Krystal Biotech to Release Interim Clinical Update on KB407 from Highest Dose Cohort of CORAL-1 Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 08 2026
0mins
Should l Buy KRYS?
Source: NASDAQ.COM
- Clinical Progress: Krystal Biotech is set to release an interim clinical update on January 8, 2026, focusing on results from the highest dose cohort of the CORAL-1 study, which is expected to provide molecular assessments of KB407 transduction and CFTR protein expression, potentially offering new treatment hope for cystic fibrosis patients.
- Study Design: CORAL-1 is an open-label, dose escalation study designed to evaluate daily inhalation of 10 billion PFU of KB407, including up to three dose escalation cohorts, demonstrating the company's ongoing commitment to innovative therapies for adult cystic fibrosis patients.
- Market Potential: With approximately 40,000 cystic fibrosis patients in the U.S. and an estimated 105,000 diagnosed globally, the demand for KB407 highlights significant market potential, and successful outcomes could substantially enhance Krystal Biotech's position in this therapeutic area.
- Financial Performance: In Q3 2025, Krystal reported $97.8 million in net product revenue from VYJUVEK, up from $83.84 million year-over-year, indicating strong commercialization progress in gene therapy and enhancing the attractiveness of its R&D pipeline.
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Analyst Views on KRYS
Wall Street analysts forecast KRYS stock price to fall
9 Analyst Rating
8 Buy
1 Hold
0 Sell
Strong Buy
Current: 270.260
Low
198.00
Averages
229.25
High
278.00
Current: 270.260
Low
198.00
Averages
229.25
High
278.00
About KRYS
Krystal Biotech, Inc. is an integrated, commercial-stage biotechnology company. The Company is focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Its product candidates in various stages of clinical and preclinical development include KB407, KB408, KB707, KB105, KB801, KB803, KB304 and KB301. Its commercial product, VYJUVEK, is a redosable gene therapy, and a genetic medicine approved in the United States and Europe for the treatment of dystrophic epidermolysis bullosa. KB407 is being developed for the treatment of Cystic Fibrosis. KB408 is being developed for the treatment of Alpha-1 Antitrypsin Deficiency, a rare lung disease. KB707 is being developed for the treatment of solid tumors. KB105 is being developed for TGM1-Deficient Autosomal Recessive Congenital Ichthyosis. KB803 is a redosable eye drop formulation of B-VEC, designed for the treatment of ocular complications.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Krystal Biotech to Announce Q4 Earnings on February 17
- Earnings Announcement: Krystal Biotech (KRYS) is set to release its Q4 2023 earnings on February 17 before market open, with consensus EPS estimates at $1.61, reflecting a modest year-over-year growth of 1.9%, indicating stable profitability.
- Revenue Expectations: The anticipated revenue for Q4 is $105.13 million, representing a 15.4% year-over-year increase, suggesting ongoing growth in market demand and product sales, which could bolster investor confidence.
- Historical Performance Review: Over the past two years, Krystal Biotech has only beaten EPS estimates 25% of the time and revenue estimates 50% of the time, indicating volatility in financial forecasting that may affect market expectations for future performance.
- Product Development Updates: Recently, Krystal Biotech showcased its KB707 program at the J.P. Morgan Healthcare Conference and received FDA RMAT status for its lung cancer therapy, highlighting potential in this area that could drive future revenue growth.
See More
Biotech Companies' Growth Prospects
- Krystal Biotech Growth: Krystal Biotech anticipates annual sales of $388 million for its skin disorder treatment Vyjuvek, representing a 34% increase from last year, which will fund further gene therapy developments.
- FDA Approval Acceleration: Krystal's KB707 recently received FDA's Regenerative Medicine Advanced Therapy designation, potentially speeding up its development for non-small cell lung cancer, thereby enhancing its market competitiveness.
- ARS Pharma Market Potential: The global epinephrine market is projected to reach $2.48 billion by 2025, and despite not being profitable yet, ARS Pharma's Neffy shows strong demand with rapid order uptake.
- Financial Comparison: ARS Pharma reported $51.8 million in revenue for the first nine months of 2025, a significant increase from $568,000 in the same period last year, although it posted a loss of $1.32 per share, its cash reserves are sufficient to sustain operations until profitability.
