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Press releases published on July 15, 2025

SELLAS Meets All Primary Endpoints in Phase 2 Trial of SLS009 in r/r AML and Receives FDA Guidance to Advance into First-Line Therapy Study
The Trial Exceeded Target Overall Response Rate (ORR) of 20%, with 44% Response Rate Among Patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML MR) Treated at Optimal Dose of 30 mg Twice a Week (BIW) and 50% in AML MR with …

Hengrui Pharma and Kailera Therapeutics Report Positive Topline Data from Phase 3 Obesity Trial in China of Dual GLP-1/GIP Receptor Agonist HRS9531
– Mean weight loss of 19.2% at 6 mg with no plateau in 48-week Phase 3 trial – – Favorable safety profile consistent with other GLP-1-based treatments – – Hengrui to submit NDA in China; Kailera plans to evaluate both higher doses and longer duration of …

Iovance Biotherapeutics Appoints Corleen Roche as Chief Financial Officer
SAN CARLOS, Calif., July 15, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for …

Emergent BioSolutions to Report Second Quarter 2025 Financial Results on August 6, 2025
GAITHERSBURG, Md., July 15, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) will host a conference call on Wednesday, August 6, 2025, at 5:00 pm eastern time to discuss the financial results for the second quarter of 2025. Participants can …

ZEVASKYN™ Gene Therapy Now Available at New Qualified Treatment Center in San Francisco Bay Area
- Lucile Packard Children’s Hospital Stanford is ready to accept patients for ZEVASKYN treatment - - Abeona Therapeutics® and Stanford Medicine conducted research collaboration for more than a decade, culminating in U.S. Food and Drug Administration (FDA) …

BriaCell Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer
PHILADELPHIA and VANCOUVER, British Columbia, July 15, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to …

ProKidney Announces Alignment with the FDA on the Accelerated Approval Pathway for Rilparencel
FDA confirmed that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with CKD and type 2 diabetes FDA also confirmed that the ongoing Phase 3 PROACT 1 study can be used for both accelerated approval and for …

Neuronetics Appoints New Chief Financial Officer
Steven Pfanstiel, a seasoned financial executive with extensive medical technology and pharmaceutical experience, replaces Steve Furlong as Chief Financial Officer following previously announced succession process Neuronetics reiterates guidance for second …

Plus Therapeutics Presents ReSPECT-LM Clinical Trial Results for REYOBIQ™ in Patients with Leptomeningeal Metastases
Presentation by trial principal investigator at the 2025 SNO/ASCO CNS Metastases Conference Plus will also host an educational symposium with leading experts titled, “Reimagining Your Approach to Leptomeningeal Metastases” HOUSTON, July 15, 2025 (GLOBE …

Aurora Spine Announces Participation in 7th Annual American Society of Pain & Neuroscience Conference
CARLSBAD, California, July 15, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in innovative spine and interventional pain management solutions, today announced it will be …

60 Degrees Pharmaceuticals Defines Potential Human Babesiosis Market Size for ARAKODA® (tafenoquine): Annual Max TAM, Sales of $245 Million; Cumulative through Patent Expiration, $1.1 Billion
New Drug Application intended for 2026, subject to generation of positive data from three U.S. clinical trials planned or in progress Total addressable market (TAM) for ARAKODA for Human Babesiosis is informed by results of a 6,000 nationwide patient …

Addgene Announces Strategic Partnership with Promega to Launch Plasmid Collection
WATERTOWN, Mass., July 15, 2025 (GLOBE NEWSWIRE) -- Addgene, a purpose-driven organization helping scientists conduct experiments with greater ease, speed, and reproducibility, today announced a strategic partnership with Promega to expand Addgene’s vast …

AAFA Names Matthew Greenhawt Chief Medical Officer
Washington, DC, July 15, 2025 (GLOBE NEWSWIRE) -- The Asthma and Allergy Foundation of America (AAFA) today announced that Matthew Greenhawt, MD, MBA, MSc, has joined the organization as Chief Medical Officer. In this new role, Dr. Greenhawt will help …

Acumen Pharmaceuticals and JCR Pharmaceuticals Enter Strategic Collaboration, Option and License Agreement to Develop Enhanced Brain Delivery™ Therapy for Alzheimer’s Disease
Acumen and JCR aim to develop a product leveraging Acumen’s amyloid beta oligomer-selective antibody expertise and JCR’s transferrin-receptor-targeting blood-brain barrier-penetrating technology Preclinical candidate data expected in early 2026, with …

Adagene Announces Regulatory Update on Clinical Development Plan for Muzastotug in Microsatellite Stable Colorectal Cancer Following Productive Type B (End of Phase 1) Meeting with FDA
- Alignment gained on Phase 2 inclusion/exclusion criteria, primary and secondary endpoints, and study design, including sample size and dosing regimen - Company expects to begin enrolling patients in Phase 2 in 2H 2025 SAN DIEGO and SUZHOU, China, July 15 …

AAVantgarde Receives FDA Clearance to Progress Stargardt Disease Asset, AAVB-039, into CELESTE, a Phase 1/2 Clinical Trial
AAVB-039 delivers the full-length ABCA4 -protein, addressing the root cause of the disease and enabling treatment of all patients, independent of mutation CELESTE is informed by the STELLA prospective natural history study, which is currently enrolling …

Apellis Announces Five Abstracts Accepted for Oral Presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting
WALTHAM, Mass., July 15, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that five abstracts were accepted for oral presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting to be held …

Verano Announces Promotion and Appointment of James Leventis as Chief Strategy and Compliance Officer
CHICAGO, July 15, 2025 (GLOBE NEWSWIRE) -- Verano Holdings Corp. (Cboe CA: VRNO) (OTCQX: VRNOF) (“Verano” or the “Company”), a leading multi-state cannabis company, today announced the promotion and appointment of James Leventis as the Company’s Chief …

Aquestive Therapeutics Provides International Expansion Update for Anaphylm™ (epinephrine) Sublingual Film
New Drug Submission meeting scheduled with Health Canada for the third quarter of 2025 Initial briefing book submitted for review to the European Medicines Agency WARREN, N.J., July 15, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) …

Merakris Therapeutics Selected as Finalist for 2025 Advanced Would Care Summit Innovation Showcase
RESEARCH TRIANGLE PARK, N.C., July 15, 2025 (GLOBE NEWSWIRE) -- Merakris Therapeutics announces its amniotic fluid-derived regenerative biologic, MTX-001, an investigational new drug, is a finalist for the Innovation Showcase: Early-Stage Disruptors in …