Cytokinetics Stock Soars After Positive Phase 3 Data as FDA Approval Decision for Aficamten Nears
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
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
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
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
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
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
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
CHARM Therapeutics; AI drug design; menin inhibitor; acute myeloid leukemia (AML); Series B funding; venture capital; biotech fundraising; Wugen; NVIDIA; drug development
Zenas BioPharma Secures $300M Royalty Deal for Obexelimab FDA Approvals
Zenas BioPharma; Royalty Pharma; Obexelimab; autoimmune diseases; IgG4-Related Disease; Systemic Lupus Erythematosus; FDA approval; royalty agreement; Phase 3 INDIGO trial; funding
Zymeworks Halts Development of ZW171 T-cell Engager After Phase 1 Trial Assesses Benefit-Risk Profile
Zymeworks; ZW171; T-cell engager; mesothelin; cancer; clinical trial; drug development; benefit-risk profile; dose-limiting toxicity