Preliminary clinical data in post-anti-PD-1 NSCLC patients demonstrated a 27% ORR and 73% DCR in monotherapy trial Monotherapy activity with inhaled KB707 provides further evidence of successful repeat administration of HSV-1 based inhaled lung gene delivery and builds on recent clinical data update for CF and AAT deficiency respiratory disease programs PITTSBURGH, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the... Read More

Clear evidence of SERPINA1 gene delivery and AAT expression following KB408 administration in AATD patients Both KB408 for AATD patients and KB407 for patients with cystic fibrosis were safe and well tolerated at all dosing regimens evaluated to date Conditional sanctioning of the KB407 Phase 1 CF Study CORAL-1 protocol by CFF TDN Investor call and webcast to be held December 12 at 8:30 am ET to discuss data update... Read More

CHMP opinion now expected in 1Q 2025 No Major Objections outstanding; continue to expect Germany launch in 2Q 2025 PITTSBURGH, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc . ( the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) cancelled the Oral Explanation regarding the Company’s... Read More

PITTSBURGH, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc . (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in fireside chats and host investor meetings at two upcoming investor conferences: Citi’s 2024 Global Healthcare Conference on December 3, 2024 in Miami, Florida; fireside chat scheduled for... Read More

PITTSBURGH, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc . (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the Company will participate in the Stifel 2024 Healthcare Conference on November 18, 2024, in New York. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 10:55 am ET and host investor meetings throughout the... Read More

PITTSBURGH, Nov. 06, 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 Securities Healthcare Innovation Conference on November 12, 2024, in Boston. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 1:30 pm ET and host investor... Read More

Net product revenue of $83.8 million in 3Q and $250.1 million since launch in August 2023 JNDA for B-VEC filed and on track for commercial launches in Japan and Europe in 2025 French health authority approved pre-marketing early reimbursed access for B-VEC in France under the Accès Précoce (AP1) program; AP1 program for DEB patients access expected to start in 4Q 2024 Advancing Jeune Aesthetics’ KB301 to Phase 2 after... Read More

PITTSBURGH, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that it will report its third quarter 2024 financial results on Monday, November 4, 2024, prior to the open of U.S. markets. The Company’s management will also host a conference call and webcast at 8:30 am ET on Monday, November 4, 2024, to discuss the financial results... Read More

PITTSBURGH, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc . (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the Company will participate in the 2024 Cantor Global Healthcare Conference on September 18, 2024, in New York. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 1:20 pm ET and host investor meetings... Read More

PITTSBURGH, Sept. 06, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc . (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the Company will participate in the H.C. Wainwright 26th Annual Global Investment Conference on September 10, 2024, in New York. Krish S. Krishnan, Chairman and Chief Executive Officer, is scheduled to give a company presentation at 12:30 pm ET and host investor... Read More

Décolleté indication selected for Phase 2 study expected to start next year Conference call to discuss results scheduled for Wednesday, August 28, 2024 at 4:30 p.m. ET PITTSBURGH, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a wholly owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) leveraging Krystal’s clinically validated gene-delivery platform to fundamentally address – and... Read More

Net product revenue of $70.3 million in 2Q and $166.2 million since launch in August 2023 On track to deliver three clinical readouts in 2H 2024 Jeune Aesthetics’ KB301 Phase 1 PEARL-1 study (Cohorts 3 and 4) in 3Q 2024; KB408 Phase 1 SERPENTINE-1 study for the treatment of AATD in 4Q 2024; and KB707 Phase 1 OPAL-1 study for the treatment of injectable solid tumors in 4Q 2024 Strong balance sheet, ending the quarter with... Read More

PITTSBURGH, July 26, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that it will report its second quarter 2024 financial results on Monday, August 5, 2024, prior to the open of U.S. markets. The Company’s management will also host a conference call and webcast at 8:30 am ET on Monday, August 5, 2024, to discuss the financial results... Read More

PITTSBURGH, June 05, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc . (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the Company will participate in the Goldman Sachs 45 th Annual Global Healthcare Conference on June 11, 2024, in Miami. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 10:40 am ET and host investor meetings... Read More

