ARS Pharmaceuticals (SPRY) is expecting approval for neffy today, the first effective intranasal epinephrine delivery system. Today is the FDA PDUFA date so I'll sum this up in as few quick points as I can:
-Global epinephrine market expected to continue to grow YoY with estimates anywhere from $3 B to $5B annually by 2029-2032
-Over $180M cash/assets on hand from merger with Silverback Therapeutics in June 2022 to support minimum 3 years commercialization runway
-Received strong majority FDA AdCom recommendation for immediate approval and in-market testing in June 2023
-FDA extended PDUFA date from June to today to finalize labelling and post-market support conditions (usually will not waste their time if they are not expecting to approve)
-Consistent insider buying, large insider holdings
-Strong institutional buys the last month of >5M total shares
-Over 100 Special Sales Rep jobs were posted recently
-Current price hovering around $7/share, analyst price targets are anywhere from $14 to $20 per share upon approval.
As of this moment, the only thing left is for ARS to release a PR statement on receiving approval which they may opt, like many companies that have been in this position, to wait until AH/PM when the market is closed. I watched the entire 12-hour AdCom review. There is nothing left to do but get this product to market to start helping people. As someone with anaphylactic allergies, this hits really close to home and am very hopeful to have this at my disposal ASAP.
I hadn't seen this ticker posted anywhere so I had to get this out. As always use any information at your own risk, NFA!
Position: 700 @ $7.02, 3 10/20 $12.50C
In since Oct 2022
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