Krystal Biotech

Krystal Biotech, Inc. is a clinical-stage biotechnology company, which focuses on the development of redosable gene therapies to improve the lives of patients living with rare diseases. The firm developed a proprietary gene delivery platform that enables off-the-shelf treatments for serious rare diseases with significant unmet need, initially in the areas of dermatology and respiratory diseases. Its platform consists of a patented, engineered viral vector derived from the herpes simplex virus type 1 that is optimized for local and repeat gene transfer to epithelial cells, and initially using its platform to develop treatments for rare or orphan monogenic diseases caused by the absence of or a mutation in a single gene. It is also involved in leveraging its platform to develop novel therapies to treat more prevalent conditions, and also focuses on developing treatments for use in the setting of aesthetic skin conditions. The company was founded by Suma M. Krishnan on April 15, 2016 and is headquartered in Pittsburgh, PA.

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Krystal Biotech reports robust Q3 earnings and eyes global expansion

Krystal Biotech's Q3 performance showcased positive earnings and high patient conversion rates.
Despite challenges in patient source diversity and conversion cycle, the company remains well-positioned.
Opportunities lie in global expansion, pipeline advancement, and leadership enhancements.
Overall, Krystal Biotech's strong financials and patient compliance bode well for future growth.

Krystal Biotech excels with VYJUVEK, eyes global expansion

Krystal Biotech's VYJUVEK shows strong performance and market potential
Balanced financials and strategic clinical trials position for future growth
Challenges include competitive landscape shifts and global expansion execution
Opportunities lie in market expansion, pipeline advancements, and partnerships

Krystal Biotech excels in Q1 2024, eyes global expansion

Krystal Biotech's strong performance in Q1 2024 reflects continued growth and execution.
The company's focus on compliance, pipeline advancements, and global expansion positions it well.
Challenges in conversion time and reimbursement delays require strategic mitigation.
Opportunities in European and Japanese markets, patient education, and new product data.

Krystal Biotech excels in Q2 2024, eyes global expansion

Krystal Biotech's Q2 2024 performance reflects strong revenue growth, profitability, and operational efficiency, positioning the company well for future success.
The company's focus on patient demand, compliance, and global expansion highlights its strategic priorities and growth trajectory.
While facing challenges in manufacturing expansion and clinical data readouts, Krystal Biotech has opportunities to drive revenue growth and market expansion through strategic initiatives.

Krystal Biotech excels in Q3 with VYJUVEK success and global expansion plans

Krystal Biotech's Q3 performance reflects strong revenue growth, profitability, and strategic advancements in product development and market access.
While facing challenges related to compliance, market dynamics, and competitive landscape, the company is well-positioned for international expansion and future growth.
By capitalizing on strengths in commercial strategies, pipeline progress, and revenue diversification, Krystal Biotech can navigate challenges and seize opportunities for sustained success.

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Krystal Biotech, Inc. engages in developing and commercializing pharmaceutical products. It offers the product, VYJUVEK. The company was founded by Krish S. Krishnan and Suma M. Krishnan on April 15, 2016 and is headquartered in Pittsburgh, PA.

Shares of Krystal Biotech Inc (NASDAQ: KRYS) more than doubled on Monday after the gene therapy company said its pivotal GEM-3 trial for VYJUVEK reported positive topline results. GEM-3 trial met its primary and secondary endpoint According to Krystal Biotech, the study involving its topical treatment for Dystrophic Epidermolysis Bullosa (Dystrophic EB) achieved the primary […] The post Krystal Biotech shares are up 140% on Monday: here's the catalyst appeared first on Invezz.

Krystal Biotech shares are up 140% on Monday: here's the catalyst

Krystal Biotech (KRYS) stock is rising higher on Monday thanks to positive results from a recent Phase 3 clinical trial of VYJUVEK. The post KRYS Stock Alert: The Study Results That Have Krystal Biotech Rocketing 118% Today appeared first on InvestorPlace.

KRYS Stock Alert: The Study Results That Have Krystal Biotech Rocketing 118% Today

Krystal Biotech Inc (NASDAQ: KRYS) has announced positive topline results from the GEM-3 Phase 3 trial of investigational beremagene geperpavec (B-VEC, Vyjuvek) for dystrophic Epidermolysis Bullosa (dystrophic EB). DEB is a genetic skin disorder affecting skin and nails that cause the skin to be very fragile and to blister easily.

Krystal Biotech Shares More Than Double During Premarket Monday: What Investors Need To Know

•  Pivotal GEM-3 trial met its primary endpoint of complete wound healing at six-month timepoints, and its secondary endpoint of complete wound healing at three-month timepoints

Krystal Biotech Announces Positive Topline Results from GEM-3 Pivotal Trial of VYJUVEK™ in Patients with Dystrophic Epidermolysis Bullosa

–  Top-line results from the pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) on track for 4Q21

Krystal Biotech Reports Third Quarter 2021 Financial Results and Provides Update on Operational Progress

PITTSBURGH, Oct. 26, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced that the last participant has completed the 26-week dosing period and 30-day safety follow up visit in the GEM-3 study, Krystal's pivotal Phase 3 clinical trial evaluating investigational beremagene geperpavec (B-VEC) as a topical gene therapy for the treatment of dystrophic epidermolysis bullosa (DEB). DEB is a rare, genetic skin disease that causes skin to tear or blister from minor contact and is caused by a lack of functional type VII collagen (COL7) protein in the skin.

