COMMUNIQUÉS West-GlobeNewswire

Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA for 1L HPV-Negative R/M HNSCC
13/10/2025
Designation supported by results from multiple dose cohorts from the Phase 1/1b trial of ficerafusp alfa in 1L HPV-negative R/M HNSCC BOSTON, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a [...]
Stereotaxis & CardioFocus Collaborate to Advance Robotic Pulsed Field Ablation for Cardiac Arrhythmias
13/10/2025
ST. LOUIS and MARLBOROUGH, Mass., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, and CardioFocus, Inc., a [...]
Apyx Medical Corporation Submits FDA 510(k) for Device Label Expansion of AYON Body Contouring System™ for Power Liposuction
13/10/2025
Initiated Nationwide Commercial Launch of AYON in September The Company is Hosting a Virtual Key Opinion Leader Event to Discuss the Commercial Launch of AYON on October 14, 2025 CLEARWATER, Fla., Oct. 13, 2025 (GLOBE [...]
Immutep Announces Successful Completion of FDA Project Optimus Requirements
13/10/2025
Confirmation of 30mg efti as optimal biological dose relevant for Immutep’s oncology pipeline and potential future Biological License Applications (BLA) Registrational TACTI-004 (KEYNOTE-F91) Phase III trial in first [...]
Theriva™ Biologics Announces Upcoming Presentations at Medical Meetings
13/10/2025
- VCN-01 expanded mPDAC data from VIRAGE Phase 2b trial to be presented at ESMO 2025 - - SYN-004 Interim blinded safety and pharmacokinetic data to be presented at IDWeek 2025 - Rockville, Md., Oct. 13, 2025 (GLOBE [...]
Connect Appoints Tre Braquet as Chief Brand & Engagement Officer
13/10/2025
SAN DIEGO, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Connect , a premier nonprofit organization in San Diego’s innovation ecosystem dedicated to supporting entrepreneurs and cultivating thriving life science and technology [...]
Soleno Therapeutics Appoints Biopharmaceutical Executive Mark W. Hahn to its Board of Directors
13/10/2025
Appointment adds three decades of financial and operational leadership to Soleno’s Board REDWOOD CITY, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical [...]
4DMT Advances 4D-710 to Phase 2 with Additional Funding and Support from the Cystic Fibrosis Foundation
13/10/2025
Cystic Fibrosis Foundation to provide up to $11 million in additional funding to accelerate development of 4D-710 for cystic fibrosis, following program and clinical data review by its independent scientific advisors [...]
Cidara Therapeutics to Present Late-Breaking Clinical Phase 2 Data on CD388 at ID Week 2025
13/10/2025
SAN DIEGO, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company applying its proprietary Cloudbreak ® platform to develop drug-Fc conjugate (DFC) therapeutics, today [...]
SELLAS Life Sciences to Present In Vivo Preclinical Data Demonstrating Statistically Significant Survival Benefit of SLS009 in T-Cell Prolymphocytic Leukemia at the European Society for Medical Oncology (ESMO) Congress 2025
13/10/2025
Preclinical data support SLS009 as a monotherapy or in combination with venetoclax for the treatment of T-PLL, a rare and highly aggressive form of mature T-cell leukemia NEW YORK, Oct. 13, 2025 (GLOBE NEWSWIRE) -- [...]
Hinge Bio Announces FDA Clearance of Investigational New Drug Application for HB2198, a Novel B cell-Depleting Agent, for Patients with Systemic Lupus Erythematosus and Lupus Nephritis
13/10/2025
Phase 1 trial to investigate novel multi-specific HB2198 to treat B cell-mediated autoimmune disorders by targeting both CD19 and CD20 plus enhanced immune cell engagement via dual Fc domains BURLINGAME, Calif., Oct. 13 [...]
Collegium to Celebrate 10-Year Anniversary with Nasdaq Opening Bell Ringing
13/10/2025
– Collegium to Ring Nasdaq Opening Bell on October 14, 2025 – STOUGHTON, Mass., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced that its management team will ring the [...]
HMNC Brain Health Presents New Analysis Supporting Rationale for Combining a Genetic Patient Selection Tool with a Vasopressin V1b Receptor Antagonist in the Treatment of Depression at ISCTM Conference in Amsterdam
13/10/2025
Findings suggest a subset of Major Depressive Disorder patients may respond preferentially to vasopressin V1b receptor antagonism MUNICH, Oct. 13, 2025 (GLOBE NEWSWIRE) -- HMNC Brain Health, a clinical-stage precision [...]
Evaxion to present a breadth of data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025
13/10/2025
Presentation will cover two-year clinical efficacy, immunogenicity and safety data Data will be presented at an oral session on October 17, 2025, followed by a webinar on October 22, 2025, providing further insights [...]
Auron Therapeutics to Participate in the 8th Annual Targeted Protein Degradation & Induced Proximity Summit
13/10/2025
NEWTON, Mass., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Auron Therapeutics, a clinical-stage biotechnology company targeting cell-state plasticity to improve patient outcomes in oncology and inflammatory disease, today [...]
MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes
13/10/2025
If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy sBLA submission based on data from the Phase 3 INHALE-1 study PDUFA target action date of May 29, [...]
ProQR to Participate in Upcoming Investor Conferences in October 2025
13/10/2025
LEIDEN, Netherlands & CAMBRIDGE, Mass., Oct. 13, 2025 (GLOBE NEWSWIRE) -- ProQR Therapeutics N.V. (Nasdaq: PRQR) (ProQR), a company dedicated to changing lives through transformative RNA therapies based on its [...]
Ardelyx Appoints Experienced Finance Executive, Sue Hohenleitner, as Chief Financial Officer
13/10/2025
WALTHAM, Mass., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet [...]
Nexalin Technology Expands Scientific Advisory Board with Appointment of Dr. Robert Rothstein to Support Alzheimer’s and Traumatic Brain Injury Programs
13/10/2025
HOUSTON, TX, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the [...]

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