Biopharma News Round Up

Reported early data for off-the-shelf gamma-delta CAR-T prula-cel/ADI-001 in lupus.

Phase 2 daxdilimab data showed a reported six-point reduction in lupus severity at the lower dose.

Retreatment data for Descartes-08 showed deep and durable responses in myasthenia gravis.

Telitacicept reported 48-week symptom-improvement data in generalized myasthenia gravis.

Expanded their long-acting-antibody alliance with a $1B upfront payment.

Presented data indicating earlier and sustained benefit with VYVGART in myasthenia gravis and CIDP.

AMT-130 48-month data showed 44% cUHDRS slowing, which was non-significant, and 61% TFC slowing with nominal significance; external coverage raised durability concerns.

FDA cleared an IND for a Phase 3 sovateltide study in traumatic brain injury.

FDA granted 510(k) clearance for a portable vertigo diagnostic system.

Zenkuda/tarcocimab Phase 3 data showed non-inferior efficacy to Eylea in wet AMD; additional retinal-program data were reported.

Reported Phase 3 retatrutide data, Phase 2 eloraTZP data, and a Phase 3 cardiovascular analysis for oral GLP-1 orforglipron.

Reported CagriSema data and Wegovy liver-fat-normalization findings.

Survodutide met Phase 3 endpoints, with up to 13.1% weight loss and improved glycemic control; coverage also emphasized lower efficacy than leading rivals.

Phase 2 petrelintide data supported progression into a pivotal program.

Discontinued muscle-preserving obesity candidate emugrobart/GYM329 and returned rights to Chugai.

Novo licensed preclinical weekly oral GLP-1/GIP candidate HRS-1596 in a deal worth up to $2.6B.

Presented preclinical KO-7246 menin-inhibitor data in diabetes models.

MN-001/tipelukast met its Phase 2 primary endpoint in NAFLD.

Updated 52-week EP-104GI results showed durable response and high remission rates in eosinophilic esophagitis.

Tulisokibart met Phase 2b endpoints in hidradenitis suppurativa, supporting Phase 3 advancement.

Zumilokibart showed statistically significant Phase 2 benefit in atopic dermatitis.

Reported positive 52-week denifanstat Phase 3 extension results in acne.

New YCANTH analysis reported faster complete clearance versus vehicle.

Presented atebimetinib-combination data in pancreatic cancer.

Published Phase 2b VCN-01 results in metastatic pancreatic cancer.

Presented aglatimagene besadenovec clinical and biomarker data in localized prostate cancer.

Published final Phase 2a data for aglatimagene besadenovec plus valacyclovir in ICI-inadequate unresectable NSCLC.

FDA granted Fast Track designation for plinabulin plus docetaxel after ICI and platinum treatment in NSCLC.

Withdrew the accelerated-approval filing for B7-H3 ADC ifinatamab deruxtecan after FDA feedback.

EU marketing authorization for Aumseqa in EGFR-mutated NSCLC was revoked following an AstraZeneca legal challenge.

FDA cleared the IND for first-in-human CUR-001 development in mesothelin-positive solid tumors.

Reported positive Phase 2 BO-112 topline data in high-risk basal-cell carcinoma.

Phase 3 teclistamab plus daratumumab data showed durable disease control and survival in relapsed/refractory multiple myeloma.

Phase 2 iopofosine I-131 analysis reported high response rates in BTKi-refractory Waldenström macroglobulinemia.

Oral azacitidine/cedazuridine combination met its Phase 3 pharmacokinetic endpoint.

Published pooled clinical evidence supporting Annamycin's cardiac-safety profile.

Lilly ended its synthetic-lethality collaboration with Foghorn; Foghorn discontinued the program and cut 40% of staff.

Merck licensed a preclinical KRAS G12D candidate for $400M upfront and up to $2.1B total.

Reported positive Phase 1 MRT-8102 data in elevated cardiovascular-risk participants.

Camzyos received pediatric approval.

FDA approved Gazyva for idiopathic nephrotic syndrome.

FDA feedback supported a single two-year registrational WVE-006 study in alpha-1 antitrypsin deficiency.

FDA approved tiratricol, branded as Emcitate, for MCT8 deficiency.

EMA validated D-PLEX100's marketing-authorization application; PolyPid also regained European commercial rights from ADVANZ.

Entered a BARDA contract supporting SCY-247 antifungal development.

Received DARPA support and FDA clearance for a Phase 3 program combining robotic TMS with NRX-101.