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Graviton BioScience Corporation Announces Publication of Positive Ph1b Trial Results for GV101 (TDI01) in Chronic Graft versus Host Disease in S

GV101, a novel, highly selective ROCK2 inhibitor, yielded an 86.2% best overall response rate (bORR) at 400 mg and a 67.9% bORR at 200 mg at 24 weeks in chronic Graft versus Host Disease (cGvHD) patients who had failed at least two prior lines of therapy. GV101's 24-week bORR exceeds published 6-month bORRs for all existing, approved steroid-refractory cGvHD therapies.

MeiraGTx Holdings PLC (MGTX) came out with quarterly earnings of $1.71 per share, beating the Zacks Consensus Estimate of a loss of $0.39 per share. This compares to a loss of $0.48 per share a year ago.

Received FDA Breakthrough Therapy Designation for AAV2-hAQP1 and reported positive three-year data from Phase 1 AQUAx clinical trial evaluating AAV2-hAQP1 for the treatment of moderate to severe grade 2/3 radiation-induced xerostomia   Completed the acquisition of all interests and rights to botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP) from Johnson & Johnson* (J&J)…

Graviton received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a novel capsule formulation of GV101 on August 7, 2026. FDA clearance marks a critical regulatory milestone in advancing this formulation of GV101, a capsule with improved PK and oral availability, into human trials for Friedreich's ataxia (FA).