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Axsome Therapeutics, Inc. (AXSM)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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34.37+1.46 (+4.42%)
As of 11:21AM EST. Market open.
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  • g
    georgejjl
    Recent approved US patents:

    United States Patent 11,185,515
    Tabuteau November 30, 2021
    Bupropion as a modulator of drug activity

    United States Patent 11,185,547
    Tabuteau November 30, 2021
    Use of reboxetine to treat narcolepsy

    United States Patent 11,185,550
    Tabuteau November 30, 2021
    Pharmaceutical compositions comprising meloxicam

    Recent US patent applications:

    United States Patent Application 20210369722
    Kind Code A1
    Tabuteau; Herriot December 2, 2021
    USE OF REBOXETINE TO TREAT NARCOLEPSY

    United States Patent Application 20210369729
    Kind Code A1
    Tabuteau; Herriot December 2, 2021
    PHARMACEUTICAL COMPOSITIONS COMPRISING MELOXICAM

    United States Patent Application 20210369845
    Kind Code A1
    Tabuteau; Herriot December 2, 2021
    PHARMACEUTICAL COMPOSITIONS COMPRISING MELOXICAM

    Good luck and GOD bless,
  • g
    georgejjl
    What's important to understand is that this regulatory hiccup reportedly centers around two issues with the company's analytical methods in the Chemistry, Manufacturing, and Controls section of the New Drug Application submitted to the Food and Drug Administration (FDA).

    As the FDA hasn't flatly rejected the NDA over these minor issues and Axsome seems confident that they can be addressed, the biotech's stock seems primed to land a major catalyst before year's end (i.e., an approval for AXS-05). Keeping with this theme, one of the biotech's directors recently bought shares, a potential sign that an approval may indeed be on the way.

    Good luck and GOD bless,
  • M
    Michael
    I have a lot of respect for Axsome’s silence. There are no leaks, they don’t toot their own horn, they don’t blame the FDA, they just plod along and follow the process.
  • N
    Nigel Tufnel
    The combined addressable market for AXS-05, AXS-07, AXS-12, and AXS-14 is $60 Billion. Every clinical trial so far for these has been wildly successful. Yet here we sit at a MC of just over $1B. If even just 2 of the above are approved you are looking at a MC valuation of conservatively $20B within a few years if it's not bought out by BP for even more first. How many opportunities in the market do you think can match this? There is a reason not a single insider has sold. This is incredible opportunity to become very wealthy.
  • M
    Michael
    Believing it was oversold I bought AXSM at $20. I’ve since added to my position several times thinking AXS-05 will be approved. This is my only “home run” stock, the only company in my portfolio who has never made money. I think I picked a winner…patiently waiting.
  • A
    Angelo Yemen
    Added 300 on the dip
  • T
    Timofei
    $BYSI Plinabulin is a completely new drug, which means that the difficulties with its trial are not surprising, while Bupropion and Dextromethorphan have been used since the 60s, they are well studied, their effects are known. This is a different story. IMO, AXS-5 will be approved.
  • E
    End2War
    The more time that passes, the better the odds for a favorable resolution of 05 issues, IMO, and the closer AXSM gets to 05 approval. Waiting can be a pain, but relief should be coming, hopefully in December. Meantime, the market worries about inflation and virus mutations, providing an opportunity to buy AXSM while it is falling again along with the entire biotech group. Do your own DD and research, and please don't rely on posters.
  • g
    georgejjl
    Insiders who bought into Axsome Therapeutics, Inc. (NASDAQ:AXSM) earlier this year might wish they'd invested more as stock gained 9.8%
    Simply Wall St
    Thu, November 25, 2021, 4:11 AM

    Last week, Axsome Therapeutics, Inc. (NASDAQ:AXSM) insiders, who had purchased shares in the previous 12 months were rewarded handsomely. The shares increased by 9.8% last week, resulting in a US$127m increase in the company's market worth. In other words, the original US$374k purchase is now worth US$384k.

    Although we don't think shareholders should simply follow insider transactions, logic dictates you should pay some attention to whether insiders are buying or selling shares.

    Check out our latest analysis for Axsome Therapeutics

    The Last 12 Months Of Insider Transactions At Axsome Therapeutics
    Notably, that recent purchase by Roger Jeffs is the biggest insider purchase of Axsome Therapeutics shares that we've seen in the last year. That implies that an insider found the current price of US$37.93 per share to be enticing. Of course they may have changed their mind. But this suggests they are optimistic. While we always like to see insider buying, it's less meaningful if the purchases were made at much lower prices, as the opportunity they saw may have passed. The good news for Axsome Therapeutics share holders is that insiders were buying at near the current price.

    In the last twelve months Axsome Therapeutics insiders were buying shares, but not selling. You can see a visual depiction of insider transactions (by companies and individuals) over the last 12 months, below. If you want to know exactly who sold, for how much, and when, simply click on the graph below!

    insider-trading-volume
    Axsome Therapeutics is not the only stock that insiders are buying. For those who like to find winning investments this free list of growing companies with recent insider purchasing, could be just the ticket.

