4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

4 - Stoke Therapeutics, Inc. (0001623526) (Issuer)

– Regulatory alignment achieved for Phase 3 EMPEROR study of zorevunersen, a potential first-in-class disease-modifying medicine for Dravet syndrome; Study start anticipated in 2Q 2025 – – Zorevunersen collaboration with Biogen brings leading capabilities for commercializing high value, disease-modifying medicines for rare genetic diseases; Stoke retains full rights in the United States, Canada, and Mexico – – As of March 31, 2025, the Company had $380.3 million in cash, cash equivalents, and marketable securities, anticipated to fund operations beyond 2H 2027 Phase 3 data and into launch readiness projected to mid-2028 – Stoke Therapeutics, Inc. (NASDAQ:STOK) is a biotechnology company

Stoke Therapeutics, Inc. (NASDAQ:STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome. The Company today announced that Interim Chief Executive Officer Ian F. Smith will present at the 24th Annual Needham Virtual Healthcare Conference on Tuesday, April 8, 2025, at 8:45 a.m. ET. A live webcast of the presentation, along with an archived replay, will be available in the Investors & News section of Stoke's website at https://investor.stoketherapeutics.com/. About Stoke The

– Phase 3 EMPEROR study of zorevunersen, a first-in-class potential disease-modifying medicine for Dravet syndrome, on track to initiate in 2Q 2025 – – As of December 31, 2024, the Company had $246.7 million in cash, cash equivalents, and marketable securities; together with the $165 million upfront and eligible proceeds from Biogen collaboration anticipated to fund operations to mid-2028 – Stoke Therapeutics, Inc. (NASDAQ:STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syn

Edward M. Kaye, M.D., to Step Down as Chief Executive Officer Director Ian F. Smith Appointed Interim Chief Executive Officer Arthur Tzianabos Appointed Interim Executive Chairman of the Board Board of Directors Initiates Search for Permanent Chief Executive Officer Stoke Therapeutics, Inc. (NASDAQ:STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome. Today the Company announced that Edward M. Kaye, M.D., has decided to step down from his role as Chief Executive Offi

Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine, today announced that management will present at the following upcoming investor conferences: TD Cowen 45th Annual Healthcare Conference Date: Wednesday, March 5, 2025 Time: 9:50 a.m. ET Leerink Partners Global Healthcare Conference Date: Monday, March 10, 2025 Time: 10:40 a.m. ET Live webcasts of each event, along with archived replays, will be available in the Investors & News section of Stoke's website at https://investor.stoketherapeutics.com/. About Stoke Therapeutics Stoke Therapeutics (NASDAQ:STOK), is a biotechnology c

Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights Collaboration broadens Biogen's rare disease pipeline and leverages global expertise commercializing high-value, disease-modifying medicines for rare genetic diseases Pivotal Phase 3 EMPEROR study of zorevunersen on track to initiate in Q2 2025 with an anticipated readout in 2H 2027 Stoke to receive $165M upfront, shared development costs and is eligible to receive up to $385M in milestones as well as royalties Biogen Inc. (NASDAQ:BIIB) and Stoke Therapeutics, Inc. (NASDAQ:STOK) today announced a collaboration for the development and

Grew fourth quarter 2024 revenues1 to $95.3 million Expanded fourth quarter 2024 adjusted gross margins1,2 to 70% Generated fourth quarter 2024 adjusted net income2 of $16.8 million FY 2025 revenue guidance of $350M to $360M, exome/genome volume and revenue growth of at least 30% GeneDx to host conference call today at 8:30 a.m. ET GeneDx Holdings Corp. (NASDAQ:WGS), a leader in delivering improved health outcomes through genomic insights, today reported its financial results for the fourth quarter and full year of 2024. "The fourth quarter capped an outstanding year for GeneDx, as we work to end the diagnostic odyssey with earlier intervention using our industry-leading exome and gen

Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine, today announced that management will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 6:00 p.m. ET (3:00 p.m. PT). A live audio webcast of the presentation will be available on the Investors & News section of Stoke's website at https://investor.stoketherapeutics.com/ and can be accessed by following this Link. A replay of the webcast will be available for 30 days following the presentation. About Stoke Therapeutics Stoke Therapeutics (NASDAQ:STOK), is a biotechnology company dedica

