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Tag: Ampio Pharmaceuticals

  • Positive Phase 3 AP-013 Data: Ampio Pharmaceuticals Inc. (AMPE) stock Advances Further After Hours

    On March 02, Ampio Pharmaceuticals Inc. (AMPE) announced positive data from Phase 3 clinical trial of AmpionTM in severe osteoarthritis of the knee (OAK). Consequently, the stock remained bullish in the following sessions.

    During the regular session, the stock fluctuated between a high of $0.51 and a low of $0.45. At an above-average volume of 5.9 million shares, AMPE stock closed the session in the green with a good gain of 10.33%. After closing the session at a value of $0.50 per share, the stock continued to hike in the after hours. As the company held a webinar in the after-hours to discuss the data along with its analysis, the stock added a further 21.00%. Hence, the stock was trading at $0.61 apiece in the after-hours on Wednesday. The after-hours volume remained more than the regular session’s average at 3.68 million shares.

    The biopharmaceutical company, Ampio Pharmaceuticals Inc. has a market capitalization of $103.34 million. Currently, the company has 227.13 million shares outstanding in the market. In the past five days, the stock has added 16.74% while losing 11.93% year to date.

    AP-013 Positive Data

    The company’s AP-013 study was designed for the confirmation of the efficacy of Ampion as observed in the first AP-003-A trial. Moreover, the trial was also detecting the difference between Apmion and saline control.

    Source: Ophthalmology Times

    Commenced in June 2019, the trial suffered a loss of huge data due to the pandemic. As per the FDA’s recommendation, the company conducted a sensitivity analysis for the impact of Covid-19 on the study. Thus, AMPE proposed a modified Intent-to-Treat (mITT) population for evaluating the efficacy.

    On Wednesday, the company reported positive data from the mITT population in its phase 3 AP-013 trial. The data confirmed the results of AP-003-A and supported the safety and efficacy of Ampion for the treatment of OAK.

    Additionally, FDA has confirmed the company’s Type C Meeting request.

    AMPE Financial Summary

    On November 10, 2021, the company declared its financial results for the third quarter of 2021 along with future guidance.

    In Q3 2021, AMPE incurred a net loss of $0.02 per diluted share against $0.06 in the previous-year period.

    The company had cash and cash equivalents of $17.1 million at the end of Q3 2021. AMPE believed the cash and cash equivalents along with external sources of liquidity to be enough for funding its operations through Q1 2023.

  • Why The Ampio (AMPE) Stock Is Up 15% In Pre-Hours?

    Shares of Ampio Pharmaceuticals Inc. (AMPE) were last seen at $2.08 in premarket trading, up 15.56%. Ampio stock closed last session at $1.80, gaining 1.12%, or $0.02. AMPE stock traded between $1.77 and $1.83 during the past session.

    Volume of the traded shares was 1.24 million, a lower number than AMPE’s 50-day volume of 1.43 million and below its Year to Date volume of 2.73 million. AMPE stock has surged after receiving approval to expand enrollment in a study.

    Which study received approval?

    Biopharmaceutical company Ampio focuses on developing immunological-based treatments for common inflammatory conditions for which limited treatment options exist. AMPE’s lead drug, Ampion, is protected by a broad patent portfolio that lasts until 2035. AMPE’s that drug will also qualify for 12-year FDA market exclusivity once it is approved as a novel biologic under the biologic price competition and innovation act (BPCIA).

    Today, Ampio announced that regulatory approval had been received for the expansion of enrollment of its AP-019 Phase II study to India.

    • Patients suffering from respiratory distress due to COVID-19 will be treated with inhaled Ampion in the study.
    • The FDA approval of AMPE’s therapy for study in India highlights the need for the treatment to continue.
    • There are currently more than 3,200 deaths per day due to COVID-19 in India, and more than 94,000 new cases are reported daily.
    • The expansion of the study should shorten the enrollment period and benefit a population afflicted with COVID-19 among the highest densities anywhere in the world.
    • Using the results from its AP-014 Phase I trial, Ampion was used in the AP-019 double-blind, placebo-controlled Phase II study.
    • AMPE announced on April 27, 2021, that the earlier Phase I study had met its primary endpoints of safety and tolerability.
    • Additionally, the top-line results in that AMPE study showed that Ampion reduced COVID-19 respiratory distress all-cause mortality by 78% over Standard of Care (SOC).
    • In those treated with SOC, mortality was 24%, compared to only 5% in those treated with Ampion.

