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RFdiffusion3 open-sourced: Baker lab releases all-atom design model
Researchers in David Baker’s lab released RFdiffusion3 as an open-source protein-design model capable of designing binders against DNA, small molecules and generating catalytic enzymes. The...
FDA moves to curb primate testing for some antibody programs — draft guidance
The FDA unveiled plans and draft guidance aimed at reducing or eliminating the need for primate testing in certain monoclonal antibody development programs. Agency documents propose alternative...
Pharvaris’ oral HAE drug wins Phase 3 — rapid onset could challenge incumbent
Pharvaris reported Phase 3 topline success for deucrictibant as an on‑demand oral treatment for hereditary angioedema (HAE), with a median time to symptom relief of 1.28 hours and median time to...
Vandria’s mitophagy drug shows target engagement — company eyes Series B to fund Phase 2
Vandria reported first‑in‑human Phase I data for VNA‑318, an orally available, brain‑penetrant mitophagy‑boosting candidate for Alzheimer’s disease, showing target engagement and tolerability...
Latus Bio clears IND for LTS‑101 in CLN2 — gets multiple orphan designations
Latus Bio announced FDA IND clearance for LTS‑101, its gene therapy candidate targeting the CNS manifestations of late‑infantile neuronal ceroid lipofuscinosis type 2 (CLN2). The agency also...
Vectory gains IND clearance for vectorized antibody targeting TDP‑43 in ALS
Vectory Therapeutics received FDA IND clearance for VTX‑002, a vectorized antibody designed to target TDP‑43 pathology in amyotrophic lateral sclerosis (ALS), clearing the way for a Phase I/II...
Regeneron backs Tessera’s gene-writing push: $150M upfront
Regeneron agreed to a $150 million upfront investment and equity purchase to partner with Tessera on TSRA-196, a gene-writing program aimed at correcting the mutation that causes alpha-1...
RFdiffusion3 open-sourced: atomic protein design goes public
The Baker lab at the University of Washington released RFdiffusion3 as open source, unveiling an all-atom de novo protein design model that can generate binders and catalytic enzymes that interact...
FDA proposes cutback on primate testing — draft guidance issued
The FDA issued draft guidance recommending circumstances where developers can reduce or omit nonhuman primate testing for certain monoclonal antibodies, formalizing an approach to rely on...
Richard Pazdur set to retire — more churn at FDA’s drug shop
Richard Pazdur, recently appointed head of the FDA’s Center for Drug Evaluation and Research (CDER), filed paperwork signaling his intent to retire at month-end, according to regulatory sources....
Pfizer-backed Triana raises $120M to take molecular glue into clinic
Triana Biomedicines closed a $120 million Series B backed by Pfizer Ventures and other investors to advance its lead molecular glue degrader toward clinical proof-of-concept. The financing will...
Protego closes $130M to fund pivotal AL amyloidosis trial
Protego Biopharma raised $130 million in an oversubscribed Series B to advance PROT-001, an oral small-molecule kinetic stabilizer of lambda immunoglobulin light chains, into a pivotal trial...
Capricor wins Phase 3: deramiocel improves heart and muscle function
Capricor Therapeutics reported that its cell therapy deramiocel met the primary endpoints in a Phase 3 trial, showing statistically significant improvements in both cardiac and skeletal muscle...
Pharvaris scores Phase 3 win: rapid on-demand relief in HAE
Pharvaris announced topline Phase 3 results showing its on-demand bradykinin B2 receptor antagonist deucrictibant reduced hereditary angioedema (HAE) attack symptoms faster than placebo. The...
Roche wins clearance for 15-minute point-of-care Bordetella PCR test
Roche secured FDA 510(k) clearance, a CLIA waiver and CE marking for a Cobas Liat point-of-care PCR test that identifies Bordetella pertussis, parapertussis and holmesii in 15 minutes. The company...
IND clearances open clinics for two CNS and rare-disease programs
The FDA granted IND clearance to Latus Bio for LTS-101, a gene therapy candidate for the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2), and also awarded orphan...
Regeneron backs Tessera: $150m pact to write AATD genes
Regeneron and Tessera signed a collaboration that delivers $150 million up front to Tessera to co-develop TSRA-196, a gene-writing therapy targeting alpha-1 antitrypsin deficiency (AATD). The deal...
Protego closes $130m: Pivotal push for oral AL amyloidosis stabilizer
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT-001, an oral small-molecule kinetic stabilizer aimed at amyloid light-chain (AL) amyloidosis, into a pivotal trial...
Pharvaris scores Phase 3 win – deucrictibant eases HAE attacks faster
Pharvaris reported topline Phase 3 data showing its on-demand drug deucrictibant significantly reduced symptom duration versus placebo for hereditary angioedema (HAE) attacks. The result meets the...
Capricor’s cell therapy: Phase 3 shows muscle and heart gains in Duchenne
Capricor Therapeutics reported that its cell therapy deramiocel met the dual efficacy goals of a placebo-controlled Phase 3 trial in Duchenne muscular dystrophy (DMD), showing statistically...