Tectonic Therapeutic Gets U.S. FDA IND Clearance For Lead Program, TX45
Portfolio Pulse from Benzinga Newsdesk
Tectonic Therapeutic, Inc. (NASDAQ: TECX) has received FDA clearance for its Investigational New Drug (IND) application for TX45, an Fc-relaxin fusion protein aimed at treating Group 2 Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction (PH-HFpEF). The company plans to initiate a global Phase 2 clinical trial in Q3 2024, with topline results expected in 2026. Phase 1a results in healthy volunteers are expected this September, and Phase 1b results in mid-2025.
July 30, 2024 | 8:22 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Tectonic Therapeutic (NASDAQ: TECX) has received FDA clearance for its IND application for TX45, targeting Group 2 PH-HFpEF. The company plans to start a Phase 2 trial in Q3 2024, with results expected in 2026. Phase 1a results are expected this September.
FDA clearance for the IND application is a significant milestone for Tectonic Therapeutic, indicating regulatory approval to proceed with clinical trials. This news is likely to positively impact the stock price in the short term, especially with upcoming Phase 1a results expected in September.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100