Exelixis announced final analysis results from the phase 3 STELLAR-303 trial evaluating zanzalintinib in combination with Roche's Tecentriq versus regorafenib in previously treated non-MSI-high metastatic colorectal cancer. In the subgroup of patients without active liver metastases, the combination showed a non-statistically significant trend with median overall survival of 15.9 months compared to 12.7 months for regorafenib. The safety profile in this subgroup was consistent with prior findings and no new safety signals were identified. The trial previously met its other primary endpoint with a statistically significant improvement in overall survival in the intention-to-treat population. The U.S. Food and Drug Administration has accepted Exelixis' New Drug Application for the combination with a target action date of December 3, 2026.
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.
Betta Pharmaceuticals' BPI-572270 Capsules Receive US FDA Clinical Trial Approval
Betta Pharmaceuticals announced that the clinical trial application for BPI-572270 capsules, submitted by its wholly-owned subsidiary Jingyao Biotech, has been approved by the US FDA for the treatment of advanced solid tumors. The drug is a self-developed pan-RAS non-degrading molecular glue inhibitor, and preclinical studies have shown strong inhibitory effects on various RAS-mutant tumor cells. The company cautioned that new drug development involves long cycles and substantial investment, and that clinical trial and approval outcomes remain uncertain, with no significant impact on near-term performance.
Biotech & Genomic Medicine › Oncology Therapeutics ▲Technology
300558.CS · Technology · Positive US FDA approved clinical trial application for its self-developed BPI-572270 pan-RAS inhibitor for advanced solid tumors.
Multiply Labs Raises $75 Million Series B Led by Patrick Soon-Shiong
Multiply Labs announced a $75 million Series B round, bringing its total capital raised to over $100 million since its founding in 2016. The round was led by Dr. Patrick Soon-Shiong with NantWorks, joined by new investors AstraZeneca, Lingotto, Teradyne, and Strange Ventures, alongside returning investors Casdin Capital, Lux Capital, Fifty Years, Ora Global, and Founders Fund. The San Francisco-based physical AI company automates biologics manufacturing with robotic clusters that integrate into existing instruments and processes without requiring a new facility, delivering a 74% reduction in cost per dose and up to 100 times more throughput than manual manufacturing. Beginning with cell and gene therapy and now expanding to advanced biologics including antibodies, viral vectors, and mRNA, the platform is owned and operated directly by pharmaceutical and biologics companies rather than run as an outsourced service. Multiply Labs will use the capital to expand manufacturing capacity, accelerate its product roadmap, and scale its team across engineering, regulatory, and commercial functions as it moves from clinical-stage deployments toward commercial-scale production.
Genmab Shares Jump 10.7% on Positive Phase III EPCORE DLBCL-2 Data
Genmab A/S Sponsored ADR shares rallied 10.7% in the last trading session to close at $38.48, following positive top-line results from the phase III EPCORE DLBCL-2 study. Genmab and its partner AbbVie announced that epcoritamab in combination with R-CHOP demonstrated a statistically significant improvement in progression-free survival in patients with newly diagnosed diffuse large B-cell lymphoma. The company is expected to post quarterly earnings of $0.37 per share in its upcoming report, a year-over-year change of -43.1%, on revenues of $1.18 billion, up 15.7% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 8.7% higher over the last 30 days, and the stock currently carries a Zacks Rank #3 (Hold).