Krystal Biotech

119 articles about Krystal Biotech

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  Krystal Gets First FDA Approval for Redosable Gene Therapy, Rare Skin Disease

  5/22/2023

  The topical treatment Vyjuvek got the FDA’s greenlight, making it the first redosable gene therapy and the first therapeutic for the rare skin disease dystrophic epidermolysis bullosa.

• Krystal Biotech Announces $160 Million Private Placement Equity Financing

  5/22/2023

  Krystal Biotech, Inc. today announced that it has entered into a securities purchase agreement for the sale of 1,729,729 shares of its common stock at $92.50 per share in a private placement (the PIPE) to certain qualified institutional buyers.

• Krystal Biotech Receives FDA Approval for the First-Ever Redosable Gene Therapy, VYJUVEK™ (beremagene geperpavec-svdt) for the Treatment of Dystrophic Epidermolysis Bullosa

  5/19/2023

  Krystal Biotech, Inc. (the Company) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, today announced the US Food and Drug Administration (FDA) has approved VYJUVEK™ (beremagene geperpavec-svdt) for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa (DEB).

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  FDA Action Alert: Krystal, Genmab/AbbVie, Pfizer and Intercept

  5/15/2023

  The FDA has four events lined up this week, including a target action date for Krystal Biotech's gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.

• Krystal Biotech Announces First Quarter 2023 Financial Results and Operational Highlights

  5/8/2023

  Krystal Biotech, Inc. today reported financial results and key operational progress updates for the first quarter ended March 31, 2023.

• Krystal Biotech Announces Clinical Data on Topical Application of B-VEC to the Eye to Treat Ocular Complications in a Patient with Dystrophic Epidermolysis Bullosa Under a Compassionate Use Program

  4/24/2023

  Krystal Biotech, Inc. announced today that the Company presented new data on the compassionate use of topical beremagene geperpavec (B-VEC) to treat a patient with dystrophic epidermolysis bullosa (DEB) with recurrent cicatrizing conjunctivitis at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting on April 23, 2023.

• Krystal Biotech to Present at Association for Research in Vision and Ophthalmology Annual Meeting

  4/13/2023

  Krystal Biotech, Inc. announced today that the Company will be presenting new data on the compassionate use of topical beremagene geperpavec (B-VEC) to treat a patient with dystrophic epidermolysis bullosa (DEB) with recurrent cicatrizing conjunctivitis at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting being held from April 23-27, 2023 in New Orleans, LA.

• Krystal Biotech Appoints Catherine Mazzacco to Board of Directors

  3/6/2023

  Krystal Biotech, Inc. today announced the appointment of Catherine Mazzacco to its Board of Directors.

• Krystal Biotech to Present at the 43rd Annual TD Cowen Health Care Conference

  3/2/2023

  Krystal Biotech, Inc. announced today that the Company will participate in the 43rd Annual TD Cowen Health Care Conference, which is taking place in Boston from March 6-8.

• Krystal Biotech Announces Fourth Quarter and Full Year 2022 Financial Results and Operational Progress

  2/27/2023

  Krystal Biotech, Inc. today reported financial results and key operational updates for the fourth quarter and year ending December 31, 2022.

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

  1/18/2023

  Krystal Biotech, Inc. announced today that the European Commission has granted orphan designation for KB407 for the treatment of Cystic Fibrosis (CF).

• Krystal Biotech Announces FDA’s 3-Month Extension of BLA PDUFA Date and Regulatory Update for B-VEC to Treat Patients with Dystrophic Epidermolysis BullosaNEW PDUFA DATE OF MAY 19, 2023

  1/9/2023

  Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that on January 5, 2023, the U.S. Food and Drug Administration (FDA) notified the Company that based on manufacturing information submitted to the Agency on December 20, 2022, in response to an information request, the PDUFA date has been revised to May 19, 2023, and proposed labeling discussions to no later than April 20, 2023.

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

  12/14/2022

  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).

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

  12/5/2022

  Jeune Aesthetics, Inc., a wholly owned subsidiary of Krystal Biotech, Inc. 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.

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

  12/1/2022

  Krystal Biotech, Inc. a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, announced 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 5th Annual Evercore ISI HealthCONx Conference

  11/23/2022

  Krystal Biotech, Inc. 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.

• 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

  11/17/2022

  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.

• Krystal Biotech Announces Third Quarter 2022 Financial Results and Operational Highlights

  11/7/2022

  Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, today reported financial results and key operational progress updates for the third quarter ended September 30, 2022.

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

  9/29/2022

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

  9/21/2022

  Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has adopted a positive opinion on the Pediatric Investigation Plan (PIP) for beremagene geperpavec (B-VEC) for the treatment of dystrophic epidermolysis bullosa.