The Pharma Closeout | Daily Pharmaceutical & Biotech News in 15 minus

Jun 17, 2026 | UniQure AMT-130 Surges 70% on FDA Reversal; Jazz-AbCellera $4.1B TCE Deal

UniQure surges 70% as FDA reverses course on Huntington's gene therapy AMT-130 filing path. Jazz and AbCellera strike $4.1B T cell engager deal for GI cancers. Novo Nordisk faces $25M ransom demand after hackers claim drug formulations and AI models.   Visit www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, UniQure, QURE, AMT-130, Huntington's disease, gene therapy, FDA accelerated approval, Jazz Pharmaceuticals, AbCellera, T cell engagers, Novo Nordisk, cyberattack, data breach, Biogen, RayThera, immunology, Moderna, mFlusiva, VRBPAC, mRNA flu vaccine, GSK, Spero Therapeutics, complicated UTI, compounded GLP-1, Vedana Biosciences, Spot Bio, Triveni Bio, Colorado drug importation

Jun 16, 2026 | BridgeBio BBP-418 Sweeps LGMD Phase 3; FDA Scrutinizes Moderna Flu Vaccine

BridgeBio's BBP-418 sweeps Phase 3 in limb-girdle muscular dystrophy — stock up 15%, no approved competition. FDA briefing docs challenge Moderna mFlusiva efficacy ahead of Thursday's VRBPAC vote. Plus Lilly acquires non-opioid pain startup 4E Therapeutics, Edgewise advances EDG-7500 toward Phase 3 in HCM, and Neumora abandons navacaprant after two Phase 3 failures. Visit www.thepharmacloseput.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, BridgeBio, BBP-418, LGMD, limb-girdle muscular dystrophy, Moderna, mFlusiva, VRBPAC, flu vaccine, Eli Lilly, 4E Therapeutics, non-opioid pain, MNK inhibitor, Edgewise, EDG-7500, HCM, hypertrophic cardiomyopathy, Adaptive Biotechnologies, MRD, Neumora, navacaprant, myelofibrosis, Jakafi, Be Biopharma, enGene, Parabilis, biotech IPO, Colorado drug import, Lilly, Novartis

Jun 15, 2026 | CMS Targets SubQ Keytruda and Opdivo Loophole; Takeda Beats Sotyktu Head-to-Head

CMS proposes closing Medicare negotiation loophole threatening Keytruda and Opdivo subcutaneous strategies — billions at stake. Plus Takeda's zasocitinib tops Sotyktu, Novartis validates $12B Avidity deal, Elicio's KRAS vaccine crashes, and FDA approves Truqap in prostate cancer and Tzield for pediatric T1D. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, CMS, Medicare drug price negotiation, IRA, Keytruda, pembrolizumab, Opdivo, nivolumab, subcutaneous, Merck, Bristol Myers Squibb, Takeda, zasocitinib, Sotyktu, deucravacitinib, TYK2, Novartis, Avidity Biosciences, del-brax, RNA therapeutics, Elicio Therapeutics, KRAS, cancer vaccine, ELI-002, pancreatic cancer, AstraZeneca, Truqap, capivasertib, prostate cancer, PTEN, Sanofi, Tzield, teplizumab, type 1 diabetes, Welireg, belzutifan, kidney cancer, J&J, Talvey, Darzalex Faspro, multiple myeloma, Summit Therapeutics, ivonescimab, oveporexton, narcolepsy, SLEEP 2026, Gan & Lee, bofanglutide, obesity, GLP-1, Eisai, Leqembi, Lilly, BMS

EHA 2026 Special — Full Meeting Recap

The Pharma Closeout's comprehensive recap of EHA 2026(Stockholm, June 11-14). HEADLINE: J&J's MonumenTAL-3 (talquetamab +daratumumab) in earlier-line R/R myeloma — PFS HR 0.28/0.33, complete-response 71% vs 34.5%, NEJM-published; ~73% dysgeusia the caveat. AML: the menin inhibitor frontline class war — ziftomenib KOMET-007 (CRc 96% NPM1m / 90%KMT2Ar) vs revumenib (frontline CRc 97%; SAVE ORR 88%) — and the gilteritinib-vs-midostaurin FLT3 survival miss (HR 1.02). CLL: BRUIN CLL-322 — pirtobrutinib + venetoclax-rituximab, PFS HR 0.55, first Phase 3 to beat a venetoclax control. LYMPHOMA: frontMIND (tafasitamab+len+R-CHOP, 1L DLBCL, PFS HR 0.75) and EPCORE DLBCL-1 (epcoritamab wins PFS, misses OS). MYELOFIBROSIS: SENTRY (selinexor+rux, SVR35 49.8% vs 28%, symptom co-primary missed). BENIGN HEME: warm AIHA gets two drugs (sovleplenib, nipocalimab) in a disease with no approved therapy; CASGEVY first pediatric gene-editing data. Lightning round, discipline corner (why three 'EHA' myeloma headlines were actually ASCO), and what to watch. Three throughlines: immunotherapy moving earlier andoff-the-shelf, a frontline standard-of-care reset, and the survival misses that set the discipline. Stock reactions qualitative only. pharma, pharmaceutical, hematology, blood cancer, clinicaltrials, biotech, EHA 2026, pharma podcast, The Pharma Closeout

Jun 12, 2026 | FDA Approves Merck Welireg-Keytruda for Kidney Cancer; Jazz Zepzelca Phase 3 Fails

FDA approves Merck's Welireg-Keytruda combo for adjuvant kidney cancer — 28% risk reduction vs. active Keytruda monotherapy in LITESPARK-022. Jazz's Zepzelca misses OS endpoint in Phase 3 LAGOON, Incyte acquires Vega Therapeutics for $1.25B, and Amgen files independent Duke review to fight FDA's proposed Tavneos withdrawal. pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Merck, Keytruda, Welireg, belzutifan, pembrolizumab, kidney cancer, renal cell carcinoma, LITESPARK-022, Jazz Pharmaceuticals, Zepzelca, lurbinectedin, small cell lung cancer, LAGOON, Incyte, Vega Therapeutics, Star Therapeutics, Amgen, Tavneos, avacopan, AstraZeneca, Truqap, capivasertib, prostate cancer, Sanofi, Tzield, type 1 diabetes, Enliven Therapeutics, WuXi AppTec, CMS, Medicare, IRA, Novo Nordisk, oral semaglutide, M&A, GSK