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Disc Medicine, a clinical-stage biopharmaceutical company, announced that the FDA granted Orphan Drug Designation to its investigational drug bitopertin for treating erythropoietic protoporphyria (EPP). Bitopertin is a selective inhibitor of glycine transporter 1 (GlyT1) aimed at reducing the toxic metabolite protoporphyrin IX (PPIX) in EPP patients. The drug is currently in two Phase 2 studies: AURORA and BEACON. Orphan Drug Designation provides development incentives and seven years of market exclusivity upon regulatory approval.
Disc Medicine has initiated the AURORA Phase 2 study to evaluate bitopertin as a disease-modifying therapy for adults with Erythropoietic Protoporphyria (EPP). This clinical trial aims to assess the safety, tolerability, and efficacy of bitopertin in approximately 75 patients across the United States. The study, which is randomized, double-blind, and placebo-controlled, will measure changes in protoporphyrin IX levels and other key outcomes over 120 days. Top-line data is expected in 2023. Bitopertin has shown promise in preclinical studies for reducing toxic metabolite accumulation in EPP patients.
Gemini Therapeutics and Disc Medicine have entered into a merger agreement to create a clinical-stage biopharmaceutical company focused on hematology. The combined entity will have approximately $175 million in cash or cash equivalents at closing, with $53.5 million coming from a concurrent financing. This funding will support several clinical studies, including trials for bitopertin and DISC-0974. The merger, subject to shareholder approval, is expected to finalize in Q4 2022, with Gemini shareholders owning about 28% and Disc shareholders 72% of the new entity.
Gemini Therapeutics (Nasdaq: GMTX) reported a net loss of $71.9 million for 2021, up from $40.8 million in 2020. Research and development expenses rose significantly to $48.7 million from $28.2 million, driven by clinical trial activities for GEM103. General and administrative costs surged to $20.3 million from $5.9 million, attributed to increased personnel and professional fees. As of December 31, 2021, cash reserves stood at $136.6 million with approximately 43.2 million shares outstanding. The company is exploring strategic options to enhance shareholder value.
Gemini Therapeutics (NASDAQ: GMTX) announces a significant leadership change, with Georges Gemayel appointed as interim President and CEO, taking over from Jason Meyenburg. The Board initiated a strategic review to enhance shareholder value, although there's no guarantee of resulting transactions. Additionally, the company plans to restructure by reducing its workforce by 80%, equating to 24 employees, to conserve resources during this evaluation phase. Gemini focuses on innovative treatments for age-related macular degeneration, with its lead candidate GEM103 undergoing clinical trials.
Gemini Therapeutics (GMTX) provides updates on the Phase 2a clinical studies for GEM103, aimed at treating age-related macular degeneration (AMD). The ongoing ReGAtta study involving 62 patients indicates GEM103 is well-tolerated and maintains high Complement Factor H (CFH) levels. Additionally, interim results from a wet AMD study show GEM103 combined with aflibercept is safe and tolerable. Both studies will conclude with a final safety visit. The company is evaluating further clinical development steps and anticipates an update by Q1 2022.
Gemini Therapeutics, Inc. (Nasdaq: GMTX) reported its third-quarter 2021 financial results, highlighting the safety of its GEM103 in over 500 injections during the ReGAtta Phase 2a study, with no increased risk of choroidal neovascularization (CNV). The company plans a six-month study update, an FDA meeting in Q4 2021, and late-stage trial initiation for geographic atrophy in Q1 2022. Financially, they reported a net loss of $18.6 million, up from $10 million year-over-year, with cash reserves of $150.1 million.
Gemini Therapeutics (NASDAQ: GMTX) announced a presentation at the 2021 American Academy of Ophthalmology Meeting, highlighting new data from its ongoing ReGAtta Phase 2a study of GEM103, aimed at treating genetically-defined age-related macular degeneration (AMD). The study involved 510 administrations, revealing no serious ocular adverse events and a low rate of mild to moderate ocular events (27.4%). No increased risk of Choroidal Neovascularization was observed. These findings suggest GEM103 is generally well-tolerated, maintaining a positive outlook for its clinical development.
Gemini Therapeutics (Nasdaq: GMTX) has announced that CEO Jason Meyeburg will participate in upcoming investor conferences this November. He is scheduled to speak at the Stifel 2021 Virtual Healthcare Conference on November 15 at 8:40 AM ET and the Jefferies London Healthcare Conference on November 18, available on-demand from 8 AM GMT. The company's lead product, GEM103, targets age-related macular degeneration and is currently in clinical trials. Webcasts of these events will be archived for 30 days on Gemini's website.
Gemini Therapeutics (Nasdaq: GMTX), a clinical stage precision medicine company, announced Chief Medical Officer Samuel Barone, M.D., will present at the 2nd Annual Dry AMD Therapeutic Development Summit on October 20, 2021, at 1:45 PM ET.
The presentation will focus on GEM103 and discuss previously released data from its Phase 2a study targeting age-related macular degeneration (AMD). GEM103 aims to restore retinal health in patients with genetically defined conditions.
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