- Data from ongoing DELIVER trial demonstrated sustained functional improvement through 18 months; results from Registrational Expansion Cohort expected late 2025 - Sept. 29, 2025 -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company, today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted Orphan Drug designation for DYNE-251 in individuals with Duchenne muscular dystrophy (DMD) who have mutations in the DMD gene that are amenable to exon 51 ski

Peer-reviewed results from Phase 1b/2a Trial of Anti-pTau Active Immunotherapy from AC Immune Published in eBioMedicine Detailed results from completed Phase 1b/2a trial of ACI-35.030 and JACI-35.054 demonstrated that two different active immunotherapy formulations against the same target can induce a differential antibody response in individuals with early Alzheimer’s disease ACI-35.030, developed using AC Immune’s SupraAntigen® technology, generated rapid, potent polyclonal response against pa

Patent supports AIM’s strategy to expand international market protection, providing opportunities for licensing, collaborations, and long-term revenue growth Japan is the third-largest pharmaceutical market globally, with oncology as the fastest-growing therapeutic area Sept. 25, 2025 -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the Japan Patent Office has issued a patent covering the Company’s proprietary use of Ampligen® (Rintatolimod) in combinat

Pilot study met key 3-month efficacy endpoint with strong statistical significance (p=0.014); Revita-treated patients lost an additional 2.5% total body weight after stopping GLP-1 drugs vs. 10% regain in sham-treated patients Revita procedure demonstrated excellent safety and tolerability to date, consistent with prior clinical studies Results validate pivotal study design and reinforce Revita’s potential to be the first therapy for post-GLP-1 weight maintenance Company to host investor call

Sept. 26, 2025 -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC. XOLAIR® is a registered trademark of Novartis AG. Omalizumab, a humanized monoclonal antibody that targets free IgE, is indicated for the treatment of moderate to severe persistent asthma (6 years and

Company to deliver oral and poster presentations for data on leronlimab’s action on PD-L1 expression and patient survival in triple-negative breast cancer Sept. 25, 2025 -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and colorectal cancer (CRC), will

Data highlights ability of Akari’s ADC payload, PH1, to suppress the levels of the AR-V7 receptor that is responsible for driving hormone refractory prostate cancer progression No current therapies have proven to be effective in AR-V7 driven tumors Sept. 24, 2025 -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced key preclinical data demonstrating the potential of its novel antibody drug conjuga

A significant, dose-dependent reduction in bone marrow lesion presence and area was observed for LEVI-04 compared with placebo in patients with osteoarthritis Changes in bone marrow lesion area were significantly correlated with changes in patient-reported symptoms including pain Further presentations detail LEVI-04 mechanism of action, functional outcomes and imaging screening exclusions LEVI-04 is a first-in-class novel biologic under development as non-addictive pain treatment Sept. 25, 202

Sept. 25, 2025 -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), today announces it will advance its second asset, a fully human anti-IL-6 receptor (“IL-6R”) monoclonal antibody, TZLS-501. There has been heightened industry activity in the IL-6 pathway space, underscored by Novartis’ recent acquisition of Tourmaline Bio for approximately $1.4 billion. Tiziana will pursue non-dilutive funding strategies for the development of TZLS-501 while continuing to advance intrana

KYV-101 IIT data demonstrate promising clinical activity, including robust CAR T penetration into the central nervous system (CNS) and improved expanded disability status scale scores (EDSS) KYV-101 continues to demonstrate a tolerable safety profile, consistent with observations from the first 100 patients treated with KYV-1011 Encouraging early data of KYV-101 in multiple sclerosis highlights broader potential within neuroimmunology autoimmune diseases Sept. 24, 2025 -- Kyverna Therapeutics