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Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) is a pre-revenue stage biotechnology company based in Greenwood Village, Colorado. The company is focused on developing innovative treatments for osteoarthritis through its OA-201 program. This program aims to develop a unique and proprietary small molecule formulation designed to alleviate pain and protect cartilage in patients suffering from osteoarthritis of the knee (OAK) and potentially other joints.
Recently, Ampio faced significant developments, including a 20-to-1 reverse stock split approved by its Board of Directors to address its stock price and meet NYSE American's listing requirements. The reverse stock split took effect in September 2023. Despite these efforts, Ampio decided to voluntarily delist its common stock from NYSE American and deregister its shares to reduce regulatory costs and conserve cash for future operations.
In the clinical field, Ampio has partnered with Ascendia Pharmaceuticals, Inc. to support the development of OA-201. Ascendia will provide comprehensive services ranging from formulation to cGMP manufacturing. Despite promising initial results, recent non-clinical studies failed to demonstrate significant pain reduction benefits, leading to the termination of the OA-201 program in February 2024.
Ampio has also been involved in legal proceedings, including securities fraud class actions and derivative actions, all of which reached settlements in early 2024. The company anticipates that the settlements will be covered by its D&O insurance policy.
The company recently announced that it will delist its common stock and terminate its reporting obligations under the Securities and Exchange Act of 1934, effective April 2024. This decision aims to preserve cash and facilitate an orderly wind down of operations.
For more information, visit the company's website or contact Ampio Pharmaceuticals directly via email at mmartino@ampiopharma.com.
Ampio Pharmaceuticals (AMPE) has received regulatory approval to expand enrollment in its AP-019 Phase II study to India, aiming to treat respiratory distress from COVID-19 using inhaled Ampion™. This decision is underscored by India's ongoing COVID-19 crisis, with over 3,200 daily deaths reported. The Phase II study follows successful Phase I results that indicated an impressive 78% reduction in all-cause mortality for patients treated with Ampion. Due to political unrest and reduced COVID cases, the study efforts in Israel will be discontinued in favor of focusing on India.
Ampio Pharmaceuticals (NYSE American: AMPE) has announced its poster presentation titled "Pivoting From One to Multiple Production Platforms to Treat COVID" at the 2021 International Society for Pharmaceutical Engineers (ISPE) Annual Meeting and Expo in Boston from November 1 to 3, 2021. The presentation will take place on November 2, 2021, from 10:30 am to 12:00 pm ET. It highlights Ampio's innovative expansion of its manufacturing capabilities to produce its drug Ampion for COVID-19 treatment after reprogramming its facility within four months.
Ampio Pharmaceuticals (NYSE American: AMPE) will participate in one-on-one meetings with institutional investors at the Alliance Global Partners' Virtual Summer Healthcare Symposium on June 17, 2021. This event is by invitation only, and no webcast will be available. Ampio focuses on immunology-based therapies for inflammatory conditions, with its lead drug Ampion™ backed by a strong patent portfolio, ensuring market exclusivity until 2035 upon FDA approval. The company emphasizes its commitment to advancing treatment options amid growing clinical demand.
Ampio Pharmaceuticals (AMPE) announced its participation in the 23rd International Congress of the International Society for Aerosols in Medicine (ISAM) from May 22-26, 2021, in Boise, Idaho. The company will present a poster titled "Regulatory Decisions during COVID-19: Efficient Nonclinical Inhalation Toxicology for a Clinical Program." The poster focuses on the results from the AP-014 Phase I trial, showing that inhaled Ampion reduced COVID-19 respiratory distress mortality by 78% compared to standard care. Ampio aims to advance inhaled therapies amidst the ongoing pandemic.
Ampio Pharmaceuticals (AMPE) announced IRB approval for its AP-018 Phase I trial, focusing on inhaled Ampion™ for patients with prolonged respiratory symptoms from long COVID. This study will assess safety and efficacy among 30 participants with confirmed COVID-19 diagnoses experiencing at least two symptoms. The trial aims to address a significant medical need, as 3 to 10 million individuals face debilitating long COVID effects. Previous trials showed Ampion reduced all-cause mortality by 78% in COVID-19 respiratory distress. The primary endpoint will be tracking adverse events over 60 days.
Ampio Pharmaceuticals (AMPE) reported its Q1 2021 financial results, highlighting progress in its therapeutic platform. Key achievements include FDA feedback allowing flexibility for the AP-013 Phase III trial in osteoarthritis and promising results from the AP-014 Phase I trial for COVID-19, which showed a 78% reduction in mortality rates compared to standard care. Financially, the company’s cash reserves were $15.8 million, while R&D expenses decreased to $2.3 million. Despite a net loss of $3.7 million, the company aims to sustain operations through mid-2022.
Ampio Pharmaceuticals (NYSE American: AMPE) announced positive results from its AP-014 Phase I trial of inhaled Ampion for treating respiratory distress in COVID-19 patients. The study achieved a significant 78% reduction in all-cause mortality compared to Standard of Care (SOC), with only 5% mortality in the Ampion group versus 24% in SOC. Patients receiving Ampion also had shorter hospital stays by 4 days and better clinical improvement. The company plans to begin Phase II trials based on these results, aiming for Emergency Use Authorization if efficacy is confirmed.
Ampio Pharmaceuticals (AMPE) announced a positive response from the FDA regarding its AP-013 Phase III trial for Ampion™, an anti-inflammatory treatment for severe osteoarthritis of the knee. The FDA's guidance will assist the company in maintaining its Special Protocol Assessment (SPA) as they consider future paths for the trial. Additionally, Ampio reported successful results from its AP-014 Phase I trial of inhaled Ampion for COVID-19, showing reduced mortality rates. Upcoming details will be shared during the earnings call on May 5, 2021.
Ampio Pharmaceuticals (AMPE) announced a conference call to discuss its financial results for Q1 2021 on May 5, 2021, at 4:30 PM EDT. The company focuses on immunology-based therapies for inflammatory conditions, notably its lead drug, Ampion, which has patent protection through 2035 and may gain 12-year FDA market exclusivity post-approval. The call will cover financial metrics and strategic updates, available via the company website for future reference.
Ampio Pharmaceuticals (AMPE) announced pre-clinical research showing that its lead drug candidate, Ampion, mimics the anti-inflammatory effects of dexamethasone without significant adverse effects. The study found that Ampion regulates 102 inflammation-associated genes similarly to dexamethasone, while also differing in 30 key transcripts, indicating distinct mechanisms of action. This research supports ongoing clinical investigations into Ampion as a novel treatment for inflammatory conditions.
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