Daily close, T-120 (9/12/25) through T+5. Run-up high $64.08 on 2/20/26, low $51.46 on 11/14/25 (T-120 to T-1). FDA decision 2/27/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-02-27
OutcomeApproved
Drug / candidatePALYNZIQ (pegvaliase-pqpz) - (PEGASUS)
CompanyBioMarin Pharmaceutical Inc.
120-day run-up (T-120→T-1)+5.8%
FDA record of the action: the FDA approved on February 27, 2026, per BLA 761079 SUPPL-31 (FDA letter). The sponsor announced it the same day. 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.
Specialist biotech funds holding BMRN, 13F for the quarter ended June 30, 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 PALYNZIQ (pegvaliase-pqpz) approved by the FDA?
Yes. The FDA approved the application for PALYNZIQ (pegvaliase-pqpz) on February 27, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind PALYNZIQ (pegvaliase-pqpz)?
PALYNZIQ (pegvaliase-pqpz) is a BioMarin Pharmaceutical Inc. (BMRN) program. The FDA decision came on February 27, 2026; the FDA's own record of the decision is linked on this page.
How did BMRN stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), BMRN moved +5.8%. 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.