Existing data supports direct path to resubmission following constructive FDA engagement July 7, 2026 -- Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SL1009, sodium dichloroacetate (DCA), for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease with no FDA-approved therapies. The resubmi

July 7, 2026 -- Kenai Therapeutics, a clinical-stage biotechnology company pioneering next generation approaches to cure neurological conditions, today announced the completion of enrollment for the REPLACE™ Phase 1b/2a clinical trial of RNDP-001, an investigational cell therapy being developed for the treatment of moderate to moderate-severe idiopathic Parkinson's disease (iPD). RNDP-001 is an off the shelf, allogeneic neuron replacement cell therapy designed to restore dopaminergic neurons lo

TTI-109 delivered TTI-101-equivalent exposure with improved tolerability and meaningful reductions in disease-relevant STAT3-driven immune cell populations including Th17, T follicular helper (Tfh) and B cells Company plans to advance TTI-109 into STAT3-driven dermatologic and gastrointestinal (GI) diseases - subject to additional funding Company to host investor webcast today, July 7th, at 8:30am ET July 07, 2026 -- Tvardi Therapeutics, Inc. (“Tvardi” or the “Company”) (NASDAQ: TVRD), a clinic

Potentially first-in-class oral TNIK inhibitor advances into late-stage development after milestones marked by vital peer-reviewed papers: the discovery-to-clinic journey in Nature Biotechnology, and positive Phase IIa clinical results in Nature Medicine Rentosertib represents a novel mechanism, novel AI-identified target, and novel AI-empowered molecule emerging from Insilico's aging-biology-driven Pharma.AI platform The GENESIS-IPF Phase IIa study showed manageable safety and tolerability, wit

Completion of enrollment anticipated within 12 months GALILEO-3 is intended to support the registration of FLT201 in the adult GD1 population July 07, 2026 -- Spur Therapeutics today announced that the first patient has been dosed in GALILEO-3, its Phase 3 pivotal clinical trial evaluating avigbagene parvec (FLT201), an investigational gene therapy for Gaucher disease type 1 (GD1). The trial will assess the safety and efficacy of FLT201 in adults currently on stable standard-of-care therapies.

– Official FDA minutes confirm the previously announced End-of-Phase 2 meeting outcomes and provide additional detail on the planned Phase 3 protocol — – FDA agreed that a single pivotal Phase 3 trial plus confirmatory evidence could support an approval of ATH434 for the treatment of MSA – – Pivotal Phase 3 trial activities on track to initiate by year-end 2026 – July 07, 2026 -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to d

Investigational n.c.a. 177Lu-edotreotide (ITM-11) demonstrated a significantly higher progression-free survival and objective response rate vs. everolimus July 7, 2026 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the publication of its primary result analysis of the Phase 3 COMPETE trial in The Lancet. The clinical data demonstrated that non-carrier-added (n.c.a.) 177Lu-edotreotide (also known as 177Lu-edotreotide or ITM-11) signific

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Phase 2 trial to evaluate the effects of B-cell depletion with BRIUMVI in approximately 60 patients with treatment-resistant schizophrenia based on emerging evidence linking immune dysfunction to disease in a subset of patients July 06, 2026 -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the initiation of a Phase 2 clinical trial evaluating BRIUMVI® (ublituximab-xiiy), in adults with treatment-resistant schizophrenia. The Phase 2 study is an open-label trial designed to evaluate the e