KRYS

Krystal Biotech to Present at the Morgan Stanley 21st Annual Global Healthcare Conference

Retrieved on: 
Thursday, September 7, 2023
KRYS, Conference, Pharmaceutical industry

PITTSBURGH, Sept. 07, 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 Morgan Stanley 21st Annual Global Healthcare Conference in New York.

Key Points: 
  • PITTSBURGH, Sept. 07, 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 Morgan Stanley 21st Annual Global 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 September 12.
  • A webcast of the presentation will be available here beginning at 4:55 pm ET on Tuesday, September 12 and will be posted on the Investor section of the Company’s website .

Krystal Biotech Announces Orphan Drug Designation Granted to KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency

Retrieved on: 
Tuesday, September 5, 2023
KRYS, Research and development, Failure mode and effects analysis, Suma, SERPINA1, AATD, Patient, Liver, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry

KB408 IND filed on August 15, 2023

Key Points: 
  • KB408 IND filed on August 15, 2023
    PITTSBURGH, Sept. 05, 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) granted Orphan Drug Designation for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD).
  • AATD is caused by mutations in the SERPINA1 gene that lead to decreased levels and/or decreased functionality of alpha-1 antitrypsin protein.
  • Over time, the deficiency can lead to progressive enzymatic destruction of the lung tissue, ultimately causing life-threatening pulmonary impairment and severe respiratory insufficiency.
  • KB408 is an inhaled (nebulized) formulation of the Company’s novel replication-defective, non-integrating HSV-1-based vector designed to deliver two copies of the SERPINA1 transgene, that encodes for human alpha-1 antitrypsin protein, for the treatment of AATD.

Krystal Biotech Announces Sale of Priority Review Voucher for $100 Million

Retrieved on: 
Monday, August 21, 2023
KRYS, DEB, PRV, Genetic distance, Sale, Concha bullosa, Patient, FDA, Food, Pharmaceutical industry

PITTSBURGH, Aug. 21, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (NASDAQ: KRYS) (the “Company”), a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced that it has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $100 million.

Key Points: 
  • PITTSBURGH, Aug. 21, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (NASDAQ: KRYS) (the “Company”), a commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced that it has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $100 million.
  • Under the Rare Pediatric Disease Priority Review Voucher Program, the FDA awards priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria.
  • The program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
  • A PRV can be redeemed to receive priority review of a subsequent marketing application for a different product, or alternatively, sold or transferred.

Krystal Biotech Announces Second Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Monday, August 7, 2023
NCT, Netherton syndrome, Cohort, Blue Cross Blue Shield Association, Neoplasm, Cystic fibrosis, Investigational New Drug, Phase 1, Investment, Patient, TGM1, Genetic distance, Medication, EMA, AATD, Phase, FDA, CF, UnitedHealth Group, Financial result, Form, Research, KRYS, Genotype, DEB, Medicaid, Inhalation, Clinical trial, Concha bullosa, Physician, Pharmaceutical industry, Clothing, Rolling (metalworking), Reinsurance, Security (finance), EU, IND

The study is on-going, and the Company plans to announce results from this study in the second half of 2023.

Key Points: 
  • The study is on-going, and the Company plans to announce results from this study in the second half of 2023.
  • Financial results for the quarter ended June 30, 2023:
    Cash, cash equivalents, and investments totaled $505.9 million on June 30, 2023.
  • For additional information on the Company’s financial results for the quarter ended June 30, 2023, please refer to the Form 10-Q filed with the SEC.
  • For additional information on the Company’s financial results for the six months ended June 30, 2023, please refer to the Form 10-Q filed with the SEC.

Krystal Biotech Announces Pipeline Expansion into Oncology and FDA Acceptance of IND Application for Lead Oncology Candidate KB707

Retrieved on: 
Wednesday, July 26, 2023
KRYS, US Foods, DNA, Human, Research and development, Krystal, Immunology, Drug discovery, Clinical trial, Skin, National Cancer Institute, Suma, Research, Associate, Lung, IL12, ET, MD, Patient, Lymph, Division, Blood, Webcast, UPMC, Cytokine, FDA, IL2, Safety, Gene, Tumor microenvironment, IND, Food, Pharmaceutical industry, Vaccine, Medicine

The Company will host an investor conference call and webcast, Thursday, July 27, 2023, at 8:00 am ET, to discuss the KB707 program.

Key Points: 
  • The Company will host an investor conference call and webcast, Thursday, July 27, 2023, at 8:00 am ET, to discuss the KB707 program.
  • The presentation for the investor conference call is attached to the Company’s Form 8-K .
  • Two formulations of KB707 are in development, a solution formulation for transcutaneous injection and an inhaled (nebulized) formulation for lung delivery.
  • “We believe KB707 is a unique and highly differentiated drug candidate with the potential to unlock the capabilities of cytokine-based immunotherapy,” said Suma Krishnan, President of Research & Development at Krystal Biotech.

Arbutus Appoints Two New Executives

Retrieved on: 
Monday, July 10, 2023
KRYS, Employment, University, Therapy, General counsel, Willamette University College of Law, HIV, Virology, Liz, Van Sweringen railroad holdings, Infection, Drug, Viral, Bristol Myers Squibb, Koch Industries, Doctor of Philosophy, Bates College, Assistant, BMY, Hospital of the University of Pennsylvania, Arbutus, Lung transplantation, Medical director, Patent, MD, Patient, Internal medicine, Oklahoma Office of the Chief Medical Examiner, Corporation, RNA interference, Hospital, Blank Rome, HCV, Hampden–Sydney College, HBV, NYSE, Behavioral neuroscience, Compensated emancipation, Pharmaceutical industry, Neuroscience, Medicine

WARMINSTER, Pa., July 10, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced the appointment of Dr. Karen Sims as Chief Medical Officer and Mr. Christopher Naftzger as General Counsel and Chief Compliance Officer. Mr. Naftzger succeeds Dr. Elizabeth Howard who will continue in an advisory role with respect to the on-going patent infringement litigations. Both Dr. Sims and Mr. Naftzger will report directly to William Collier, Arbutus President and Chief Executive Officer, effective immediately.

