After a share price rollercoaster in the previous weeks, Alcobra (NASDAQ:ADHD) finally released top-line results from its Phase III MDX ER study. Alcobra's announcement revealed that the effect of MDX was only trending towards statistical significance in the study's intent-to-treat (ITT) population (p=0.15), but following the removal of the four placebo "outliers" from the analysis (modified ITT/mITT population) the results became statistically significant (p=0.029). The scores of the four patients which were considered to be extreme outliers in the trial differed by more than 3 standard deviations from the mean of their group's score. Although Alcobra openly revealed they discarded the results from the outliers, most investors saw the move to announce results in the mITT population as meddling with bad data. The results appear frustrating for Alcobra, particularly because "extreme placebo response" outlier scores collected from four patients may have essentially been responsible for the trial's failure. Interestingly, three of these four patients were enrolled and treated in one specific US site. This single-site-related outliers remind us of the results from Neurocrine Bio's (NASDAQ:NBIX) phase 2a study with NBI-98854 in tardive dyskinesia patients, following which the company had to discard a clinical site altogether due to established note keeping errors. In terms of trial set-up and protocol, all endpoints and inclusion and exclusion criteria remained identical to MDX's Phase IIb trial. According to the company, patient characteristics were also the same as in the previous trial, with the exception that average body weight was higher in the current trial. It is important to note that even in the mITT population and the doubling of the sample size compared to the phase IIb study, the statistical significance values were not striking (p=0.029 according to the company's conference call). The MDX treatment effect was comparable to that previously achieved in Alcobra's 120-patient Phase IIb MDX trial. However, Alcobra confirmed in their conference call that placebo effect was significantly more pronounced in the Phase III trial. As we have postulated previously, placebo effect posed a threat to the current trial, particularly as the patient sample became more heterogeneous, moving from two, exclusively Israeli, trial sites to predominantly US-based sites. Although the secondary endpoints have not yet been analyzed, according to the press release, "Patients with both predominately inattentive (PI) ADHD and combined type (CT) ADHD subtypes appeared to benefit similarly in this trial". In the company's recent conference call, Alcobra's CEO further stated that the trial revealed a certain effect of MDX on the symptoms of inattentiveness (CAARS-INV subscale A) in both PI and CT patient sub-groups, and that the inattentiveness score was the one that drove the MDX arm to separate from the placebo arm. As a comparison, in the previous phase IIb study, MDX was also revealed to have an effect only on the inattentiveness score (CAARS-INV subscale A), but it did so only in the ADHD-PI subgroup (and not the ADHD-CT patient). To summarize the differences between the two studies - in the phase IIb, MDX seemed to be ADHD-PI subgroup-specific, whereas in the phase 3, MDX seems to be inattention-specific (regardless of subgroup). The latter statement makes more sense clinically, since ADHD-CT patients also have attention deficits.
ING initiated a buy on Alcobra (ADHD)
A number of other firms have also recently commented on ADHD. Analysts at FBR Capital Markets initiated coverage on shares of Alcobra in a research note on Wednesday, August 27th. They set a market perform rating and a $23.00 price target on the stock. Separately, analysts at Piper Jaffray initiated coverage on shares of Alcobra in a research note on Monday, August 4th. They set an overweight rating and a $42.00 price target on the stock. Finally, analysts at Roth Capital initiated coverage on shares of Alcobra in a research note on Friday, August 1st. They set a buy rating and a $40.00 price target on the stock. Two analysts have rated the stock with a hold rating, five have given a buy rating and one has issued a strong buy rating to the company’s stock. The company presently has a consensus rating of Buy and an average price target of $32.29.
Where the hell did you come from Hit a Home Run. Who are you pumping, yourself, no one else seems to be listening. I was in long at 12.90 and out at 14.30 looking to buy again at 12.90 and sell at ????? Day trading is terrific, although it takes your time, but the hourly wage is usually pretty good. I don't fall for the short #$%$, I but only the low and sell the highs, you shorts make this just too easy. Trend lines always on the money the past week time the downs and the ups. Not likely to see the up today, hopefully will see $12.80 - 13.05, my target, otherwise wherever we are at on closing bell.
Me too, actually I have sold out 6 times since 12.94 .. holding over and this morning at $15.01 ready to sell out again sometime today. As long as we are going up it's a day trading dream.
