KRYS

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

Retrieved on: 
Monday, August 1, 2022
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KB407 is a modified HSV-1 vector carrying two copies of the cystic fibrosis transmembrane conductance regulator (CFTR) gene to the respiratory cells in the lungs.

Key Points: 
  • KB407 is a modified HSV-1 vector carrying two copies of the cystic fibrosis transmembrane conductance regulator (CFTR) gene to the respiratory cells in the lungs.
  • On July 1, 2022, the Company submitted an IND application to initiate the Phase 1 clinical trial of KB407.
  • At the end of the 30-day review period, the Company received notification that the FDA accepted the IND allowing the Phase 1 clinical trial to begin.
  • The Phase 1 clinical trial will utilize nebulized administration to deliver KB407 in up to 20 adults with CF.

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

Retrieved on: 
Monday, August 1, 2022
Private Securities Litigation Reform Act, Death, United, KRYS, Spirometry, Skin, GLOBE, CF, Drug, Epithelium, Degenerative disease, U.S. Securities and Exchange Commission, Â, Twitter, Cystic fibrosis, Pancreas, Safety, NASDAQ, Lung, Drug discovery, Clinical trial, CFTR, Review, Disease, FDA, Company, Cystic Fibrosis Foundation, LinkedIn, Patient, Mucus, Senior, Lists of diseases, Cystic fibrosis transmembrane conductance regulator, Urinary tract infection, IND, Pharmaceutical industry, Antibiotics, Medical device

KB407 is a modified HSV-1 vector carrying two copies of the cystic fibrosis transmembrane conductance regulator (CFTR) gene to the respiratory cells in the lungs.

Key Points: 
  • KB407 is a modified HSV-1 vector carrying two copies of the cystic fibrosis transmembrane conductance regulator (CFTR) gene to the respiratory cells in the lungs.
  • On July 1, 2022, the Company submitted an IND application to initiate the Phase 1 clinical trial of KB407.
  • At the end of the 30-day review period, the Company received notification that the FDA accepted the IND allowing the Phase 1 clinical trial to begin.
  • The Phase 1 clinical trial will utilize nebulized administration to deliver KB407 in up to 20 adults with CF.

Krystal Biotech to Present at William Blair Biotech Focus Conference 2022

Retrieved on: 
Wednesday, July 6, 2022
GLOBE, Skin, KRYS, NASDAQ, LinkedIn, Company, Patient, Degenerative disease, Twitter, Lung, Conference, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • Krish Krishnan, Chairman and Chief Executive Officer, will participate in a fireside chat during the conference and host investor meetings on July 13.
  • Krystal Biotech, Inc. (NASDAQ: KRYS) is a pivotal-stage gene therapy company leveraging its proprietary, redosable gene therapy platform and in-house manufacturing capabilities to develop life-changing medicines for patients with serious diseases, including rare diseases in skin, lung, and other areas.
  • For more information please visit http://www.krystalbio.com , and follow @KrystalBiotech on LinkedIn and Twitter .

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

Retrieved on: 
Wednesday, June 22, 2022
Fibrosis, Skin, Concha bullosa, Review, FDA, Tears, Safety, Private Securities Litigation Reform Act, KRYS, Tissue, Priority, Squamous cell carcinoma, Degenerative disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Finger, Blister, Wound healing, COL7A1, Company, Securities and Exchange Commission (Philippines), Suma, Research and development, VII, Trauma, DEB, LinkedIn, BLA, Marketing, GLOBE, Lung, NASDAQ, COL7, Twitter, Food, The, EMA, Patient, Biologics license application, U.S. Securities and Exchange Commission, Dermis, Epidermis, Risk, Pharmaceutical industry, Medical device, Nature Medicine

The GEM-3 trial was a randomized, double-blind, intra-patient placebo-controlled multi-center trial designed to evaluate the efficacy and safety of B-VECfor the treatment of DEB.

Key Points: 
  • The GEM-3 trial was a randomized, double-blind, intra-patient placebo-controlled multi-center trial designed to evaluate the efficacy and safety of B-VECfor the treatment of DEB.
  • In the trial, matched wounds receiving topical B-VEC or placebo were evaluated in 31 DEB patients over 26 weeks.
  • The pivotal GEM-3 trial met its primary endpoint of complete wound healing at six-months and its secondary endpoint of complete wound healing at three-months.
  • In the trial, matched wounds receiving topical B-VEC or placebo were evaluated in nine recessive dystrophic epidermolysis bullosa patients over 12 weeks.

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

Retrieved on: 
Wednesday, June 22, 2022
Fibrosis, Skin, Concha bullosa, Review, FDA, Tears, Safety, Private Securities Litigation Reform Act, KRYS, Tissue, Priority, Squamous cell carcinoma, Degenerative disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Finger, Blister, Wound healing, COL7A1, Company, Securities and Exchange Commission (Philippines), Suma, Research and development, VII, Trauma, DEB, LinkedIn, BLA, Marketing, GLOBE, Lung, NASDAQ, COL7, Twitter, Food, The, EMA, Patient, Biologics license application, U.S. Securities and Exchange Commission, Dermis, Epidermis, Risk, Pharmaceutical industry, Medical device, Nature Medicine

The GEM-3 trial was a randomized, double-blind, intra-patient placebo-controlled multi-center trial designed to evaluate the efficacy and safety of B-VECfor the treatment of DEB.

