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.
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.
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.
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.