Bluejay Therapeutics Receives Positive Opinion on Orphan Designation from the European Medicines Agency for BJT-778 for the Treatment of Chronic Hepatitis D

SAN MATEO, Calif., May 29, 2024 (GLOBE NEWSWIRE) — Bluejay Therapeutics, a private clinical-stage biopharmaceutical company focused on viral and liver diseases with unmet medical needs, today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Company’s application for orphan designation for BJT-778 for the treatment of chronic hepatitis D (CHD).

“We are delighted that the EMA has issued a positive opinion for orphan designation for BJT-778. This recognition underscores the urgent need for new treatment options for people living with this devastating chronic infection,” said Keting Chu, Founder and CEO of Bluejay Therapeutics. “We are eager to accelerate the development of BJT-778 and make it available to patients as soon as possible. We look forward to continuing our collaboration with the EMA and other regulatory agencies to expedite the availability of this promising treatment for patients with CHD.”

In addition to orphan designation, BJT-778 has also been granted Priority Medicines (PRIME) designation by the EMA for the treatment of chronic HDV, an endorsement to the therapy’s potential to address a high unmet need in patients with these serious conditions.

About BJT-778

BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) against hepatitis B surface antigen (anti-HBsAg mAb). BJT-778 neutralizes and clears hepatitis B and hepatitis D virions and depletes HBsAg-containing subviral particles, which may help to reconstitute antiviral immunity and contribute to a functional cure for chronic hepatitis B (CHB). BJT-778’s preclinical safety and efficacy profiles make it an ideal candidate for combination therapies with existing and emerging treatments for CHB and chronic hepatitis D (CHD). BJT-778 is currently being evaluated for the treatment of CHD and as a functional cure for chronic HBV.

About Bluejay Therapeutics

Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatments for viral and liver diseases. The Company’s lead program, BJT-778, is a potentially best-in-class fully human IgG1 anti-HBsAg mAb, being developed for both chronic HBV and HDV. Bluejay is also developing and advancing other innovative programs for chronic HBV, including a proprietary TLR9 agonist (Cavrotolimod) and a liver-targeted transcript inhibitor (BJT-628), with the goal of achieving higher rates of functional cure. For more information on Bluejay, please visit the company’s website at