Forward going earning is expected to be $7.50 EPS i.e PPS $133/ share. De-risked stock. Great stock for day traders and short play for the next 10 day. I am hoping stock will shot up above $140 after Dr. Michael Boyle presentation on Oct 9 th in the NACFC.
I think it is a justified and a very welcome price to get a break from CF. I don't know why Street think drug should be around 150 K? If Ivacaftor is North of 294 K, combination can't be lower than that. It will be unfair to G551 D patient to pay a higher price because they have rare mutation. If combo is less than 294 K, VRTX will have to bring Ivacaftor price down to match, which I doubt going to happen.
Drug companies and their investors deserve rewards because when risk and losses happen, they are the losers and no one else shares the losses like insurance companies, clients or medicare? Look at Incivek and Telazar cases?
General rule of thumb is if you prevent CF exacerbation, FEV-1 gain/preservation in 1 year is 5%. So if Combo prevent 40% exacerbation ( and I know this number game is tricky) in first 6 months, by logic there should be some improvement and stability in the FEV-1, while drug is targeting another front i.e CF modulation via ND-1 and other associated pathways.
Presentation is between 4 pm-6 pm ET. Friday 10/10/2014 will be an interesting trading day. I am hoping to see continued improvement in absolute FEV1 to greater than 5% in the follow up studies.
I thought I separated compound 31 and stem cell research in a separate paragraph. Stem cell research is a big plus for VRTX in my opinion.
HPS alpha/beta selective inhibitor has been identified and published as a drug target for Huntington disease and VRTX has "compound 31"in works that crosses the blood brain barrier and decreases Htt level in brain. Data in mouse published in Nature chemistry magazine 4/2014. J L said Huntington disease was VRTX next target after CF and VRTX was not interested in spending $$ on VX 509 in Jan 2014.
It amazes me to see a small molecule developer like VRTX has so much future investments and moves in Stem cell therapies when all the initial stem cell companies failed to bring any product to the market.
Pancreatic cancer cell line data is superior to any other drug combo I have known. Have you ever seen 106 patients in phase 1 trial? It shows their confidence on this therapy. They have been running trial under the radar since 09/2012 in England and have very positive reviews. I smile when people talk about CF franchise. and reimbursement. Do people have any idea about the history of CF and drugs that have failed CF treatment. Remember CF gene therapy flu virus vector failure?
If you ask me I would say VRTX should buy out " calimmune", privately held biotech that is working on modifying stems cells of a patient to hunt down HIV virus, even in hidden places like spleen to get AIDS cured. President Obama has signed a new grand in Dec 2013 and VRTX can easily tap into it for the drug development.
VX 970 is a super star. Check out pancreatic cancer and NSCL cancer data. Drug selectively kills cancer cells without touching normal cells when given with cisplatin, etoposide and gemcitabine. Results beat all drugs including Avastin. July 3, 2014 has pub med article regarding NSCL cancer.
Problem with these studies has been identified. VX 770 doses used in these lab experiments are way higher than what are used in human trial. Most of the drugs work well in lab but they fail in human trial and I am glad that something fails in lab but working in real life. The investigator in one study has conflict of interest and he has work on a drug similar to VX 770 and he believes the other drug will work better in combo.
I am extremely upbeat on VX 970. I think they are working on West nile and yellow fever virus as well. They has some research on PKC theta for autoimmune disease which selects the blockade of T cell function so that viral immunity is intact i.e JC virus issues with drugs like Tysabri and Rituxan etc.
Van Vollenhoven group presented the data in Annual European Congress of Rheumatology and ACR 20 of 61-62% with various doses, Moderator of the conference at the conclusion did talk positively about this drug's phase II B trial with Methotrexate. This event on 06/14/2014 is now published and available in Medscape. I think VX 809 data was so important that VX 509 became non event full. With Hep C program gone, I think VRTX may will move forward with phase III. VX 509 now has a name " Decernotinib" and also a web site IP has been reserved for it and this makes me think that work is in progress.
I also have done some back ground work on VX 970 and it seems like VRTX has been working on ATR kinase inhibitors for a while and they have portfolio of molecules,
Good luck to all longs.
Nothing on my radar yet for 765 but I don't expect so soon. There is another Oncology drug VXc 984 in development. I hope VX 509 moves into phase III trial sooner then later. It is a real deal in my opinion.
VX 970 is VRTX new first in class oncology compound already in clinical trial in Europe since 09/2013 and now started phase 1 in North America. This drug enhances the effect of already existing chemotherapy drugs like Gemcitabine, Cisplatin and Etoposide and thus is added to already approved chemotherapy regimen. If proven safe and effective, could be a good asset in coming years as it will cover major cancer indications. My understanding is that this is NOT an immune modulator agent and is given as an IV Infusion.
PTCT is conducting phase III trial of their Ataluren drug for non sense mutation in CF. Sub set analysis shows that patient without inhaled aminoglycoside did better in their previous phase III trial and now they are conducting a new phase III with exclusion of inhaled aminoglycoside patients. Their numbers are weak, no matter how you see the previous trial and relative FEV-1 is only 5% at best.
I think VRTX need to be proactive and should ring PTCT door bell and offer to combine these drugs for non sense mution and see if they have better luck. I will say combine both drugs even for muscle dystrophy patient s and you never know if they will do better.
PCD or immotile cilia syndrome is another genetic disease and lung manifestations are exactly like CF. In fact my major worry about VX 809 and VX 770 trial was that a significant CF patients has PCD as well. Trial turn out to be okay and I think VRTX should take a shot at this indication with VX 770 and VX 809 and if by good luck we show benefit, you are looking to add another 25000 plus patients in USA only. PCD has a foundation and it is an orphan disease and fits with Dr. Jeff Leiden criterion. I wish my post can be forwarded to VRTX chief scientist.
It will be nice to have input from VRTX leadership regarding AIDS and VX 765 potential. They should give us pipe line update especially about VX 509. I have not heard about MRI and synovial joint biopsy trial results nor I have seen any publications? Look at SLXP, how they have grown from a 1 B company to a 9 billion company. I have posted couple of years ago that I wish VRTX acquires SLXP and sells Incivek through their gastroenterology sales team. Just having revenues from CF is repeating mistake of the past i.e Hep C.