September 2, 2025

Servier Pays $210M Upfront for Ex-US Rights to Ideaya’s PKC Inhibitor Darovasertib

1 week ago talkbio0Tagged Clinical Trials, Darovasertib, Ideaya Biosciences, Inhibitor, milestone payments, oncology licensing deal, Protein Kinase C, Protein Kinase C Inhibitor, royalties, Servier, uveal melanoma

Servier; Ideaya Biosciences; darovasertib; protein kinase C inhibitor; PKC inhibitor; uveal melanoma; oncology licensing deal; clinical trials; milestone payments; royalties

Sanofi’s Wayrilz Receives FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia

1 week ago talkbio0Tagged Approved, Autoimmune thrombocytopenia, BTK inhibitor, Inosine Triphosphate, LUNA 3 trial, Rilzabrutinib, sanofi, United States Food and Drug Administration, Wayrilz

Wayrilz; rilzabrutinib; FDA approval; immune thrombocytopenia; ITP; BTK inhibitor; Sanofi; LUNA 3 trial

Cytokinetics Stock Soars After Positive Phase 3 Data as FDA Approval Decision for Aficamten Nears

1 week ago talkbio0Tagged Aficamten, Approved, Cytokinetics, Hypertrophic obstructive cardiomyopathy, PDUFA, Performance, REMS, United States Food and Drug Administration

Cytokinetics; Aficamten; FDA approval; Phase 3 trial; obstructive hypertrophic cardiomyopathy (oHCM); PDUFA date; REMS; stock performance

Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

1 week ago talkbio0Tagged Alzheimer 's disease, Approved, at-home, AutoInjector, Biogen, dosing, Eisai, Lecanemab, Leqembi, Maintenance, Subcutaneous Injections, United States Food and Drug Administration

Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen

Vertex forges $2B-plus alliance with Enlaza to create new autoimmune drugs, improve conditioning methods

1 week ago talkbio0Tagged Autoimmune Diseases, conditioning regimens, covalent biologics, drug conjugates, engagers, Enlaza, gene therapy, T-Lymphocyte, War-Lock platform

Vertex Pharmaceuticals; Enlaza Therapeutics; autoimmune diseases; gene therapy; conditioning regimens; War-Lock platform; covalent biologics; drug conjugates; T-cell engagers; biotech alliance

Novartis Takes Another Shot at Alpha-Synuclein With $2.2B Arrowhead CNS Deal

1 week ago talkbio0Tagged alpha-Synuclein, ARO-SNCA, Arrowhead Pharmaceuticals, biotech partnerships, Gene Silencing, Nerve Degeneration, Novartis, Parkinson 's disease, RNA Interference, TRiM platform

Novartis; Arrowhead Pharmaceuticals; alpha-synuclein; Parkinson’s disease; RNA interference (RNAi); gene silencing; ARO-SNCA; TRiM platform; neurodegeneration; biotech partnerships

United Therapeutics’ Tyvaso Succeeds in Phase 3 IPF Trial, Marking Major Advance in Lung Disease Treatment

1 week ago talkbio0Tagged Clinical Trials, Forced Vital Capacity, Idiopathic Pulmonary Fibrosis, IPF, Lung diseases, nebulized body site, Pulmonary Fibrosis, TETON-2, Tyvaso, United States Food and Drug Administration, United Therapeutics, Vital capacity test

Tyvaso; United Therapeutics; idiopathic pulmonary fibrosis; IPF; Phase 3 trial; TETON-2; lung disease; forced vital capacity; FVC; clinical trial; FDA; nebulized treprostinil

Vinay Prasad Details New Approach to COVID-19 Vaccine Approvals in Recent FDA Memos

1 week ago talkbio0Tagged Child, COVID19 (disease), Evidence, Prasad, regulatory decisions, risk-benefit analysis, Spikevax, United States Food and Drug Administration, vaccine approval, Vaccine Safety, Vaccines, Vinay

Vinay Prasad; COVID-19 vaccine; FDA; vaccine approval; children; Spikevax; regulatory decisions; vaccine safety; evidence; risk-benefit analysis

Ionis Posts Strong Results for Tryngolza in Severe Blood Fat Disease

1 week ago talkbio0Tagged Approved, cardiovascular risk reduction, drug launch, Familial chylomicronemia syndrome, Hypertriglyceridemia, Ionis Pharmaceuticals, Olezarsen, Phase III Essence study, Triglycerides, TRYNGOLZA, United States Food and Drug Administration

Ionis Pharmaceuticals; Tryngolza; olezarsen; hypertriglyceridemia; triglycerides; Phase III Essence study; FDA approval; familial chylomicronemia syndrome; cardiovascular risk reduction; drug launch

Fierce Biotech Fundraising Tracker ’25: CHARM attracts $80M; Wugen reels in $115M

1 week ago talkbio0Tagged AI drug design, charmed, Drug Development, Leukemia, Myelocytic, Acute, Menin Inhibitor, NVIDIA, Series B funding, venture capital, Wugen

CHARM Therapeutics; AI drug design; menin inhibitor; acute myeloid leukemia (AML); Series B funding; venture capital; biotech fundraising; Wugen; NVIDIA; drug development