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Krystal Biotech Announces Publication in the New England Journal of Medicine on the Application of B-VEC to Treat Ocular Complications in Patient with Dystrophic Epidermolysis Bullosa

Retrieved on:

Thursday, February 8, 2024

PITTSBURGH, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced data on the compassionate use of beremagene geperpavec (B-VEC), administered as an eyedrop to treat a patient with dystrophic epidermolysis bullosa (DEB) with cicatrizing conjunctivitis has been published in the New England Journal of Medicine (NEJM). The full manuscript, titled “Ocular Gene Therapy in a Patient with Dystrophic Epidermolysis Bullosa,” can be found in the February 8, 2024 issue of the NEJM.

Key Points:

The full manuscript, titled “Ocular Gene Therapy in a Patient with Dystrophic Epidermolysis Bullosa,” can be found in the February 8, 2024 issue of the NEJM.
Over 25% of patients with DEB develop ocular complications such as corneal erosions, abrasions, blistering and scarring that can lead to impaired vision.
The NEJM publication describes the first application of B-VEC to treat ocular complications in a patient with DEB under a compassionate use program.
If approved, this approach could drastically benefit these patients.”
A patient presented with severe cicatrizing conjunctivitis secondary to DEB.

Krystal Biotech to Present at Guggenheim 6th Annual Biotechnology Conference

Retrieved on:

Thursday, February 1, 2024

KRYS, Conference, Guggenheim, Cryptocurrency

PITTSBURGH, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the Company will participate in the Guggenheim 6th Annual Biotechnology Conference, which takes place in New York on February 7-8.

Key Points:

PITTSBURGH, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the Company will participate in the Guggenheim 6th Annual Biotechnology Conference, which takes place in New York on February 7-8.
Krish S. Krishnan, Chairman and Chief Executive Officer, will participate in a fireside chat at 10 am ET during the conference and host investor meetings on February 7.
A webcast of the presentation will be available here beginning at 10 am ET on Wednesday, February 7 and will be posted on the Investors section of the Company’s website .

Krystal Biotech Receives Permanent J-code (J3401) for VYJUVEK®

Retrieved on:

Thursday, January 4, 2024

Food, Government, DEB, Medicare, KRYS, Patient, Food and Drug Administration, CMS

The J-code for VYJUVEK became effective on January 1, 2024.

Key Points:

The J-code for VYJUVEK became effective on January 1, 2024.
“The permanent J-code will help ensure efficient and accurate reimbursement of VYJUVEK and further enable us to bring this important treatment to DEB patients in need,” said Krish S. Krishnan, Chairman & CEO at Krystal Biotech.
J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate billing of treatments that must be administered by a healthcare professional.
J-codes simplify and streamline the billing and reimbursement processes, allowing for efficient claims processing.

Krystal Biotech Receives Orphan Drug Designation from the Japanese MHLW for Beremagene Geperpavec-svdt (B-VEC)

Retrieved on:

Tuesday, December 19, 2023

Research and development, Suma, Concha bullosa, Research, MHLW, ODD, DEB, KRYS, Patient, Safety, Pharmaceutical industry

PITTSBURGH, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to beremagene geperpavec-svdt (B-VEC or VYJUVEK) for the treatment of dystrophic epidermolysis bullosa (DEB).

Key Points:

PITTSBURGH, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to beremagene geperpavec-svdt (B-VEC or VYJUVEK) for the treatment of dystrophic epidermolysis bullosa (DEB).
“Receiving ODD is an important step in expediting the development of B-VEC in Japan and underscores the unmet needs of patients with DEB,” said Suma Krishnan, President, Research & Development, Krystal Biotech, Inc. “We look forward to working closely with MHLW to bring this important treatment to patients in Japan as soon as possible.”
The orphan drug designation system in Japan aims to support the development of drugs for diseases that affect fewer than 50,000 patients in Japan, for which significant unmet medical need exists.
An investigational therapy is eligible to qualify for ODD if there is no approved alternative treatment option or if there is high efficacy or safety compared to existing treatment options expected.
Specific measures to support the development of orphan drugs include subsidies for research and development expenditures, prioritized consultation regarding clinical development, reduced consultation fees, tax incentives, priority review of applications, reduced application fees, and extended registration validity period.

Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa

Retrieved on:

Monday, November 27, 2023

Research and development, Marketing, Suma, Concha bullosa, EMA, MAA, Orphan, DEB, KRYS, Committee, Patient, CHMP

PITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review.

Key Points:

PITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review.
A CHMP opinion is anticipated in the second half of 2024.
Based on this positive opinion, the Company would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval in the EU.
Previously, VYJUVEK received Orphan Drug Designation and PRIority Medicines (PRIME) eligibility from the EMA.

Krystal Biotech to Present at the Stifel 2023 Healthcare Conference

Retrieved on:

Thursday, November 9, 2023

Conference, KRYS, Pharmaceutical industry

PITTSBURGH, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the Company will participate in the Stifel 2023 Healthcare Conference in New York.

Key Points:

PITTSBURGH, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the Company will participate in the Stifel 2023 Healthcare Conference in New York.
Krish Krishnan, Chairman and Chief Executive Officer, will participate in a fireside chat during the conference and host investor meetings on November 15.
A webcast of the presentation will be available here beginning at 11:30 am ET on Wednesday, November 15 and will be posted on the Investors section of the Company’s website .

Krystal Biotech Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on:

Monday, November 6, 2023

Financial results for the quarter ended September 30, 2023:

Key Points:

Financial results for the quarter ended September 30, 2023:
Cash, cash equivalents, and investments totaled $598.6 million on September 30, 2023.
For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.
For additional information on the Company’s financial results for the nine months ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.
Krystal Biotech will host a conference call to discuss its third quarter 2023 financial results and business highlights today, November 6, 2023, at 8:30 a.m.

Krystal Biotech to Report Third Quarter 2023 Financial Results on November 6, 2023

Retrieved on:

Monday, October 30, 2023

ET, KRYS, Pharmaceutical industry

PITTSBURGH, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, will report its third quarter 2023 financial results on Monday, November 6, 2023, prior to the open of U.S. markets.

Key Points:

PITTSBURGH, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, will report its third quarter 2023 financial results on Monday, November 6, 2023, prior to the open of U.S. markets.
Subsequently, at 8:30 am ET, the Company will host an investor conference call to discuss the financial results and provide a business update.
The Company will host an investor conference call on Monday, November 6, 2023 at 8:30 am ET.
For those unable to listen to the live conference call, a replay will be available for 30-days on the Investors section of the Company’s website at www.krystalbio.com .

Krystal Biotech to Present at the Chardan 7th Annual Genetic Medicines Conference

Retrieved on:

Thursday, September 28, 2023

KRYS, Conference, Pharmaceutical industry, Cryptocurrency

PITTSBURGH, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the Company will participate in the Chardan 7th Annual Genetic Medicines Conference in New York.

Key Points:

PITTSBURGH, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the Company will participate in the Chardan 7th Annual Genetic Medicines Conference in New York.
Krish Krishnan, Chairman and Chief Executive Officer, will participate in a fireside chat during the conference and host investor meetings on October 3.
A webcast of the presentation will be available here beginning at 11:30 am ET on Tuesday, October 3 and will be posted on the Investor section of the Company’s website .

Krystal Biotech Announces FDA Clearance of Investigational New Drug Application for KB408 for the Treatment of Type 1 Alpha-1 Antitrypsin Deficiency

Retrieved on:

Thursday, September 21, 2023

KRYS, Krystal, PI, Senior, NCT, Epithelium, Drug, SERPINA1, AATD, Patient, AAT, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Gene, Food, Safety, Pharmaceutical industry

PITTSBURGH, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug Application (IND) for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD).

Key Points:

KB408 is a modified, replication-defective, non-integrating HSV-1-derived vector carrying two full-length copies of the serpin family A member 1 (SERPINA1) gene to enable expression of alpha-1 antitrypsin (AAT).
KB408 is formulated for inhaled delivery to the respiratory cells of the lungs via nebulization.
“We are excited to advance KB408, our investigational gene therapy for patients with alpha-1 antitrypsin deficiency, into the clinic in our Serpentine-1 study,” said Hubert Chen, M.D., Senior Vice President of Clinical Development at Krystal Biotech.
On September 5th, the FDA granted orphan-drug designation for KB408 for the treatment of AATD.