Exelixis Inc - EXEL STOCK NEWS

Exelixis reported impressive financial results for Q2 2021, with total revenues reaching $385.2 million, a 48% increase from Q2 2020. Net product revenues from CABOMETYX rose 59% year over year, driven by strong adoption of the CABOMETYX and OPDIVO combination therapy for renal cell carcinoma. The company has raised its revenue guidance for 2021, projecting total revenues between $1.3 billion and $1.4 billion. Key milestones include a supplemental NDA filing for cabozantinib in thyroid cancer and promising results from clinical trials.

Exelixis (NASDAQ: EXEL) announced the FDA's acceptance of its supplemental New Drug Application (sNDA) for CABOMETYX^® (cabozantinib) to treat patients aged 12 and older with radioactive iodine-refractory differentiated thyroid cancer. The FDA has granted Priority Review, with a PDUFA target action date of December 4, 2021. The sNDA is based on promising results from the COSMIC-311 pivotal trial that indicated significant progression-free survival benefits. This development could position CABOMETYX as a critical treatment option for patients lacking standard care.

Exelixis, Inc. (Nasdaq: EXEL) will release its second quarter 2021 financial results on August 5, 2021, post-market close. A conference call is scheduled at 5:00 p.m. EDT to discuss the results and provide a business update. Access to the call will be available on their website and via phone. Exelixis focuses on oncology and has developed four commercial products, including CABOMETYX and COTELLIC, with ongoing partnerships to advance cancer therapies.

Exelixis, Inc. (Nasdaq: EXEL) announced that Dr. Peter Lamb, its Executive VP and Chief Scientific Officer, will present at the William Blair Biotech Focus Conference on July 15, 2021, at 2:00 p.m. EDT. Interested participants can access the webcast via www.exelixis.com and should connect 15 minutes early. A replay will be available for 14 days. Founded in 1994, Exelixis focuses on oncology and has developed four commercial products, including CABOMETYX and COMETRIQ, while also collaborating with leading pharmaceutical companies.

Exelixis and Ipsen announced the positive results of their pivotal phase 3 COSMIC-312 trial, evaluating cabozantinib with atezolizumab in advanced hepatocellular carcinoma (HCC) patients. The trial met its primary endpoint, showing a 37% reduction in disease progression or death with cabozantinib compared to sorafenib (P=0.0012). However, the secondary endpoint of overall survival did not reach statistical significance, with Exelixis anticipating low probability of achieving this at final analysis, expected in early 2022. The results will inform potential regulatory filing with the FDA.

Exelixis, Inc. (Nasdaq: EXEL) announced that Dr. Gisela M. Schwab, its President and Chief Medical Officer, is on medical leave. Dr. Schwab has been a key figure for 15 years, and her team will continue leading product development and medical affairs during her absence. The company remains focused on 2021 priorities, including upcoming results from the COSMIC-312 trial and potential regulatory filings for cabozantinib. Exelixis, recognized for its oncology innovations, emphasizes a commitment to advancing its drug pipeline while maintaining business continuity.

Exelixis, Inc. (Nasdaq: EXEL) has announced a collaboration with Bristol-Myers Squibb Company for the STELLAR-002 clinical trial, evaluating the combination of XL092 with immuno-oncology therapies for advanced solid tumors. This phase 1b trial will assess the safety and efficacy of XL092, a next-generation tyrosine kinase inhibitor, alongside nivolumab, ipilimumab, and bempegaldesleukin in patients with genitourinary cancers. The trial aims to explore treatment options for those with limited options following disease progression.

Exelixis and Ipsen announced detailed results from the phase 3 COSMIC-311 trial of cabozantinib (CABOMETYX®) in treating radioactive iodine-refractory differentiated thyroid cancer. The trial met its co-primary endpoint, showing a 78% reduction in disease progression risk compared to placebo. Median progression-free survival (PFS) was not reached for cabozantinib, while it was 1.9 months for placebo. The FDA has received a supplemental New Drug Application for cabozantinib, aiming to address urgent treatment needs in this patient population.

Exelixis, Inc. (NASDAQ: EXEL) reported encouraging Phase 2 trial results for CABOMETYX^® (cabozantinib) combined with OPDIVO^® (nivolumab) in treating advanced non-clear cell renal cell carcinoma (nccRCC). The regimen showed a 47.5% objective response rate (ORR) in patients with papillary histology. The trial involved 47 patients with median follow-up of 13.1 months. Adverse events were noted in 17% of CABOMETYX and 13% of OPDIVO patients, with hypertension and diarrhea being the most common severe reactions. This data will be presented at the 2021 ASCO Annual Meeting.