AMPE Ampio Pharmaceuticals Inc.

1.55
+0.05  (+3%)
Previous Close 1.5
Open 1.54
52 Week Low 0.31
52 Week High 2.98
Market Cap $286,835,250
Shares 185,055,000
Float 182,524,317
Enterprise Value $269,498,500
Volume 2,417,495
Av. Daily Volume 6,184,900
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Drug Pipeline

Drug Stage Notes
Ampion
COVID-19
Phase 1
Phase 1
Phase 1 trial 55% enrolled as of January 14, 2021.
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., Jan. 14, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion (AP-014) is 55% enrolled.

    The Phase I clinical trial is ongoing, with the primary focus to evaluate the impact of inhaled Ampion treatment in patients with respiratory distress due to COVID-19. Inhaled Ampion specifically targets inflammation in the lung and is currently being investigated to determine whether its use will improve the clinical outcome for patients with respiratory distress due to COVID-19.

    "We've received amazing feedback from healthcare providers about the improvement seen in patients receiving inhaled Ampion," said Mike Macaluso, CEO of Ampio Pharmaceuticals. "We continue to remain very optimistic at the early, anecdotal evidence regarding the clinical effectiveness of inhaled Ampion in COVID-19 patients, and eagerly await the full results of this trial."

    "Our experience using inhaled Ampion to treat patients with COVID-19 continues to trend positively showing no serious drug-related adverse effects," said Chief of Medical Staff for Penrose-St. Francis Health Services Michael Roshon, MD, PhD. "We look forward to seeing the full results of the study as therapeutics for COVID-19 continue to be in high demand."

    More than 22 million people in the United States have been diagnosed with COVID-19, making up nearly a quarter of the cases worldwide. Despite the growing availability of vaccines, therapeutics are and will continue to be necessary to treat patients suffering from some of the virus' most challenging and damaging effects, including, but not limited to, systemic inflammation in the lungs.

    Currently, the study of inhaled Ampion in COVID-19 patients has exhibited no drug-related serious adverse events (SAE). Feedback from the Safety Monitoring Committee (SMC), analyzing any safety concerns related to inhaled Ampion, is expected later this month.

    In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, which is directly associated with the more serious symptoms of COVID-19. The benefit of this effect from Ampion is currently being studied in multiple human clinical trials. In addition to the U.S. based trial of inhaled Ampion, Ampio Pharmaceuticals has initiated a global study commencing in Israel and the U.S. for patients with moderate to severe COVID-19, assessing the safety and efficacy of intravenous Ampion treatment in both a hospital setting and as a therapy for out-patient care.

    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

    Investor Relations

    Joe Hassett

     

    484-686-6600

    Media Contact

    Sarah May

     

    215-205-1217

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-ongoing-phase-i-clinical-trial-for-inhalation-treatment-of-covid-19-with-ampion-is-55-enrolled-301208409.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  2. ENGLEWOOD, Colo., Jan. 4, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced an update on the launch of a new global clinical trial for intravenous ("IV") treatment of COVID-19 with Ampion and provided updates on its ongoing U.S. trial for inhalation treatment of COVID-19.

    In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, which is directly associated with the more serious symptoms of COVID-19. The benefit of this effect from Ampion is currently being studied in multiple human clinical trials. The latest updates on these trials include:

    • Initiation of a global clinical trial for IV treatment of COVID-19 patients, including in out-patient settings



      A global study has been initiated in Israel and the U.S. with the focus on patient safety and efficacy, as measured by improvement in the clinical course of the disease and related outcomes for patients with moderate to severe COVID-19. Ampion IV treatment targets systemic inflammation in the body of patients with moderate to severe COVID-19 symptoms. In addition, this study will assess the effect of Ampion IV treatment in both a hospital setting and as a therapy for out-patient care.
    • U.S. based clinical trial underway for inhalation treatment of COVID-19 patients expands to new hospitals



      A Phase I clinical trial is ongoing, with the primary focus to evaluate the impact of inhaled Ampion treatment in patients with respiratory distress due to COVID-19. The trial is currently ongoing with no drug-related serious adverse events ("SAEs") reported to date. The rate of enrollment is expected to increase once requisite front-line workers receive the recently released COVID-19 vaccines. Additional hospitals are also being added to the inhalation study with the goal to conclude enrollment in January. Inhaled Ampion targets inflammation in the lung and is currently being investigated to determine whether its use will improve the clinical outcome for patients with COVID-19. Of note, there have been no drug-related SAEs to date in the inhaled clinical trial.

    "While the vaccine will hopefully help many people avoid the more serious complications of COVID-19, the rollout of vaccines will take time and is unlikely to ever reach 100% of the public," said Michael Macaluso, Chairman and Chief Executive Officer of Ampio Pharmaceuticals. "We will no doubt continue to need treatments to provide the essential relief and improve outcomes for patients. We are especially excited to begin the testing of Ampion for COVID-19 in an outpatient setting."

    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

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May



    215-205-1217

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-provides-update-on-clinical-trials-for-ampion-treatment-of-covid-19-patients-301199940.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  3. ENGLEWOOD, Colo., Dec. 29, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today it has received guidance from the U.S Food & Drug Administration ("FDA") regarding the impact of COVID-19 on its Phase III clinical trial for osteoarthritis of the knee ("OAK").

    The COVID-19 health emergency has impacted clinical trials, with over 1,000 studies suspended as a result of the pandemic, including the Phase III clinical trial ("AP-013") for the intra-articular injection of Ampion for treatment of severe OAK. The AP-013 study is being conducted under a Special Protocol Assessment ("SPA") which provides a documented framework for communication and gaining agreement with the FDA to support a commercial Biologics Licensing Application ("BLA").

