Welcome to our dedicated page for Exelixis news (Ticker: EXEL), a resource for investors and traders seeking the latest updates and insights on Exelixis stock.
Exelixis Inc. (symbol: EXEL) is a leading biopharmaceutical company that specializes in the discovery, development, and commercialization of small molecule therapies aimed at improving cancer treatment. Founded in the early 1990s, Exelixis has dedicated the past decade to establishing a robust development platform to bring new, effective cancer therapies to patients in need.
Exelixis’s flagship product, Cometriq® (cabozantinib), received its initial regulatory approval in late 2012 and has since been a cornerstone in the company’s portfolio. Cometriq is prescribed for the treatment of metastatic medullary thyroid cancer, while its variant Cabometyx is used for treating kidney and liver cancers.
Another significant achievement is the development and commercialization of Cotellic in partnership with Roche, targeted at melanoma treatment. These therapies have not only enhanced Exelixis’s market presence but also brought substantial improvements in patient outcomes.
Exelixis remains steadfast in its commitment to clinical excellence and patient care, consistently exploring new avenues for innovative cancer treatments. The company continues to engage in rigorous research and development activities, underpinned by strategic partnerships and collaborations.
Financially, Exelixis has shown solid performance with steady revenue growth driven by its commercial products and a promising pipeline of new therapies under development. The company’s dedication to research, patient care, and financial prudence makes it a notable entity in the biopharmaceutical landscape.
For more information about Exelixis and potential job opportunities, please visit their official website at www.exelixis.com.
Sairopa B.V. has achieved a significant milestone in its partnership with Exelixis (NASDAQ: EXEL) regarding ADU-1805, an anti-SIRPα antibody for cancer treatment. The collaboration has generated substantial payments, including a $40 million upfront payment, $35 million for IND clearance, and an additional $35 million in clinical development milestones. The agreement grants Exelixis an exclusive option for worldwide development and commercialization rights following phase 1 clinical studies data review.
ADU-1805 is currently in a first-in-human phase 1 study across the U.S. and Europe, evaluating both monotherapy and combination treatment with pembrolizumab. The partnership combines Exelixis' oncology expertise with Sairopa's immunotherapy capabilities.
Exelixis (NASDAQ: EXEL) has announced its participation in two major healthcare investor conferences this December. The company will present at the Piper Sandler 36th Annual Healthcare Conference in New York City on December 3 at 8:30 a.m. ET, and at the Citi 2024 Global Healthcare Conference in Miami on December 4 at 1:45 p.m. ET. Both fireside chats will be accessible via webcast on www.exelixis.com under the Investors & News section, with replays available for at least 30 days after the events.
Exelixis (EXEL) announced that the FDA will discuss their supplemental New Drug Application (sNDA) for CABOMETYX® at an Oncologic Drugs Advisory Committee meeting in March 2025. The application seeks approval for treating previously treated advanced pancreatic and extra-pancreatic neuroendocrine tumors. The FDA has set a target action date of April 3, 2025, following the orphan drug designation granted in August 2024.
The sNDA is supported by the phase 3 CABINET trial, which demonstrated significant improvements in progression-free survival compared to placebo, leading to early trial termination and allowing placebo patients to cross over to CABOMETYX® treatment. Final results confirmed statistically significant benefits across all clinical subgroups.
Exelixis (Nasdaq: EXEL) will participate in fireside chats at three investor conferences in November. The events are:
- Guggenheim’s Inaugural Healthcare Innovation Conference on November 12 at 9:00 a.m. ET in Boston.
- Stifel 2024 Healthcare Conference on November 18 at 10:20 a.m. ET in New York City.
- Jefferies London Healthcare Conference on November 19 at 10:30 a.m. BST in London, UK.
Webcasts of these presentations will be accessible via the Exelixis website under the Event Calendar page in the Investors & News section. Replays will be available for 30 days.
