Avidity Biosciences Reports Q2 2025 Financial Results and Key Milestones, with Strong Cash Position and Upcoming FDA Submissions

Avidity Biosciences reported Q2 2025 financial results with $1.2 billion in cash and a potential FDA submission for del-zota in DMD44 by year-end 2025. The company plans three BLA submissions within a year and anticipates its first commercial launch in 2026. Avidity secured Breakthrough Therapy designation for del-zota and achieved positive Phase 1/2 trial results for del-brax in FSHD. Collaboration revenues grew 90% YoY to $3.8 million, while research and development expenses doubled to $138.1 million.

Avidity Biosciences (NASDAQ: RNA) reported its second-quarter 2025 financial results, highlighting significant progress in its drug development programs and a robust cash position. The company reported $1.2 billion in cash and cash equivalents as of June 30, 2025, with an additional $185.5 million raised through an at-the-market stock offering post-quarter-end. This substantial cash reserve extends the company's runway to mid-2027, providing ample funding for pivotal trials and potential commercial launches.

Revenue (GAAP) for the quarter jumped 88.2% to $3.8 million, far exceeding the $1.49 million average analyst estimate, driven primarily by collaboration activities [1]. Despite the revenue surge, the company reported a net loss (GAAP) of $157.3 million, reflecting a 122.2% increase from the same period in 2024. This loss is attributed to sharply higher research and pre-commercialization expenses, which doubled to $138.1 million [1].

Key highlights of the quarter include Avidity's progress toward regulatory submissions. The company is preparing for three potential Biologics License Application (BLA) submissions within a 12-month period, with the first submission for del-zota (DMD44) planned by year-end 2025. Del-zota received Breakthrough Therapy designation from the FDA, which may expedite its review and development [1]. Del-desiran (DM1) completed enrollment in its Phase 3 HARBOR trial, setting it up for a major clinical readout in 2026. Del-brax (FSHD) achieved multiple milestones, including positive Phase 1/2 data and FDA alignment on approval pathways [2].

Collaboration revenues grew 90% year-over-year (YoY) to $3.8 million, reflecting the company's strategic partnerships with larger firms. Research and development expenses doubled to $138.1 million, underscoring Avidity's investment in advancing its core clinical programs and expanding its commercial infrastructure [1].

Avidity's strong cash position and ongoing clinical progress position it as a frontrunner in RNA therapeutics. The company's Antibody Oligonucleotide Conjugate (AOC) platform has shown consistent efficacy and safety across multiple neuromuscular disease programs. The company's three lead candidates are advancing rapidly toward regulatory submissions, with the first commercial product potentially reaching the market in the U.S. in 2026 if ongoing trials and regulatory processes stay on track [2].

References:
[1] https://www.nasdaq.com/articles/avidity-rna-q2-revenue-jumps-88
[2] https://www.stocktitan.net/news/RNA/avidity-biosciences-reports-second-quarter-2025-financial-results-gf3f9hk9ngd8.html