PITTSBURGH, May 15, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, announced today that the Company will be presenting new preclinical data on respiratory genetic medicine candidates KB407 and KB408 at the American Thoracic Society (ATS) 2024 International Conference being held from May 17-22, 2024 in San Diego, California. KB407 and KB408 are... Read More

PITTSBURGH, May 08, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc . (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the Company will participate in the BofA Securities 2024 Health Care Conference on May 14, 2024, in Las Vegas. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 2:20 pm PT and host investor meetings throughout... Read More

Net product revenue of $45.3 million in 1Q and $95.9 million since August First patient dosed in inhaled KB707 study for locally advanced or metastatic tumors of the lung Received Fast Track Designations for both inhaled and intratumoral KB707 Strong balance sheet with $622.3 million in cash and investments PITTSBURGH, May 06, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage... Read More

PITTSBURGH, May 02, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, announced today that the Company will be presenting new preclinical data highlighting the potential of the Company’s HSV-1 based vector platform for back of the eye gene delivery at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting being held from May... Read More

PITTSBURGH, April 26, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that it will report its first quarter 2024 financial results on Monday, May 6, 2024, prior to the open of U.S. markets. The Company’s management will also host a conference call and webcast at 8:30 am ET on Monday, May 6, 2024, to discuss the financial results and... Read More

Received Fast Track Designations for both inhaled and intratumoral KB707 PITTSBURGH, April 22, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, announced today that the first patient was dosed in its Phase 1 clinical trial (KYANITE-1) evaluating inhaled KB707, a modified HSV-1 vector designed to deliver genes encoding both human interleukin-12 (IL-12)... Read More

PITTSBURGH, April 04, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, announced today that the Company will be presenting new preclinical data on local and systemic immune activation following intratumoral injection of the Company’s platform technology encoding murine interleukin-12 (IL-12) and interleukin-2 (IL-2), the species matched equivalent to the... Read More

PITTSBURGH, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the Company will participate in the TD Cowen 44 th Annual Health Care Conference, which takes place in Boston on March 4-6. Krish S. Krishnan, Chairman and Chief Executive Officer, will participate in a fireside chat at 9:50 am ET during the conference and host... Read More

Net product revenue of $42.1M in 4Q and $50.7M for the year New England Journal of Medicine publication of the use of B-VEC eyedrop formulation Reached alignment with FDA to enable approval of B-VEC eyedrop formulation for the treatment of lesions in the eye of DEB patients First patient dosed in Phase 1 KB408 trial for the treatment of AATD; five active clinical trials in 2024 Strong balance sheet, closing the year with... Read More

PITTSBURGH, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, will report its fourth quarter and full year 2023 financial results on Monday, February 26, 2024, prior to the open of U.S. markets. Subsequently, at 8:30 am ET, the Company will host a webcast to discuss the financial results and provide a business update. Investor Conference Call The... Read More

FDA clears IND and Phase 1 (KYANITE-1) clinical trial expected to be initiated in 1H 2024 PITTSBURGH, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that... Read More

Initial clinical data suggest the potential of B-VEC to treat lesions in the eye of DEB patients and additional applications of Krystal’s HSV-1 platform to treat ocular diseases Repeat administration of B-VEC eyedrops was well tolerated and associated with full corneal healing by 3 months as well as significant visual acuity improvement from hand motion to 20/25 at 8 months Second NEJM publication of B-VEC clinical data... Read More

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 6 th 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... Read More

PITTSBURGH, Jan. 04, 2024 (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 U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code (J3401) for VYJUVEK ®... Read More

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... Read More

If approved, ~3,000 people with DEB in the European Union could receive VYJUVEK to treat the underlying cause of the disease for the first time VYJUVEK received Orphan Drug Designation and PRIME designation from the EMA 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... Read More

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... Read More

284 VYJUVEK Patient Start Forms and $8.6 million in VYJUVEK U.S. net product revenue as of the end of the third quarter Cohort 1 completed in Phase 1 clinical trial of KB407 for the treatment of CF First patient dosed in Phase 1 Clinical Trial of KB707 in patients with locally advanced or metastatic solid tumor malignancies IND cleared for KB408 for the treatment of AATD Strong balance sheet, closing the quarter with $598.6... Read More

