Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
✕ NOT APPROVABLE LETTER (device PMA)
Verified against: FDA action day not yet posted on Drugs@FDA · Announcement November 9, 2026 (Novocure 8-K) · Goal date none sourced.
Novocure announced on November 9, 2026 that the FDA issued a Not Approvable Letter on its Premarket Approval (PMA) application for Optune Mya in adults with brain metastases from non-small cell lung cancer following stereotactic radiation.
Run-up into the decision (T-120 → T+2)
Daily close, T-120 (5/19/26) through T+2. Run-up high $19.99 on 7/23/26, low $13.11 on 10/29/26 (T-120 to T-1). FDA decision 11/9/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-11-09
OutcomeNot approvable letter
Drug / candidateOptune Mya
IndicationBrain metastases from non-small cell lung cancer, after stereotactic radiation (adults)
CompanyNovoCure Limited
Market-cap tierSmall
120-day run-up (T-120→T-1)-21.9%
Cohort decision-day move (history)3.7% median (n=302)
This is a medical-device PMA decision, not a drug application, so there is no PDUFA goal date and no Complete Response Letter. Per Novocure, the FDA cited uncertainty around the degree of clinical benefit and raised no safety concerns; Novocure plans to meet the FDA to discuss options that would not require additional clinical studies. The letter's own date is not public; the date on this page is Novocure's announcement.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Not in this review cycle. A Complete Response Letter, declining to approve the application for Optune Mya in its current form, was announced on November 9, 2026. A CRL is not final; the primary source is linked on this page.
Which company is behind Optune Mya?
Optune Mya is a NovoCure Limited (NVCR) program. The company announced the FDA decision on November 9, 2026; the primary source is linked on this page.
How did NVCR stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), NVCR moved -21.9%. 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.