Exelixis
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1994-01-01
- Employees
- 1.3K
- Market Cap
- $7.3B
- Website
- http://www.exelixis.com
- Introduction
Exelixis, Inc. operates as an oncology company, which focuses on discovering, developing, and commercialization of new medicines for difficult-to-treat cancers. Its products include cabometyx, cometriq, and cotellic. The company was founded by Stelios Papadopoulos on November 15, 1994, and is headquartered in Alameda, CA.
Exelixis Initiates Phase 1 Trial of XB628, a Novel Bispecific NK Cell Engager for Advanced Solid Tumors
• Exelixis has begun dose-escalation in a first-in-human Phase 1 trial of XB628, a first-in-class bispecific antibody targeting both NKG2A and PD-L1 in patients with recurrent advanced or metastatic solid tumors.
• XB628 represents a novel immunotherapy approach by engaging natural killer cells through dual targeting of an inhibitory receptor (NKG2A) and the immune checkpoint protein PD-L1.
• The investigational therapy was developed through a collaboration between Exelixis and Invenra, leveraging Invenra's proprietary B-Body® platform for creating multispecific antibodies with superior biophysical properties.
Novartis Acquires Regulus Therapeutics for $800M, Expanding Kidney Disease Portfolio
• Novartis has agreed to acquire Regulus Therapeutics for $800 million upfront, with potential additional payments of up to $900 million tied to regulatory milestones.
• The acquisition centers on farabursen, Regulus' experimental oligonucleotide therapy targeting miR-17 for autosomal dominant polycystic kidney disease (ADPKD), currently in Phase Ib trials.
• The deal values Regulus shares at $7 each—a 108% premium over the biotech's closing price—and could ultimately be worth $1.7 billion if all milestones are achieved.
FDA Grants Fast Track Designation to BioInvent's BI-1808 for Cutaneous T-cell Lymphoma
• BioInvent International has secured FDA Fast Track Designation for BI-1808 in the treatment of relapsed or refractory mycosis fungoides and Sézary syndrome, two subtypes of cutaneous T-cell lymphoma.
• This regulatory milestone follows the earlier Orphan Drug Designation for BI-1808 in T-cell lymphoma, strengthening BioInvent's position in developing novel immunotherapies for difficult-to-treat lymphomas.
• The company anticipates multiple data readouts across its six clinical programs throughout 2025, with additional BI-1808 data expected by mid-year as part of a data-rich period for the company.
Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development
• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development.
• FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer.
• Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.
Ryvu Therapeutics Advances Synthetic Lethality Pipeline with Promising Preclinical Data at AACR 2025
• Ryvu's RVU305, a brain-permeable MTA-cooperative PRMT5 inhibitor, demonstrates significant tumor growth inhibition in MTAP-deleted cancer models and enhances responses when combined with anti-PD-1 antibodies.
• The company's proprietary ONCO Prime platform has identified novel synthetic lethal targets for KRAS-driven colorectal cancer, potentially offering new personalized treatment options for patients based on their tumor's genetic profile.
• Ryvu is advancing multiple preclinical programs simultaneously, including next-generation ADC payloads that will be presented at the upcoming ADC Payload Summit in Boston, with IND/CTA-enabling studies for RVU305 on track for completion in H2 2025.
Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape
• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies.
• Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma.
• The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.
Insilico Medicine Secures $110M Series E Funding, Achieves Unicorn Status for AI-Driven Drug Discovery
• Insilico Medicine has raised $110 million in Series E financing led by Value Partners Group, valuing the company at over $1 billion and officially achieving unicorn status.
• The AI drug discovery company will use funds to advance its lead candidate Rentosertib for idiopathic pulmonary fibrosis, which has shown promising results in Phase IIa trials, and expand its portfolio of 30 AI-discovered drug candidates.
• Insilico's proprietary Pharma.AI platform has demonstrated ability to reduce drug discovery timelines to 12-18 months compared to traditional 2.5-4 years, while requiring significantly fewer test molecules.
PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial
• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months.
• The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk.
• Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.
Cabozantinib Demonstrates Promising Results in Neuroendocrine Tumors, Analyst Recommends 'Buy' for Exelixis
• Cabozantinib significantly improved progression-free survival (PFS) in patients with extra-pancreatic neuroendocrine tumors originating from the gastrointestinal tract, showing a 50% increase compared to placebo.
• The CABINET trial data presented at the ASCO Gastrointestinal Cancers Symposium highlighted cabozantinib's clinical benefits across various factors, including tumor grade and prior treatments, with a favorable safety profile.
• Anticipated FDA approval by April 2025 further supports Exelixis's stock potential, leading analysts to consider it a worthwhile investment opportunity with a projected 17.4% return.
• Analyst David Lebowitz from Citi maintained a Buy rating on Exelixis (EXEL) with a price target of $38.00, based on the promising trial results and potential for growth.
Cabozantinib Shows Promise in Advanced GI Neuroendocrine Tumors
• Cabozantinib (Cabometyx) significantly improved progression-free survival (PFS) in patients with advanced gastrointestinal neuroendocrine tumors (GI-NETs) after prior therapy.
• The CABINET trial subgroup analysis revealed a median PFS of 8.5 months with cabozantinib versus 5.6 months with placebo in GI-NET patients.
