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SPRY FDA decision: May 15, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
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Neffy 1 mg (epinephrine nasal spray) was approved by the FDA for anaphylaxis; the approval was announced on May 15, 2026.

ARS Pharmaceuticals Inc., Neffy 1 mg (epinephrine nasal spray) · Anaphylaxis.

Run-up into the decision (T-120 → T+5)

PDUFA 5/15/26$13.06$6.7311/28/25
Daily close, T-120 (11/28/25) through T+5. Run-up high $13.06 on 1/14/26, low $6.73 on 11/28/25 (T-120 to T-1). FDA decision 5/15/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-05-15
OutcomeApproved
Drug / candidateNeffy 1 mg (epinephrine nasal spray)
CompanyARS Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+18.0%

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Specialist biotech funds holding SPRY, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
RA Capital Management10,860,977$87.0 millionfiled August 14, 2026
OrbiMed Advisors8,288,510$66.4 millionfiled 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.

Questions

Was Neffy 1 mg (epinephrine nasal spray) approved by the FDA?

Yes. The approval of the application for Neffy 1 mg (epinephrine nasal spray) was announced on May 15, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.

Which company is behind Neffy 1 mg (epinephrine nasal spray)?

Neffy 1 mg (epinephrine nasal spray) is an ARS Pharmaceuticals Inc. (SPRY) program. The company announced the FDA decision on May 15, 2026; the primary source is linked on this page.

How did SPRY stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), SPRY moved +18.0%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.