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Aquestive Therapeutics, Inc. (AQST)

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4.4100-0.5600 (-11.27%)
At close: 4:00PM EDT

4.4500 +0.04 (0.91%)
Before hours: 4:12AM EDT

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  • H
    Harry-SGYP
    Time to buy more I was long term investor bought at 3.90 and then double down at $2 did not sell at $9

    This will be $15 next year
    Aquestive Therapeutics leverages proprietary PharmFilm® technology to improve the delivery of approved drug active ingredients and has a diversified pipeline with both wholly-owned and partnered candidates. On September 25, Aquestive announced that the FDA issued a CRL for the Libervant™/Acute Repetitive/Refractory Seizures (ARRS) NDA due to lower than desired drug exposure levels (Cmax) in five subjects from two weight groups in the crossover pharmacokinetic (PK) Study 180323 (n=28; Figure 1). The Company plans to provide the FDA additional information on PK modeling to show that minor changes to the dosing regimen in these two weight groups can help attain the desired drug exposure levels. Also, the FDA identified protocol deviation in Study 180323 in a few blood draws in a limited number of patients (timepoints three days or later); however, Management does not anticipate this to be a major issue. Of note, the FDA did not identify any safety, clinical pharmacology, CMC or non-clinical issues and has not requested additional clinical studies in the CRL. Aquestive plans to engage with the FDA in the coming weeks (within 30 days) to discuss the CRL and formulate the next steps before Libervant™ NDA resubmission. We estimate the FDA meeting to occur in October and anticipate the potential announcement regarding requirements for resolving the CRL for Libervant™ to occur in Q4:20. The Company plans to resubmit the NDA by YE:20 and we anticipate FDA acceptance of the filing for review in Q1:21 (the Company estimates potential PDUFA in H1:21). Management noted that the FDA did not provide any guidance on the Orphan Drug exclusivity for Libervant™. Aquestive plans to request a shorter review process (~2-month vs. standard 6-month) for Libervant™'s NDA since the FDA did not request any additional clinical studies in the CRL. We have pushed our U.S. launch date for Libervant™/ARRS from 10/1/2020 to 6/30/2021 to allow enough time to fulfill FDA requirements, which decreased our PT from $33 to $31. Next in September, we also look forward to the potential monetization of royalty rights for KYNMOBI™ (we anticipate an update during the Q3 earnings call).

    Next: Aquestive plans to meet with the FDA in the coming weeks to discuss the Libervant™/ARRS CRL.
  • s
    sdale16669
    With The RSI Near 25.....This Is A Good Place To Start Buying....Just my Opinion Of Course...If Your waiting For 2-3 Dollars You Might Miss.......I will Add More Tomorrow....Another 35%.....With 50% Powder Just In Case
    the 3's Get Breached...Good Luck All
  • C
    Chimichanga
    Let me summarize the cc. The main concern for the CRL was that some weight groups had drug levels below desirable levels. No safety issues were noted, and no additional clinical trials are needed. They’ll use their dosing model to adjust the values for those weight groups such that you get to the desirable exposure levels. At most it can take up to 6 months for FDA to conduct a review (~2 months for minor adjustments and ~6 months for clinical adjustments). Since their path forward is to use their robust model to adjust the dosing regimens, the intent to use this as a basis for a shorter review period. CEO declined to comment on the monetization of kynmobi. Bunch of stuff about the Type A meeting with FDA that wasn’t much value added.

    My two cents:
    AQST-108’s first PK trial results will still come out this year. They have enough cash to get into 2021 and at worst it’s a 6 month delay. I highly doubt there will be an offering, it makes no sense. Libervant is still a much needed treatment option for patients with epilepsy as it was yesterday so I’m confident of its success in the near future.
    Bullish
  • j
    justin
    Revenue is growing every Quarter and Last time aquestive absolutely destroyed earning estimations.

    With already marketed drugs and a pdufa with Kempharm on 2nd of March this is undervalued at the moment. Not even talking about Aqst 108 (epinephrine) wich could possibly a block buster drug and wich is much needed for patients!

    Ofcourse i’m disappointed with Libervant CRL but I still have faith in this company! Will see what happens with Libervant.

    Good luck everyone!
  • s
    sdale16669
    AQST Update....The Company,which will provide the agency with additional information to demonstrate that dose adjustments will obtain the desired exposure levels,said it does not believe it will to conduct additional clinical studies.

    The company said it is planning to request a meeting with the FDA in the Coming weeks and resubmit its application before year end with the adjusted dosage regiment for the concerned weight groups.

