I'm sorry for being out MIA for the past week but just returned from a trip back east to see my family. There has been a lot going on since I left for my trip.
Mannkind MNKD won a convincing 13-1-1 and 14-0 advisory panel for it's inhaled insulin drug Afrezza in type 1 and type 2 diabetes, respectively. That took just about everyone by surprise as the stock soared after the vote. I predicted a positive vote in type 2 but was shocked by the type 1 vote. I also predicted a strict label which I'm sticking to as the panel echoed the FDA's concerns for patients with asthma and COPD. I'd also expect two post-approval studies for lung cancer though Mannkind is already performing a phase 3 study to evaluate the long-term effects so this might alleviate some of those requirements. I still believe Mannkind is overpriced as it's carrying a $2.5 billion market cap, lacks a commercial partner, has a negative book value, is burning through cash, and I expect an unfavorable label. I guess time will tell how this story plays out.
Cyclacel CYCC announced a public offering of stock after the market closed today. Management has been communicating that they have "plenty" of cash to get through their recruitment of their lead product in AML but looks like they are going to the well again. They expect full enrollment in their phase 3 trial in AML in Q4 due to expanding the enrollment centers into Europe. I only own 2,000 shares and the stock is down after hours due to the announcement.
Vivus VVUS was downgraded by Piper Jaffray from $8 to a $3 price target. They have concerns about the lack of sales traction of their obesity drug Qsymia and inability to land a large pharma partner. I own 6,000 shares so I share in these concerns but I'm not giving up hope. The new management team was able to land solid partnerships in the United States and abroad for their erectile dysfunction drug Stendra so I have confidence in their ability to land a partner for Qsymia (did you hear my Vivus management? You stink at selling. Close a damn deal before you burn through your cash!!!!!)
Stay tuned for more from the Biotechinvestor.com
Disclosure: I am long CYCC, VVUS.