The KRAS inhibitor market across the seven major markets was valued at approximately $526 million in 2025 and is projected to reach approximately $7.85 billion by 2034, a compound annual growth rate of roughly 35% over its 2024 to 2034 forecast period, according to DelveInsight, with the United States expected to account for nearly 70% of the total. Roots Analysis sizes the category differently, projecting the global KRAS market will grow from approximately $557 million in 2025 to approximately $3.98 billion by 2035, a CAGR of about 21%, and expects intravenously administered therapies to grow faster than the oral drugs that dominate the category today. KRAS mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, according to Eli Lilly and Company, while in colorectal cancer KRAS mutations appear in approximately 40% of all cases, according to Amgen, yet the G12C subtype targeted by the first approved inhibitors is present in only about 3% to 5% of colorectal cancers. The clinical bar moved sharply in April 2026, when a Phase 3 trial of an oral RAS(ON) multi-selective inhibitor in previously treated metastatic pancreatic cancer reported a median overall survival of 13.2 months versus 6.7 months for chemotherapy, according to the sponsor's SEC filing. Oncolytics Biotech announced positive preclinical results on September 10, 2026 from a study evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model, reporting that pelareorep activity was maintained alongside RAS inhibition without evidence of antagonism, though the company said the incremental activity associated with pelareorep became less evident after a transition to less frequent weekly dosing. Oncolytics also said it received written FDA feedback on August 18, 2026 on the design of a potential pivotal Part B expansion of its ongoing REO 033 study in second-line RAS-mutant, microsatellite stable metastatic colorectal cancer, with objective response rate potentially supporting accelerated approval and progression-free survival potentially supporting full approval; the ongoing Part A enrolls 60 patients. Revolution Medicines announced the FDA accepted for review its New Drug Application for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma, supported by the Phase 3 RASolute 302 trial in which daraxonrasib delivered a median overall survival of 13.2 months versus 6.7 months for chemotherapy with a hazard ratio of 0.40. Amgen reported LUMAKRAS/LUMYKRAS sales up 23% year-over-year to $111 million in its second quarter 2026 results, while total revenues rose 10% to $10.1 billion, and Eli Lilly announced the FDA granted Breakthrough Therapy designation to olomorasib as a monotherapy for adults with advanced pancreatic cancer with a KRAS G12C mutation. Verastem Oncology said it will host an investor event on October 14, 2026 to present initial efficacy and updated safety and tolerability data for VS-7375, its investigational oral KRAS G12D inhibitor, and reported second quarter 2026 net product revenue of $25.1 million for AVMAPKI FAKZYNJA CO-PACK.
Oncolytics reported positive preclinical results for pelareorep combined with a pan-RAS inhibitor in RAS-driven colorectal cancer, maintaining activity without antagonism.
Article highlights the April 2026 Phase 3 win for an oral RAS(ON) multi-selective inhibitor in pancreatic cancer, the class Revolution Medicines leads.
Tempus Expands Multi-Year Collaboration with Moderna and Merck for Intismeran Autogene
Tempus announced an expanded, multi-year collaboration with Moderna and Merck to support the potential commercialization of intismeran autogene, also known as V940 or mRNA-4157, a potential first-in-class individualized neoantigen therapy being evaluated in combination with KEYTRUDA in patients with completely resected stage IIB-IV melanoma and other cancer types. Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside the United States and Canada, and the new collaboration builds on joint efforts initiated last year. Under the agreement, Tempus will manage the timely collection and transfer of tumor tissue and blood samples required for next-generation sequencing, and, subject to applicable regulatory approvals, will also provide NGS services to support the intismeran autogene design and manufacturing process. Financial terms of the collaboration were not disclosed. Moderna Chief Business Officer Said Francis said the partnership lets the company leverage Tempus's commercial footprint and advanced sequencing capabilities, while Jannie Oosthuizen, President of Global Oncology and MSD International, said such collaborations are helping build the infrastructure needed to bring individualized neoantigen therapies to patients at scale.
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Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Supply
TEM · Demand · Positive Tempus wins an expanded multi-year collaboration to provide tissue/blood collection and NGS services for intismeran autogene.
MRK · Demand · Positive Expanded collaboration supports commercialization of intismeran autogene, which Merck co-develops with Moderna and evaluates with KEYTRUDA.
MRNA · Demand · Positive Moderna's jointly developed intismeran autogene gains Tempus support for sample collection, NGS design, and manufacturing toward commercialization.
