uniQure Files Huntington's Gene Therapy — FDA Reversed Twice Already

October 22, 2026 edition, released October 23. Reporting reflects the October 22 research cutoff. Merck and Moderna's investigational intismeran autogene, added to Keytruda (pembrolizumab) after surgery for high-risk cutaneous melanoma, posted a 0.58 hazard ratio for recurrence or death versus placebo plus Keytruda; overall survival is immature. AbbVie's investigational lutikizumab beat placebo in a Phase 3 hidradenitis suppurativa trial, 31.4% versus 23.4% on HiSCR75. The daily roundup covers BioNTech's planned pairing of pumitamig with Gilead's Trodelvy (sacituzumab govitecan), Menarini subsidiary Stemline's GIM-621 license from Georgiamune, Cencora's American Oncology Network deal and Roche's removal of RG6540 from its Phase 1 pipeline. It also covers Krystal Biotech's Vyjuvek (beremagene geperpavec) storage update, Biohaven's statement, reported by Dow Jones, that FDA accepted its Vyglxia resubmission, and QIAGEN's agreed EQT-led acquisition. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

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.