The FDA's Endocrinology Division this morning released its review document for Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent, which will be reviewed by the Committee on June 9. Piper views the draft discussion points as "generally tame" and says the briefing contained "no nasty surprises." The firm remains confident in a positive panel vote on Tuesday and still expects approval for Praluent by the July 24 PDUFA date. It keeps a Neutral rating on Regeneron with a $484 price target.

Reports business EPS of EUR 1.78, down 17.6% reported and 7.4% at CER. Reports Q1 IRFS net sales EUR 10.464B, up 2.4%. Paul Hudson, Chief Executive Officer, commented: "We are off to an excellent start in 2024, delivering on our strategic priorities and a transformation of our portfolio of medicines and vaccines to become a development-driven, tech-powered biopharma company committed to serving patients and accelerating growth. Continued strong performance by Dupixent and our new launches drove sales growth of seven percent. In parallel, we are delivering on our promise of increased investments in our late-stage pipeline to fully realize its value for patients and Sanofi. We are awaiting regulatory decisions for Dupixent in COPD, a progressive disease with limited effective treatment options. If approved, Dupixent will be the first biologic treatment in COPD. With the robust progress in our portfolio transformation, we reaffirm our financial guidance for 2024."