ALAMEDA, Calif. - Exelixis, Inc. (NASDAQ:EXEL) announced the FDA acceptance of its supplemental New Drug Application (sNDA) for cabozantinib, marketed as CABOMETYX®, for treating certain advanced neuroendocrine tumors (NET). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for April 3, 2025.
The sNDA submission is supported by data from the phase 3 CABINET trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients with advanced pancreatic neuroendocrine tumors (pNET) and extra-pancreatic NET (epNET) compared to placebo. The trial was halted early due to these positive interim results, allowing placebo patients to switch to cabozantinib.
The FDA also granted orphan drug designation to cabozantinib for the treatment of pNET, acknowledging the therapy's potential for treating a rare condition. The CABINET study, sponsored by the National Cancer Institute (NCI) and conducted by the NCI-funded Alliance for Clinical Trials in Oncology, enrolled 290 patients across the United States.
Amy Peterson, M.D., Executive Vice President of Product Development & Medical Affairs and Chief Medical Officer at Exelixis, expressed the company's commitment to bringing cabozantinib to patients with limited treatment options. Final trial results will be presented at the ESMO Congress on September 16th in Barcelona, Spain.
NETs are a type of cancer originating from neuroendocrine cells and can develop in various body parts, commonly the gastrointestinal tract and lungs. Treatment options for advanced NET patients include somatostatin analogs, chemotherapy, targeted therapy, and peptide-receptor radionuclide therapy.
CABOMETYX is currently approved in the U.S. for several indications, including advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC), among others. However, it is not yet indicated for NET treatment. The safety profile of cabozantinib includes warnings for severe hemorrhage, fistulas, thrombotic events, hypertension, and other adverse reactions.
This article is based on a press release statement from Exelixis, Inc.
In other recent news, Exelixis Inc . has been the focus of several key developments. The biopharmaceutical company recently reached a settlement agreement with Cipla over patent litigations tied to Cabometyx, a cancer treatment drug. This settlement allows Cipla to market a generic version of Cabometyx in the United States starting January 1, 2031, subject to FDA approval.
This resolution, seen as a testament to Exelixis's efforts to protect its intellectual property, has been positively received by analysts. Citi analyst David Lebowitz reiterated a Buy rating with a $31.00 price target, while BMO Capital Markets maintained its Outperform rating and a $29.00 price target. Stephens also initiated coverage on Exelixis with an Overweight rating and a $23.00 price target, citing the success of the Cabometyx franchise.
The outcomes of these patent litigations are crucial for Exelixis, as they could impact the company's market exclusivity period for Cabometyx. The final ruling on the ongoing MSN II patent litigation is expected soon and will provide further clarity on the company's future market exclusivity period. These developments are being closely watched by investors and market watchers alike.
InvestingPro Insights
Exelixis, Inc. (NASDAQ:EXEL) has shown a strong commitment to expanding the indications for its flagship drug, CABOMETYX®, with the FDA's acceptance of its sNDA for treating advanced neuroendocrine tumors (NET) under review. This dedication to product development is mirrored in the company's financial health and market performance, as evidenced by real-time data and analysis from InvestingPro.
InvestingPro Data indicates a robust market capitalization of $6.85 billion for Exelixis, reflecting investor confidence in the company's potential for growth. The company's price-to-earnings (P/E) ratio stands at 29.58 for the last twelve months as of Q1 2024, suggesting that investors are willing to pay a higher price for its earnings potential. Moreover, Exelixis has demonstrated a solid revenue growth of 10.98% during the same period, underlining its ability to increase sales effectively.
Two notable InvestingPro Tips highlight the company's strategic financial management: Exelixis has been aggressively buying back shares, which can indicate confidence from management in the company's future prospects. Furthermore, it holds more cash than debt on its balance sheet, providing financial stability and flexibility to navigate market conditions and invest in growth opportunities.
InvestingPro provides additional insights into Exelixis, Inc., including a total of 14 InvestingPro Tips that can offer investors a deeper understanding of the company's financial nuances and market position. For example, investors might be interested to know that analysts have revised their earnings upwards for the upcoming period, and the company is trading at a low P/E ratio relative to near-term earnings growth, indicating potential undervaluation. Interested readers can find more detailed analysis and tips on Exelixis by visiting InvestingPro at https://www.investing.com/pro/EXEL.
As Exelixis continues to innovate in the oncology space, these financial metrics and insights provide investors with a clearer picture of the company's current market standing and future potential, particularly as it awaits the PDUFA target action date for its expanded indication of CABOMETYX®.
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