LOGO
LOGO

Slide Shows

Biotech Stocks Facing FDA Decision In June 2026

Swedish Orphan Biovitrum
Swedish Orphan Biovitrum

The FDA decision on global biopharmaceutical company Sobi’s (SOBI.ST) Biologics License Application seeking approval of NASP for the treatment of uncontrolled gout is expected on June 27, 2026.

NASP, which is Nanoecapsulated Sirolimus plus Pegadricase, is a novel, every 4-week infusion therapy consisting of nanoencapsulated sirolimus, which has a targeted immunomodulating effect, and Pegadricase, a pegylated uricase.

Uncontrolled gout can cause chronic inflammation, often resulting in severe gout flares and a buildup of uric acid, leading to the formation of painful uric acid deposits called tophi.

Approximately 200,000 people in the United States suffer from uncontrolled gout, with serum uric acid (sUA) levels above 6 mg/dL despite treatment with oral urate-lowering therapies.

According to the company, the phase 3 trials of NASP met their primary goal of reducing and maintaining serum uric acid levels below 6mg/dL for at least 80% of the time during month six of the treatment.

SOBI.ST closed Friday's trading at 442.20 Swedish kronor (SEK), up 1.05%.