Syndax Pharmaceuticals Inc. won U.S. FDA approval – the company’s second this year – for menin inhibitor Revuforj (revumenib) with a black box warning for differentiation syndrome. “We’ve long expected that would be the case,” said CEO Michael Metzger. For “the last six years or so” the agency has had a “heightened awareness” of the problem, and he predicted all drugs in the class would bear similar cautionary language. But there’s also a warning about QT prolongation and a requirement for monitoring.
The competitive menin-inhibitor space chalked further data from Syndax Pharmaceuticals Inc., which disclosed positive top-line results from the pivotal phase II portion of the Augment-101 study, designed to test oral small-molecule revumenib for safety and efficacy. But shares of the firm (NASDAQ:SNDX) closed Nov. 12 at $16.21, down $5.57, or 26%, after the Augment-101 numbers were disclosed.
The U.S. FDA clamped a full clinical hold Biomea Fusion Inc.‘s phase I/II study of BMF-219 for treating type 1 diabetes and type 2 diabetes. The hold sank the stock on June 7 as the company looked to find answers so it could sit down with the agency to discuss next steps.
Eilean Therapeutics LLC has announced clearance by the Human Research Ethics Committee in Australia for a first-in-human phase I trial of balamenib (ZE63-0302), an oral small-molecule inhibitor of the menin-KMT2A interaction.
It’s not every day you see a small drug company’s presentations get picked for both the plenary session and the late-breaker session at a conference, but Syndax Pharmaceuticals Inc. managed to do just that at the 65th American Society of Hematology Annual Meeting 2023 – with a little help from a friend.
Syndax Pharmaceuticals Inc. is gearing up for a U.S. FDA filing by the end of 2023 on the back of positive data from a pivotal phase I/II study testing menin inhibitor revumenib in adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute myeloid leukemia and acute lymphoid leukemia.
Shares of Biomea Fusion Inc. (NASDAQ:BMEA) rocketed up 89% to close at $29.30 March 28 after the company reported early cohort data from its Covalent-111 phase I/II trial, showing treatment with the lowest dose of menin inhibitor BMF-219 reduced median A1c levels in patients with type 2 diabetes by 1% at only four weeks.
Biomea Fusion Inc. has received IND clearance from the FDA to begin a phase I/Ib trial of BMF-219, a selective, covalent menin inhibitor in patients with unresectable, locally advanced, or metastatic non-small-cell lung cancer (NSCLC), colorectal cancer, or pancreatic ductal adenocarcinoma with an activating KRAS mutation.
As the American Society of Clinical Oncology meeting nears, presenters are talking up their prospects, including Biomea Fusion Inc. with early data from experiments testing BMF-219, an oral, irreversible covalent menin inhibitor – one in an intriguing class that has sparked efforts by various developers.
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