Here are the 8-K filings from Krystal Biotech, Inc. (KRYS) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
An 8-K covers material events a company has to report between its quarterly reports, so if you follow KRYS 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 KRYS filings page.
Krystal Biotech, Inc. reported third-quarter 2026 net product revenue of $127.3 million, up 30% from $97.8 million a year earlier, and net income of $63.1 million versus $79.4 million. For the first nine months, product revenue was $362.9 million versus $282.0 million, while net income was $173.8 million versus $153.4 million. Gross margin was 94%, and cash, cash equivalents and investments totaled $1.2 billion as of September 30, 2026.
The board authorized repurchases of up to $400 million of common stock; the program has no expiration date and does not require purchases. Krystal expects opportunistic repurchases over the next two years, and may modify, suspend or discontinue the program. FY 2026 non-GAAP combined R&D and SG&A expense guidance is $155.0 million to $165.0 million, excluding stock-based compensation. In a three-patient KB113 pilot, more than 80% of assessed basal cell carcinoma lesions showed investigator-assessed clinical regression. KB801 enrollment was slower than anticipated, with top-line results now expected in 2027; Krystal expects an Italy VYJUVEK launch in early 2027.
Krystal Biotech, Inc. (KRYS) reported preliminary KB113 results from a Gorlin syndrome pilot involving three adult patients. At the final assessment, 69 of 83 landmark lesions (83.1%) had some clinical regression; 42 of 83 (50.6%) regressed by more than 50%, and 8 of 83 (9.6%) by at least 90%. One lesion per patient with at least 90% regression was biopsied, and all three showed histologically confirmed complete response.
The poster reports that all 22 adverse events were mild or moderate, transient, and resolved during the study; no serious adverse events were reported. Krystal said it had initiated discussions with the FDA about advanced clinical development and would update its plans following alignment with the agency. The data were from an unaudited snapshot dated September 17, 2026. Each patient received six doses over 14 weeks, with the first two doses two weeks apart and subsequent doses every three weeks. Results were presented at the PeDRA conference held October 15–17, 2026.
Krystal Biotech reported solid profitability and growth for the quarter ended June 30, 2026. Product revenue, net was $119.2 million versus $96.0 million a year earlier, driven by VYJUVEK, which generated $119.2 million in global net product revenue in the quarter and $965.9 million since launch, with a gross margin of 95%. Quarterly net income was $54.8 million, or $1.85 basic and $1.79 diluted EPS, compared with $38.3 million and EPS of $1.33 basic and $1.29 diluted in the prior-year quarter. For the first six months of 2026, product revenue, net totaled $235.6 million and net income was $110.7 million.
Cash, cash equivalents and investments totaled $1.1 billion as of June 30, 2026, supporting a broad pipeline. Key upcoming milestones include a registrational IOLITE readout for KB803 in 4Q 2026, continued EMERALD-1 enrollment for KB801, advancement of KB407 toward a registrational study in 2027, interim data for KB111 and KB407/KB408 programs, and further development of KB707 in NSCLC and Gorlin syndrome. The company guided full-year 2026 non-GAAP combined R&D and SG&A expense to $175.0–$195.0 million, excluding stock-based compensation, while continuing global VYJUVEK expansion, including anticipated launches in Spain and Italy in 2026.
Krystal Biotech, Inc. reported that on July 21, 2026 it submitted a response to a U.S. Patent and Trademark Office Office Action for a published patent application covering KB801, its investigational gene therapy for neurotrophic keratitis. The response includes data from a single patient in a discontinued clinical study who, after receiving KB801, experienced complete closure of a persistent corneal epithelial defect. The study was discontinued to advance KB801 into a pivotal trial, and no safety concerns or serious adverse events were observed in patients treated in that study.
Krystal Biotech explains that this single-patient observation had not been previously shared and is being disclosed so investors and other stakeholders have equal access to information that will appear in the patent prosecution record. The company emphasizes that this anecdotal result is not top-line data from any clinical trial and that no conclusions about the safety or efficacy of KB801 should be drawn from it. Krystal Biotech does not plan to provide subject-level updates from the discontinued study and expects to report pivotal trial results in the ordinary course. The described information and an image of the defect closure, furnished as an exhibit, are treated as furnished rather than filed under the Exchange Act and are not incorporated into other SEC reports except by specific reference, and the company notes forward-looking statements remain subject to clinical and other risks outlined in its risk factor disclosures.
