FDA accepted FYLREVY filing and Richter Gedeon stock costs EUR 35.13

Published on 10/16/2026 at 10:04 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

FDA accepted FYLREVY on October 14, 2026. Richter Gedeon stock costs EUR 35.13 on October 16, 2026 before results.

FYLREVY filing and H1 performance

Richter Gedeon received FDA filing acceptance for FYLREVY on October 14, 2026.
First-half 2026 revenue reached HUF 151.8 billion, up 3.00 percent year over year.
Richter Gedeon stock traded at EUR 35.13 at 10:00 a.m. CEST at Lang & Schwarz on October 16, 2026.

Richter Gedeon, HU0000123096, Illustration mit AI erstellt.

Richter Gedeon (ISIN HU0000123096) was trading at EUR 35.13 at Lang & Schwarz on October 16, 2026 at 10:00 a.m. CEST. The company had announced on October 14 that the U.S. Food and Drug Administration accepted its FYLREVY application for review, according to Gedeon Richter.

FYLREVY reaches US review

FYLREVY is an oral estrogen therapy based on estetrol for moderate to severe vasomotor symptoms linked to menopause. If approved, the product would become the first menopausal hormone therapy containing E4 on the U.S. market, giving Richter a potential new route into women's healthcare.

The FDA decision is expected by the third quarter of 2027, according to the company's announcement. That timetable makes the filing an operational milestone rather than an immediate earnings contribution, while the commercial value depends on a later approval and launch process.

What does H1 mean for margins?

Richter's first-half 2026 results show why the filing sits alongside an efficiency story. In the earnings call published on August 7, Yahoo Finance reported that constant-currency revenue rose 8.70 percent in the first half, while reported revenue reached HUF 151.8 billion, up 3.00 percent year over year.

Constant-currency Clean EBIT increased 21.00 percent in the first half, and management upgraded its 2026 pharma Clean EBIT outlook to double-digit growth. The counter-factor was foreign exchange: first-half net profit fell to HUF 103.5 billion, while the second quarter included more than HUF 32.0 billion of foreign-exchange losses.

Upcoming reporting date

Yahoo Finance lists November 10, 2026 as Richter Gedeon's next earnings date. The report will give investors a fresh test of the Clean EBIT upgrade and the extent to which currency pressure continues to affect reported profit.

Stock trades above EUR 35

For the German investor, the current euro quotation places the FDA filing beside a measurable market reference. Richter Gedeon stock was trading at EUR 35.13 at Lang & Schwarz on October 16, 2026 at 10:00 a.m. CEST.

The further course of trading is shown by the continuously updated real-time quote of Richter Gedeon stock.