Regeneron - DB-OTO

Musings on a possible new franchise in hearing loss

Friends of NFTBC.

I hadn’t been intending to write about REGN this week, but events happen - and within 24 hours of my last post there were two important ones for REGN.

The first (and most discussed) is this:

We’ve talked about the Catalent / Eylea HD delays previously. It’s a complex regulatory situation involving two separate supplemental applications and, not being a regulatory expert, I’m not inclined to weigh in on it very much. If you’ve got any experience in these matters I’d be happy to hear your thoughts. But, short of rabbits emerging from hats, a positive resolution seems decreasingly likely this year - hence why REGN is doing the necessary to side-step the offending Catalent site. It could be well into 2026 by the time REGN gets the approvals. Beyond that, I’m inclined to wait to hear from management in a couple of weeks with the quarterly results.

But there’s been another development, and I would argue a more interesting one. No one is talking very much about the possibility of a major hearing loss franchise at REGN starting as soon as next year, so I thought I’d take it upon myself. Actually I’ve had conversations with some NFTBC readers about this, so I know at least some of you REGN watchers are thinking about it, even if it’s generally off the radar for now. It’s been in the back of my mind for a few years but this week things started to get more real with a surprising pace of advancement.

Let’s have a look.

[NFTBC does not give advice - please do your own research. I currently own shares in REGN]

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