes analyst Robert Hazlett.
“The FDA’s response suggested other methods that would suffice, adding additional time and expense to M207’s development course,” Mr. Hazlett said.
“Though we recognize the potential for M207 once it arrives in the acute migraine market, given its excellent efficacy in the treatment of acute migraine (injectable-like efficacy, without the injection), this additional unplanned work creates financial strains that we believe will continue to be a challenge for the company,” he added.
Mr. Hazlett said Zosano’s Phase 3 results demonstrated “some of the most robust efficacy of the recent acute migraine therapeutics either approved or in development.”
