Halozyme's clinical hold lifted for PEGPH20
Halozyme shares are up over 13% in premarket this morning following the announcement that the clinical hold on the company's mid-stage pancreatic cancer treatment dubbed "PEGPH20" has been lifted. As a reminder, patient enrollment and dosing in the trial was halted in April over concerns regarding an elevated risk of blood clotting. After reviewing the recommendation from the trial's independent Data Monitoring Committee, the Food and Drug Administration decided to allow the trial to proceed under a revised protocol.
What's my take? Halozyme views PEGPH20 as a potential front line treatment for late-stage pancreatic cancer, where it would compete with the likes of Celgene's Abraxane. With that in mind, I think there are a few points to consider going forward.
Firstly, pancreatic cancer drugs have a poor track record in clinical trials, which is why there are so few approved treatments. That's not to say PEGPH20 is destined to fail, only that clinical risks are still high at this juncture. Secondly, the pancreatic cancer market is one of the smaller commercial opportunities in oncology and recent approvals have significantly increased competition for market share. In other words, it's hard to quantify PEGPH20's value for this indication because of these issues. As such, you may want to exercise caution today on the heels of this breaking news.
Novavax falls hard after $100 million offering
Shares of the nanoparticle vaccinemaker Novavax fell over 11% in after hours trading yesterday following the announcement that the company was raising $100 million through an offering of its common stock. The underwriters of the offer have a 30 day option to purchase another $15 million in shares as well.
According to the press release, Novavax said it plans to use these monies for "general corporate purposes, the advancement of its clinical-stage vaccine candidates and its preclinical research programs, manufacturing and process development activities, capital expenditures and other strategic purposes."
Is it time to hit the panic button? Given that Novavax reportedly has more than $100 million still in the bank and is generating revenue through its BARDA contract, I understand why this fairly large offering is striking a sour note with investors. That being said, I think investors should focus on the phrase "other strategic purposes" as a key reason behind this offering.
Novavax is known to make strategic acquisitions that help to build out its infrastructure and technology platform. And earlier this year, management expressed interest in pursuing additional deals, even hiring Sven Andreasson specifically for this purpose. So, I think there is more than meets the eye with this offering.