Hello Avadel Pharmaceuticals is looking to receive FDA approval tomorrow on Oct 15.
Dublin-based Avadel is specialty pharmaceutical company, with a focus on the treatment of narcolepsy, or excessive daytime sleepiness. The company estimates that there are up to 170,000 diagnosed patients in the US alone, making a significant potential patient base for an approved drug. Avadel’s key drug candidate, FT218, a formulation of sodium oxybate, makes use of a proprietary drug delivery technology for once-daily dosing at bedtime for the treatment of adults.
Last year, Avadel reported the successful completion of the REST-ON Phase 3 clinical trial of FT218 for the treatment of EDS (excessive daytime sleepiness) and cataplexy in patients suffering from narcolepsy, which demonstrated statistically and clinically meaningful results in meeting three key endpoints. The drug is currently undergoing the open-label RESTORE clinical study, and has received orphan drug designation from the FDA.
The final step before commercialization of FT218 can commence is regulatory approval, and Avadel got that process started in February of this year, with the New Drug Application (NDA) filing with FDA. The Agency’s review process is nearing completion, and the PDUFA date – when the FDA will announce its decision – is set for this coming October 15.
The likely FDA approval, the high profit potential of FT218, as well as Avadel’s likely success in court are the key factors behind Needham analyst Ami Fadia’s bullish stance on AVDL. “Our investment thesis is three-fold,” she writes. “We believe that: (1) FT218 will be approved on PDUFA date October 15th, 2021 for the treatment of excessive daytime sleepiness (EDS) and cataplexy in narcolepsy, and will not be subject to a 30-month stay; (2) IP litigation initiated by JAZZ against Avadel shouldn’t delay FT218’s launch; (3) FT218 sales can grow to > $300M in 2023, and generate sales in the $400M+ range in the outer years on a non-risk-adjusted basis given its more convenient once-nightly dosing vs other sodium oxybates.” Fadia believes that the company will be able to initiate its commercial launch on schedule in early 2022.
In line with this outlook, the analyst sets a Buy rating on AVDL stock, and her $17 price target suggests room for 73% share appreciation in the coming year.
Thanks for the writeup. Been in since earlier in the week. For some extra information, I asked a relative of mine who works in the Pharma industry to take a look at this (public domain, not an insider). He had the following to say for what it’s worth:
"On Avadel, I just reviewed the data from their pivotal clinical trial and it is strong. The drug works. The drug is a single dose taken at night and there is already the same drug approved (Jazz) but it is dosed twice during the night, so less convenient. It was supposed to have better side effects and it looks a little better, except enuresis (bed wetting) which looks slightly worse (9% and 9% at the highest doses vs. 3% and 7%). If the has been no news to date a CRL and rejection is unlikely. I think it will be approved and the Package Insert - which is what the company can use to sell it over the Jazz product - look slightly better. From a trading perspective, all this information is in the public domain in a publication of there pivotal trial out this summer.
Now to comments on an area that you have greater expertise in.
To me that means the stock price already accounted for the published results and their comparison with the other product. So I would not expect a big pop when the last doubt is removed. You have to decide whether to sell on the news! Good luck. Happy to chat."
I’ve been holding for a while now and mentioned this play a few times in the now defunct Discord threads. I’m currently a user of the twice nightly formulation with Jazz but I was involved with the trials of FT218. This drug will be a game changer. There’s also still room for growth - they can reformulate a low sodium version of the drug as well, so there is real longevity with their drug delivery system.
For what it’s worth, they posted three new jobs last night, including one for Manager REMS Program, which is a government program required to dispense a GHB medication, so I don’t see how an approval isn’t forthcoming.
Are people expecting a big sell off come Monday on AVDL? The fda just seems to have kicked the can down the road wasn’t exactly terrible news. Wonder if people are expecting a similar thing to PTGX short term hold of sorts and are trying to buy the dip still expecting it to be approved? Just speculation of course
I f*cked up a bit. Bought 4 x Call $7.5 Nov 21. Then due to my dumb oversight, I bought Put $12.5 expiring 10/15 instead of Nov. If it tanks Monday, nice stupid loss right there!
Someone on the trading floor talked showed the PR to his wife that works in the industry and said that kind of response isn’t surprising as the FDA is really backlogged right now.
I kind of knee-jerked when it went down and sold (only 40 shares), which in this case was a bad move as it did recover considerably. I already scalped it a little a couple times previous days so the loss was minimal. Wish I did like JB and just bought the dip and scalped it on the recovery. But again I panicked (was up since 3am so my mind wasn’t fully functioning) and missed the opportunity. At least it’s a lesson learned.
The algos immediately sell off on anything but positive news, and I think some were buying back in after realizing the news was just a delay and not a denial. I believe this is what happened to PTGX. For me, this could be a potential future play if the FDA continues to be severely backlogged then it seems a legit scalping strategy if you care to sit PM/AH watching a stock and have their press release page pulled up ready to read (obviously would want to stay away from a denial as that could be a lot longer recovery).
I’m likely going to buy back in if it takes another good dip on Monday. There will likely be a sell-off from people not wanting to hold for an undetermined amount of time. Like many others, I think this drug would be a real game changer as it is only a single dose, and seeing as how it’s based off an existing drug (that is used in 2 doses) I think it has a very high chance of FDA approval.
Ouch… Yeah, got to pay attention to expiration dates and always give some buffer room with FDA plays! Paki bought some FD Calls by accident, but I’m pretty sure he also bought some for Nov afterwards.
Thought I’d deal some fresh hopium, because why not.
Here’s a table of a few other missed PDUFA dates with their final resolution and action date. As you can see this isn’t infrequent and the resolution can occur in as little as 10 days or a few weeks and take as long as several months.
Tough one here dont want to “bag hold” but with another analyst PT of $16 today and perhaps a chance at an approval ill hold on a week or so. Nov calls so dont want to wait too long
