Ra Capital Healthcare Fund, L.P reported ownership of 18,125,115 shares (18.7%).
Ra Capital Management , LLC reported ownership of 23,366,007 shares (24.2%).
Schedule 13D. Reporting person Peter Kolchinsky.
Added together representing 42.9% ownership in Achillion's stock.
Buy and Hold for better things to come.
SanDisk has another 10 points to go for its Fair Value. You want to see GS pumping Machine; look no further than TSLA. How TSLA attains this valuation is beyond comprehension!LOL.
The Company expects an answer from the FDA in the second quarter of 2014. They have put together scientific documents on Sovaprevir to be submitted this Q. If the FDA wants to expedite and makes a final decision on the Hold; we would see another Trading Halted soon enough.
By the FDA could be Lifted in 2Q 2014. Reasons:
Phase 2 trials dubbed -007 produced impressive results as per press released @ the APASL 2014.
Furthermore, other protease inhibitors for HCV have also had issues with HIV protease inhibitors, and this has not prevented them from securing FDA approval in the past: Merck's (MRK) Victrelis and Johnson & Johnson's (JNJ) simeprevir both demonstrated similar interactions.( when used with Reyataz aka Atazanavir ).
Reyataz has a fairly extensive list of drug drug interactions.( See Reyataz black box warnings from its maker ).
Seven other DDI studies with sovaprevir have shown no safety issues.
With the 78% drop in pps due to the FDA not warranted a Lift on the Hold when Achillion Submitted additional data last September; if Sovaprevir gets the lift this time, I don't expect the 'Thieves' would give back everything they stole from the Company but it will pave the way and give Achillion another 'prong' in developing a Cure for HCV population.
Even with the one subject who carries all 6 mutations at baseline; Ach_3102 is able to suppress viral rebound typical associated with first generation NS5A. Impressive indeed when the trial supposed to enroll GT1b naive subjects. The one who exhibited a panel of replicons carrying mutations at loci 28, 30, 31, 58, and 93 of NS5A, Ach_3102 is able to suppress Viral Replication for the duration of 12 weeks treatment.
Buy and Hold.
If Vertex wants to get back to the HepC race, they will need to open up their wallet. Last HepC compound VX-135 which they acquired from Alios was but on Hold by the FDA. If I remembered correctly, Vertex paid 25 millions to Alios for the right to develop the compound.
On another note, I tried to respond to 'inspctr_columbo' but the post didn't stick( Yahoo and its whimsical Mood again ). It was my wishful thinking Interim data for the combo testing with Solvadi could make it in time for the 2014 EASL meeting. The deadline for submitting abstracts or posters was in late February 2014.
Nonetheless the results presented are impressive. These are Data from SVR12, No Viral breakthrough for treatment duration even for subjects who had the Y93H mutation at Baseline. These Data could be submitted to the FDA and just maybe the Hold on Sovaprevir can be lifted this time.
Maybe the Data could be used to convince the FDA to remove the Hold on Sovaprevir......always a possibility.
Achillion needs to start at its earnest the Pilot Trial combining Gilead's Solvadi with Ach_3102 so enough Interim data can be collected in time for a poster/oral presentation for the upcoming 2014 EASL in London, April 9th through the 13th.
Absolutely agreed with stv. Retails panic and sold AH. The shelf registration is by no mean an immediate shares offering. Achillion will wait until they have some concrete and upbeat data then might do a direct offering like they did last year with QVT. The 159 millions cash on hand will carry the company through 2014 and beyond.
Buy on dip.
Yes I mean 3422 IND.
As far as my confidence with 3102, I suggest reading all published scientific literature regarding that compound ie the PK/PD Data and its multiples trials the company has done so far.
Give this stock another 6 months or so when we will hear some interim Data. I am counting on FDA acceptance for 3422 and most of all, the synergy between Gilead's Sovaldi with Ach-3102. A cure rate in the 95+ percentile would see us a much needed upswing. Hedge Funds are still accumulating so the pps goes nowhere....for now!
to accumulate more. Anyway I believe 4Q and year end for 2013 would be released sometime next week around the 13th/14th of March as I see other Biotechs recent announcements.
" James Hui from Achillion Pharmaceuticals and colleagues found no clinically significant pharmacokinetic interactions between ACH-3102 and sovaprevir in healthy HCV negative volunteers, paving the way for combined use in interferon-free regimens.
In a prior Phase 1b study, sovaprevir monotherapy demonstrated robust antiviral activity against both genotype 1a and 1b HCV, including virus with pre-existing resistance mutations. A Phase 2a study showed that adding sovaprevir to pegylated interferon/ribavirin improved virological response."
" Eric Lawitz from Alamo Medical Research and colleagues reported that another second-generation protease inhibitor candidate, ACH-2684, showed potent viral suppression of genotype 1 HCV in patients with and without liver cirrhosis. At tested doses of 100 mg once-daily, 400 mg once-daily, and 400 mg twice-daily, ACH-2684 monotherapy demonstrated mean maximum HCV RNA reductions ranging from 3.36 to 4.16 log. Again, the drug appeared safe and well-tolerated in both cirrhotic and non-cirrhotic patients, with no serious adverse events or discontinuations due to safety concerns."
Fine with me when Achillion is completely ignored. The possibility and probability of the resurgence of this stock are good in my opinion. Again emphasis is on Ach-3102 and its synergy with other inhibitors:
" Andrew Muir from Duke Clinical Research Institute and colleagues reported findings from a Phase 1b trial of ACH-3102 in non-cirrhotic patient with hard-to-treat HCV genotype 1a. A total of 14 treatment-naive participants received a single dose of 50, 150, or 300 mg ACH-3102 or placebo. A majority had baseline NS5A resistance mutations in a genotypic analysis. Pharmacokinetic, viral load, and safety data were collected for 35 days.
Viral load reductions ranged from 3.52 to 3.93 log. Following these promising results, a lower 25 mg dose versus placebo was tested in 9 additional patients, yielding a reduction of 4.04 log. HCV RNA declined rapidly and remained below baseline levels until 15 days post-dosing. ACH-3102 was well-tolerated at all doses, with no serious adverse events or discontinuations due to safety concerns.
"These data provide evidence that ACH-3102 is a safe and well-tolerated second-generation NS5A inhibitor with potent anti-viral activity against both wild-type HCV virus and NS5A-resistant viral variants, making it a promising candidate for future use in the treatment of chronic HCV infection," the researchers concluded."
If Folks listened to the Cowen Presentation; the ceo has stated the company ended the year with a little over 150 millions and gave a concise overview on several milestones for 2014 and its pipeline. One can detect the upbeat sentiment regarding Ach-3102 and its synergy with other compounds in development. So up to this point, one can expect an 8k filing any day now. To me it's a non event.
Very good buy in the 2s when shorts are pilling in after the FDA refused to lift Hold on 1625. Institutions were also bailing and took Losses. My Holding still shows a Huge paper Loss. Need 4 bucks to break even. Nowadays Focus is on Gilead's Sovaldi 's sale, Abbvie next in line to file for FDA approval on their 5 pills combo. Bristol Myers are also in the hunt as of late promoting their NS5A with other PI and Non Nuc for the treatment Of HCV infected patients. Patience and a strong stomach to hold on to ACHN are a must!