Daily Snap - 20. August 2025

Author

Joachim Eeckhout
August 20, 2025

Good morning! Researchers in George Church’s lab at Harvard are making progress toward creating human eggs from stem cells. The team has developed the first in vitro method to trigger meiosis—a crucial step in the formation of eggs and sperm—using human induced pluripotent stem cells (iPSCs). This discovery could pave the way for new approaches to drug testing, contraceptive development, and ultimately the generation of healthy human gametes. Merrick Pierson Smela, who has led the work, will now carry it forward through a new biotech startup, Ovelle Bio. Smela also helped launch Gameto, a femtech company spun out of Church’s lab that raised $44M just last week. Clearly, Church’s lab is brimming with fertile ideas.

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

✂️Job chop: CSL announced a major restructuring that will see up to 3,000 job cuts and the separation of its vaccine division, Seqirus, into an independent company by June 2026. The move aims to give Seqirus strategic autonomy in the evolving vaccine market, where it currently generates $2.2 billion in annual revenue, largely from influenza vaccines. The restructuring is expected to save $550 million over three years, with funds redirected to key growth areas. CSL shares dropped over 15% following the announcement.

👀Visionary licensing: China’s RemeGen has licensed the Asia rights (excluding some regions) to its phase 3 stage eye disease drug RC28-E to Japan’s Santen Pharmaceutical in a deal worth up to 1.3 billion yuan ($180 million), starting with a 250 million yuan ($34.8 million) upfront payment. RC28-E is a dual target VEGF/FGF fusion protein aimed at treating ocular neovascular diseases like diabetic macular edema (DME) and wet age-related macular degeneration (wAMD), with regulatory submissions planned in China through 2026.

🚫FDA rejection: PTC Therapeutics has received a complete response letter (CRL) from the FDA rejecting its application for vatiquinone as a treatment for Friedreich’s ataxia (FA), citing insufficient evidence of efficacy and requesting a new, well-controlled study. The drug had previously failed to meet its primary endpoint in a Phase 3 trial. Despite adding data from two extension studies, the FDA remained unconvinced. PTC, which had previously narrowed its pipeline following other setbacks, plans to meet with the FDA to explore next steps amid competition from Biogen’s approved FA treatment, Skyclarys.

😤Nebulizer drama: BiomX announced that the FDA has placed a clinical hold on its Phase 2b trial of BX004, a phage therapy for cystic fibrosis patients with chronic Pseudomonas aeruginosa infections, due to a review of the third-party nebulizer used for drug delivery, not the drug itself. The company has submitted the requested data from the device manufacturer and expects the hold to be temporary. While U.S. patient screening and enrollment are paused, the trial continues in Europe, where the device is CE marked. BX004 previously showed positive safety and efficacy results and holds FDA Fast Track and Orphan Drug Designations.

💔Mass layoffs:  Opthea is drastically downsizing after back-to-back phase 3 trial failures of its eye disease drug sozinibercept. The drug was unable to outperform Regeneron’s Eylea or Roche’s Lucentis, leading to an 85% workforce reduction and the resignations of CEO Fred Guerard, CFO Tom Reilly, and Director Sujal Shah. The Australian biotech also resolved a financial dispute with investors that had threatened its funding, leaving the company solvent with $20 million remaining. Chairman Jeremy Levin will lead a six-month strategic review to determine whether Opthea should pursue further development, seek partnerships, or return capital to shareholders.

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