Newamsterdam Pharma Co. NV will look toward regulatory filings on the back of positive data from the phase III Tandem study, showing the fixed-dose combination of its CETP inhibitor, obicetrapib, and established cholesterol-lowering drug ezetimibe hit all four co-primary endpoints. The trial enrolled patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol (LDL-C), who do not adequately respond to, or do not tolerate existing therapies. Despite the solid “p” values of less than 0.001, investors of the company appeared to focus on other aspects of the dataset, sending shares of Newamsterdam (NASDAQ:NAMS) down 14% in midmorning trading.

New diagnostics, trials address deadly disparities in women’s cardiac care

While women with “big hearts” play well in popular culture, cardiologists see a very different picture – with significant implications for women’s health and medical care. Women have smaller hearts and narrower blood vessels than men and their cardiovascular systems respond to disease and treatment in very different ways. Growing evidence that failure to reflect women’s distinct anatomy in cardiac care leads to deadly disparities in outcomes has recently stimulated development of new diagnostics and increased focus on inclusion of women in medical device trials.

US FDA adds hidradenitis suppurativa to Bimzelx label for UCB

UCB SA gained from the U.S. FDA clearance to use Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), marking the drug’s fifth approval. A humanized IL-17A and IL-17F antagonist, Bimzelx was first greenlighted by the agency in October 2023 for moderate to severe plaque psoriasis. HS is a chronic condition that causes painful, boil-like lumps to appear under the skin. A handful of other developers are known to be working in the space.

Sage shuts down Huntington’s program after phase II failure

The bad news keeps piling up for Sage Therapeutics Inc. Having absorbed other study stumbles in the past few months, the company now has halted development of dalzanemdor in treating Huntington’s disease after top-line phase II data showed it missed a statistically significant difference compared to placebo on the primary endpoint. In early October, Sage stopped development of dalzanemdor in Alzheimer's disease after a phase II study also missed its primary endpoint. In late July, the Cambridge, Mass.-based company faltered in the phase II Kinetic 2, dose-ranging study of oral Zurzuvae (zuranolone) for essential tremor.

Radiopharma Telix acquires FAP-targeting agents for bladder cancer

Radiopharmaceutical company Telix Pharmaceuticals Ltd. has inked a deal worth up to AU$264 million (US$171 million) to license and develop next-generation radiopharma imaging and therapy technology targeting fibroblast activation proteins found in a wide range of cancers. The agreement with Germany’s SCV GmbH and Medianeza GmbH adds several new clinically validated imaging and therapeutic assets to Telix’s pipeline of cancer therapies and diagnostics. The initial clinical focus will be on bladder cancer to round out its urology franchise. Under terms of the deal, Telix will pay an up-front fee of AU$11 million, with another AU$5 million coming in 12 months. A further AU$215 million is payable upon achieving certain clinical milestones and up to A$33 million in commercial milestones.

BioWorld Insider podcast: Modifi gets creative on the rocky road to a multibillion-dollar buyout

For a small company, Modifi Biosciences has come a long way very quickly. In the newest episode of the BioWorld Insider podcast, founder Ranjit Bindra talks about how his company went from tiny to nearly extinct at least twice until it was acquired by Merck for $30 million up front.

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