Argenx is well-positioned for growth with the new trial data and a “big revenue beat” for Vyvgart in the first quarter, Piper Sandler analyst Allison Bratzel wrote in a note to investors. The drug pulled in net sales of $21.2 million in the period, surpassing the consensus Wall Street estimate of $7 million and Piper Sandler’s expectation of $5.1 million, Bratzel wrote.
The Phase 3 ADVANCE trial in primary immune thrombocytopenia found that 22% of patients receiving Vyvgart had a sustained platelet response, compared with 5% of patients on placebo, a statistically significant difference. Importantly, the safety profile of the drug was consistent with previous studies, even though patients in the new trial were treated for 24 weeks, Argenx said.
ADVANCE included 131 adults with primary immune thrombocytopenia who had already received an array of other treatments. About two-thirds of the participants had received three or more therapies for their condition before enrolling in the new trial.
The study is the first of two pivotal trials the company is conducting for the potential new indication. The second, ADVANCE-SC, will likely have top-line data in the first quarter of 2023, Argenx said.
By Kristin Jensen
Big Pharma has long seen the potential for AI and machine learning to accelerate drug development. But Novo Nordisk is going a step further by channeling $200 million toward the creation of a computer that will outrun anything in existence.
Current methods for diagnosing Alzheimer’s disease rely on a complex combination of self- and caregiver-reported symptoms, a physical examination and either a PET scan or a spinal tap to look for evidence of amyloid plaque build-ups in the brain. But a new artificial intelligence-based method may make the diagnostic process a much more objective one.
There is lots of talk about diversity and inclusion in business, including in pharma and medtech. A new report by the Open Political Economy Network (OPEN), a think tank focusing on migration and diversity, released its “Minority Businesses Matter: Europe” report highlighting the successes and challenges of ethnic minority-owned businesses in Europe.