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10.12.2025
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PTC Therapeutics Announces Health Canada Approval of Sephience™ (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria (PKU)
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- Broad label includes all age groups and full range of PKU subtypes -TORONTO, Dec. 10, 2025 /CNW/ - PTC Therapeutics Canada ULC announced that Health Canada has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninem...
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01.12.2025
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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WARREN, N.J., Dec. 1, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on Nov. 24, 2025 , the company approved non-statutory stock options to purchase an aggregate of 2,000 shares of its common stock and 8,200 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon v...
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20.11.2025
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PTC Therapeutics to Host R&D Day
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Event to take place on Dec. 2, 2025 in New York City
WARREN, N.J., Nov. 20, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that it will host an R&D Day to discuss its pipeline on Dec. 2, 2025, at 9:30 a.m. EST in New York City. Th...
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20.10.2025
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04.11.2025
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PTC Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results
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– Initiated US and EU launch of Sephience™ (sepiapterin) –
– Strong initial Sephience uptake with global revenue of $19.6M and 521 start forms in the US as of September 30 –
– Robust Q3 performance with total...
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20.10.2025
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31.10.2025
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PTC Therapeutics to Participate at Upcoming Investor Conferences
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WARREN, N.J., Oct. 31, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that its executives will speak at the following conferences:...
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27.10.2025
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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WARREN, N.J., Oct. 27, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on Oct. 23, 2025, the company approved non-statutory stock options to purchase an aggregate of 2,000 shares of its common stock and 1,990 restricted stock units ("RSUs"), each representing the right to receive o...
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21.10.2025
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PTC Therapeutics to Host Conference Call to Discuss Third Quarter 2025 Financial Results
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WARREN, N.J., Oct. 21, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the company will host a webcast conference call to report its third quarter 2025 financial results and provide an update on the company's business and outlook on Tuesday, November 4, at 4:30 p.m. ET....
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01.10.2025
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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WARREN, N.J., Oct. 1, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on Sept. 28, 2025, the company approved non-statutory stock options to purchase an aggregate of 19,475 shares of its common stock and 39,060 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upo...
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19.08.2025
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PTC Therapeutics Receives Complete Response Letter for Vatiquinone NDA
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WARREN, N.J., Aug. 19, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) related to the New Drug Application (NDA) for vatiquinone for the treatment of children and adults living with Friedreich's ataxia.
"We are of course disapp...
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07.08.2025
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PTC Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results
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– European and FDA approval of Sephience™ (sepiapterin) with broad labeling for PKU –
– Global launch underway in Europe and U.S. –
– Total Q2 Revenue of $179M –
WARREN, N.J., Aug. 7, 2025 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ: PTCT) today announced a corporate update and financial results for the second quarter ended June 30, 2025. ...
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28.07.2025
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PTC Therapeutics Announces FDA Approval of Sephience™ (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria (PKU)
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- Broad labeling inclusive of all disease subtypes for individuals 1 month of age and older -
- PTC will host a conference call on Monday, July 28th at 5:00 pm ET -
WARREN, N.J., July 28, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has approved SEPHIENCE™ (sepiapterin...
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21.07.2025
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PTC Therapeutics to Host Conference Call to Discuss Second Quarter 2025 Financial Results
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WARREN, N.J., July 21, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the company will host a webcast conference call to report its second quarter 2025 financial results and provide an update on the company's business and outlook on Thursday, August 7, at 4:30 p.m. ET....
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20.10.2025
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23.06.2025
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Sephience™ (sepiapterin) Granted Marketing Authorization by the European Commission for the Treatment of Children and Adults Living with Phenylketonuria (PKU)
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– Broad label inclusive of all ages and disease severities –
– Launch to be initiated in Germany –
WARREN, N.J., June 23, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Sephience™ (sepiapterin) was granted marketing authorization by the European Commission for the treatment of children and adults living with phe...
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19.06.2025
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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WARREN, N.J., June 19, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on June 16, 2025, the company approved non-statutory stock options to purchase an aggregate of 12,725 shares of its common stock and 27,790 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upo...