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Netflix Highlights a Rare Disease While Pearl Jam's Lead Singer Raises Funds for a Cure.
Nonprofit's Approach: A nonprofit organization is focusing on finding a cure for Epidermolysis Bullosa, a group of rare genetic skin disorders, by adopting a venture-capital-like strategy rather than traditional charity methods.
Goal Timeline: The organization aims to achieve its goal of finding a cure by the end of the decade.
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- Asset Allocation Shift: Celcuity now accounts for 6.7% of Soleus Capital's AUM, becoming its third-largest holding among 95 positions, reflecting investor interest in the biotechnology sector.
- Stock Performance: Celcuity's stock price surged 745% over the past year, significantly outperforming the S&P 500's 14.4% and NASDAQ Composite's 15.7%, highlighting strong market expectations for its future potential.
- Risk Advisory: Despite Celcuity's impressive stock performance, the company currently generates no revenue, necessitating caution from investors regarding inherent risks, as the stock's value is heavily reliant on drug approvals and future profitability prospects.
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Krystal Biotech Receives FDA RMAT Designation for KB707
- FDA Designation Progress: Krystal Biotech announced that its immunotherapy candidate KB707 has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, marking a significant milestone in its development for non-small cell lung cancer, potentially accelerating its clinical development timeline.
- Clinical Research Basis: This designation is based on early data from the ongoing KYANITE-1 study, which involves heavily pretreated advanced NSCLC patients receiving the gene therapy via inhalation, showing promising initial efficacy.
- Fast Track Advantages: With RMAT designation, KB707 becomes eligible for FDA's Fast Track and Breakthrough Therapy designations, which not only expedite the approval process but also facilitate closer and more frequent interactions with regulators to advance the drug's development.
- Innovative Mechanism of Action: KB707 is designed to target advanced or metastatic NSCLC by delivering cancer-targeting cytokines, interleukin-2 and interleukin-12, within the tumor microenvironment, showcasing its potential innovation and competitive edge in cancer treatment.
See More
Krystal Biotech Receives FDA RMAT Designation for KB707
- FDA Designation Progress: Krystal Biotech announced that its immunotherapy KB707 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating the therapy's potential in treating advanced non-small cell lung cancer (NSCLC) and reflecting the urgent need for new therapies.
- Clinical Evidence Support: The company provided early clinical evidence from its ongoing KYANITE-1 study, demonstrating significant antitumor activity of KB707 in heavily pre-treated advanced NSCLC patients, including durable responses and clinically meaningful tumor reductions, enhancing its market prospects.
- Accelerated Development Benefits: The RMAT designation will provide KB707 with all the benefits of the FDA's Fast Track and Breakthrough Therapy designations, including rolling review and close FDA guidance, thereby shortening the potential approval timeline and enhancing the company's competitiveness in the biotech sector.
- Future Outlook: With ongoing enrollment in the KYANITE-1 study, Krystal Biotech plans to present more research details at upcoming scientific conferences, further driving its innovation and market impact in the gene therapy field.
See More
Krystal Biotech to Announce Q4 Earnings on February 17
- Earnings Announcement: Krystal Biotech (KRYS) is set to release its Q4 2023 earnings on February 17 before market open, with consensus EPS estimates at $1.61, reflecting a modest year-over-year growth of 1.9%, indicating stable profitability.
- Revenue Expectations: The anticipated revenue for Q4 is $105.13 million, representing a 15.4% year-over-year increase, suggesting ongoing growth in market demand and product sales, which could bolster investor confidence.
- Historical Performance Review: Over the past two years, Krystal Biotech has only beaten EPS estimates 25% of the time and revenue estimates 50% of the time, indicating volatility in financial forecasting that may affect market expectations for future performance.
- Product Development Updates: Recently, Krystal Biotech showcased its KB707 program at the J.P. Morgan Healthcare Conference and received FDA RMAT status for its lung cancer therapy, highlighting potential in this area that could drive future revenue growth.
