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Krystal Biotech, Inc. (KRYS)

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Previous Close70.41
Open70.91
Bid5.25 x 800
Ask88.00 x 1000
Day's Range68.61 - 71.70
52 Week Range37.68 - 87.29
Volume79,852
Avg. Volume163,210
Market Cap1.572B
Beta (5Y Monthly)1.15
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
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  • Krystal Biotech Appoints Andy Orth as Chief Commercial Officer
    GlobeNewswire

    Krystal Biotech Appoints Andy Orth as Chief Commercial Officer

    PITTSBURGH, May 03, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, announced today the appointment of Andy Orth as Chief Commercial Officer. Mr. Orth has more than 25 years of global biotechnology experience, most recently in the role of Senior Vice President, Head of US Business at Alnylam Pharmaceuticals. “We are excited to welcome Andy to the Krystal team at such an exciting time for our lead investigational program B-VEC for DEB, and the rest of our growing rare disease pipeline,” said Krish S. Krishnan, chairman and chief executive officer of Krystal Biotech. “He is an accomplished biotechnology executive who has successfully launched several genetic medicines in the rare disease space and will be a key asset for Krystal as we work towards our goal of building a fully integrated biotechnology company with a strong commercial capability.” “I am thrilled to be joining Krystal and see tremendous potential in the innovative technology platform and rapidly maturing pipeline,” Andy commented. “I look forward to enhancing the commercial capabilities at Krystal to achieve our ultimate goal of bringing important medicines to patients in need.” In his role of Senior Vice President, Head of U.S. Region at Alnylam, Andy led the organization through multiple launches of rare disease genetic medicines and was responsible for leading the U.S. Business Account Teams, Market Access, Marketing, Patient Services and Operations. Previously, Andy served as Alnylam’s Vice President of Commercial Practice where he helped build out Alnylam’s global commercial capabilities. Prior to Alnylam, Andy held various roles across Commercial and Finance with Biogen, Genzyme and Amgen. Andy received his MBA from Cornell University and his undergraduate degree from the University of Wisconsin. About Krystal BiotechKrystal Biotech, Inc. (NASDAQ:KRYS) is a pivotal-stage gene therapy company leveraging its novel, redosable gene therapy platform and in-house manufacturing capabilities to develop therapies to treat serious rare diseases. For more information, please visit http://www.krystalbio.com. Forward-Looking StatementsAny statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., including but not limited to statements about the development of Krystal’s product candidates, such as plans for the design, conduct and timelines of ongoing pre-clinical and clinical trials of beremagene geperpavec (“B-VEC”), KB105, KB104, KB301, KB407, and KB408; the clinical utility of B-VEC, KB105, KB104, KB301, KB407 and KB408, and Krystal’s plans for filing of regulatory approvals and efforts to bring B-VEC, KB105, KB104, KB301, KB407 and KB408 to market; the market opportunity for and the potential market acceptance of B-VEC, KB105, KB104, KB301, KB407 and KB408; plans to pursue research and development of other product candidates; the sufficiency of Krystal’s existing cash resources; the unanticipated impact of COVID-19 on Krystal’s business operations, pre-clinical activities and clinical trials; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including B-VEC, KB105, KB104, KB301, KB407 and KB408, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption “Risk Factors” in Krystal’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Krystal’s views as of the date of this release. Krystal anticipates that subsequent events and developments will cause its views to change. However, while Krystal may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Krystal’s views as of any date subsequent to the date of this release. CONTACTS: Investors:Whitney Ijemwijem@krystalbio.com Media:Mary CoyleTellMed Strategiesmary.coyle@tmstrat.com Source: Krystal Biotech, Inc.

  • Krystal Biotech Announces Virtual Presentation of Data from its Vector-Encoded-Antibody Platform at ASGCT
    GlobeNewswire

    Krystal Biotech Announces Virtual Presentation of Data from its Vector-Encoded-Antibody Platform at ASGCT

