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

GSK walked away from its $2.2 billion Alector alliance,ending its neuroscience re-entry as clinical setbacks piled up. Plus: the FDA resumes releasing rejection letters with fourteen new CRLs, Hengrui and Elevar's PD-1 liver cancer combo is rejected a third time, Sanofi's subcutaneous Sarclisa wins approval, Pfizer/Astellas and Merck expandPadcev-Keytruda in muscle-invasive bladder cancer,...

AstraZeneca and Ionis's Wainua missed its Phase 3 ATTR-CMendpoint — Ionis fell ~20% while BridgeBio surged ~17%. We break down the CARDIO-T Transform failure and what it means for Alnylam's Amvuttra and BridgeBio's Attruby, plus Roche scrapping tominersen in Huntington's, GSKexiting its Alector pact, Ipsen's Dysport dual Phase 3 migraine wins, Vera Therapeutics' IgA nephrop...

The FDA quietly paused publishing complete response letters after a citizen petition — reversing the Makary-era transparency push and closing a live window into rival drug failures. Plus: Sino Biopharmaceutical's dual respiratory deals with AstraZeneca ($200M upfront, TQC3721 in COPD) and GSK (Trelegy and Anoro Ellipta China rights), Vera Therapeutics' Trutakna approval in IgA nephropathy, Bristol...

Vera Therapeutics wins FDA accelerated approval for TRUTAKNA (atacicept) in IgA nephropathy on a 42% placebo-adjusted proteinuria cut — setting up a head-to-head with Otsuka's VOYXACT. Plus Oberland Capital's up-to-$400M royalty deal for MeiraGTx eye gene therapies, Novartis cuts 322 New Jersey jobs, Bristol Myers' Krazati confirmatory failure in colorectal cancer, Roche's divarasib KRAS win, and...

Vertex pays $10B cash for Crinetics Pharmaceuticals — its largest deal ever — betting on acromegaly drug Palsonify and Phase 3 CAH candidate atumelnant. Also: Novartis acquires ADC platform Myricx Bio for up to $1.5B; HSBC downgrades Pfizer to Hold after sigvotatug vedotin Phase 3 miss; BMS Krazati confirmatory study fails in CRC as Roche divarasib wins KRAS Phase 3; FDA closes H1 2026 with 23 nov...

Federal court blocks Colorado's 70% price cap on Enbrel — ruling could shut down state drug pricing laws nationwide. Plus: Casgevy label expansion to age 2 for SCD/TDT sends CRISPR Therapeutics surging 8%. Moderna mFLUSIVA rally hits 70% ahead of August 5 FDA decision. AstraZeneca-CSPC $1.7B kidney deal; Celea raises $180M for IPF; Orca Bio prices Tregzi at $428K. Visit us at www.thepharmcloseout....

Roche's divarasib beats both KRAS G12C rivals on PFS and OS in head-to-head Phase 3, hitting survival significance at interim. AstraZeneca returns to CSPC in a $1.7B siRNA kidney disease deal; Abivax surges on $920M raise and cleared obefazimod cancer concerns; Ipsen acquires Memo Therapeutics; BridgeBio secures $1B; Scribe Therapeutics files for IPO; FDA CBER gene therapy leadership transition. V...

FDA approves Orca Bio's Tregzi — the first precision-engineered cell therapy for allogeneic transplant, sparking IPO speculation. Plus BridgeBio secures $1B from Sixth Street and KKR at a 100%+ conversion premium, Ipsen's $2.55B deal spree continues with Memo Therapeutics,Merck scraps Alzheimer's drug MK-1167 as AlzeCure lands a $2.2B QuantumCell partnership, and FDA warns Sanofi's...

NEJM retracts Amgen's ADVOCATE study after FDA findsendpoint data for 9 patients re-evaluated post-unblinding. Plus: Ionis faces the Tryngolza sNDA PDUFA in severe hypertriglyceridemia, AbbVie's Epkinly delivers chemo-free PFS in R/R DLBCL, Ipsen acquires Kartos for up to $1.75B,and Roche enters the TED race with Enspryng Priority Review. Visit us at www.thepharmacloseout.com pharma, pharm...

