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Avidity Biosciences, Inc. (Nasdaq: RNA) generates news flow centered on its development of Antibody Oligonucleotide Conjugates (AOCs™), a class of RNA therapeutics designed to combine monoclonal antibody specificity with oligonucleotide precision. Company announcements frequently highlight progress across its late-stage neuromuscular pipeline, including programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).
News items for RNA often cover clinical trial milestones, such as topline and long-term data from the EXPLORE44® and EXPLORE44-OLE™ studies of delpacibart zotadirsen (del-zota) in DMD44, enrollment and data plans for the HARBOR™ Phase 3 trial of del-desiran in DM1, and development updates for del-brax and the FORTITUDE™ and FORTITUDE-3™ programs in FSHD. Regulatory developments are another key theme, including the FDA’s Breakthrough Therapy designation for del-zota and disclosures about planned Biologics License Application (BLA) submissions.
Investors following Avidity’s news can also expect coverage of financing activities, such as public offerings of common stock, collaboration milestones with partners like Eli Lilly and Company and Bristol Myers Squibb, and updates on the company’s cash position as reported in periodic financial results. Corporate and strategic news includes participation in scientific and investor conferences, as well as detailed announcements about the definitive merger agreement with Novartis AG and the planned separation of early-stage precision cardiology programs into a new company referred to as SpinCo.
In addition, Avidity regularly reports on its engagement with patient and advocacy communities, particularly during National Muscular Dystrophy Awareness Month and events focused on Duchenne muscular dystrophy, myotonic dystrophy, FSHD and rare diseases. For readers tracking RNA, this news page provides a centralized view of clinical, regulatory, financial and transaction-related developments that shape the company’s trajectory.
Avidity Biosciences, Inc. (Nasdaq: RNA) announced its participation in the SVB Securities Global Biopharma Conference scheduled for February 14 at 1:20 p.m. PT / 4:20 p.m. ET. The event can be accessed via a live webcast on the company's Investors page. Avidity is focused on developing a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), aimed at treating diseases like myotonic dystrophy and facioscapulohumeral muscular dystrophy. Currently, several AOCs are undergoing clinical trials, furthering their innovative approaches in RNA therapy.
Avidity Biosciences (RNA) announced on January 20, 2023, that its Compensation Committee granted stock options and restricted stock units (RSUs) to three new non-executive employees. The awards include 12,350 stock options priced at $22.47 per share, equivalent to the stock's closing price on the grant date, and 6,175 RSUs. These awards are part of Avidity's 2022 Employment Inducement Incentive Award Plan, designed to attract new talent under Nasdaq Listing Rule 5635(c)(4). The stock options will vest over four years, while the RSUs will vest in four equal installments annually.
Avidity Biosciences (Nasdaq: RNA) announced that the FDA has granted Fast Track designation to AOC 1020 for treating facioscapulohumeral muscular dystrophy (FSHD), a rare genetic condition leading to progressive muscle weakness. Currently, there are no FDA-approved treatments for FSHD. AOC 1020 is being tested in a Phase 1/2 clinical trial called FORTITUDE, involving about 70 participants. The trial aims to evaluate the safety, tolerability, and efficacy of the therapy. Preliminary assessment data is expected by mid-2024. This designation allows Avidity to expedite development and review processes related to this serious condition.
Avidity Biosciences, Inc. (Nasdaq: RNA) announced the pricing of an underwritten public offering of 12,000,000 shares at $17.25 per share, aiming for gross proceeds of approximately $207 million. The offering, closing around December 20, 2022, is intended to fund research and development of its RNA therapeutics, specifically Antibody Oligonucleotide Conjugates (AOCs™). The company also granted underwriters a 30-day option for an additional 1,800,000 shares. This offering is registered with the SEC under an effective shelf registration statement.
Avidity Biosciences (Nasdaq: RNA) announced a proposed public offering of $150 million in common stock, with a potential additional 15% from underwriters. The proceeds aim to support research and development, enhance its AOC platform, and cover general corporate expenses. This offering will be made under a shelf registration statement filed with the SEC, with no assurance on completion timing or final terms. The underwriters include Cowen, Evercore ISI, and Wells Fargo Securities.
Avidity Biosciences (RNA) announced promising Phase 1/2 MARINA trial results for AOC 1001, the first successful targeted delivery of siRNA to muscle in humans. Key findings include a 45% mean reduction in DMPK across all participants, with splicing improvement of 31% in muscle-specific genes. Early clinical activity was noted, with improvements in myotonia observed in some adults with DM1. The company is actively working to lift a partial clinical hold on new participant enrollment. AOC 1001 aims to address the root cause of myotonic dystrophy type 1 (DM1), a life-threatening condition without approved therapies.
Avidity Biosciences (RNA) reported Q3 2022 results, highlighting advances in three rare disease programs: DM1, FSHD, and DMD. The MARINA trial for AOC 1001 is set for a preliminary assessment this quarter, despite a partial clinical hold due to a serious adverse event. The company has a cash runway of approximately $425 million through 2024, supporting its AOC platform expansion. Q3 collaboration revenue rose to $2.5 million, while R&D expenses increased to $37.3 million, reflecting ongoing clinical developments.
Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company specializing in RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), announced upcoming conference participation. The company will present at the 31st Annual Credit Suisse Healthcare Conference on November 8 at 11:00 a.m. PT and the 5th Annual Evercore ISI HealthCONx Conference on November 29 at 7:30 a.m. PT. Live webcasts and event details will be available on their website. Avidity is advancing three programs in clinical development targeting various muscular dystrophies.
Avidity Biosciences has initiated the Phase 1/2 EXPLORE44 clinical trial for AOC 1044, targeting Duchenne muscular dystrophy (DMD) mutations amenable to exon 44 skipping. AOC 1044 is the first antibody oligonucleotide conjugate engineered to deliver phosphorodiamidate morpholino oligomers to treat DMD. This marks a significant step forward as there are currently no approved therapies for DMD44. The trial aims to assess the safety and efficacy of AOC 1044 in healthy volunteers and DMD patients, with enrollment expected for 64 participants.
Avidity Biosciences, Inc. (Nasdaq: RNA) announced it will present five poster presentations at the 27th International Hybrid Annual Congress of the World Muscle Society from October 11-15, 2022, in Halifax, Nova Scotia. Key presentations include the MARINA™ study for myotonic dystrophy type 1 and data on facioscapulohumeral muscular dystrophy (FSHD) and Duchenne muscular dystrophy (DMD). Notable presentations are scheduled for October 14, including a Phase 1/2 trial of AOC 1001 in adults with myotonic dystrophy type 1.