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Tag: AMPE stock

  • Ampio Pharmaceuticals Inc. (AMPE) Collapse After Hours on Regulatory Update

    On April 20, the biopharma, Ampio Pharmaceuticals Inc. (AMPE) provided regulatory updates regarding the Type C meeting request for AP-013. Upon news of receiving a complete response letter from the FDA, AMPE stock collapsed in the after hours. Thus, the stock declined by a huge 36.78% at a heavy volume of 3,13 million shares. APME then reached a new low of $0.22 per share in the session while the previous low was $0.33.

    AMPE’s Regulatory Update

    The company had recently submitted a Type C meeting request for clarity on the acceptability of the proposed mITT population as the primary analysis population. Furthermore, in addition to the proposed population being the primary population for assessing the efficacy of the AP-013 trial, the acceptability of AP-013 as a second trial to support BLA for Ampion was also part of the discussion.

    Source: Florence Healthcare

    In the complete response letter to the request, FDA did not agree with changing the intent-to-treat population to a modified intent-to-treat population. Furthermore, the FDA also said that before analyzing and unbinding the data AMPE should have sought FDA’s approval. Additionally, the FDA also did not agree to AP-013 being a second pivotal trial for Ampion.

    Hence, based on FDA’s response, the company now feels the AP-013 trial’s salvation as a pivotal trial now seems highly unlikely. Despite the disappointing response, the company now plans to assess its various options for salvaging the trial while keeping FDA in the loop.

    However, according to Chairman and CEO, Mike Martino, the best path forward seems to be a new Phase 3 trial.

    Market Analysis

    The global biopharmaceutical market is expected to deliver a health CAGR of 9.5% from 2022 to 2028 while it generated $298.50 billion in 2021. On the other hand, the osteoarthritis market is also showing alarming growth as the elderly population continues rising. Another concerning factor is that the disease is on the rise in the younger population as well while previously it was thought that aging is responsible for the disease as general bone health tends to deteriorate with it. The near past has shown a varying trend with the degenerative bones disease being increasingly found in the young population. The possible cause of this is a sedentary lifestyle with people sitting for long hours on top of rising obesity.

    Conclusion

    While there lies a huge market opportunity to leverage, AMPE is struggling to complete the development of Ampion for severe Arthritis of the knee. After hitting another setback in the regulatory process, now the company thinks it can design and execute a trial that will possibly lead to BLA approval.

    The company had enough funds to run operations into the second half of 2023.

  • 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.

  • 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.