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... Read More

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 7 th Annual Genetic Medicines Conference in New York. Krish Krishnan, Chairman and Chief... Read More

Orphan Drug Designation Granted to KB408 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... Read More

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 21 st Annual Global Healthcare Conference in New York. Krish Krishnan, Chairman and... Read More

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... Read More

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. The Company was awarded the PRV... Read More

VYJUVEK™ approved in the U.S. as the first and only topical redosable gene therapy for the treatment of dystrophic epidermolysis bullosa 121 Patient Start Forms in the first six weeks of launch First cystic fibrosis patient dosed in Phase 1 Clinical Trial of KB407 IND for KB707, Krystal’s first oncology candidate for solid tumors, accepted by FDA and granted Fast Track Designation Strong balance sheet, closing the quarter... Read More

PITTSBURGH, July 26, 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 it has expanded its R&D pipeline to oncology and that the US Food and Drug Administration (FDA) has accepted its Investigational New... Read More

PITTSBURGH, July 03, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with debilitating diseases, announced today that the first patient has been dosed at the Cystic Fibrosis Institute of Chicago in the Company’s Phase 1 CORAL-1/US study evaluating KB407, an engineered HSV-1-based, aerosol-delivered,... Read More

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 43 rd Annual Growth Stock Conference: Krish S. Krishnan, Chairman and Chief Executive Officer, will... Read More

PITTSBURGH, May 22, 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, 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... Read More

Dystrophic Epidermolysis Bullosa (DEB) is a serious rare genetic disease that affects the skin and mucosal tissues and is caused by one or more mutations in the COL7A1 gene, resulting in lack of production of functional type VII collagen (COL7) protein VYJUVEK is a topical gel that addresses the genetic cause of DEB by... Read More

PDUFA date of May 19, 2023 Presented clinical data at ARVO on topical application of B-VEC to the eye to treat ocular complications in a patient with recessive dystrophic epidermolysis bullosa under Compassionate Use Program Strong balance sheet, closing the quarter with $355.5 million in cash, cash equivalents and investments PITTSBURGH, May 08, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS),... Read More

Data presented at Association for Research in Vision and Ophthalmology Annual Meeting on April 23, 2023 Topical application of B-VEC to the eye was well tolerated and patient showed significant improvement of visual acuity and complete corneal re-epithelization PITTSBURGH, April 24, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech,... Read More

PITTSBURGH, April 18, 2023 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a wholly-owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS), today announced treatment of the first subject in the Phase 1, Cohort 3 study of KB301 for the improvement of lateral canthal lines at rest. Jeune’s lead product candidate, KB301, delivers the human COL3A1 gene to targeted skin cells that in turn produce natural type... Read More

Clinical data on the compassionate use of B-VEC to treat a RDEB patient, with recurrent cicatrizing conjunctivitis that leads to conjunctival scarring, at the Bascom Palmer Eye Institute PITTSBURGH, April 13, 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... Read More

PITTSBURGH, March 06, 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, today announced the appointment of Catherine Mazzacco to its Board of Directors. “I am pleased to welcome Catherine to our Board of Directors at this crucial next stage of Krystal’s evolution,” said Krish S.... Read More

PITTSBURGH, March 02, 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 43rd Annual TD Cowen Health Care Conference, which is taking place in Boston from March 6-8. Krish S. Krishnan, Chairman and Chief Executive Officer, will... Read More

B-VEC PDUFA date May 19, 2023 Data from the pivotal Phase 3 (GEM-3) trial of B-VEC for dystrophic epidermolysis bullosa published in the New England Journal of Medicine Four pipeline clinical trials in dermatology, respiratory and aesthetics to initiate in 2023 Strong balance sheet, closing the quarter with $383.8 million in cash, cash equivalents and investments PITTSBURGH, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech,... Read More

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). KB407 is an investigational, redosable gene therapy designed to correct the... Read More

