On Wednesday, Exelixis Inc . (NASDAQ:EXEL) shares received a reiteration of an Equal Weight rating and a $29.00 price target from a Stephens research analyst. This follows the company's announcement on Tuesday that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting for March 2025.
The meeting will discuss Exelixis's supplemental New Drug Application (sNDA) for CABOMETYX (Cabo), aimed at treating patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors (pNET/epNET).
The Prescription Drug User Fee Act (PDUFA) target action date remains April 3, 2025. This date is critical as it is when the FDA is expected to make a decision regarding the label expansion approval for CABOMETYX. The timeline follows a positive recommendation in August 2023 by the Alliance for Clinical Trials in Oncology's independent Data and Safety Monitoring Board.
The Board advised unblinding and crossover from placebo in clinical trials due to an observed improvement in progression-free survival (PFS) from Cabo treatment.
The upcoming ODAC meeting introduces a new layer of uncertainty for Exelixis as the committee's recommendation could influence the FDA's final decision. The analyst's commentary suggests that the outcome of the ODAC review is anticipated with interest, given the potential impact on CABOMETYX's market growth and the company's future.
Exelixis's stock rating and price target have been maintained by Stephens as the market awaits further clarity on the path forward for CABOMETYX. The analyst's statement indicates a watchful approach as the company navigates through the upcoming regulatory milestones.
In other recent news, Exelixis, Inc. has demonstrated robust financial performance in its Third Quarter 2024 Earnings Call. The company reported a 9% increase in net product revenues from the previous quarter, reaching $478 million, and a 12% increase year-over-year. This growth prompted Exelixis to raise its full-year revenue guidance for 2024, projecting that U.S. sales could approach $3 billion by 2030.
Further, the company highlighted its expanding oncology portfolio, including a collaboration with Merck (NS:PROR) for zanzalintinib (Zanza), and its focus on pivotal trials and product launches starting in 2024. Exelixis also reported total revenues of approximately $539.5 million for Q3 2024, with the cabozantinib franchise contributing $478 million.
These recent developments indicate a strong financial trajectory for Exelixis, with no reported challenges or setbacks during the call. The company's strategic initiatives, including its collaboration with Merck and favorable litigation outcomes, position it well for continued growth in the oncology market.
InvestingPro Insights
As Exelixis (NASDAQ:EXEL) approaches its critical FDA milestones for CABOMETYX, recent financial data and market performance provide additional context for investors. According to InvestingPro, Exelixis has shown strong financial health and market momentum. The company's revenue grew by 17.31% over the last twelve months, reaching $2.08 billion, with a remarkable gross profit margin of 96.25%. This robust financial performance aligns with the potential expansion of CABOMETYX's market reach.
InvestingPro Tips highlight that Exelixis holds more cash than debt on its balance sheet, indicating financial stability as it navigates the regulatory process. Additionally, the company's net income is expected to grow this year, which could provide a buffer against potential setbacks or delays in the FDA approval process.
The market has responded positively to Exelixis's prospects, with the stock showing a strong return of 68.67% over the past year and trading near its 52-week high. This performance suggests investor confidence in the company's pipeline and current product portfolio, including CABOMETYX.
For investors seeking a deeper understanding of Exelixis's potential, InvestingPro offers 16 additional tips, providing a comprehensive view of the company's financial health and market position.
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