Oppenheimer’s Christopher Marai has reiterated an Outperform rating on the company today. Commented that the P3 results satisfies the conditional approval requirements in the EU while also making it approvable by the FDA.
Not only are they ahead of schedule, they have a perfected target patient population with derivative uses as well. This crystallizes the approval case and makes it easy for the FDA to approve.
So you are saying that Cramer was right all along? OK. He was right.
Oppenheimer says $156.
Cramer says $180.
Some say $200. Some say $100. They are all way above today's price.
Barclays’ Geoffrey Meacham maintained an Overweight rating on the company, with a price target of $100.
Meacham believes that Translarna would get approval, lending upside to the company’s shares.
PTC Therapeutics announced results from the Phase III ACT study of Translarna, or ataluren, in Duchene Muscular Dystrophy [DMD] patients with nonsense mutations.
No posts for months, then on the heels of amazingly good phase 3 trial data, the shorts are hitting it hard. Spreading lies and misleading information as fast as they can in dire hopes nobody looks at the actual P3 trials data. These spammers will be gone in a few days.
Believe whatever you want. Everybody else knows the truth. The efficacy is clearly there. The P3 trials crystallize the target patient population.
Know what else? They will also soon figure out the mitigating factors in the late stage patients as a simple deficiency in another area (e.g., Vitamin C deficiency, it isn't this, this is just an example) that when corrected, makes Translarna a treatment for late stage patients too. Shorts are done.
Only late stage patients where they had already lost ambulatory function didn't meet the end point. For those early and mid-stage patients, they showed very strong results. So, this means that early treatment is essential for success, which bodes extremely well for the US FDA approval as well as in the EU.
Safety was same as placebo, so no safety issues either, makes it a compelling approval case.
It wasn't a failed study at all. Look at the efficacy rates and you will see a resounding success. True, the drug did not reverse the damage in late stage patients that have already lost ambulatory function, but when administered early there is a significant improvement.
The data is all there, and the market agrees which is why it was up $5.75/share after hours.
Stop it. Quit buying dammit. I need to buy more tomorrow and want to get it at today's prices.
Didn't you read the headline? They missed the primary endpoint. Don't look at the underlying data, stick to the headline. Stop thinking for yourself. Just read th headline. Ignore the massively overwhelming positive data for early and mid-stage patients plus the perfect safety profile.
I want mmmoooorrrrreeeeeee.
You may want to recheck that data. Trials were far better than expected.
Wow, the level of efficacy was way higher than I ever expected. Now it is true that late stage patients didn't get the same level of benefit, but what that tells me is (what we already pretty much new) that early treatment is imperative. The level of efficacy is way higher than earlier studies and crystallizes the target patient population. This is REALLY REALLY good news.
We can take advantage of the low profile because it won't move much until news is imminent or released. While it is always possible for smart money to start buying in as we get closer to the news release and share prices to rise, the big move will come after the news is released. This gives the retail investor a chance for monster returns because this one simply hasn't caught the attention of the big boys yet. I'm watching for volume increases that may indicate this is in play early, otherwise we will simply gap up huge one day and we will be sitting in a 4-bagger or 5-bagger instantly.
Probably should be, but the biotech sector is taking it hard on the chin right now. Watch where it ends up at the end of the year.
I haven't read the Oppenheimer report, so not sure what it said. The company website stated that they have Translarna on sale in 8 countries. There was a recent press release about Canada accepting the filing there, and updated news on the NICE meeting in the EU which was also favorable.
On the negative side, looking at the clinical trials data, it didn't seem to be dose dependent. Meaning, they were able to achieve statistically significant results in the lower dose without any real meaningful change in the higher dose. To me that means that the drug works but has a saturation point at the lower dosage. So more isn't needed once you reach critical mass, which they were able to achieve because it provided a statistical benefit over the placebo.
An if Norman was unable to comprehend my first post, he will be absolutely befuddled by this one.
That's easy. Because the share price does not reflect future outlook. No gibberish about it at all, though I'm sorry if you don't understand it.
With Translarna already approved and on sale in 8 countries, Canada having accepted the NDA (equivalent), and US pending with P3 trials data due before year end, things are looking really good. Even if P3 trials are mediocre, the fact that there is no treatment whatsoever on the market means approval is extremely likely.
I think P3 results will be much better than "mediocre" too which bodes even better for PTCT.
You couldn't have known. The only ones who knew about the dilution before it happened were on this message board. None of the institutional investors knew it was coming, which is why the stock is getting punished now and will have to go up 25% to recover back to where it was before the dilution. I guess it is just me-myself-and-I who are doing all the selling causing the stock to crater.
Yep, you caught me. Every single person who thinks for themselves and isn't a blind-faith moron, is me. Just keep thinking that way. That is what makes you a good blind-faith-fool.