TG Therapeutics up 34% premarket on positive umbralisib data • TG Therapeutics (NASDAQ:TGTX) announces positive topline results from a Phase 3 clinical trial, UNITY-CLL, comparing unbralisib plus ublituximab (U2) to obinutuzumab plus chlorambucil in patients with previously untreated relapsed/refractory chronic lymphocytic leukemia (CLL).
• Based on a prespecified interim analysis by the independent Data Safety Monitoring Board, treatment with U2 resulted in a statistically significant improvement in progression-free survival (PFS). As a result, the study will be stopped early.
• Management will host a conference call this morning at 8:30 am ET to discuss the results.
Y esta tb la tengo, no se si alguien más Adverum gene therapy shows positive action in wet AMD; shares up 22% premarket • Adverum Biotechnologies (NASDAQ:ADVM) announces positive preliminary data from the first three cohorts in a Phase 1 dose-ranging clinical trial, OPTIC, evaluating gene therapy candidate ADVM-022, administered via intravitreal injection, in patients with wet age-related macular degeneration (wet AMD).
• The company says ADVM-022 continues to show "robust" efficacy with long-durability of beyond a year from a single administration with no injections in cohort 1.
• On the safety front, the gene therapy continues to be well-tolerated with a favorable safety profile.
• Mean gain in best corrected visual acuity (BCVA) in cohort 3 was +6.8 letters.
• It plans to file an IND for ADVM-022 in diabetic retinopathy (DR) this quarter.
• Key H2 milestones: Present data from all four cohorts in OPTIC and launch enrollment in Phase 1/2 study of ADVM-022 in DR.
