What are you basing this assessment on. Agree that the technology seems exciting but who in senior management has ever developed a drug before? They seem to all have come from academics, and they've already made a few missteps. But agree if data are good all else is forgiven.
The FDA discussion seems odd and not transparent. It wouldn't be hard to describe the issues especially with an open label study. Plus if there are data release issues, it calls into question why they are investing in similar studies without FDA feedback. I don't think the loss is really the issue, but the overall spend with this injection of uncertainty, the large expansion of headcount and ambitious promises seems to have unnerved folks. Plus, it is likely that many with unlocked shares didn't sell on the first day and simply may have waited for a time or "news." In this case the news wasn't clearly positive.
Shire has not been strong ex-US ever. They have been creamed by Genzyme, have not done well with NPS, and failed recently with their business development. For ex-US there are many better suitors. Shire's major value has been its tax structure, which is why Abbvie dumped them so quickly when tax benefits were made uncertain. But Shire has been successful as a financial engineering play for several years, but without the product innovation and acquisition success that Valeant and Allergan have had. I think this is why they desperately need Baxalta, and moved so quickly. It will be surprising if Shire ends up with Baxalta, especially at so small a premium. IMO
Look at Shire numbers and decide for yourself. In this market and given Shire's recently bad record in acquisitions, 36% premium is way too low.
Shire execution in Europe has not been strong, and their rare-disease pipeline has not been a success at all. Their new products and gains were driven by their binge eating program and treatments for ADHD. The Shire CEO needs revenues and they have a weak orphan pipeline as evidenced by going hostile. They need Baxalta badly and this price is way too low IMO.
They are hurt by their complex structure I think, and they don't really have any biotech A-players with great track records in bringing products to market IMO. Too bad as the story seems interesting. Somebody with experience should come in, streamline the place, and then they should do a raise !
Lower tier sell-side analysts seldom carry much worth or weight. More ominous to me is that some of the more speculateive hedge types- RA capital who were behind Axovant- are now taking positions here. Similar story- a drug that has disappointed in trials with a management claiming post-hoc analyses are promising. Guess we will see, but since the fund guys aren't dumb maybe they are betting on an upside surprise.. IMO
I take a slightly different view. The drug to me I agree seems inactive and the company is desperate, not doing anything technically wrong, and trying to sell a story. Their commentary is geared to having one beleive there is hope for future studies, and that if they go to FDA and get guidance on an endpoint it validates their findings. It does not, but this then allows them to keep the program ( and the company) alive for another study as they kick the can down the road. At this point it is up to investors to apply judgement. So what do we know? FDA won't stop a company from wasting it's time unless there is a safety issue. Unlikely here as the drug seems pretty inert, though there was the fact that patients on drug overall fared worse than PB. The claim that the original EP was chosen incorrectly is comical - we all know if it worked they'd be proclaiming success. And what company chooses the wrong Primary and doesn't fire their head of R&D? Next there are the multiple secondary endpoints, so by chance alone a few can be positive. Finally, unless they produce a term sheet, it seems unlikely they are pushing away partners save for family members. So the facts are all out there for investors to bet on. JMO
Missed on the primary. They are noting some positive secondary findings. Hard to interpret how meaningful that is without knowing how many secondary endpoints were measured. However, overall trial failed according to the release.
Thanks - this stock has perplexed me. On the one hand intriguing science and top bankers, on the other amateurish approach to publicity and communication.
These are both "one-off" meetings. JPM were their banker of course, but Roth is not a first rank conference by any measure, and to many participation at Roth is not a positive. Plus the CEO already attempted to differentiate Spark approach in the trades so unless there is real news not looking for much here.
The Avalanche data were criticized for several reasons- the control group seemed to be inadequately treated, leading to a larger than expected decline in VA that amplified a small gain in VA for the AAVL drug. And their CC was a mess. However, there has been substantial exuberance over gene therapy, and very large investments including Spark, and when any AAV based program flounders all the companies in the space go down. Spark has already had to distance themselves from other Penn AAV research which showed less durability than hoped. AAV has always faced an issue of durability vs lenti, and as this is the Spark platform the company will need to show data that this isn't an issue, and subsequently, immunogenicity isn't an issue if repeat treatments are needed.
Wow- your Yahoo postings are all the same nonsense wherever you post about how stocks will go down, usually with your wildly off-target predictions about price movements. Shouldn't you be back in your remedial classes now?