Press Releases

CalciMedica, Inc. (CalciMedica or the Company) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic diseases, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for the Company's lead product candidate, Auxora™, a potent and selective small molecule inhibi

Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases today announced last patient last visit in the phase II/III study of its lead candidate buntanetap in patients with mild to moderate Alzheimer’s disease (AD).  "The completion of the Alzheimer’s study marks a significant step in our efforts to bring new therapies to patients,” said Maria Maccecchini, Ph.D., Founder, President, a

AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the first subject has been dosed at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC Study”). The DURIPANC Study is an investigator

The topic of  new pharma strategies is one of the highlights of the Pharmaceutical Manufacturing and Packaging Congress 2024 (PHARMAP). The Congress gathers the leading industry representatives to discuss ongoing trends, challenges, and new realities of the industry. PHARMAP 2024 is held in Amsterdam, the Netherlands, on April, 22-23.

Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced that it is now preparing to launch the Phase 2b head-to-head trial of its next-generation COVID-19 vaccine in the Fall of 2024 rather than 1Q24. This is to allow use of fully GMP-grade raw materials in the vaccine, which is expected to increase the regulatory utility of the trial. “After recent communication with the FDA and inpu

Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive can

Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC) and our parent company Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce topline results of the phase 3 clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease (Trial 17-AVP-786-305; NCT03393520). A statistically significant difference was not achieved on the primary efficacy endpoint, mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced preliminary outcomes of the Company’s discussion with the U.S. Food and Drug Administration (FDA) on the path to approval of IkT-001Pro in blood cancers,

Encoded Therapeutics Inc., a biotechnology company focused on developing genetic medicines for severe central nervous system (CNS) disorders, today outlined the global development strategy for its lead gene therapy candidate, ETX101, for the treatment of SCN1A+ Dravet syndrome. Individuals with Dravet syndrome, the most common developmental and epileptic encephalopathy, experience a spectrum of clinical symptoms, including treatment-resistant seizures and neurodevelopmental stagnation. Dravet

Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the first patient has been randomized at the M Health Fairview Masonic Children’s Hospital in a registrational trial evaluating the efficacy and safety of OTL-203, an investigational hematopoietic stem cell (HSC) gene therapy, in patients with the Hurler subtype of mucopolysaccharidosis type I (MPS-IH). The trial, referred