Every 8-K that Design Therapeutics, Inc. (DSGN) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow DSGN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full DSGN filings page.
Design Therapeutics reported second quarter 2026 results and pipeline updates. In the RESTORE-FA trial of DT-216P2 for Friedreich ataxia, four-week data showed dose-dependent increases in endogenous frataxin and clinical improvements. The study is being modified to treat 10 patients for 12 weeks at a planned go-forward dose of 1 mpk, designate endogenous blood FXN protein percent change from baseline as the primary efficacy endpoint, and explore a dose above 1 mpk. An update on registrational plans is expected in the fourth quarter of 2026, with 12-week data expected in the first quarter of 2027.
Across the GeneTAC® pipeline, patient dosing has begun in a Phase 1 multiple-ascending dose trial of DT-818 in myotonic dystrophy type 1, with data anticipated in 2027, and a Phase 2 biomarker trial of DT-168 in Fuchs endothelial corneal dystrophy is ongoing, with data now expected in 2027 following a supply delay. For the quarter ended June 30, 2026, research and development expenses were $16.4 million, general and administrative expenses were $5.8 million, and net loss was $20.2 million, or $0.32 per share. Cash, cash equivalents and investment securities totaled $207.4 million, which the company stated provides a “strong financial runway.”
Design Therapeutics, Inc. reported the results of its 2026 Annual Meeting of Stockholders. As of the April 14, 2026 record date, 62,441,429 shares of common stock were outstanding and entitled to vote.
Stockholders elected Simeon George, M.D. as a Class II director, with 29,205,208 votes for, 7,608,724 votes withheld and 13,264,883 broker non-votes. They also ratified Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026, with 50,077,708 votes for, 201 votes against and 906 abstentions.
Design Therapeutics reported new biomarker and clinical data from its ongoing Phase 1/2 RESTORE-FA trial of DT-216P2 in Friedreich ataxia. Sixteen patients received weekly intravenous doses from 0.1 to 1 mpk for four weeks.
At the 1 mpk dose, patients showed mean improvements of 6.4 points on the modified Friedreich’s Ataxia Rating Scale and 2.7 points in the Upright Stability Score. Patient-reported fatigue improved by more than five points on the PROMIS Fatigue Scale at four weeks and two weeks after the last dose, exceeding the three-point minimal important change. Whole blood FXN mRNA increased 65%, FXN-M and FXN-E protein rose 22–27%, and muscle FXN mRNA increased 42%, indicating robust frataxin restoration. DT-216P2 was generally well-tolerated, with only mild to moderate adverse events. The company plans to pursue a registrational path and provide an update in the fourth quarter of 2026.
Design Therapeutics, Inc. reported first quarter 2026 results and highlighted progress across its GeneTAC® pipeline. The company posted a net loss of $17.6 million for the quarter, with research and development expenses of $14.4 million and general and administrative expenses of $5.3 million.
Cash, cash equivalents and investment securities totaled $222.8 million as of March 31, 2026, which Design expects to fund planned operations into 2029. The RESTORE-FA Phase 1/2 trial of DT-216P2 in Friedreich ataxia is ongoing, with frataxin biomarker data expected in the second half of 2026.
Additional programs include a Phase 2 biomarker trial of DT-168 in Fuchs endothelial corneal dystrophy with data anticipated in the second half of 2026, and a Phase 1 multiple-ascending dose trial of DT-818 in myotonic dystrophy type-1 expected to begin dosing in the first half of 2026, with results anticipated in 2027. The company also appointed David Shapiro, M.D., to its board of directors to strengthen clinical and regulatory expertise.
Design Therapeutics, Inc. reported that its Board appointed David Shapiro, M.D., as a Class III director effective March 31, 2026, with a term running until the 2027 annual meeting of stockholders. He will also serve on the Nominating and Corporate Governance Committee.
Under the company’s non-employee director compensation policy, Dr. Shapiro will receive an annual cash retainer of $40,000 for Board service and $5,000 for Nominating Committee service. He was granted an initial option to purchase 60,000 shares of common stock vesting monthly over three years and a prorated annual option for 7,500 shares vesting monthly over one year.
Design Therapeutics reported higher operating expenses and a wider loss in 2025 as it advanced multiple GeneTAC® programs. Research and development spending was $59.1 million for the year, up from $44.4 million, and net loss increased to $69.8 million from $49.6 million.
Fourth-quarter 2025 net loss was $16.0 million, or $0.27 per share. The company ended 2025 with $219.8 million in cash, cash equivalents and investment securities, which it expects will fund planned operations into 2029.
Clinically, Design continues dosing Friedreich ataxia patients with DT-216P2 and running a Phase 2 biomarker trial of DT-168 in Fuchs endothelial corneal dystrophy, with data from both anticipated in the second half of 2026. It plans to begin dosing myotonic dystrophy type-1 patients with DT-818 in a Phase 1 trial in the first half of 2026, with results expected in 2027, while also progressing preclinical work in Huntington’s disease.
Design Therapeutics, Inc. reported a governance change, stating that board member Deepa Prasad has decided to resign from the Company’s Board of Directors. Her resignation is effective February 1, 2026 and is attributed to conflict-avoidance policies tied to her newly appointed role with a major bank.
The filing does not describe any disagreement with the Company, instead framing the departure as a compliance requirement related to her new external position. Design Therapeutics remains listed on the Nasdaq Global Select Market under the ticker DSGN, with Pratik Shah continuing as President, Chief Executive Officer and Chairperson.
Design Therapeutics, Inc. (DSGN) furnished an 8‑K announcing it issued a press release with financial results for the three and nine months ended September 30, 2025. The press release is attached as Exhibit 99.1.
The company states this information is being furnished, not filed, under the Exchange Act and is not subject to Section 18 liabilities nor incorporated by reference into other filings. The report was signed by President and CEO Pratik Shah, Ph.D. on November 5, 2025.
Design Therapeutics reported a board change effective September 9, 2025. Director Arsani William, M.D. resigned from the board, and the company stated his resignation was not due to any disagreement over operations, policies, or practices.
On the same date, the board appointed Justin Gover as a Class III director with a term running through the 2027 annual meeting of stockholders. He was also named chair of the Compensation Committee. Under the company’s non-employee director compensation policy, he will receive annual cash retainers of $40,000 for board service and $12,000 for serving as Compensation Committee chair, plus stock options to purchase 30,000 shares vesting over three years and a prorated annual option for 15,833 shares vesting over one year.