• Benefits were observed across various clinical factors, including tumor grade and prior treatment, except in non-midgut GI primary tumors.
• The safety profile of cabozantinib was consistent with previous data, with manageable adverse events reported.
MiNK Therapeutics' Allo-iNKT Cell Therapy Shows Promise in Refractory Gastric Cancer
• MiNK Therapeutics' agenT-797, combined with botensilimab and balstilimab, demonstrates robust immune activation in refractory gastroesophageal cancer.
• The Phase 2 study reveals increased interferon-gamma levels and enhanced T-cell infiltration, suggesting improved clinical outcomes.
• Early administration of agenT-797 alongside checkpoint inhibitors before chemotherapy amplifies immune responses, optimizing T-cell priming.
• The off-the-shelf allogeneic iNKT platform offers a scalable and accessible treatment option for patients with hard-to-treat cancers.
Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones
• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor.
• Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025.
• Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025.
• Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.
FDA Foregoes Advisory Committee for Cabozantinib's Neuroendocrine Tumor Application
• The FDA has canceled the Oncologic Drugs Advisory Committee meeting for Exelixis' cabozantinib sNDA, streamlining the review process.
• The sNDA seeks approval for cabozantinib to treat advanced pancreatic and extra-pancreatic neuroendocrine tumors in previously treated adults.
• The FDA's decision is based on Phase III CABINET trial results, which showed significant progression-free survival improvements with cabozantinib.
• The Prescription Drug User Fee Act (PDUFA) target action date for the FDA's decision on cabozantinib remains April 3, 2025.
Corcept Therapeutics Submits New Drug Application for Relacorilant to Treat Cushing's Syndrome
• Corcept Therapeutics has submitted a New Drug Application to the FDA for relacorilant, a selective cortisol modulator designed to treat patients with endogenous hypercortisolism (Cushing's syndrome).
• The application is supported by positive results from multiple clinical trials, including the pivotal GRACE trial, Phase 3 GRADIENT study, and long-term extension studies, demonstrating improvements in various symptoms with an acceptable safety profile.
• Relacorilant showed no instances of serious adverse events common in current treatments, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation, positioning it as a potential new standard of care.
Keytruda Approved in China for Early-Stage NSCLC Treatment
• Keytruda gains approval in China for resectable stage II, IIIA, or IIIB NSCLC in combination with platinum-containing chemotherapy.
• The approval is based on the KEYNOTE-671 trial, demonstrating a significant improvement in overall survival and event-free survival.
• This marks Keytruda's fourth indication for NSCLC in China, extending its use to earlier stages of the disease.
• The treatment involves neoadjuvant Keytruda plus chemotherapy, followed by adjuvant Keytruda monotherapy post-surgery.
FDA Grants Priority Review to Belzutifan for Advanced Pheochromocytoma and Paraganglioma
• The FDA has granted priority review to belzutifan (Welireg) for treating advanced pheochromocytoma and paraganglioma (PPGL) in adult and pediatric patients.
• The sNDA is based on positive objective response rate (ORR) and duration of response (DOR) data from the Phase 2 LITESPARK-015 trial.
• Belzutifan, a HIF-2α inhibitor, could become the first approved therapy for advanced PPGL in the U.S., addressing a significant unmet need.
• The FDA's target action date is set for May 26, 2025, indicating an expedited review process for this potential new treatment option.
Novartis and Apellis Advance C3G Therapies Towards FDA Submission
• Novartis' Fabhalta (iptacopan) demonstrated significant proteinuria reduction in the Phase III APPEAR-C3G trial, meeting its primary endpoint and supporting regulatory submissions.
• Apellis' Empaveli (pegcetacoplan) showed a substantial reduction in proteinuria and C3c deposit clearance in the Phase III VALIANT trial, indicating early efficacy in C3G patients.
• Nephrologists express a strong interest in new C3G therapies that can slow eGFR decline and reduce proteinuria, addressing the urgent need for innovative treatments.
• Spherix data suggests treatment preferences may be influenced by administration route, with Fabhalta's oral administration potentially offering an advantage.
Allogene Therapeutics Advances AlloCAR T Pipeline in Oncology and Autoimmune Diseases
• Allogene's ALPHA3 trial for cema-cel in large B-cell lymphoma is actively enrolling, potentially integrating CAR T into first-line treatment.
• ALLO-316 demonstrated a 50% overall response rate in heavily pretreated renal cell carcinoma patients, earning FDA's RMAT designation.
• ALLO-329, a dual CD19/CD70 CAR T for autoimmune diseases, is set for IND filing in Q1 2025, aiming to reduce lymphodepletion.
• The company maintains a strong financial position with $403.4 million in cash, projecting operations funding into the second half of 2026.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
Insilico Medicine Pioneers AI-Driven Drug Discovery with Multimodal Transformers and Robotic Labs
• Insilico Medicine has successfully developed nine preclinical candidates in small molecules during 2022, demonstrating AI's potential to double traditional pharma R&D productivity.
• The company secured an $80 million upfront deal with Exelixis for its AI-generated USP1 inhibitor ISM3091, marking a significant validation of AI-generated drug assets.
• Insilico's integration of multimodal transformers and AI-automated laboratories is revolutionizing drug discovery by reducing human bias and enabling cross-species analysis for more efficient therapeutic development.
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