Welcome to our dedicated page for Avidity Biosciences news (Ticker: RNA), a resource for investors and traders seeking the latest updates and insights on Avidity Biosciences stock.
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 (Nasdaq: RNA) has partnered with the FSHD Society to raise awareness of facioscapulohumeral muscular dystrophy (FSHD) on World FSHD Day. In a webinar today at 1:00 p.m. ET, they will present promising initial data from their Phase 1/2 FORTITUDE trial. The trial investigates del-brax, the first therapy targeting the root cause of FSHD, showing over 50% reduction in DUX4 regulated genes and functional improvements for participants. Avidity emphasizes their commitment to advancing treatments for FSHD, a debilitating genetic disorder. The FSHD Society, a leading patient organization, supports this initiative, hopeful for a potential treatment from the FORTITUDE study.
Avidity Biosciences has concluded an upsized public offering of 12,132,500 shares of common stock, priced at $38.00 per share, including 1,582,500 shares sold under the underwriters' option. The gross proceeds from the offering amount to $461 million before deductions. The funds will support the development of Avidity's clinical programs, research and development of its AOC platform, and general corporate purposes. Joint bookrunning managers for the offering included TD Cowen, Leerink Partners, Cantor, Barclays, and Wells Fargo Securities. The offering was made under an automatically effective shelf registration filed with the SEC.
Avidity Biosciences (Nasdaq: RNA), a biopharmaceutical company focused on developing RNA therapeutics known as Antibody Oligonucleotide Conjugates (AOCs™), announced its participation in the TD Cowen Genetic Medicines & RNA Summit on June 20, 2024. The presentation will occur at 8:20 a.m. PT/11:20 a.m. ET. A live webcast and replay of the event will be accessible on Avidity’s investor relations webpage.
Avidity Biosciences (Nasdaq: RNA) announced the pricing of a public offering of 10,550,000 shares of its common stock at $38.00 per share, expected to raise $400.9 million in gross proceeds. The offering is set to close around June 17, 2024, pending customary conditions. Avidity has also provided underwriters a 30-day option to purchase up to an additional 1,582,500 shares. Proceeds will support the development of clinical programs, research on its AOC platform, and general corporate purposes. TD Cowen, Leerink Partners, Cantor, Barclays, and Wells Fargo are the joint bookrunning managers.
Avidity Biosciences announced a proposed public offering to sell $300 million of common stock, with an additional $45 million available via a 30-day underwriters' option. The proceeds will fund clinical program development, AOC platform R&D, working capital, and general corporate purposes. Completion of the offering is subject to market conditions, and the terms are uncertain. Joint bookrunning managers include TD Cowen, Leerink Partners, Cantor, Barclays, and Wells Fargo Securities. The offering is pursuant to an automatically effective shelf registration statement filed with the SEC.
Avidity Biosciences announced positive results from its Phase 1/2 FORTITUDE trial for AOC 1020 (delpacibart braxlosiran), targeting facioscapulohumeral muscular dystrophy (FSHD). The therapy showed over 50% reduction in DUX4 regulated genes and improvements in muscle strength and function after four months at a 2 mg/kg dose. All adverse events were mild or moderate. The company plans to accelerate the registrational cohorts of the trial. Delpacibart braxlosiran directly targets the root cause of FSHD, a rare genetic disorder with no approved treatments. The data will be presented at the FSHD Society International Research Congress. The company also hosted a virtual investor event to discuss these findings.
Avidity Biosciences (Nasdaq: RNA) will present preliminary data from the Phase 1/2 FORTITUDE™ trial of AOC 1020 targeting facioscapulohumeral muscular dystrophy (FSHD) at the 31st Annual FSHD Society International Research Congress in Denver, CO. Dr. Jeffrey M. Statland, a trial investigator, will join Avidity's management for the presentations. The data will be discussed in an oral presentation on June 14, 2024, and a poster presentation on June 13, 2024, focusing on increasing diversity in clinical trial participation. A live webcast event to discuss the trial's preliminary data will be held on June 12, 2024, at 8:00 a.m. ET, with a replay available afterward on the company's website.
Avidity Biosciences, a biopharmaceutical company specializing in RNA therapeutics, announced inducement grants under Nasdaq Listing Rule 5635(c)(4) on May 20, 2024.
The Human Capital Management Committee granted stock option awards for 150,500 shares and 33,250 restricted stock units (RSUs) to seven new non-executive employees.
The stock options, priced at $29.24 per share, will vest over four years with 25% vesting after one year and the remainder vesting monthly.
RSUs will vest in four equal annual installments, contingent on continued employment.
These awards are part of the 2022 Employment Inducement Incentive Award Plan, targeting new employees as a material inducement for employment, in accordance with Nasdaq Listing Rule 5635(c)(4).
Avidity Biosciences (Nasdaq: RNA) announced the appointment of Simona Skerjanec to its board of directors. Ms. Skerjanec brings nearly three decades of pharmaceutical experience, specializing in developing and launching therapies, and corporate strategy. Her roles at Roche, The Medicines Company, Eli Lilly, Pfizer, and Johnson & Johnson highlight her expertise in neurology, cardiology, and rare diseases. Avidity CEO Sarah Boyce emphasized the importance of Ms. Skerjanec’s experience in advancing Avidity's RNA therapeutic programs, including neuromuscular and precision cardiology. Ms. Skerjanec expressed her excitement to contribute to Avidity's mission of revolutionizing RNA therapeutics.
Avidity Biosciences reported their first-quarter 2024 financial results and recent highlights, including the initiation of a global Phase 3 trial for del-desiran in DM1, positive long-term del-desiran data showing disease progression reversal in DM1 patients, and a cash position of $915 million. The company also received Breakthrough Therapy designation from the FDA for del-desiran and announced positive data from their FSHD and DMD44 trials. They raised $400 million through an equity raise and plan to share more data from ongoing trials later in the year.