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Avenue Therapeutics, Inc. (ATXI)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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1.3100+0.0500 (+3.97%)
At close: 04:00PM EST
1.2600 -0.05 (-3.82%)
After hours: 07:56PM EST
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  • D
    Dan
    Stink Bomb stock plain and simple,Don't waste money or time on This or it's cousin FBIO
    Bearish
  • S
    Sram
    *DJ Avenue Therapeutics Prices Public Offering of 1.95M Shares of Common Stock at $1.34 Each>ATXI
    Dow Jones
  • t
    thomas
    Is there hope to approve the medicine after the advisory committee meeting "OND needs additional input from an Advisory Committee in order to reach a decision on the Formal Dispute Resolution Request (“FDRR”), the details of which have previously been disclosed."
  • a
    alex
    Over the past several months, the Company has communicated with InvaGen relating to InvaGen’s assertions that Material Adverse Effects (as defined in the SPMA) have occurred due to the impact of the COVID-19 pandemic on potential commercialization and projected sales of IV Tramadol. Additionally, in connection with the resubmission of the Company’s New Drug Application (“NDA”) in February 2021, InvaGen communicated to the Company that it believes the proposed label for IV Tramadol would also constitute a Material Adverse Effect (as defined in the SPMA) on the purported basis that the proposed label under certain circumstances would make the product commercially unviable. InvaGen has communicated to the Company its desire to consider all options on the proposed merger, including the option to not consummate the merger. Since the Company did not receive FDA approval for IV Tramadol by April 30, 2021, these assertions have no impact as to whether InvaGen is obligated to close the SPMA because, as discussed above, InvaGen no longer has such an obligation. As a result, the possible timing and likelihood of the completion of the merger are uncertain. There can be no assurance that the Merger Transaction will be completed on the expected terms, anticipated schedule, or at all. It is also possible InvaGen could attempt to pursue monetary claims against the Company.
    Bullish
  • N
    Nigel
    It seems the FDA is back on track with the calendar and catching up with the backlog, I am sure we will have news soon :) but what a pain in the ....
  • D
    DAVID M
    Just been through this with another stock KMPH. They announced fda approved at 11:45pm ET the date on PDUFA scheduled date. Hold tight!!! We will get there!
  • M
    Michael
    When this thing runs, it'll be real hard to stop with the amount of shares there are available to retail!
    Insiders own 61%
    Institutions own 16%
    With 16.7 Million shares outstanding, there are only about 3.85 million for us!
    Bullish
  • O
    Olivier
    It's gonna run hard if it gets approved still, tramadol is a big deal. 6 million float. I expect 15$+
  • R
    Roty
    NDA resubmitted in February as stated here in previous messages. It's clear that will be approved rapidly, that's why they excluded on label the problematic indications of Tramadol that drove to CRL. Now the dance with Cipla-Invagen to reduce the total price paid-last stage of their deal. As estimated few months ago the last price will be around $10.Even if they don't agree Invagen's stake will be bought back by FBIO at a small price.
  • N
    Nigel
    Decision for first submission by Protalix Bio Therapeutics of PRX–102 decision scheduled yesterday was rejected by FDA, so I am thinking it's positive for Avenue or would have already been rejected, plus being a resubmission all should be good. Hopefully news today :)
  • P
    Peter
    We need some news.
    But frankly I don’t really see the point of FDA to refuse it.
    Tramadol is way more bioavailable through IV and refuse it just because of the stacking up the doses.
    This looks like it was orchestrated...
  • N
    Nigel
    There is a difference between a postponement and a delay "FDA was still reviewing IV tramadol NDA and had not provided a decision yet" So nothing changed as the 12th was only a goal date. All that happened was a badly handled announcement by Fortress Bio followed by misinformation spread on this social media and then of course panic which is what those spreading that misinformation wanted. An own goal for the shareholders. Keeping my shares although some short-term pain, perhaps I need an IV.
  • M
    Mark
    Get more before last bell on tommorow ! !
    It would not be a shock at all if FDA approves pre-market on Monday..
    Bullish
  • a
    alex
    Again focus on how many approval's have been made on IV Tramadol around the world for a post op setting and or need.............Do you really think the USA doesn't need nor would approve
  • P
    Peter
    If FDA will approve, with Cipla’s agreement, share price will jump to 14-15 range...
  • H
    H
    Any reasons to believe that the FDA responce will be different than in September next month??
    ATXI dropped 57% after FDA responce.
    Has anything fundamentally changed???
    https://finance.yahoo.com/news/avenue-therapeutics-sinks-fda-rejects-173541339.html
    Bullish
  • P
    Peter
    @Andy
    I believe that the delivery system and timing of ATXI will not need any stacking. There will be an ongoing response. Slow release will increase O-DSMT to be metabolised by CYP2D6 enzyme. Also that will decrease chance of serotonine syndrome. Also you can facilitate with non-opioid analgesics.

    Hope this helped...
  • J
    Jiaxing
    Does anyone know whether it's common for FDA to miss the goal date? Is it a truly indicator that the application can be rejected?
  • i
    iorgi
    This company has no money, one product in pipeline and that was just rejected again by the FDA. Not good, not good at all. There is nothing left here.
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