Daily close, T-120 (11/6/25) through T+5. Run-up high $812.27 on 1/12/26, low $628 on 11/12/25 (T-120 to T-1). FDA decision 4/23/26. Historical price action, not a forecast.
Drug / candidateOtarmeni (lunsotogene parvec-cwha)
CompanyRegeneron Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+14.3%
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Otarmeni (lunsotogene parvec-cwha) approved by the FDA?
Yes. The approval of the application for Otarmeni (lunsotogene parvec-cwha) was announced on April 23, 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 Otarmeni (lunsotogene parvec-cwha)?
Otarmeni (lunsotogene parvec-cwha) is a Regeneron Pharmaceuticals Inc. (REGN) program. The company announced the FDA decision on April 23, 2026; the primary source is linked on this page.
How did REGN stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), REGN moved +14.3%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.