FDA breaks Amgen's Tepezza monopoly with Viridian's Lumvoa approval in thyroid eye disease. Plus Merck KGaA's $11.3B Bio-Techne acquisition, Biogen gutting the Apellis pipeline post-$5.6B deal, CHMP moves to revoke Tavneos, and Lilly's orforglipron PDUFA lands Monday. Www.thepharacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pha...

FDA approves Ionis Tryngolza as first treatment to reduce pancreatitis risk in severe hypertriglyceridemia — a potential blockbuster expansion. Merck KGaA acquires Bio-Techne for $11.3B in largest deal in a decade. SCOTUS limits Bayer Roundup state-level claims; Gilead-Pfizer ADC divergence deepens. pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast,...

Gilead's Trodelvy wins front-line triple-negative breast cancer approval — and the stock barely moves. Lilly expands its Abbisko partnership to $1.9B, Novartis pays $105M upfront to Antares for undruggable cancer targets, and three ADC stories in two days force a class-level reckoning. pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Clo...

Pfizer's sigvotatug vedotin disappoints in Phase 3 NSCLC — another blow to the $43B Seagen deal. Plus CMS settles with Incyte on Opzelura classification, Sangamo Therapeutics closes after 30 years, and Moderna's flu vaccine wins unanimous FDA panel support. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The P...

AbbVie bets $10.9B on Apogee Therapeutics to challenge Dupixent — its biggest deal since Allergan. Plus: the first CAR-T approved for a solid tumor clears in China, Merck's $10.8B Prometheus IBD bet pays off with a Phase 3 win, and HHS clinical trial reforms target China.   Visit www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma pod...

US government opens formal probe into Germany's drug pricing reforms, escalating transatlantic pharma trade tensions. Kardigan IPO raises $400M and pops 31%. Moderna flu vaccine gets unanimous FDA advisory panel support ahead of Aug 5 PDUFA. Jazz and AbCellera strike $4.1B T cell engager collaboration. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, dru...

Moderna's mRNA flu vaccine gets unanimous FDA panel backing — PDUFA August 5. NovoCure's TRIDENT trial misses overall survival in glioblastoma; stock drops ~18%. Biogen acquires immunology startup RayThera for up to $1B; Kardigan IPO raises $400M. Visit us at www.thepharmacloseput.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Clos...

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 Close...

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...

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, biotec...

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%; SA...

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, hea...

Zasocitinib hits 35% complete skin clearance at week 16,topping Sotyktu by more than 2.5x in Takeda's head-to-head Phase 3. Plus: Novartis validates its $12B Avidity AOC platform in FSHD, Summit withdraws $500M offering, and Genentech reshapes its research organization. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharm...

Parabilis Medicines prices the largest-ever venture-backed biotech IPO at $670M as 12 startups top $4.1B in 2026. Sanofi stops MOBILIZE Phase 3 for riliprubart in CIDP. TG Therapeutics surges on Briumvi myasthenia gravis data. AstraZeneca's oral GLP-1 elecoglipron hits 11.8% weight loss. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, he...

The Pharma Closeout's full recap of the American Diabetes Association's 86th Scientific Sessions (New Orleans,June 5-8, 2026) - the meeting that ended the A1C-only era and reset what obesity medicine can do. Hosts Alex Mercer and Maya Patel walk every major readout, with the commercial read on each. Visit us at www.thepharmacloseout.com ADA 2026, American DiabetesAssociation, diabetes, obe...

In about six weeks this spring, four of the biggest names in pharma each picked an AI partner — Bristol Myers Squibb chose Anthropic's Claude for 30,000+ employees, Merck signed with Google Cloud for up to $1B, Novo Nordisk went with OpenAI, and Eli Lilly built what NVIDIA calls the industry's most powerful AI supercomputer. A Pharma Closeout Special Report, fact-checked against the primar...