Stoke Therapeutics Stock Price, News & Analysis

Stoke Therapeutics (NASDAQ: STOK) reported strong Q1 2025 financial results and significant progress in developing zorevunersen for Dravet syndrome. The company achieved regulatory alignment for its Phase 3 EMPEROR study, expected to start in Q2 2025. A notable collaboration with Biogen was established, bringing in $165 million upfront with potential milestone payments of up to $385 million. Stoke maintains exclusive rights in North America while Biogen gets rest-of-world commercialization rights. Q1 2025 financials showed net income of $112.9 million ($1.90 per diluted share), compared to a loss in 2024. The company's strong cash position of $380.3 million is expected to fund operations through mid-2028, supporting Phase 3 data readout and launch preparations.

Stoke Therapeutics (Nasdaq: STOK), a biotechnology company focused on RNA medicine to restore protein expression, has announced its participation in the 24th Annual Needham Virtual Healthcare Conference.

The company's Interim Chief Executive Officer Ian F. Smith will deliver a presentation on Tuesday, April 8, 2025, at 8:45 a.m. ET. Stoke's lead investigational medicine, zorevunersen, is being developed as a potential first-in-class disease-modifying treatment for Dravet syndrome.

Investors and interested parties can access the live webcast and archived replay of the presentation through Stoke's website investor section at https://investor.stoketherapeutics.com/.

Stoke Therapeutics (NASDAQ: STOK) has reported its Q4 and full-year 2024 financial results, highlighting significant progress in its Dravet syndrome treatment program. The company's lead investigational medicine, zorevunersen, is advancing to Phase 3 EMPEROR study in Q2 2025.

Key financial highlights include:

• Cash position of $246.7 million as of December 31, 2024
• Full-year 2024 revenue of $36.6 million, up from $8.8 million in 2023
• Net loss of $89.0 million ($1.65 per share) in 2024, improved from $104.7 million in 2023

Notable developments include a new collaboration with Biogen, FDA Breakthrough Therapy Designation for zorevunersen, and positive clinical data presented at AES 2024. The company expects its current cash position, combined with the $165 million Biogen collaboration upfront payment, to fund operations until mid-2028.

Stoke Therapeutics (NASDAQ: STOK) announced a significant leadership transition as CEO Edward M. Kaye, M.D., will step down effective March 19, 2025. Ian F. Smith has been appointed Interim CEO, while Arthur Tzianabos, Ph.D., will serve as Interim Executive Chairman.

Dr. Kaye, who led the company for seven years, will continue as a board director and advisor. Under his leadership, Stoke achieved several milestones, including FDA Breakthrough Therapy Designation for zorevunersen, their lead investigational medicine for Dravet syndrome, positive data supporting potential disease modification, global Phase 3 alignment, and a partnership with Biogen.

Ian F. Smith brings over 20 years of biotechnology experience, previously serving as Executive VP, COO, and CFO at Vertex Pharmaceuticals. The Board has initiated a search for a permanent CEO as the company prepares for late-stage clinical development and commercialization.

Stoke Therapeutics (Nasdaq: STOK), a biotechnology company focused on RNA medicine for protein expression restoration, has announced its participation in two major investor conferences in March 2025:

• TD Cowen 45th Annual Healthcare Conference on Wednesday, March 5, 2025, at 9:50 a.m. ET
• Leerink Partners Global Healthcare Conference on Monday, March 10, 2025, at 10:40 a.m. ET

Live webcasts and archived replays of both presentations will be accessible through the Investors & News section of Stoke's website.

Biogen and Stoke Therapeutics announced a collaboration for developing and commercializing zorevunersen, a potential first-in-class treatment for Dravet syndrome. Stoke retains rights in US, Canada, and Mexico, while Biogen receives rights for the rest of world.

The deal includes a $165 million upfront payment to Stoke, with potential for $385 million in additional milestones plus tiered royalties. The pivotal Phase 3 EMPEROR study is scheduled to begin in Q2 2025, with results expected in 2H 2027.

Zorevunersen, which targets the SCN1A gene, has received FDA Breakthrough Therapy Designation. Phase 1/2a and open-label extension studies showed substantial reductions in seizure frequency and improvements in cognition and behavior. The treatment addresses an estimated 38,000 patients across the U.S., UK, EU-4, and Japan.

Stoke Therapeutics (Nasdaq: STOK), a biotechnology company focused on RNA medicine for protein expression restoration, has announced its upcoming participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's management will deliver a presentation on Wednesday, January 15, 2025, at 6:00 p.m. ET (3:00 p.m. PT).

The presentation will be accessible through a live audio webcast on the Investors & News section of Stoke's website. Interested parties can access the webcast through the company's investor relations portal, and a replay will remain available for 30 days following the presentation.

Stoke Therapeutics (Nasdaq: STOK) has achieved alignment with FDA, EMA, and PMDA for its Phase 3 EMPEROR study of zorevunersen, potentially the first disease-modifying treatment for Dravet syndrome. The study will evaluate two loading doses of 70mg followed by two maintenance doses of 45mg over 52 weeks versus sham in patients aged 2 to <18 years.

The primary endpoint will measure reduction in major motor seizure frequency, while key secondary endpoints include improvements in cognition and behavior. Recent clinical data showed an 87% median reduction in convulsive seizure frequency at month eight in treated patients. The Phase 3 study, planned to start in mid-2025, will enroll approximately 150 patients globally, with data expected by end of 2027.

Zorevunersen has received FDA Breakthrough Therapy Designation, which may expedite development and review. The treatment has been generally well tolerated, with over 600 doses administered to patients, some remaining on treatment for more than three years.

Stoke Therapeutics (NASDAQ: STOK) has announced a webcast and conference call scheduled for January 7, 2025, at 8:00am Eastern Time to discuss successful regulatory alignment regarding a Phase 3 study of zorevunersen. The drug is being developed as potentially the first disease-modifying treatment for Dravet syndrome.

The company will host the event for investors and analysts, with research analysts having the opportunity to participate in a Q&A session through registration. The webcast will be accessible through Stoke's investor relations website, and a replay will be available for at least 90 days following the event.