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16.06.2025
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PTCT Investors Have Opportunity to Join PTC Therapeutics, Inc. Fraud Investigation with the Schall Law Firm
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The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of PTC Therapeutics, Inc. (“PTC” or “the Company”) (NASDAQ: PTCT) for violations of the securities laws.
The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to d...
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06.05.2025
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PTC Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results
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– Strong revenue performance of $190 million –
– Positive CHMP opinion for Sephience™ (sepiapterin) received in April 2025, NDA review remains on track for July 29, 2025 PDUFA date –
– Global Sephience launch activities progressing well –
– Strong cash position of over $2.0 billion as of March 31, 2025 –
WARREN, N.J., May 6, 2025 /PRNewswire/...
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05.05.2025
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PTC518 PIVOT-HD Study Achieves Primary Endpoint
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- Study met primary endpoint with dose-dependent blood HTT protein lowering at Week 12 -
- Favorable dose-dependent trends across clinical scales in Stage 2 patients at Month 12 -
- Signals of dose-dependent clinical benefit relative to matched natural history cohort as well as dose-dependent lowering of NfL in Stage 2 patients at Month 24 -
- Co...
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01.05.2025
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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WARREN, N.J., May 1, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that on April 25, 2025, the company approved non-statutory stock options to purchase an aggregate of 7,000 shares of its common stock and 10,780 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon...
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25.04.2025
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PTC Therapeutics Receives Positive CHMP Opinion for Sephience™ (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria (PKU)
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- Label includes full spectrum of PKU patients -
- European launch preparations underway -
WARREN, N.J., April 25, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the marketing authoriza...
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24.04.2025
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PTC Therapeutics to Participate at Upcoming Investor Conferences
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WARREN, N.J., April 24, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that its executives will speak at the following conferences:
Bank of America Securities 2025 Health Care ConferenceTuesday, May 13 a...
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17.04.2025
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PTC Therapeutics to Host Conference Call to Discuss First Quarter 2025 Financial Results
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WARREN, N.J., April 17, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the company will host a webcast conference call to report its first quarter 2025 financial results and provide an update on the company's business and outlook on Tuesday, May 6, at 4:30 p.m. ET....
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28.03.2025
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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WARREN, N.J., March 28, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on March 24, 2025, the company approved non-statutory stock options to purchase an aggregate of 12,000 shares of its common stock and 28,220 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock u...
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28.03.2025
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PTC Therapeutics Provides Regulatory Update on Translarna™ (ataluren) in Europe
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WARREN, N.J., March 28, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the European Commission (EC) has adopted the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to not renew the authorization of Translarna™ (ataluren) for the treatment of nonsense muta...
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20.03.2025
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PTC Therapeutics Presents New Sepiapterin Data from Ongoing Studies
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— Results show 97% of phenylalanine (Phe) tolerance study participants were able to increase their dietary Phe intake with a mean increase of 126% —
— Genetic variant analysis of Phase 3 APHENITY trial demonstrates meaningful effect in classical subjects with non-BH4 responsive genotypes —
WARREN, N.J., March 20, 2025 /PRNewswire/ -- PTC Therapeu...
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27.02.2025
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PTC Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results
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– Full year 2024 revenue of $807 million, exceeding guidance –
– All 2024 clinical and regulatory milestones were achieved on schedule, including four NDA submissions, all of which were accepted for filing –
– License and collaboration agreement with Novartis for PTC518 Huntington's disease program closed in January 2025 –
– Cash of over $2.0 bi...
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20.02.2025
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PTC Therapeutics to Participate in Upcoming Investor Conferences
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WARREN, N.J., Feb. 20, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that its executives will participate in fireside chats at the following investor conferences:
TD Cowen 45th Annual Health Care 2025 C...
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19.02.2025
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PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia
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- PDUFA target action date of Aug. 19, 2025 -
WARREN, N.J., Feb. 19, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for vatiquinone for the treatment of children and adults living with Friedreich's ataxia (FA). The a...
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13.01.2025
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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WARREN, N.J., Jan. 13, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on Jan. 3, 2025, the company approved 1,200 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon vesting, to two new employees. The awards were made pursuant to the Nasdaq inducement grant ex...