    Axsome Therapeutics Insiders Bought Stock Recently
    It's good to see that Axsome Therapeutics insiders have made notable investments in the company's shares. In total, insiders bought US$345k worth of shares in that time, and we didn't record any sales whatsoever. That shows some optimism about the company's future.

    Insider Ownership of Axsome Therapeutics
    I like to look at how many shares insiders own in a company, to help inform my view of how aligned they are with insiders. We usually like to see fairly high levels of insider ownership. Insiders own 1.9% of Axsome Therapeutics shares, worth about US$27m. While this is a strong but not outstanding level of insider ownership, it's enough to indicate some alignment between management and smaller shareholders.

    So What Do The Axsome Therapeutics Insider Transactions Indicate?
    It's certainly positive to see the recent insider purchases. And the longer term insider transactions also give us confidence. But we don't feel the same about the fact the company is making losses. Given that insiders also own a fair bit of Axsome Therapeutics we think they are probably pretty confident of a bright future. So while it's helpful to know what insiders are doing in terms of buying or selling, it's also helpful to know the risks that a particular company is facing

    https://finance.yahoo.com/news/insiders-bought-axsome-therapeutics-inc-091122863.html

    Good luck and GOD bless,
  • g
    georgejjl
    Axsome is scheduled to present data at the following upcoming scientific conference:

    American College of Neuropsychopharmacology (ACNP) Annual Meeting, December 5-8, 2021

    Good luck and GOD bless,
  • F
    Fabio
    come on axsm at least for christmas give us a gift after two years of merciless torture ....
  • S
    Steven
    Great article in Fierce Pharma today that basically explains the delays with AXS-05 with the FDA and how other companies are in the same boat and that the good news is that they trying to rectify it. In my mind all good news for being long with AXSM and how patience gets rewarded.

    Quote from article: “ More than a year and a half into the COVID-19 pandemic, the FDA has started to right the ship on the pace of its domestic drug manufacturing inspections. Still, the agency continues to struggle with oversight of foreign plants, and a growing number of new drug applications are facing delays, a report shows.”

    https://www.fiercepharma.com/manufacturing/fda-beats-u-s-inspection-forecast-as-it-continues-to-struggle-oversight-abroad
  • T
    Terry
    During their Earnings call, Axsome referenced that they'll be presenting data at the American College of Neuropsychopharmacology Conference, which starts tomorrow and concluded Tuesday.
    Anyone have insight on what they're presenting?
    No reference of the conference on their website--These folks either have a second-rate PR department, or the data is trivial
  • S
    Sam713
    Some people here compare bysi with axsm. The bysi trial is small, efficacy is marginal. It only lower the adverse event from 86% to 68%. That is not enough for approval. If it can lower the adverse event to 30~40%, most likely it will get approval.
  • J
    Jacob
    Anyone have a bottom in mind? I'd like to add more shares at a good price
  • s
    samael
    When is the presentation today?
  • g
    georgejjl
    “Over the past several months we have continued to advance our differentiated late-stage CNS product candidates aimed at meaningfully improving the lives of patients. FDA review of our NDA for AXS-05 in depression continues, and the NDA for AXS-07 in migraine was accepted, positioning Axsome to potentially commercialize two new treatments in the near to intermediate term for patients living with these serious CNS disorders,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Our commercial launch preparations are essentially complete and we remain focused on ensuring timely and successful launches, assuming approvals. The rest of our rich pipeline continues to progress, highlighted by our ongoing Phase 3 ACCORD trial of AXS-05 in Alzheimer’s disease agitation, the recent initiation of our Phase 3 SYMPHONY trial of AXS-12 in narcolepsy, and the ongoing manufacturing work to support the planned NDA filing of AXS-14 for fibromyalgia. In addition, based on FDA Pre-IND meeting guidance, we plan to proceed to a Phase 2/3 trial of AXS-05 in smoking cessation and expect to provide timing on initiation of that trial next year.”

    Happy Thanksgiving Day and GOD bless,
  • J
    John
    The insider buys that we saw over the past week are a huge positive. Not only does it show a willingness by a smart bunch of people to put fresh money into AXSM, but it also shows that given the opportunity to trade (we know the window was open) these people chose to ADD instead of SUBTRACT. Some of these insiders have HUGE investments in AXSM, and they could have used the open window to take some chips off the table (when the insider trading window opens, it is usually for buys or for sells... not just buys). They didn't... instead they added more. This is a very bullish signal. One negative is that the fact that the window was open probably means we aren't going to get an FDA decision imminently. But the window can be open now even with a decision weeks to months away. So I conclude from these buys that the fundamental prospects of AXSM look good. We probably aren't going to get a decision this week or next. But a decision can still come in 1-3 months and it is likely to be a good one.
  • S
    Steven
    A third executive just acquired more shares at market prices. Roger Jeffs (a member of the board of directors) added to his over $4 million dollar stake yesterday at over $37/share. Now the rules are very specific of when insiders can buy and they have to file in advance so all of you with conspiracy theories should go back to the basement you live in but it’s always great when top level executives add to their positions…especially in accounts for their family members.
  • R
    Rick
    If this is any consolation the SPDR S&P Biotech ETF, symbol XBI hit a 52 week low today. Down 35% from it's 52 week high. MidCap Bio has been destroyed the last few months.