Daily Snap - 6. October 2025

Author

Joachim Eeckhout
October 06, 2025

 

Good morning! After years of throwing paperwork at each other, Vanda and the FDA have finally called a ceasefire to establish a “collaborative framework” following Vanda’s recent appeals court victory regarding its sleep disorder drug Hetlioz. The court had criticized the FDA’s handling of Vanda’s clinical trial data as “cursory,” prompting the agency to agree to an expedited re-review of Hetlioz’s jet lag indication by January 7, 2026. Additionally, the FDA will re-review a partial clinical hold on Vanda’s motion sickness drug tradipitant, while maintaining a December 30, 2025 decision date. In return, Vanda will pause or dismiss several lawsuits and administrative actions against the FDA. At this rate, Vanda and the FDA might actually start sending each other holiday cards.

Enjoy today’s read!

—Joachim E. 

SNIPPETS

What’s happening in biotech today?

🌊 SPAC splash: Singapore-based Nanyang Biologics, an AI-driven drug discovery company, is set to go public on Nasdaq through a reverse merger with RF Acquisition Corp II, a special purpose acquisition company (SPAC), in a deal valuing Nanyang at $1.5 billion and expected to close by Q2 2026. Leveraging a partnership with Nanyang Technological University, Nanyang has developed the DTIGN platform to identify therapeutic compounds from natural sources, aiming to build the world’s largest AI-curated natural compound library. Its pipeline includes five preclinical candidates, led by NB-A002 for chemo-resistant cancers.

🧬AMD focus: Cirrus Therapeutics has raised $11 million in seed funding to advance its lead gene therapy program targeting dry age-related macular degeneration (AMD), the leading cause of vision loss in people over 50. The therapy uses an adeno-associated virus (AAV) vector to restore IRAK-M, a key immune regulator in retinal cells whose decline with age contributes to AMD progression. The funding, led by ClavystBio with participation from Polaris Partners and SEEDS, will support IND-enabling studies and pipeline development.

 🪓Half axed: Bolt Biotherapeutics has announced its second round of workforce reductions in two years, cutting staff by half to extend its financial runway amid delays in its lead immunotherapy program. The company is modifying the protocol for its phase 1 trial of BDC-4182, an immune-stimulating antibody conjugate targeting Claudin 18.2 for gastric and gastroesophageal cancers, after observing strong immune responses at initial dose levels. This adjustment pushes the anticipated data readout to Q3 2026. With $48.5 million in cash projected to last until mid-2026, the layoffs aim to fund operations into 2027.

👋Farewell: Rocket Pharmaceuticals has voluntarily withdrawn its biologics license application (BLA) for RP-L102, a gene therapy intended to treat Fanconi anemia, citing strategic and business considerations rather than safety or efficacy concerns. The decision follows a broader restructuring effort that began in July 2025, during which Rocket deprioritized hematology programs to focus on cardiovascular therapies with clearer regulatory and commercial paths. The company emphasized that it may revisit RP-L102 through potential external partnerships. This marks another regulatory setback for Rocket, which previously faced FDA delays for Kresladi and a clinical hold on its Danon disease program, lifted only recently.

📈CTLA-4 climb: OncoC4 has raised nearly $50 million in a series B funding round to advance its pipeline of cancer and immunology therapies. The round was led by Hong Kong's GBA Fund, with continued support from China-based investors HM Capital, 3E Bioventures Capital, and Kaitai Capital. Key programs include AI-081, a bispecific antibody targeting PD-1 and VEGF, currently in Phase II testing for advanced solid tumors, and gotistobart (BNT316/ONC-392), an anti-CTLA-4 antibody licensed to BioNTech and in Phase III trials for metastatic non–small-cell lung cancer.

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