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FDA Grants Priority Review for HYMPAVZI® (marstacimab) sBLA for the Treatment of Two Hemophilia A or B Patient Populations with Significant Medical Need
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s supplemental Biologics License Application (sBLA) for HYMPAVZI® (marstacimab) to expand the approved indication to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors. In the U.S., HYMPAVZI is currently approv...
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Natera Launches EDEN Study on Early Risk Assessment for Preeclampsia and Adverse Pregnancy Outcomes
AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the launch of EDEN, a large, multi-center prospective study designed to evaluate the company’s non-invasive prenatal screening test for early risk assessment of preeclampsia and other serious pregnancy complications. Preeclampsia affects approximately 5-8% of pregnancies and remains a leading cause of maternal and neonatal morbidity.1 While clinical guidelines re...
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Sensorion annonce sa participation à la 49ème rencontre annuelle de l’Association pour la Recherche en Otorhinolaryngologie ARO
MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN), société pionnière de biotechnologie au stade clinique, spécialisée dans le développement de nouvelles thérapies pour restaurer, traiter et prévenir les troubles de la perte auditive, annonce aujourd'hui sa participation à la 49ème rencontre annuelle de l'Association pour la Recherche en Otorhinolaryngologie (ARO), qui se tiendra du 7 au 11 février 2026 à San Juan, Porto Rico. Arnaud Giese, Ph.D., Responsabl...
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Sensorion Announces its Participation in the Association for Research in Otolaryngology ARO 49th Annual Midwinter Meeting
MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent loss disorders, today announces its participation in the Association for Research in Otolaryngology (ARO) 49th Annual Midwinter Meeting, taking place on February 7-11, 2026, in San Juan, Puerto Rico. Arnaud Giese, Ph.D., Group Leader for Animal Pharmacology Platform at Senso...
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Pulse Biosciences Presents Late-Breaking Data from nPulse™ Cardiac Catheter System First-In-Human Feasibility Study at the AF Symposium
HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of the novel nPulse™ technology using proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced late-breaking clinical data from the nPulse Cardiac Catheter first-in-human feasibility study. The study demonstrates successful treatment of atrial fibrillation in 150 patients with rapid procedure times and minimal adverse effects. The data were presented today at the 31st Annu...
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Aro Biotherapeutics Reports Preliminary Efficacy for ABX1100, a Muscle-targeted GYS1 siRNA, in Patients with Late-Onset Pompe Disease (LOPD)
PHILADELPHIA--(BUSINESS WIRE)--Aro Biotherapeutics Reports Preliminary Efficacy for ABX1100, a Muscle-targeted GYS1 siRNA, in Patients with Late-Onset Pompe Disease (LOPD)...
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Arrowhead Pharmaceuticals Reports Fiscal 2026 First Quarter Results
PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2026 first quarter ended December 31, 2025. The Company is hosting a conference call today, February 5, 2026, at 4:30 p.m. ET to discuss the results. “We had another quarter of strong execution across all areas of our business and we think Arrowhead is extremely well positioned to build on this progress throughout 2026 and beyond,” said Christopher Anzalone, Ph.D.,...
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Long-Term Data Presented at the 22nd Annual WORLDSymposium™ Highlights Tralesinidase Alfa Enzyme Replacement Therapy’s Potential as the First Disease-Modifying Treatment Option for Sanfilippo Syndrome Type B (MPS IIIB)
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, announced that data from two different analyses presented today at the 22nd Annual WORLDSymposium™ demonstrate that the long-term administration of tralesinidase alfa enzyme replacement therapy (TA-ERT) resulted in rapid and durable reduction of hepar...
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Veradermics Announces Closing of Full Exercise of Underwriters’ Option to Purchase Additional Shares in Initial Public Offering
NEW HAVEN, Conn.--(BUSINESS WIRE)--Veradermics, Incorporated (“Veradermics”), (NYSE: MANE) a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for common aesthetic and dermatological conditions, today announced the closing of its previously announced upsized initial public offering of 17,339,294 shares of its common stock at an initial public offering price of $17.00 per share, including 2,261,647 shares sold pursuant to the exerc...
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Bayer’s Asundexian Demonstrated a Substantial 26% Reduction in Stroke After a Non-Cardioembolic Ischemic Stroke or High-Risk Transient Ischemic Attack, With No Increase in ISTH Major Bleeding Versus Placebo
NEW ORLEANS--(BUSINESS WIRE)--Bayer today presented the results from the global, pivotal Phase III OCEANIC-STROKE study evaluating the use of its investigational, once-daily, oral, Factor XIa inhibitor asundexian (50mg) compared to placebo, both in combination with antiplatelet therapy. Asundexian significantly reduced ischemic stroke by 26% (csHR 0.74; 95% CI 0.65–0.84; p<.0001), in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack, with no increase i...