John McCamant, editor of The Medical Technology Stock Letter, reiterates his buy rating on this biotech stock, noting the most productive (and busiest) period in its history is about to begin.
One key event for Novovax (NVAX) was a FDA meeting taking place this summer to discuss the RSV vaccine clinical plan (respiratory syncytial virus) and whether or not the company would be initiating a Phase II study in pregnant women.
The fact that, on the call, NVAX announced it will start the trial on time and, as expected, confirms to us that meeting has occurred and went well. That is a major positive in our view, as some had questioned that the FDA would allow such a study to take place.
In our latest update, we provided an overview of the multitude of events/clinical trials set for NVAX for the remainder of 2014.
Included are: a) four new studies with the RSV vaccines will be initiated this year; b) data from the H7N9 vaccine released during the third quarter; c) a Fall analyst meeting in NYC; d) the start of the respiratory (“RSV/Flu” combo) vaccine in late-2014/early 2015 . All are part of the Q2:14 earnings press release.
The excellent momentum at NVAX was evident on its latest conference call. In addition to what we already expected, we learned of several new important near-term and value-creating events.
First, the confirmation of the RSV pregnant women study, likely an early October initiation. Next, the analyst meeting will take place on September 23. In addition, the company will be presenting at vaccine/scientific conferences in September, October, plus the big annual RSV meeting in Capetown this November.
Updates from malaria and rabies vaccines (India) are due by yearend, and the novel MERS program is also moving forward.
We remain confident that NVAX management is well on its way to developing the first RSV vaccine and a disruptive respiratory vaccine that will project it to the upper tier of biotech valuations over the next few years.
The confidence is higher now that the company has completed four successful studies, and is developing the RSV vaccine in three target populations in parallel—not in sequence.
With over $200 million in cash, they are financially prepared to move all of their programs—plus some new ones—through clinical trials. By next year, they will be initiating regulatory Phase III studies. NVAX’s major event calendar is about to begin. NVAX is a buy under $6 with a target price of $13.
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