Key Points: 
  • Both Dr. Sims and Mr. Naftzger will report directly to William Collier, Arbutus President and Chief Executive Officer, effective immediately.
  • “Karen has played an integral role in the clinical development of AB-729, our lead RNAi therapeutic, during her six-year tenure at Arbutus, and has continued to advance our pipeline of HBV programs.
  • Prior to joining Arbutus, Dr. Sims held multiple positions during her seven-year tenure at Bristol-Myers Squibb (NYSE: BMY).
  • Christopher Naftzger joins Arbutus with more than 25 years of legal experience, including over a decade of experience serving as senior in-house counsel with life science companies.

Krystal Biotech Announces First Patient Dosed in Phase 1 Clinical Trial of KB407 for the Treatment of Cystic Fibrosis

Retrieved on: 
Monday, July 3, 2023
Tissue, KRYS, Genotype, Pediatrics, Senior, NCT, Urine, Cohort, Drug, Mutation, Cystic fibrosis, Feinberg School of Medicine, Lung, CFTR, Patient, Blood, Data monitoring committee, CF, Skin, Safety, Pharmaceutical industry, Vaccine

The primary endpoint of the trial will be the safety and tolerability of nebulized KB407.

Key Points: 
  • The primary endpoint of the trial will be the safety and tolerability of nebulized KB407.
  • Changes in lung function from baseline will be assessed by the percent predicted forced expiratory volume in one second (ppFEV1).
  • At select sites, subjects may undergo an optional bronchoscopy 24 to 96 hours after the last dose of KB407.
  • Details about the Phase 1 study can be found at www.clinicaltrials.gov under NCT identifier NCT05504837.

Krystal Biotech to Present at Upcoming Investor Conferences

Retrieved on: 
Monday, June 5, 2023
Webcast, KRYS, Goldman Sachs, Rare, Patient, Conference, Cryptocurrency

PITTSBURGH, June 05, 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 Company will participate in the following upcoming investor conferences:

Key Points: 
  • PITTSBURGH, June 05, 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 Company will participate in the following upcoming investor conferences:
    William Blair 43rd Annual Growth Stock Conference: Krish S. Krishnan, Chairman and Chief Executive Officer, will present at 10:40 AM CT and host investor meetings on June 6, 2023 in Chicago, IL.
  • Goldman Sachs 44th Annual Global Healthcare Conference: Krish S. Krishnan, Chairman and Chief Executive Officer, will present at 8:00 AM PT and host investor meetings on June 13, 2023 in Dana Point, CA.
  • A live webcast of the presentations can be accessed on the Investors section of the Company’s website and an archived replay of each webcast will be available for approximately 30 days following the presentation.

Option Care Health Selected by Krystal Biotech as Part of a Limited Distribution Specialty Pharmacy Network for VYJUVEK™

Retrieved on: 
Tuesday, May 23, 2023
COL7A1, KRYS, DEB, Pharmacy, Medicine, History, Concha bullosa, VII, OPCH, Patient, FDA, Syringe, Pharmaceutical industry, Nursing, Amedisys

BANNOCKBURN, Ill., May 23, 2023 (GLOBE NEWSWIRE) -- Option Care Health, Inc. (“Option Care Health”) (Nasdaq: OPCH) today announced that it was selected by Krystal Biotech, Inc. (“Krystal Biotech”) (Nasdaq: KRYS) as part of a limited distribution specialty pharmacy network for VYJUVEK™. VYJUVEK was approved by the U.S. Food & Drug Administration (FDA) on May 19, 2023 for the treatment of patients with dystrophic epidermolysis bullosa (DEB).

Key Points: 
  • BANNOCKBURN, Ill., May 23, 2023 (GLOBE NEWSWIRE) -- Option Care Health, Inc. (“Option Care Health”) (Nasdaq: OPCH) today announced that it was selected by Krystal Biotech, Inc. (“Krystal Biotech”) (Nasdaq: KRYS) as part of a limited distribution specialty pharmacy network for VYJUVEK™.
  • VYJUVEK was approved by the U.S. Food & Drug Administration (FDA) on May 19, 2023 for the treatment of patients with dystrophic epidermolysis bullosa (DEB).
  • Through the national footprint of over 95 specialty pharmacies strategically located across the U.S., Option Care Health will serve as the only specialty pharmacy provider for mixing and delivering prepared VYJUVEK gel administration syringes to professional healthcare and home settings.
  • Option Care Health will collaborate with Amedisys, Inc. on this effort, including for Amedisys nurses to deliver and administer VYJUVEK to patients.

Krystal Biotech Announces $160 Million Private Placement Equity Financing

Retrieved on: 
Monday, May 22, 2023
KRYS, Priority review, PIPE, Exchange, Sale, Patient, Investment, Security (finance), Rare, FDA

Gross proceeds from the PIPE are expected to be approximately $160 million, before deducting any offering-related expenses.

Key Points: 
  • Gross proceeds from the PIPE are expected to be approximately $160 million, before deducting any offering-related expenses.
  • The transaction is expected to close on May 22, 2023, subject to the satisfaction of customary closing conditions.
  • The PIPE financing was led by Avoro Capital Advisors and Redmile Group, LLC with participation from Braidwell LP and Frazier Life Sciences.
  • The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this PIPE within 60 days of closing.