Galapagos Announces Phase 3 Results for GLPG3667
Galapagos (GLPG) announced the topline results from two Phase 3-enabling studies evaluating the efficacy and safety of GLPG3667, a selective TYK2 inhibitor, in patients with dermatomyositis and active systemic lupus erythematosus. The GALARISSO DM study met its primary endpoint, showing that GLPG3667, administered once daily at 150 mg in addition to standard-of-care therapy, achieved a statistically significant clinical benefit in the Total Improvement Score at Week 24, compared to placebo. The pre-specified threshold of statistical significance was set at 10%. GLPG3667 also showed meaningful clinical improvements compared to placebo on several secondary endpoints of disease activity, including TIS20, TIS40, TIS60 and m-CDASI-A2. GLPG3667 demonstrated a favorable safety and tolerability profile throughout the 24-week treatment period. In the GALACELA SLE study, GLPG3667, administered once daily at 75 mg and 150 mg in addition to standard-of-care therapy, the primary endpoint analysis of dose-response on SLE responder index -4 at Week 32 did not meet statistical significance. However, GLPG3667 showed numerical improvements over placebo on several secondary endpoints, particularly on skin-related outcomes. The safety profile was consistent with previous studies with GLPG3667. The GALACELA study is currently ongoing, and the final Week 48 data, expected in the second quarter of 2026, will be essential to assess the totality of the evidence and determine potential next steps for the SLE program. The company aims to present data at an upcoming medical conference. Gilead (GILD) agreed to temporarily waive certain rights under the 10-year global option, license and collaboration agreement between Galapagos and Gilead, enabling Galapagos to pursue external partnership opportunities for GLPG3667.
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Gilead Acquires Genhouse's MAT2A Inhibitor for $80M
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- Clinical Approval: GH31 has received IND approval in both the US and China, laying a solid foundation for Gilead's subsequent development and market promotion, further strengthening its positioning in the global oncology treatment market.
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- Milestone Payments: The agreement allows Genhouse to potentially receive up to $1.45 billion in milestone payments, which not only provides financial support to Genhouse but may also accelerate the development of GH31, enhancing its market competitiveness.
- Global Development Responsibility: Gilead will be responsible for the global development, regulatory submissions, and future commercialization of GH31, reflecting Gilead's confidence in the drug and potentially facilitating its rapid market introduction worldwide.
- Clinical Approval: GH31 has received IND approval in both the US and China, laying a solid foundation for Gilead's subsequent development and market promotion, further strengthening its positioning in the global oncology treatment market.
FDA Pushes for Prescription Drugs to Become Over-the-Counter
- Policy Advocacy: FDA Commissioner Marty Makary stated in Washington that the agency plans to push for more prescription drugs to become over-the-counter (OTC) this year, aiming to improve drug accessibility and reduce healthcare costs, which could allow patients to obtain basic safe medications without a doctor's visit.
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- Industry Pushback: The pharmaceutical industry has raised concerns about this policy, arguing that OTC drugs may not be covered by insurance, leading to higher costs for patients, and that the FDA lacks authority over drug pricing, necessitating thorough consultations with manufacturers before any transitions.
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Investment Increase: Mubadala Investment Company has raised its stake in CVS Health Corporation by 17.3%.
Share Count: The new total of shares held by Mubadala in CVS Health is now 149,769 shares.
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