I saw a Market Talk headline yesterday, but I did not know the source. Will they pay a 50% premium? It should not be sold below 150/shr.
I consider Kalydeco is a more secure drug than Sovaldi in the sense that Kalydeco opened up a new life to a lot of people and there are no other alternative to treat at the very basic level.
If you had sold shares at 60's, buy them before they go over 100. You can recover the loss in a year. You can also make money by selling put options for the future months. Put premiums are still quite high... to buy 1 Contract of Jan put at sp of 85 cost you around $570, but if you SELL the same put, you can collect 570 per Contract. If the VRTX share price ever goes below 85, then you have to buy them at 85 in January.
Verity, the Traffic trial yielded the absolute change of 3.6% for 600mg Lum within the group, and 4% relative to placebo. The Transport yielded a lower value of 2.6%. These compared with the Phase II 4+4 wk data of 3.4% within group and 6.7% relative to the placebo. All numbers quoted above were absolute ones. The Ph II data were noisy. As you stated, Ph II data of 661/Iva combo gave slightly better results. After 4 wks' of the 100mg 661 dosing, FEV1 changed by 4.8% absolute (9% relative) within group as well as relative to placebo.
The most important results from the Ph III data are not FEV1 changes, but the significant reduction in the frequency of pulmonary exacerbations that participants experienced, and the high number(90%) of participants in the rollover study.
Vertex is borrowing $300M at an interest rate of 7.2%. The purpose for this loan is said to be related to strengthening financial position:
[[ The credit agreement is intended to strengthen our financial position as we invest in our key development programs in cystic fibrosis and in research for future medicines, including potential collaborations to support priority programs. ]]
Vertex may need funds for supporting Phase 2 trials of reversing, and blocking AIDS using caspase-1 inhibitor, VX-765.
Agree 100%. Selection of a 2nd gen corrector and start of clinical trials of triple combo will be another sp moving events just as the FDA marketing approval of 508 homozygote treatment. An optimistic disclosure of the collaboration with Greene and co. for HIV treatment using VX-765 would be a lifting event also.
I think it was Q2 earnings call, not Q1, when Mueller mention gene therapy. In a year or two Vertex will have money to partner with, or acquire a promising CF drug companies.
In response to analyst's query into future drug research in the Q1 E CC, Peter Mueller mentioned that he is looking into gene therapy. He didn't specify what disease the gene therapy targeted at the time, but I suspected it was CF therapy by the context. A UK consortium is running a clinical trial since 2012. Bluemoon appeared to have succeeded in treating a rare disease using lentivirus recently, and Bayer also has committed to work with Dimension Th. for hemophilia A. I am certain that Vertex is intensely watching the development. As you suggested, Vertex learned an important lesson from Incivek debacle.
I liked the phase 2 result of their JAK1 inhibitor for RA. They still have not started phase 3. I would think that even if their potentiator is effective and safe it won't be out for at least 3 years and their corrector for 6 years. Their potentiator has to compete against the VX-661+Kalydeco combo for 551/508 heterozygotes.
Geoffrey Porges also changed his mind.
Vertex Pharm tgt raised to $107 from $65 at Bernstein
Vertex Pharm tgt raised to $115 from $93 at UBS; Buy
Vertex Pharm target raised to $125 from $100 at Leerink Partners; Outperform
Needham raises their VRTX tgt to $115 from $95 given favorable outcome and
substantial commercial opportunity. Co announced positive results today from
two Phase 3 trials of ivacaftor/ lumacaftor (TRAFFIC/TRANSPORT) in Cystic
Fibrosis patients with two copies of the F508del mutation. Both trials met the
primary endpoint as well as key secondary endpoints. A trend toward
improvement with respect to a quality of life metric was also observed.
Although impact on lung function was moderate, overall data suggest a
clinically meaningful and commercially viable drug regimen; maintain Buy.
Vertex Pharm: Hearing Tier 1 firm raising tgt to $130 from $100 following data
Maxim Group raises their VRTX tgt to $107 from $92; their valuation is driven
by the potential of a Kalydeco/corrector combination expanding the franchise
in CF. As they further understand the totality of the Vertex data we will
review their market size calculations which may show our valuation is
The same person (most likely) posted the following blog on May 30 two weeks after the one you posted appeared. In both blogs she wrote without using punctuation marks.
[[ Judy Law My daughter took part in this study in england it was double blinded for 6 months but now she is taking the active drug [there has to be a "period" here (my comment)] when she started in september she just managed to get on the trial with a lung function of 40% [another period is missing here] to cut a long story short we dont know any results from the trial but we do from the clinic visits weight is up to 56kg sats stable at 96_98 and her lung function at last visit was a whooping 59 % x x ]]
It is possible this person manufactured this story to encourage other CF persons, but it is likely that she has a valid story to tell because the blogs appeared in QUEST for KALYDECO.
Don't get confused about individual's data with group averages. In the 661 Ph 2 trial, one 508 patient who is receiving a placebo had an increase of 26% for FEV1. Does it mean that the patient is faking! All are 508 homozygous patients, but the dispersion is huge.
Getrich, the story quoted by Gladpick from Facebook sounds so real and internally consistent that it is very unlikely a fabrication. The daughter started the trial in September last year and finished the trial in March, then put on the extension study.
The rollover study is also supposed to be a double-blinded trial, but some participants are finding out good enhancement for FEV1 and weight gains. Getrich, do you have anecdotal stories to tell?
Verity, it is very difficult to understand his argument of molecular stability when the 508 CFTR is in a cell culture system. Any thing can happen in cultured cells.
How can he believe in such results while he does not believe in Cohort 2 and Cohort 3 results of Phase 2.
Only thing I am concerned is drug fatigue for a long term dosing. But there is no basis for that to occur.
Good luck to you and to all longs.
Verity, you exactly pointed out the very weak point of Porges' pseudo-science. They believe in molecular stability argument but do not believe in in vitro biology of Van Goor. Biology is a better predictor of clinical outcome than molecular argument is.
[[ Underscoring the bullish sentiment in Vertex's favor, Cowen's Eric Schmidt noted his bet that the drug will likely succeed. Schmidt wrote: "The imminent release of results from VX-809's Ph. III trials has the potential to be one of the biggest binary events in biotech during 2014. We think that there is a 60% chance the trials succeed, and a 40% chance they fail (or have mixed results). We expect VRTX's stock to go to $100+ on success, but $40 on failure. We continue to think that VRTX is fairly valued, and remain at Market Perform."]]
Eric Schmidt is a MIT PhD who studied at the Paul Schimmel's lab.
Geoffrey Porges holds a Harvard Business School MBA.
Glad, thank you for posting this. The mother's blog is entirely believable. Presumably, the lung function she was referring to was FEV1, and it changed from the prior 38% to 59% at the first several weeks of open-labeled rollover study, whether or not the daughter had received the real drug or not during the double-blinded trial. This is an absolute change of 21% and a relative change of 21/38 = 55%. Astounding. Some placebo effect might be superposed, but it cannot be all placebo effect because it is too large for placebo effect.