The Pharma Closeout | Daily Pharmaceutical and Biotech News in 15 Minutes

Artiva ends AlloNK and cuts about 94% of staff after a risk-benefit review covering durability and two separately assessed deaths. Ferring agrees to acquire Gameto for up to $1.3825 billion subject to milestones, before Fertilo's pivotal fertility trial reports. Pfizer's ELREXFIO (elranatamab) meets a Phase 3 myeloma goal with higher rates of severe infections; AstraZeneca and Daiichi Sankyo gain EU approval for Enhertu (trastuzumab deruxtecan) in postoperative HER2-positive early breast cancer; Novartis discontinues remibrutinib in generalized myasthenia gravis for futility. Also: Teva closes its BioXcel asset deal for IGALMI (dexmedetomidine) and the pending at-home BXCL501 program; Vanda's NEREUS (tradipitant) reduces vomiting in a single-dose semaglutide challenge; and Kiniksa raises its ARCALYST (rilonacept) sales forecast.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at thepharmacloseout.com.

October 26, 2026 edition, released October 27. Recorded October 26: references to today mean October 26, and tomorrow means October 27.

BioNTech and DualityBio's breast cancer ADC beat chemo in Phase 3, yet the companies call the gain modest. Merck and Kelun's sac-TMT showed interim median overall survival of 19.0 vs 12.1 months in endometrial cancer after platinum and immunotherapy and is under FDA priority review. Also: Keytruda (pembrolizumab) alone in first-line dMMR endometrial cancer; FDA approval of Talzenna (talazoparib) plus Xtandi (enzalutamide) for adults with metastatic, androgen pathway modulation-naive or -sensitive prostate cancer with HRR mutations detected by an FDA-authorized test; BMS/SystImmune's iza-bren in EGFR-mutated lung cancer; GSK/Hansoh's ris-rez in osteosarcoma; and Corxel US/Amanat's proposed deal that would help fund oral GLP-1 CX11.

Sources:
- SEC (BioNTech Exhibit 99.1): DYNASTY-Breast02 topline Phase 3 results for trastuzumab pamirtecan — October 26, 2026 — https://www.sec.gov/Archives/edgar/data/0001776985/000177698526000074/a991261025_bntxdbxtpamxtop.htm
- FDA: Approval of fam-trastuzumab deruxtecan-nxki in HR-positive HER2-low or HER2-ultralow metastatic breast cancer — January 2025 — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2
- Merck: TroFuse-005 sacituzumab tirumotecan endometrial results and FDA priority review — October 26, 2026 — https://www.merck.com/news/sacituzumab-tirumotecan-sac-tmt-reduced-the-risk-of-death-by-32-and-the-risk-of-disease-progression-or-death-by-41-compared-to-chemotherapy-in-certain-patients-with-advanced-or-recurrent-endometrial/
- Merck: KEYNOTE-C93 Keytruda monotherapy in dMMR endometrial cancer — October 26, 2026 — https://www.merck.com/news/keytruda-pembrolizumab-as-monotherapy-reduced-the-risk-of-disease-progression-or-death-by-43-for-certain-patients-with-advanced-or-recurrent-endometrial-cancer-with-mismatch-repair-deficient/
- FDA: Approval of talazoparib with enzalutamide in metastatic androgen pathway modulation-naive or -sensitive prostate cancer — October 26, 2026 — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-talazoparib-enzalutamide-metastatic-androgen-pathway-modulation-naive-or-sensitive
- Bristol Myers Squibb: PANKU-Lung01 Phase 3 results for izalontamab brengitecan — October 26, 2026 — https://news.bms.com/news/corporate-financial/2026/Izalontamab-Brengitecan-Iza-Bren-Doubles-Median-Progression-Free-Survival-in-Patients-with-Previously-Treated-EGFR-Mutated-Non-Small-Cell-Lung-Cancer-Compared-to-Chemotherapy-in-the-Phase-3-PANKU-Lung01-Study/default.aspx
- FDA: Approval of amivantamab-vmjw with carboplatin and pemetrexed after EGFR TKI — September 19, 2024 — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-carboplatin-and-pemetrexed-non-small-cell-lung-cancer-egfr-exon-19
- GSK: ARTEMIS-011 ris-rez in relapsed osteosarcoma in China — October 26, 2026 — https://www.gsk.com/en-gb/media/press-releases/ris-rez-reduced-risk-of-disease-progression-or-death-by-67-versus-chemotherapy-in-patients-with-relapsed-osteosarcoma-in-china/
- SEC (Exhibit 99.1): Corxel and Amanat proposed business combination and financing — October 26, 2026 — https://www.sec.gov/Archives/edgar/data/2112457/000121390026112236/ea030895401ex99-1.htm
- FDA: Approval of talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer — June 20, 2023 — https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-talazoparib-enzalutamide-hrr-gene-mutated-metastatic-castration-resistant-prostate

