I have No clue whatsoever. Only thing came to mind was Funds Repositioning Options and stocks during the last hour of trading. Last Friday wasn't simply another Expiration Day but it fell into Double or Triple Witching Day. Thus you see some ridiculous amount of transactions happened not only in ACHN but others as well.
...And I don't Care either!LOL.
As far as SVR12 for the 12 Patients Arm, they will have to wait until EOT then another 4 to 6 six to collect Data which shall put the released date in late August or early September.
Enrollment and trial started in April 30 of 2014.
' Achillion is conducting a Phase 2, open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of ACH-3102 and sofosbuvir in treatment-naïve genotype 1 HCV-infected patients. The primary objective for the study is determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Twelve patients will be enrolled and receive eight weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily. The trial protocol also allows for the enrollment of additional HCV-infected patients who may be eligible to receive six weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily. Preliminary results from the eight-week treatment duration cohort are anticipated during the summer of 2014. This study is being conducted outside the United States.'
So the Preliminary of the 6-week Cohort ie SVR4 could be released any day now. There are two Arms 12 for 8-week duration and another 8 patients for 6 weeks.
Gilead is the 800 lbs Gorilla in the HepC Arena.
If you believe in Achillion, keep your Faith. Those who have conviction and tenacity investing and believing in their Company; those are the ones who Merit my Warmest Congrats......Idenix's Investors come to mind. Well done!
I looked closer to BMS pipeline; the PI they will use is their own Asunaprevir and the other NNUC could be their own BMS-791325.
It's all boil down to cost. But that's not the point for the time being. Emphasis again for developing companies is that without a Nucleotide Polymerase Inhibitor, you will be left out of the Race. Whether the price of ACHN will go up or down matter little to me as I am not selling. I could have made a little over 100% for my investment should I sold all last Friday morning at the High of 8.61 but I want to see the SVR4 this Summer for the 20 patients treated for 8 weeks with Solvaldi and 3102 but most importantly will be the POC results Monotherapy of 3422 this Fall.
We have Merck and Idenix to thank for they just put Achillion Pharma back to the Game couple with the FDA lifting the Hold of 1625. I have been in this stock for several years when a 52 week treating HCV infected patients was the Norm. I want to see the finish line even it will take me a couple more years.
I don't see the trial as a threat to Achillion but more of a value added to 3422. The article went on to say the trial will cost Bristol 28,000 for Solvadi alone. Out the the trio, one of them is Bristol's own NS5A Daclatasvir; the other 2 could be a PI and a mystery one which we will when they post on the clinicaltrials.gov. What would be the Final Tally to patients and Insurance companies?.
Ach-3422 , according to Achillion preclinical trial is as potent as solvadi and 7X more potent in GT3.
Frankly I really don't what would transpire down the road as the landscape in treating HepC infected population change so quickly. But for those who are in this Business, they know without a 'Nuc', they would be out of the Race.
This News will just make Achillion a lot more attractive with their own pipeline.
Again this is my speculation only. First is the relationship of current Management with Bristol former ties ( Dr. Milind Deshpande and Dr.David Apelian ) both have held Senior Management Position @ Bristol.
Friday June 20 -2014
A 4-week hep C cure? Bristol to test drugs with Gilead's Sovaldi
Reuters - In the race to find a faster cure for hepatitis C, Bristol-Myers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences Inc's blockbuster drug Sovaldi, hoping to cut treatment time to four weeks.
Bristol-Myers disclosed plans for the exploratory 30-patient trial testing its three-drug combination with Sovaldi in an interview with Reuters. Eric Hughes, the leader of Bristol's global hepatitis program, said the details were due to be posted on the clinicaltrials.gov website next week.
The new study, set to begin in late July, will test a trio of Bristol drugs with Sovaldi in previously untreated patients with the most common Genotype 1 form of the virus. It will involve two groups of 15 patients each - one getting four weeks of treatment and the other six.
If Bristol can demonstrate cure rates in excess of 90 percent in four weeks, it plans to conduct larger trials with a more diverse patient population.
