Avidity Biosciences, Inc. Stock Price, News & Analysis

Avidity Biosciences (Nasdaq: RNA) announced a U.S. Managed Access Program (MAP) to provide investigational delpacibart zotadirsen (del-zota) to eligible people with Duchenne muscular dystrophy mutations amenable to exon 44 skipping (DMD44) under an FDA-authorized treatment protocol.

Enrollment is anticipated to begin by year-end 2025, and participants in EXPLORE44-OLE may transition to the MAP after completing two years of treatment. Avidity aligned with FDA after an October 2025 pre-BLA meeting and plans a BLA submission in 2026 seeking accelerated approval; patients would move to commercial supply if approved. Full MAP eligibility details will be posted on clinicaltrials.gov.

Avidity Biosciences (Nasdaq: RNA) announced a definitive merger agreement with Novartis valuing the company at about $12 billion, with closing expected in H1 2026 following the separation of early-stage cardiology programs into a new public SpinCo.

The company reported clear FDA alignment after an October 2025 pre-BLA meeting for del-zota, plans a 2026 BLA submission, and highlighted one-year data showing sustained muscle protection and reversal of disease progression. Del-zota holds Breakthrough Therapy designation.

Financials: cash and marketable securities of approximately $1.9 billion (9/30/25), expected to fund operations to mid-2028; Q3 collaboration revenue included a $10.0M milestone; Q3 R&D and G&A expenses rose materially versus 2024.

Avidity Biosciences (NASDAQ:RNA) has entered into a definitive merger agreement to be acquired by Novartis for USD 72.00 per share in cash, valuing Avidity at approximately USD 12.0 billion on a fully diluted basis. The deal prices Avidity at ~46% above the October 24, 2025 close and ~62% above the 30-day VWAP.

Prior to closing, Avidity will spin out its early-stage precision cardiology programs into a new public company ("SpinCo") capitalized with USD 270 million; SpinCo leadership and board roles are specified. The transaction includes three late-stage neuroscience programs being acquired by Novartis. Closing is expected in 1H 2026, subject to the SpinCo separation, regulatory approvals and stockholder approval.

Avidity Biosciences (Nasdaq: RNA) said management will participate in a panel at the Chardan 9th Annual Genetic Medicines Conference in New York on Oct 21, 2025 at 11:00 a.m. PT / 2:00 p.m. ET. A live webcast, event details, and an archived replay will be available on the company's Investors > Events and Presentations webpage.

This is a scheduled investor-conference panel appearance; no financial or clinical data, guidance, or transactions were announced.

Avidity Biosciences (Nasdaq: RNA) announced a positive pre-BLA meeting with the U.S. FDA for delpacibart zotadirsen (del-zota) in Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44). The company updated its planned BLA submission timing to Q1 2026 (previously year-end 2025) to provide additional CMC data requested by FDA. Del-zota holds Breakthrough Therapy designation; Avidity plans this as the first of three BLA submissions over a 12-month period and is preparing a confirmatory study for full approval.

Avidity Biosciences (NASDAQ: RNA) will present late-breaking oral and poster data from the EXPLORE44 clinical development program for delpacibart zotadirsen (del-zota) at the 30th Annual World Muscle Society Congress in Vienna, October 7-11, 2025.

The company said the presentations build on September 2025 results that showed reversal of disease progression and improvements versus baseline and natural history in multiple functional measures after one year of continuous treatment in Phase 1/2 EXPLORE44 and Phase 2 EXPLORE44-OLE in Duchenne muscular dystrophy patients amenable to exon 44 skipping (DMD44). Del-zota is investigational and not approved by the FDA.

Oral presentation: Kevin M. Flanigan, M.D., on October 11, 2025, 12:33–12:45 p.m. CET. Poster 674P: Aravindhan Veerapandiyan, M.D., on October 8, 2025, 2:30–3:30 p.m. CET. Slides and poster will be posted on the company publications page.

Avidity Biosciences (NASDAQ: RNA) has successfully closed its upsized public offering of 17,250,000 shares of common stock at $40.00 per share, including the full exercise of the underwriters' option for additional shares. The offering generated gross proceeds of $690.0 million.

The company plans to use the proceeds to advance its three late-stage clinical programs, build commercial inventory for multiple potential launches, expand commercial infrastructure, and progress research and development of its AOC™ (Antibody Oligonucleotide Conjugates) platform. The offering was managed by Leerink Partners, J.P. Morgan, TD Cowen, Cantor, and Wells Fargo Securities as joint bookrunners.

Avidity Biosciences (NASDAQ: RNA) has announced the pricing of its upsized public offering of 15,000,000 shares of common stock at $40.00 per share. The offering is expected to generate gross proceeds of $600.0 million before deducting underwriting discounts and commissions.

The company has granted underwriters a 30-day option to purchase up to an additional 2,250,000 shares. The proceeds will be used to advance three late-stage clinical programs, build commercial inventory, expand infrastructure, progress AOC platform research, and for working capital. The offering is expected to close around September 15, 2025.

Avidity Biosciences (NASDAQ: RNA) has announced plans for a $500 million public offering of common stock, with an additional 30-day option for underwriters to purchase up to $75 million of shares. The company, which specializes in Antibody Oligonucleotide Conjugates (AOCs™), will use the proceeds to advance three late-stage clinical programs, build commercial inventory, expand infrastructure, and support platform development.

The offering will be managed by joint bookrunners including Leerink Partners, J.P. Morgan, TD Cowen, Cantor, and Wells Fargo Securities. The securities will be offered through a shelf registration statement that is already effective with the SEC.