COMMUNIQUÉS West-GlobeNewswire

Kiniksa Pharmaceuticals Reports Third Quarter 2024 Financial Results and Recent Portfolio Execution

29/10/2024 - 12:30

– ARCALYST ® (rilonacept) Q3 2024 net product revenue of $112.2 million, representing 73% year-over-year growth – – ARCALYST 2024 expected net product revenue increased to $410 - $420 million – – Life DisRPted ™ disease [...]

Sensei Biotherapeutics to Present at Two Upcoming Scientific Conferences

29/10/2024 - 12:30

BOSTON, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage company focused on the discovery and development of next-generation therapeutics for cancer patients, today [...]

Ardena Expands Bioanalytical Services in Europe

29/10/2024 - 12:24

GHENT, Belgium, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Ardena, a specialist pharmaceutical Contract Development and Manufacturing Organisation (CDMO) with GMP facilities in Belgium, Spain, the Netherlands and Sweden, today [...]

Vara Raises $8.9M in Funding While Expanding AI-Enabled Early Breast Cancer Detection to India

29/10/2024 - 12:10

BERLIN, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Vara, the pioneering AI-enabled early breast cancer detection platform, today announced the successful funding raise of $8.9 million USD (€8M EUR), which took place earlier this [...]

Invivyd Reports Preliminary Third Quarter 2024 Results, Withdraws Prior Financial Guidance, and Targets Near-Term Profitability

29/10/2024 - 12:03

Preliminary Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with approximately $107 million in cash and cash equivalents Expects to finish 2024 with $65 million or more in cash [...]

Invivyd Phase 3 Long-Term Exploratory Clinical Efficacy Data Shows PEMGARDA™ (pemivibart) Provided Substantial Protection from Symptomatic COVID-19 Versus Placebo Over Six Months of Follow-Up, With No Additional Doses, In Immunocompetent Participants

29/10/2024 - 12:01

Following strong protection (84% relative risk reduction versus placebo) demonstrated through month 6 with pemivibart, CANOPY clinical trial participants were followed for an additional six-month period (months 7-12), [...]

Fractyl Health to Report Third Quarter 2024 Financial Results and Provide Business Updates on November 12, 2024

29/10/2024 - 12:00

BURLINGTON, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type [...]

Bitterroot Bio Completes Enrollment in Phase 1 First-in-Human Study of BRB-002 in Healthy Volunteers

29/10/2024 - 12:00

PALO ALTO, Calif. and NEEDHAM, Mass. and MELBOURNE, Australia, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Bitterroot Bio, a leader in developing innovative medicines in the field of cardio-immunology, today announced the [...]

BioXcel Therapeutics to Present at ThinkEquity Conference

29/10/2024 - 12:00

NEW HAVEN, Conn., Oct. 29, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today [...]

BioStem Technologies Initiates Nationwide Launch of Vendaje AC® with Venture Medical Following Established Reimbursement in All Medicare Administrative Contractor (MAC) Regions

29/10/2024 - 12:00

The pricing announcement from the Center for Medicare Services became effective on October 1, 2024, and allows BioStem to begin marketing initiatives with Venture Medical POMPANO BEACH, Fla., Oct. 29, 2024 (GLOBE [...]

Axsome Therapeutics Presents Data from Multiple Programs Spanning Its Innovative Neuroscience Portfolio at Psych Congress 2024

29/10/2024 - 12:00

NEW YORK, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, [...]

Skye Bioscience Names Independent Director Paul Grayson as Chairman of the Board

29/10/2024 - 12:00

SAN DIEGO, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, today announced [...]

Sagimet Biosciences Announces Successful Completion of End-of-Phase 2 Interactions with FDA on the Development of Denifanstat for MASH; Phase 3 Program Initiation Expected by End of 2024

29/10/2024 - 12:00

The planned registration program consists of two double-blind, placebo-controlled multicenter Phase 3 trials, FASCINATE-3 and FASCINIT, to evaluate the safety and efficacy of denifanstat in patients with MASH and MASLD [...]

Quris-AI Acquires Nortis

29/10/2024 - 12:00

Adds Proven Kidney-on-Chip Technology to Its Pioneering Bio-AI Platform BOSTON and TEL AVIV, Israel, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Quris-AI (Quris) , a leading Bio-AI company focused on revolutionizing the [...]

Neumora Therapeutics to Report Third Quarter 2024 Financial Results on Tuesday, November 12, 2024

29/10/2024 - 12:00

WATERTOWN, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven clinical and pre-clinical brain [...]

Regeneration Biomedical Presents Data on First Cohort from an Ongoing Phase I Clinical Trial of Stem Cell Therapy Delivered Directly into the Brains of Patients with Alzheimer’s Disease

29/10/2024 - 09:05

Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) administered directly into lateral ventricles of the brain were well tolerated and reduced levels of p-Tau and amyloid-beta at 12 weeks Mini- [...]

First Patient In - BioPorto Initiates Patient Enrollment for US Study of ProNephro AKI (NGAL)™ for Adult Use at Massachusetts General Hospital

29/10/2024 - 08:56

October 29, 2024 Announcement no. 20 First Patient In - BioPorto Initiates Patient Enrollment for US Study of ProNephro AKI (NGAL)™ for Adult Use at Massachusetts General Hospital COPENHAGEN, Denmark and BOSTON, MA, USA [...]

QIAGEN receives FDA clearance for QIAstat-Dx mini panel to improve precision in outpatient respiratory treatment

29/10/2024 - 07:30

QIAstat-Dx Respiratory Panel Mini targets the five most actionable respiratory pathogens in outpatient settings to help clinicians make precise treatment decisions // With the new test and the 21-target QIAstat-Dx [...]

First Children Vaccinated in New Clinical Study Seeking to Expand the Indication for Bavarian Nordic’s Mpox Vaccine

29/10/2024 - 07:30

Clinical study in children 2-11 years of age follows the recent EMA and WHO approvals of the MVA-BN mpox vaccine for adolescents 12-17 of age. COPENHAGEN, Denmark, October 29, 2024 – Bavarian Nordic A/S (OMX: BAVA) [...]