Daily Snap - 14. July 2025

Author

Joachim Eeckhout
July 13, 2025

Good morning! The FDA has approved the first in vitro diagnostic test for Alzheimer's disease that measures the ratio of tau and beta amyloid proteins to identify potential plaque build-up in the brain, offering a less invasive alternative to brain scans or spinal taps. This is good news, given that the number of Alzheimer's cases is expected to double by 2060!

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

🧬 Killer cells: NK CellTech, a Chinese developer of natural killer (NK) cell therapies, has raised approximately $14 million in an extended Series A round to advance clinical development of its lead candidates and expand its pipeline. Founded in 2020 and based in Shanghai, NK CellTech is developing next-generation, gene-edited NK cell therapies with a focus on scalable manufacturing. The new capital will also support early-stage research into treatments for autoimmune and neurodegenerative diseases.

💥 Depression flop: Relmada Therapeutics has officially terminated its license agreement for esmethadone (REL-1017), a once-promising depression treatment that failed in multiple late-stage trials. Initially licensed in 2018 for $180,000 upfront and quarterly payments of $45,000, esmethadone underperformed across three phase 3 studies targeting major depressive disorder, leading to early trial terminations. Relmada is now shifting focus to other assets: NDV-01 for bladder cancer and sepranolone for Tourette syndrome.

👴 Elderly OK’d: The EMA has lifted its temporary restriction on Valneva’s chikungunya vaccine, Ixchiq, for adults aged 65 and older, following a safety review. The vaccine, which uses a weakened form of the virus, was previously paused for elderly use in May 2025 due to concerns over serious adverse events, including two deaths among individuals aged 62 to 89 with underlying health conditions. While reaffirming Ixchiq’s effectiveness in generating immunity, the EMA now advises its use in older adults only when there is significant infection risk, following a careful benefit-risk assessment.

🌡️ Hot flash fix: Bayer has received the green light from the U.K.’s MHRA for Lynkuet (elinzanetant), a hormone-free oral treatment for moderate to severe vasomotor symptoms of menopause. Unlike traditional hormone therapies, Lynkuet is a dual-action neurokinin receptor antagonist targeting both NK-1 and NK-3 receptors, making it the first of its kind. Three successful phase 3 trials showed significant reductions in hot flashes and night sweats, with over 80% of patients achieving at least a 50% reduction in symptoms. Bayer has also submitted the drug for review in the U.S. and EU, with an FDA decision expected by July 26.

✅ BTK backup plan: Ascentage Pharma has received conditional approval from China’s National Medical Products Administration for lisaftoclax (APG-2575), a novel, orally administered Bcl-2 inhibitor for adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) previously treated with BTK inhibitors. This marks the first approval of a Bcl-2 inhibitor in China and the second globally. Ascentage plans to continue global development through four registrational Phase III trials.

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