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Piper Sandler has maintained an Overweight rating and $140.00 price target for Glaukos Corporation (NYSE: NYSE:GKOS), following the company's announcement of positive results from their Phase 3 trial of Epioxa (Epi-on) for treating keratoconus.
The trial met its primary efficacy endpoint, showing a significant improvement in Kmax at 12 months. This successful second Phase 3 trial adds to the first completed trial, setting the stage for a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by the end of 2024, as anticipated.
The management of Glaukos has completed a promising pre-NDA meeting with the FDA. With this progress, approval for Epioxa is expected in the early fourth quarter of 2025, assuming a 10-month review period after submission. The treatment represents an advancement over the current standard of care, preserving the corneal epithelium and potentially reducing procedure times for patients.
In other recent news, Glaukos Corporation has reported significant developments in its operations and financial performance. The company announced successful results from its second Phase 3 trial for Epioxa, a non-invasive drug therapy designed for keratoconus treatment.
The trial met its primary efficacy endpoint, demonstrating a significant improvement in corneal curvature. The positive results from this trial are expected to support Glaukos' New Drug Application submission to the FDA by the end of 2024.
Glaukos also reported a notable 19% increase in consolidated net sales for the second quarter, reaching $95.7 million. This robust performance led the company to revise its full-year 2024 net sales guidance upwards to between $370 and $376 million. The growth was primarily attributed to the success of its US interventional glaucoma franchises, including the iStent portfolio and iDose TR.
The company also announced the redemption of its outstanding 2.75% Convertible Senior Notes due 2027, with a principal amount of $57.5 million. This move is part of Glaukos' financial management strategy.
On the analyst front, both BTIG and Stifel maintained a positive outlook on Glaukos. BTIG reaffirmed its Buy rating with a steady price target of $139.00, while Stifel raised its price target to $145 from $130.
InvestingPro Insights
Glaukos Corporation's recent positive Phase 3 trial results for Epioxa align with the company's strong market performance and growth trajectory. According to InvestingPro data, Glaukos has demonstrated impressive revenue growth, with a 19.02% increase in quarterly revenue as of Q2 2024. This growth is reflected in the stock's performance, with a remarkable 86.26% price total return over the past year.
InvestingPro Tips highlight that Glaukos is trading near its 52-week high, with the current price at 93.85% of its peak. This aligns with the positive sentiment surrounding the company's pipeline developments, including Epioxa and iDose. Additionally, the company operates with a moderate level of debt, which could provide financial flexibility as it moves towards the NDA submission for Epioxa.
It's worth noting that while Glaukos shows strong revenue growth and market performance, it is not currently profitable. An InvestingPro Tip indicates that analysts do not anticipate the company will be profitable this year. This is consistent with the company's focus on research and development in advancing treatments like Epioxa.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Glaukos, providing a deeper understanding of the company's financial health and market position.
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