|Over a month ago|
Ampio initiated with a Buy at Roth Capital » 16:1012/1812/18/19
Roth Capital analyst…
Roth Capital analyst Jonathan Aschoff initiated coverage of Ampio with a Buy rating and $4 price target, stating that he is optimistic for its success in its final pivotal trial for its therapy for intra-articular injection of patients with severe osteoarthritis of the knee.
Ampio provides update on AP-013 clinical trial and Ampion manufacturing facility » 08:4312/0412/04/19
Ampio provided updates…
Ampio provided updates regarding the continued progress of its Phase III AP-013 clinical trial and its manufacturing facility. Ampio's COO, Holli Cherevka, stated: "As of December 3, 2019, of the 1,034 patients to be enrolled in AP-013, more than 700 have been injected and an additional 50 patients have been approved for injection in the near term.(...) the clinical trial is more than 33% complete. (...) to date, study investigators have identified no remarkable safety findings. These results are consistent with the safety profile observed in over 2,000 patients in the Ampion clinical development." Ampio has built a GMP manufacturing facility at its corporate headquarters to enable the company to have direct oversite and control over the ongoing manufacturing and commercial launch of Ampion shortly after FDA approval of Ampion. Approximately 200,000 Ampion vials have been filled without contamination. The company believes that three-shift annual capacity of this facility would be ~ 8,000,000 vials.
|Over a quarter ago|
Ampio announces progress in SPA Phase 3 clinical trial for Ampion » 08:3809/1709/17/19
Ampio Pharmaceuticals announced the progress to date in the Company's special protocol assessment, or SPA, phase three clinical trial titled, "A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee." As of September 16th the company has consented/enrolled 661 patients of which 423 have been injected and an additional 52 of these patients have been approved for injection, which should take place shortly. 186 of the consented patients did not meet the inclusion/exclusion criteria and will not be participating in the trial. FDA has authorized the use of 8 additional clinical sites, which will be operational by the end of September and will bring the total number of active sites to 25.
Ampio retains financial advisor, appoints Transaction Advisory Committee » 08:3508/2208/22/19
Ampio Pharmaceuticals has…
Ampio Pharmaceuticals has retained Torreya Partners as a financial advisor and has appointed Willam Bindley and Bruce Terker to a newly formed Transaction Advisory Committee. Ampio CEO Michael Macaluso stated, "We are at a pivotal moment in the company's transition from a development stage company to the filing of a Biologics License Application and subsequent commercialization of our lead drug, Ampion. As such, we are now upgrading the expertise level primarily devoted to further evaluating our near term strategic options in a rapidly evolving healthcare market place". Torreya is a global investment banking boutique serving companies in the life sciences industry. Since its inception in 2007, Torreya has advised clients on more than $100B worth of deals for biotechnology, branded pharmaceutical, generic pharmaceutical, and life sciences companies. Bindley is Chairman of Bindley Capital Partners, a private investment firm headquartered in Indianapolis, Indiana and is also a Founder and Current Chairman of Guardian Pharmacy Services, the largest privately held long term care pharmacy in the United States. Bindley also founded and was Chairman of Priority Healthcare, a national provider of bio-pharmaceuticals and complex therapies for chronic disease states.
Ampio updates progress of SPA clinical trial » 08:3507/2507/25/19
Ampio Pharmaceuticals announced the progress to date in the company's special protocol assessment or SPA phase three clinical trial titled "A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee." This pivotal trial seeks to enroll approximately 1,000 patients and assess co-primary endpoints of pain and function. Ampio CEO Michael Macaluso declared, "Over the last two weeks, approximately two-thirds of the scheduled sites have completed their preparations and have begun dosing patients. As of July 24th, 280 patients have enrolled into the study, and almost half of those patients have been dosed. The remaining scheduled clinical sites are expected to begin enrolling patients in August."
Ampio appoints Moss Adams as new independent auditor » 08:4007/1107/11/19
Ampio Pharmaceuticals appointed Moss Adams LLP as the company's new independent auditor. Moss Adams has served for over 100 years as a fully integrated professional services firm with over 3,200 professionals across more than 25 locations in the western United States. Moss Adams will replace Plante Moran, PLLC who had served as the company's independent auditor since 2010. The decision to change auditors was not caused by any disagreement between the company and Plante Moran on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure.
Ampio appoints Dan Stokely as CFO » 08:3207/1007/10/19
Ampio has appointed Dan…
Ampio has appointed Dan Stokely as CFO. Dan Stokely most recently served as Executive Vice President and CFO of Sentynl Therapeutics, a privately-held specialty pharmaceutical company, which was sold to Cadila Healthcare in January 2017.
Ampio files announces public offering » 08:3506/1706/17/19
Ampio announced today…
Ampio announced today that it will offer up to $12 Million of its common stock in public offering. Ampio has entered into purchase agreements for the purchase of an aggregate 25,320,000 common shares of the Company at an offering price of $0.40 per Common Share for aggregate gross proceeds of $10.1 million, before placement agent fees and other offering expenses. ThinkEquity, a division of Fordham Financial Management, Inc., is acting as the exclusive placement agent for this transaction.
Ampio files to sell common stock, no amount given » 16:0306/1406/14/19
ThinkEquity, a division…
ThinkEquity, a division of Fordham Financial Management, is acting as sole book-running manager for the offering.
Ampio receives FDA approval of special protocol assesment » 07:3206/1406/14/19
Ampio announced that it…
Ampio announced that it received FDA approval of the company's special protocol assessment of a clinical protocol titled "A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee." The FDA response noted, "We have completed our review, and based on the information submitted, agree that the design and planned analysis of your study adequately address the objectives necessary to support a regulatory submission." The FDA continued, "However, final determinations for marketing application approval are made after a complete review of the marking application and are based on the entire data in the application."