Formycon rises on FYB206 trial progress, stays in lead on Keytruda biosimilar

Investing.com -- Shares of Formycon AG (ETR:FYB) rose over 4% on Thursday after the company announced it had completed patient enrollment in the pivotal Dahlia pharmacokinetic (PK) study for FYB206, its biosimilar to Merck’s blockbuster cancer drug Keytruda.

The PK trial, launched in June 2024 at selected Southeastern and Eastern European sites, enrolled 96 participants. 

It compares the pharmacokinetics, safety, and tolerability of FYB206 against Keytruda. 

Formycon said the first patients have completed all 17 treatment cycles, and results for the study’s primary endpoint are expected in the first quarter of 2026.

The study is central to Formycon’s streamlined clinical development strategy for FYB206. In late 2024, the company submitted a modified clinical plan to the U.S. Food and Drug Administration (FDA), aiming to demonstrate therapeutic equivalence using analytical data and PK results alone. 

Following a favorable FDA response, Formycon halted recruitment for a previously launched Phase III trial in February 2025. 

Patients already enrolled in that trial continued treatment with the locally available Keytruda outside the study.

This approach has allowed Formycon to significantly reduce development costs while accelerating its timeline, without compromising regulatory rigor. 

According to Dr. Andreas Seidl, Chief Scientific Officer at Formycon, the “last patient in” milestone reflects the company’s operational efficiency and strong recruitment performance across study centers.

Keytruda posted global sales of US$29.5 billion in 2024, making it the world’s top-selling drug. 

Forecasts project sales could exceed US$50 billion by 2032, driven by its broad oncology indications. 

The International Agency for Research on Cancer estimates a 77% increase in global cancer diagnoses by 2050, highlighting the growing need for affordable immunotherapy options.

However, competition looms. Merck (NSE:PROR) is expected to launch a subcutaneous (SC) formulation of Keytruda as early as this year, a move analysts suggest could complicate biosimilar substitution in the U.S. market. 

Formycon currently anticipates that FYB206 could enter the U.S. market after Keytruda’s exclusivity expires in 2029, and in the EU after 2030.

RBC Capital Markets, which maintains an “Outperform” rating with a €51 price target, values FYB206 at €19 per share,over 37% of the firm’s valuation. 

While acknowledging Formycon’s leadership in the pembrolizumab biosimilar space, RBC maintains a “neutral” sentiment due to the speculative nature of biosimilar development, regulatory risks, and Merck’s lifecycle management strategies.