Avidity Biosciences, Inc. Stock Price, News & Analysis

Avidity Biosciences, Inc. (Nasdaq: RNA) announced that the European Commission has granted orphan designation for AOC 1001, following the FDA's earlier designation. AOC 1001 targets myotonic dystrophy type 1 (DM1), offering potential benefits for patients suffering from this debilitating condition. The company has received FDA clearance to initiate the Phase 1/2 MARINA trial in the U.S. AOC 1001 aims to reduce disease-related mRNA levels and has shown promise in preclinical studies, demonstrating a favorable safety profile.

Avidity Biosciences (RNA) announced a partnership with the Facioscapulohumeral Muscular Dystrophy Clinical Trial Research Network to support the MOVE+ study. This initiative aims to enhance understanding of FSHD through whole-body MRI and biomarkers, focusing on accelerating clinical trial designs. Avidity is sponsoring 100 participants in the US to gather crucial data, as highlighted by CEO Sarah Boyce. This study could lead to significant advancements in patient care and therapeutic development for FSHD.

Avidity Biosciences (Nasdaq: RNA) reported its Q2 2021 results, highlighting significant advancements in its RNA therapeutics pipeline. The FDA approved the Phase 1/2 MARINA trial for AOC 1001, targeting myotonic dystrophy type 1, marking a major milestone for the company. Financially, Avidity has $280 million in cash, a decrease from $328.1 million at the end of 2020. Collaboration revenue increased to $2.6 million in Q2 2021, up from $1.5 million in Q2 2020. R&D expenses rose significantly, totaling $22.7 million in Q2 2021, driven by the advancement of AOC candidates.

Avidity Biosciences (RNA) announced a public offering of 8,000,000 shares at $18.00 each, aiming to raise approximately $144.0 million. The offering is expected to close on August 6, 2021. Proceeds will fund the Phase 1/2 MARINA trial for AOC 1001, advance AOC 1044 and the AOC FSHD program, and general corporate purposes. A 30-day option for underwriters to purchase an additional 1,200,000 shares is included. The offering is conducted under a shelf registration statement with the SEC.

Avidity Biosciences, Inc. (RNA) announced a proposed public offering of $100 million in common stock, with an additional 15% option for underwriters. The offering aims to fund the Phase 1/2 MARINA trial for AOC 1001, advance AOC 1044 and the AOC FSHD program, and support working capital. The offering is subject to market conditions and uncertainties regarding completion and terms. Joint bookrunning managers include Cowen, SVB Leerink, Evercore ISI, and Wells Fargo Securities.

Avidity Biosciences (RNA) has received FDA clearance to commence its Phase 1/2 MARINA trial for AOC 1001, aimed at treating myotonic dystrophy type 1 (DM1). This trial will enroll approximately 44 adults to assess the safety and tolerability of AOC 1001, which utilizes a monoclonal antibody conjugated with siRNA targeting DMPK mRNA, the root cause of DM1. The company has also obtained Orphan Drug Designation for AOC 1001, offering potential market exclusivity and financial incentives. Initial assessments of key biomarkers are expected in the second half of 2022.

Avidity Biosciences (RNA) reported significant updates on its therapeutic pipeline during a virtual investor event on May 19, 2021. The event highlighted the favorable safety profile of AOC 1001, its lead program for Myotonic Dystrophy Type 1, supporting its advancement to clinical trials. Additionally, AOC 1044 was named a clinical development candidate for Duchenne Muscular Dystrophy, entering IND-enabling studies. Avidity's AOCs aim to revolutionize oligonucleotide therapies, potentially leading to impactful treatments for severe diseases.

Avidity Biosciences (Nasdaq: RNA) reported its Q1 2021 financial results, highlighting significant progress in its AOC platform, particularly AOC 1001 for myotonic dystrophy type 1 (DM1). The company has over $300 million cash reserves, enabling continued investment in its pipeline. Collaboration revenue rose to $2.7 million, driven by a partnership with Eli Lilly. R&D expenses surged to $20.7 million due to advancing clinical programs. G&A expenses also increased to $5.9 million, reflecting higher personnel and professional costs.

Avidity Biosciences, Inc. (Nasdaq: RNA) announced a virtual investor and analyst event on May 19, 2021, from 8:00 a.m. to 10:00 a.m. PT. The event will showcase the company's innovative AOC platform and include a panel discussion with experts Drs. Phillip D. Zamore, Steven F. Dowdy, and Avidity's Chief Scientific Officer, Art Levin. Attendees will have the opportunity to engage in a Q&A session. A live video webcast of the event will be available on Avidity's website, along with a replay post-event.