Krystal Biotech Announces Completion of the GEM-3 Pivotal Phase 3 Study Evaluating B-VEC for the Treatment of Dystrophic Epidermolysis Bullosa

PITTSBURGH, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced the presentation of pre-clinical data describing the nonclinical pharmacology of nebulized KB407, a redosable gene therapy candidate for the treatment of cystic fibrosis, in a poster at the North American Cystic Fibrosis Conference (NACFC) taking place virtually November 2 – 5, 2021. The data include more detailed results from the IND-enabling good laboratory practice (GLP) toxicology study of KB407 from which top line results were previously announced. The company was recently granted approval to conduct a Phase 1 clinical study of inhaled KB407 in patients with cystic fibrosis (CF) in Australia by the Bellberry Human Research Ethics Committee (HREC) and plans to initiate a clinical trial in the United States in 2022.

Krystal Biotech Announces Virtual Presentation of Pre-clinical Data on KB407 for the Treatment of Cystic Fibrosis

PITTSBURGH, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced that it will present pre-clinical pharmacology data on its second genetic pulmonary disease candidate KB408, for the treatment of alpha-1 antitrypsin deficiency (AATD), at the upcoming European Society of Gene & Cell Therapy (ESGCT) Virtual Congress held October 19 – 22, 2021.

Krystal Biotech Announces Virtual Presentation of Pre-clinical Data on KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency at ESGCT

The Krystal Decode DEB™ program is designed to shorten time to accurate diagnosis and facilitate the delivery of optimal care The Krystal Decode DEB™ program is designed to shorten time to accurate diagnosis and facilitate the delivery of optimal care

Krystal Biotech and GeneDx Announce Collaboration to Provide No-charge Genetic Testing for Patients with Suspected Dystrophic Epidermolysis Bullosa (DEB)

PITTSBURGH, Oct. 01, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced its participation in the Chardan Virtual 5th Annual Genetic Medicines Conference, taking place October 4-5, 2021. Krish Krishnan, Chairman and CEO at Krystal Biotech, will participate in a fireside chat, and Whitney Ijem, SVP, Strategy & Business Development, will join a panel discussion on the utility of non-traditional viral vectors.

Krystal Biotech to Present at the Chardan 5th Annual Genetic Medicines Conference

-  KB407 is an investigational inhaled gene therapy derived from Krystal's clinically validated redosable gene delivery technology platform

Krystal Biotech Receives Approval from the Human Research Ethics Committee in Australia for Phase 1 Trial of KB407 for Cystic Fibrosis

KRYS, a clinical-stage gene therapy developer, has quadrupled its valuation since its IPO in 2017, and is currently 35% off from its 52 week high, a market cap of $1.25B. Within 3 years of its IPO, KRYS moves successfully from IND (Investigational New Drug) to a pivotal phase 3 trial of their lead candidate B-VEC for DEB (Dystrophic Epidermolysis Bullosa).

Krystal Biotech: A Buy Ahead Of Their Pivotal DEB P3 Trial Readout

PITTSBURGH, Sept. 15, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced the appointment of Laurent Goux as the General Manager of Europe. Mr. Goux has more than 20 years of global biotechnology experience, including serving as the Head of Global Strategic Marketing and Market Access at Galderma.

Krystal Biotech Appoints Laurent Goux as General Manager of Europe

PITTSBURGH, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced that it will present data on its lead product candidate beremagene geperpavec (B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) at the upcoming DEBRA International Conference 2021. Data to be presented includes preclinical evidence of safety and collagen VII expression after topical B-VEC application to induced corneal wounds. This preclinical study was conducted in response to a compassionate use request from a physician for the use of topical (eye drop) B-VEC in the eye of a single recessive DEB patient after undergoing surgical removal of the scared layer of the cornea. The U.S. FDA recently approved the physician's request.

Krystal Biotech to Present Data on DEB and B-VEC at the DEBRA International Conference 2021

PITTSBURGH, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced it will be featured as a presenting company at the H.C. Wainwright 23rd Annual Global Investment Virtual Conference. The conference is being held as a virtual conference on September 13-15, 2021.

Krystal Biotech to Participate in H.C. Wainwright 23rd Annual Global Investment Conference

PITTSBURGH, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today reported financial results and key operational progress updates for the second quarter ending June 30, 2021.

Krystal Biotech Reports Second Quarter 2021 Financial Results and Provides Update on Operational Progress

Krystal Biotech Inc (NASDAQ: KRYS) announced updated results from the Phase 1/2 trial evaluating topical administration of KB105 in patients with autosomal recessive congenital ichthyosis (ARCI) associated with mutations in the TGM1 gene.  Data showed that repeat doses of KB105 were well-tolerated with no adverse events and no evidence of immune response, systemically or at the application sites.

Krystal Biotech's KB105 Shows Detectable, Functionally Active TGM-1 Enzyme In Genetic Skin Condition

-  New data include update from the fourth patient treated in the Phase 1/2 trial

Krystal Biotech Provides Update on the Clinical Trial Evaluating Topical KB105 for the Treatment of TGM-1 Associated Ichthyosis

Completed enrollment in pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB)

Krystal Biotech Reports First Quarter 2021 Financial Results and Provides Update on Operational Progress

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).

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

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).

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

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).

Krystal Biotech Provides Updates from its Rare Genetic Lung Disease Pipeline

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.

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 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.

Krystal Biotech to Participate in Upcoming Investor Conferences

-  Initial data from Cohort 1 of the PEARL-1 study shows safety and tolerability of repeat KB301 injections

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