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
CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines. The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological and solid tumour indications with high unmet medical needs.
FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed.
Sanofi’s global restructuring and downsizing is now fully underway, with layoffs stretching to the company’s Belgian offices. Belgian newspaper De Tijd reports that 67 employees have been laid off at a site in Ghent and 32 jobs are on the chopping block at Sanofi’s Belgium HQ in Diegem.
