Daily Snap - 9. September 2025

 

Good morning! This year’s hottest red carpet isn’t in Hollywood, it’s at the World Health Organization. The newest inductees to the Essential Medicines List? None other than the GLP-1 superstars: semaglutide, tirzepatide, liraglutide, and dulaglutide. Yes, Ozempic and Mounjaro have officially “made the list,” earning their spot alongside the world’s most vital drugs. The WHO committee cited “strong scientific evidence” in their favor, though with monthly prices climbing over $1,000, these drugs are still more red-carpet exclusive than everyday blockbuster.

Enjoy today’s read!

—Joachim E.

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SNIPPETS

What’s happening in biotech today?

🐱 Cat relief: Regeneron’s allergen-blocking monoclonal antibodies demonstrated strong efficacy in two phase 3 trials targeting cat and birch pollen allergies. In the cat allergy study, a combination of REGN1908 and REGN1909 reduced itchy eyes by 52%, with secondary improvements in eye redness and skin reactivity. Similarly, treatment with REGN5713 and REGN5715 in birch pollen allergy patients reduced itchy eyes by 51%, with comparable secondary benefits. Both treatments involved a single subcutaneous dose followed by direct allergen exposure to the eye and were generally well-tolerated with no serious adverse events. Regeneron plans further development of both programs in 2025 and 2026.

🏆Jaypirca jump: Eli Lilly announced that its BTK inhibitor Jaypirca (pirtobrutinib) significantly extended progression-free survival (PFS) compared to chemoimmunotherapy in treatment-naïve patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL), according to results from the Phase III BRUIN CLL-313 trial. The study met its primary endpoint, showing a statistically significant and clinically meaningful PFS benefit, with overall survival (OS) data trending positively but not yet mature. Jaypirca’s safety profile was consistent with previous studies. These findings, along with results from BRUIN CLL-314 and BRUIN CLL-321, will support Lilly’s planned global submissions, aiming to expand Jaypirca’s use earlier in CLL/SLL treatment.

💸IPO impact: LB Pharmaceuticals plans to raise up to $263.4 million through an initial public offering on the Nasdaq under the symbol "LBRX" to fund late-stage development of its oral schizophrenia drug, LB-102. The company aims to use $133 million of the proceeds for a phase 3 schizophrenia trial and $25 million for a phase 2 study in bipolar disorder, with the remainder allocated to general corporate purposes. LB-102 is a modified version of amisulpride, showing promising phase 2 results. With only $14 million in cash and a $114 million deficit, the IPO is critical to extending operations through early 2028.

📈Stock pop: Dianthus Therapeutics reported positive Phase II MaGic trial results for claseprubart (DNTH103) in treating generalized myasthenia gravis (gMG), prompting a 20% rise in its stock and plans for Phase III trials in 2026. Claseprubart, a subcutaneously administered antibody targeting the active form of C1s to minimize infection risk, showed clinically meaningful improvements on MG-ADL and QMG scores, with benefits appearing as early as week one. The drug was well tolerated, with no serious safety concerns. Analysts noted its potential to outperform AstraZeneca’s Ultomiris, though argenx’s Vyvgart is expected to remain the leading therapy in the space.

💰 Fragile X finance: Servier has acquired KER-0193, a clinical-stage therapy for Fragile X syndrome, from U.K.-based Kaerus Bioscience in a deal worth up to $450 million, marking its first neurology asset acquisition. KER-0193, which has completed a phase 1 trial demonstrating safety in healthy volunteers, targets BK channels disrupted in Fragile X syndrome, a rare genetic condition with no approved treatments. Servier plans to begin phase 2 trials in the U.S. and Europe next year, adding the asset to its growing neurology pipeline focused on rare diseases.

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