Atrium Therapeutics develops RNA therapeutics designed for targeted delivery to heart tissue. The biopharmaceutical company focuses on precision cardiology programs for rare genetic cardiomyopathies, including candidates ATR 1072 for PRKAG2 syndrome and ATR 1086 for PLN cardiomyopathy, and uses ligand-based targeting approaches with oligonucleotide-based therapies.
Recurring Atrium news covers RNA delivery-platform development, cardiology research collaborations, clinical and regulatory preparation, capital-structure updates and governance matters such as equity inducement grants. Company updates also include milestone activity under its global cardiovascular collaboration with Bristol Myers Squibb and public-company developments following Atrium's launch as an independent Nasdaq-listed issuer.
Avidity Biosciences (Nasdaq: RNA) announced the dosing of the first participants in the Phase 1/2 MARINA trial for its lead product candidate, AOC 1001, marking a significant milestone in RNA therapeutics. The trial targets myotonic dystrophy type 1 (DM1) and is designed to evaluate the safety and tolerability of AOC 1001, which aims to reduce levels of disease-related mRNA DMPK. AOC 1001 has received Orphan Designation from the FDA and EMA, with Fast Track Designation also granted by the FDA for expedited development.
Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical firm specializing in RNA therapeutics, will participate in two upcoming conferences. The Credit Suisse 30th Annual Healthcare Conference is scheduled for November 10, 2021, at 2:40 PM ET. Following that, the 4th Annual Evercore ISI HealthCONx Conference will take place on November 30, 2021, at 10:05 AM ET. Live webcasts and archived replays of both events will be available on the company’s website.
Avidity Biosciences, Inc. (Nasdaq: RNA) announced that the FDA granted Fast Track Designation to its lead program, AOC 1001, for treating myotonic dystrophy type 1 (DM1). This designation facilitates more frequent interactions with the FDA, expediting the development process for serious conditions. AOC 1001 aims to reduce DMPK mRNA levels, addressing the disease's root cause. The Phase 1/2 MARINA trial will evaluate the safety and tolerability of AOC 1001, enrolling around 44 adults. Currently, DM1 lacks therapeutic options, highlighting the significance of AOC 1001's advancement.
Avidity Biosciences, Inc. (NASDAQ: RNA) has announced its participation in two upcoming investor conferences. The Wells Fargo Virtual Healthcare Conference will take place on September 9, 2021, featuring a fireside chat at 11:20am ET. The Chardan Virtual 5th Annual Genetic Medicines Conference is scheduled for October 5, 2021, with a panel discussion at 12noon ET and a fireside chat at 1:30pm ET. Interested parties can access live webcasts and replays on Avidity's website.
Avidity aims to revolutionize RNA therapeutics through its Antibody Oligonucleotide Conjugates (AOCs™), with promising therapies in development for diseases like myotonic dystrophy and Duchenne Muscular Dystrophy.
Avidity Biosciences (Nasdaq: RNA) announced the appointment of Eric Mosbrooker to its board of directors, enhancing its commercial perspective as the company's pipeline matures. Mosbrooker brings extensive experience in global commercial operations, particularly in gene therapy and rare diseases. The press release also noted the departure of Roderick Wong from the board, who played a crucial role during the company’s IPO and early financing stages. Avidity's mission focuses on innovative RNA therapeutics, with lead candidate AOC 1001 moving towards clinical trials.
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.