Biotech Stocks Facing FDA Decision In June 2026

(RTTNews) - The month of May saw important regulatory developments, with the FDA approving new therapies for rare and underserved patient populations.

On May 8, 2026, Partner Therapeutics' Bizengri secured the regulatory nod to treat NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts. This approval marks the seventh approval under the Commissioner's National Priority Voucher (CNPV) pilot program.

Gilead Sciences' Hepcludex injection was approved by the FDA on May 22 to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis. It is the first FDA-approved treatment for chronic HDV infection.

So far this year, the FDA has approved 20 novel drugs through the end of May.

Now let's take a look at the biotech stocks facing FDA decisions in June 2026.