Nov. 21, 2024 -- DANNCE.AI raised $2.6 million in pre-seed funding led by LDV Capital, following initial investment from Glasswing Ventures, with participation from The Leo Lion Company, Duke Capital Partners, and Merck Digital Sciences Studio. DANNCE.AI is bringing to market DANNCE, a novel phenotyping platform to digitize the clinical assessments used by doctors and therapeutic developers to quantify movement. DANNCE is a new approach to the clinical exam that ingests videos of patients and a

The PRIME initiative provides enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation Pivotal trials of NX-5948 are planned to initiate in 2025 Nov. 20, 2024 -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the European Medicines Agency (EMA) has granted PRIME designation f

Nov. 21, 2024 -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Approval pathway. The C

— PYX-201 achieved a confirmed 50% ORR by RECIST 1.1 including one Complete Response and 100% Disease Control Rate in six heavily pretreated HNSCC patients, supporting differentiated mono and front-line combo therapy expansion trials to begin dosing 1Q25 — Overall, 26% ORR across all six Solid Tumor Types of Interest (n=31) with Dose Dependent Responses Observed, Supporting First-In-Concept Mechanism with Novel Extracellular Targeting ADC — New Clinical Trial Collaboration Agreement with Merck (

Nov. 20, 2024 -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the European Medicines Agency (EMA) has granted both Orphan Drug and Advanced Therapy Medicinal Product (ATMP) designations to its lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD). The Orphan Drug designation provides Capricor with several benefits that support the deve

Workshop, poster and oral presentation of data given as part of the 8th Annual Antifibrotic Drug Development (AFDD) Summit Data demonstrate that NKT cells are activated in airways in IPF patients and inhibition of iNKT cell activity with GRI-0621 ameliorates pulmonary fibrosis in a preclinical model Ongoing Phase 2 study with GRI-0621 in IPF patients to examine iNKT activity along with key biomarkers; Topline data readout expected in Q2 2025 Nov. 21, 2024 -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bi

MIPLYFFA, the first FDA-approved treatment for Niemann-Pick disease type C, is available at Zevra’s specialty pharmacy for dispense AmplifyAssist™, Zevra’s comprehensive patient support program, in place to address access barriers Nov. 21, 2024 -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage rare disease therapeutics company, today announced that MIPLYFFA™ (MY-PLY-FAH) (arimoclomol), the first treatment approved by the U.S. Food and Drug Administration (

LPX-TI641 is an oral novel Treg-expanding T cell/transmembrane, immunoglobulin, and mucin (Tim)receptor agonist therapy in development for the treatment of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and multiple sclerosis with the intent to expand into additional therapeutic indications. In healthy adults, LPX-TI641 was orally bioavailable and was safe and well tolerated up to the highest tested doses. Exploratory pharmacodynamic endpoints showed an exposure-dependent

— Lilly to Develop Two Targets Identified and Validated Using Verge Genomics’ AI-Enabled, All-in-Human CONVERGE® Platform — Demonstration of the Robust Predictive Power of CONVERGE® - 83% of Prioritized Targets were Validated in Disease-Relevant Models, a Rate Significantly Higher than Industry Standards Nov. 20, 2024 -- Verge Genomics, a clinical-stage biotechnology company pioneering the use of artificial intelligence (AI) and human data to transform drug discovery and development, announced

Company is evaluating IMSB301 in a Phase 1 clinical trial in healthy volunteers and plans to move rapidly into Phase 1b/2 clinical studies in patients with AGS, lupus and other cGAS-driven diseases Receiving RPDD is the initial step in obtaining a priority review voucher Nov. 20, 2024 -- ImmuneSensor Therapeutics, a clinical-stage biotherapeutics company focused on the development of first- and best-in-class cGAS inhibitors to address diverse peripheral and CNS indications in inflammation and a