Fixed-antigen BNT113 missed progression-free survival
On October 13, 2026 BioNTech said the Phase 2/3 AHEAD-MERIT trial (NCT04534205) missed its first dual primary endpoint. BNT113, also called tenumomeran/raplemomeran or tenu-ra, plus pembrolizumab did not show a statistically significant progression-free survival improvement versus pembrolizumab alone. The setting is first-line treatment of unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma that expresses PD-L1, with a combined positive score of at least 1. BioNTech published no hazard ratio and no median. An independent data monitoring committee recommended that the trial continue to overall survival. Under the pre-specified design, a statistically significant overall-survival result can still make the trial positive. The company said it remains blinded to the ongoing data. BNT113 encodes a fixed pair of HPV16 E6 and E7 antigens. It is not an individualized neoantigen therapy. The FDA granted Fast Track designation in January 2026.
ClinicalTrials.gov lists AHEAD-MERIT as active, not recruiting, with actual enrollment of 358. Primary completion and study completion are both dated August 2028. Part B follows progression-free survival to blinded-independent RECIST 1.1 progression or death, and overall survival to death from any cause, each with a time frame of up to 48 months. Treatment lasts up to about 24 months. Those dates are the registry calendar, not a company forecast for the next interim analysis.
Individualized melanoma numbers are still set for October 24
Moderna's September 21, 2026 notice still places INTerpath-001 at ESMO as late-breaking abstract LBA1. Georgina V. Long is scheduled to present on Saturday, October 24, 2026, at 4:30 p.m. CEST (10:30 a.m. EDT) in Madrid. The comparison is intismeran autogene, an individualized neoantigen therapy, plus pembrolizumab versus pembrolizumab alone in resected stage IIB-IV melanoma. Moderna's investor webcast is the same day at 7:00 p.m. CEST (1:00 p.m. EDT). That notice contains no hazard ratio, no median, and no filing.
CRISPR's lipid oral is still November 9; Vertex reports on November 2
CRISPR Therapeutics' October 8, 2026 release still schedules Phase 1b CTX310 data in severe hypertriglyceridemia as a late-breaking oral at the American Heart Association Scientific Sessions. The session is LBS.05 on Monday, November 9, 2026, at 8:00 a.m. CST. The abstract and presentation remain embargoed until then, so this is a dated slot, not a published efficacy table. CTX310 is an in vivo CRISPR/Cas9 edit of ANGPTL3. The same release does not give a CTX611 topline.
On October 7, 2026 Vertex said it will report third-quarter 2026 financial results on Monday, November 2, 2026, after the market close. The call and webcast are at 4:30 p.m. ET. The US dial-in is (833) 630-2124 and the international dial-in is +1 (412) 317-0651. That report is the next scheduled official quarterly print. Vertex books Casgevy sales, so the third-quarter Casgevy figure waits on that release. The release itself is an earnings date, not the sales number.
What to watch before year-end
Watch October 24 for INTerpath-001 hazard ratios, medians, and whether Moderna and Merck file. Watch AHEAD-MERIT overall survival: a significant result can still count as a positive trial, and the registry dates primary completion in August 2028. Watch CRISPR's November 9 CTX310 oral for the first Phase 1b efficacy table. Watch Vertex's November 2 report for the quarter's Casgevy sales. The zugo-cel ACR poster, Earendil's Genentech close, BioNTech's plant-sale comments, and the continuing-resolution date were not given a newer source in this pass.