Key Points: 
  • The GEM-3 trial was a randomized, double-blind, intra-patient placebo-controlled multi-center trial designed to evaluate the efficacy and safety of B-VECfor the treatment of DEB.
  • In the trial, matched wounds receiving topical B-VEC or placebo were evaluated in 31 DEB patients over 26 weeks.
  • The pivotal GEM-3 trial met its primary endpoint of complete wound healing at six-months and its secondary endpoint of complete wound healing at three-months.
  • In the trial, matched wounds receiving topical B-VEC or placebo were evaluated in nine recessive dystrophic epidermolysis bullosa patients over 12 weeks.

Krystal Biotech to Present at Goldman Sachs 43rd Annual Global Healthcare Conference

Retrieved on: 
Tuesday, June 7, 2022
Goldman Sachs, KRYS, Company, Conference, Lung, LinkedIn, Goldman, GLOBE, Patient, PDT, NASDAQ, Twitter, Degenerative disease, Skin

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.

Key Points: 
  • 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.
  • Krish Krishnan, Chairman and Chief Executive Officer, will represent the Company in a session scheduled at 10:40 am PDT on Wednesday, June 15.
  • Krystal Biotech, Inc. (NASDAQ: KRYS) is a pivotal-stage gene therapy company leveraging its proprietary, redosable gene therapy platform and in-house manufacturing capabilities to develop life-changing medicines for patients with serious diseases, including rare diseases in skin, lung, and other areas.
  • For more information please visit http://www.krystalbio.com , and follow @KrystalBiotech on LinkedIn and Twitter .

Krystal Biotech to Present Additional Data on B-VEC from the GEM-3 Phase 3 Study at the Society for Investigative Dermatology Annual Meeting

Retrieved on: 
Friday, May 20, 2022
The, Epidermis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Concha bullosa, Risk, Company, Disease, VII, Food, Finger, DEB, Skin, Patient, Poster, COL7, NASDAQ, Trauma, Dermis, Degenerative disease, FDA, Fibrosis, Booth, Blister, COL7A1, EMA, KRYS, Tears, Priority, Lung, LinkedIn, Society, Twitter, Squamous cell carcinoma, Tissue, GLOBE, Medical device, Vaccine, Pharmaceutical industry

To register for the conference, please visit SID 2022 Annual Meeting | Society for Investigative Dermatology .

Key Points: 
  • To register for the conference, please visit SID 2022 Annual Meeting | Society for Investigative Dermatology .
  • The Company will be present at Booth 218 to educate about DEB and the mechanism of the disease.
  • Following the presentation, materials will be available to view online on the Investor section of the Companys website .
  • Food and Drug Administration(FDA) and theEuropean Medicines Agency(EMA) have each granted B-VEC an orphan drug designation for the treatment of DEB.

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

Retrieved on: 
Monday, May 9, 2022
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New GEM-3 Phase 3 results for B-VEC were presented at the 2022 American Academy of Dermatology Annual Meeting.

Key Points: 
  • New GEM-3 Phase 3 results for B-VEC were presented at the 2022 American Academy of Dermatology Annual Meeting.
  • Financial results for the quarter ended March 31, 2022:
    Cash, cash equivalents, and investments totaled $468.0 million on March 31, 2022.
  • General and administrative expenses for the first quarter ended March 31, 2022 were $15.9 million, compared to $8.2 million for first quarter 2021.
  • For additional information on the Companys financial results for the first quarter ended March 31, 2022, refer to form 10-Q filed with the SEC.

Krystal Biotech to Participate in Bank of America Merrill Lynch Global Healthcare Conference

Retrieved on: 
Tuesday, May 3, 2022
Degenerative disease, Skin, Patient, Investor, Twitter, NASDAQ, KRYS, LinkedIn, Lung, Auction, Medical device, Pharmaceutical industry

A webcast of the presentation will be available on the Investors section of the Companys website for 90 days following the presentation.

Key Points: 
  • A webcast of the presentation will be available on the Investors section of the Companys website for 90 days following the presentation.
  • Krystal Biotech, Inc. (NASDAQ: KRYS) is a pivotal-stage gene therapy company leveraging its proprietary, redosable gene therapy platform and in-house manufacturing capabilities to develop life-changing treatment options for patients with serious diseases, including rare diseases in skin, lung, and other areas.
  • For more information, please visit http://www.krystalbio.com and follow @KrystalBiotech on LinkedIn and Twitter .

Krystal Biotech Announces Home Dosing in B-VEC Open Label Extension Study

Retrieved on: 
Monday, April 11, 2022
BLA, HCP, LinkedIn, NASDAQ, Private Securities Litigation Reform Act, Degenerative disease, COL7, Lung, Krystal, Marketing, Suma, KRYS, HF, Compliance, Skin, DEB, Ageing, Food, Priority, COL7A1, Travel, Safety, Review, Twitter, U.S. Securities and Exchange Commission, Concha bullosa, Securities and Exchange Commission (Philippines), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, EMA, Agency, Research and development, FDA, Patient, Phase, Pharmaceutical industry

Krystal is offering this convenience to patients based on feedback from the U.S. Food and Drug Administration (FDA) following review of Krystals human factors (HF) validation study report submitted in January 2022.

Key Points: 
  • Krystal is offering this convenience to patients based on feedback from the U.S. Food and Drug Administration (FDA) following review of Krystals human factors (HF) validation study report submitted in January 2022.
  • Per the FDAs guidance, Krystal plans to address the convenience of dosing a patient at home of our intend-to-market B-VEC commercial product in its BLA submission that is anticipated in 2Q, 2022.
  • The GEM-3 B-VEC OLE study is a 78-week (approximately a year and a half) open-label extension study of B-VEC for participants diagnosed with DEB who are aged 6 months and older that began in May 2021.
  • The study will enroll subjects who participated in GEM-3 Phase III study, as well as new participants who were unable to participate in the Phase III study and who meet all enrollment criteria.