Sunday, October 25 edition, released Monday, October 26 with the SANOVO update. Amgen's Imdelltra plus AstraZeneca's Imfinzi extended median survival to 21.1 months from 12.7 in extensive-stage small-cell lung cancer maintenance, while Roche's divarasib beat pooled KRAS G12C comparators. AstraZeneca's Sone-Ve delivered a gastric-cancer survival win beside a missed progression endpoint; SANOVO then showed Tagrisso plus Orpathys improved progression-free survival in untreated, biomarker-selected patients in China. Gilead's $1.275 billion PepStar IL-23 deal and AbbVie's Skyrizi Crohn's approval lead gastroenterology, with hematology, immunology, diagnostics and biotech investment rules rounding out the full Week in Review.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at thepharmacloseout.com.

Delayed release on October 24, 2026 of the Friday, October 23 edition. News and relative-date references are as of October 23.

Novartis's investigational remibrutinib cut MS relapse rates 35.2% and 31.2% versus teriflunomide; Biokin's Bristol Myers Squibb/SystImmune-partnered iza-bren improved breast cancer PFS. Jazz/BeOne's Ziihera (zanidatamab), licensed from Zymeworks, has mature gastroesophageal survival data, while Tango reports pancreatic cancer responses with vopimetostat and Revolution Medicines' daraxonrasib. Johnson & Johnson's Tecvayli (teclistamab) moves earlier in European myeloma treatment, as we examine BMS's zola-cel safety in MS and Alnylam's brezosiran target engagement in Huntington's. Plus Bolt's Prana acquisition and Treasury's proposed biotech investment rules.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

The Pharma Closeout's UEG Week 2026 Debrief covers the readouts from United European Gastroenterology Week in Barcelona that matter for drug, device and payer strategy. Takeda's VERDICT, the first randomized treat-to-target strategy trial in ulcerative colitis, and the new STRIDE-III guidance sharpen what IBD treatment should aim at, and what that means for how therapies win switches. Then the orals (Abivax's obefazimod ahead of its NDA, Gilead's emvistegrast dose curve, J&J's icotrokinra), the TL1A race with Teva and Sanofi's first 44-week duvakitug data, the incumbents' franchise defense from AbbVie and J&J, Tremfya at week 48 in Crohn's with fistulas, and a gastroparesis drug heading to Phase 3. Plus what to watch: AbbVie's October 30 results, AASLD from November 5 and the November 27 PBC decision.

0:00 Cold open and introduction

0:50 Story of the Congress: the target, not the molecule (Takeda's VERDICT, STRIDE-III, PROFILE)

5:06 The orals: obefazimod, emvistegrast, icotrokinra and OD-001

8:38 The TL1A race: Teva and Sanofi's duvakitug

10:01 Franchise defense: AbbVie, J&J, Spyre and the biosimilar squeeze

13:26 The IL-23 incumbents: Tremfya in fistulizing Crohn's, Skyrizi's subcutaneous induction

15:26 Beyond IBD: gastroparesis, EoE and the liver

17:27 What to watch: AbbVie's results, AASLD and the PBC decision

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

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.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

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.

0:00 Cold open and introduction

1:06 Story of the Congress: retina's durability race (Kodiak, Ocular, EyePoint)

4:29 The old standard goes biosimilar

5:08 Inherited retinal disease moves into the FDA queue: Belite, Beacon, Nanoscope

8:00 Geographic atrophy: PRIMA, K8 and OCU410

9:45 GLP-1 drugs and the eye: two studies, two directions

11:01 Roundup: Lytenava's billing code, Oculis, SpyGlass

12:14 What to watch: the myopia advisory committee and the Stargardt decision

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.