Daily Snap - 2. October 2025

Author

Joachim Eeckhout
October 02, 2025

 

Good morning! If you were planning to submit a drug application to the FDA in the coming days, you may be out of luck. Due to the ongoing U.S. government shutdown, the FDA has stopped accepting new drug and medical device submissions. Although the agency will retain 86% of its workforce, many “non-critical regulatory activities” are also being put on hold. Meanwhile, the agency faced fresh controversy when shares of biotech company Aurinia plunged after a senior FDA official briefly posted—and then deleted—comments on LinkedIn questioning the safety and benefits of its lupus nephritis drug, Lupkynis. This was despite the drug’s full approval and continued backing from both the company and industry analysts. Perhaps the FDA should fast-track an internal LinkedIn approval process.

Enjoy today’s read!

—Joachim E.

  

PRESENTED BY BIOIVT

Making sense of cell-based technologies: a deep dive

Cell-based biotech is both promising and complex. From the role of cell-based assays in drug discovery to the evolving landscape of CAR-T and tumor-infiltrating lymphocyte therapies, progress often raises as many questions as it answers.

A new eBook brings together key perspectives and examples that trace these developments, offering context on how researchers approach disease models, controls, and next-gen sequencing. For those tracking the science, it’s a clear-eyed look at where the field is now and where it could go next.

SNIPPETS

What’s happening in biotech today?

💊 Lupus bet: Kyorin Pharmaceutical has signed a $105 million licensing deal with Hinge Bio for the Japanese rights to HB2198, a preclinical lupus drug targeting CD19 and CD20 for B-cell depletion. Kyorin will pay $10 million upfront, with up to $95 million in development milestones related to systemic lupus erythematosus, and may make further payments if the drug is explored for other autoimmune conditions.

👁️AMD ambitions: French biotech company SeaBeLife has secured €2 million in a pre-Series A funding round to advance its development of first-in-class drug candidates targeting necroptosis and ferroptosis, two key pathways of regulated cell death, with a focus on treating dry age-related macular degeneration (AMD) and severe acute hepatitis. Backed by existing and new investors, the funding will support progression toward clinical trials, expected to begin in 2026. Founded in 2019, SeaBeLife aims to address unmet medical needs with its dual-inhibition approach, supported by promising preclinical results and €9 million raised to date.

💰Another launch: Athernal Bio, a Cambridge-based biotech company, has launched with £3.5M ($4.7M) in funding from Delin Ventures to develop targeted immunotherapies for high-risk clonal haematopoiesis (CH), a common precursor to blood cancers such as acute myeloid leukaemia. The funding will support in vivo validation and preclinical milestones toward clinical trials, with a focus on stopping cancer before it starts.

🪓Pipeline cut: Takeda is exiting the cell therapy space as part of a strategic portfolio shift, narrowing its focus to small molecules, biologics, and antibody-drug conjugates. The Japanese drugmaker is seeking a partner to take over its cell therapy platform and preclinical programs, including the gamma delta T-cell therapy platform acquired from GammaDelta Therapeutics in 2021, which contributed to an expected impairment loss of approximately $394 million. With no current cell therapy assets in clinical trials, Takeda plans to redirect investment toward areas promising faster, large-scale impact. This move aligns with broader industry trends, as several major pharma companies have recently scaled back or abandoned cell therapy ventures.

🧪Isotope hustle: Full-Life Technologies, a China-Belgium biotech firm, has secured $77 million in funding, $50 million in Series C equity, and $27 million in debt, to advance its radiopharmaceutical pipeline and complete construction of its manufacturing facility in Gembloux, Belgium. This brings the company’s total funding since its 2021 launch to nearly $200 million.

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