    Why AMPE has reallocated?

    Ampio (AMPE) has made the strategic decision to discontinue the AP-019 study efforts in Israel due to the current political unrest in Israel and the surrounding region. As a result of this decision, the AMPE reallocated and refocused these resources towards select areas of India and other potential locations outside the U.S., based on the magnitude of cases of COVID-19.

  • 15 Trending Stocks in Biotechnology Industry

    15 Trending Stocks in Biotechnology Industry

    This year, biotech companies on the stock exchange have skyrocketed. This is no surprise since biotech firms are the leaders in the battle against the coronavirus pandemic. Even with Pfizer’s first vaccine in the UK, investors and pharmaceutical companies are well aware that the race is far ahead.
    Other diseases should not be ignored apart from coronavirus vaccines. The biotech sector is also creating headlines and innovating in areas linked to dementia, cancer, hereditary disorders, etc. Given the above, buyers are probably faced with the difficulty of choosing the best ones to purchase.

    Curis Inc. (NASDAQ:CRIS) shares were trading up 354.86% at $6.55 at the time of writing on Tuesday following announcement of proposed public offering of common stock.

    Curis Inc. (NASDAQ:CRIS) share price went from a low point around $0.62 to briefly over $3.59 in past 52 weeks, though shares have since pulled back to $6.55. CRIS market cap has remained high, hitting $409.70M at the time of writing, giving it price-to-sales ratio of more than 30.

    If we look at the recent analyst rating CRIS, Laidlaw initiated coverage on CRISshares with a Buy rating.

    Lexicon Pharmaceuticals Inc. (LXRX) last closed at $3.08, in a 52-week range of $1.03 to $5.33. Analysts have a consensus price target of $2.37. On November 17, 2020, the firmreported that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.

    IGM Biosciences Inc. (IGMS) stock soar by 57.75% to $115.03 after declaringpricing of upsized $200 million public offering. The most recent rating by Robert W. Baird, on July 17, 2020, is at an Outperform.

    Infinity Pharmaceuticals Inc. (NASDAQ:INFI) Shares headed rising, higher as much as 29.44%. The company will hold a conference call on Wednesday, December 9, 2020 at 10:00 a.m. ET to discuss clinical data from ongoing studies evaluating eganelisib in triple negative breast cancer (TNBC) The most recent rating by Oppenheimer, on June 27, 2019, is at an Outperform.

    Oncternal Therapeutics Inc. (NASDAQ:ONCT) rose 27.64% after gaining more than $1.1 on Tuesday after reporting updated interim clinical data from the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial.

    Proteostasis Therapeutics Inc. (PTI) last closed at $1.23, in a 52-week range of $0.87 to $4.72. The firm reported on November 16, 2020. a net loss of approximately $8.2 million for the three months ended September 30, 2020, as compared to a net loss of $12.8 million for the same period in the prior year.

    InflaRx N.V. (IFRX) stock soar by 18.27% to $4.79. The most recent rating by SVB Leerink, on November 06, 2020, is at an Outperform.

    Syros Pharmaceuticals Inc. (NASDAQ:SYRS) Shares headed rising, higher as much as 17.47% after closing $90.5 million strategic financing. The most recent rating by H.C. Wainwright, on November 04, 2020, is at a Buy.

    Aerpio Pharmaceuticals Inc. (NASDAQ:ARPO) rose 16.28% after gaining more than $0.28 on Tuesday.

    Ampio Pharmaceuticals Inc. (AMPE) last closed at $1.35, in a 52-week range of $0.31 to $1.39. The firm recently revealed that it will conduct its annual meeting in a virtual format only on December 12, 2020 at 9:00 am MST.

    Regulus Therapeutics Inc. (RGLS)stock soar by 15.19% to $0.93 following the closing of $19.4 million private placement of equity. The most recent rating by B. Riley FBR Inc., on March 28, 2018, is at a Neutral.

    Cancer Genetics Inc. (NASDAQ:CGIX) Shares headed rising, higher as much as 14.79%. The most recent rating by Maxim Group, on December 07, 2017, is at a Buy.

    Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) fall -11.85% after losing more than -$1.85 on Tuesday. The healthcare firm lately declared pricing of $70 million public offering of common stock, which is expected to close on or about December 10, 2020.

    iBio Inc. (IBIO) last closed at $1.31, in a 52-week range of $0.19 to $7.45 after declaring pricing of $35 million public offering of common stock. Analysts have a consensus price target of $2.00.