Alcobra was the recipient of a large growth in short interest in September. As of September 15th, there was short interest totalling 1,002,396 shares, a growth of 35.4% from the August 29th total of 740,441 shares, Analyst RN reports. Currently, 13.7%of the stock are short sold. Based on an average trading volume of 217,826 shares, the short-interest ratio is presently 4.6 days. A number of research firms have recently commented on ADHD. Analysts at FBR Capital Markets initiated coverage on shares of Alcobra in a research note on Wednesday, August 27th. They set a “market perform” rating and a $23.00 price target on the stock. Separately, analysts at Piper Jaffray initiated coverage on shares of Alcobra in a research note on Monday, August 4th. They set an “overweight” rating and a $42.00 price target on the stock. Finally, analysts at Roth Capital initiated coverage on shares of Alcobra in a research note on Friday, August 1st. They set a “buy” rating and a $40.00 price target on the stock. Two analysts have rated the stock with a hold rating, four have issued a buy rating and one has given a strong buy rating to the company’s stock. The stock presently has a consensus rating of “Buy” and a consensus target price of $32.29.
The stock has a 50-day moving average of $18.44 and a 200-day moving average of $18.04. The company’s market cap is $208.1 million.
Israel shuts down on Yom Kippur. Around 4-5PM Yom Kippur's Eve, Israel goes quiet as almost all private cars+motor bikes stop running. Satuedat Full Day Off on Yom Kippur. No Transportation at all on Streets and Roads Except for Emergencies.
Alcobra will issue a news tomorrow for PRESS CONFERENCE on Mon 10/06/2014 to discuss Phase 3. Headquarter will shut down early on Friday (Yom Kippur's Eve).
5:45 PM up in after hours $18.80 (+.57) Nearly 4%.
Roth Capital analyst XXXXX maintained a Buy rating on Alcobra with a $40 price target. The report comes in light of the recent pull-back that was driven by speculation of negative phase 3 data.
Chattopadhyay wrote, “Potentially flawed comparisons between metadoxine (which positively impacts cognitive function) with its structural analog pyridoxine (which has no impact on cognitive function) has been highlighted as a potential driver of phase 3 failure. Despite the negative sentiment on the phase 3 outcome, we expect MDX to deliver a clinically meaningful benefit in the ADHD-PI subgroup, but not the ADHD-C subgroup.”
According to XXXXXX, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Debjit Chattopadhyay has a total average return of -4.4% and a 21.1% success rate. Chattopadhyay has a -30.5% average return when recommending ADHD, and is ranked #3036 out of 3314 analysts.
"Alcobra ADHD management team is sitting on the results as RIGHT NOW and writing up the press release...probably tickling as right now." " the downside is now limited after SHORTS attacked ADHD to pushed it down -38%. With a positive data, SHORTS will be toasted & BBQ too!" " A key bullet point from research: essentially every drug within the ADHD market that has passed phase2 studies has went on to be APPROVED!" " and furthermore company has already stated 1 goal is to sell itself to a larger pharmaceutical company during an interview in 2013." Now Looking to the high side...
ADHD ....if results not out tomorrow morning, probably won't see them at least until Monday. Friday morning Yom Kippur begins for many . Company likely closed. October 3-4, 2014 - Yom Kippur being a National holiday in Israel and for many in America.
Waiting for close or news ... I was just thinking as little as 2 weeks ago, shorts only controlled 6-7% of the ADHD stock. Than they came out of the woodwork and now I would say 15-20% or more have it. I hate that the SEC let's investors bet against success, not just here but across the board. When you go to Vegas you always for the most part bet against the house, but that is sanctioned gambling. Is the market now just sanctioned gambling. No one want's a product to get to market, so it seems. Betting against anyone else's success seems to be the thing to do on Wall Street. We all have some greed, but what is going on now is just way beyond some greed. If you want any success now to beat the shorts you have to get in at IPO or lower, lower than they find their positions. I realize they are my friends and neighbors, but I still loath they way they celebrate someone else's loss. Many hold their position and never own it or have paid for it, supposedly they have to cover if called, but never hear much about that. I'm usually long and have mixed success, but I see more and more shorts entering the market as if it is the only way to bet. So now my contemplation is exiting the market all together and maybe that is what will happen after I close this position in ADHD .. Win or Lose. Okay, I'm done, killed a few minutes.
Looks like buyers may have dried up, only a few sellers here and their. We are in a ubiquitous place at the moment. It's hard to see positive after so much negative. Those that write the negative articles are always short positioned and garner lot's of attention, but they are often wrong, but most feed on fear and that is who they appeal too. If you follow and bow to your fear, you will lose for sure.
Back in @ $13.05 hope that is the bottom, it's the year new low. It's going to be a long and painful wait for news, seems every minute now get's longer and longer. I remain optimistic, although I just saw I did not but at bottom ... now $12.90
Interesting story, but I don't think ADHD is that. I might if they were located in the Bahamas or Belize, not sure punishment would be lenient in Israel for such scams, but who really knows. Anything is possible if you want it to be.