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PTC Therapeutics, Inc. (PTCT) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Investors to Seek Compensation for Alleged Wrongdoings
GlobeNewswire News Room· 2024-07-09 18:00
NEW YORK, July 09, 2024 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of PTC Therapeutics, Inc. ("PTC" or "the Company") (NASDAQ: PTCT). Investors who purchased PTC securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/PTCT. Investigation Details On June 28, 2024, PTC issued a press release announcing that the European Medicines Agency's Committ ...
PTC Therapeutics (PTCT) Down on Negative CHMP Opinion on DMD Drug
ZACKS· 2024-07-01 13:01
PTC Therapeutics (PTCT) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Commission (EC) once again adopted a negative opinion on the annual renewal of the conditional marketing authorization of Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD). PTC Therapeutics plans to further request a re-examination of the negative opinion regarding Translarna in the EU. Meanwhile, the marketing authorization for Translarna will remain in effect ...
CHMP Issues Negative Opinion on Translarna™ Following European Commission Request for Review
Prnewswire· 2024-06-28 10:00
- PTC to submit a request for re-examination - WARREN, N.J., June 28, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the CHMP has issued a negative opinion on the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nmDMD. This opinion follows the return of the previously issued negative opinion by the European Commission (EC) for re-review. PTC plans to request re-examination of the opinion. The marketing authorization for Transl ...
PTC Therapeutics (PTCT) Soars 9.7%: Is Further Upside Left in the Stock?
ZACKS· 2024-06-24 09:45
This rise in share price is attributable to the company's progress with its pipeline development. Last week, management reported encouraging interim data from the mid-stage PIVOT-HD study evaluating PTC518, its investigational treatment for Huntington's disease (HD). Following 12 months of treatment with PTC518, patients achieved dose-dependent lowering of mutant huntingtin (mHTT) protein in the blood and cerebrospinal fluid (CSF). The FDA also removed a partial clinical hold on this study, which was previo ...
PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Prnewswire· 2024-06-21 20:30
WARREN, N.J., June 21, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on June 17, 2024, the company approved non-statutory stock options to purchase an aggregate of 1,380 shares of its common stock and 6,260 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon vesting, to nine new employees. The awards were made pursuant to the Nasdaq inducement grant exception as a component of the new hires' employment compensation. ABO ...
Interim PIVOT-HD Results Demonstrate Evidence of Favorable CNS Biomarker and Clinical Effects at Month 12 in Huntington's Disease Patients
Prnewswire· 2024-06-20 10:30
- Conference call and webcast to be held June 20th at 8:00 am EDT - PTC is a global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC's ability to innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC's mission is to provide access to best-in-clas ...
PTC Therapeutics Announces Validation of Sepiapterin European MAA
Prnewswire· 2024-05-28 12:30
- Review of European marketing application for PKU now initiated - WARREN, N.J., May 28, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the sepiapterin MAA for PKU has been validated and accepted for review by the EMA. "The validation of the MAA is an important step towards making sepiapterin available to children and adults affected by PKU in Europe," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "The European submission is the first of several g ...
PTC Therapeutics (PTCT) Up as EC Returns CHMP Opinion on DMD Drug
zacks.com· 2024-05-21 17:30
PTC Therapeutics, Inc. (PTCT) announced that the European Commission (EC) has decided against adopting the Committee for Medicinal Products for Human Use's (CHMP) negative opinion of January 2024 on the annual renewal of the conditional marketing authorization of Translarna (ataluren). Translarna is a protein restoration therapy designed to enable the formation of a functioning protein in patients with genetic disorders caused by a nonsense mutation. Following the decision, the EC has returned the opinion t ...
PTC Therapeutics Announces European Commission Returns Translarna™ Opinion to CHMP For Re-evaluation
Prnewswire· 2024-05-20 11:00
- European Commission decides against adoption of negative opinion - - Translarna authorization remains active in Europe - - 2024 revenue guidance paused - WARREN, N.J., May 20, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the European Commission (EC) has decided not to adopt the CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna™ (ataluren) and has returned the opinion to the CHMP for re-evaluation. A ...
PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™
Prnewswire· 2024-05-14 11:30
- PDUFA target action date of November 13, 2024 - WARREN, N.J., May 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has accepted for filing the Biologics License Application (BLA) for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of AADC deficiency. The application has been granted Priority Review with a target regulatory action date of November 13, 2024. "We are excited to be one step closer to bringing an approved therapy to patients with ...