    Have Nice Day Ladies...
  • R
    RICK
    HC Wainwright just issued a buy rating with a $14 price target!!
    Bullish
  • T
    Todd
    For People that are saying there’s nothing wrong with the drug.... of course there’s nothing wrong with the drug. It’s been a frontline anticonvulsant for years. The fda would not say there’s anything wrong with it. Aqst is solely about delivery system for the drug with the fda saw some problems. They will get it fixed. But question is can they monetize the product when they do. Or does it go on the shelve with some others because of Intranasal getting orphan status. It was never about the drug itself
  • d
    dick
    $5.05 200mda did not hold... the trend is not your friend. It should retest $4.70??? Lets see if that holds again?? Time will tell.
  • C
    Cullen
    I see many who want to get in cheaper are scaring others with a "new offering coming" tactic; just synical.
  • d
    dick
    Lets see if the 200mda of 5.05 will hold?? If not $4.67-75 should hold for today?
  • s
    sdale16669
    I am Assuming None Of The Brain Surgeons On This Message-Board Read My Previous Message.....There Will Be No Cash Offering ......Besides The Cash AQST Has.....They Also Have Over 130 Million Debt Facility and Pending Monetization..
  • P
    Prashant
    This company has so much experience in buccal films, so many of their products are already approved, a very similar product Sympazan was approved last year and is on the market. There is no reason for FDA to not approve this product. The route of administration and the product has so much advantage over other products. I am confident that approval should be coming soon. I will be holding on to all stocks I have. Good luck to all of you.
    Bullish
  • P
    Paul
    Still holding the rising trend line from mid july. Wondering, is this our run up? Been a volatile one if this is the case. My understanding of the approval process is that the company gets a FAX.... Yes a FAX! From the FDA and it occurs at 2:30 PM. So if it happens Friday afternoon, we would likely hear something before market close. I doubt that it will happen one way or another (good news or bad news) on Friday anyway.

    This has been an awesome equity to be in, and do appreciate most of the people on this board..... It isnt like some of the boards on Yahoo.
  • M
    MichaelP
    2 weeks, if it dips between $2-3 snag up shares and wait. If you bought at 6, 7, 8 etc..... double down and you will get your money back. It's going to go thru an adjustment period and it will take a quick dip.

    Richard and Sdale - how many times have we seen this?

    Good luck guys. You only lose when you sell. If you're down just hold on and wait - double down when the price is in the high 2s or 3s.
  • s
    sdale16669
    AQST...There Is No Need For Offering: With 100 Million Debt Facility and Pending Monetization.

    "Thomas Flaten--Lake Street Capital Markets
    Got It Appreciate that...And Then Just One Final 1 From John..John,Have you made any decisions about Tapping into Additional Debt Capacity In the Event that KYNMOBI Gets delayed or You have some Challenges With Getting Libervant On to The Market or How should We Think About That?
    John Maxwell--Chief Financial Officer
    Yes...So Our Debt Capacity,As You Know,We Have A 100 Million Facility,30 Million of Reopeners,10 Million Upon Libervant Filing Which We've Completed,But We Did Not Access,and 20 Million That would be Upon Libervant Approval...So Upon Libervant Approval, We'll Make that Decision.
    It Is Part of Our Tool-Chest of Capital Options.But at this Time,We Don't Have Any Plans to Take that Debt Down..
  • P
    Paul
    Well there it is. No question on the CC related to cash burn and position. Interesting to see where this goes Monday. Plenty of buyers and sellers on my trade platform
  • H
    Harry-SGYP
    Weekly Symphony Health Estimates for SYMPAZAN™

    For the week ending September 18, Symphony Health sales and volume estimates for SYMPAZAN™ were more than $205K (down by 4% w/w) and more than 180 pack units (up by 34% w/w), respectively. Of the total sales and volume estimates, ~69% were from new prescriptions and ~31% were from refill prescriptions.
    Bullish
  • O
    Old Man Logan
    The follow up meeting with the FDA will happen within the next 30 days.
    The only thing that they need to submit (as we understand it now) is the new PK modelling... Interesting things is that they only have to make the Libervant dosing the same as the Diastat drug dosing (again, why not go with that from the start?)
    1 month til meeting, I month after meeting resubmit the application, ideally a 2 month turnaround ... means approval in January. Alternatively, if the FDA elects to take 6 months to review then approval will be in May...
  • O
    Old Man Logan
    Guys remember... as great as approval will be, Libervant is the appetizer... AQST-108 is the main course... Libervant for Epilepsy has estimated peak sales of $300M... (since bios often go for 3-5x peak sales, AQST should be worth multiples of share price on that alone...) however, AQST-108 should completely replace the Epi-pen market in a few years... that probably worth closer to $2B peak annual sales... AQST has the potential to be a a monster... don't sell yourself short on this one...
  • d
    dick
    This is the exact reason... I could not see taking this risk with this management that is unproven! I will have a hard time investing again in them with the current team! I hate to see people get hurt, but this is what it takes sometimes for the learning process to sink in. The sheep came and the hunt was on! I am very interested to see the events unfold for Aqst. I would love to see the Aqst farma film tech put into hands that could see things through! The question now is... how much confidence can you have in this team to be 1st to market with the Epi??