Today, investors in Entera Bio (NASDAQ:ENTX) and ENTX stock are seeing massive gains of as much as 40% at the time of writing. This move comes on extremely heavy volume, with more than 150 million shares having traded hands. This is compared to an average daily volume around 500,000 shares.
Indeed, any move such as this implies some sort of big news has arisen. And that’s certainly the case with Entera. As a clinical-stage biotech company, volatile swings tend to be the norm, particularly on any announcement of clinical results.
Today, Entera announced the results of its Topline Phase 2 study for its osteoporosis treatment. Let’s dive into what this announcement is all about, and why investors are driving up the price of ENTX stock today.
ENTX Stock Surging on Positive Clinical Results
Today’s announced positive results were related to the company’s EB613 osteoporosis drug. This is an oral formulation of human parathyroid hormone. The company hopes to have the first oral bone building treatment for osteoporosis.
Why is this big?
Well, most of the current therapies for osteoporosis involve injections. Less-invasive therapeutics are obviously preferred. Accordingly, the market for this EB613 drug could be massive.
The company’s positive clinical trial results included the following:
- Subjects receiving the 2.5 mg dose of EB613 showed significant dose-related increases in BMD at the lumbar spine, total hip, and femoral neck at 6 months
- Subjects receiving the 2.5 mg dose of EB613 for 6 months had a significant placebo adjusted increase of 3.78% in lumbar spine BMD (p<0.008)
- The study’s primary efficacy endpoint, a statistically significant increase in P1NP at 3 months was achieved, as previously reported
- EB613 exhibited an excellent safety profile, with no drug related serious adverse events
- An End of Phase 2 meeting with FDA to review the EB613 development program is anticipated in the coming months. It is planned to conduct a single pivotal one-year Phase 3 study comparing changes in lumbar spine BMD in patients treated with EB613 versus treatment with Forteo, as per a 505(b)(2) pathway
- EB613 is positioned to be the first oral bone building agent for the treatment of osteoporosis
On the date of publication, Chris MacDonald did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.