    In their feedback, the FDA agrees that OAK is a highly prevalent condition that affects millions of patients in the United States. In addition, the FDA provided practical guidance for the AP-013 study to navigate the pandemic, and to complete the study without re-running the trial. The FDA options give us the opportunity to provide additional evidence to support the use of existing data and/or add more patients to the trial. Ampio is thankful for this flexibility, is considering all options and is working to find a solution that will allow us to proceed despite COVID-19 and will present our analysis and proposal to the FDA as soon as possible.

    Answers to questions are available on our website by clicking on the link below:

    https://ampiopharma.com/news/latest-news/

    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

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May



    215-205-1217

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-receives-feedback-from-the-fda-on-ampios-proposed-modifications-to-the-special-protocol-assessment-for-ampion-treatment-of-severe-osteoarthritis-of-the-knee-301198986.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  4. ENGLEWOOD, Colo., Dec. 17, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today it has completed its Phase I clinical trial and has initiated the first steps for a global Phase II clinical trial for intravenous ("IV") Ampion treatment in COVID-19 patients.

    The Phase I study was a randomized, controlled study of adults hospitalized with severe COVID-19. The primary endpoint for the study was evaluated after a 5-day treatment period, and safety was followed for an additional 3 months. Half of the patients received IV Ampion plus the standard of care ("SOC") for COVID-19 while the other half received SOC alone. The following highlights were observed:

    • Based on data review, the Safety Monitoring Committee ("SMC") found the IV treatment of Ampion to be safe and well-tolerated for 90-days following treatment.
    • The study met its primary safety endpoint after 5 days of IV Ampion treatment and again after 3 months, with no remarkable safety differences between the Ampion treatment and SOC control groups.
    • The study showed promising efficacy with the IV Ampion treatment group seeing stronger clinical improvement than the SOC group as measured by the World Health Organization ("WHO") clinical improvement scale and the National Early Warning Score ("NEWS2"), which is recommended by the National Institute for Health and Care Excellence ("NICE") in its guidelines for the management of COVID-19 patients in critical care.
    • Additionally, Ampion-treated patients showed greater improvement compared to patients treated with the SOC, including anti-viral therapies.

    The beneficial clinical applications for IV Ampion treatment in COVID-19 patients will be further explored using two treatment groups in a larger Phase II study while building on the safety profile from the Phase I study. The following highlights are presented:

    • Clinical sites in Israel will be used concurrently with sites in the United States, as Israel has been recognized by the FDA as capable for sharing knowledge and inspection information to support the safety and efficacy of drugs in the United States.
    • In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, associated with COVID-19 infection. IV Ampion targets systemic inflammation in the body observed with COVID-19 patients, which is being investigated to improve the clinical course of the diseases and outcomes in patients treated with Ampion.
    • The IV Ampion clinical program complements ongoing clinical studies evaluating inhaled Ampion, which targets localized inflammation in the lungs.

    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

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May



    215-205-1217

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampion-demonstrates-safety-in-covid-19-patients-and-initiates-global-clinical-trial-for-intravenous-ampion-301195209.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  5. ENGLEWOOD, Colo., Dec. 10, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that it has entered into two collaborative research agreements to explore new clinical indications for its immunomodulatory drug, Ampion™.

    Rare Inflammatory Pediatric Diseases

    The Company entered into a collaborative research agreement with the oldest and one of the top children's hospitals in the United States whereby both parties will work together and conduct exploratory research to determine whether the anti-inflammatory and signaling pathways of Ampion could play a role in the treatment of certain rare Inflammatory Pediatric Diseases.

    Currently in clinical trials for treatment of inflammation due to osteoarthritis and COVID-19 related acute respiratory distress syndrome (ARDS), Ampion has been shown to reduce inflammation through multiple pathways. The exploratory research conducted under the collaborative research agreement will utilize cell culture models and proteomic, metabolomic, genomic and in silico computational methods as well as in vitro characterization of identified dysregulated signaling pathways in human cultured cell types (e.g. human epithelial cells, microvascular endothelial cells, peripheral blood mononuclear cells (PBMC)).

    Inflammatory Kidney Disease Research with Andrew Terker, M.D., Ph.D.

    Dr. Andrew Terker, a prominent basic research scientist specializing in kidney research at Vanderbilt University Medical Center, has entered into a research collaboration with Ampio in which the immunology based anti-inflammatory properties of Ampion will be investigated as a treatment for acute and chronic kidney disease, extremely common conditions for which new therapies are needed. Dr. Terker's interest in exploring Ampion's anti-inflammatory effects in acute kidney injury (AKI) and chronic kidney disease (CKD) is based on more than a dozen peer-reviewed publications that reported Ampion modulates anti-inflammatory signaling pathways known to be relevant in kidney disease. The FDA has approved three different methods of administration of Ampion: by direct intra articular injection, intravenous administration and by inhalation in the course of clinical trials for the treatment of ARDS in COVID-19 patients, COVID-19 patients requiring supplemental oxygen, and osteoarthritis of the knee. Equally important to Dr. Terker, there have been no drug-related adverse events reported with any method of administration in any Ampion clinical trials.

    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 United States Private Securities Litigation Reform Act of 1995, as amended to date. 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 the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, 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, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. 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

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Sarah May

    com

    215-205-1217

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-enters-into-collaborative-research-agreements-to-explore-additional-clinical-indications-for-its-immunomodulatory-drug-ampion-301190462.html

    SOURCE Ampio Pharmaceuticals, Inc.

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