Stoke Therapeutics, Inc. - STOK STOCK NEWS

Stoke Therapeutics announced positive interim results for STK-001, an investigational medicine for treating Dravet syndrome. The Phase 1/2a MONARCH study indicated that single doses up to 30mg were well-tolerated, showing no safety concerns. A trend toward reduced convulsive seizures was noted, especially in younger patients. Over 95% of subjects could achieve pharmacologically active levels with three doses of 30mg. The FDA has allowed the evaluation of a higher 45mg dose in the study. Ongoing studies aim to establish effective dosing and long-term treatment strategies.

Stoke Therapeutics, Inc. (Nasdaq: STOK) announced its Q2 2021 financial results, reporting a net loss of $22.0 million or $0.60 per share, up from $13.0 million or $0.39 per share in Q2 2020. Research and development expenses increased to $14.1 million from $8.0 million. The company completed dosing in the MONARCH study of STK-001 for Dravet syndrome and expects interim analysis results in Q3 2021. Stoke plans to identify a clinical candidate for autosomal dominant optic atrophy (ADOA) by year-end 2021, and as of June 30, 2021, had around $251.4 million available to fund operations into 2024.

Stoke Therapeutics (Nasdaq: STOK), a biotechnology company focused on RNA-based medicines, will have CEO Edward M. Kaye present at the UBS Global Healthcare Virtual Conference on May 24, 2021, at 5:00 p.m. ET. The presentation will be in a fireside chat format and will be available through a live audio webcast on Stoke's website. A replay will be accessible for 30 days. Stoke is known for its innovative TANGO approach, working on antisense oligonucleotides (ASOs) to treat severe diseases like Dravet syndrome and autosomal dominant optic atrophy.

Stoke Therapeutics (Nasdaq: STOK) reported a net loss of $16.8 million for Q1 2021, increasing from $11 million a year prior. R&D expenses rose to $9.9 million, and general administrative costs reached $6.9 million. The company is advancing its pipeline with full enrollment of the Phase 1/2a MONARCH study for STK-001 in Dravet syndrome. Key upcoming milestones include preliminary data from MONARCH expected in Q3 2021 and initiation of the ADMIRAL study in the UK. Stoke holds approximately $267.7 million in cash to fund operations through 2024.

Stoke Therapeutics (Nasdaq: STOK) announced new preclinical data showing successful in-vitro protein upregulation and enhanced mitochondrial function in fibroblasts from ADOA patients. This data highlights the effectiveness of their TANGO approach in addressing the OPA1 protein deficiency, the primary cause of ADOA. With ADOA affecting approximately 1 in 30,000 people, the findings suggest a path toward disease-modifying treatment. Key results include a 35% to 47% increase in OPA1 protein isoform expression and improved mitochondrial bioenergetics.

Stoke Therapeutics (Nasdaq: STOK) announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized its Clinical Trial Application for a Phase 1/2a study (ADMIRAL) of STK-001, targeting Dravet syndrome. This proprietary antisense oligonucleotide aims to be the first disease-modifying therapy for this genetic epilepsy, which involves severe seizures and cognitive deficits. The study plans to enroll 22 patients across UK sites, with patient enrollment expected in the second half of 2021. STK-001 is currently in another trial (MONARCH) in the U.S., where initial dose cohorts are underway.

Stoke Therapeutics (Nasdaq: STOK) announced CEO Edward M. Kaye, M.D., will present at two investor conferences. The events include the Stifel 3rd Annual CNS Day on March 31, 2021, at 2:00 PM ET, and the 20th Annual Needham Virtual Healthcare Conference on April 15, 2021, at 12:45 PM ET. Both presentations will be available via live audio webcast on the company's investor site, with replays accessible for 30 days post-event. Stoke Therapeutics focuses on treating severe diseases through RNA-based medicines, including its lead compound STK-001 for Dravet syndrome.

Stoke Therapeutics (Nasdaq: STOK) reported a net loss of $52.3 million for 2020, equating to $1.56 per share, an increase from $32.3 million or $1.80 per share in 2019. R&D expenses rose to $32.2 million from $23.8 million, while G&A expenses surged to $20.8 million from $11.9 million. The Phase 1/2a MONARCH study for STK-001 in Dravet syndrome is progressing, with initial dosing completed. Stoke holds $287.5 million in cash to support operations into 2024, focusing on advancing RNA-based therapies.

Stoke Therapeutics (Nasdaq: STOK) announced that CEO Edward M. Kaye, M.D., will present at the Barclays Global Healthcare Conference on March 11, 2021, at 3:35 p.m. ET. The presentation will focus on the company's innovative RNA-based medicines designed to up-regulate protein expression and address severe diseases. A live audio webcast will be available on the Investors & Media section of Stoke’s website, with a replay accessible for 30 days post-presentation. Stoke’s lead candidate, STK-001, is aimed at treating Dravet syndrome, a severe genetic epilepsy.