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

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).

Sep 26, 2024

FDA Grants Fast Track Designation to PTC518 Huntington's Disease Program

WARREN, N.J. , Sept. 26, 2024 /PRNewswire/ -- PTC Therapeutics (NASDAQ: PTCT) announced today that the FDA has granted Fast Track designation to the PTC518 program for the treatment of Huntington's disease. Fast Track designation is awarded to promising therapies for diseases of high unmet need.

Sep 12, 2024

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

WARREN, N.J. , Sept. 12, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on Sept. 8, 2024 , the company approved non-statutory stock options to purchase an aggregate of 16,180 shares of its common stock and 23,725 restricted stock units ("RSUs"), each representing

Aug 28, 2024

PTC Therapeutics to Participate at Upcoming Investor Conferences

WARREN, N.J. , Aug. 28, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company will present a company overview at the following conferences: Morgan Stanley 22 nd Annual Global Healthcare Conference Thursday, Sept. 5 at 9:15 am ET 2024 Wells Fargo Healthcare

Aug 08, 2024

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

– Continued strong revenue performance – – NDAs for sepiapterin and Translarna™ submitted to FDA – – Positive interim data readout from PTC518 PIVOT-HD study – – On track to achieve remaining 2024 clinical and regulatory milestones – WARREN, N.J. , Aug.

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