It's fitting that our first day here at Daily Biotech begins with a number of major events across the sector. So, without further ado, here are the companies making news today in biotech.
First big buyout of the year?
Despite the need for big pharmas to make deals to stave off the so-called 'patent cliff'', we've only seen a handful of small deals for relatively unknown start-up or early stage companies thus far. This week that trend may change if Actavis (NYSE: ACT) closes on a deal to buy Forest Laboratories (NYSE: FRX) for a reported $25 billion. The deal would come at a 24% premium compared to Forest Laboratories closing price of $71.39 last Friday.
Vimizim is approved!
In unsurprising news, BioMarin's (NASDAQ: BMRN) orphan drug for Morquio A Syndrome called Vimizim has officially been approved by the FDA. The company will host a conference call premarket to discuss Vimizim and give prelim financial results for the fourth quarter of 2013. Of particular interest, BioMarin may give sales projections for Vimizim going forward.
Is today the day?
Shares of Chelsea Therapeutics International Ltd (NASDAQ: CHTP) saw whipsaw action last Friday, as the company's drug Northera was supposed to hear back from the FDA about its NDA as a potential treatment neurogenic orthostatic hypotension. At one point during the day, the stock dropped 35% from its intraday high of $5.63.
But this nauseating action was all for naught because the drug's PDUFA action date was ultimately delayed until today on the account of inclement weather.
What to look for: I think investors should key in on what Northera's label looks like. Personally, I believe the approval is a foregone conclusion following the 16-1 vote by the Advisory Committee, and now its all about the label and postmarketing requirements.
Will MannKind surprise investors today?
MannKind (NASDAQ: MNKD) will report fourth quarter financial results after the bell today and there could be some important information released during the call. In particular, investors need to keep an eye on for the company's tenuous cash position. A large debt instrument came due last quarter that may have cut deeply into MannKind's reserves.
There is also a chance MannKind may reveal further details about the upcoming PDUFA action date for Afrezza. The PDUFA date is tentatively scheduled two weeks after the Advisory Committee on April 1st, which seems like a date made to be moved.
How good are Prana's Phase 2 results?
Prana Biotechnology Ltd (NASDAQ: PRAN) announced today that its experimental treatment for Huntington disease called PBT2 reached statistical significance for both its primary and secondary endpoints. However, the press release was vague on details in regards to the primary endpoint, giving considerable more color on the secondary endpoints.
Management has scheduled a conference call after the bell in the U.S. today to discuss the results.