AbbVie's Temab-A Wins Two FDA Breakthrough Therapy Designations for CRC and NSCLC
AbbVie announced that the U.S. Food and Drug Administration has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan, known as Temab-A or ABBV-400, in colorectal cancer and non-small cell lung cancer. The first designation covers Temab-A in combination with bevacizumab for adults with refractory, metastatic colorectal cancer previously treated with fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and, if indicated, anti-EGFR monoclonal antibody therapy. The second covers Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer who have previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. These are the first Breakthrough Therapy Designations for Temab-A and bring AbbVie's antibody-drug conjugate portfolio to four such designations; they were primarily based on results from the first-in-human study M21-404. Temab-A is an investigational, next-generation, c-Met-directed antibody-drug conjugate with a novel topoisomerase 1 inhibitor payload and has not been approved by any global regulatory authority.
Biotech & Genomic Medicine › Oncology Therapeutics ▲Regulation
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Regulation
ABBV · Technology · Positive FDA granted two Breakthrough Therapy Designations for AbbVie's investigational ADC Temab-A in colorectal and non-small cell lung cancer.
AstraZeneca Opens US$1b R&D Center in Kendall Square
AstraZeneca has opened a new US$1b global research and development center in Kendall Square, Massachusetts, consolidating its US work in oncology, cell therapy, chronic and rare diseases, and obesity into a single expanded hub. The site uses robotics and AI-enabled automation to support the company's research programs and broader drug development efforts. AstraZeneca is a GB-based biopharmaceutical group with a £185.5 billion market cap that spends heavily on discovering and developing prescription medicines. The company said the center tightens the link between early science and late-stage assets, which could affect how quickly it refines drug candidates and retires weaker programs. Investors will be watching for Phase II or Phase III readouts in obesity, COPD and key oncology programs over 2027 to 2029 as markers of whether the build-out is translating into a more resilient portfolio mix.
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AZN.LSE · Technology · Positive AstraZeneca opened a $1B R&D center using robotics and AI to speed drug discovery and refine candidates across oncology, cell therapy, and obesity.
Genmab Reports Phase 3 Win for Epcoritamab and Phase 1/2 Data for Rina S
Genmab posted two fresh oncology trial readouts, including a Phase 3 win for epcoritamab in newly diagnosed diffuse large B cell lymphoma. The EPCORE DLBCL 2 trial, run with AbbVie, reported that epcoritamab plus R CHOP cut the risk of disease progression or death by 51% versus R CHOP alone in patients with higher risk DLBCL. Separately, the Phase 1/2 RAINFOL 01 study of rinatabartsesutecan, or Rina S, in platinum resistant ovarian cancer reported a 45.9% confirmed objective response rate in a heavily pretreated population, with a median duration of response of 12.1 months and no clear safety signals around eye toxicity, peripheral neuropathy, interstitial lung disease or stomatitis. The trial headlines arrive after a strong run in the shares, with the DKK2,482.0 price coming alongside a 31.18% 90 day share price return and a 23.67% year to date share price return, while the 5 year total shareholder return is down 8.75%.
Enliven and FDA Agree on Phase 3 Design for Relcobatinib in CML
Enliven Therapeutics and the US FDA have agreed on a design for the phase 3 trial of relcobatinib for chronic myeloid leukemia in patients who have failed on prior treatments. The trial, called ENABLE-2, plans to enroll 450 adults with CML who were previously on one or more tyrosine kinase inhibitors. Participants will be randomized to receive either relcobatinib 80 mg once daily or an investigator-selected second-generation TKI. The primary endpoint is major molecular response at week 24. Relcobatinib, also known as ELVN-001, is a kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, which promotes the development of CML.
Biotech & Genomic Medicine › Oncology Therapeutics Regulation
ELVN · Technology · Positive FDA agreement on the phase 3 ENABLE-2 design for relcobatinib (ELVN-001) advances the company's lead drug development in CML.
Allist's Furmonertinib Phase III Trial Misses Primary Endpoint
Allist announced that the FURVENT Phase III trial of its product furmonertinib as monotherapy for first-line treatment of EGFR exon 20 insertion mutation NSCLC did not meet its primary endpoint, namely progression-free survival as assessed by blinded independent central review. The company said secondary endpoints such as investigator-assessed progression-free survival and blinded independent central review-assessed objective response rate showed clinical benefit, and although overall survival data are not yet mature, a trend toward improvement has been observed. The safety profile was consistent with previous studies, with no new signals identified. The company is working with ArriVent to evaluate the full dataset to determine next steps. As of September 30, 2026, cumulative investment in this clinical trial was approximately 70.82 million yuan, which has been expensed in the current period and will not have a material impact on current-period results.
Biotech & Genomic Medicine › Oncology Therapeutics Technology
688578.CG · Technology · Negative FURVENT Phase III trial of furmonertinib missed its primary endpoint of progression-free survival in first-line EGFR exon 20 insertion NSCLC.