Galapagos and Gilead Sciences have both evolved since inking their R&D collaboration agreement in 2019. Separating Galapagos into two offers a way for that company to pursue its cell therapy strategy while also keeping the Gilead alliance alive, executives from both companies said.
Gilead Sciences is acquiring LEO Pharma’s oral small molecule inhibitors of STAT6, a protein key to two validated inflammation pathways. Other STAT6 drug developers include Kymera Therapeutics and Sanofi-partnered Recludix Pharma, which is presenting this week during the J.P. Morgan Healthcare Conference.
FASENRA® (benralizumab) injection, for subcutaneous use, 30 mg is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). FASENRA provides a treatment option for HCPs to consider when managing this challenging disease.
Arcellx’s cell therapy for multiple myeloma has shown no signs of the parkinsonism complication observed in clinical testing of Carvykti, a rival product from partners Johnson & Johnon and Legend Biotech. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.
Gilead Sciences' Trodelvy did not meet the main overall survival goal of its confirmatory Phase 3 test. The antibody drug conjugate was awarded accelerated approval for advanced urothelial carcinoma in 2021.
Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year.
Gilead Sciences reported Trodelvy’s Phase 3 test in metastatic urothelial cancer fell short of showing a statistically significant benefit on the overall survival main goal. The antibody drug conjugate had received accelerated FDA approval for this type of cancer in 2021.
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Gilead Sciences’ partnership with Merus could yield novel antibody drugs capable of binding to three targets simultaneously. The alliance follows a collaboration that Gilead started last year with Tentarix Biotherapeutics, a startup also developing antibodies that bind to multiple targets.
Acquiring CymaBay Therapeutics gives Gilead Sciences another drug for its liver disease portfolio. CymaBay’s molecule, seladelpar, is under FDA review for treating primary biliary cholangitis, a rare disease affecting the bile ducts of the liver.
Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.
Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.
Patient expectations continue to evolve, and healthcare practices that fail to adapt risk more than just revenue—they risk losing trust.
Gilead Sciences said even though Trodelvy missed the main goal of its Phase 3 test in non-small cell lung cancer, the drug’s preliminary results show numerical improvement in patients whose disease did not respond to prior treatment with immunotherapy. The company plans to discuss with regulators a possible path forward in these patients.
Gilead Sciences is increasing its stake in partner Arcellx and expanding the cell therapy alliance the companies started in 2022. The deal expands the lead partnered program to more cancers and gives Gilead a chance at another Arcellx cell therapy candidate made with different technology.
Gilead Sciences is partnering with Tentarix Biotherapeutics, a startup developing multifunctional antibody drugs that it calls "Tentacles." Tentarix’s technology offers the potential to selectively address targets in cancer and inflammation.
Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.
Gilead Sciences drug Trodelvy is now approved for treating patients whose breast cancer is classified as HR positive and HER2 negative, expanding use of the drug to a much wider group of patients. In other regulatory approval news, use of a Takeda Pharmaceutical rare disease drug has expanded to younger children.