Forecast

The analysts' average price target is €193.34 (+47.59%). The median is €187.29 (+42.97%).

Buy	6
Hold	0
Sell	0

News Go to news feed

Belite Bio beats Q2 EPS expectations, stock falls despite FDA progress

Belite Bio reported adjusted EPS of -$0.54 for Q2 2026, beating the consensus estimate of -$0.7525. The company has no product revenue yet; R&D and SG&A expenses rose significantly, while cash and cash equivalents amounted to $780 million. The FDA accepted the NDA for Tinlarebant for priority review and set a PDUFA date of February 12, 2027. The stock fell 7.08% in regular trading and recovered slightly after hours. » More on de.investing.com
Belite Bio presents positive DRAGON data on Tinlarebant for Stargardt disease

Belite Bio presented data from the Tinlarebant DRAGON study at a scientific conference showing a 35.7% reduction in the annualized growth of macular lesions and reporting an overall manageable safety profile. Clinicians emphasized that structural benefits will require longer follow‑up before clear functional improvements in visual acuity appear. Belite has submitted the NDA, is awaiting the FDA Day‑74 letter, and is seeking accelerated pathways in the US and Japan; commercial uptake will depend on diagnosis rates, reimbursement, and longer confirmatory data. » More on de.investing.com
Belite Bio supports FDA filing for tinlarebant with phase‑3 data

Belite Bio reports that the phase‑3 DRAGON study of tinlarebant showed a 37% reduction in progression of decreased‑autofluorescence lesions and reinforces an ongoing New Drug Application (NDA) process at the FDA. The company highlights its already granted Breakthrough Therapy designation and an expected accelerated review. Safety data are described as manageable; mostly mild, reversible visual adjustment effects occurred and there were no serious treatment‑related ocular events. The confirmatory DRAGON II study is fully recruited (73 patients) and is intended to support approvals in additional markets; tinlarebant is positioned as a once‑daily oral, first‑in‑class therapy for Stargardt. » More on de.investing.com

Financials

In the last quarter, Belite Bio Inc. ADR had revenue of €0 and net profit of -€24.89M

(EUR)	Jun 2026	YoY
Revenue	0	-
Gross profit	0	-
Net profit	-24.89M	79.80%
EBITDA	-30.59M	121.47%

Fundamentals

Metric	Value
Market capitalization	€5.43B
Number of shares	40.09M
52-week high/low	€172.62 - €53.67
Dividends	No
Beta	-1.23
P/E ratio	-56.89
PEG ratio	1.12
P/B ratio	7.93
P/S ratio	0.00

Company profile

Belite Bio, Inc., ein biopharmazeutisches Entwicklungsunternehmen im klinischen Stadium, beschäftigt sich mit der Erforschung und Entwicklung neuartiger Therapeutika zur Behandlung der atrophischen altersbedingten Makuladegeneration und der autosomal rezessiven Stargardt-Krankheit. Der führende Produktkandidat ist LBS-008, eine einmal täglich oral einzunehmende Behandlung, die die Zufuhr von Vitamin A zum Auge reduzieren und aufrechterhalten kann, um die Anhäufung von toxischen Vitamin-A-Nebenprodukten im Augengewebe zu verringern, und die sich in der klinischen Phase 3 befindet. Das Unternehmen entwickelt außerdem LBS-009, eine orale Anti-Retinol-Bindungsprotein-4-Therapie zur Behandlung von Lebererkrankungen, einschließlich nichtalkoholischer Fettleber, nichtalkoholischer Steatohepatitis und Typ-2-Diabetes, die sich in der präklinischen Entwicklungsphase befindet. Belite Bio, Inc. wurde im Jahr 2016 gegründet und hat seinen Sitz in San Diego, Kalifornien. Belite Bio, Inc. ist eine Tochtergesellschaft von Lin Bioscience International Ltd.