Avidity Biosciences, Inc. Stock Price, News & Analysis

Avidity Biosciences, Inc. (Nasdaq: RNA) has made significant leadership changes as part of its strategy to enhance its RNA therapeutic development. Dr. Arthur A. Levin transitions from Chief Scientific Officer to a member of the board of directors while continuing his role as a distinguished scientist. Dr. W. Michael Flanagan has been promoted to Chief Scientific and Technical Officer, emphasizing his crucial technical expertise. This leadership adjustment aims to strengthen Avidity's mission of advancing Antibody Oligonucleotide Conjugates (AOCs) and expanding its clinical programs, including ongoing trials for myotonic dystrophy type 1, facioscapulohumeral muscular dystrophy, and Duchenne muscular dystrophy.

Avidity Biosciences, Inc. (NASDAQ: RNA) announced on February 20, 2023, that its Compensation Committee granted stock options and restricted stock units (RSUs) to three new non-executive employees. The total awards comprise 27,400 stock options and 13,700 RSUs as part of the 2022 Employment Inducement Incentive Award Plan, aimed at attracting new talent. The options have an exercise price of $25.65 per share, equating to Avidity's closing stock price on February 17, 2023. The stock options will vest over four years, while the RSUs will vest in four equal installments on the anniversaries of the grant date, dependent on ongoing employment.

Avidity Biosciences (Nasdaq: RNA) has announced that the FDA granted Orphan Drug designation to AOC 1020 for treating facioscapulohumeral muscular dystrophy (FSHD), a severe genetic disorder causing progressive muscle weakness. This designation aims to facilitate the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S. AOC 1020 is currently in the Phase 1/2 FORTITUDE clinical trial, with preliminary data expected in mid-2024. The drug targets the DUX4 gene, the root cause of FSHD, and offers market exclusivity, fee exemption, and tax credits for clinical trials upon regulatory approval.

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.