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• Gilead has at long last won US approval of its hepatitis D treatment Hepcludex, which the FDA previously rejected over issues with its manufacturing and distribution.

• The drug, known generically as bulevirtide, treats chronic hepatitis D infections in patients who aren’t yet in the later stages of liver damage.

• Hepcludex has been available in Europe for several years. But the FDA rejected the drug in 2022 over issues with “manufacture and delivery.”

• It’s unusual for a drugmaker of Gilead’s size to take this long to remedy those sorts of problems, and Gilead has said little since then about what exactly the issues were.

• But with the approval, US patients will finally have an option for a condition that can lead to liver damage and cancer, and the eventual failure of the organ and death. (Endpoints)

• Datroway is approved by the FDA for some previously untreated patients with metastatic triple-negative breast cancer (TNBC), the first drug in the class to move into the first-line setting in the US.

• The green light – which comes on the back of the TROPION-Breast02 trial and after a priority review – makes the TROP2-targeting antibody-drug conjugate (ADC) a treatment option for patients who are not eligible for frontline immunotherapy with PD-1/PD-L1 inhibitors.

• The news has been celebrated by the Triple Negative Breast Cancer Foundation, whose executive director, Arlene Bothers, noted that seven out of 10 patients with metastatic TNBC are not candidates for immunotherapy, with chemotherapy the only treatment option.

• "Today's approval of Datroway means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment," she added. (Pharmaphorum)

• The FDA cleared the use of AbbVie’s antibody-drug conjugate for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm.

• Decnupaz is the first and so far only ADC approved for this indication, according to the company. The approval also marks AbbVie’s first ADC entry in the blood cancer space.

• The FDA’s decision was backed by data from the phase 1/2 CADENZA study, which enrolled 33 treatment-naive patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and 51 patients with relapsed or refractory BPDCN. None of the patients had signs of central nervous system disease. (Biospace)

• GSK is pulling back the curtain on the phase 3 success of its chronic hepatitis B drug bepirovirsen, revealing that nearly one-fifth of all treated patients across two trials were functionally cured of the virus.

• The B-Well studies focused on patients already receiving daily standard-of-care treatment with nucleos(t)ide analogue tablets, which block the virus’ ability to replicate. Though this cuts down viral numbers, the approach often stops short of eliminating the pathogen entirely.

• After treatment with bepirovirsen, however, 19% of patients achieved the strictly defined “functional cure” criteria.

• For the subset of patients who already had levels of hepatitis B virus (HBV) surface antigen—a protein on the virus’ outer shell—below 1,000 international units per milliliter, functional cure rates hit 26%.

• The results were published today in the New England Journal of Medicine. (Fierce Biotech)

• Verge Genomics is turning over a new leaf, rebranding as Verge Labs, a biotech company that will provide drug developers with data to identify the best targets for their experimental programs.

• Verge laid off about 90% of its workforce after it decided to change course, said Alice Zhang, the company’s CEO and founder.

• In December, Verge wrapped an early-stage clinical trial of VRG50635, an experimental drug for ALS that the biotech designed with AI technology, and found that prospect had failed to benefit the patients it sought to help. (BioPharma Dive)

• Placement on the plenary session of the upcoming ASCO 2026 annual meeting has significantly elevated enthusiasm around Akeso’s first-line non-small cell lung cancer data for its Summit Therapeutics-partnered ivonescimab.

• As the first China-developed asset to score this primetime slot in the oncology event’s more than six decades of history, ivonescimab will showcase its overall survival capability from the phase 3 Harmoni-6 trial.

• The study previously showed that the first-in-class PD-1xVEGF inhibitor, alongside chemo, beat BeOne Medicines’ PD-1 inhibitor Tevimbra and chemo on progression-free survival (PFS) in Chinese patients with newly diagnosed squamous NSCLC.

• But with honor comes scrutiny. The premium status means the Harmoni-6 results will be put under the microscope and carefully critiqued, Leerink Partners analyst Daina Graybosch, Ph.D., said in an interview previewing the readout.

• “It’s totally going to get minced,” Graybosch said. “That’s the risk of getting in the plenary. If you had the same data in the regular oral [session], I’m sure they’ll get less of a critical discussant.” (Fierce Pharma)

• Biohub says the release includes a protein-structure prediction model, a protein language model and ESM Atlas, a map of 6.8 billion proteins and 1.1 billion predicted structures.

“What we've shown is that these models have learned such a high-fidelity world model of biology that you can design protein interfaces computationally, take them into the laboratory and they function as predicted," Biohub head of science Alex Rives said in a statement.

• Isomorphic Labs, a spinout from Google, has raised more than $2 billion to fund AI-based drug discovery.

• In April, OpenAI announced a series of models aimed at helping accelerate biological research, while Anthropic has set up its own life sciences effort.