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Outlook Therapeutics, Inc. (OTLK)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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2.4100+0.0100 (+0.42%)
At close: 4:00PM EDT
2.4101 0.00 (0.00%)
After hours: 04:46PM EDT
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  • D
    Darrell
    With only $19 mil in cash left I smell an offering coming up this qtr any time now...
    Bearish
  • P
    Pedro
    OTLK - H.C. Wainwright 23rd Annual Global Investment Conference
    Listen to the communication from the OTLK CEO at H.C. Wainwright 23rd Annual Global Investment Conference
    September 13, 2021 at 7:00 AM EDT
    https://journey.ct.events/view/35736f41-adf4-4cc5-909a-f5586b7cd548
    (see more information about OTLK at r/OTLK_INVESTORS )
    Journey
    journey.ct.events
  • P
    Pedro
    Outlook Therapeutics Presents Positive NORSE THREE Safety Data for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at EURETINA Virtual 2021 Medical Conference
    ISELIN, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the presentation of safety data from the NORSE THREE trial evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at the EURETINA Virtual 2021 conference on September 12, 2021. The previously announced topline results from the open-label safety study demonstrated that ONS-5010 ophthalmic bevacizumab, under evaluation for the treatment of wet AMD, showed no unexpected safety trends and had a safety profile consistent with that of prior published data undertaken by the National Eye Institute (2011 CATT trial).

    “ONS-5010 has the potential to close the gap on a high unmet need for patients and retinal clinicians,” said Professor Timothy L. Jackson, PhD, MB ChB FRCOphth, Ophthalmic and Retinal Surgeon and Professor of Retinal Research at King’s College London and data presenter at EURETINA. “If approved, ONS-5010 ophthalmic bevacizumab may improve clinical outcomes of patients with wet AMD while potentially avoiding serious adverse events associated with off-label repackaging of IV bevacizumab, including variability in potency, eye infections and loss of sight.”

    The NORSE THREE study was conducted to ensure an adequate number of patients with wet AMD and other retinal diseases had been dosed with ONS-5010 to support Outlook Therapeutics’ planned new biologics license application (BLA) submission in the United States and for other global regulatory filings. The open-label study met its goal of ensuring that a sufficient number of individuals have now been treated with ONS-5010 by enrolling 197 treatment-naïve and previously treated subjects with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet AMD, diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study received three monthly intravitreal doses of ONS-5010 ophthalmic bevacizumab.

    “ONS-5010 has been rigorously tested to support our efforts to provide the first approved ophthalmic formulation of bevacizumab,” said C. Russell Trenary III, President and Chief Executive Officer, Outlook Therapeutics. “With the trial data and market insight seen to date, we believe ONS-5010 has the potential to become the cornerstone of care for multiple retinal indications and we look forward to working closely with the U.S. Food and Drug Administration and other global regulatory authorities toward our goal of bringing this important therapy to market.”

    Outlook Therapeutics’ wet AMD ONS-5010 clinical program for the planned BLA submission consists of three clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE, all of which have now been completed. Most recently, Outlook Therapeutics reported positive topline data from its NORSE TWO pivotal Phase 3 clinical trial. In NORSE TWO, ONS-5010 achieved statistically significant and clinically relevant primary (p = 0.0052) and key secondary (p = 0.0043) efficacy endpoints with 41% of subjects gaining at least 15 letters of BVCA. ONS-5010 was also found to be safe and well tolerated in the NORSE TWO trial.

    With the registration clinical trials now completed, Outlook Therapeutics plans to submit a new BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.
  • B
    Biotec
    Anybody knows whether is it really true that once you have an FDA-approval for a given product you are not authorised to sell the off-label not-FDA product for that specific condition? They claim that in their corporate presentation, but although I work in the biotech/pharma space, I am not definitely an expert in regulatory..
  • P
    Pedro
    OTLK - Corporate Presentation - September 2021 with very good news
    https://ir.outlooktherapeutics.com/static-files/9844808b-f00c-49f6-8606-8d1ea9bbf2f2
  • P
    Pedro
    August 31, 2021 ; OTLK is still have a continues Uptrend since 9 Trading days
    On Tuesday August 31, 2021 OTLK have another day with good volume.
    Today above 2M, volume was 2.172.300 shares.

    OTLK continue with a BUY pressure by Institutional who are buy more shares and also NEW Institutional start buying OTLK Shares.
    OTLK with higher highs and higher lows in this upward trend.
    OTLK are in a continues Uptrend since 9 trading days (from August 19, 2021 +30,2%).
    Buy and STRONG HOLD, for Bid Profits
    I believe September will be a great month for OTLK, ...with a great Uptrend.
  • P
    Pedro
    We are at the end of the month. Let's squeeze the shorts at $OTLK!
  • P
    Pedro
    $OTLK - ZACKS give again a BUY recommendations.
    On September 09, 2021, ZACKS give again to OTLK a BUY recommendations.
  • P
    Pedro
    OTLK is in a continues Uptrend since 7 Trading days
    Today Monday August 30, 2021 another day with volume above 1M, today volume was 1.293.285 shares,

    OTLK continue with a BUY pressure by Institutional who are buy more shares and also NEW Institutional start buying OTLK Shares.

    OTLK are in a continues Uptrend 7 trading days (since August 19, 2021 +24,1%).

    "The train is leaving the station"....

    See more information about OTLK at OTLK_Investors
  • B
    Bill
    If you need a smile, take a look at the one year daily chart of OTLK. If that doesn't make you smile, I can't help you.
  • P
    Pedro
    ONS-5010 (bevacizumab-vikg), for treatment of wet AMD, 12 years market exclusivity under new BLA.
    FDA has taken hundreds of unapproved prescription drugs off the market since 2006 and has executed multiple class actions announced through Federal Register Notices.
    FDA does not remove an unapproved drug used to treat serious medical conditions until a sufficient and reliable supply of FDA approved drug is available.

    FDA Actions to Remove Unapproved Drugs from the Market by Company
    https://www.fda.gov/drugs/enforcement-activities-fda/fda-actions-remove-unapproved-drugs-market-company
  • L
    Logical
    OTLK share price accelerating in anticipation of regulatory approval and rapid commercialization. This is easy money folks. Quality product. Strong and growing demand. Excellent team. Impeccable research results.

    Buy today and reap gains at least to $8/share.
    Bullish
  • B
    Brit
    This will easily be $10-12 this time next year if it isn’t bought out first
  • J
    Jay
    +$0.23 in pre market, -$.07 open.....somebody playin games.
    Bullish
  • M
    Mike
    Charts looking pretty good
    Bullish
  • B
    Bill
    One of these days OTLK is going to creep up and then just keep going. Just a gut feeling.
  • P
    Paul
    Don’t hold your breath on guaranteed partnership. The same was said at the end of last year. IMO, long term buyout after approval is more realistic or they continue to go at it alone.
  • P
    Pedro
    $OTLK Today August 27, 2021 another day with volume above 1M, today volume was 1.354.012 shares, OTLK continue with a BUY pressure by Institutional. Price increased today +6,15%.

    Great Week OTLK +13,6% (From $2,28 to $2,59)
  • M
    Mike
    Seems like a screaming buy I’ve got a small position & can’t understand why this hasn’t doubled already with recent news any input appreciated - thx
    Bullish
  • B
    Brit
    Last wednesday, 8/11, Black Rock Inc. purchased 5,753,938 shares @ $2.37 ($13,636,833)

    Last friday, 8/13, Vanguard Group Inc. purchased 4,634,410 shares @ $2.37 ($10,983,551)

    *Totaling $24,620,384 dollars