Filings & news by date
Hover (PC) or tap (mobile) a candle to see that day only
EXELIXIS, INC.
Exelixis announced that the FDA has extended the review period for its new drug application (NDA) for the combination of zanzalintinib and atezolizumab in metastatic colorectal cancer patients by three months. The extension follows the FDA's classification of updated safety and efficacy data as a major amendment, setting the new PDUFA action date to March 3, 2027.…more
EXELIXIS, INC.
On August 31, 2026, the U.S. Court of Appeals for the Federal Circuit affirmed the validity of three Exelixis patents (Nos. 11,091,439, 11,091,440, and 11,098,015). Consequently, the effective date for any FDA final approval of MSN's generic product cannot occur before January 15, 2030, the expiration date of these patents.…more
EXELIXIS, INC.
Exelixis, Inc. executive Mary C. Beckerle filed a Form 4 on August 12, 2026, reporting changes in beneficial ownership of securities as of August 10, 2026. This filing provides transparency regarding insider stock transactions, allowing investors to track changes in the executive's equity holdings.…more
7 more filings
Sign up free to unlock the full feed and real-time filing & news alerts.
Exelixis FDA Review Period for Zanzalintinib Extended by Three Months
The FDA has extended the review period for Exelixis's new drug application by three months after classifying submitted safety and efficacy data as a major amendment. The new target action date for the drug combination is now March 3, 2027.…more
●●●●●●●● ●●●●● ●●●●●●
Exelixis announced that the U.S. Court of Appeals affirmed the validity of three key patents covering its cabozantinib product. This ruling strengthens the company's position by upholding its intellectual property rights against MSN Laboratories.…more
1 more news items
Sign up free to unlock the full feed and real-time filing & news alerts.