“It all comes down to outcomes,” said Michael Davidson, CEO of Newamsterdam Pharma Co. NV, which hailed “robust” and “consistent” data from its phase III study testing a fixed-dose combination of CETP inhibitor obicetrapib plus established anti-cholesterol drug ezetimibe, even as investors focused on a couple of findings that turned up lower than expected, sending shares of the company (NASDAQ:NAMS) down 15.5% to close Nov. 20 at $20.01.
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.
Advertisements for Rezdiffra (resmetirom, Madrigal Pharmaceuticals Inc.), which was approved by the U.S. FDA in March 2024, adorned the lobby of The Liver Meeting 2024 being held at the San Diego Convention Center as well as the trolley stop across the street and other areas that doctors attending the meeting might be swayed. But inside the ballrooms of the convention center, companies were making presentations of data from clinical trials testing their drugs in patients with metabolic dysfunction-associated steatohepatitis (MASH) in hopes of potentially competing with Rezdiffra in a few years.
Incyte Corp.’s mention of would-be “backup molecules” could bode well for findings yet to roll out with Mas-related G protein-coupled receptor X2 antagonist INCB-000262 in chronic spontaneous urticaria. Meanwhile, though, the news is not good, as Incyte said in a terse press release that it will pause enrollment in the ongoing phase II study with the drug because of in vivo preclinical toxicology findings.
IL-23 receptor antagonist icotrokinra hit co-primary phase III endpoints in moderate to severe plaque psoriasis, positioning the oral peptide at the forefront of a multibillion-dollar franchise for partners Protagonist Therapeutics Inc. and Johnson & Johnson.
Neurogene Inc.’s stock sank 43% on news that its phase I/II gene therapy, NGN-401, resulted in a serious adverse event in a pediatric Rett syndrome patient receiving the highest dose.
Patients infected with hepatitis C have had the ability to rid their livers of the virus for some time, while patients with chronic hepatitis B virus infection have been required to take medications for the rest of their lives in the hopes of just dampening damage to the liver caused by the virus. But, at The Liver Meeting 2024, Arbutus presented data from the phase IIa Im-prove study suggesting a cure might be on its way with its DNAi drug, which binds to the viral mRNA promoting its cutting, leading to loss of translation of the viral proteins.
While women’s health has slid under the research radar for decades, large biopharma companies and venture capital firms are beginning to take notice of the untapped market potential. More companies are wandering into the space and exploring avenues of science that were largely ignored for years. A BioWorld analysis of biopharma companies working on women’s health solutions found that while many efforts to improve the well-being of women exist, the proportion of funding and partnering for this emerging sector of medicine still represents only a small slice of the industry’s overall activity.
On the heels of U.S. FDA approval of its first T-cell therapy, Adaptimmune Therapeutics plc reported positive results from a pivotal study for its second candidate, letetresgene autoleucel, expected to support a rolling BLA submission in 2025 that could bolster the firm’s offerings as it narrows its focus on the rare sarcoma space.
Amgen Inc. has shrugged off a Cantor Fitzgerald analyst report that wiped about $12 billion from the company’s market cap. The Nov. 12 analyst report noted supplemental data from the company’s phase I study of obesity drug Maritide showing bone mineral density loss in patients.
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