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Krystal Biotech, Inc. (KRYS)

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78.69+0.69 (+0.88%)
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Previous Close78.00
Open78.01
Bid65.25 x 900
Ask79.23 x 800
Day's Range75.94 - 81.50
52 Week Range37.68 - 87.29
Volume89,064
Avg. Volume153,645
Market Cap1.747B
Beta (5Y Monthly)1.15
PE Ratio (TTM)N/A
EPS (TTM)-1.71
Earnings DateMar 01, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est98.80
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  • Krystal Biotech Provides Updates from its Rare Genetic Lung Disease Pipeline
    GlobeNewswire

    Krystal Biotech Provides Updates from its Rare Genetic Lung Disease Pipeline

    New preclinical data from GLP toxicology and biodistribution study demonstrates in vivo safety of KB407 for cystic fibrosisCompany expands rare genetic lung disease pipeline with KB408 for the treatment of alpha-1 antitrypsin deficiency PITTSBURGH, April 19, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced positive results of its IND-enabling good laboratory practice (GLP) toxicology study of KB407, an inhaled gene therapy candidate for the treatment of cystic fibrosis (CF), in nonhuman primates (NHPs). In addition, the Company announced initial preclinical proof-of-concept for its second genetic pulmonary disease candidate, KB408, for the treatment of alpha-1 antitrypsin deficiency (AATD). “Successful completion of this GLP toxicology and biodistribution study is an important milestone not only for KB407, but also for our emerging pulmonary portfolio,” said Suma Krishnan, founder and chief operating officer of Krystal Biotech. “We are excited to expand our pulmonary pipeline with the addition of KB408 for the potential treatment of alpha-1 antitrypsin deficiency and look forward to continued progress with our additional discovery phase candidates.” KB407 for Cystic FibrosisKB407 is an inhaled (nebulized) formulation of an engineered HSV-1 based vector designed to deliver two copies of the full-length CFTR gene for the treatment of cystic fibrosis. Previously presented in vitro and in vivo data demonstrate robust transduction efficiency in patient-derived airway epithelial cells, correction of the CF phenotype in patient-derived organoids irrespective of the underlying CFTR mutation within 24 hours of infection, and distribution throughout the lungs of mice and a single nonhuman primate when dosed via nebulization. To further characterize the safety profile of KB407, Krystal conducted a repeat-dose GLP toxicology and biodistribution study in 36 nonhuman primates (NHPs) who received three weekly doses of either KB407 high dose (n=10), KB407 low dose (n=10), vehicle (n=10), or air (n=6). Results of the study were positive and included: Repeat doses of KB407 in NHPs were well tolerated, and the No-Observed-Adverse-Effect Level (NOAEL) was at the highest dose tested;KB407 was distributed throughout the lung tissue, including the bronchioles and alveoli, with little-to-no vector detected in all other tissues and fluids tested;Tissue samples collected for immunofluorescent analysis show specific transduction of airway epithelia, with little-to-no vector detected in lung-resident macrophages; andLung samples harvested 28 days after the last dose demonstrate persistence of the vector and CFTR expression to at least that timepoint. Next Steps: The Company intends to initiate a Phase 1 study of KB407 in 3Q21. KB408 for Alpha-1 Antitrypsin Deficiency KB408 is an inhaled (nebulized) formulation of our novel vector designed to deliver two copies of the SERPINA1 gene, that encodes for normal human alpha-1 antitrypsin (AAT) protein, for the treatment of alpha-1 antitrypsin deficiency (AATD). AATD is a genetic condition caused by mutations that lead to decreased levels and/or decreased functionality of the AAT protein. The predominant disease manifestation of severe AAT deficiency is emphysema, as lower levels of functional AAT are insufficient to fully protect the lungs from the enzymatic activity of neutrophil elastase and progressive destruction of the lung tissue. There are an estimated 90,000 to 100,000 people in the US with severe AAT deficiency. Building on the positive preclinical experience with repeat-dose gene delivery to the lungs with KB407, KB408 leverages the same formulation and route of administration. Initial preclinical data show: KB408 successfully transduces primary airway epithelial cells in vitro, leading to production and secretion of full length, normal human AAT protein;In healthy immunocompetent mice administered a single dose of KB408 or vehicle control to the airways​, analyses of lung tissue samples 24 hours post-dose show efficient vector transduction and human AAT transgene expression;Analysis of bronchoalveolar lavage fluid harvested at the same 24-hour timepoint shows secretion of full-length AAT protein in dosed animals; and​Quantitative analysis of lung fluid harvests at necropsy reveals no evidence of local immune activation/toxicity​. Next steps:More detailed preclinical data will be presented at a future scientific conference. In addition, the Company has submitted a pre-IND (Investigational New Drug) briefing package and is scheduled to meet with the U.S. Food and Drug Administration (FDA) regarding the preclinical IND enabling study requirements in 2Q21, which will determine next steps and timelines for the program. 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 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 Completion of Patient Enrollment in the GEM-3 Pivotal Trial of B-VEC for the Treatment of Dystrophic Epidermolysis Bullosa
    GlobeNewswire

