Enliven Therapeutics Inc. made public updated positive data from the phase I Enable trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML). The drug is a small-molecule kinase inhibitor designed to target the BCR::ABL1 gene fusion, identified as the oncogenic driver for patients living with CML. Data being discussed at the European Hematology Association congress in Stockholm showed that the major molecular response achieved by 24 weeks in the proposed go-forward 80-mg daily cohort increased to 48% vs. 38% previously reported, “well north of the investor bogey” in the low 40% range, Mizuho analyst Salim Syed noted in a report. Enliven’s stock (NASDAQ:ELVN) was trading at $41.49, up $4.49, or 12%, having traded as high as $45.05. A phase III trial is expected to start in the second half of this year.

Dermasensor receives CE mark for skin cancer detection device

Dermasensor Inc. received CE mark approval for its handheld skin cancer detection device which uses spectroscopy and AI to test suspicious skin lesions for cancer in real time at the point of care. The device is designed to help qualified healthcare professionals decide whether suspicious skin lesions need further investigation. With skin cancer rates rising, the Dermasensor joins several other AI-based tools entering the European market to help with the analysis of suspicious lesions.

China clears Alphamab’s HER2 bispecific antibody in gastric cancer

China’s National Medical Products Administration has approved Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), through priority review for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received at least one trastuzumab-containing regimen. Anbenitamab combined with chemotherapy could become a new standard of care for patients with HER2-positive gastric cancer who have failed at least one prior line of therapy, according to phase III results showing the combination reduced the risk of disease progression or death by 75%.

Laekna licenses LAE-118 ex-China to Vasque in $527M deal 

Laekna Inc. is handing ex-China rights to internally discovered PI3Kα pan-mutant selective inhibitor LAE-118 to U.S.-based Vasque Bio Inc. in a deal worth up to $527 million, marking another asset-monetization move by the Shanghai company as it looks to fund and accelerate development across its oncology and metabolic disease pipeline. The agreement gives Vasque exclusive rights to develop, manufacture and commercialize LAE-118 worldwide, excluding mainland China, Hong Kong, Macau and Taiwan. In return, Laekna receives $10 million up front, the right to acquire up to a high-teen percentage of Vasque’s common stock, up to $517 million in development and sales milestones, tiered royalties and additional upside tied to any qualifying strategic partnership or acquisition involving LAE-118.

Ethyreal launches to treat the underlying cause of Graves’ and thyroid eye diseases

Ethyreal Bio Inc. has come out of stealth mode, announcing $101 million in financing that includes both series A and B rounds. The company is developing ETHY-001, designed to work by blocking the autoantibody-mediated activation of the thyroid stimulating hormone receptor, which causes Graves’ disease and thyroid eye disease. Ethyreal expects to start a clinical trial for the drug in the second half of 2026.

EY report: Biopharma is balancing record growth and mounting pressures

The EY Beyond Borders 2026 report, an annual industry analysis produced by EY Insights, framed the sector’s defining challenge in a single question: “How can biopharma keep its balance?” The report examines the forces testing that balance: a financing landscape defined by mega-rounds alongside a deepening liquidity squeeze, a wave of U.S. policy actions reshaping strategy, and China's rising role as both partner and geopolitical risk.

Another FDA no for Camurus’ monthly acromegaly drug Oclaiz

In a repeat move, the U.S. FDA issued yet again a complete response letter (CRL) to Camurus AB for its subcutaneous extended-release injection drug CAM-2029 (octreotide) to treat the rare chronic growth disorder acromegaly. The latest CRL is related to observations from the September 2024 cGMP inspection at a third-party manufacturer and raises no issues of efficacy or safety, but it does recommend a labeling change to the oxygen absorber component of the product packaging. The earlier 2024 CRL also cited deficiencies at the manufacturer, which has since worked with the FDA to correct the issues, and is welcoming a reinspection. “The CRL is disappointing,” said Fredrik Tiberg, president and CEO, of Lund, Sweden-based Camurus. “We are working toward resubmission of the NDA in the near term, while maintaining launch readiness and with no change to our 2026 financial outlook.”

Also in the news

Aldeyra, Alnylam, Beren, Cellectis, Cervomed, Circio, Cordex, Cosylab, Covalon, Cullinan, Cytospire, Dermasensor, Eli Lilly, Ethyreal, Excellthera, Fesarius, Genesis, GT Medical, Hansa, Heron, Italfarmaco, Lophora, Medexus, Molecular, Nexalin, Onkos, Organon, Phoremost, Predicta, Radiomedix, Rakuten, Sanofi, Sensorion, Shattuck Labs, Sibel, Sonothera, SPR, Subtle, Takeda, Tango, Tenacia, Tris, Vara, Vascarta, Verge