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SNIPPETS

What’s happening in biotech today?

🥊 Prostate punch: GSK has signed a licensing agreement worth up to $357 million with French biotech Syndivia for a preclinical antibody-drug conjugate (ADC) targeting metastatic castration-resistant prostate cancer (mCRPC). The ADC, developed using Syndivia’s GeminiMab conjugation technology, has shown strong tumor-shrinking effects in preclinical studies without significant side effects. This deal highlights GSK’s strategic focus on tumor-targeted therapies and expands its growing oncology pipeline, which includes multiple phase 3 ADC candidates. The agreement also reflects the increasing momentum behind ADCs, a dominant theme at the recent European Society for Medical Oncology (ESMO) Congress.

🚀 Muscle boost: BridgeBio Pharma plans to seek FDA approval for its experimental drug BBP-418 following positive late-stage trial results in patients with limb-girdle muscular dystrophy type 2I/R9, a rare condition with no approved treatments. The oral therapy led to a sustained 17% improvement in glycosylated αDG levels, a key marker of muscle stability, and showed statistically and clinically significant gains in mobility and lung function over 12 months without unexpected safety issues. With a potential $1 billion market opportunity, BridgeBio aims to submit an approval application in the first half of 2026, positioning BBP-418 as a potential first-in-class treatment.

⚠️ CRISPR caution: Intellia Therapeutics has paused enrollment and dosing in two Phase 3 trials of its CRISPR-based therapy, nexiguran ziclumeran (nex-z), for transthyretin amyloidosis after a study participant was hospitalized due to severe liver toxicity. The patient, an 80-year-old man, experienced a grade 4 spike in liver enzymes and elevated bilirubin nearly a month after treatment, prompting concerns about potential organ damage. This is the second such liver-related safety event reported by Intellia since May. The company is investigating the cause, suspecting a delayed gene-target-specific reaction rather than delivery-related issues, and will consult regulators to determine next steps toward resuming the trials.

🧠 Lesion lockdown: Zenas BioPharma reported that its autoimmune drug obexelimab achieved a 95% reduction in new Gd-enhancing T1 brain lesions over 12 weeks in a Phase 2 study of 116 patients with relapsing multiple sclerosis (MS), meeting its primary endpoint with highly statistically significant results. The drug, a bifunctional monoclonal antibody administered via subcutaneous injection, showed “near-complete suppression” of lesions by Week 8, sustained through Week 12, with a safety profile consistent with prior trials. Investor response was strong, boosting Zenas’ stock by 20%. The company plans to release 24-week data in early 2026 and is also pursuing obexelimab in other autoimmune indications.

💡 IPO glow: MapLight Therapeutics debuted on the Nasdaq with a valuation of $787 million after its shares opened at $19, a 12% increase over the IPO price of $17. The company raised $250.8 million by selling 14.75 million shares, with Goldman Sachs affiliates also participating through a private placement. MapLight, focused on central nervous system disorders, is developing its lead drug candidate, ML-007C-MA, for schizophrenia and Alzheimer’s-related psychosis. Its IPO proceeded under a rarely used regulatory provision triggered by the ongoing U.S. government shutdown, marking a cautious resurgence in biotech IPOs amid challenging market conditions and investor demand for late-stage data.

SPEED READ

More news

• Bayer's newly FDA-approved drug Lynkuet offers a non-hormonal treatment for moderate to severe menopausal hot flashes by targeting NK1 and NK3 receptors, positioning it as a direct competitor to Astellas Pharma’s Veozah amid growing interest in menopause care.

• Eli Lilly and Innovent’s dual agonist mazdutide significantly outperformed Novo Nordisk’s semaglutide in a head-to-head phase 3 trial, achieving superior blood sugar control and weight loss in Chinese patients with type 2 diabetes and obesity.

• Guardant Health and Zephyr AI have partnered to combine multimodal molecular data with AI to accelerate the discovery of cancer biomarkers, enhance targeted therapy predictions, and advance precision oncology solutions.

• Evotec has received a $25 million milestone payment from Bristol Myers Squibb to support the advancement of their joint preclinical pipeline targeting neurodegenerative diseases, highlighting ongoing progress in their long-term neuroscience collaboration.

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