Zidesamtinib (NVL-520) is a Nuvalent Inc. program in ROS1 Non-small cell lung cancer (NSCLC). The FDA approved it on Jul 22, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: ROS1 Non-small cell lung cancer (NSCLC) (approved Jul 22, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Nuvalent Inc. (NUVL). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Perceptive Advisors | 1,580,505 | $195.2 million | filed August 14, 2026 |
| RA Capital Management | 1,246,456 | $153.9 million | filed 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.
No upcoming catalyst is on our calendar for Zidesamtinib (NVL-520); 1 FDA decision is on record below.
On Jul 22, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Zidesamtinib (NVL-520) is FDA-approved for ROS1 Non-small cell lung cancer (NSCLC) (approved Jul 22, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Nuvalent Inc. (NUVL).
Yes. The FDA approved an application for Zidesamtinib (NVL-520) on Jul 22, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.