Shares of Viking Therapeutics Inc. (NASDAQ:VKTX) were trading at $23.70, down $18.39, or 43%, on 13-week data from the phase II trial of the oral tablet formulation of VK-2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. The drug is being developed in oral and subcutaneous formulations for the treatment of metabolic disorders such as obesity. Called Venture-Oral, the experiment showed that the GLP-1/GIP mechanism achieved its primary and secondary endpoints, with patients on VK-2735 turning up statistically significant reductions in body weight compared with placebo. The drug proved safe and well-tolerated, Viking said.

FDA rejects PTC’s Friedreich’s ataxia drug, for now

It looks like Biogen Inc.’s Nrf2 activator, Skyclarys (omaveloxolone), will maintain its status as the sole therapy approved for treating patients with Friedreich’s ataxia, at least for now. The U.S. FDA asked for another “adequate and well-controlled study” in the complete response letter (CRL) issued to PTC Therapeutics Inc. for 15-lipoxygenase inhibitor vatiquinone. The agency said “substantial evidence of efficacy was not demonstrated.” The CRL had been somewhat anticipated, and the company said it plans to meet with the agency to discuss next steps.

CSL to shave off 3,000 jobs, Seqirus vaccine unit

CSL Ltd.’s stock tumbled 16.88% on the news that it plans to cut 3,000 jobs and to hive-off its Seqirus vaccine unit in a cost-cutting measure to save more than $500 million per year over the next three years. A “dynamic geopolitical backdrop, competitive pressure and organizational complexity have challenged CSL and hindered its ability to deliver superior returns,” CSL CEO Paul McKenzie told analysts during an Aug. 19 year-end earnings call. “With a sense of urgency, I want us to re-focus on our core strengths, lift R&D productivity and instill a lean and efficient mindset, while at the same time optimizing our capital structure and removing complexity.”

Halda, in a $1B+ deal, joins up with Vantai

Halda Therapeutics Inc. could bring in more than $1 billion in a new collaboration with generative AI drug discovery company Vantai Inc. The amount includes up-front and milestone payments, support for research and royalties on nets sales for therapies across multiple cancer and immunology targets. Halda is developing what it calls RIPTAC (regulated induced proximity targeting chimera) therapeutics to selectively kill cancer cells. Just a week ago the U.S. FDA granted Halda’s lead candidate, HLD-0915, fast track designation in treating metastatic castration-resistant prostate cancer. Both companies are privately held.

Purpose-driven longevity fund launches in face of regulatory issues

Singapore-based Immortal Dragons has launched with $40 million under management, mostly from its founder Boyang Wang, with a focus on investing in early stage companies developing treatments to extend life. Immortal Dragons is focused on pre-seed or seed-stage companies. “We are not clinical trial experts,” Wang noted. “A better position would be to fill in the vacuum – that is for many seed and pre-seed companies that are starving. They can’t get funding because they are still early stage.”

Dx&Vx subsidiary Avixgen in $360M deal for drug delivery tech

Avixgen Co. Ltd., a subsidiary of Dx&Vx Co. Ltd., inked a $360 million license agreement with an unidentified U.S.-based biotechnology company, granting the latter rights to its advanced cell penetrating (ACP) peptide drug delivery platform. Dx&Vx currently holds a 66.2% stake in Avixgen. Dx&Vx’s largest shareholder is Lim Chong-yoon, chairman of Coree Co. Ltd. and the eldest son of the founder of Hanmi Pharmaceutical Group. "This global licensing-out agreement is the first for our company and represents the fruition of years of continuous research and development efforts,” Avixgen CEO Han Sung-jun said

AAP unveils its own childhood vaccine schedule

After decades of working with the U.S. CDC’s Advisory Committee for Immunization Practices to develop evidence-based vaccine schedules, the American Academy of Pediatrics (AAP) is returning to its historic roots of developing its own recommendations. The AAP’s 2025 vaccine schedule for children and adolescents, published today, provides updated guidance on COVID-19 immunizations that diverges from the CDC’s 2025 recommendations by advising that all children ages 6 through 23 months, as well as older children in certain risk groups, get the COVID-19 shot. “The AAP will continue to provide recommendations for immunizations that are rooted in science and are in the best interest of the health of infants, children and adolescents,” AAP President Susan Kressly said.

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Abcuro, Alto, Aptose, Astrazeneca, Biocartis, BMS, Boehringer, Enlivex, Fibrogen, Huadong, Lakeshore, Legend, Merck, Newamsterdam, Novo Nordisk, Oncoc4, Palatin, Pharmacyte, Plus, Quoin, Reunion, Soligenix, Springworks, Stealth, Systimmune, Tonix, Valneva, Vcare.