BioNTech (NASDAQ: BNTX) Clinical Trial Update: BNT113 Misses First Primary Endpoint

• BioNTech’s investigational mRNA cancer immunotherapy BNT113, combined with pembrolizumab, did not produce a statistically significant improvement in progression-free survival.

• The AHEAD-MERIT Phase 2/3 trial will continue to evaluate overall survival, its second primary endpoint.

• BioNTech shares declined following the update, while Citi maintained its Buy rating and $125 price target.

BioNTech (NASDAQ: BNTX) develops immunotherapies, including mRNA-based cancer treatments. Citi maintained its Buy rating and $125 price target after the BNT113 trial update, indicating that the firm still sees a potential development path for the treatment.

BioNTech announced that BNT113, combined with pembrolizumab, did not produce a statistically significant improvement in progression-free survival compared with pembrolizumab alone. The result came from the randomized portion of the AHEAD-MERIT Phase 2/3 trial involving patients with unresectable recurrent or metastatic HPV16-positive, PD-L1-positive head and neck squamous cell carcinoma.

Progression-free survival is the length of time patients live without their cancer worsening. It is the first of the trial’s two primary endpoints. The Independent Data Monitoring Committee recommended that the study continue as planned to evaluate overall survival. Under the trial’s predefined statistical design, a statistically significant overall-survival improvement could still establish a positive trial outcome despite the missed progression-free survival endpoint. BioNTech remains blinded to the continuing trial data.

Moderna (NASDAQ: MRNA) has experienced much stronger stock performance in 2026. According to The Motley Fool, Moderna shares had gained more than 660% year to date by October 13, while BioNTech was only slightly positive. Moderna’s market capitalization was close to $90 billion, approximately 3.6 times BioNTech’s valuation of less than $25 billion. The difference reflects their recent clinical results and investor expectations, although market capitalization alone does not determine which company has the stronger long-term pipeline.

Moderna and Merck (NYSE: MRK) reported positive Phase 3 results for intismeran autogene, an individualized mRNA-based cancer therapy, combined with Keytruda in patients with surgically removed high-risk melanoma. The trial met its primary recurrence-free-survival endpoint and a key secondary endpoint measuring distant metastasis-free survival. Overall-survival follow-up is continuing.

BioNTech shares traded near $90.60 around midday on October 13, down approximately 5.5% following the clinical update. The stock’s intraday range was $89.78–$93.08, its 52-week range was $79.52–$124.00, and its market capitalization was approximately $22.8 billion. These figures were recorded while the market was still open and could change before the closing bell.