Shares of Novo Nordisk A/S (NYSE: NVO) ticked upward to $87.01, a hike of $5.91, on favorable top-line results from a phase Ib/IIa trial with amycretin, a unimolecular GLP-1 and amylin receptor agonist intended for once-weekly subcutaneous administration in people overweight or with obesity. The study investigated the safety, tolerability, pharmacokinetics, and proof of concept in 125 people. The trial was a combined single ascending-dose, multiple ascending-dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks. The primary endpoint was treatment-emergent adverse events (AEs). Bagsvaerd, Denmark-based Novo said the most common AEs were gastrointestinal and the vast majority were mild to moderate in severity.

Ascentage prices first US IPO of the year

Ascentage Pharma Group Corp. Ltd. has priced the first IPO of the year in the U.S. The offering of 7.32 million shares has the Suzhou, China, and Rockville, Md.-based company looking for gross proceeds of about $126.4 million, assuming a price of $17.25 per share. The shares began trading on Nasdaq under the ticker AAPGV on a “when-issued” basis Jan. 24 and were at $17.19 each at midday. They will trade on Jan. 27 under the ticker symbol AAPG for “regular-way” trading. Ascentage has olverembatinib, a tyrosine kinase inhibitor, in a phase III study of chronic myeloid leukemia in a third-line setting. The drug is the subject of a $1.2 billion option agreement signed with Takeda Pharmaceutical Co. Ltd. in June 2024.

Linkgevity targets aging as it joins startup accelerator KQ Labs

Newco Linkgevity Ltd. has won backing from the KQ Labs accelerator program at the Francis Crick Institute in London, enabling it to take forward the lead program, an anti-necrotic drug for treating acute kidney injury, and to further develop its AI-driven system for identifying aging-related therapeutic targets. Alongside access to the Crick’s expertise in translational research and in shaping academic science to make it investible, companies joining KQ Labs receive an equity investment. “This program will be pivotal to our plans, which include initiating a clinical trial for kidney disease,” said Carina Kern, CEO and co-founder of Linkgevity. “What is additionally exciting is that the kidney provides an accelerated aging model to validate this drug as a candidate to treat aging more broadly.”

Lilly’s Zepbound outpaces Wegovy as December logs 212 trial updates

In December 2024, BioWorld recorded 212 clinical trial updates, an increase from 180 in November and closely aligning with 219 in October. The month saw 16 successful phase III outcomes, along with two mixed results and two trial failures.

US Claims Court rules Vanda’s trade secrets not so secret

A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda. In its complaint, which the court partially dealt with a year ago, Vanda claimed that in reviewing generic applications referencing the company’s Fanapt (iloperidone), a schizophrenia drug, and Hetlioz (tasimelteon), a sleep disorder treatment, FDA reviewers disclosed to the ANDA applicants information regarding dissolution rates, impurities testing and micronization, revealing the company’s confidential manufacturing information and causing economic injury. Vanda said the disclosures were an unconstitutional, uncompensated taking of its property. Not so, the claims court said in an opinion unsealed Jan. 22.

Vaxxas, CEPI advance program for thermostable mRNA vaccines

Vaxxas Pty. Ltd. and the Coalition for Epidemic Preparedness Innovations (CEPI) are progressing heat-stable, dried-formulation mRNA vaccines using Vaxxas’ needle-free high-density microarray patch (HD-MAP). CEPI will provide $4.8 million in funding to advance the vaccine program that showed promising proof-of-concept results in preclinical models. The HD-MAP technology offers the potential for needle-free vaccination, reduction of refrigerated storage, and self-administration, making it less expensive, more effective and easier to distribute vaccines in the future.

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Abbvie, Agenus, ALX Oncology, Biogen, Disc Medicine, Exicure, Genmab, GPCR, Humanetics, Lisata, Meiragtx, Nimble, Quoin, Sellas, Stealth, Tiziana, Valneva, Vigil, Ymmunobio, Zai Lab