Sanaregen Vision Therapeutics Inc. has received FDA clearance to conduct a phase I/II trial of SVT-001, an investigational cell therapy for individuals with familial drusen.
Tessera Therapeutics Inc.’s lead in vivo gene editing program, TSRA-196, has been awarded orphan drug and fast track designations by the FDA for adults with α-1 antitrypsin deficiency (AATD).
CSPC Pharmaceutical Group Ltd. has obtained IND approval from the FDA for SYH-2082 injection, a GLP-1/GIP receptor dual-biased agonist polypeptide long-acting injection for weight management for individuals with obesity or overweight and at least one weight-related comorbidity.
Precision Biosciences Inc. has received FDA clearance of its IND application enabling clinical trial site activation for a phase I/II trial (FUNCTION-DMD) of PBGENE-DMD for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD). The first site in the U.S. will be activated in the first half of this year.
Nextpoint Therapeutics Inc. has obtained IND clearance from the FDA to initiate clinical development of NPX-372, a first-in-class B7-H7-targeted T-cell engager (TCE) for the treatment of patients with solid tumors.
Affinia Therapeutics Inc. has obtained IND clearance from the FDA for AFTX-201, an investigational genetic medicine for the treatment of BAG3-associated dilated cardiomyopathy (DCM). The phase I/II UPBEAT trial will begin in the first half of this year.
Prelude Therapeutics Inc. has received IND clearance from the FDA for PRT-12396, a mutant-selective JAK2 V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms.
ABL Bio Inc. has submitted an IND application to the FDA seeking clearance to begin a phase I trial of ABL-209 (NEOK-002). Pending approval, the trial is expected to begin by mid-year in the U.S.
Onchilles Pharma Inc. has obtained IND approval from the FDA for N-17350, enabling initiation of first-in-human studies in patients with advanced solid tumors. The study will enroll patients in the U.S. and Australia with advanced solid tumors.
Trace Biosciences Inc. has obtained IND approval from the FDA for LGW16-03 (Nervetrace Dx), the company’s first nerve-specific fluorescent imaging agent. The IND clearance enables Trace to initiate a first-in-human study evaluating the safety and intraoperative performance of LGW16-03 in surgical settings.
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