    Krystal Biotech Announces Completion of Patient Enrollment in the GEM-3 Pivotal Trial of B-VEC for the Treatment of Dystrophic Epidermolysis Bullosa

    PITTSBURGH, March 30, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced that enrollment is complete in the pivotal GEM-3 study of B-VEC for dystrophic epidermolysis bullosa (DEB). Based on the timing of this milestone, Krystal expects to report top-line results from the study in the fourth quarter of 2021. “Completion of enrollment in the GEM-3 study marks a significant milestone for us,” said Suma Krishnan, Founder and Chief Operating Officer of Krystal Biotech. “We would like to extend our gratitude to the patients, caregivers, investigators and study staff who, through their commitment during an especially difficult year, have helped bring us closer to potentially providing an easy-to-use topical treatment that addresses the underlying cause of DEB.” About the GEM-3 Pivotal StudyThe GEM-3 trial is a randomized, double-blind, intrapatient placebo-controlled multicenter study designed to evaluate the efficacy and safety of B-VEC for the treatment of DEB. The trial enrolled 31 patients ranging in ages from one (1) year to forty-four (44) years old. Sixty-one percent (61%) of the patients enrolled were pediatric patients (18 years old or younger). As anticipated, less than ten percent (10%) of enrolled patients have the dominant form of dystrophic epidermolysis bullosa (DDEB). In each patient, a primary wound pair(s) was identified by the investigator; one wound was randomized to receive a weekly topical application of B-VEC and the other to placebo. Primary wound pairs selected in the study fell into each of the three wound area segments of <20 cm2, 20-40 cm2 and 40-60 cm2 and were assigned the corresponding doses of 4×108 PFU/wound, 8×108 PFU/wound or 1.2×109 PFU/wound, respectively. Weekly application will be continued until the investigator determines that the wound is completely closed. Re-application may occur at any point throughout the study should the wound re-open. The Primary Outcome Measure is complete wound healing as determined by the Investigator in B-VEC treated wounds versus placebo treated at Weeks 20, 22 and 24. In addition to the primary target wound pair(s), additional wounds (secondary wounds) may be selected to be treated with B-VEC giving the treating physicians and patients flexibility to treat a larger number of wounds. For more information about the pivotal GEM-3 study, visit www.clinicaltrials.gov (NCT04491604). Subjects will return to the clinical site 30 days following the last dosing visit (week 24) for safety evaluation by the investigator, and will subsequently have the option to roll into the Open Label Extension (OLE) Study. 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 clinical trials of beremagene geperpavec (“B-VEC”), KB105, KB104, KB301 and KB407; the clinical utility of B-VEC, KB105, KB104, KB301 and KB407, and Krystal’s plans for filing of regulatory approvals and efforts to bring B-VEC, KB105, KB104, KB301 and KB407 to market; the market opportunity for and the potential market acceptance of B-VEC, KB105, KB104, KB301 and KB407; 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 and KB407, 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 to Participate in Upcoming Investor Conferences
    GlobeNewswire

    Krystal Biotech to Participate in Upcoming Investor Conferences

    PITTSBURGH, March 29, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced participation in two upcoming virtual conferences. Details for the presentations are as follows: Guggenheim Healthcare Talks: 2021 Genomic Medicines & Rare DiseaseDate: Thursday, April 1Time: Krystal leadership will participate in a panel discussion at 4:00pm ET 2021 Virtual Cell & Gene Meeting on the MediterraneanDate: Tuesday, April 6 – Friday, April 9Time: Company presentations will be available to view on-demand throughout the entirety of the conference. Please visit www.meetingonthemed.com for full information, including registration. 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 clinical trials of beremagene geperpavec (“B-VEC”), KB105, KB104, KB301 and KB407; the clinical utility of B-VEC, KB105, KB104, KB301 and KB407, and Krystal’s plans for filing of regulatory approvals and efforts to bring B-VEC, KB105, KB104, KB301 and KB407 to market; the market opportunity for and the potential market acceptance of B-VEC, KB105, KB104, KB301 and KB407; 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 and KB407, 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.