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Hyloris Pharmaceuticals: FDA classifies manufacturing site as OAI and halts approval of valacyclovir

The FDA has classified the manufacturing site of a Greek supplier for Hyloris as "Official Action Indicated" (OAI), which effectively blocks approval of the oral valacyclovir suspension. As a result, the NDA remains pending well beyond the PDUFA date of October 12, 2025; no new timeline has been provided. Hyloris stresses there are no efficacy or safety concerns but has suspended production for the US market, making longer delays or a relocation of manufacturing possible. The incident highlights Hyloris' reliance on external production partners in its business model. » More on de.investing.com

Financials

In the last quarter, Hyloris Pharmaceuticals SA had revenue of €2.3m and net profit of -€1.39m

(EUR)	December 2025	YoY
Revenue	2.3m	-
Gross profit	2.17m	-
Net profit	-1.39m	-
EBITDA	-2.1m	-

Fundamentals

Metric	Value
Market capitalization	€108.08m
Number of shares	28m
52-week high/low	€8.40 - €3.38
Dividends	No
Beta	0.64
P/E ratio	-23.83
PEG ratio	5.24
P/B ratio	4.27
P/S ratio	17.24

Company profile

Hyloris Pharmaceuticals SA engages in the develop, manufacture, and deliver pharmaceutical products to address unmet medical needs in cardiovascular health, oncology, women's health, and other major therapeutic areas. The company offers cardiovascular products for atrial fibrillation, acute coronary syndrome, advanced heart failure, congestive heart failure, acute coronary syndrome, and coronary heart disease. It also provides other products, such as post operation pain, dental indications, severe and recurring vulvovaginal candidiasis, acute myeloid leukemia and small cell lung cancer, IC/PBS, attention deficit hyperactivity disorder, and viral infection. Hyloris Pharmaceuticals SA was incorporated in 2012 and is headquartered in Liège, Belgium.