    Vaccinex Inc. (VCNX) stock soar by 14.08% to $2.35. The most recent rating by BTIG Research, on September 23, 2020, is at a Neutral.

  • 41 Stocks Making Sharp Moves in Pre Market Session

    41 Stocks Making Sharp Moves in Pre Market Session

    NanoVibronix Inc. (NASDAQ: NAOV) shares are trading down -4.55% at $1.05 at the time of writing after announcing $6.0 million private placement. Company’s 52-week ranged between $0.54 to $3.50.
    Merrimack Pharmaceuticals Inc. (MACK) stock plunged -6.93% to $6.04 in the pre-market trading. The most recent rating by JP Morgan, on October 07, 2016, is a Neutral.
    Curis Inc. (CRIS) is down more than -5.85% at $1.77 in pre-market hours Thursday December 03, 2020 after declaring that it will host Virtual Event to discuss CA-4948 clinical data. The stock had jumped over 22.88% to $1.88 in the last trading session.
    Before the trading started on December 03, 2020, Obalon Therapeutics Inc. (OBLN) is down -8.62% to reach $1.06. It has been trading in a 52-week range of $0.62 to $2.14.
    Artelo Biosciences Inc. (ARTL) grew over 7.53% at $0.7065 in pre-market trading today following announcement its appointment of drug discovery and development veteran Gregory R. Reyes, M.D., Ph.D. to the Company’s Board of Directors.
    Acorda Therapeutics Inc. (ACOR), a Biotechnology company, dropped about -3.54% at $0.79 in pre-market trading Thursday.
    Ampio Pharmaceuticals Inc. (AMPE) is up more than 6.8% at $1.1 in pre-market hours Thursday December 03, 2020 after declaring its phase I study for Inhaled Ampion advances to completing enrollment of COVID-19 patients with respiratory distress. The stock had jumped over 12.65% to $1.03 in the last trading session.
    Nxt-ID Inc. (NASDAQ: NXTD) shares are trading down -6.11% at $0.446 at the time of writing. Company’s 52-week ranged between $0.21 to $0.89.
    OrganiGram Holdings Inc. (OGI) stock moved down -2.86 percent to $1.36 in the pre-market trading. The company recently released fourth quarter 2020 results.
    InVivo Therapeutics Holdings Corp. (NVIV) gained over 14.27% at $0.7999 in pre-market trading Thursday December 03, 2020.
    HEXO Corp. (HEXO) lost over -5.98% at $1.1 in pre-market trading Thursday December 03, 2020 as the firm recently revealed that it has repositioned the UP Cannabis brand with a differentiator of 20% THC or higher in all dried flower products, every time.
    Before the trading started on December 03, 2020, Aurora Cannabis Inc. (ACB) is down -2.92% to reach $10.63. It has been trading in a 52-week range of $3.71 to $32.88.
    Before the trading started on December 03, 2020, Golar LNG Limited (GLNG) is down -6.67% to reach $8.75 after declaring that it intends to offer, issue and sell to the public 11,000,000 common shares, par value $1.00 per share, through an underwritten public offering. It has been trading in a 52-week range of $4.54 to $15.24.
    Aeterna Zentaris Inc. (AEZS) stock soared 3.1% to $0.455 in the pre-market trading. The most recent rating by Maxim Group, on July 19, 2017, is a Buy.
    Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) shares are trading up 9.23% at $4.26 at the time of writing after reporting that it has screened the first patients in a global trial of its oral insulin capsule ORMD-0801 for the treatment of Nonalcoholic steatohepatitis (NASH). Company’s 52-week ranged between $2.40 to $6.05. Analysts have a consensus price target of $5.50.
    Ashford Hospitality Trust Inc. (AHT), a REIT – Hotel & Motel company, rose about 7.36% at $2.48 in pre-market trading Thursday.
    Ideanomics Inc. (IDEX) grew over 0.86% at $2.35 in pre-market trading today. The technology firm lately declared that its subsidiary, Tree Technologies Sd. Bhd., which owns the Treeletrik brand, has hired Richard Teoh as its Chief Financial Officer.
    AIkido Pharma Inc. (AIKI) is down more than -2.2% at $0.59 in pre-market hours Thursday December 03, 2020. The stock had jumped over 8.94% to $0.60 in the last trading session.
    NIO Limited (NIO), a Auto Manufacturers company, dropped about -2.21% at $46.92 in pre-market trading Thursday after providing its November 2020 delivery results.
