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PITTSBURGH - Krystal Biotech, Inc. (NASDAQ:KRYS), a $4.2 billion biotech company with impressive 93% gross margins and strong financial health according to InvestingPro, announced Thursday it has been granted an End of Phase 2 meeting with the U.S. Food and Drug Administration in October to discuss potential registration pathways for its inhaled KB707 immunotherapy treatment for non-small cell lung cancer (NSCLC).
The company is prioritizing the development of inhaled KB707, which is designed to express interleukin-2 and interleukin-12 in the tumor microenvironment to promote immune-mediated tumor clearance.
According to data presented at the 2025 American Society of Clinical Oncology Annual Meeting, the treatment showed a 36% objective response rate in heavily pre-treated NSCLC patients as of April 15, 2025. The company reported that median duration of response and progression-free survival were not reached at the time of data analysis.
"The acceleration of our work on inhaled KB707 is a reflection of both the clear and acute unmet need that exists for new treatments of NSCLC and the promising efficacy profile we have observed to date," said Suma Krishnan, President of Research and Development at Krystal Biotech.
The company continues to enroll patients in its KYANITE-1 study evaluating inhaled KB707 in patients with locally advanced or metastatic solid tumors of the lung. Meanwhile, enrollment in the OPAL-1 study for intratumoral KB707 has been paused, though patients already enrolled continue to be followed.
Krystal Biotech reported that inhaled KB707 has been generally well tolerated with no Grade 4 or 5 adverse events observed, and is suitable for outpatient administration.
The information in this article is based on a press release statement from Krystal Biotech. With revenue growth exceeding 116% in the last twelve months and currently trading below its Fair Value, Krystal presents an interesting case for investors. Get the full analysis and 10+ additional ProTips for KRYS with InvestingPro, including detailed insights from our comprehensive Pro Research Report.
In other recent news, Krystal Biotech reported stronger-than-expected earnings for the second quarter of 2025. The company achieved earnings per share of $1.29, surpassing the forecasted $1.22, while revenue reached $96.04 million, exceeding expectations of $92.24 million. Despite these positive earnings results, Krystal Biotech provided cautious guidance for the next quarter, which contributed to a decline in its stock. BofA Securities subsequently lowered its price target for Krystal Biotech from $192 to $182, maintaining a Buy rating due to concerns about the company’s near-term growth trajectory. The firm’s decision followed Krystal Biotech’s second-quarter Vyjuvek revenues of $96 million, which exceeded both BofA’s estimate of $95 million and consensus expectations of $92 million. Management indicated that third-quarter revenue might be lower than the second quarter due to patient pausing trends. These developments reflect the challenges Krystal Biotech faces despite its recent financial performance exceeding estimates.
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