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13.01.2025
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PTC Therapeutics Provides Update on Commercial Performance and R&D Pipeline at 43rd Annual J.P. Morgan Healthcare Conference
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– Unaudited 2024 total revenue of approximately $814 million, exceeding guidance –
– Four approval applications submitted to FDA in 2024 –
– Global launch preparations underway for sepiapterin for PKU, a $1 billion market opportunity; CHMP opinion expected Q2 2025, U.S. approval decision in July 2025 –
– License and collaboration agreement with...
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23.12.2024
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PTC Therapeutics to Present at the 43rd Annual J.P. Morgan Healthcare Conference
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WARREN, N.J., Dec. 23, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that CEO Matthew B. Klein, M.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 11:15 a.m. PST / 2:15 p.m. EST.
The presentation will be webcast live on the Events and Presentations page under the I...
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19.12.2024
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PTC Therapeutics Announces Vatiquinone NDA Submission to FDA for the Treatment of Children and Adults Living with Friedreich Ataxia
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- 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 Drug Application (NDA) for the treatment of children...
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17.12.2024
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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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 right to receive one share of its common stock upon...
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02.12.2024
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PTC Therapeutics Enters into a Global License and Collaboration Agreement with Novartis for PTC518 Huntington's Disease Program
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- 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 responsibilities following completion of placebo-con...
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27.11.2024
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PTC Therapeutics Enters into Agreement to Sell Priority Review Voucher for $150 Million
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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.
PTC was granted the PRV on November 13, 2024 along with the U.S. Food and Drug Administratio...
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26.11.2024
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PTC Therapeutics Announces Topline Results of CardinALS Trial of Utreloxastat in ALS Patients
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- 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 composite ALSFRS-R and mortality analysis. While ther...
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25.11.2024
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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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 right to receive one share of its common stock upo...
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14.11.2024
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PTC Therapeutics Announces FDA Approval of AADC Deficiency Gene Therapy
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- 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) announced today the U.S. Food and Drug Administratio...
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07.11.2024
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PTC Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results
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– 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 vatiquinone –
WARREN, N.J., Nov. 7, 2024 /PRNewsw...
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04.11.2024
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PTC Therapeutics to Participate at Upcoming Investor Conferences
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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 ConferenceWednesday, Nov. 13 at 2:45 p.m. PST / 5:45 p.m. EST
Jefferies London Healthcare ConferenceTuesday, Nov. 19 at 11:30 a.m. GMT / 6:30 a.m. ES...
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25.10.2024
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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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 right to receive one share of its common stock upo...
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24.10.2024
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PTC Therapeutics to Host Conference Call to Discuss Third Quarter 2024 Financial Results
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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. EST.
To access the call by phone, please click here...
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18.10.2024
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CHMP Maintains Negative Opinion on Translarna™ Reexamination
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- 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 the conditional marketing authorization of Transla...
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14.10.2024
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PTC Therapeutics Announces FDA Target Regulatory Action Date for Sepiapterin and Lancet Publication of Phase 3 Trial Results
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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. The NDA was submitted with an indication for the treatment of pediatr...
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08.10.2024
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PTC Therapeutics Announces Positive Results from Long-Term Treatment Studies and Updates on Regulatory Progress for Vatiquinone Friedreich Ataxia Program
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- 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 vatiquinone Friedreich ataxia (FA) program. The pre-specifie...
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01.10.2024
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PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
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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). A Prescription Drug User Fee Act (PDUFA) target action date is expected to be provided i...
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26.09.2024
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FDA Grants Fast Track Designation to PTC518 Huntington's Disease Program
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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.
"The granting of Fast Track designation to the PTC5...
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12.09.2024
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PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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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 the right to receive one share of its common stock up...
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28.08.2024
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PTC Therapeutics to Participate at Upcoming Investor Conferences
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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 22nd Annual Global Healthcare ConferenceThursday, Sept. 5 at 9:15 am ET
2024 Wells Fargo Healthcare ConferenceFriday, Sept. 6 at 12:00 pm ET
Cantor 2024 Gl...
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08.08.2024
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PTC Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results
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– 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. 8, 2024 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ: PTCT) today announced a corporate upda...
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