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

Lilly Expands Breast Cancer Choices & Novo Signs for Three Obesity Programs

FDA fully approved Lilly's Inluriyo (imlunestrant) plus Verzenio (abemaciclib) after progression in ESR1-mutated advanced breast cancer; evidence is exploratory in 159 pa

Ultragenyx Wins Sanfilippo Type A Approval & Xenon Pauses New Psychiatry Enrollment

Ultragenyx's Fayuvi approval opens a first treatment path for eligible children with Sanfilippo syndrome type A, with preserved function and center access defining the bo

Skyhawk's Early Huntington Signal Faces a Bigger Test & Sling Raises $123M

Skyhawk's early SKY-0515 Huntington's signal faces randomized confirmation, while Sling's $123M financing advances oral linsitinib for thyroid eye disease. Alex and Maya

Vera’s Kidney Data Strengthen Full-Approval Case & Curium Challenges Novartis’ Lutathera

Vera reports a 76% reduction in composite kidney-disease progression risk and near-stable two-year kidney function for TRUTAKNA (atacicept-vymj) in sponsor topline data,

Daily Roundup | Enhertu Delays Lung Cancer Progression, Survival Benefit Unproven

Enhertu delayed lung cancer progression in a Phase 3 trial, but immature survival results and fatal lung toxicity complicate the first-line case. Definium reports a secon

Week in Review | AstraZeneca’s Setback, Novartis Under Pressure & Scholar Rock’s Approval

AstraZeneca's broader-use trial of Etcamah (camizestrant)missed its primary goal in advanced breast cancer, while the existing approval stands. Scholar Rock's ISEMBYLD (a

Exelixis Faces FDA Delay & Karyopharm Faces October Deadline

FDA extended its review of Exelixis's zanzalintinib-Tecentriq combination for metastatic colorectal cancer to March 3, 2027, after classifying updated data as a major ame

Biohaven Faces FDA Enrollment Hold & AbbVie Reports Menstrual Migraine Results

Biohaven's FDA partial hold pauses new epilepsy-trialenrollment; the company still expects RISE-3 results this year. AbbVie reports LUNA menstrual-migraine results for or

Bayer's Hyrnuo Enters First-Line Rivalry & FDA Gets Permanent Center Chiefs

Bayer's Hyrnuo (sevabertinib) gains first-line accelerated approval in HER2-mutant lung cancer, joining an established rival. Permanent FDA center leaders follow repeated

Novartis's HARBOR Miss Tests Confidence in the Growth Plan & Rasonque's Access Hurdles

Novartis's del-desiran missed HARBOR's primary endpoint in myotonic dystrophy, adding pressure to a growth plan already facing setbacks. Roivant and Pulmovant's moslicigu

Novo Ends Two Ziltivekimab Heart-Failure Trials & SynAct Plans Another Arthritis Trial

Novo is ending the HERMES and ATHENA ziltivekimab trials after a monitoring committee judged them unlikely to succeed, leaving ARTEMIS as its remaining Phase 3 cardiovasc

Week in Review | Bristol's CAR-T Pause Was Three Months Old Before the Public Heard

Bristol Myers Squibb told regulators in early June. The rest of us found out this week, after an analyst note. Three months sat between those two facts, and that gap is t

Novartis's Pelacarsen Misses—What's Next for Rivals? & FDA Approves Etcamah Before Progression

Novartis's pelacarsen missed its cardiovascular endpoint despite lowering Lp(a)—what should Amgen and Lilly rethink? FDA accelerated approval brings AstraZeneca's Etcamah

AbbVie's Etentamig Clears Phase 3 Myeloma Trial on Both Endpoints & GSK Pays HUTCHMED $110M Upfront for KRAS-EGFR Drug

AbbVie's BCMA x CD3 bispecific etentamig met both primary endpoints in the Phase 3 CERVINO myeloma study — a 74.0% response rate versus 45.7% for standard therapy and a 6

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

uniQure filed AMT-130 for FDA and UK approval on three-year Phase 1/2 data with a propensity-matched external control, and a potential accelerated-approval action date in

Alumis TYK2 Pill Fails Lupus: What's Left of the Platform & Kazia's PI3K Inhibitor Cuts CRC Tumor Burden 52%

Alumis shares fell 55% after envudeucitinib missed every endpoint in a mid-stage systemic lupus study - and the CEO still sees a path to Phase 3 built on a prespecified i

Novartis, BMS Halt Autoimmune CAR-T Trials on Safety & FDA Clears Takeda's Mimrylo in Polycythemia Vera

Two of the biggest names in cell therapy just hit the brakes on the most ambitious idea in immunology - Novartis and Bristol Myers Squibb have paused their autoimmune CAR

Week in Review | AstraZeneca's Wainua Missed in ATTR-CM: The Stabilizer Problem

Three hundred eighty-one events versus three hundred ninety-two — AstraZeneca and Ionis's Wainua (eplontersen) missed in ATTR-CM, and the Munich post-mortem points at bac

Cytokinetics Wins Non-Obstructive HCM, Stock Falls Anyway & Teva bids $57.5M for BioXcel asset as shares collapse 66%

Cytokinetics' aficamten hit both primary endpoints in non-obstructive hypertrophic cardiomyopathy — a 3.0-point symptom score gain — and the stock still fell about 6%. We

Roivant's JAK1/TYK2 Pill Wins First Dermatomyositis Nod & Spyre Deprioritizes TL1A Drug After RA Miss

Roivant and Priovant won FDA approval for LISRAYA (brepocitinib) in dermatomyositis — 55% of patients achieved both symptom improvement and minimal steroid use at 52 week