– Alignment achieved with U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for EMPEROR – – One-year study of zorevunersen will evaluate reductions in major motor seizure frequency as well as improvements in behavior and cognition in children and adolescents ages 2 to <18 years old – – FDA Breakthrough Therapy designation positions zorevunersen on efficient development path; Company plans to start Phase 3 in mid-2025 – – Webcast and conference call for analysts and investors at 8:00AM Eastern Time today – Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to restoring protein

Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine, today announced that its management team will host a webcast and conference call for investors and analysts to discuss successful alignment with global regulatory agencies related to a Phase 3 study of zorevunersen as potentially the first disease-modifying medicine for the treatment of Dravet syndrome. The webcast will be conducted Tuesday, January 7, 2025 at 8:00am Eastern Time and can be accessed from the Investors & News section of Stoke's website at https://investor.stoketherapeutics.com/. Research analysts who plan to join th

– Mr. Olson brings two decades of successful corporate business development experience with an emphasis on rare diseases and RNA therapeutics – Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine, today announced the appointment of Eric Olson as Chief Business Officer. Mr. Olson has two decades of experience in life sciences business development and strategy with a track record of success, completing numerous transactions to maximize value for company pipelines across a variety of therapeutic areas, including rare genetic diseases, neurology and ophthalmology. In his new role, Mr. Ol

– Mr. Hoitt brings more than two decades of successful commercial experience with an emphasis on rare diseases – Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines, today announced the appointment of Jason Hoitt as Chief Commercial Officer. Mr. Hoitt has more than 20 years of experience successfully planning and executing commercial strategies at leading biopharma companies. As Chief Commercial Officer and a member of Stoke's leadership team, Mr. Hoitt will be responsible for overseeing the Company's global commercial strategy for STK-001. Recently annou

– Mr. Smith brings significant experience in the successful development and commercialization of medicines for rare genetic diseases – Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines, today announced the appointment of Ian Smith to its Board of Directors effective September 19. "Ian brings more than two decades of significant executive management experience in the life sciences industry, with a strong track record of successfully building valuable biotech businesses," said Edward M. Kaye, M.D., Chief Executive Officer of Stoke Therapeutics. "His div

Nuvig Therapeutics, Inc., a biopharma company developing proprietary recombinant human therapeutics for patients with autoimmune diseases, today announced the appointment of Julie Anne Smith as Chief Executive Officer (CEO) and member of the Board of Directors. Ms. Smith has over 20 years of experience in the life science industry, with a focus on leading private and public biotech companies through development and commercialization of therapeutics for orphan diseases. Pamela Conley, Ph.D., cofounder and founding CEO of Nuvig Therapeutics, will serve as the Company's Chief Scientific Officer. "The board is very grateful to Pam for leading Nuvig from inception to this exciting inflection po

Grew fourth quarter 2024 revenues1 to $95.3 million Expanded fourth quarter 2024 adjusted gross margins1,2 to 70% Generated fourth quarter 2024 adjusted net income2 of $16.8 million FY 2025 revenue guidance of $350M to $360M, exome/genome volume and revenue growth of at least 30% GeneDx to host conference call today at 8:30 a.m. ET GeneDx Holdings Corp. (NASDAQ:WGS), a leader in delivering improved health outcomes through genomic insights, today reported its financial results for the fourth quarter and full year of 2024. "The fourth quarter capped an outstanding year for GeneDx, as we work to end the diagnostic odyssey with earlier intervention using our industry-leading exome and gen

– Alignment achieved with U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for EMPEROR – – One-year study of zorevunersen will evaluate reductions in major motor seizure frequency as well as improvements in behavior and cognition in children and adolescents ages 2 to <18 years old – – FDA Breakthrough Therapy designation positions zorevunersen on efficient development path; Company plans to start Phase 3 in mid-2025 – – Webcast and conference call for analysts and investors at 8:00AM Eastern Time today – Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to restoring protein

Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine, today announced that its management team will host a webcast and conference call for investors and analysts to discuss successful alignment with global regulatory agencies related to a Phase 3 study of zorevunersen as potentially the first disease-modifying medicine for the treatment of Dravet syndrome. The webcast will be conducted Tuesday, January 7, 2025 at 8:00am Eastern Time and can be accessed from the Investors & News section of Stoke's website at https://investor.stoketherapeutics.com/. Research analysts who plan to join th

