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PTC Therapeutics has withdrawn its New Drug Application resubmission for Translarna (ataluren) as a treatment for nonsense mutation Duchenne muscular dystrophy after U.S. FDA feedback on the review. FDA indicated the data are unlikely to meet its standard of substantial evidence of effectiveness needed for approval.
CEO Matthew B. Klein said the company is disappointed that FDA approval for Translarna in the U.S. “cannot be achieved” despite more than two decades of development work. The update underscores the challenges of securing U.S. approval for this rare disease therapy, even as PTC continues broader work on treatments for genetic disorders.
Wellington Management Group LLP and affiliated entities report a passive ownership position in PTC Therapeutics, Inc. common stock. As of the event date of December 31, 2025, they collectively report beneficial ownership of 3,867,380 shares, representing 4.8% of the outstanding common stock.
The filing shows no sole voting or dispositive power, with 3,316,002 shares subject to shared voting power and 3,867,380 shares subject to shared dispositive power. The shares are owned of record by clients of various Wellington investment advisers, and no single client is known to hold more than five percent of the class.
The reporting groups certify the position was acquired and is held in the ordinary course of business and not for the purpose of changing or influencing control of PTC Therapeutics.
State Street Corporation has reported a significant passive stake in PTC Therapeutics, Inc.. As of December 31, 2025, State Street beneficially owned 4,206,126 shares of PTC Therapeutics common stock, representing 5.2% of the outstanding class.
State Street reports no sole voting or dispositive power, with 3,973,329 shares subject to shared voting power and 4,206,126 shares subject to shared dispositive power, held through investment management subsidiaries. It certifies the holdings are in the ordinary course of business and not for the purpose of influencing control of PTC Therapeutics.
PTC Therapeutics senior vice president and chief accounting officer Christine Marie Utter reported an automatic sale of 1,034 shares of common stock on January 8, 2026 at $76.45 per share. The filing explains these shares were sold under an irrevocable "sell to cover" election to satisfy tax withholding obligations tied to the vesting of 2,900 restricted stock units from a January 7, 2022 grant of 11,600 RSUs. After this tax-related sale, she beneficially owned 72,693 shares of PTC Therapeutics common stock.
PTC Therapeutics, Inc. chief business officer Eric Pauwels reported a series of planned stock sales in January 2026. The Form 4 shows multiple open-market sales of PTC Therapeutics common stock on January 8, 9, and 12, 2026, at weighted average prices around the mid‑$70s per share, with transaction prices including $76.42, $76.98, $76.45, $77.41 and $78.70 per share. These transactions were executed under a written Rule 10b5‑1 trading plan adopted on September 15, 2025, meaning they were pre‑scheduled rather than discretionary trades.
One sale of 1,454 shares on January 8, 2026, was automatically executed to cover tax withholding obligations tied to the vesting of 4,200 restricted stock units from a January 7, 2022 grant of 16,800 RSUs. After the reported transactions, Pauwels directly held 80,141 shares of PTC Therapeutics common stock.
PTC Therapeutics, Inc. reported an insider share sale by its chief executive officer Matthew B. Klein. On January 8, 2026, he sold 2,514 shares of common stock at $76.45 per share. After this transaction, he beneficially owned 394,453 shares of PTC Therapeutics common stock in direct ownership.
The filing explains that these shares were automatically sold under an irrevocable “sell to cover” election to satisfy tax withholding obligations tied to the vesting of 5,250 restricted stock units (RSUs) from a January 7, 2022 grant of 21,000 RSUs. This indicates the sale was made to cover taxes due on equity compensation rather than as a discretionary open‑market sale of investment holdings.
PTC Therapeutics executive Golden Lee Scott reported an automatic share sale related to tax withholding. On January 8, 2026, Scott sold 866 shares of PTC Therapeutics common stock at $76.45 per share. After this transaction, Scott beneficially owned 92,428 shares of common stock in direct form.
According to the footnote, the sale was made automatically under an irrevocable "sell to cover" election entered into when the equity awards were granted. The sale was used to satisfy tax withholding obligations tied to the vesting of 3,539 restricted stock units (RSUs) from January 7, 2022 grants that originally totaled 14,155 RSUs. This indicates the transaction was administrative in nature and connected to previously granted equity compensation.
PTC Therapeutics executive Mark Elliott Boulding reported multiple open-market sales of company common stock. As Executive Vice President and Chief Legal Officer, he filed a Form 4 showing several sales on January 8 and 9, 2026 at per-share prices in the mid-to-high $70s. Individual transactions included sales such as 2,482 shares at a weighted average price of $76.56 and 1,521 shares at a weighted average price of $77.46, with all shares held directly.
After the reported sales, Boulding beneficially owned slightly more than 111,000 shares of PTC Therapeutics common stock. One block of 1,286 shares was automatically sold under an irrevocable “sell to cover” election to satisfy tax withholding tied to the vesting of 3,600 restricted stock units from a 2022 equity grant. The filing notes that the sales were carried out under a written Rule 10b5‑1 trading plan adopted on December 4, 2024, with several prices disclosed as weighted averages over narrow trading ranges.
PTC Therapeutics, Inc. reported insider share sales by its Chief Technical Ops Officer, Neil Gregory Almstead, related to tax withholding on equity awards. On January 8, 2026, Almstead automatically sold 881 shares of common stock at $76.45 per share under a sell-to-cover election tied to the vesting of 3,600 RSUs from a January 7, 2022 grant of 14,400 RSUs.
On the same date, 59 additional shares of common stock were automatically sold at $76.45 per share, held indirectly through his spouse, to cover taxes on the vesting of 195 RSUs from a January 7, 2022 grant of 780 RSUs. After these transactions, Almstead beneficially owned 115,196 shares directly and 6,791 shares indirectly through his spouse.
PTC Therapeutics released preliminary, unaudited 2025 figures and issued 2026 guidance. For the year ending December 31, 2025, it expects to report total net product and royalty revenue of approximately $823.4 million, including total net product revenue of about $587.8 million and net product revenue for Sephience™ (sepiapterin) of roughly $112.1 million. Final results will follow completion of the year-end audit.
For 2026, the company anticipates full-year total product revenues of $700 million to $800 million, excluding Evrysdi® royalty and collaboration revenue. It projects GAAP R&D and SG&A expenses of $775 million to $815 million and non-GAAP R&D and SG&A expenses of $680 million to $720 million, excluding an estimated $95 million of non-cash stock-based compensation. PTC plans to discuss these figures and 2026 milestones at the J.P. Morgan Healthcare Conference and then enter an investor quiet period.