FibroGen, Inc.

FibroGen has reached agreement with the FDA on key design elements for a pivotal Phase 3 trial of roxadustat in lower-risk myelodysplastic syndrome patients with high transfusion burden.

FG-3246, a first-in-class antibody-drug conjugate targeting CD46, demonstrated an 80% disease control rate and 20% objective response rate in heavily pre-treated metastatic castration-resistant prostate cancer patients.

FibroGen has agreed to sell its China subsidiary to AstraZeneca for approximately $160 million, comprising $85 million in enterprise value plus an estimated $75 million in net cash holdings.

• Over 75 drugs are in development for Duchenne Muscular Dystrophy (DMD), targeting various mechanisms and routes of administration. • REGENXBIO initiated a Phase I/II trial of RGX-202 in young boys with DMD to assess safety and efficacy. • Emerging therapies focus on gene modulation, dystrophin replacement, and anti-inflammatory approaches to combat DMD. • Key companies like Sarepta Therapeutics, Italfarmaco, and FibroGen are advancing DMD therapeutics through clinical trials.

• FibroGen's lead drug pamrevlumab fails to demonstrate survival benefits in two pivotal pancreatic cancer trials, leading to complete termination of the program. • The company announces plans to reduce its workforce by 75% following the drug's failure, marking a significant setback after previous unsuccessful trials in Duchenne muscular dystrophy. • Despite setbacks, FibroGen maintains a $215 million cash reserve and continues development of other pipeline candidates, including promising ADC therapy FG-3246 for prostate cancer.

FibroGen anticipates top-line data from Phase 3 trials of pamrevlumab in metastatic and locally-advanced pancreatic cancer, addressing a significant unmet need.

Sarepta Therapeutics' Elevidys (delandistrogene moxeparvovec) gains accelerated FDA approval for treating ambulatory pediatric Duchenne muscular dystrophy (DMD) patients aged 4-5.