December 15, 2025

Immunome’s desmoid tumor drug varegacestat posts landmark Phase 3 results, setting up a potential challenge to Merck KGaA’s Ogsiveo

18 hours ago talkbio0Tagged Fibromatosis, Aggressive, Frequency of Responses, gamma secretase inhibitor, Immunome, Infrequent, Merck KGaA, NDA, Neoplasms, Ogsiveo, Phase 3 RINGSIDE trial, Progression-Free Survival, varegacestat

Immunome; varegacestat; desmoid tumors; Phase 3 RINGSIDE trial; gamma secretase inhibitor; Merck KGaA; Ogsiveo; progression-free survival; objective response rate; rare tumors; oncology; NDA filing

Aviceda’s AVD-104 misses Phase 2b primary endpoint vs Izervay but still headed to Phase 3

18 hours ago talkbio0Tagged avacincaptad, AVD-104, Clinical trial failure, Clinical Trials, Dry AMD, Genus Aviceda, Geographic Atrophy, IZERVAY, pegol, Phase 3 prospects, Sialic Acid Binding Immunoglobulin-like Lectins

Aviceda; AVD-104; geographic atrophy; dry AMD; Phase 2b; SIGLEC trial; Izervay; avacincaptad pegol; clinical trial failure; Phase 3 prospects

Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

18 hours ago talkbio0Tagged BTK inhibitor, Clinical trial failure, Deferred, Mississippi (geographic location), Multiple Sclerosis, non-relapsing secondary progressive, nrSPMS, Parts per million (qualifier value), PDUFA, Progressive, Regulatory Setback, Review [Publication Type], sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback

Scaling for a New Era: The Rise of Radiopharma

19 hours ago talkbio0Tagged Clinical Trials, CROs, Diagnostics, Funding, Lutetium-177, M&A, Neoplasms, Pet Animal, precision oncology, radioligand therapy, Radiopharmaceuticals, radiotheranostics, Research Infrastructure, supply chain, targeted alpha therapy

radiopharmaceuticals; radioligand therapy; oncology; precision oncology; targeted alpha therapy; Lutetium-177; Actinium-225; clinical trials; radiotheranostics; M&A; biotech funding; supply chain; infrastructure; CROs; companion diagnostics

Sobi Acquires Arthrosi Therapeutics for $950M Upfront in Gout Drug Deal

22 hours ago talkbio0Tagged Acquisition, Arthrosi, Gout, pozdeutinurad, Sobi

Sobi; Arthrosi Therapeutics; acquisition; gout; pozdeutinurad; AR882

‘Au Revoir TIGIT’: Gilead, Arcus Cut Gastro Cancer Drug After Late-Stage Failure

23 hours ago talkbio0Tagged Arcus Biosciences, casdatifan, domvanalimab, EDGE-Gastric, Esophageal Neoplasms, Failure (biologic function), Gilead Sciences, immuno-oncology, Malignant neoplasm of stomach, nivolumab, Opdivo, Overall Survival, Phase 3 trial, STAR-221, TIGIT gene, zimberelimab

domvanalimab; TIGIT; Gilead Sciences; Arcus Biosciences; STAR-221; gastric cancer; esophageal cancer; zimberelimab; Opdivo (nivolumab); Phase 3 trial failure; overall survival; casdatifan; immuno-oncology; EDGE-Gastric

Cynata Completes Patient Enrolment in Phase 2 aGvHD Clinical Trial

2 days ago talkbio0Tagged acute graft, aGvHD, Cynata, enrolment, host disease, Phase 2 trial

Cynata Therapeutics; CYP-001; Phase 2 trial; acute graft versus host disease; aGvHD; patient enrolment