DiaSorin wins FDA clearance as DiaSorin stock nears EUR 80

Published on 10/14/2026 at 12:22 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

First-half revenue reached EUR 602 million, flat at constant rates. DiaSorin stock costs EUR 78.44 on October 14, 2026, below EUR 80.

FDA clearance and earnings trajectory

Two DiaSorin assays received FDA approval on October 13, 2026.
First-half 2026 revenue reached EUR 602 million at constant exchange rates.
DiaSorin stock traded at EUR 78.44 at 12:16 p.m. CEST on October 14, 2026, 1.61 percent below its 52-week high.

Techniker im Reinraum bedienen automatisierte Diagnostikgeräte in modernem Biotech-Labor — Modernes Diagnostiklabor von DiaSorin S.p.A., ISIN IT0003497168, zeigt präzise Biotech-Produktion und klinische Fertigung, Illustration mit AI erstellt.

DiaSorin (ISIN IT0003492391) was trading at EUR 78.44 at Lang & Schwarz on October 14, 2026, with the quote 1.61 percent below the EUR 79.72 52-week high. On October 13, 2026, the company obtained FDA approval for two DiaSorin LIAISON XL assays covering Human Parvovirus B19 IgM and IgG, according to DiaSorin. The stock therefore remains near the EUR 80 resistance level identified by Ftaonline on October 14, 2026.

FDA approval adds a product marker

The approval expands the regulatory base for the LIAISON XL immunoassay system in a defined infectious-disease application. The development matters alongside DiaSorin's broader effort to rebuild growth through specialty testing and new platform placements.

First-half figures show uneven recovery

According to the DiaSorin earnings-call transcript published by Yahoo Finance, first-half 2026 revenue was EUR 602 million, flat at constant exchange rates versus the first half of 2025. Second-quarter revenue grew 4.00 percent at constant exchange rates, contrasting with the flat first-half performance.

The same transcript showed first-half 2026 EBITDA of EUR 194 million, down 7.00 percent at constant exchange rates, while the EBITDA margin was 32.00 percent. Management confirmed full-year 2026 guidance for revenue growth of 5.00-6.00 percent and an adjusted EBITDA margin of 32.00-33.00 percent.

What does the next report add?

The next reporting date is listed as November 6, 2026, by Ftaonline. Its October 13, 2026 report also put adjusted second-quarter net income at EUR 57 million, down 7.00 percent year over year, making profitability the key counterweight to the regulatory progress.

Three dated developments

On July 31, 2026, DiaSorin reported first-half revenue of EUR 602 million and first-half EBITDA of EUR 194 million in its results call. On October 7, 2026, the company completed a EUR 250 million buyback program, as reported by Teleborsa. On October 13, 2026, DiaSorin obtained FDA approval for two LIAISON XL assays.

Dates that shape the setup

The November 6, 2026 third-quarter reporting date is the next company event identified in the cited coverage. The October 13, 2026 FDA approval gives the next report a product-regulatory milestone to place alongside the 5.00-6.00 percent full-year revenue-growth guidance.

Stock remains near EUR 80

At 12:16 p.m. CEST on October 14, 2026, DiaSorin stock was trading at EUR 78.44 at Lang & Schwarz, compared with a EUR 79.72 52-week high and a EUR 52.34 52-week low. The current market capitalization was EUR 3.9 billion as of October 14, 2026, while the primary listing is on Euronext Milan.

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