Annexon, Inc.（ANNX）资讯与事件ANNXAnnexon, Inc.

Annexon Adds Month 24 Dual Primary Endpoint in ARCHER II Trial

Annexon announced the addition of a Month 24 dual primary endpoint to complement the current Month 15 primary endpoint in its Phase 3 ARCHER II trial, and launch of an open-label extension study of vonaprument for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy. With a dual primary endpoint strategy, ARCHER II can achieve success in protecting against vision loss at either Month 15 or 24, which are independent efficacy timepoints.

Annexon Cash and Short-term Investments Reach $209.2 Million

Cash, cash equivalents and short-term investments were $209.2M as of June 30, 2026. Annexon's current cash, cash equivalents and short-term investments and funds from the credit facility are expected to fund operations and anticipated milestones into 2028. "2026 is a defining year for our company, with meaningful progress across both our Guillain-Barre syndrome and geographic atrophy programs that position us to potentially deliver two transformative therapies for millions of patients in need. The quality and consistency of the data generated to date reinforce our confidence in the differentiated potential of our C1q-targeted approaches to address neuroinflammatory diseases at their source, and we are encouraged by the growing enthusiasm from patients and physicians," said Douglas Love, president and chief executive officer of Annexon. "With our leadership capabilities and financial position strengthened, we are entering an exciting period of execution, with multiple important clinical and regulatory milestones expected over the next 6 to 12 months and a significant opportunity to create value for patients and stakeholders."

Annexon Reports Tanruprubart Efficacy in Guillain-Barre Syndrome Patients

Annexon announced early improvement in strength and clinically meaningful reduction in disability shown with tanruprubart in the first ten U.S. and European patients with Guillain-Barre syndrome from its ongoing, open-label FORWARD study. Notably, initial cohort FORWARD data showed clinically meaningful and rapid improvement in strength and reduced disability within days of a single infusion of 30 mg/kg tanruprubart. Outcomes include: All patients treated in the study showed rapid, clinically meaningful improvement in muscle strength within four days. Four patients who were bedbound early in the course of their disease walked with or without assistance between day two and eight. The one patient who required ventilation early in the course of disease came off the ventilator within four days. Five other patients all showed marked gains in function within 48 hours. Tanruprubart was generally well-tolerated, with most common adverse events related to GBS or complications with the disease consistent with Phase 3 results. Initial cohort included both male and female patients, ranging in age from 12 to 78 years old, and covered the spectrum of disease from moderate to severe. Outcomes of the FORWARD trial are consistent with outcomes demonstrated in the GBS Phase 3 study where approximately 90% of patients demonstrated rapid, clinically meaningful improvement by day 8 of treatment. Data from FORWARD will be presented at upcoming medical conferences and are expected to support consistent clinical benefit of tanruprubart across global patient populations to supplement Annexon's planned Biologics License Application (BLA) submission targeted for Q4 2026. The Marketing Authorisation Application for tanruprubart is currently under review by the European Medicines Agency.