Clinical-stage precision oncology company developing novel targeted therapies for RAS-addicted cancers.
Clinical Trials
24
6 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2014
Active, not recruiting
6
25.0%
Approved For Marketing
1
4.2%
Completed
3
12.5%
Recruiting
13
54.2%
Unknown
1
4.2%
No approval data available
- The FDA granted Breakthrough Therapy designation to daraxonrasib combined with gemcitabine and nab-paclitaxel for previously untreated metastatic pancreatic adenocarcinoma, announced by Revolution Medicines on Sept. 14. - The designation follows the drug's Aug. 26 approval for previously treated metastatic disease, which was based on the phase 3 RASolute 302 trial showing median overall survival of 13.2 versus 6.7 months. - First-line designation rests on the phase 1/2 RMC-GI-102 study of 40 patients, where the combination produced a 58% confirmed response rate with no randomized comparison group. - The global phase 3 RASolute 303 trial, enrolling about 900 patients regardless of RAS mutation status, will compare daraxonrasib alone, the combination, and chemotherapy alone.
- The FDA granted Breakthrough Therapy Designation to daraxonrasib combined with gemcitabine and nab-paclitaxel for treatment-naive metastatic pancreatic adenocarcinoma, announced September 14, 2026. - The designation was supported by the Phase 1/2 RMC-GI-102 trial, where 40 previously untreated patients achieved a confirmed objective response rate of 58%, including one complete response. - At the December 1, 2025 data cutoff, median progression-free and overall survival had not been reached, with estimated 6-month rates of 84% and 90%, respectively. - The designation is Revolution Medicines' third for daraxonrasib and fifth across its RAS(ON) inhibitor portfolio, following the drug's August 26, 2026 FDA approval in previously treated disease.
- The FDA approved daraxonrasib, sold as Rasonque by Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma after at least one prior systemic therapy. - In the phase III RASolute 302 trial, median overall survival nearly doubled to 13.2 months with daraxonrasib versus 6.7 months with chemotherapy in 500 previously treated patients. - The oral once-daily multiselective RAS(ON) inhibitor targets KRAS mutations that drive tumor growth in more than 90% of pancreatic cancer cases, a target long considered undruggable. - Approval came 6.5 months ahead of the user fee deadline and carried Breakthrough Therapy, Orphan Drug and Priority Review designations, with common side effects including rash, diarrhea and stomatitis.
- Veru announced preclinical data showing sabizabulin overcomes daraxonrasib resistance with an IC50 of 18.2 nM in a resistant human pancreatic cancer cell line, a concentration achievable with current human dosing. - The company will advance oral sabizabulin into a planned Phase 2b trial for metastatic KRAS-driven pancreatic cancer that has progressed on the recently FDA-approved daraxonrasib. - Sabizabulin demonstrated collateral sensitivity (resistance index of 0.25) in daraxonrasib-resistant pancreatic cancer cells, with prior Phase 1b/2 data showing a favorable safety profile in 80 prostate cancer patients. - Veru plans a preIND meeting with the FDA in Q4 2026 and holds global rights to sabizabulin with patent protection until 2043.
- KRAS, the most frequently mutated oncogene across cancers, was long considered undruggable due to its smooth surface and high-affinity GTP-binding site. - The G12C mutation's cysteine residue enables covalent inhibition, leading to the approval of sotorasib (2021) and adagrasib (2022) in the US. - In CodeBreaK 200, sotorasib improved progression-free survival versus docetaxel (5.6 vs. 4.5 months, HR 0.66) in previously treated KRAS G12C NSCLC. - In colorectal cancer, KRAS G12C inhibition alone shows limited efficacy, requiring combination with anti-EGFR antibodies such as cetuximab or panitumumab.
- BeOne Medicines and Revolution Medicines announced a clinical collaboration to evaluate novel drug combinations using four clinical-stage RAS(ON) inhibitors with select BeOne oncology assets. - Planned combination studies include BeOne's BGB-58067 (MTA-cooperative PRMT5 inhibitor) and BG-T187 (EGFR x MET x MET trispecific antibody) with daraxonrasib or zoldonrasib. - A separate regional rights agreement grants BeOne exclusive development and commercialization rights to four Revolution Medicines RAS(ON) inhibitors in select Asian markets, excluding Japan and South Korea. - BeOne will fund and conduct a global registrational Phase 3 study for one of Revolution Medicines' RAS(ON) inhibitors, while Revolution Medicines receives milestone payments and tiered royalties on net sales.
- Yosemite, the oncology-focused venture firm founded by Reed Jobs in 2023, has announced the first close of its second fund targeting $350 million, with a team now numbering 17. - The firm builds biotech companies from scratch using a hybrid model of no-strings-attached philanthropy and venture capital, with about one-third of the fund dedicated to internally created companies. - Jobs highlights AI's transformative role in drug discovery, noting it has expanded the druggable genome beyond the historical 15% and is reshaping clinical trial design through innovations like synthetic control arms. - Portfolio priorities include targeting historically undruggable oncogenes such as p53 and KRAS, with Tune Therapeutics advancing epigenetic editing against hepatitis B and Histosonics developing noninvasive liver tumor destruction technology.
- Biotech stocks have surged over the past year, with the NYSE Arca Biotechnology Index and Nasdaq Biotechnology Index returning more than 56%, outpacing the Nasdaq 100's 29% gain. - Goldman Sachs analysts point to strong fundamentals driven by innovation in cardiovascular disease, cancer, and Alzheimer's, with key data readouts expected in the second half of the year. - The obesity drug market is projected to reach $114 billion globally by 2030, with oral medications expected to comprise 40% of the market and Medicare coverage unlocking further growth. - Large-cap biopharma companies face patent expirations and are actively seeking M&A to fill pipelines, with oncology, immunology, neuroscience, and cardiometabolic health as key areas of interest.
- An arbitration panel ruled in favor of Prime Medicine, determining the company does not owe Beam Therapeutics monetary damages in a dispute over rival AATD gene editing therapies. - Both companies originated from David Liu's labs and entered a 2019 collaboration that Beam claimed Prime breached by advancing its own AATD treatment. - Prime's prime editing therapy for AATD is in preclinical testing and could produce initial human data next year, while Beam's base editing treatment is in advanced clinical development. - Beam stated it "respectfully disagrees" with aspects of the ruling but acknowledged the decision does not affect its broader exclusive rights to certain prime editing tools.
- Kura Oncology's menin inhibitor ziftomenib (Komzifti) received FDA approval in November 2025 for AML patients with NPM1 mutations or KMT2A rearrangements. - The San Diego-based biotech, founded in 2014, is now pursuing broader AML indications for ziftomenib to address this notoriously difficult-to-treat cancer. - Kura is also advancing darlifarnib, a farnesyl transferase inhibitor, which the company believes could complement Revolution Medicines' breakthrough RAS inhibitor daraxonrasib. - CEO Troy Wilson previously co-founded three companies — Intellikine, Ambrx, and Avidity Biosciences — all of which were successfully acquired.
