Phase III
Following promising Phase IIa data, Vertex Pharmaceuticals will now evaluate its oral drug candidate inaxaplin in a late-stage study of APOL-1 mediated kidney disease.
Bristol Myers Squibb’s $4.8 billion acquisition of Mirati pays off with strong data from the KRYSTAL-12 study of Krazati, showing that the KRAS inhibitor significantly improves progression-free survival.
Data from a late-stage study showed that Bristol Myers Squibb’s Zeposia (ozanimod) was unable to significantly improve clinical remission in adult patients with moderate to severe active Crohn’s disease.
Now in Phase III with its small molecule orforglipron, Eli Lilly is leading the oral GLP-1 race against Novo Nordisk, Pfizer, Roche and others.
Novocure’s stock spiked more than 15% Wednesday morning after the company announced its Tumor Treating Fields therapy met the primary endpoint in a late-stage trial.
While Pfizer has ended one of its two Phase III studies for inclacumab in sickle cell disease, the company is still eyeing an approval for the antibody in the inherited blood disorder by 2026.
Health economics and outcomes research (HEOR) is a critical but sometimes overlooked part of drug development. Decentralized trials now make it easy.
Axsome clinched a late-stage victory for its chronic sleep disorder candidate AXS-12, which demonstrated significant improvement in cataplexy—the sudden loss of muscle tone while a person is awake—after five weeks.
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
Despite meeting its primary endpoint in a late-stage generalized myasthenia gravis trial, Roche and Chugai Pharmaceutical’s Enspryng did not demonstrate clinical benefit as expected, the companies announced Thursday.
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