    Genius Brands International Inc. (GNUS) is up more than 2.14% at $1.43 in pre-market hours Thursday December 03, 2020. The stock had jumped over 5.26% to $1.40 in the last trading session.
    Micro Focus International plc (MFGP) gained over 2.81% at $5.12 in pre-market trading Thursday December 03, 2020 following the publication its findings of ‘Endless Modernization’ research with Standish Group.
    Trine Acquisition Corp. (NYSE: TRNE) shares are trading up 6.44% at $14.22 at the time of writing. Company’s 52-week ranged between $9.40 to $13.94.
    Before the trading started on December 03, 2020, Borr Drilling Limited (BORR) is down -6.29% to reach $0.7625. The firm recently declared unaudited results for the three and nine months ended September 30, 2020. It has been trading in a 52-week range of $0.24 to $9.12.
    Blink Charging Co. (BLNK), a Specialty Retail company, dropped about -2.83% at $22.35 in pre-market trading Thursday.
    Boxlight Corporation (BOXL) lost over -2.53% at $1.54 in pre-market trading Thursday December 03, 2020. An education technology firm recently reported that Shaun Marklew has been appointed as Chief Technology Officer and Patrick Foley will be appointed as Chief Financial Officer on January 16, 2021.
    Before the trading started on December 03, 2020, Pyxis Tankers Inc. (PXS) is up 10.87% to reach $1.02. It has been trading in a 52-week range of $0.62 to $1.37.
    Orbital Energy Group Inc. (OEG) is down more than -3.1% at $1.25 in pre-market hours Thursday December 03, 2020 following announcement its wholly-owned transmission & distribution division, Orbital Power Services signed a Master Services Agreement with a midwestern investor-owned utility.
    Telefonica S.A. (TEF) is down more than -2.64% at $4.43 in pre-market hours Thursday December 03, 2020. The stock had jumped over 1.56% to $4.55 in the last trading session.
    Longview Acquisition Corp. (NYSE: LGVW) shares are trading up 7.86% at $15.79 at the time of writing. Company’s 52-week ranged between $9.34 to $17.99.
    UP Fintech Holding Limited (NASDAQ: TIGR) shares are trading up 3.51% at $5.61 at the time of writing. Company’s 52-week ranged between $2.03 to $7.60.
    Veru Inc. (VERU) gained over 10.39% at $3.4 in pre-market trading Thursday December 03, 2020.
    Tonix Pharmaceuticals Holding Corp. (TNXP) grew over 2.46% at $0.6414 in pre-market trading today.
    Before the trading started on December 03, 2020, Orange S.A. (ORAN) is down -5.39% to reach $12.28 after reporting that it plans to launch a conditional voluntary public takeover bid on all the shares of Orange Belgium that it does not yet own. It has been trading in a 52-week range of $9.93 to $16.08.
    Switchback Energy Acquisition Corporation (SBE) gained over 2.27% at $30.17 in pre-market trading Thursday December 03, 2020.
    Nano Dimension Ltd. (NNDM), a Computer Hardware company, rose about 4.69% at $6.7 in pre-market trading Thursday after closing the previously reported registered direct offering of 11,960,160 of the Company’s American Depositary Shares at a price of $5.00 per ADS.
    Harmony Gold Mining Company Limited (HMY) is down more than -2.42% at $4.44 in pre-market hours Thursday December 03, 2020. The stock had dropped over 0.00% to $4.55 in the last trading session.
    Waddell & Reed Financial Inc. (WDR) stock moved up 46.33 percent to $24.89 in the pre-market trading after declaring a merger agreement with Macquarie Asset Management, under which Macquarie would acquire Waddell & Reed Financial, Inc. for $1.7 Billion.
    Limelight Networks Inc. (LLNW) stock plunged -2.78% to $4.2 in the pre-market trading. The most recent rating by Goldman, on November 30, 2020, is a Neutral.
    Before the trading started on December 03, 2020, XP Inc. (XP) is down -1.88% to reach $39.65 after announcing pricing of public follow-on offering. It has been trading in a 52-week range of $15.50 to $52.94.
    CBAK Energy Technology Inc. (NASDAQ: CBAT) shares are trading up 2.75% at $7.1 at the time of writing. Company’s 52-week ranged between $0.36 to $11.40.
    Splunk Inc. (SPLK) tumbled over -20.5% at $163.69 in pre-market trading today as the firm released fiscal third quarter 2021 financial results.