Daily Snap - 9. October 2025

Good morning! Eli Lilly just hired Peter Marks, the former head of the FDA’s biologics division, to lead its infectious disease and molecule discovery teams. Marks spent over a decade at the FDA, overseeing the approval of the first COVID-19 vaccines before being forced out earlier this year after clashes with RFK Jr. over vaccine policy. Now, he joins a long list of ex-FDA leaders crossing into pharma, as companies like Pfizer and AstraZeneca also scoop up former regulators. Here’s a new motto for FDA execs who get fired: ”If you can’t approve ‘em, join ‘em”.

Enjoy today’s read!

—Joachim E.

PRESENTED BY BMG LABTECH

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SNIPPETS

What’s happening in biotech today?

🌽Fresh grant: The U.S. government, through ARPA-H, has committed up to $48 million to support Kernal Biologics and its partners in advancing an in vivo mRNA-based CAR-T cell therapy program. The funding will help develop Kernal's KR-402 candidate targeting hematological cancers and autoimmune diseases, including multiple sclerosis and B-cell malignancies. Unlike traditional CAR-T therapies, Kernal’s approach uses selective mRNA and targeted lipid nanoparticles for precise delivery to T cells. Despite recent federal pullbacks from mRNA vaccine funding, this initiative highlights continued interest in mRNA-based therapeutics. Additional funding supports research partners, including Stanford, Dana-Farber, and Jackson Laboratory.

 🧠Brain-immunity: Nilo Therapeutics has launched with $101 million in Series A funding to develop therapies that target neural circuits regulating immune responses, aiming to restore immune homeostasis in autoimmune and inflammatory diseases. Founded by prominent academics from Columbia University, Yale, and Harvard, the biotech is building on research identifying vagal neurons that influence systemic immune activation. The company plans to modulate "master regulator" brain-body circuits to coordinate immune pathways more effectively. The funding will support lab development, team expansion, and advancement of preclinical programs.

🃏 PDE4B play: The FDA has approved Boehringer Ingelheim’s new drug Jascayd for idiopathic pulmonary fibrosis (IPF), marking the first new treatment for the condition in over a decade. Jascayd, a twice-daily oral medication, targets the PDE4B enzyme to reduce lung scarring and inflammation, showing a slower decline in lung function compared to placebo and potentially better tolerability than Boehringer’s earlier IPF drug, Ofev. While analysts view it as a modest advancement due to limited efficacy and potential combination challenges, its approval reflects progress in a historically difficult therapeutic area. Boehringer has not yet announced the drug’s pricing.

🔱 Autoimmune trio: Zenas BioPharma has entered a deal potentially worth over $2 billion with China’s InnoCare Pharma to acquire rights to three autoimmune drug candidates, including orelabrutinib, a BTK inhibitor currently in Phase 3 trials for primary progressive multiple sclerosis. The agreement includes up to $100 million in upfront and near-term payments, stock options, and future royalties for InnoCare. Zenas also secured $120 million through a private stock placement to fund operations into late 2026 or early 2027. This move reflects a broader trend of U.S. pharmaceutical firms sourcing innovation from Chinese biotech companies, despite growing regulatory and political scrutiny.

♀️Hope for endometriosis: Hope Medicine Inc. has announced the successful completion of a global Phase 2 clinical trial for HMI-115, a potential first-in-class, non-hormonal treatment for moderate to severe endometriosis-related pain. The monoclonal antibody, which targets the prolactin receptor, demonstrated statistically significant reductions in dysmenorrhea (42%) and non-menstrual pelvic pain (52%) over a 12-week period, with no serious treatment-related adverse events reported. Notably, patients maintained normal menstrual cycles, stable hormone levels, and bone mineral density without experiencing typical menopausal symptoms. Following these results, Hope Medicine is preparing for Phase 3 trials and engaging with regulatory bodies to advance development globally.

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