Krystal Biotech, Inc. reported results of its 2026 annual stockholder meeting held on May 15, 2026. Stockholders elected Class III directors Krish S. Krishnan and Christopher Mason for three-year terms, each receiving over 22 million votes in favor with additional broker non-votes recorded.
Stockholders also ratified KPMG LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with over 28.4 million votes for and minimal opposition. In a non-binding advisory vote, stockholders approved named executive officer compensation for 2025, and unaffiliated stockholders approved the company’s Non-Employee Director Compensation Policy after excluding directors and certain litigation defendants from voting on that item.
Krystal Biotech reported strong first quarter 2026 results, driven by VYJUVEK gene therapy sales and advancing its genetic medicine pipeline. VYJUVEK net product revenue reached $116.4 million in Q1 2026, a 32% increase over the prior-year quarter, with a gross margin of 95%.
Net income rose to $55.9 million, or $1.83 per diluted share, compared with $35.7 million, or $1.20 per diluted share, in Q1 2025. The company ended the quarter with a $1.0 billion cash and investment balance, supporting ongoing commercial and R&D activities.
Management highlighted global VYJUVEK uptake, including over 695 U.S. reimbursement approvals and growing European use, alongside multiple late-stage programs. Two ophthalmology registrational readouts are anticipated in 2026, and the FDA granted platform technology designation for KB407 and KB111, reinforcing the company’s HSV-1-based gene therapy platform.
Krystal Biotech reported strong fourth quarter and full year 2025 results, with full-year product revenue, net of $389.1 million and net income of $204.8 million, or $6.84 per diluted share. Fourth quarter product revenue reached $107.1 million, driving quarterly net income of $51.4 million, or $1.70 per diluted share. The company ended December 31, 2025 with $955.9 million in cash, cash equivalents, and investments, and generated a gross margin of 94% on VYJUVEK revenue. Krystal also highlighted global commercialization progress for VYJUVEK and advancement across its respiratory, ophthalmology, dermatology, oncology, and aesthetics pipelines, including FDA RMAT and Fast Track designations and multiple ongoing or planned registrational studies.
Krystal Biotech furnished preliminary 2025 financial figures ahead of a major healthcare conference. The company expects total net product revenue from its VYJUVEK therapy to be between $106–$107 million for the fourth quarter of 2025 and between $388–$389 million for the full year 2025. Krystal also expects to end 2025 with approximately $955 million in cash, cash equivalents and investments, indicating a substantial liquidity position.
The company’s press release also outlines its rare disease strategic vision, 2026 corporate objectives, and preliminary 2026 combined non-GAAP R&D and SG&A expense guidance. All reported figures are unaudited and subject to change as the year-end 2025 audit is still in progress.
Krystal Biotech reported a positive interim clinical update from its KB407 Phase 1 CORAL-1 study in patients with cystic fibrosis. The company confirmed delivery of wild-type CFTR to the lungs, an important early step for a gene therapy approach targeting the underlying cause of the disease rather than just symptoms.
To explain the interim data and the broader KB407 development program, Krystal Biotech scheduled a conference call and webcast at 4:30 p.m. ET on January 8, 2026. A detailed slide presentation and the full announcement were made available to investors through the company’s website and as accompanying exhibits.
Krystal Biotech furnished an update on its recent performance, announcing financial results for the quarter ended September 30, 2025. The company provided these results via a press release, which is attached as Exhibit 99.1.
The disclosure is furnished under Item 2.02 (Results of Operations and Financial Condition) and is not deemed “filed” for purposes of Section 18 of the Exchange Act. It is also not incorporated by reference into other SEC filings except where expressly stated by specific reference. Krystal Biotech’s common stock trades on the Nasdaq Global Select Market under the symbol KRYS.
Krystal Biotech (KRYS) announced that its wholly owned subsidiary, Krystal Biotech Japan KK, commenced the commercial launch of VYJUVEK (beremagene geperpavec) in Japan effective October 22, 2025. The launch follows VYJUVEK’s inclusion on Japan’s National Health Insurance Drug Price List the same day, enabling reimbursed access for the treatment of dystrophic epidermolysis bullosa. VYJUVEK is listed at 2,955,232.7 yen per unit. The company stated this information is furnished for informational purposes.