Exelixis Inc (EXEL) News & Events

$69.390

+3.345 (+4.82%)At close

EXEL News

9.010-25Fool

Exelixis Faces FDA Review Delay for Zanzalintinib

8.510-14PRnewswire

Rapid Growth in Cancer Drug Market Forecasted

9.009-11stocktwits

FDA Extends Exelixis Drug Review Deadline to 2027

4.509-11Yahoo Finance

Healthcare Stocks Decline Late Friday

9.009-11Newsfilter

FDA Extends Exelixis NDA Review for Zanzalintinib to March 2027

7.509-03NASDAQ.COM

Biotech Stocks Reach 52-Week Highs Driven by Regulatory Milestones

7.008-31Newsfilter

Exelixis Wins Key Patent Lawsuit Affirmation

9.508-17PRnewswire

Exelixis Reports Q2 Revenue Miss, Shares Drop

7.008-16Newsfilter

Exelixis Under Investigation by Shareholder Rights Law Firm

9.508-13Newsfilter

Exelixis Reports Q2 Earnings Miss, Stock Declines

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EXEL Events

10/29 17:02

Exelixis Sees FY26 Revenue of $2.5B-$2.55B

Exelixis sees FY26 revenue $2.5B-$2.55B, consensus $2.55B

10/29 17:00

Exelixis Q3 Revenue $658.7M Beats Expectations

Reports Q3 revenue $658.7M, consensus $646.51M. "Exelixis continued to execute across all of our key priorities in the third quarter, driving the cabozantinib franchise forward while preparing for zanzalintinib as our next potential franchise opportunity," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "The zanzalintinib development program gained further momentum as the organization focused on trial initiations, enrollment progress for ongoing studies and in-depth planning for the next wave of new pivotal trials. The enthusiasm around the zanzalintinib franchise continues, and we look forward to sharing more progress when appropriate. As we execute on our priorities, we remain disciplined in our deployment of capital as we invest in our R&D portfolio, return value to shareholders through our stock repurchase program and actively evaluate external innovation opportunities that can strengthen our pipeline and create long-term value for patients and all of our stakeholders."

9/11 07:30

Exelixis New Drug Application Review Extended by Three Months to March 3, 2027

Exelixis announced that on September 10, the U.S. Food and Drug Administration notified Exelixis that it had extended the review period for Exelixis' new drug application for zanzalintinib, in combination with atezolizumab, for the treatment of patients with metastatic colorectal cancer by three months. In response to an FDA information request, Exelixis had submitted updated safety and efficacy data, which the FDA has deemed a major amendment. The updated Prescription Drug User Fee Act action date is March 3, 2027.

9/9 08:30

Adagene Achieves $2M Milestone with Exelixis

Adagene (ADAG) announced the achievement of a milestone in its ongoing collaboration and license agreement with Exelixis (EXEL). The milestone achievement is related to a preclinical milestone event for XB404 and resulted in a $2M milestone payment from Exelixis. XB404, built with Adagene's SAFEbody masking technology, is designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects. An additional payment to Adagene was triggered by the selection of candidates for another SAFEbody antibody-drug conjugate program. Exelixis has the right to utilize Adagene's SAFEbody technology platform to generate masked monoclonal antibodies for the development of masked ADC candidates. Adagene is eligible to receive development and commercialization milestones and royalties on net sales of products developed.

8/31 15:00

Exelixis Wins Patent Lawsuit Against MSN Laboratories

Exelixis announced that in the lawsuit Exelixis, Inc. vs. MSN Laboratories Private Limited et al., Civil Action No. 22-00228, the U.S. Court of Appeals for the Federal Circuit has "affirmed a key portion of the 2024 judgment of the U.S. District Court for the District of Delaware in Exelixis' favor." The company said: "The appellate court upheld the District Court's decision that three patents covering the crystalline malate salt of cabozantinib (No. 11,091,439 [crystalline salt]; 11,091,440 [pharmaceutical compositions]; and 11,098,015 [methods of treatment]) are not invalid. Concurrently, the appellate court dismissed the appeal regarding the validity dispute over one of Exelixis' patents covering low-impurity cabozantinib formulations (U.S. Patent No. 11,298,349), ruling the matter moot. The Federal Circuit's decision upholds the validity of the '439, '440 and '015 crystalline salt patents, preserving market exclusivity of Exelixis' cabozantinib (marketed under the brand name CABOMETYX). While the appellate court issued a procedural ruling dismissing the '349 formulation patent appeal as moot, this decision does not impact the broader strength or integrity of the cabozantinib patent estate. Exelixis will continue to pursue all necessary legal actions to defend its intellectual property portfolio, which is essential to safeguarding the scientific innovation that drives the company's mission to help cancer patients recover stronger and live longer. Given today's decision, the earliest that MSN may be permitted to commercially launch its proposed generic product in the U.S. is January 15, 2030, subject to any additional appeals or regulatory exclusivity. MSN's ability to commercially launch would depend on the outcome of litigation involving another low-impurity formulation patent (U.S. Pat. No. 12,128,039) that expires in February 2032, with a trial scheduled to begin in November 2026."

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