Formycon AG

Formycon AG and MS Pharma enter licensing and supply agreement for FYB202 (ustekinumab biosimilar) in MENA region. MS Pharma to commercialize and produce FYB202 locally in Saudi Arabia. Formycon retains rights to out-license FYB202 in specific MENA countries. FYB202 approved by FDA and European Commission in September 2024.

Biosimilar candidates for aflibercept, indicated for age-related macular degeneration (AMD), are progressing towards approval in Europe. Samsung Bioepis' OPUVIZ, Sandoz Group's Afqlir, and Formycon AG/Klinge Biopharma GmbH's FYB203 have all received significant regulatory approvals.

Formycon reports nine-month results for 2024, highlighting product approvals for FYB202 in the USA and Europe, the start of clinical development for Keytruda® biosimilar FYB206, and the initiation of FYB210 development. Financial results reflect successful business performance, confirming guidance.

The CHMP of EMA issued a positive opinion for FYB203, a biosimilar to aflibercept, recommended for treating nAMD, DME, myopic CNV, and RVO. Formycon AG CEO expressed excitement, highlighting the biosimilar's potential to enhance patient care. European Commission approval expected in Jan 2025, following FDA approval in June 2024.

The CHMP of EMA issued a positive opinion for FYB203, a biosimilar candidate to aflibercept, recommended for nAMD, DME, CNV, and macular oedema following RVO. Formycon AG anticipates European Commission approval in Jan 2025, following FDA approval in June 2024.

The CHMP of EMA issued a positive opinion for FYB203, a biosimilar to aflibercept, recommended for treating nAMD, DME, myopic CNV, and RVO. Formycon AG anticipates EU approval in Jan 2025, following FDA approval in June 2024.

Formycon receives positive CHMP opinion for FYB203, a biosimilar candidate to Eylea®, recommended for approval in Europe for treating nAMD and other retinal diseases. European Commission approval expected in the second half of January 2025.

Formycon announces EMA's CHMP positive opinion for FYB203/AHZANTIVE®/Baiama® biosimilar to Eylea®, recommended for EU approval in treating nAMD, DME, Myopic CNV, and RVO, with expected marketing authorization by Jan 2025.

Formycon AG's FYB203, an aflibercept-biosimilar, received a positive opinion from the CHMP for EU market approval, targeting nAMD and other retinal diseases. The endorsement is based on comprehensive data showing equivalent quality, efficacy, and safety to Eylea®, with a European Commission decision expected by January 2025.

Formycon AG applies for admission to the Prime Standard of the Frankfurt Stock Exchange, aiming to expand its international investor base. Trading is expected to start on November 12, 2024, enhancing share visibility, tradability, and liquidity. The company seeks to strengthen its international market position and meet stringent transparency and disclosure criteria.