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

Dec 19, 2024

PTC Therapeutics Announces Vatiquinone NDA Submission to FDA for the Treatment of Children and Adults Living with Friedreich Ataxia

- If approved, vatiquinone would be the first and only authorized therapy for children with FA - - PTC's fourth approval application submitted to FDA in 2024 - WARREN, N.J. , Dec. 19, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the submission of the vatiquinone New

Dec 17, 2024

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

WARREN, N.J. , Dec. 17, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on Dec. 13, 2024 , the company approved non-statutory stock options to purchase an aggregate of 1,725 shares of its common stock and 5,060 restricted stock units ("RSUs"), each representing the

Dec 02, 2024

PTC Therapeutics Enters into a Global License and Collaboration Agreement with Novartis for PTC518 Huntington's Disease Program

- PTC to receive $1.0B in cash at closing - - PTC is eligible to receive up to $1.9B in development, regulatory and sales milestones - - PTC to share profits in the U.S. and tiered double-digit royalties on ex- U.S. net sales - - Novartis will assume global development, manufacturing and commercial

Nov 27, 2024

PTC Therapeutics Enters into Agreement to Sell Priority Review Voucher for $150 Million

WARREN, N.J. , Nov. 27, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction.

Nov 26, 2024

PTC Therapeutics Announces Topline Results of CardinALS Trial of Utreloxastat in ALS Patients

- Study failed to meet primary and secondary efficacy endpoints - WARREN, N.J. , Nov. 26, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the global Phase 2 placebo-controlled CardinALS study did not meet its primary endpoint of slowing disease progression on the

Nov 25, 2024

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

WARREN, N.J. , Nov. 25, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on Nov. 20, 2024 , the company approved non-statutory stock options to purchase an aggregate of 18,815 shares of its common stock and 17,995 restricted stock units ("RSUs"), each representing the

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

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