    PITTSBURGH, April 27, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced that it will present preclinical data from its vector-encoded-antibody platform in a digital poster presentation at the upcoming American Society of Genetic & Cell Therapy (ASGCT) Annual Meeting held virtually May 11-14, 2021. Data to be presented includes evidence of in vitro molecular efficacy with KB501 (expressing a TNF-α targeting antibody), and in vivo proof-of-concept in two models of atopic dermatitis with KB501 and KB502 (expressing an IL-4Rα targeting antibody). “The ability to deliver sustained antibody expression locally in the target tissue of interest opens up exciting new strategic optionality for our platform,” said Suma Krishnan, founder and chief operating officer of Krystal Biotech. “This approach holds the potential to transform the management of chronic conditions where redosability is critical and limiting systemic exposure is desirable from a safety or tolerability perspective.” Abstract Information: Title: Engineered Herpes Simplex Virus Type 1 (HSV-1)-Based Vectors as a Platform for Localized Delivery of Therapeutic Antibodies in the Treatment of Skin DisordersSession date/time: Tuesday May 11, 2021 8:00 AM - 10:00 AMSession title: Vector Product Engineering, Development or ManufacturingAbstract number: 822 Abstracts are now available online at https://annualmeeting.asgct.org/. The poster will be available through ASGCT’s website on May 11, 2021 at www.asgct.org. About Krystal BiotechKrystal Biotech, Inc. (NASDAQ:KRYS) is a pivotal-stage gene therapy company leveraging its novel, redosable gene therapy platform and in-house manufacturing capabilities to develop therapies to treat serious rare diseases. For more information please visit http://www.krystalbio.com. Forward-Looking StatementsAny statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., including but not limited to statements about the development of Krystal’s product candidates, such as plans for the design, conduct and timelines of ongoing pre-clinical and clinical trials of beremagene geperpavec (“B-VEC”), KB105, KB104, KB301, KB407, and KB408; the clinical utility of B-VEC, KB105, KB104, KB301, KB407 and KB408, and Krystal’s plans for filing of regulatory approvals and efforts to bring B-VEC, KB105, KB104, KB301, KB407 and KB408 to market; the market opportunity for and the potential market acceptance of B-VEC, KB105, KB104, KB301, KB407 and KB408; plans to pursue research and development of other product candidates; the sufficiency of Krystal’s existing cash resources; the unanticipated impact of COVID-19 on Krystal’s business operations, pre-clinical activities and clinical trials; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including B-VEC, KB105, KB104, KB301, KB407 and KB408, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption “Risk Factors” in Krystal’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Krystal’s views as of the date of this release. Krystal anticipates that subsequent events and developments will cause its views to change. However, while Krystal may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Krystal’s views as of any date subsequent to the date of this release. CONTACTS: Investors:Whitney Ijemwijem@krystalbio.com Media:Mary CoyleTellMed Strategiesmary.coyle@tmstrat.com Source: Krystal Biotech, Inc.

  • Krystal Biotech Provides Update on Pivotal GEM-3 Study of B-VEC for DEB
    GlobeNewswire

    Krystal Biotech Provides Update on Pivotal GEM-3 Study of B-VEC for DEB

    PITTSBURGH, April 26, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced modifications to the Statistical Analysis Plan (SAP) in the ongoing Phase 3 study of B-VEC for the treatment of dystrophic epidermolysis bullosa (DEB) based on feedback from the U.S. Food and Drug Administration (FDA). The GEM-3 trial is a randomized, double-blind, intra patient placebo-controlled multicenter study designed to evaluate the efficacy and safety of B-VEC for patients living with both recessive and dominant forms of dystrophic epidermolysis bullosa. The trial enrolled 31 subjects with DEB, aged 6 months or older at time of consent. Each subject will serve as their own control. To account for paired binary data in the study design and the within-pair correlation in the GEM-3 study, Krystal will use the McNemar test for primary efficacy analysis. The primary outcome measure is complete wound healing determined by the Investigator in B-VEC treated wounds versus placebo. In the updated SAP, a positive response is defined as: Complete wound healing at Week 22 and Week 24; orComplete wound healing at Week 24 and Week 26. Only wounds that achieve complete wound healing for at least 2 weeks are counted as a positive response. “As the GEM-3 trial remains double blinded until database lock occurs in the fourth quarter of 2021, we had the flexibility to adjust the planned SAP with no impact on trial conduct or progress,” said Suma Krishnan, chief operating officer of Krystal Biotech. She added, “We believe that the updated SAP accounts for the within-wound-pair correlation and will better assess the potential benefit of B-VEC against placebo.” With 90% power and a two-sided Type 1 error rate of 5%, and an assumed 20% drop out rate, 30 subjects (i.e., 30 wound pairs) were required for the GEM-3 study assuming a 50% difference in response rate between B-VEC and placebo treated wounds. Because the calculation assumes no correlation within subjects, the estimate is conservative. Any positive correlation will cause an increase in power. Retrospective analysis of Phase 2 study looking at complete wound healing at Week 8 and Week 10 or Week 10 and Week 12 resulted in 78.6% response rate for B-VEC treated wounds versus 0% response rate for placebo wound, with a p<0.003 using the McNemar test. About Krystal BiotechKrystal Biotech, Inc. (NASDAQ:KRYS) is a pivotal-stage gene therapy company leveraging its novel, redosable gene therapy platform and in-house manufacturing capabilities to develop therapies to treat serious rare diseases. For more information, please visit http://www.krystalbio.com. Forward-Looking StatementsAny statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., including but not limited to statements about the development of Krystal’s product candidates, such as plans for the design, conduct and timelines of ongoing pre-clinical and clinical trials of beremagene geperpavec (“B-VEC”), KB105, KB104, KB301, KB407, and KB408; the clinical utility of B-VEC, KB105, KB104, KB301, KB407 and KB408, and Krystal’s plans for filing of regulatory approvals and efforts to bring B-VEC, KB105, KB104, KB301, KB407 and KB408 to market; the market opportunity for and the potential market acceptance of B-VEC, KB105, KB104, KB301, KB407 and KB408; plans to pursue research and development of other product candidates; the sufficiency of Krystal’s existing cash resources; the unanticipated impact of COVID-19 on Krystal’s business operations, pre-clinical activities and clinical trials; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including B-VEC, KB105, KB104, KB301, KB407 and KB408, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption “Risk Factors” in Krystal’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Krystal’s views as of the date of this release. Krystal anticipates that subsequent events and developments will cause its views to change. However, while Krystal may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Krystal’s views as of any date subsequent to the date of this release. CONTACTS: Investors:Whitney Ijemwijem@krystalbio.com Media:Mary CoyleTellMed Strategiesmary.coyle@tmstrat.com Source: Krystal Biotech, Inc.