With positive results from a phase III study, ITM Isotope Technologies Munich SE said it has reached a landmark. The clinical trial of ITM-11, a synthetic, targeted radiotherapeutic agent for treating inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors, met its primary endpoint of prolonging progression-free survival when compared to the mTOR inhibitor everolimus, a targeted molecular therapy and a standard of care.
In another cautionary tale of kicking all the tires before an acquisition, Pfizer Inc. agreed to a nearly $60 million settlement to resolve a whistleblower’s claims that Biohaven Pharmaceutical Holding Co. Ltd. was paying kickbacks to induce prescriptions of its migraine drug ahead of Pfizer’s $11.6 billion acquisition of the company in October 2022.
Positive data for Veru Inc.’s enobosarm lend more weight to the potential progress of the company’s body-mass preservation program in patients taking Wegovy (semaglutide). The side effect of lean mass loss has dogged those taking GLP-1s. The study results didn’t support the company’s stock on the day of the data release as it had the previous four weeks.
What a difference 60 weeks can make. That’s the lesson Akero Therapeutics Inc. shared with the rollout of what executives called “unprecedented” data from the phase IIb Symmetry trial testing efruxifermin (EFX), its FGF21 receptor agonist, in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). While earlier findings had shown only a trend in improvement at 36 weeks, full 96-week results showed more than doubling of earlier effect size, hitting the primary endpoint and sending shares of Akero (NASDAQ:AKRO) up 97% to close Jan. 27 at $51.71.
Researchers from Southwest Jiaotong University published the discovery of novel high affinity peptides against the protein of human DNA binding domain of FOXM1 (FOXM1-DBD) to be developed for the treatment of cancer.
As investors look ahead to data shortly from Veru Inc. with enobosarm, the weight-loss space remains hot, with Novo Nordisk A/S reporting favorable top-line results from a phase Ib/IIa trial evaluating amycretin, a unimolecular GLP-1 and amylin receptor agonist for once weekly subcutaneous administration in people overweight or with obesity.
A study published in Jama Network Open in December indicated a direct correlation between adult weight loss and reduced health care spending, suggesting that current glucagon-like peptide-1 receptor agonists (GLP-1RAs) should be reimbursed by Medicare and employer insurances for obesity and overweight conditions.
Tris Pharma Inc.’s positive top-line data from a pivotal phase III study of cebranopadol in pain relief has the company thinking about an NDA submission later in the year. The company’s goal is to avoid the problems opioids have brought to treating pain.
Pseudomonas aeruginosa is included in the World Health Organization’s Bacterial Priority Pathogen List 2024 because of its concerning ability to acquire and develop high levels of antimicrobial resistance. New-in-class antimicrobial options specifically targeting multidrug-resistant (MDR) P. aeruginosa are lacking.
Researchers from the Mayo Clinic described the efficacy of NPA-7, a potential first-in-class multivalent fusion protein comprising a sequence of 22 amino acids of human BNP fused to the Mas receptor agonist Ang 1-7.
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