those are planned sells. Very normal for BIO´s. Planned sells are away to subsidize income for executives as salaries are nominal. Stock is close to breaking out.... do your own Due diligence
Pfizer (NYSE: PFE ) is struggling to offset slowing sales tied to expiring patents, and that has some observers thinking that Pfizer remains on the hunt to buy another drugmaker that can spark its growth. Earlier this week, Pfizer announced that it would acquire Hospira, the top provider of injectable drugs. The deal will net Pfizer an intriguing biosimilar program, but some suspect that the company is still hungry for more. If Pfizer is indeed still on the lookout for another buyout, three of our top Motley Fool contributors think these three companies should be on Pfizer's wish list.
George Budwell: Over the past couple of years, Pfizer's R&D efforts have decidedly shifted away from small-molecule drugs and more toward next-generation types of therapies, such as biologics, evidenced most recently by the aforementioned acquisition of Hospira. So it's not entirely surprising that the pharma giant has taken a keen interest in cardiovascular gene therapy company Celladon Corporation (NASDAQ: CLDN ) . At last count, Pfizer owned nearly 1.8 million shares of Celladon, making it one of the company's largest shareholders.
My take is that Pfizer's initial interest could turn into a full-blown tender offer if Celladon's lead clinical candidate, Mydicar, reports positive mid-stage results this April as a treatment for systolic heart failure. Such a deal would give Pfizer access to a potential megablockbuster. And, as a biological-based treatment, Mydicar would benefit from the high standards for generic "biosimilars" set by the Affordable Care Act in 2010, meaning the drug could effectively be immune from generic rivals for several years past its patent expiration. Furthermore, as a gene therapy, it would hold a competitive moat simply by the lack of competitors that can easily manufacture the viral vector on a commercial scale.
Mydicar would also fit in nicely with the big pharma's strong cardiovascular product portfolio and clinical pipeline. All told, this pairing looks like a great match -- that is, if Celladon's gene therapy platform is validated by the upcoming clinical data readout.
Board Members, Upon reading about the newly registered trial on clinical. gov. I contacted Mr. Wiklund from CLDN IR DEPT. Please see his below response. I omitted a couple sentences that were not pertinent to the subject matter. He states as you can read below its normal protocol to test higher dosages to determine potential toxicity levels in a new therapy. As, the current dosage has not shown any safety issues. In my humble opinion this is still a risk on FDA event in April. As, his response to me does not speak to the efficacy in the current trial only the safety profile. Hopefully we will get more information on Tuesday. Please do your own due diligence. Blessings.
I was surprised to find that via Clinical.gov that a 36 person mydicar trial thats gated to start April with a dosage 2.5x that of CUPID.What is extremely concerning is if this is a signal that the efficacy in the current trial end points will be too low for the FDA.
With respect to the higher dose trial, we have not seen any dose limiting toxicities, safety concerns, or lab abnormalities with our current dose. Our DSMB has met four times during the CUPID trial without safety concerns. Proper Drug development then argues to initiate small scale studies to explore what a dose limiting tox may be. Particularly with a novel, first in man, gene therapy.
Fredrik Wiklund Less
CLDN could potentially see 30 prior to April FDA news, the float Is 12mm , if the FDA momentum traders show up it could go parabolic. Its got a huge chance of getting approved if that happens it could see 60 plus overnight. as for now, definitely under the radar screen. the market makers are having a field day taking out stops. I'm long of course and feel good about this one.
throw in the fact that the float is 12mm ,brokerage houses will allow for margin again once the V picks and that the FDA MOMO crowd will show up in the next 30 days we could be looking at 30 pre announcement. in my humble opinion.... yet, i'm often wrong just ask my wife.
that sucks.. when do think the brokerage houses will allow for margin again. ... seems like volume would have to really pick up as its all about liquity
thanks Banman.... I'm adding here as well. I hate to ask a tea leaf question as I don't want to annoy anyone. But, I was thinking based on similar story stocks that CLDN could run to 30- 40 pps prior to announcement then if approved could perhaps get to 75... call me crazy. any thoughts on this weegie board question... lol !
Thanks for framing the bull /bear case so clearly. On the bull side, I was also factoring in the FDA had granted them a Breakthrough Therapy designation based on risk reduction on phase 1. Furthermore, Ogut comments regarding the dosses being to inadequate for humans versus rate confuses me as the finding of phase 1 data was based on humans ? or was the phase 1 on rats and the phase 2 data to be released is on humans ? sorry to sound so ignorant. please advise ? thanks for the assistance.
thanks brother for the conviction. adding here as well. fingers crossed. Based on your experience with running into a FDA decision when do you think we start getting some upside MOMO ? thanks again man. nice to have someone to communicate with.