Is the Surge in Ampio Sustainable?

Early on Tuesday, the company announced that it commenced the second Phase 3 Study of Ampion to treat pain and inflammation due to osteoarthritis of the knee. Like most biotech and pharma companies, any positive news surrounding a clinical trial is bound to give the stock a boost.

To keep up this momentum, the company will have to perform well in the trial. Otherwise we can expect the stock to give back these gains just as quickly as it got them.

Ampio is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options.

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Ampio CEO Michael Macaluso said:

We have been awarded multiple patents to protect the formulation of Ampion. But more importantly, the FDA has required Ampion to meet the clinical obligations for a novel biologic, a special designation that comes with 12 years of market exclusivity. Finally, this second pivotal trial is clinically identical to the previously successful Spring Study, which was confirmed by the agency as one of the two pivotal trials required for approval. In our recent communication with the agency confirming the SPA, the FDA wrote: protocol AP-003-B is adequate to serve as a pivotal trial in support of a future BLA.  With positive results and an SPA, Ampion has a clearly defined path to market.

Vaughan Clift, M.D. and chief medical officer of Ampio, also commented:

We greatly appreciate the effort by the FDA in reviewing the extensive data and protocols we submitted before granting the SPA. The Ampion drug and control saline were manufactured in our state-of-the-art, cGMP facility in Colorado.  Our sites have been carefully chosen and the site personnel and monitors have been thoroughly trained on the protocol and administration of the WOMAC 3.1 pain index. The pre-trial preparation has been extensive.

So far in 2015, this company has underperformed the market. Shares are down over 7% year to date and down 8.6% in the past 52 weeks.

Shares of Ampio were up 16.5% at $3.70 late Tuesday morning. The stock has a consensus analyst price target of $14 and a 52-week trading range of $1.94 to $9.01.

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