ARS Pharma : FDA Issues CRL For Nasal Spray NDA With Request For Addl Study; Stock Down

(RTTNews) - The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding ARS Pharmaceuticals Inc.'s (SPRY) New Drug Application for neffy (epinephrine nasal spray) in the treatment of Allergic Reactions (Type I), including anaphylaxis for adults and children greater than equal to 30 kg, the company said in a statement.

"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 Richard Lowenthal, Co-founder, President and CEO of ARS Pharma.

SPRY closed Tuesday regular trading at $6.61 down $0.84 or 11.22%. In the after-hours trading, the stock further dropped $0.16 or 2.35%.

ARS Pharma said it plans to submit a Formal Dispute Resolution Request to appeal the issuance of the CRL.

In the letter, the FDA requested completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval.

The FDA request comes after the recommendation of the FDA Advisory Committee (PADAC) in May 2023 to approve neffy without the need for additional studies to demonstrate its efficacy or safety. In addition FDA and ARS Pharma previously aligned in August 2023 on final physician's labeling and a post-marketing requirement to conduct this study as informative for labeling.

ARS Pharma anticipates a resubmission to the FDA in the first half of 2024, positioning the company for an anticipated FDA action date in the second half of 2024.

ARS Pharma expects to have anticipated cash, cash equivalents and short-term investments on hand of approximately $195 million at the time of the anticipated launch of neffy, if approved in the second half of 2024.

The company noted that a marketing authorization application for neffy is also under review by the European Medicines Agency with a Committee for Medicinal Products for Human Use opinion expected by year end 2023. Submissions to other regulatory authorities in additional countries are planned for 2024.

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