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2 Upcoming FDA Approval Decisions That Investors Should Really Watch

By Keith Speights and Brian Orelli, PhD – Oct 23, 2021 at 6:01AM

Key Points

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The FDA is scheduled to announce these two key approval decisions in late November.

Few things are more important to drugmakers than winning regulatory approvals for new products. In this Motley Fool Live video recorded on Oct. 13, Fool contributors Keith Speights and Brian Orelli discuss two upcoming U.S. Food and Drug Administration (FDA) approval decisions that investors should keep an eye on.

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Keith Speights: Brian, on another note, the FDA is set to make several important approval decisions in the fourth quarter. Which of those do you think are ones that investors should really be watching?

Brian Orelli: Biomarin (BMRN 0.70%) has one coming up on Nov. 20. That's Voxzogo, it's for basically short stature. I think that's one that investors should really be looking at.

Then Legend (LEGN 5.11%) and Johnson & Johnson (JNJ 1.01%) on Nov. 29. This is a BCMA CAR-T. They go by cilta-cel, that's the short name for the long name that I'm not going to try to pronounce.

They'll compete against Bristol Myers Squibb (BMY 1.04%) and Bluebird Bio (BLUE 1.84%), which is going to become, what's the name of the new company? Spinoff will now have this drug, which is Abecma.

That will be important for Bluebird Bio's spinoff as well as Bristol Myers Squibb's. If you're invested in either one of those, to watch this Legend Biotech and Johnson & Johnson BCMA CAR-T.

Speights: We were talking earlier about not being able to predict what happens in biopharmaceutical markets. I never would've thought Legend Biotech would've been as successful as it has been in the CAR-T world, but it has been. You're right, this is an important FDA announcement that'll be upcoming in November there.

Brian Orelli, PhD has no position in any of the stocks mentioned. Keith Speights owns shares of Bristol Myers Squibb. The Motley Fool owns shares of and recommends Bristol Myers Squibb. The Motley Fool recommends BioMarin Pharmaceutical, Bluebird Bio, and Johnson & Johnson. The Motley Fool has a disclosure policy.

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