<div id="readability-page-1"><div id="ctl00_CPI_dvBody"><div><div><p>Add <img src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/RTTNews-Logo-224x61.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/RTTNews-Logo-224x61.png"/> as your preferred news source on Google</p><div><p><img src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/google.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/google.png"/> Add Now</p></div></div></div><p> The month of May saw important regulatory developments, with the FDA approving new therapies for rare and underserved patient populations.</p><p>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.</p><p>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. </p><p>So far this year, the FDA has approved 20 novel drugs through the end of May.</p><p>Now let's take a look at the biotech stocks facing FDA decisions in June 2026. </p><p>For comments and feedback contact: editorial@rttnews.com</p><p>Business News</p></div></div>

GILD

SPRO

KNSA

<p>June 2026 FDA calendar features key biotech decisions. Spero Therapeutics awaits approval for a UTI antibiotic, Kiniksa Pharma seeks manufacturing process approval for Arcalyst, and Merck pursues first approval for the WELIREG-KEYTRUDA combination. This follows May's approvals of Partner Therapeutics' Bizengri and Gilead's Hepcludex.</p>

Biotech Stocks Facing FDA Decision In June 2026