Welcome to our dedicated page for MGEN news (Ticker: MGEN), a resource for investors and traders seeking the latest updates and insights on MGEN stock.
Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect MGEN's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.
Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of MGEN's position in the market.
Viridian Therapeutics, formerly miRagen Therapeutics, has appointed Jonathan Violin, Ph.D., as President and CEO, succeeding Lee Rauch, who remains a strategic advisor. Barrett Katz, M.D., has joined as Chief Medical Officer. The company is developing VRDN-001 and VRDN-002 for thyroid eye disease, targeting a significant unmet medical need. Recent licensing from Xencor allows for the development of therapeutic antibodies. Viridian aims to file Investigational New Drug applications for both products in 2021.
miRagen Therapeutics (NASDAQ: MGEN) has secured exclusive rights to develop and market antibody therapeutics targeting insulin-like growth factor-1 receptor (IGF-1R) using Xencor’s Xtend™ technology. This innovation aims to enhance antibody half-life, potentially reducing dosage frequency for patients with Thyroid Eye Disease (TED). miRagen is set to file an Investigational New Drug (IND) application for its product candidate VRDN-002 by the end of 2021. The agreement includes upfront shares for Xencor and provisions for future milestone payments and royalties.
miRagen Therapeutics has completed the acquisition of Viridian Therapeutics, gaining VRDN-001, an anti-IGF-1R monoclonal antibody aimed at treating thyroid eye disease (TED). The private placement raised approximately $91 million, giving miRagen about $144 million cash on hand and a runway through 2023. The company plans to initiate a Phase 2 trial of VRDN-001 in 2021. Additionally, a 1-for-15 reverse stock split will be effective November 12, 2020. The third quarter of 2020 saw a reduced net loss of $5.5 million.
miRagen Therapeutics has successfully acquired Viridian Therapeutics, a company focused on treatments for underserved diseases, for a stock-for-stock transaction. The deal includes the clinical-stage anti-IGF-1R monoclonal antibody VRDN-001, aimed at treating thyroid eye disease, and plans to utilize approximately $91 million from a private placement to advance multiple compounds in clinical studies. The acquisition was approved by both companies' Boards and will expand miRagen's orphan disease pipeline, with pro forma cash expectations of $140 million following the closure.
miRagen Therapeutics has announced the discontinuation of further internal development of cobomarsen following a review of preliminary topline data from the Phase 2 SOLAR clinical trial in patients with Cutaneous T-Cell Lymphoma (CTCL). The data from 37 patients indicate that cobomarsen did not meet the primary endpoint of demonstrating significant efficacy compared to the vorinostat control group. However, it was well-tolerated with no related discontinuations. miRagen will focus on advancing its lead program, MRG-229, for Idiopathic Pulmonary Fibrosis (IPF), while exploring strategic partnerships.
miRagen Therapeutics has appointed Lee Rauch as President and CEO, succeeding William Marshall, who has resigned. The Board believes Rauch's experience will benefit the company's future. miRagen plans to conduct a thorough review of its R&D pipeline, focusing on MRG-229 for Idiopathic Pulmonary Fibrosis (IPF). Upcoming data from non-human primate studies show no adverse effects for MRG-229. The company is also concluding the Phase 2 SOLAR trial for cobomarsen in Cutaneous T-Cell Lymphoma and will report topline data by the end of 2020.
miRagen Therapeutics (NASDAQ: MGEN) announced a Type C meeting with the FDA on August 11, 2020, regarding cobomarsen for Adult T-Cell Leukemia/Lymphoma (ATLL). The FDA provided guidance on a possible path to registration through a small randomized trial focusing on progression-free survival. Data from the Phase 2 SOLAR trial in Cutaneous T-Cell Lymphoma (CTCL) is expected soon, which may lead to partnerships for late-stage development. Cobomarsen has received orphan drug designation, offering advantages in its clinical path.
miRagen Therapeutics (NASDAQ: MGEN) announced positive developments in its clinical programs and financial results for Q2 2020. The company reported $30.6 million in cash as of June 30, 2020, enough to fund operations into Q3 2021. Revenue plummeted to $0.2 million from $2.5 million YoY, attributed to reduced R&D activities. MRG-229, targeting pulmonary fibrosis, showed promising anti-fibrotic effects in preclinical studies, leading to new NIH grant funding. Cobomarsen is set for FDA guidance on its development for ATLL by year-end, with ongoing trials for CTCL patients.
miRagen Therapeutics (NASDAQ: MGEN) announced that its CEO, William S. Marshall, Ph.D., will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on August 12, 2020, at 1:10 p.m. ET. A live webcast will be available on the company's investors page, with a replay also accessible post-event.
miRagen focuses on RNA-targeted therapies, with candidates in clinical stages including cobomarsen, remlarsen, and MRG-110, aimed at treating various cancers and fibrotic conditions.
miRagen Therapeutics (NASDAQ: MGEN) announced that the FDA granted orphan drug designation to its treatment cobomarsen for T-cell lymphoma. cobomarsen, a miR-155 inhibitor, is in a Phase 2 trial for cutaneous T-cell lymphoma (CTCL) and a Phase 1 trial for adult T-cell leukemia/lymphoma (ATLL). This designation highlights the need for new therapies for these rare conditions, potentially providing incentives such as seven years of market exclusivity post-approval and FDA assistance in clinical design.
