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
Source: biopharmadive.com
The Food and Drug Administration’s top scientist Namandjé Bumpus will assume the role of principal deputy commissioner when longtime agency leader Janet Woodcock retires from that role in early 2024, according to an announcement Thursday.
US biopharma AbbVie has agreed to acquire ImmunoGen in a deal which values the company at about $10.1 billion and gives AbbVie access to flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx), a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer (PROC), as well as a pipeline of promising next-generation ADCs.
EUROAPI today announced the appointment of David Seignolle as Chief Operating Officer, succeeding Eric Berger, and Marion Santin as Chief Legal, Compliance, and IP Officer, both joining the company’s Executive Committee. In his new role, David Seignolle will lead the transformation of the Industrial Operations organization.
