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.

PITTSBURGH, Jan. 18, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, announced today that the European Commission has granted orphan designation for KB407 for the treatment of Cystic Fibrosis (CF).

Krystal Biotech Receives European Commission Orphan Designation for KB407 for the Treatment of Cystic Fibrosis

Shares of Krystal Biotech Inc. KRYS, +0.15% fell 9.5% in premarket trading on Monday after the company said the Food and Drug Administration moved back the decision date for its experimental treatment for a rare skin condition. The new PDUFA date for the dystrophic epidermolysis bullosa treatment candidate is May 19.

Krystal Biotech's stock is down on delayed PDUFA date

NEW PDUFA DATE OF MAY 19, 2023 NEW PDUFA DATE OF MAY 19, 2023

Krystal Biotech Announces FDA's 3-Month Extension of BLA PDUFA Date and Regulatory Update for B-VEC to Treat Patients with Dystrophic Epidermolysis Bullosa

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PITTSBURGH, Dec. 14, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, announced today that data from the pivotal Phase 3 (GEM-3) trial of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa (DEB) have been published here in the New England Journal of Medicine (NEJM). The full manuscript, titled “Trial of Beremagene Geperpavec (B-VEC) for Dystrophic Epidermolysis Bullosa,” will appear in the December 15, 2022 issue of the NEJM.

New England Journal of Medicine Publishes Phase 3 Data on B-VEC in Patients with Dystrophic Epidermolysis Bullosa

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PITTSBURGH, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a wholly owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) today announced that the company will participate in the investor-focused Cantor Fitzgerald Medical and Aesthetic Dermatology, Ophthalmology and Medtech/Diagnostic Conference, which is taking place in Miami on December 8.

Jeune Aesthetics to Participate in the Cantor Fitzgerald Medical and Aesthetic Dermatology, Ophthalmology and Medtech/Diagnostic Conference

PITTSBURGH, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, announced today that the Company will participate in the BofA Securities 2022 Biotech SMID Cap Conference, which is taking place virtually from December 7-8.

Krystal Biotech to Present at BofA Securities 2022 Biotech SMID Cap Conference

PITTSBURGH, Nov. 23, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, announced today that the Company will participate in the Evercore ISI 5th Annual HealthCONx Conference, which is taking place virtually from November 29-December 1.

Krystal Biotech to Present at 5th Annual Evercore ISI HealthCONx Conference

PITTSBURGH, Nov. 17, 2022 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a wholly owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) today announced nine-month durability of effect in the extension cohort of the PEARL-1 study of KB301, an investigational gene-based treatment designed to address the underlying biology of aging skin for improvement of fine lines and wrinkles.

Jeune Aesthetics Announces Positive Durability Results for KB301 in the PEARL-1 Extension Cohort, an Investigational Gene-based Treatment for Improvement of Fine Lines and Wrinkles

•  Received US FDA filing acceptance of B-VEC BLA with Priority Review designation for treatment of dystrophic epidermolysis bullosa; PDUFA target action date of February 17, 2023

Krystal Biotech Announces Third Quarter 2022 Financial Results and Operational Highlights

Children suffering dystrophic epidermolysis bullosa (DEB), a serious genetic disease, are affectionately called butterfly children, depicting their fragile, recurrent blistering skin with chronic open wounds. Currently, there are three potential DEB treatments that have completed, or are near the end of the developmental/regulatory process, namely AMYT's Filsuvez, KRYS's B-VEC and ABEO's EB-101.

Krystal Biotech: A Buy For Growth Potential

PITTSBURGH, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the Company will participate in the Chardan's 6th Annual Genetic Medicines Conference in New York from October 3-4.

Krystal Biotech to Present at Chardan's 6th Annual Genetic Medicines Conference

• Company on track to submit European marketing application in Q4 2022

Krystal Biotech Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for B-VEC for the treatment of Dystrophic Epidermolysis Bullosa

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PITTSBURGH, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the Company will participate in the H.C. Wainwright 24th Annual Global Investment Conference in New York from September 12-14.

Krystal Biotech to Present at H.C. Wainwright 24th Annual Global Investment Conference

PITTSBURGH, Aug. 18, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, today announced that the US Food and Drug Administration (FDA) has accepted for filing the Company's Biologics License Application (BLA) for B-VEC for the treatment of patients with dystrophic epidermolysis bullosa (DEB). The application has been granted Priority Review designation, and the Prescription Drug User Fee Act (PDUFA) action date is February 17, 2023. The FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the application.

FDA Accepts Krystal Biotech's Biologics License Application for Dystrophic Epidermolysis Bullosa

Krystal Bio (KRYS) has performed well in the last two months that I have had it. Its B-VEC looks highly approvable.

Krystal Biotech: Solid Performance, Let's Keep Holding

PITTSBURGH, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. , (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, today reported financial results and key operational progress updates for the second quarter ending June 30, 2022.

Krystal Biotech Announces Second Quarter 2022 Financial Results and Reports Updates on Operational Progress

PITTSBURGH, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, today announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate KB407 in a clinical trial for cystic fibrosis (CF).

Krystal Biotech Announces FDA Acceptance of KB407 IND Application for Cystic Fibrosis Clinical Trial

Krystal Biotech Receives FDA Acceptance of KB407 IND Application for Cystic Fibrosis Clinical Trial

This biotech looks promising, but there are potential pitfalls to consider.

Can This Healthcare Stock Keep Beating the Market?

PITTSBURGH, July 06, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the Company will participate in the William Blair Biotech Focus Conference 2022 taking place in New York from July 12-13.

Krystal Biotech to Present at William Blair Biotech Focus Conference 2022

PITTSBURGH, June 22, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of B-VEC (beremagene geperpavec) for the treatment of patients with dystrophic epidermolysis bullosa (DEB). B-VEC is an investigational non-invasive, topical gene therapy designed to treat DEB at the molecular level by providing the patient's skin cells with two copies of the COL7A1 gene to make functional COL7 protein, thereby addressing the fundamental disease-causing mechanism.

Krystal Biotech Submits Biologics License Application to U.S. FDA Seeking Approval of B-VEC for the Treatment of Patients with Dystrophic Epidermolysis Bullosa

PITTSBURGH, June 07, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the Company will participate in the Goldman Sachs 43rd Annual Global Healthcare Conference in Rancho Palos Verdes, California.

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