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
The U.S. Patent and Trademark Office issued a patent to MedTrace for their method of diagnosing the human heart via 15O-water PET. The patented method is the foundation of the company’s software aQuant, currently under development. Hendrik “Hans” Harms, PhD and Senior Scientist at MedTrace, and Jens Soerensen, Professor and Clinical Advisor to MedTrace, are the originators of the method.
Teresa Graham, currently head of global product strategy for Roche pharma, will become the division’s new CEO next month, Roche said Thursday. Simultaneously, Roche is elevating Levi Garraway, chief medical officer, to the executive committee.
Fierce Pharma has obtained internal documents and video of a town hall meeting conducted this week describing what J&J called a “comprehensive review” of its portfolio. Moving forward, J&J plans to operate its vaccines and infectious diseases outfits as one group, the executives explained.