Investor Alert: PTC Therapeutics (PTCT) Under Investigation for Potential Wrongdoing

Bronstein, Gewirtz & Grossman is investigating PTC Therapeutics, Inc. for potential claims after its stock dropped following a negative opinion on the renewal of Translarna™ from the European Medicines Agency. The firm encourages affected investors to provide information and participate in the investigation. The investigation is being conducted on a contingency basis, with costs covered if successful.

The biopharmaceutical industry experienced a significant setback on June 28, 2024, when PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a negative opinion on the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nmDMD [1]. This decision follows a previous negative opinion returned by the European Commission (EC) for re-review [1].

Bronstein, Gewirtz & Grossman, a securities fraud and shareholder rights law firm, is investigating PTC Therapeutics over potential claims related to this development. The firm encourages affected investors to provide information and participate in the investigation, which is being conducted on a contingency basis, with costs covered if successful [2].

The marketing authorization for Translarna remains in effect pending the outcome of the re-examination procedure and subsequent EC ratification [1]. Based on the timeline of these procedures, the drug is expected to remain on the market through the end of 2024, even if the negative opinion is maintained and ratified [1].

The CHMP's decision follows a review of the STRIDE real-world evidence, which concluded that the evidence of significant efficacy provided by STRIDE "should not be ignored" [1]. This view is consistent with that of DMD key opinion leaders worldwide [1]. Despite this, PTC Therapeutics plans to request re-examination of the CHMP opinion to ensure the continued availability of Translarna on the market for as long as possible for boys and young men with nmDMD [1].

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 [1]. It is currently licensed in multiple countries for the treatment of nmDMD in ambulatory patients aged 2 years and older [1]. In the United States, ataluren is an investigational new drug [1].

Investors interested in participating in the investigation are encouraged to contact Jonas N. Terence, Esq., at (212) 239-4567, or jonas@bgandg.com.

References:

[1] PTC Therapeutics. (2024, June 28). CHMP issues negative opinion on Translarna™ following European return. Retrieved from https://ir.ptcbio.com/news-releases/news-release-details/chmp-issues-negative-opinion-translarnatm-following-european

[2] Bronstein, Gewirtz & Grossman. (2024, June 28). Bronstein, Gewirtz & Grossman, a securities fraud and shareholder rights law firm, is investigating PTC Therapeutics, Inc. (PTCT) following negative opinion from European Medicines Agency (EMA) on Translarna™ (ataluren). Retrieved from https://www.bgandg.com/news/ptc-therapeutics-inc-ptct-investigation

View Source