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Formycon: FDA accepts application for Keytruda biosimilar FYB206 for review

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. » More on deraktionaer.de
Formycon: H1 2026 revenue nearly tripled, adjusted EBITDA significantly improved

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. » More on de.investing.com
Formycon raises half‑year revenue to €25.8m and reduces EBITDA loss

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. » More on de.investing.com

Historical dividends Dividends

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In 2022, Formycon has already paid €0.26 in dividends. The last payout was in March 2022.

Financials

In the last quarter, Formycon had revenue of €25.76m and net profit of -€14.63m

(EUR)	June 2026	YoY
Revenue	25.76m	-
Gross profit	-3.04m	-
Net profit	-14.63m	-
EBITDA	-4.98m	-

Fundamentals

Metric	Value
Market capitalization	€329.07m
Number of shares	17.67m
52-week high/low	€26.85 - €15.90
Dividends	No
Beta	0.72
P/E ratio	-13.38
PEG ratio	-0.08
P/B ratio	0.87
P/S ratio	5.48

Company profile

Formycon AG develops and markets biosimilar products. Its product pipeline includes FYB201, a biosimilar candidate for Lucentis, an ophthalmic drug used in the treatment of neovascular age-related macular degeneration and other serious eye diseases; FYB202, a biosimilar candidate for Stelara, a biopharmaceutical used in the treatment of inflammatory diseases, such as moderate to severe psoriasis, as well as for the treatment of Crohn's disease and ulcerative colitis, which is in the Phase III clinical trial; and FYB203, a biosimilar candidate for Eylea to treat neovascular age-related macular degeneration and other eye diseases that is in Phase III clinical trials. The company is also developing FYB206; and FYB207, an antiviral drug for the treatment of COVID-19. It has a collaboration agreement with Leukocare AG to develop stable formulations for various candidates in its product pipeline. The company was formerly known as Nanohale AG and changed its name to Formycon AG in 2012. Formycon AG was founded in 1999 and is headquartered in Planegg, Germany.