ARS Pharmaceuticals stock falls toward record selloff after FDA issues surprise CRL, requesting additional studies

Sharesof ARS Pharmaceuticals Inc. (SPRY) plunged 46.9% toward a 15-month low in premarket trading Wednesday, after the biopharmaceutical company said the U.S. Food and Drug Administration issued a Complete Response Letter regarding the New Drug Application for its epinephrine nasal spray Neffy. In the CRL, the FDA requested completion of a study assessing repeat doses of Neffy. The request comes after an FDA advisory panel recommended in May that Neffy be approved without additional studies. "We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive advisory committee vote," said Chief Executive Richard Lowenthal. The stock, which is headed for the biggest one-day selloff since it went public in December 2020, has lost 22.6% year to date through Tuesday, while the iShares Biotechnology ETF (IBB) has lost 4.3% and the S&P 500 has gained 15.7%.

-Tomi Kilgore

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09-20-23 0621ET

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