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) reported strong financial results for Q4 and full year 2024. Q4 revenues increased 116% to $91.1 million, while full-year revenues grew 473% to $290.5 million compared to 2023. The company ended Q4 with $749.6 million in cash and investments.
VYJUVEK, their treatment for Dystrophic Epidermolysis Bullosa, achieved a 95% gross margin in Q4 and secured over 510 reimbursement approvals in the U.S., with 97% coverage under commercial and Medicaid plans. Patient compliance remained strong at 85%.
The company reported Q4 net income of $45.5 million ($1.58 per share basic) and full-year net income of $89.2 million ($3.12 per share basic). Clinical progress includes positive developments in their CF, AATD, and oncology programs, with KB707 showing a 27% objective response rate in lung cancer patients.
Krystal Biotech (NASDAQ: KRYS), a commercial-stage biotechnology company, has announced it will release its fourth quarter and full year 2024 financial results on Wednesday, February 19, 2025, 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 financial results and provide a business update.
A live webcast will be accessible to investors and the public, with a 30-day replay available on the company's investor relations website.
Jeune Aesthetics, a subsidiary of Krystal Biotech (NASDAQ: KRYS), has appointed Nishant Saxena as Chief Financial Officer, effective January 15, 2025. Saxena brings over 20 years of experience in finance, strategy, capital markets, M&A, and corporate development. He previously served as Managing Director at Evercore's healthcare group, where he advised on transactions exceeding $500 billion in total value.
In his 15+ years at Evercore, Saxena led numerous client engagements including mergers, IPOs, private placements, and structured financings. He holds both a B.S. in Economics and an MBA from the Wharton School. The appointment comes as Jeune prepares to advance its lead program into Phase 2 later in 2025, building on promising KB301 Phase 1 data in addressing aged skin treatments.
Krystal Biotech (NASDAQ: KRYS) reported promising preliminary results from its KYANITE-1 study evaluating inhaled KB707 in lung tumor patients. The study showed significant efficacy in non-small cell lung cancer (NSCLC) patients, with a 27% objective response rate (ORR) and 73% disease control rate (DCR).
The trial involved 37 patients, including 17 with advanced NSCLC. Among 11 evaluable NSCLC patients, who had received median 4 prior therapy lines, KB707 demonstrated notable results with 7 patients still on treatment. In lung lesions specifically, the ORR was 36% with three partial responses and one complete response.
Based on these positive results, Krystal Biotech has expanded the study to include combination therapy cohorts with anti-PD-1 therapy and chemotherapy. The treatment has been generally well-tolerated with mostly mild to moderate adverse events.
Krystal Biotech (NASDAQ: KRYS) announced clinical updates for its inhaled genetic medicine programs KB408 and KB407. The KB408 Phase 1 SERPENTINE-1 study showed successful SERPINA1 gene delivery and AAT expression in AATD patients. In two patients receiving bronchoscopies, conducting airway epithelial cells showed significant increases in AAT expression (35-39%) after KB408 dosing. One patient demonstrated an 8-fold increase in lung AAT levels and over 50% reduction in active neutrophil elastase.
The KB407 Phase 1 CORAL-1 study for cystic fibrosis received conditional sanctioning from CFF TDN. Five patients have been enrolled, with three receiving single doses and three receiving two daily doses. Both KB408 and KB407 demonstrated favorable safety profiles with only mild to moderate, transient adverse events reported. Additional data updates are expected in 2025.
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.
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