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Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) announced that two abstracts from its clinical programs will be presented at the American Association for the Study of Liver Diseases The Liver Meeting® from Nov. 12-15, 2021. The first abstract discusses the Phase 1 trial of belcesiran, targeting alpha-1 antitrypsin deficiency-associated liver disease, showing it was well-tolerated and reduced serum AAT levels in healthy volunteers. The second abstract covers RG6346, aimed at chronic hepatitis B virus infection, providing pharmacokinetic and safety analysis results.
Dicerna Pharmaceuticals announced inducement grants of stock options for 61,350 shares and 13,650 RSUs to a new employee, dated Oct. 1, 2021. The options have an exercise price of $20.26 and vest over four years. RSUs will vest similarly, with the first 25% on Sept. 15, 2022. The grants comply with Nasdaq listing Rule 5635(c)(4). Dicerna focuses on RNA interference therapeutics aimed at silencing disease-causing genes in various conditions. The company maintains partnerships with leading pharmaceutical firms and has a robust pipeline of over 20 programs.
Dicerna Pharmaceuticals has initiated a Phase 1 clinical trial for DCR-AUD, an investigational treatment for alcohol use disorder (AUD). The trial doses the first subjects to evaluate the safety and tolerability of DCR-AUD, which utilizes GalXC™ RNAi technology. It will assess the interaction between DCR-AUD and alcohol consumption through Ethanol Interaction Assessments. Approximately 14 million Americans suffer from AUD, yet only about 1.4 million receive treatment. Interim data from the trial is expected to be shared next year.
Dicerna Pharmaceuticals (Nasdaq: DRNA) announces key executive appointments aimed at driving growth and enhancing operational execution. Rob Ciappenelli has been appointed Chief Strategy Officer, responsible for product pipeline expansion and alliance management. Marc Abrams, Ph.D., is promoted to Senior Vice President of Discovery Research, focusing on productivity and new pipeline candidates. Kristen Sheppard, Esq., joins as Senior Vice President of Investor Relations and Corporate Communications, bringing over 20 years of experience.
Dicerna Pharmaceuticals (Nasdaq: DRNA) announced that Douglas M. Fambrough, Ph.D., will participate in a virtual fireside chat at the 16th Annual Citi Biopharma Conference on Sept. 9, 2021, at 7:55 a.m. ET. This event will be accessible via an audio webcast from the "Events and Presentations" page on Dicerna's website. Dicerna is focused on developing RNAi therapeutics aimed at selectively silencing disease-causing genes, with over 20 active programs in collaboration with major pharmaceutical companies tackling various diseases.
Dicerna Pharmaceuticals (Nasdaq: DRNA) reported its Q2 2021 financial results, highlighting significant progress in its pipelines. The pivotal PHYOX2 trial for nedosiran achieved primary endpoints, showing a substantial reduction in urinary oxalate excretion in patients with PH1, with an NDA submission planned for Q4 2021. The company plans to pursue commercial out-licensing instead of building a commercial infrastructure. As of June 30, 2021, Dicerna had $709.6 million in cash, reporting revenues of $41.3 million, and a net loss of $40.8 million.
Dicerna Pharmaceuticals (Nasdaq: DRNA) announced positive results from the PHYOX™2 pivotal trial for nedosiran, a monthly treatment for primary hyperoxaluria (PH). The trial met its primary endpoint with a statistically significant reduction in urinary oxalate excretion (p<0.0001). Key secondary endpoints also showed that 50% of participants achieved normal or near-normal urinary oxalate levels at consecutive visits (p=0.0025). Nedosiran was well-tolerated. Dicerna plans to submit a New Drug Application to the FDA in Q4 2021, based on these findings.
Dicerna Pharmaceuticals (Nasdaq: DRNA) will announce its Q2 2021 financial results on August 9, 2021, before the market opens. Following the release, management will hold a conference call at 8:00 a.m. ET to discuss the results and provide a business update. The call will be webcast live and accessible on Dicerna's website, where a replay will also be available. Dicerna focuses on developing RNAi therapeutics targeting various diseases, leveraging its proprietary technologies.
Dicerna Pharmaceuticals (Nasdaq: DRNA) announced FDA clearance for its Investigational New Drug (IND) application for DCR-AUD, a treatment targeting alcohol use disorder (AUD). This investigational RNAi candidate aims to silence the ALDH2 gene in the liver, potentially helping over 14 million affected individuals in the U.S. DCR-AUD is set for a Phase 1 trial later in 2021 to assess its safety and pharmacodynamics. Financial support from the NIH has aided its development, showcasing Dicerna's commitment to advancing RNAi-based therapeutics.
Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) announced interim results from its Phase 1 trial of belcesiran, an investigational RNAi therapeutic for alpha-1 antitrypsin deficiency-associated liver disease (AATLD). Interim data show dose-dependent reductions in serum alpha-1 antitrypsin levels, with reductions of up to 91% in the highest dose cohort (6.0 mg/kg). The treatment demonstrated an acceptable safety profile with no serious adverse events reported. The final dose cohort (12.0 mg/kg) remains ongoing, with further results expected at an upcoming medical congress.