Krystal Biotech Receives FDA RMAT Designation for KB707
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Should l Buy KRYS?
Source: seekingalpha
- 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.
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Analyst Views on KRYS
Wall Street analysts forecast KRYS stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for KRYS is 229.25 USD with a low forecast of 198.00 USD and a high forecast of 278.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
9 Analyst Rating
8 Buy
1 Hold
0 Sell
Strong Buy
Current: 272.740
Low
198.00
Averages
229.25
High
278.00
Current: 272.740
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 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 Rated as One of the Top Growth Stocks for the Next Decade
- Price Target Increase: Goldman Sachs analyst Andrea Tan raised Krystal Biotech's price target from $206 to $327, indicating a 16.7% upside from current levels, reflecting strong market confidence in its short-term growth potential.
- Strategic Program Development: The company is positioning itself for future growth with three registrational programs, KB801, KB803, and KB407, expected to support product launches around 2028, highlighting its strategic focus in the biotechnology sector.
- Investor Interest: Clear Street analyst William Maughan increased the price target from $288 to $338, offering a further 20.7% upside, emphasizing the sustained growth of Vyjuvek and the attractiveness of the company's expanding pipeline to investors.
- Neurotrophic Keratitis Market Potential: Analysts noted that KB801's potential in the neurotrophic keratitis market is a key focus for investors, with upcoming data releases expected to serve as significant catalysts for the stock's performance.
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- Technical Analysis Tool: Comparing the current stock price to the 200-day moving average can provide valuable insights for investors, helping to assess market trends and potential buying opportunities.
- ETF Trading Mechanism: Exchange-traded funds (ETFs) trade similarly to stocks, where investors buy and sell 'units' that can be created or destroyed based on demand, impacting the liquidity and market performance of the ETF.
- Inflows and Outflows Monitoring: Weekly monitoring of changes in ETF shares outstanding focuses on those experiencing significant inflows (new units created) or outflows (old units destroyed), allowing assessment of their impact on underlying assets.
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- Innovative Treatment Regimen: The study's use of CD19 CAR-NK cells combined with Roche's Rituxan allows outpatient treatment without chemotherapy, highlighting the therapy's strategic importance in terms of patient-friendliness and scalability.
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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 Rated as One of the Top Growth Stocks for the Next Decade
- Price Target Increase: Goldman Sachs analyst Andrea Tan raised Krystal Biotech's price target from $206 to $327, indicating a 16.7% upside from current levels, reflecting strong market confidence in its short-term growth potential.
- Strategic Program Development: The company is positioning itself for future growth with three registrational programs, KB801, KB803, and KB407, expected to support product launches around 2028, highlighting its strategic focus in the biotechnology sector.
- Investor Interest: Clear Street analyst William Maughan increased the price target from $288 to $338, offering a further 20.7% upside, emphasizing the sustained growth of Vyjuvek and the attractiveness of the company's expanding pipeline to investors.
- Neurotrophic Keratitis Market Potential: Analysts noted that KB801's potential in the neurotrophic keratitis market is a key focus for investors, with upcoming data releases expected to serve as significant catalysts for the stock's performance.
See More
Analysis of FBT Stock's 52-Week High and Low Points
- Price Fluctuation Analysis: FBT's stock has a 52-week low of $141.375 and a high of $224.9399, with the last trade at $220.41, indicating its price is nearing the high point, which may attract investor interest.
- Technical Analysis Tool: Comparing the current stock price to the 200-day moving average can provide valuable insights for investors, helping to assess market trends and potential buying opportunities.
- ETF Trading Mechanism: Exchange-traded funds (ETFs) trade similarly to stocks, where investors buy and sell 'units' that can be created or destroyed based on demand, impacting the liquidity and market performance of the ETF.
- Inflows and Outflows Monitoring: Weekly monitoring of changes in ETF shares outstanding focuses on those experiencing significant inflows (new units created) or outflows (old units destroyed), allowing assessment of their impact on underlying assets.
See More
ImmunityBio (IBRX) Shares Surge 39.8% on Positive QUILT-106 Study Data
- Efficacy Data Update: ImmunityBio's updated efficacy and safety data from the QUILT-106 clinical study show that patients receiving CD19 CAR-NK therapy achieved 100% disease control over 15 months, significantly enhancing the company's competitive position in the Waldenström non-Hodgkin lymphoma space.
- Innovative Treatment Regimen: The study's use of CD19 CAR-NK cells combined with Roche's Rituxan allows outpatient treatment without chemotherapy, highlighting the therapy's strategic importance in terms of patient-friendliness and scalability.
- Strong Market Reaction: ImmunityBio's stock surged 106% over the past six months, significantly outpacing the industry's 22.1% growth, reflecting strong market confidence in its new therapy and positive investor sentiment.
- Future Development Plans: ImmunityBio aims to submit a biologics license application to the FDA by the end of 2026, with full enrollment in the QUILT-2.005 study expected to further bolster the company's market position in treating BCG-unresponsive bladder cancer.
See More
S&P 500 Futures Decline in Pre-Market Trading; Tempus AI and Klarna Group Take the Lead
Stock Market Opening: U.S. stock markets are set to open in two hours.
Tempus AI Inc. Performance: Tempus AI Inc. (TEM) saw a 12.4% increase in pre-market trading.
Klarna Group PLC Performance: Klarna Group PLC (KLAR) experienced a 6.6% rise in pre-market trading.
Market Sentiment: The pre-market gains indicate positive sentiment for both companies ahead of the market opening.
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