Syndax looks to rebound from stinging late-stage failure, uncorking early data for next cancer drug up
A year ago, Syndax Pharmaceuticals suffered a major Phase III flop that forced it to forgo an FDA filing for its lead cancer drug and refocus on two earlier-stage programs. Now the biotech’s back with Phase I data on one of those candidates, and says it’s ready for a rebound — but investors aren’t fully convinced.
SNDX-5613, an oral menin inhibitor, achieved a 48% overall response rate in 31 evaluable patients with acute leukemias, Syndax said Tuesday. CEO Briggs Morrison, who once held a senior R&D post at AstraZeneca, laid out plans for a pivotal Phase II launch by the end of Q2, which he says could line up an NDA submission in 2023.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.