Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for dasiglucagon in CHI for up to three weeks of dosing due to the timing of a third-party manufacturing facility reinspection The reinspection of the facility was completed in August/September 2024 for which a new inspection classification is pending Zealand remains committed to working with the FDA and the third-party manufac

Oct. 08, 2024 -- Oragenics Inc. (NYSE American: OGEN), a company focused on developing new treatments for brain-related health conditions, has completed a key study for their new concussion drug, ONP-002. This drug is designed to be delivered through the nose, which could help it reach the brain quickly after a head injury. The recent study shows that the drug successfully targets areas inside the nose that are connected to the brain. This makes it more likely to reach and treat the brain afte

Oct. 08, 2024 -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced a regulatory update from the U.S. Food and Drug Administration (FDA). The FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment

Rapid epinephrine absorption with a time to reach the 100 pg/mL threshold concentration in 9 minutes after dosing Sustained pharmacokinetics (PK) with plasma epinephrine concentration remaining above 100 pg/mL for 2 hours post-dose, ensuring a durable treatment effect Safe and well tolerated, with only mild, transient, and self-resolving adverse events (AEs) reported Oct. 07, 2024 -- Insignis Therapeutics, a leader in innovative allergy and anaphylaxis treatments, is excited to announce positiv

Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva’s robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory medicine Anticipated decision by both agencies is expected in 2H 2025 Oct. 08,

Oct. 08, 2024 -- E-Star BioTech, LLC (“E-Star” or the “Company”), an innovative developer of novel peptides designed to treat cardiovascular, metabolic, and kidney diseases, today announced that it is set to initiate a Phase 2 clinical trial of MANP for the treatment of Resistant Hypertension (BOLD-HTN) supported by a recent round of financing. MANP was originally discovered by John C. Burnett Jr., MD, Director of the Cardiorenal Research Laboratory at Mayo Clinic. E-Star and Mayo Clinic enter

Kineta has completed enrollment in the monotherapy cohorts of the Phase 1 VISTA-101 clinical trial. The ongoing Phase 1 study is now enrolling patients into cohorts evaluating KVA12123 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The company will present additional scientific data in 2024 at an upcoming scientific meeting. Oct. 08, 2024 -- Kineta, Inc. (OTC Pink: KANT) (“Kineta” or the “Company”), a clinical-stage biotechnology company focused on the development of

– KB-7898, a p300 KAT inhibitor, is the Company's first development candidate for autoimmune diseases and originates from its proprietary discovery engine that decodes complex transcription factor regulatory networks – – Preclinical data for KB-7898 will be presented at ACR Convergence 2024 – Oct. 07, 2024 -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and autoimmune diseases driven by deregulated transcription, today annou

VIP943 demonstrates promising safety and tolerability and achieves two complete responses to date in Phase 1 dose-escalation study, reinforcing the program’s potential and validating the VersAptx™ Platform technology Vincerx focusing resources on continued development of VIP943 Expected cash runway into early 2025 Management to host webcast and Q&A today at 5:00 PM EDT to review pipeline and corporate updates, followed by commentary from key opinion leader Dr. M. Yair Levy Oct. 07, 2024 -- Vinc

Oct. 07, 2024 -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for setrusumab (UX143) as a treatment to reduce the risk of fracture associated with osteogenesis imperfecta (OI) Type I, III, or IV in patients 2 years of age and older. "FDA designation of setrusumab as a