Daily Roundup| GSK to File Jemperli in Rectal Cancer After Phase 2 Win

Daily Roundup| GSK to File Jemperli in Rectal Cancer After Phase 2 Win

GSK will file Jemperli with the FDA for dMMR rectal cancer after a Phase 2 win, extending its PD-1 franchise into curative-intent oncology. Plus Q32 Bio's bempikibart hits its alopecia areata goal, the FDA finalizes psychedelics guidance ahead of a Compass Pathways COMP360 decision, LEQEMBI clears a subcutaneous at-home dose for Eisai and Biogen, Hengrui and Elevar's PD-1 liver cancer combo is rejected a third time, and Biogen's tau drug diranersen takes the spotlight at AAIC. Visit us at www.thepharmcloseout.com Tags pharma, biotech, FDA, clinical trials, drug approvals, Jemperli, GSK, Q32 Bio, alopecia areata, Compass Pathways, LEQEMBI, rectal cancer

Last Week's Recap| AstraZeneca's Wainua Stumbles: The Week the Clinic Pushed Back on Pharma's Deal Boom

AstraZeneca's Wainua missed in cardiomyopathy — one of three clinical setbacks in five days even as pharma dealmaking stayed red-hot with Vertex's ~$10B Crinetics buy and GSK's biggest oncology bet in a decade. Webreak down what the Wainua miss means for the ATTR cardiomyopathy race, Bausch + Lomb's BL1107 glaucoma flop, the third Hengrui/Elevar liver-cancer rejection, Corcept's misread insider sale and late-2026 Cushing's catalyst forrelacorilant, plus the week ahead: Q32 Bio's bempikibart in alopecia areata, Celcuity's gedatolisib FDA decision in breast cancer, Novartis's pelacarsen, and Lilly's muted Foundayo launch. Visit us at www.thepharmacloseout.com Tagspharma, biotech, FDA, clinical trials, drug approvals,Wainua, AstraZeneca, ATTR cardiomyopathy, Corcept Therapeutics, gedatolisib, Q32 Bio, alopecia areata

July 10, 2026| GSK Ends Alector Neuroscience Bet: What the $2.2B Unwind Signals

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, Vera Therapeutics scores an IgA nephropathy nod against Otsuka, AstraZeneca and Ionis miss a Phase 3 heart trial, Apnimed files to IPO amid its sleep apnea review, and Moderna sinks in abroad biotech selloff. Visit us at www.thepharmacloseout.com Tags pharma, biotech, FDA, clinical trials, drug approvals, GSKAlector, immuno-neurology, Hengrui Elevar hepatocellular carcinoma, Sarclisa multiple myeloma, Apnimed IPO, Moderna biotech selloff, Padcev-Keytruda bladder cancer

July 09, 2026| Wainua Fails Pivotal ATTR-CM Trial; Ionis Sinks 20%

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 nephropathy approval versus Otsuka, NICE rejecting Amgen'sLumakras, and Sino Biopharm's China deals with AstraZeneca and GSK. Visit us at www.thepharmacloseout.com Tags pharma, biotech, FDA, clinical trials, drug approvals,eplontersen Wainua, Ionis Pharmaceuticals, AstraZeneca, BridgeBio Attruby, ATTR-CM, Ipsen Dysport migraine, Roche tominersen

July 08, 2026| FDA Halts Drug Rejection Letters — What It Means for Competitive Intel

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 Myers' Krazati confirmatory failure in colorectal cancer, Kailera's oral GLP-1 Phase 3 obesity data, Tampa General's 340B suit against Lilly over Mounjaro, and Biohaven's taldefgrobep push into muscle-sparing obesity. Visit us at www.thepharmacloseout.com Tags pharma, biotech, FDA, clinical trials, drug approvals, complete response letters, Sino Biopharmaceutical, AstraZeneca, GSK, Vera Therapeutics, IgA nephropathy, obesity