Exelixis (EXEL) reported strong Q3 2024 financial results with total revenues of $539.5 million, including net product revenues of $478.1 million from its cabozantinib franchise. The company achieved GAAP diluted EPS of $0.40 and non-GAAP diluted EPS of $0.47. Following strong commercial performance, Exelixis increased its 2024 guidance for total revenues to $2.150-$2.200 billion. The company received a favorable ruling on cabozantinib patent litigation and expanded its zanzalintinib development program through a new collaboration with Merck.
Exelixis (Nasdaq: EXEL) has announced the release date for its third quarter 2024 financial results. The results will be disclosed on Tuesday, October 29, 2024, after the markets close. Following the release, Exelixis management will host a conference call and webcast at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results and provide a general business update.
Interested parties can access the event via the Internet from the company's website. To join the conference call, registration is required through a provided link, which will supply a dial-in number and unique PIN. The live webcast can be accessed through the Event Calendar page under the Investors & News section of www.exelixis.com. A replay of the webcast will be archived on the company's website for one year.
Exelixis, Inc. (Nasdaq: EXEL) announced a favorable ruling in its patent litigation against MSN Laboratories. The U.S. District Court for the District of Delaware upheld the validity of three Orange Book-listed patents related to cabozantinib, rejecting MSN's challenge. These patents expire on January 15, 2030. The court also ruled that Exelixis' pharmaceutical composition patent is not invalid and not infringed by MSN's proposed ANDA product.
Previously, MSN had stipulated that its proposed generic cabozantinib product would infringe the patents in question. As a result of this ruling, the earliest MSN may launch its generic product in the U.S. is January 15, 2030, subject to appeals and regulatory exclusivity. Exelixis expressed confidence in its cabozantinib patent estate and commitment to defending its intellectual property rights.
Exelixis (EXEL) and Merck (MRK) have announced a clinical development collaboration to evaluate combinations of Exelixis' investigational tyrosine kinase inhibitor zanzalintinib with Merck's therapies in head and neck cancer and renal cell carcinoma (RCC). The collaboration includes:
1. A phase 3 trial combining zanzalintinib with KEYTRUDA (pembrolizumab) for head and neck squamous cell carcinoma (HNSCC).
2. A phase 1/2 trial and two phase 3 trials combining zanzalintinib with WELIREG (belzutifan) for RCC.
Merck will supply KEYTRUDA for the ongoing STELLAR-305 trial in HNSCC and sponsor the RCC trials. Exelixis will co-fund some studies and supply zanzalintinib and cabozantinib. Exelixis retains global commercial rights to zanzalintinib.
Exelixis (EXEL) announced final results from the phase 3 CABINET study evaluating cabozantinib in advanced neuroendocrine tumors (NET). The study showed significant improvement in progression-free survival (PFS) versus placebo in both pancreatic NET (pNET) and extra-pancreatic NET (epNET) cohorts:
- pNET cohort: median PFS of 13.8 months for cabozantinib vs 4.4 months for placebo (HR 0.23, p<0.0001)
- epNET cohort: median PFS of 8.4 months vs 3.9 months (HR 0.38, p<0.0001)
The data supported Exelixis' supplemental New Drug Application to the FDA for cabozantinib in advanced NET, with a target action date of April 3, 2025. The safety profile was consistent with known data, and no new signals were identified.
Exelixis (EXEL) presented final overall survival (OS) results from the CONTACT-02 phase 3 study evaluating cabozantinib (CABOMETYX®) with atezolizumab in metastatic castration-resistant prostate cancer (mCRPC) at ESMO 2024. The study showed a numerical but not statistically significant improvement in OS favoring the combination (HR: 0.89; P=0.296). Notably, improved OS was observed in patients with bone or liver metastases. The combination demonstrated a manageable safety profile with treatment-related grade 3-4 adverse events occurring in 40% of patients. Exelixis plans to submit a supplemental New Drug Application for this combination in mCRPC later this year, based on the previously reported statistically significant progression-free survival benefit.
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