AMPE Ampio Pharmaceuticals Inc.

0.66
0  1%
Previous Close 0.66
Open 0.7
52 Week Low 0.26
52 Week High 0.9101
Market Cap $109,494,034
Shares 164,851,000
Float 162,320,317
Enterprise Value $107,793,660
Volume 2,174,667
Av. Daily Volume 2,678,725
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Drug Pipeline

Drug Stage Notes
IV Ampion
COVID-19
Phase 1
Phase 1
Phase 1 trial to be initiated.
Ampion
Osteoarthritis of the Knee
Phase 3
Phase 3
Phase 3 enrolment has been suspended - noted March 24, 2020.
Optina
Diabetic Macula Edema
Phase 2b
Phase 2b
Phase 2b data released May 2015 did not meet endpoints

Latest News

  1. ENGLEWOOD, Colo., June 19, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) (the "Company"), is a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions. As part of this program, the Company is developing therapies for patients infected with the SARS-CoV-2 virus ("COVID-19").

    The U.S. Food and Drug Administration ("FDA") completed its review of the Company's Investigative New Drug ("IND") application for intravenous ("IV") Ampion treatment for COVID-19 affected patients and has cleared the company to proceed with human trials.

    The Company will begin a Phase 1 clinical trial to evaluate IV Ampion as a treatment for COVID-19 patients on supplemental oxygen. The need for supplemental oxygen in COVID-19 patients is indicative of an inflammatory process in the lungs. As an immunomodulatory anti-inflammatory agent, Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome of patients.

    Years of extensive in-vitro studies on cell cultures have confirmed that the mechanism of action ("MOA") of Ampion may be suitable for the treatment of inflammatory conditions, such as acute respiratory distress syndrome ("ARDS") and the cytokine storm, associated with COVID-19. Many of these research related findings have been published in peer reviewed, scientific journals, which can be found on our website.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements                                                                   

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "may," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, the timing and outcome of clinical trials, and that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact

    Dan Stokely, CFO

    Phone: (720) 437-6500



    Ampio Pharmaceuticals, Inc.

    AMPE

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-to-start-first-clinical-trial-in-covid-19-program-301080033.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  2. ENGLEWOOD, Colo., May 22, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE) is a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions. As part of this program, the company is developing therapies for patients infected with the SARS-CoV-2 virus ("COVID-19").

    Ampio has filed Investigative New Drug ("IND") applications for Ampion™ with the FDA and has maintained ongoing dialog with the FDA regarding the Company's development of treatment options which includes inhalation and intravenous applications for COVID-19 affected patients.

    Years of extensive in-vitro studies on cell cultures have confirmed that the mechanism of action ("MOA") of Ampion may be suitable for the treatment of inflammatory conditions, such as acute respiratory distress syndrome ("ARDS") and the cytokine storm, associated with COVID-19. Many of these research related findings have been published in peer reviewed, scientific journals, which can be found on the Company's website.

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements                                                                                              

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Dan Stokely, CFO
    Phone: (720) 437-6500
     
    Ampio Pharmaceuticals, Inc.
    AMPE

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-provides-update-on-covid-19-program-301064052.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  3. ENGLEWOOD, Colo., May 11, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the development of immunology based therapies for prevalent inflammatory conditions, today announced a manuscript accepted for publication in The Journal of Patient Safety in Surgery that showed Ampion treatment could improve clinical outcomes for COVID-19 patients.

    The manuscript titled, "The novel immunomodulatory biologic LMWF5A (Ampion) for pharmacological attenuation of the "cytokine storm" in COVID-19 patients: a hypothesis", provides a detailed description of the biochemical and immunological phenomena collectively termed the "cytokine storm" encountered in COVID-19 patients and evaluates the potential benefit of Ampion treatment for these patients. A link to the publication will be provided on the company's website once available.

    Ampio has submitted an Investigational New Drug ("IND") Application to the FDA for the use of nebulized Ampion to treat COVID-19 patients with acute respiratory distress syndrome ("ARDS") and is engaged in active discussions with the CBER division of the FDA with the goal to obtain permission to initiaite a U.S. clinical trial.

    About Ampio Pharmaceutical

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, AmpionTM, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements                                                                                              

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," "potential," "improve," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, including, but not limited to, discussions with the FDA to open an IND for AmpionTM to treat COVID-19 patients with ARDS, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, that treatment with Ampion will improve clinical outcomes of certain COVID-19 patients, and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K, quarterly report of Form 10-Q and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Dan Stokely, CFO
    Phone: (720) 437-6500

    Ampio Pharmaceuticals, Inc.
    AMPE

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-reports-acceptance-of-publication-on-the-potential-benefits-of-nebulized-ampion-for-covid-19-patients-301056319.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  4. ENGLEWOOD, Colo., April 2, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions announced today that it was featured on a FOX segment titled, "Englewood pharmaceutical company looking to treat COVID-19 patients with anti-inflammatory drug," reported by an affiliated television station in Denver, Colorado. The primary cause of death associated with SARS-Cov-2 ("COVID-19") infection is Acute Respiratory Distress Syndrome ("ARDS"), and there are no approved treatments for ARDS or COVID-19. The segment featured the Company's application to the FDA to study the treatment of COVID-19…

    ENGLEWOOD, Colo., April 2, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions announced today that it was featured on a FOX segment titled, "Englewood pharmaceutical company looking to treat COVID-19 patients with anti-inflammatory drug," reported by an affiliated television station in Denver, Colorado. The primary cause of death associated with SARS-Cov-2 ("COVID-19") infection is Acute Respiratory Distress Syndrome ("ARDS"), and there are no approved treatments for ARDS or COVID-19. The segment featured the Company's application to the FDA to study the treatment of COVID-19 induced ARDS with nebulized Ampion.

