NEW YORK (AP) -- Shares of The Medicines Co. surged in premarket trading Monday after the company and its partner Alnylam Pharmaceuticals Inc. reported study results suggesting effectiveness for a potential cholesterol drug.
The companies said that results from an ongoing Phase 1 clinical trial showed that their experimental treatment ALN-PCSsc lowered bad cholesterol by up to 83 percent compared to published results from studies with anti-PCSK9 MAbs, another class of drugs aimed at treating cholesterol. Both classes of drugs work by blocking a gene related to high cholesterol.
according to the 10k filing released after the close
And then I'd just probably add Linzess in there. We have our foot on the gas. The response to our second wave of direct-to-consumer advertising is exceeding industry norms. We just launched a effort into long-term care for the first time since Linzess was approved, and that's about 25% of the market. Our relationship with Ironwood is excellent. And we're waiting to launch a low-dose version of Linzess.
Solid 2Q15 L
ed 2Q15 US Linzess sales of $112.1
above Consensus estimate of $107.8
Sales grew 79% y/y
and 17% q/q
driven by a 56%
increase in total filled prescriptions.
Management noted inventory levels were within the 2
3 week range in the quarter.
Linzess could see a boost from the removal of Amit
iza from the CVS formulary
Read the story in Investors Business Daily -Sucampo Stock Hits High On EPS, But CVS Nixes Drug
PropThink @PropThinker 2m2 minutes ago
$IRWD Linzess U.S. sales up 17% QoQ. 510K scripts in the quarter, from 460 in 1Q15.
Michael W. Aguiar - President and Chief Executive Officer:
"And then the last piece here we talked about was what we've called terminal value are staring to look at potentially things beyond the range of our current portfolio and that's really where Mike (Faerm) comes in.
The good news on the hiring and you talk about timing is we have plenty of time in front of us here. We have 14, 15, years left in front of us in terms of life from these programs. So there is no immediate urgency around doing a deal tomorrow morning. If the right deal came up we would certainly look at it."
"So, I would just say stay tuned we'll continue to look and be thoughtful about this like we always have in terms of the types of things we look at and the timing and all of that. These projects don’t happen overnight and it does take a period of time to get things up and running. So again I would say we don’t feel any pressure at all about getting a deal done. However if the right thing came up we will certainly take a prudent look at it. So we are pretty excited to have Mike on board and I would just say stay tuned but don’t expect something come out tomorrow morning." (seeking alpha)
Reuters today: GlaxoSmithKline Plc CEO Andrew Witty told analysts: * CEO says headline results of SUMMIT trial with Breo likely around Sept/Oct *
We look for things on sale, not clearance. GlaxoSmithKline [GSK] is a high-quality company on sale. It has underperformed because of very weak earnings momentum in the past few years, as its blockbuster respiratory drug Advair came off patent. The next five years look much more positive than the Street thinks.
What do you see in GlaxoSmithKline?
There are three ways the stock can move higher. First, the patent expirations are almost behind it, which will provide respite. Glaxo also recently swapped its oncology business for Novartis’ vaccine business. Glaxo’s existing vaccine business had estimated stand-alone margins of 35%, but Novartis’ was losing money. Now that Glaxo owns it, they can improve the margins, providing earnings growth. The third avenue is its consumer business, which includes things like Aquafresh toothpaste. It was poorly managed, but the company recently brought in new management from L’Oréal to run it. Plus, it is so out of favor, and earnings estimates have come down so much, Glaxo has limited downside, especially with a 6% dividend yield that is unlikely to be cut.
AAVL is SO oversold!!! Let's not forget that it was $48 and change AH after last week's news release before it reversed and headed straight down. Most, if not all, the margin calling selling is done. What a gift to new investors at these price levels!!
Piper Jaffray analyst Joshua Schimmer weighed in today with his views on Avalanche Biotechnologies Inc (NASDAQ:AAVL) after the company reported its highly anticipated results of the P2a for gene therapy AVA-101 for treatment of wet AMD (age-related macular degeneration) yesterday after market close. Schimmer reiterated an Overweight rating on the stock with a price target of $52.00, which represents a potential upside of 34% from where the stock is currently trading.
Schimmer noted, “Overall, it’s still early, but the data is largely in line with our expectations, showing what we believe is real biological activity in a subset of responders with a meaningful reduction in injection frequency, along with improvements in BCVA, but also with plenty of room for improvement. Our overall positive outlook for AAVL looks beyond this data and towards its expanding gene therapy pipeline and vector evolution strategy, which is underappreciated in our view.”
Furthermore, “While many have expressed disappointment in management’s handling of the results release and call, there is only so much they could do with an early limited dataset; don’t hate the player, hate the game. We recommend jets be cooled and the company be given the opportunity to hone in on a group of wet AMD patients most likely to respond to ‘101 therapy in the upcoming P2b trial and to further analyze these P2a results.”
People have forgotten that this was a 'safety 'trial and a modest one at that in two australian centers. P2b which is to be conducted in many validated clinicall centers should yield more robust data.
This from a blog post on seeking alpha:
"Pharma Investor , contributor
The OCT data does not jive with the reported vision results. Did the control group experience a lot of atrophy to account for thinning and worse vision? Retinal thickening (as in the AVA-101 group) would typically lead to worse vision, not better.
I'm still looking into this study, but doesn't feel right from what I've seen reported so far. Need to see what exactly criteria for "rescue" injections were. "
There is usually a correlation between structure and function- the OCT (structure) does not match the visual improvement (function). The detailed OCT analysis that is underway may shed more light.
"evaluation of SD-OCT images by an image reading center are ongoing" according to AAVL and that could potentially be a catalyst. Amid all the noise of the past few days, the fact that the Phase 1 36-month follow-up data demonstrated continued safety and tolerability, has been forgotten. A Regeneron partnership is another potential catalyst, so is the detailed data from the study that will be reported at a medical meeting . Lots to like! A good speculative buy at these levels, IMO!