Welcome to our dedicated page for Krystal Biotech news (Ticker: KRYS), a resource for investors and traders seeking the latest updates and insights on Krystal Biotech stock.
Krystal Biotech, Inc. (KRYS) is a leader in redosable gene therapies targeting rare dermatological conditions and respiratory diseases through its proprietary HSV-1 delivery platform. This page aggregates official press releases, clinical trial updates, and regulatory developments directly from the company.
Investors and researchers can monitor progress across four key areas: dermatology (including VYJUVEK commercialization), oncology (KB707 cytokine therapy), respiratory (inhaled genetic medicines), and aesthetic medicine through subsidiary Jeune Aesthetics. All content is sourced from verified corporate communications.
Bookmark this page for real-time updates on FDA submissions, partnership announcements, and financial results. Our curation ensures you never miss critical developments in KRYS's mission to transform genetic medicine delivery.
Krystal Biotech (NASDAQ: KRYS) provided an update on the European Medicines Agency's (EMA) review of B-VEC for dystrophic epidermolysis bullosa (DEB). The EMA's Committee for Medicinal Products for Human Use (CHMP) cancelled the scheduled Oral Explanation and requested written responses to remaining issues. Notably, there are no Major Objections outstanding regarding B-VEC's full approval. The company now expects a CHMP opinion in 1Q 2025, while maintaining its planned commercial launch in Germany for Q2 2025.
Krystal Biotech (NASDAQ: KRYS) has announced its participation in two upcoming investor conferences. Chairman and CEO Krish S. Krishnan will participate in fireside chats at Citi's 2024 Global Healthcare Conference on December 3 at 8:45 am ET in Miami, Florida, and the 7th Annual Evercore HealthCONx Conference on December 4 at 2:10 pm ET in Coral Gables, Florida. Both presentations will be available via webcast on the company's website's Investors section, with recordings accessible for at least 30 days afterward.
Krystal Biotech (NASDAQ: KRYS) announced its participation in the Stifel 2024 Healthcare Conference on November 18, 2024, in New York. Chairman and CEO Krish S. Krishnan will participate in a fireside chat at 10:55 am ET and conduct investor meetings throughout the day. The presentation will be accessible via webcast and will be available on the company's website's Investors section.
Krystal Biotech (NASDAQ: KRYS) has announced its participation in the upcoming Guggenheim Securities Healthcare Innovation Conference in Boston on November 12, 2024. Krish S. Krishnan, Chairman and CEO, will participate in a fireside chat at 1:30 pm ET and conduct investor meetings throughout the day. The presentation will be accessible via webcast and will be available on the company's Investors section of their website.
Krystal Biotech (KRYS) reported strong Q3 2024 financial results with net product revenue of $83.8 million and total revenue of $250.1 million since VYJUVEK's launch in August 2023. The company secured over 460 reimbursement approvals in the U.S. with 97% coverage under commercial and Medicaid plans. The quarter ended with $694.2 million in cash and investments. Key developments include JNDA filing for B-VEC in Japan, French early access approval, and positive Phase 1 results for KB301. The company maintained a strong 92% gross margin and reported net income of $27.2 million, or $0.95 per basic share.
Krystal Biotech (NASDAQ: KRYS) has scheduled its third quarter 2024 financial results announcement for Monday, November 4, 2024, before U.S. markets open. The company's management will host a conference call and webcast at 8:30 am ET on the same day to discuss the results and provide a business update. A live webcast will be available, and a replay will be accessible for 30 days on the company's investor website.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has announced its participation in the 2024 Cantor Global Healthcare Conference on September 18, 2024, in New York. Krish S. Krishnan, Chairman and CEO, will engage in a fireside chat at 1:20 pm ET and conduct investor meetings throughout the day.
A webcast of the presentation will be available starting at 1:20 pm ET on Wednesday, September 18, 2024, and will be accessible on the Investors section of the company's website. This event provides an opportunity for Krystal Biotech to showcase its developments and engage with investors in the healthcare sector.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference on September 10, 2024, in New York. Krish S. Krishnan, Chairman and CEO, will deliver a company presentation at 12:30 pm ET and engage in investor meetings throughout the day.
A webcast of the presentation will be available starting at 12:30 pm ET on Tuesday, September 10, 2024, accessible through a provided link and subsequently posted on the Investors section of the company's website. This event presents an opportunity for Krystal Biotech to showcase its progress and engage with potential investors in a prominent global investment forum.
Jeune Aesthetics, a subsidiary of Krystal Biotech (NASDAQ: KRYS), announced positive interim safety and efficacy results from Phase 1 study PEARL-1 for KB301, an investigational aesthetic treatment. The study evaluated KB301 for improving lateral canthal lines and dynamic wrinkles of the décolleté.
Key findings include:
- 94% of décolleté subjects showed improvement in wrinkles after two months
- 75% of lateral canthal subjects showed improvement in wrinkles after two months
- Improvements were also seen in crepiness, hydration, and radiance
- The safety profile was consistent with prior clinical experience
Based on these results, Jeune will progress KB301 into Phase 2 development for treating dynamic wrinkles of the décolleté. A conference call to discuss results is scheduled for August 28, 2024.
Krystal Biotech (NASDAQ: KRYS) reported strong Q2 2024 financial results, with net product revenue of $70.3 million, up 55.3% from Q1. VYJUVEK, their treatment for Dystrophic Epidermolysis Bullosa, has generated $166.2 million since launch in August 2023. The company secured over 400 reimbursement approvals in the U.S., with 97% positive access determinations for commercial and Medicaid plans. Krystal ended Q2 with $628.9 million in cash and investments.
The company expects three clinical readouts in H2 2024, including KB301 for aesthetics, KB408 for alpha-1 antitrypsin deficiency, and KB707 for solid tumors. Krystal is advancing its pipeline across respiratory, ophthalmology, oncology, and dermatology indications. For FY2024, they anticipate $150-$175 million in non-GAAP R&D and SG&A expenses.
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