    To view the FOX video segment in its entirety please visit the link below. Additional information about the potential suitability of the anti-inflammatory properties of Ampion being used for this clinical indication (ARDS) is included in a companion white paper summary titled, "Rationale and scientific evidence for the use of Ampion in the treatment of Acute Respiratory Distress Syndrome secondary to SARS-COV-2," provided in the link below.

    Michael Macaluso, Ampio CEO, noted "The Company is exploring options that may enable the completion of the AP-013 study, our Phase 3 clinical trial for the treatment of severe osteoarthritis of the knee, during this COVID-19 pandemic. Simultaneously, we have directed our R&D efforts to explore the possible application of the immunomodulatory and anti-inflammatory properties of Ampion in the most severe and lethal complication of the COVID-19 infected patients: ARDS. The FDA has been very responsive, and the Company is grateful for the Agency's efforts as we work together to study the potential benefits of Ampion in this population."

    Enquiries from health professionals and media should be directed via email to  

    About Ampio Pharmaceuticals   

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward-Looking Statements 

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Dan Stokely, CFO
    Phone: (720) 437-6500

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-application-to-the-fda-for-a-clinical-study-of-ampion-to-treat-covid-19-induced-acute-respiratory-distress-syndrome-ards-featured-in-fox-news-video-301034091.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  5. ENGLEWOOD, Colo., March 24, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE, the ", Company", )), a pre-revenue development stage biopharmaceutical company announced today that it has suspended patient enrollment in its Phase 3 clinical trial of Ampion ("AP-013") for the treatment of severe osteoarthritis of the knee ("OAK"). The trial focuses on individuals with the most severely diseased OAK, which represents an underserved patient population typically excluded from clinical studies because of the intractable nature of their condition. The average and maximum age of a patient in the AP-013 clinical trial is 65 and 87 years old, respectively. The Centers for Disease Control and Prevention ("CDC") have indicated that older adults…

    ENGLEWOOD, Colo., March 24, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE, the ", Company", )), a pre-revenue development stage biopharmaceutical company announced today that it has suspended patient enrollment in its Phase 3 clinical trial of Ampion ("AP-013") for the treatment of severe osteoarthritis of the knee ("OAK"). The trial focuses on individuals with the most severely diseased OAK, which represents an underserved patient population typically excluded from clinical studies because of the intractable nature of their condition. The average and maximum age of a patient in the AP-013 clinical trial is 65 and 87 years old, respectively. The Centers for Disease Control and Prevention ("CDC") have indicated that older adults, 65 years and older, are at higher risk for severe illness during the current COVID-19 pandemic.

    The Safety Monitoring Committee ("SMC") for the AP-013 clinical trial has unanimously recommended, following an interim analysis and due to extenuating circumstances relating to the COVID-19 virus, to minimize risk to study participants that, "The study cease enrolling patients because the number of injected patients, 1,019, is sufficiently close to the number of patients called for by the sample size re-estimation algorithm, 1,034."

    The Federal Drug Administration ("FDA") has recognized that challenges may arise, for example, from quarantines, site closures, travel limitations, and/or other considerations due to the pandemic. The Contract Research Organization ("CRO") running the AP-013 clinical trial for the Company has notified the Company that due to the COVID-19 virus, all travel has been suspended for clinical study monitors, which severely limits our ability to monitor the conduct of the AP-013 clinical trial.  Recognizing these challenges, the Company is exploring options to enable it to complete the trial but notes that it is possible that the COVID-19 pandemic may prevent completion of the AP-013 trial at this time or at all.

    Concurrently, the Company is focusing on investigating the potential use of nebulized Ampion for the treatment of a serious complication of COVID-19, the rapid onset of respiratory failure, termed Acute Respiratory Distress Syndrome ("ARDS"). Based on Ampion's immunomodulatory and anti-inflammatory action, we believe that it may help individuals with widespread inflammation in the lungs and may reduce this serious complication of COVID-19.

    About Osteoarthritis
    Osteoarthritis ("OA") is an incurable and progressive disorder of the joint involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

    About Ampio Pharmaceuticals
    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead product candidate, AmpionTM, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and is eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward-Looking Statements
    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contact
    Daniel G. Stokely, CFO
    Phone: (720) 437-6500

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-suspends-patient-enrollment-in-its-phase-3-study-of-ampion-for-severe-osteoarthritis-of-the-knee-and-explores-other-options-to-complete-trial-301028683.html

    SOURCE Ampio Pharmaceuticals, Inc.

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