Welireg (belzutifan) plus Lenvima (lenvatinib) was approved by the FDA on September 24, 2026 for adults with advanced renal cell carcinoma with a clear cell component following a PD-1 or PD-L1 inhibitor.
The FDA approved Welireg (belzutifan) in combination with Lenvima (lenvatinib) for adults with advanced clear cell renal cell carcinoma after a PD-1 or PD-L1 inhibitor on September 24, 2026, through two supplements: Merck's NDA 215383 S-013 and Eisai's NDA 206947 S-035. Merck and Eisai announced it on September 25, 2026.
The FDA's approval letters for Welireg (NDA 215383, supplement 13) and Lenvima (NDA 206947, supplement 35) are both dated September 24, 2026 and add the same indication, based on the Phase 3 LITESPARK-011 trial (Welireg letter; Lenvima letter). Merck and Eisai announced the approval on September 25, 2026 (Merck release). LITESPARK-011 (NCT04586231) randomized 747 patients to belzutifan 120 mg plus lenvatinib 20 mg daily or cabozantinib 60 mg daily. Per the companies, progression-free survival by blinded independent central review improved with the combination (HR 0.74, 95% CI 0.61 to 0.89; p=0.001; median 14.6 vs 10.6 months), objective response rate was 53% vs 40%, and overall survival, the other primary endpoint, did not reach statistical significance at the final analysis. pdufa.bio did not hold a goal date for these supplements, so no early or late margin is computed.
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.
Primary source: FDA approval letters, NDA 215383 S-013 and NDA 206947 S-035, September 24, 2026
FDA record of the action: the FDA approved on September 24, 2026, per NDA 215383 SUPPL-13 (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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 663,400 | $85.2 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.
Yes. The FDA approved the application for Welireg (belzutifan) plus Lenvima (lenvatinib) on September 24, 2026, per the FDA's own record. The primary source is linked on this page.
Welireg (belzutifan) plus Lenvima (lenvatinib) is a Merck & Co. and Eisai (MRK) program. The FDA decision came on September 24, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), MRK moved +22.5%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.