It's obviously too early for details--no way they could have met with the FDA yet--but the brief PR conveyed optimism and the assurance that there will be another attempt with a "new strategy."
I got the impression that it won't take nearly as long to generate the necessary data for the acute care pre-IND meeting. Maybe that will now precede the other one. I hope the delay is not too long!
In the last presentation he said the NASH 1b was being done in two cohorts, and that the first one was completed, implying that there might be some data from that. Apparently there will be none until both are done. Isn't that something that the CEO of the company should actually KNOW, rather than merely guess or speculate about it?
Six months lost on the Posimir trial. Reprimand by the FDA over content on the website. Repeated announcements of imminent DUR-928 trial results, which never seem to materialize. How much does he in fact know about what is going on there? Perhaps it's time for a change.
Above .79 there is no technical resistance until .98. And the resistance at .79 and .98 also is very weak. This can go back above $1 very fast, once it starts moving.
The ClinicalTrials.gov Identifier is NCT02574520. The Estimated Enrollment is 264, and the Estimated Primary Completion Date is August, 2017.
So as of October 12 they enrolled the first patient in the pivotal PK study and the pain trial. 120 patients for the first and 60 for the second. One thing we know is that they have a real sense of urgency and that they want to submit the sNDA as soon as possible.
The April Fund owned 11.4 million shares in March, 2015, and this year they have added 8.8 million shares. That's 20.2 million shares. That's 14.7%. So Institutional Holdings are 49.3%, and the largest insider holder owns 14.7%. That's over 64% total, and you can add a few more percent for additional insiders. You'd never guess these bullish facts from the current price action, but there they are!a
Source: NASDAQ Website. DRRX's largest shareholder, First Eagle, has added 5.5 million shares and now owns nearly 20%. Blackrock now owns 9.2 million shares and recently added 800,000. And Broadfin and Sabby have initiated positions of 2.9 and 2.5 million respectively. The April Fund, designated as an insider holder, has purchased 8.8 million shares in the last year.
DUR-928 had striking therapeutic effects in animal trials, and Phase 1 human trials showed a clean side effect profile, even in very large doses. So even if a human benefit were limited, with zero risk it could still have great value.
All that the FDA has asked PTIE to do is to redo the tests associated with the label claims in a somewhat different manner. It is likely that they will redo the tests for the inhalation and injection claims, which the CEO affirms can be done in a couple of months, and then resubmit. Unfortunately they have to wait first for an appointment with the FDA. I am still reasonably optimistic that the drug will eventually be approved.
On 09/13 they downgraded the stock from Buy to Hold, maintaining a 2.50 target price. Now they should shift back to Buy, with a target price between 1.50 and 2.00. That would help stabilize the price.
And with only the tests to support those claims to look at, the FDA may grant them a two month review instead of the usual six.
All three parts of the pipeline will have important milestones next year. The Remoxy NDA will be resubmitted. The Posimir PERSIST Phase 3 trial will conclude in Q3, with results available by Q4. And Phase 2 proof of concept trials for both the acute (damaged kidney) and chronic (NASH) applications of DUR-928 should begin sometime in H1. That's a lot, and the NASH trial will I trust attract a good deal of attention.
This was announced yesterday. The company was previously owned by Allergan, PLC. "We are pleased that Anda, Inc, one of the leading distributors of generic medicines in the U.S., is now part of Teva. This acquisition reflects our continued view that attractive growth opportunities, both external and organic, exist for our business and for our extensive supply chain network in particular," said Siggi Olafsson, President and CEO of Global Generic Medicines. Surely a continuing expansion of Teva's generics distribution network can only benefit Antares.
This is basically the study that Adam Feuerstein criticized Antares for omitting way back when. It seems to fully support the thesis put forward by Wotton. Let's hope that it has a positive effect on sales going forward.