Daily Roundup | Genmab's Epkinly Wins Frontline Trial & Vaxcyte's Vaccine Passes With Caveats

October 21, 2026 edition, released October 22. Relative dates in the audio refer to October 21. Roivant's Priovant reports two positive Phase 3 trials of oral brepocitinib in non-infectious uveitis, run through a mandatory steroid taper. F2G and Shionogi add kidney, liver and hospital-stay detail from olorofim's OASIS trial, where survival was noninferior rather than better. Also in the daily roundup: Alcon completes its Neurotech acquisition, the European Commission approves perioperative Keytruda plus Padcev regardless of cisplatin eligibility, Summit and ECOG-ACRIN set up a trial of ivonescimab in biliary tract cancer, Roche discloses fenebrutinib lesion imaging ahead of its MSToronto presentation, TG releases data on a single-infusion Briumvi start, OpenAI acquires Orchestra Bio, and FDA's warning letter to Baxter becomes public. Sources: https://www.biospace.com/press-releases/roivant-and-priovant-announce-positive-results-in-clarity-1-and-clarity-2-phase-3-trials-for-brepocitinib-in-non-infectious-uveitis-niu https://www.sec.gov/Archives/edgar/data/1635088/000114036126034854/ef20081283_ex99-1.htm https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5023a17b-e96a-67d4-e063-6394a90a14a7 https://www.shionogi.com/global/en/news/2026/10/e20261021_3.html https://www.biospace.com/press-releases/alcon-acquires-neurotech-and-encelto-the-only-fda-approved-treatment-for-mactel-type-2 https://www.merck.com/news/european-commission-approves-keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-as-perioperative-treatment-for-adults-with-resectable-muscle-invasive-bladder-cancer-mibc/ https://www.prnewswire.com/news-releases/akeso-announces-summit-therapeutics-and-ecog-acrin-cancer-research-group-enter-into-phase-iiiii-clinical-trial-collaboration-to-evaluate-ivonescimab-in-first-line-biliary-tract-cancer-302915469.html https://www.roche.com/media/releases/med-cor-2026-10-21 https://clinicaltrials.gov/study/NCT04544449 https://www.tgtherapeutics.com/wp-content/uploads/2026/10/ENHANCE-600-mg_ECTRIMS-2026_Final-Poster_PDF.pdf https://openai.com/index/openai-to-acquire-orchestra-bio/ https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baxter-international-inc-733231-09292026 https://www.merck.com/news/european-commission-approves-keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-as-first-pd-1-inhibitor-plus-antibody-drug-conjugate-regimen-for-adults-with-cisplatin-ineligibl/ https://www.roche.com/media/releases/med-cor-2026-09-30

FDA approved GSK's Hibsago (bepirovirsen) for selected adults with chronic hepatitis B without cirrhosis, opening a possible path off long-term treatment after a staged treatment and testing process. We examine who qualifies, the B-Well results and the boxed safety warnings. Amgen and AstraZeneca's detailed Phase 3 CROSSING results show Tezspire's biopsy remission and swallowing outcomes in eosinophilic esophagitis, where Dupixent is already established. The daily roundup covers Rapport's RAP-219 bipolar mania results; TriGemX's proposed SPAC combination to fund migraine development; Veradermics' second Phase 3 hair-loss study; UroGen's UGN-103 filing acceptance; Nouscom's financing for cancer interception; Ambrose's AM-Pharma acquisition; and ICER's new-drug launch-price and prescription-access findings. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

FDA granted accelerated approval to GSK's Jemperli (dostarlimab) for biomarker-defined locally advanced rectal cancer, with continued surveillance required for responders. Disc Medicine's bitopertin met both Phase 3 APOLLO co-primary endpoints in erythropoietic protoporphyria after an earlier FDA rejection. The roundup covers Roche and Hansoh's oncology ADC deal, Merck KGaA's acquisition agreement for Silence Therapeutics in polycythemia vera, Lilly's Omvoh (mirikizumab) and Gilead's emvistegrast in ulcerative colitis. Also: AbbVie's ABBV-466 Crohn's data and EyePoint's DURAVYU Phase 3 miss in wet AMD and restructuring.

The Pharma Closeout's AAO 2026 Debrief covers the readouts from the American Academy of Ophthalmology meeting in New Orleans that matter for drug, device and payer strategy. Kodiak's DAYBREAK and Ocular Therapeutix's SOL-1 show retina's durability race: fewer injections than fixed-schedule aflibercept, with Eylea HD and Vabysmo untested and the old standard going biosimilar. Belite Bio's tinlarebant heads to a February FDA decision in Stargardt disease, Beacon's VISTA data back a gene therapy filing, and Nanoscope's optogenetic therapy holds at four years. Plus geographic atrophy's next bets, two GLP-1 eye studies pointing in opposite directions, Lytenava's billing-code gap, and what to watch: the October 30 myopia advisory committee and the February 12 Stargardt decision.

Fractyl Health reports that its investigational Revita met the six-month co-primary endpoint of the double-blind, sham-controlled REMAIN-1 pivotal study in adults who lost weight on tirzepatide and then stopped it; the twelve-month co-primary is expected in early 2027. Liquidia and United Therapeutics settled all pending patent litigation: Yutrepia stays available for PAH, Liquidia has asked FDA to remove PH-ILD from the label, and total obligations come to $380.7 million. Alex Mercer and Maya Patel cover Revita's safety and missing-data context, then turn to Verdiva's terminated switch-maintenance study, Biomea's BMF-650 Phase 1 data with its confined-placebo caveat, CHMP opinions for Lilly's oral Foundayo and for broadening Tryngolza in severe hypertriglyceridemia, Roche's ALK7 RNAi license from Rona, Zealand's AI-designed protein deal with Generate, and OMass Therapeutics' Series C. Also covered: Alaunos' completed Velaris acquisition and separate private placement; BMS's split admilparant Phase 3 and Syndax's IPF exit; Verastem's KRAS G12D pancreatic cohort and planned first-line Phase 3; CHMP opinions for Rasonque and Talvey; BNT113, Anktiva's papillary-only expansion and Nurix; tab-cel's accepted FDA resubmission; CHMP's confirmed negative opinion on re-examination for Omeros's narsoplimab; KB113 and RYZ101; Modus's sevuparin enrollment pause, Estuary's launch and Novartis's terminated iptacopan lupus nephritis study; maralixibat, obexelimab and garetosmab data; the Zilbrysq autoinjector, ARO-MAPT and Vanda's VQW-765 result and program hold; Anaphylm's FDA review date; FDA approvals for Enspryng in thyroid eye disease and RYZUMVI in presbyopia; interim six-year MIUDELLA data; Galderma's agreement to buy ZO Skin Health; Osivax's flu vaccine result; Pfizer's Enodia deal; IPOs from Iambic and City Therapeutics; China's export-control registration and draft catalog; a CMS proposed rule with PBM provisions; FDA's rare-disease framework initiative; and Marengo's upcoming ESMO presentation. The episode closes on the week's shared CHMP meeting and its different outcomes, the still-open question of weight maintenance after obesity drugs stop, and financings at different stages of completion. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at thepharmacloseout.com.