Press Releases | PTC Therapeutics, Inc.

The press releases contained in this archive section are provided for historical purposes only. The information contained in each press release is accurate only as of the date each press release was originally issued. PTC Therapeutics disavows any obligation to update the information contained in such press releases after the date of their issuance.

Year

Nov 13, 2024

PTC Therapeutics Announces FDA Approval of AADC Deficiency Gene Therapy

- First-ever FDA approval for gene therapy directly administered to the brain - - Priority review voucher granted - - Broad label including children and adults - - PTC pioneers new approach for CNS drug delivery - WARREN, N.J. , Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics , Inc. (NASDAQ: PTCT)

Nov 07, 2024

PTC Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results

– Strong revenue performance, supporting increase in full-year revenue guidance to $750-800 million – – Regulatory filings for sepiapterin, Translarna™ and AADC gene therapy under review by FDA – – On track to achieve remaining 2024 clinical and regulatory milestones, including NDA submission for

Nov 04, 2024

PTC Therapeutics to Participate at Upcoming Investor Conferences

WARREN, N.J. , Nov. 4, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company will present a company overview at the following conferences: UBS Global Healthcare Conference Wednesday, Nov. 13 at 2:45 p.m. PST / 5:45 p.m.

Oct 30, 2024

PTC Therapeutics Announces FDA Acceptance of Translarna™ NDA Resubmission

WARREN, N.J. , Oct. 30, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne

Oct 25, 2024

PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

WARREN, N.J. , Oct. 25, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on Oct. 23, 2024 , the company approved non-statutory stock options to purchase an aggregate of 13,690 shares of its common stock and 20,250 restricted stock units ("RSUs"), each representing the

Oct 24, 2024

PTC Therapeutics to Host Conference Call to Discuss Third Quarter 2024 Financial Results

WARREN, N.J. , Oct. 24, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company will host a webcast conference call to report its third quarter 2024 financial results and provide an update on the company's business and outlook on Thursday, Nov. 7 , at 4:30 p.m.

Oct 18, 2024

CHMP Maintains Negative Opinion on Translarna™ Reexamination

- Opinion to be reviewed by European Commission - WARREN, N.J. , Oct. 18, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has maintained its negative opinion on the renewal of

Oct 14, 2024

PTC Therapeutics Announces FDA Target Regulatory Action Date for Sepiapterin and Lancet Publication of Phase 3 Trial Results

WARREN, N.J. , Oct. 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has set a target regulatory action date of July 29, 2025 , for the review of the New Drug Application (NDA) for sepiapterin, consistent with a standard review timeline.

Oct 08, 2024

PTC Therapeutics Announces Positive Results from Long-Term Treatment Studies and Updates on Regulatory Progress for Vatiquinone Friedreich Ataxia Program

- Statistically significant results on primary endpoint of long-term study analyses - - Following FDA pre-NDA feedback, submission on track for December 2024 - WARREN, N.J. , Oct. 8, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) provided today several positive updates on the

Oct 01, 2024

PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients

WARREN, N.J. , Oct. 1, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of pediatric and adult patients living with phenylketonuria (PKU).

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