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Krystal Biotech, Inc. 8-K Filings

KRYS NASDAQ

Every 8-K that Krystal Biotech, Inc. (KRYS) 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 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.

Rhea-AI Summary

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.

Rhea-AI Summary

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.

Rhea-AI Summary

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.

Rhea-AI Summary

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.

Rhea-AI Summary

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.

Rhea-AI Summary

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.

Rhea-AI Summary

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.

Rhea-AI Summary

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.

Rhea-AI Summary

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.