Genomics-based drug discovery company developing cancer treatments, specializing in tyrosine kinase inhibitors; its Cabometyx is FDA-approved for kidney cancer and other malignancies.
Clinical Trials
159
108 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
1994
Active, not recruiting
104
65.4%
Approved For Marketing
1
0.6%
Completed
22
13.8%
Enrolling By Invitation
1
0.6%
Not yet recruiting
3
1.9%
Recruiting
11
6.9%
Suspended
1
0.6%
Terminated
14
8.8%
Unknown
1
0.6%
Withdrawn
1
0.6%
- The FDA extended its review of Exelixis' NDA for zanzalintinib plus atezolizumab in metastatic colorectal cancer by three months, setting a new PDUFA date of March 3, 2027. - The extension followed Exelixis' submission of updated safety and efficacy data in response to an FDA information request, which the agency classified as a major amendment. - The filing is based on the Phase 3 STELLAR-303 trial, where the combination reduced the risk of death by 20% versus regorafenib in the intent-to-treat population. - William Blair said the rejection risk remains low given the overall survival benefit, though a second pre-specified analysis in patients without liver metastases missed statistical significance.
- Adagene announced a preclinical milestone in its collaboration and license agreement with Exelixis tied to XB404, triggering a $2.0 million payment from Exelixis. - XB404 uses Adagene's SAFEbody masking technology to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects. - A second payment was triggered by candidate selection for another SAFEbody antibody-drug conjugate program, with Adagene also eligible for development, commercialization milestones and royalties.
- The U.S. Court of Appeals for the Federal Circuit affirmed the validity of three Exelixis patents covering the crystalline malate salt of cabozantinib, upholding a key portion of the 2024 Delaware District Court judgment. - The appellate court dismissed as moot the appeal concerning a low-impurity cabozantinib formulation patent (U.S. Patent No. 11,298,349), without affecting the broader cabozantinib patent estate. - The ruling preserves market exclusivity for CABOMETYX, with the earliest possible U.S. commercial launch of MSN's proposed generic product now set for January 15, 2030. - A separate trial over another low-impurity formulation patent (U.S. Patent No. 12,128,039) is scheduled to begin in November 2026.
- Exelixis surged 5.0% to $50.99 on Wednesday amid a broad biotechnology rally, with no company-specific catalysts driving the move. - PTC Therapeutics jumped 5.1% to $89.80 on Tuesday, riding the same sector-wide momentum alongside peers posting gains of 4.0% to 6.9%. - Coordinated buying across multiple biotech names suggests institutional investors are rotating into the sector, reflecting improved risk appetite toward growth-oriented healthcare. - Trading volumes remained moderate, with Exelixis at 1.1M shares and PTC Therapeutics at 823,046 shares, indicating measured rather than explosive positioning.
- CABOMETYX demonstrated significant improvements in progression-free survival for patients with previously treated advanced neuroendocrine tumors regardless of functional status in the phase 3 CABINET trial. - The drug reduced the risk of disease progression or death by 74% in non-functional NET and 60% in functional NET compared to placebo. - Median progression-free survival increased threefold in non-functional NET (9.4 vs 3.1 months) and more than doubled in functional NET (12.7 vs 5.4 months) compared to placebo. - The safety profile remained consistent with known CABOMETYX adverse events, with hypertension being the most frequent grade 3/4 adverse event in both patient groups.
- Exelixis has entered a clinical development collaboration with Merck to evaluate zanzalintinib combined with subcutaneous Keytruda Qlex in the phase 3 STELLAR-316 study for resected stage II/III colorectal cancer patients. - The trial will target high-risk patients who test positive for molecular residual disease following definitive therapy, representing a population with substantial unmet medical need. - STELLAR-316 is expected to initiate in mid-2026, with disease-free survival as the primary endpoint and circulating tumor DNA clearance as a key secondary endpoint. - This collaboration adds external validation to Exelixis' zanzalintinib program, which already has a pending FDA application for metastatic colorectal cancer treatment with a December 2026 target action date.
- Over 70 companies are developing 75+ neuroendocrine tumor therapies across various clinical phases, with recent FDA approvals demonstrating significant progress in this rare cancer field. - Cabozantinib (Cabometyx) received FDA approval for pancreatic and extra-pancreatic NETs in March 2025, while ITM-11 showed statistically significant progression-free survival improvement in Phase III trials. - Belzutifan demonstrated durable responses with 26% objective response rate and 85% disease control rate in advanced pheochromocytoma/paraganglioma patients in Phase II studies. - The pipeline includes diverse therapeutic approaches from targeted radiotherapy to immunotherapy, addressing the heterogeneous nature of neuroendocrine tumors across different anatomical sites.
- Exelixis and Merck have initiated the LITESPARK-033 Phase 3 trial testing belzutifan plus zanzalintinib versus cabozantinib in advanced kidney cancer patients who experienced disease recurrence after prior immunotherapy. - The randomized, open-label study aims to determine if the experimental combination can improve survival and progression-free survival compared to the current standard cabozantinib treatment. - The trial targets a high-need patient population with advanced renal cell carcinoma that has returned after modern anti-PD-1/L1 adjuvant therapy, representing a significant unmet medical need. - Positive results could reshape treatment choices in kidney cancer and strengthen both companies' positions in the competitive renal oncology market.
- Exelixis and Natera announced collaboration on STELLAR-316, a phase 3 pivotal trial evaluating zanzalintinib in patients with resected stage II/III colorectal cancer who test positive for molecular residual disease (MRD). - The trial will use Natera's Signatera assay to identify MRD-positive patients for enrollment and monitor response to therapy, targeting approximately 20% of stage II/III CRC patients who remain MRD-positive after definitive therapy. - If successful, zanzalintinib could become the first MRD-guided treatment for this high-risk patient population, addressing a significant unmet medical need with no currently approved therapies. - The collaboration builds on recent JAMA Oncology data showing Signatera-positive CRC patients experienced over 40% reduction in death risk when treated with celecoxib plus chemotherapy versus chemotherapy alone.
- DelveInsight's 2025 assessment reveals a robust prostate cancer pipeline with 140+ companies developing 150+ treatment therapies across various clinical phases. - Recent clinical milestones include Novartis's positive Phase III PSMAddition trial results for Pluvicto combination therapy and MSD-Daiichi Sankyo's initiation of the IDeate-Prostate01 trial for ifinatamab deruxtecan. - Emerging therapies span diverse mechanisms including radioligand therapy, antibody-drug conjugates, and EZH2 inhibitors, with companies like Telix Pharmaceuticals, Pfizer, and AstraZeneca leading development efforts. - The pipeline includes promising late-stage candidates such as 177Lu-DOTA-rosopatamab, mevrometostat, and capivasertib, targeting various stages of prostate cancer progression.
