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RCKT FDA decision: Mar 27, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

KRESLADI (marnetegragene autotemcel) was approved by the FDA for leukocyte Adhesion Deficiency-I (LAD-I); the approval was announced on March 27, 2026.

Rocket Pharmaceuticals Inc., KRESLADI (marnetegragene autotemcel) · Leukocyte Adhesion Deficiency-I (LAD-I).

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

PDUFA 3/27/26$5.3$2.8410/10/25
Daily close, T-120 (10/10/25) through T+5. Run-up high $5.3 on 3/10/26, low $2.84 on 11/27/25 (T-120 to T-1). FDA decision 3/27/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-03-27
OutcomeApproved
Drug / candidateKRESLADI (marnetegragene autotemcel)
CompanyRocket Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+48.9%

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

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

FundSharesValue at quarter endFiling
RTW Investments17,687,772$60.5 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 KRESLADI (marnetegragene autotemcel) approved by the FDA?

Yes. The approval of the application for KRESLADI (marnetegragene autotemcel) was announced on March 27, 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 KRESLADI (marnetegragene autotemcel)?

KRESLADI (marnetegragene autotemcel) is a Rocket Pharmaceuticals Inc. (RCKT) program. The company announced the FDA decision on March 27, 2026; the primary source is linked on this page.

How did RCKT stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), RCKT moved +48.9%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.