PITTSBURGH, Jan. 09, 2023 (GLOBE NEWSWIRE) -- 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... Read More

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... Read More

Up to nine months durability of effect observed in patients aged 55 to 76 in the extension cohort following administration of high dose KB301 Mean change in Subject Satisfaction Scores from baseline ranged from 1.6 to 1.85 points up to nine months after dosing Company plans on initiating a Phase 2 trial in fine lines and wrinkles in 1H 2023 PITTSBURGH, Nov. 17, 2022 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a... Read More

Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the Company will participate in the Chardan’s 6 th Annual Genetic Medicines Conference in New York from October 3-4. Krish Krishnan, Chairman and Chief Executive Officer, will participate in a fireside chat during the conference and host investor meetings on October 4. A webcast of the presentation will be... Read More

• Company on track to submit European marketing application in Q4 2022 • No additional studies required 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... Read More

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 24 th Annual Global Investment Conference in New York from September 12-14. Krish Krishnan, Chairman and Chief Executive Officer, will deliver a presentation and host investor meetings on September 13. A webcast of the presentation will be available here... Read More

FDA granted Priority Review designation PDUFA target action date is February 17, 2023 FDA stated that it is not currently planning to hold an advisory committee meeting 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... Read More

Biologics License Application for B-VEC filed with the FDA on June 22, 2022 FDA accepts IND on KB407 for the treatment of Cystic Fibrosis Strong balance sheet, closing the quarter with $438.5 million in cash, cash equivalents and investments 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... Read More

KB407 is an investigational, redosable gene therapy candidate designed to treat all patients with cystic fibrosis regardless of the underlying genetic mutation 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... Read More

KB407 is an investigational, redosable gene therapy candidate designed to treat all patients with cystic fibrosis regardless of the underlying genetic mutation 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... Read More

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. A webcast of the event will be available... Read More

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... Read More

Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today that the Company will participate in the Goldman Sachs 43 rd 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. A live webcast of the presentation will be... Read More

Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, is pleased to present new data entitled “GEM-3: phase 3 safety and immunogenicity results of beremagene geperpavec (B-VEC), an investigational, topical gene therapy for dystrophic epidermolysis bullosa (DEB)” at the Society for Investigative Dermatology 2022 Annual Meeting, taking place May 18-21 in Portland, Oregon. Krystal... Read More

Biologics License Application for B-VEC remains on track to file in the US in 2Q 2022 and Marketing Authorization in the EU on track to file in 2H 2022 FDA allows dosing at a patient’s home in the Open Label Extension Study of B-VEC for the treatment of DEB Positive Clinical Phase 1 (Pearl-1 Study) Efficacy Results for KB301 reported by Jeune Aesthetics, Inc., Krystal Biotech’s subsidiary Strong balance sheet, closing the... Read More

Krystal Biotech, Inc. , (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, today announced that Krish S. Krishnan, Chairman and Chief Executive Officer, will participate in the Bank of America Merrill Lynch Global Healthcare Conference. Details for the event are as follows: Bank of America Merrill Lynch Global Healthcare Conference Date: Tuesday, May 10, 2022 Time: 9:20am PDT Webcast Link:... Read More

Jeune Aesthetics, Inc. (“Jeune Aesthetics”), a wholly-owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) today announced the formation and members of its Scientific Advisory Board, comprised of industry leaders to serve as strategic advisors assisting with program strategy and clinical development. "I am immensely proud of the Scientific Advisory Board that we’ve assembled," said Bhushan Hardas, M.D.,... Read More

Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies, today announced that it plans to offer patients with dystrophic epidermolysis bullosa (DEB), who are enrolled in the GEM-3 open label extension study, the opportunity to be dosed in their homes by a health care professional (HCP). Krystal is offering this convenience to patients based on feedback from the U.S. Food and Drug... Read More

Treatment with B-VEC demonstrated robust functional COL7 expression followed by its assembly into basement membrane-associated anchoring fibrils Treatment with B-VEC improved durable wound closure in patients with recessive dystrophic epidermolysis bullosa (RDEB) compared with placebo with minimal adverse events Krystal Biotech, Inc. , (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases,... Read More