Recent Funding:
Epicrispr Biotechnologies (SF) secures $68M to advance CRISPR-based therapy for rare muscle disease
Epicrispr raised $68M in a Series B led by Ally Bridge Group to develop EPI-321, a CRISPR-based therapy for facioscapulohumeral muscular dystrophy (FSHD). Unlike traditional gene editing, Epicrispr’s method uses CRISPR to chemically modify the DUX4 gene without cutting DNA, aiming to stop its harmful expression.
Character Biosciences (SF) raises $93M Series B for AMD treatments
The Series B round, led by aMoon and Luma Group, will advance two AMD drug candidates, CTX114 (geographic atrophy) and CTX203 (intermediate AMD), into Phase 1 trials this year. CTX114 targets the complement system like Apellis’ Syfovre and Astellas’ Izervay but uses a different mechanism to regulate immune overactivation. CTX203 stabilizes ABCA1 expression to prevent disease progression.
Recent Layoffs:
Nkarta (SF) Lays off One-Third of Its Workforce
Nkarta is laying off 53 employees (about one-third of its workforce) and more than half of its executive team, including Chief Strategy and Business Officer Alyssa Levin, to extend operations into 2029. After struggling in oncology, Nkarta pivoted to autoimmune diseases and expects initial clinical data for NKX019 later this year.
BioAtla (SD) lays off 30% of staff, prioritizes ADC pipeline
BioAtla is cutting over 30% of its workforce to extend cash runway into 2025 while seeking partners for certain CAB antibody assets. The company is focusing on mecbotamab vedotin (anti-AXL ADC) for NSCLC, with a Phase 2 readout expected next year. Other priority programs include BA3182 (CAB-EpCAM x CAB-CD3 T-cell engager) in metastatic adenocarcinoma and ozuriftamab vedotin (CAB-ROR2 ADC) for HPV-positive head and neck cancer, which has shown a 45% response rate.
Tenaya Therapeutics (SF) lays off 30-40% of staff amid restructuring
Tenaya is cutting up to 40% of its workforce, mainly in research and manufacturing, and will decommission its Union City, CA manufacturing site while retaining the facility. The restructuring, combined with a recent $52.5M stock sale, is expected to extend cash runway into late 2026.
FDA Approvals:.
FDA Approves Qfitlia for Hemophilia A and B
The FDA approved Qfitlia (fitusiran), a new hemophilia treatment co-developed by Sanofi and Alnylam, which works by inhibiting a protein that prevents blood clotting. Administered as a bi-monthly injection, Qfitlia reduces bleeding rates by ~70% and has a list price of $642,000 annually, though Sanofi offers financial assistance programs.
Soleno Therapeutics’ (SF) First Prader-Willi drug to reduce hunger approved by FDA
Soleno Therapeutics received FDA approval for Vykat XR, the first treatment for hyperphagia associated with Prader-Willi syndrome in patients aged four and older. The drug, priced at approximately $466,000 per year, represents a potential $1.5 billion market opportunity. Approval follows an unconventional study design after initial Phase 3 failure.
Other Interesting News:
Corcept Therapeutics (SF) reports positive Phase 3 results for relacorilant in ovarian cancer
In the ROSELLA study, relacorilant + nab-paclitaxel reduced disease progression risk by 30% and extended median overall survival to 16 months (vs. 11.5 months in the control group). Corcept will present full results at an upcoming medical conference and plans to file for FDA approval in Q3, with an EU submission to follow.
HHS Announces Major Workforce Cuts
The Department of Health and Human Services (HHS) will cut 10,000 jobs, reducing divisions from 28 to 15 and halving regional offices. FDA, CDC, and NIH will face significant staff reductions, with FDA losing 3,500 employees (~20% of its workforce). The cuts target administrative roles, aiming to streamline bureaucracy.
