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RNAZ FDA Decision Approved · 2025-03-13

Page updated October 4, 2026·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

Price into the decision (T-120)

Daily close, T-120 (9/26/24) through T+5. Run-up high $682.836 on 10/23/24, low $28.56 on 3/12/25 (T-120 to T-1). FDA decision 3/13/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-03-13

DrugTTX-MC138 - (PRE-I-SPY)

IndicationMetastatic solid tumors

Outcome✓ Approvedprimary-sourced

Decision-day move-27.3%

T-120 run-up (low→high)+0.0% ($14.54→$258.44)

ValidationVerified 2026-08-12: SEC filing 0001104659-25-027565 of 2025-03-25 containing 'approval of'

Market-cap tierSmall

Cohort decision-day move (history)3.6% median (n=280)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

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

Questions

Was TTX-MC138 approved by the FDA?

Yes. The approval of the application for TTX-MC138 was announced on March 13, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.

What was TTX-MC138 under FDA review for?

The application covered Metastatic solid tumors. The FDA approved the application on March 13, 2025.

How did RNAZ stock react to the FDA decision?

On the decision day RNAZ moved -27.3%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.