KB407 trial update at Krystal Biotech (NASDAQ: KRYS) confirms CFTR

Rhea-AI Filing 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.

Insights

Biotech and clinical development analyst

Early KB407 data show lung delivery of wild-type CFTR in cystic fibrosis patients.

Krystal Biotech released interim results from the KB407 Phase 1 CORAL-1 study indicating successful delivery of wild-type CFTR to the lungs of patients with cystic fibrosis. This suggests the gene therapy reached its intended target tissue and introduced a functional CFTR sequence, a key technical hurdle for respiratory gene therapies.

The update is still early stage, limited to a Phase 1 interim readout focused on feasibility and biological activity rather than full clinical outcomes. Safety, durability of expression, and meaningful clinical benefit will need to be clarified as the KB407 program progresses. A conference call and webcast on January 8, 2026, along with a slide deck, are intended to provide more detail on the data and development plans.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549 

FORM 8-K 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 8, 2026

KRYSTAL BIOTECH, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38210

82-1080209

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification Number)

2100 Wharton Street, Suite 701

Pittsburgh, Pennsylvania 15203

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (412) 586-5830

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

KRYS

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 7.01    Regulation FD Disclosure

On January 8, 2026, Krystal Biotech, Inc. (the “Company”) issued a press release announcing a positive interim clinical update from its KB407 Phase 1 CORAL-1 Study with confirmation of wild-type CFTR delivery to the lungs of patients with cystic fibrosis. In addition, the press release indicated that the Company would host a conference call and webcast at 4:30 p.m. ET on January 8, 2026, to discuss the interim clinical data and its KB407 clinical development program. For purposes of the call and webcast, the Company provided a slide presentation, which is available on the “Investors” section of the Company’s website at www.krystalbio.com. Copies of the press release and the slide presentation are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated by reference herein.

The information in this Item 7.01 of this Current Report on Form 8-K and in Exhibits 99.1 and 99.2 attached hereto shall not be (i) deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, or (ii) incorporated into any registration statement or other document filed with the Securities and Exchange Commission by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.						Description
99.1						Press Release, dated January 8, 2026
99.2						Slide Presentation, dated January 2026
104						Cover Page Interactive Data file (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 8, 2026

KRYSTAL BIOTECH, INC.

By:

/s/ Krish S. Krishnan

Name:

Krish S. Krishnan

Title:

Chairman and Chief Executive Officer

FAQ

What did Krystal Biotech (KRYS) report about its KB407 program?

Krystal Biotech reported a positive interim clinical update from its KB407 Phase 1 CORAL-1 study, confirming delivery of wild-type CFTR to the lungs of patients with cystic fibrosis.

What is the goal of Krystal Biotech’s KB407 therapy for cystic fibrosis?

KB407 is designed to deliver wild-type CFTR to the lungs of cystic fibrosis patients, aiming to address the underlying genetic defect rather than only treating symptoms.

What stage is the KB407 CORAL-1 study mentioned by Krystal Biotech (KRYS)?

The CORAL-1 study for KB407 is a Phase 1 clinical trial, and the company disclosed an interim update focused on early biological and feasibility signals.

How did Krystal Biotech share more details on the KB407 interim data?

Krystal Biotech scheduled a conference call and webcast at 4:30 p.m. ET on January 8, 2026, and provided a slide presentation for investors on its website.

Where can investors access Krystal Biotech’s KB407 presentation and announcement?

Investors can find the slide presentation and the related announcement through the Investors section of Krystal Biotech’s website, which were also provided as exhibits.

Does the Krystal Biotech KB407 update include financial results or earnings data?

The disclosure focuses on a clinical update for KB407 in cystic fibrosis and related investor materials, not on financial results or earnings metrics.