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AI drug discovery accelerates: RFdiffusion3 open-sourced — Terray hits BMS milestone
Two AI-driven advances landed this week: the Baker lab released RFdiffusion3 as open source, demonstrating de novo designs for DNA-binding proteins and catalytic enzymes, and Terray Therapeutics...
Triana raises $120M — molecular glue degrader heads to clinic
Triana Biomedicines closed an oversubscribed $120 million Series B to advance its molecular glue degrader pipeline toward clinical proof-of‑concept. The financing included participation from...
Two IND clears advance CNS and rare-disease programs — Latus and Vectory move to clinic
The FDA cleared INDs for two early-stage programs: Latus Bio’s LTS-101 gene therapy to treat the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, and...
Big pharma dealmaking: Regeneron backs Tessera gene writing ($150M) — AstraZeneca buys Neurimmune asset
Regeneron struck a $150 million upfront deal with Tessera Therapeutics to develop TSRA-196, a gene-writing therapy for alpha-1 antitrypsin deficiency (AATD). Tessera will lead initial...
Diagnostics scale-up and approvals: GeninCode teams with Thermo Fisher — Devyser wins Canada clearance
GeninCode partnered with Thermo Fisher Scientific to manufacture, distribute and sell its Cardio InCode-Score, an in vitro polygenic risk score (PRS) test for cardiovascular disease, across the...
CARB‑X backs rapid infectious‑disease diagnostics — funds for ProtonDx and Scout Health
CARB‑X awarded two diagnostic developers new funding to advance point‑of‑care tests addressing pediatric respiratory infections and sexually transmitted infections. ProtonDx received $1 million to...
Deramiocel triumphs—Capricor posts positive Phase 3 topline
Capricor announced positive topline results from its pivotal Phase 3 HOPE-3 study of deramiocel in Duchenne muscular dystrophy (DMD). The company reported that the trial met its primary endpoint...
Pharvaris clocks Phase 3 win: oral HAE pill eyes 2026 filing
Pharvaris reported that deucrictibant, its oral bradykinin B2 receptor antagonist, met primary and secondary endpoints in a pivotal Phase 3 study as an on‑demand treatment for hereditary...
Protego raises $130M—preps pivotal trial for AL amyloidosis stabilizer
Protego Biopharma closed a $130 million Series B financing to advance its lead oral candidate, PROT‑001, into a pivotal trial for AL (amyloid light‑chain) amyloidosis. The company said the funds...
Regeneron-Tessera deal: $150M upfront for AATD gene‑writing program
Regeneron agreed to a strategic collaboration and equity investment in Tessera Therapeutics worth $150 million upfront to co‑develop TSRA‑196, a gene‑writing candidate for alpha‑1 antitrypsin...
Triana raises $120M—pushes molecular‑glue degrader toward clinic
Triana Biomedicines closed a $120 million Series B round, backed in part by Pfizer Ventures, to advance its lead molecular‑glue degrader into clinical development. The financing will support...
FDA clears Latus Bio IND for CLN2—designations accelerate program
Latus Bio reported FDA clearance of its investigational new drug (IND) application for LTS‑101, a gene therapy candidate targeting CNS manifestations of late‑infantile neuronal ceroid...
Vectory wins IND clearance—vectorized anti‑TDP‑43 enters ALS trials
Vectory Therapeutics secured FDA IND clearance for VTX‑002, a first‑in‑class vectorized antibody targeting TDP‑43 pathology in amyotrophic lateral sclerosis (ALS). The company said PIONEER‑ALS, a...
RFdiffusion3 open source... de novo DNA binders and advanced enzymes
Researchers from David Baker’s lab released RFdiffusion3 as open‑source software, demonstrating de novo design of proteins that bind DNA and catalyze complex chemistries. The model, described in a...
FDA shake‑up: Pazdur signals exit—Tracy Hoeg named acting CDER chief
The FDA is undergoing rapid leadership change: Richard Pazdur filed to retire as director of the agency’s drug center, and the FDA named Tracy Beth Høeg as acting director of the Center for Drug...
Crescent inks two‑way Kelun pact—raises $185M for PD‑1xVEGF and ADC programs
Crescent Biopharma announced a strategic two‑way collaboration with Kelun‑Biotech and completed an $185 million financing to accelerate its PD‑1xVEGF asset and antibody‑drug conjugate (ADC)...
FDA leadership turmoil: Høeg installed as Pazdur signals exit
The FDA has undergone rapid leadership change this week as Tracy Beth Høeg, M.D., Ph.D., was named acting director of the agency’s Center for Drug Evaluation and Research and Richard Pazdur filed...
FDA retools approvals and fees: one pivotal trial and user-fee incentives
FDA leaders signaled a substantive shift in regulatory practice by proposing a default approval pathway that accepts one pivotal clinical trial in many cases and by floating user-fee changes to...
Capricor’s deramiocel shocks market: Phase III success revives approval bid
Capricor Therapeutics reported positive topline results from its pivotal Phase III HOPE‑3 trial of deramiocel in Duchenne muscular dystrophy (DMD), meeting its primary functional endpoint and a...
Pharvaris clinches Phase III: oral HAE pill positions to file in 2026
Pharvaris reported that deucrictibant, its oral bradykinin B2 receptor antagonist, met primary and secondary endpoints in a Phase III on‑demand study for hereditary angioedema (HAE). Topline...