neffy (epinephrine nasal spray) was approved by the FDA on March 26, 2026 for emergency treatment of type I allergic reactions including anaphylaxis in adults and pediatric patients weighing 15 kg or more.
The FDA approved a labeling change for neffy (epinephrine nasal spray) on March 26, 2026 that removes the age criterion, so the indication now covers adults and pediatric patients weighing 15 kg (33 lb) or more (NDA 214697, supplements 2 and 4). ARS Pharmaceuticals announced it on March 27, 2026.
The FDA's approval letters for NDA 214697 supplement 2 (efficacy) and supplement 4 (labeling) are both dated March 26, 2026 (S-002 letter, S-004 letter). ARS announced the approval on March 27, 2026 (ARS release). The 1 mg dose for children weighing 15 to 30 kg was approved separately on March 5, 2025 and has its own page. Correction, October 14, 2026: an earlier page on this site listed a neffy approval announced May 15, 2026; that date was ARS's first-quarter earnings release, which recapped this March approval, not a new FDA action.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, NDA 214697 supplement 2, March 26, 2026
FDA record of the action: the FDA approved on March 26, 2026, per NDA 214697 SUPPL-2 (FDA letter). The sponsor announced it on March 27, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| RA Capital Management | 10,860,977 | $87.0 million | filed August 14, 2026 |
| OrbiMed Advisors | 8,288,510 | $66.4 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The FDA approved the application for neffy (epinephrine nasal spray) on March 26, 2026, per the FDA's own record. The company announced it on March 27, 2026. The primary source is linked on this page.
neffy (epinephrine nasal spray) is an ARS Pharmaceuticals (SPRY) program. The FDA decision came on March 26, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), SPRY moved -17.0%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.