See More
Biotech Companies' Growth Prospects
- Krystal Biotech Growth: Krystal Biotech anticipates annual sales of $388 million for its skin disorder treatment Vyjuvek, representing a 34% increase from last year, which will fund further gene therapy developments.
- FDA Approval Acceleration: Krystal's KB707 recently received FDA's Regenerative Medicine Advanced Therapy designation, potentially speeding up its development for non-small cell lung cancer, thereby enhancing its market competitiveness.
- ARS Pharma Market Potential: The global epinephrine market is projected to reach $2.48 billion by 2025, and despite not being profitable yet, ARS Pharma's Neffy shows strong demand with rapid order uptake.
- Financial Comparison: ARS Pharma reported $51.8 million in revenue for the first nine months of 2025, a significant increase from $568,000 in the same period last year, although it posted a loss of $1.32 per share, its cash reserves are sufficient to sustain operations until profitability.
See More
Netflix Highlights a Rare Disease While Pearl Jam's Lead Singer Raises Funds for a Cure.
Nonprofit's Approach: A nonprofit organization is focusing on finding a cure for Epidermolysis Bullosa, a group of rare genetic skin disorders, by adopting a venture-capital-like strategy rather than traditional charity methods.
Goal Timeline: The organization aims to achieve its goal of finding a cure by the end of the decade.
See More
Soleus Capital Increases Stake in Celcuity
- Share Increase: Soleus Capital Management disclosed a purchase of 629,398 shares of Celcuity in an SEC filing, raising its total holdings to over 1.8 million shares valued at $180.36 million, indicating strong confidence in the company.
- Asset Allocation Shift: Celcuity now accounts for 6.7% of Soleus Capital's AUM, becoming its third-largest holding among 95 positions, reflecting investor interest in the biotechnology sector.
- Stock Performance: Celcuity's stock price surged 745% over the past year, significantly outperforming the S&P 500's 14.4% and NASDAQ Composite's 15.7%, highlighting strong market expectations for its future potential.
- Risk Advisory: Despite Celcuity's impressive stock performance, the company currently generates no revenue, necessitating caution from investors regarding inherent risks, as the stock's value is heavily reliant on drug approvals and future profitability prospects.
See More
Krystal Biotech Receives FDA RMAT Designation for KB707
- FDA Designation Progress: Krystal Biotech announced that its immunotherapy candidate KB707 has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, marking a significant milestone in its development for non-small cell lung cancer, potentially accelerating its clinical development timeline.
- Clinical Research Basis: This designation is based on early data from the ongoing KYANITE-1 study, which involves heavily pretreated advanced NSCLC patients receiving the gene therapy via inhalation, showing promising initial efficacy.
- Fast Track Advantages: With RMAT designation, KB707 becomes eligible for FDA's Fast Track and Breakthrough Therapy designations, which not only expedite the approval process but also facilitate closer and more frequent interactions with regulators to advance the drug's development.
- Innovative Mechanism of Action: KB707 is designed to target advanced or metastatic NSCLC by delivering cancer-targeting cytokines, interleukin-2 and interleukin-12, within the tumor microenvironment, showcasing its potential innovation and competitive edge in cancer treatment.
See More
Krystal Biotech Receives FDA RMAT Designation for KB707
- FDA Designation Progress: Krystal Biotech announced that its immunotherapy KB707 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating the therapy's potential in treating advanced non-small cell lung cancer (NSCLC) and reflecting the urgent need for new therapies.
- Clinical Evidence Support: The company provided early clinical evidence from its ongoing KYANITE-1 study, demonstrating significant antitumor activity of KB707 in heavily pre-treated advanced NSCLC patients, including durable responses and clinically meaningful tumor reductions, enhancing its market prospects.
- Accelerated Development Benefits: The RMAT designation will provide KB707 with all the benefits of the FDA's Fast Track and Breakthrough Therapy designations, including rolling review and close FDA guidance, thereby shortening the potential approval timeline and enhancing the company's competitiveness in the biotech sector.
- Future Outlook: With ongoing enrollment in the KYANITE-1 study, Krystal Biotech plans to present more research details at upcoming scientific conferences, further driving its innovation and market impact in the gene therapy field.
See More
