Sionna Therapeutics' cystic fibrosis drug fails Phase 2 trial, shares plunge nearly 100%
Sionna's CFTR modulator did not show meaningful additive benefit when combined with Vertex's Trikafta, removing a competitive threat to Vertex and sending Sionn
BioPharma Dive · +12 outlets
Trump signs executive order seeking to split MMR vaccine and overhaul childhood immunization schedule
The executive order aims to separate MMR into three single-shot vaccines and reduce the CDC-recommended schedule, drawing pushback from doctors, the pharma indu
BioPharma Dive · +14 outlets
FDA rejects ITM's radiopharmaceutical therapy over manufacturing issues, blocking Novartis rival
The FDA declined to approve ITM's cancer radiopharmaceutical due to manufacturing quality concerns, halting what analysts expected to be a competitor to Novarti
STAT · +2 outlets
FDA grants accelerated approval to Replimune's herpes virus-based melanoma drug RP1
The FDA approved Replimune's RP1 (RP1/Opdivo combo) for advanced melanoma after prior rejections, marking a new oncolytic virus-based therapy option.
Medical Xpress · +12 outlets
Epicrispr Biotechnologies closes $90M Series C for FSHD epigenetic editing therapy
The oversubscribed round will fund a first-in-class epigenetic therapy for facioscapulohumeral muscular dystrophy (FSHD) as the company completes enrollment of
BioPharma Dive · +7 outlets
Vaderis raises $152M Series B to test AKT inhibitor for rare bleeding disorder HHT
Vaderis will use the funding to advance engasertib, an AKT-targeting drug for hereditary hemorrhagic telangiectasia, a rare disease that has had no approved tre
BioPharma Dive · +3 outlets
AbCellera stock surges 35% on positive Phase 2 data for menopause hot flash treatment
AbCellera's antibody therapy showed strong results in treating moderate-to-severe vasomotor symptoms from menopause, described by analysts as 'off the chart' ef
The Globe and Mail · +6 outlets
Jazz Pharmaceuticals to acquire Actio Biosciences for up to $1.3B in rare epilepsy deal
Jazz will pay $820M upfront for Actio, gaining access to a pipeline of therapies for rare neurological disorders including epilepsy, part of a major upswing in
BioPharma Dive · +5 outlets
MoonLake Immunotherapeutics' nanobody sonelokimab meets all endpoints in Phase 3 psoriatic arthritis trial
MoonLake's IL-17A/F nanobody hit all primary and secondary endpoints in psoriatic arthritis, though STAT raised questions about the company's reluctance to rele
STAT · +6 outlets
FDA approves palbociclib (Ibrance) for HR+, HER2+ breast cancer maintenance therapy
Pfizer's CDK4/6 inhibitor palbociclib received FDA approval as maintenance treatment for patients with HR-positive, HER2-positive breast cancer.
ajmc.com · +14 outlets
Tenax Therapeutics' heart failure drug levosimendan fails Phase 3 study
Levosimendan, unapproved in the U.S. for decades, did not meet its primary endpoint in a Phase 3 trial for heart failure, though Tenax may still pursue a narrow
STAT · +8 outlets
Sobi inks $580M deal with Innate Pharma for skin cancer drug lacutamab
Sobi licensed lacutamab, a KIR3DL2-targeting antibody for cutaneous T-cell lymphoma, from Innate Pharma ahead of a pivotal trial readout.
finance.biggo.com · +1 outlets
Silence Therapeutics reports positive Phase 2 data in rare blood cancer, competing with Takeda
Silence's RNAi therapy showed efficacy in a Phase 2 study for a rare blood cancer, positioning it as a potential competitor to Takeda's approved drug.
Fierce Biotech · +5 outlets
Scholar Rock addresses manufacturing issue, keeps apitegromab FDA review on schedule
Scholar Rock resolved a manufacturing hurdle for its SMA drug apitegromab as the FDA review continues, though the incident highlights sponsor due diligence gaps
Benzinga · +6 outlets
FDA proposes first-ever requirement for food additive notification (GRAS rule change)
The FDA's new proposal would require companies to notify the agency before using food additives, closing the 'generally recognized as safe' (GRAS) loophole, tho
STAT · +1 outlets
PDS Biotech pivots to PDS0301 after 71% response rate in colorectal cancer, discontinues PDS0101 Phase 3
PDS Biotech is refocusing on PDS0301 for metastatic colorectal cancer after data showed 80% 24-month survival in liver metastasis patients, while halting its PD
pulse2.com · +3 outlets
Legend Biotech reports Q2 profitability as CARVYKTI sales surge 50%
Legend turned profitable on strong CARVYKTI (cilta-cel) sales growth, with the CAR-T therapy showing accelerating uptake in multiple myeloma.
sekbernews.id · +6 outlets
Former Legend CEO Ying Huang takes helm at K2 Therapeutics with $50M seed round
K2 Therapeutics, a Singapore-based startup scouting China-licensed assets, raised $50M and appointed former Legend Biotech CEO Ying Huang.
BioPharma Dive · +1 outlets