Formycon

The FDA has officially accepted the marketing application for FYB206, a biosimilar candidate to Keytruda, for review, making Formycon, according to the company, the first publicly known firm with such an application. An approval decision is expected in the third quarter of 2027 based on typical review timelines. The dossier was also submitted to Health Canada. Formycon stresses that FYB206 was developed without a comparative phase‑3 efficacy study to speed the program and reduce costs; the stock then rose sharply. » Plus sur deraktionaer.de

Formycon reports that first-half 2026 revenue nearly tripled year-on-year and adjusted EBITDA improved to -6.9 Mio. EUR (previously -19.2 Mio. EUR). Drivers were milestone payments (14.3 Mio. EUR) and stronger commercial sales, with FYB206 accounting for more than 40% of revenue. Cash resources fell to 51.8 Mio. EUR, and total assets amount to 714 Mio. EUR. Management confirmed the full-year guidance but warned of non-linear revenue timing and competitive risks in the biosimilar market. » Plus sur de.investing.com

Formycon reports H1 2026 revenue of €25.8m and a reduced EBITDA loss of €3.4m. Growth was driven by milestone and advance payments from partnerships for FYB206 as well as increased licensing income and milestone payments from FYB202. Lower research and development costs due to project progress and capitalization of development expenses contributed to the improved results. Formycon confirmed its full‑year guidance of €60–70m revenue and group EBITDA of €0–10m and completed the clinical development of FYB206. » Plus sur de.investing.com