Sage Therapeutics Inc. is reducing its workforce by 40% and pausing its earlier-stage programs, just a few weeks after receiving mixed news of both a U.S. FDA approval and a complete response letter for its depression drug Zurzuvae (zuranolone). The move offers the Cambridge, Mass.-based company an annualized net savings of approximately $240 million, 60% of which is related to R&D, and will extend its runway into 2026.
In response to the Biden administration announcing on Aug. 29 the first 10 medications up for price negotiations with the Centers for Medicare & Medicaid Services as part of the Inflation Reduction Act of 2022, U.S. Senate and House Republicans are firing back, calling the imposed “price-controls set by Washington bureaucrats” part of a scheme that “will lead to higher prices for new drugs coming to market, stifle the development of new cures and destroy jobs,” ultimately driving up costs for seniors.
Heterozygous familial hypercholesterolemia (HeFH) patients treated with lerodalcibep achieved a 58.6% reduction in LDL-cholesterol at week 24 and a 65% reduction at the mean of weeks 22 and 24 in the phase III trial Liberate-HeFH. The developer, Cincinnati-based Lib Therapeutics Inc., was founded in 2015 when it licensed the technology from Bristol Myers Squibb Co. but is just now emerging from stealth.
The first special purpose acquisition company (SPAC) merger announced in 2023 has fallen apart. Aprinoia Therapeutics Inc. and Ross Acquisition Corp. II mutually agreed to call off the merger that had been valued at $280 million. The failed deal is part of a larger trend that has gained momentum in the past year as a struggling economy and tighter U.S. SEC restrictions dampened SPAC deals.
Shares of Fulcrum Therapeutics Inc. shot up 38.5% on Aug. 22 following news that the U.S. FDA had lifted the clinical hold on the company’s phase Ib sickle cell disease candidate, FTX-6058.
Building out its metabolic franchise, Novo Nordisk A/S is buying privately held Montreal-based Inversago Pharma Inc. for up to $1.075 billion, gaining lead asset INV-202, an oral cannabinoid 1 (CB1) inverse agonist. The candidate has demonstrated weight loss potential in a phase Ib trial and is currently in a phase II for diabetic kidney disease. Novo Nordisk’s interest in INV-202 is to explore its potential for obesity and obesity-related complications.
Investors have known for some time that the GLP-1 receptor agonist class offers tremendous promise for treating the underserved obesity population worldwide, but news from Novo Nordisk A/S on cardiovascular outcomes data sent a shiver throughout the space on Aug. 8. Top-line results from the Select trial comparing subcutaneous once-weekly Wegovy (semaglutide) 2.4 mg with placebo showed the treatment reduced major adverse cardiovascular events by a statistically significant 20%.
New company Amber Bio emerged on Aug. 3 with $26 million in seed funding that will help advance an RNA-based gene editing platform that leverages Cas-based systems to create safer medicines. Through the company’s platform, a single drug can be used to treat diseases with high allelic diversity. The company plans to develop its own genetic medicines internally, while also licensing out the technology to expand its reach.
It only took a couple of billion-dollar transactions in the second quarter (Q2) of 2023 to push med-tech dealmaking values above all other recent years. Despite the surge in value, the volume of deals is level with other quarters.
Stoke Therapeutics Inc.’s stock tumbled 32% after the company reported phase I/IIa data of its antisense oligonucleotide, STK-001, in Dravet syndrome, showing it reduced convulsive seizures in children most consistently at the highest dose, with benefits increasing as time progressed.