Will Ach-3422 fits into Bristol aggressive game plan?
Uptick Ration was 1.77 suggests greater Buying Pressure.
Net Money Flow was +24.78 Millions.
And to say today was a Triple witching Day. Not bad at all in term of where the stock finished.
By the way the June 8 call buyer cashed out nicely yesterday and early this morning sucking in the 'Johnnies come late' again. Smart option traders have already book profit for an easy double in just a few hours. Like said yesterday, the ones buying the June 8 calls and held may as well gave their money to Charity!LOL.
I don't think if there is a buyout it would be Gilead. But Vertex or Bristol- Myers Squibb are more likely.
Mine of course!LOL. But if someone is to paid only 2.85 Billions for Achillion; it equates to 29+ dollars per share on 96.8 million shares outstanding.
Idenix stated they don't why Patients' response was so poor at higher Dose of Samatasvir.----Yet, it's good enough for Merck to go ahead with the Deal ------
It's also know by the Scientific Community that Samatasvir has Low Barrier Resistance to Y93H Mutattion. Again Merck doesn't care.
After reviewing Achillion's own Pipeline, a 22 dollars per share tag is still Cheap.
Please Take Note Adam G.
Quoting directly from Dr. Perlmutter head of Merck Research Laboratories:
" Dr. Perlmutter conceded that Idenix’s drug had not been tested for a long enough time to exclude safety risks but said the early data was reassuring. “We feel it’s worth the risk,” he said.
So 28-Day Toxicity studies in Animal Models is Good Enough. ( Mr.Adam G, are you listening? )
Samatasvir: Idenix NS5A . Let see how good the Interim Data in Trial Helix-I
HELIX-1 INTERIM DATA
The combination treatment regimen has been well-tolerated, and there have been no treatment-related serious adverse events in the clinical trial to date. The most frequently reported adverse events were fatigue, pruritus, anemia, nausea and insomnia.
Virologic response data from Part A of the HELIX-1 study are as follows:
Phase II HELIX-1 Combination Clinical Trial Samatasvir/Simeprevir Treatment Groups
50 mg/150 mg 100 mg/150 mg 150 mg/150 mg
n 20 21 22*
Rapid Virologic Response (RVR);
Measured after 4 weeks of treatment (LOQ) 20/20 (100%)
End Of Treatment Response (EOT);
Measured at end of 12-week treatment period (LOD) 18/20 (90%) ---100 mg/150mg ----
Sustained Virologic Response (SVR4);
Measured 4 weeks after end of treatment (LOD) 17/20 (85%)
* Three subjects prematurely discontinued treatment within the first 3 weeks (1 lost to follow-up, 2 non-compliance)
LOQ = limit of quantitation (
With the Hold lifted, Achillion now have more options to do with this first generation PI. Before the Hold, 560 patients have been treated with 1625 in combination with SOC. Two Phase IIs are completed. The Data from March 2014 @ the APASL in Brisbane Australia showed a 100% cure rate ( Results from the -007 trial ). The outstanding results encompassed the one patient infected with HepC-1b with all 6 baseline mutations. He has been cured and achieved 100% cure rate with no Viral Breakthrough.
What to do remains a good Dilemma for Achillion?. Advancing 1625 into Phase III with 3102 and 3422 while exploring 2684 a more potent, macrocyclic second generation PI which shows good potency for cirrhotic hepC infected patients. Put the puzzle all together and Jason Kolbert target is not far fetched. But do not tell Adam G and his minions for he will refute all Facts!LOL
Fall 2014 is when the results for the proof of concept trial of 3422. The reason it takes that long to publish is because Achillion is conducting single and ascending dose. They will start with 50 mg of 3422 and go for there while monitoring both the PD/PK Data.
20 patients infected with Hepc -1b enrolled and trial started in April for 8 weeks. By end of June Achillion should have Data available. If the results beat their expectation; I wouldn't be surprised they will publish SVR4 any day now. Go ahead Adam G. short some more!