– Totality of data from these ongoing studies suggest clinical benefit for patients ages 2 to 18 years old, including reductions in seizures and improvements in cognition and behavior that support the potential for disease modification – – Phase 1/2a ADMIRAL Study Data STK-001 (70mg): Patients treated with 2 or 3 initial doses experienced substantial and sustained reductions in convulsive seizure frequency; Median reductions at 3 months after last dose (n=6) of 80% and 89% (n=3) at 6 months after last dose, compared to baseline – – OLE Study Data STK-001 (30mg, 45mg): Sustained reductions in convulsive seizure frequency and improvements in cognition and behavior – – MONARCH & ADMIRAL

Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines, today announced that management will hold a webinar and conference call for analysts and investors at 8:00 a.m. Eastern Time on Tuesday, July 25, 2023, to present new data from the two ongoing Phase 1/2a studies (MONARCH and ADMIRAL) and the SWALLOWTAIL open-label extension study in children and adolescents with Dravet syndrome. The webinar will be broadcast live on the Investors & News section of Stoke's website at https://investor.stoketherapeutics.com/. Participants who want to join the call and ask

– Company announces positive interim data from the ongoing Phase 1/2a clinical studies of STK-001 in children and adolescents with Dravet syndrome – – Single and multiple doses of STK-001 up to 45mg were well-tolerated – – 55% median reduction from baseline in convulsive seizure frequency was observed among patients treated with three doses of 45mg – – In 2023 the Company plans to report data from more patients treated with multiple doses of 45mg as well as those treated with multiple doses of 70mg – – As of September 30, 2022, Company had $252.2 million in cash, cash equivalents, marketable securities, and restricted cash, anticipated to fund operations into 2025 – – Management will h

Stoke Therapeutics, Inc. (NASDAQ:STOK), a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines, today announced that management will hold a webinar and conference call for analysts and investors at 8:30 a.m. Eastern Time on Monday, November 14, 2022, to present data from a planned interim analysis of the Phase 1/2a studies of STK-001 in children and adolescents with Dravet syndrome. To participate in the call, please dial (800) 715-9871, or (646) 307-1963 for international callers and provide conference call ID number 2168761. The webinar will be broadcast live on the Investors & News section of St

– Results show that single doses of STK-001 up to 30mg and multiple doses of 20mg were well-tolerated with no safety concerns related to the study drug – – A trend toward a reduction in convulsive seizure frequency was observed among patients treated with single doses of STK-001 – – >95% of patients anticipated to achieve pharmacologically active levels of STK-001 with three monthly doses of 30mg – – Complementary Phase 1/2a studies ongoing; First patients dosed in the 30mg multiple ascending dose (MAD) cohorts of MONARCH in the U.S. and ADMIRAL in the UK – – FDA will allow the evaluation of an additional higher dose level (45mg) in the MONARCH study – – Management will host a webinar

Chardan Capital Markets initiated coverage of Stoke Therapeutics with a rating of Buy and set a new price target of $24.00

Leerink Partners resumed coverage of Stoke Therapeutics with a rating of Outperform and set a new price target of $18.00

TD Cowen upgraded Stoke Therapeutics from Market Perform to Outperform

JP Morgan resumed coverage of Stoke Therapeutics with a rating of Neutral

TD Cowen downgraded Stoke Therapeutics from Outperform to Market Perform

BofA Securities upgraded Stoke Therapeutics from Underperform to Neutral and set a new price target of $12.00 from $9.00 previously

Canaccord Genuity resumed coverage of Stoke Therapeutics with a rating of Buy and set a new price target of $24.00

BofA Securities downgraded Stoke Therapeutics from Buy to Underperform and set a new price target of $9.00 from $22.00 previously

SVB Leerink upgraded Stoke Therapeutics from Mkt Perform to Outperform and set a new price target of $30.00

Jefferies initiated coverage of Stoke Therapeutics with a rating of Buy and set a new price target of $50.00

10-Q - Stoke Therapeutics, Inc. (0001623526) (Filer)

8-K - Stoke Therapeutics, Inc. (0001623526) (Filer)

144 - Stoke Therapeutics, Inc. (0001623526) (Subject)

DEFA14A - Stoke Therapeutics, Inc. (0001623526) (Filer)

DEF 14A - Stoke Therapeutics, Inc. (0001623526) (Filer)

S-8 - Stoke Therapeutics, Inc. (0001623526) (Filer)

10-K - Stoke Therapeutics, Inc. (0001623526) (Filer)

8-K - Stoke Therapeutics, Inc. (0001623526) (Filer)

8-K - Stoke Therapeutics, Inc. (0001623526) (Filer)

SCHEDULE 13G/A - Stoke Therapeutics, Inc. (0001623526) (Subject)