It appears momentum is developing in KPTI based on the realization that multiple ph2 studies in a wide variety of CA have been started. Don't think they have found a type of cancer yet where Selinexor hasn't at least led to stable disease, with objective tumor regression in several other ph1 studies. With such a broad range of oncologic response, this could be a MAJOR advance
Sentiment: Strong Buy
1.Impressive phase 1 data in advanced prostate cancer and phase 2 for this indication has commenced.
2. FDA has granted orphan drug status for diffuse large B cell lymphoma based on very promising phase 1 data in this malignancy
3.Impressive phase 1 data for colorectal cancer as well, with imminent start of phase 2 for this cancer
And the list goes on. Be careful shorting this stock with excellent science and the potential to be effective for MANY different types of cancer
As a hematologist with 40 years experience, I am very impressed with the results of sel/dex in very advanced cases, and with a low side effect profile. Larger studies are obviously needed, but this is a powerful signal for effectiveness of the drug in myeloma.
the correction I intended is market cap of bio. Also, Board of Directors of CYTR includes former chairman of Sandoz, a Nobel prize winner in med., and a co-founder of Amgen.
I have 40 years experience in the field, and also do biotech investing as an avocation. I bought in after the release of the of the ph 2b data when the price immediately popped 6.. While I certainly do not condone some of what happened with the company's PR , it does seem to me that CYTR was under attack by AF and many on this Board in late 2013; there has been much written on this Board that AF works for the shorts. I had an email exchange with David Hearn of CYTR on 12/16 asking him about the criticisms, I liked his response, and have continued buying. The long term price of the stock will be determined by the science. The mechanism of action of Aldox is very appealing and the available data on the drug so far is very supportive. The drug has orphan drug status, and the ph3 study is being conducted under a SPA, which is very favorable. Furthermore, the FDA is allowing unlimited use of Aldox until cancer progression; this is a huge plus since the major toxicity of anthracyline chemotherapy is dose related cardiotoxicity. . I took advantage of the recent sell off( short attack-Mr. Pearson was short when he released the SA article) to buy more CYTR. Aldox has the potential to be a blockbuster and you can buy the company when it has a market cap of 1bil with a drug only in ph1.
SGMO up 20% this morning based on success of genomic program in HIV. SGPG has exclusive partnership to utilize SGMO's gene Rx in hemophilia, etc. Looking like a wise partnership move by Shire
stands at 10.9 according to Yahoo, down from 13..5. That is 10.9 days of average daily volume to cover. Do the shorts really want to take a chance that the BPH and cancer studies will have positive results? I doubt it. The pop with positive results will be huge. I see short covering as a positive going forward.
Although there is skepticism toward the company management, particularly its secretive approach to providing information,ClinicalTrials.gov indicates a conclusion date for both phase 3 trials as April 2014. So it is likely we will have the verdict in 2Q2014.
A Google search indicates that many urologists involved in the trials( who are not paid consultants for the company) have publicly praised the ease of use and efficacy of NX-1207. The drug only has to do significantly better then the saline placebo in the phase3 studies, which seems highly likely. The independent safety review board has already cleared the drug. Hence, I see a high likelihood of FDA approval. Urology colleagues tell me there is a strong need for a simple, office based procedure for BPH, which afflicts 40% of men over 50. The procedure will almost certainly be a money maker for urologists, and there is a huge reservoir of symptomatic men who are afraid of surgery but would be eager for a simple office procedure, so a rapid ramp-up is very likely. Add on the possibility of an effective Rx for low grade prostate cancer, and I think you have a compelling risk reward scenario.
Sentiment: Strong Buy
The phase 2 studies on nx-1207 are favorable, and the comments of several urologists are also quite favorable. The drug is being compared to a placebo, which sets a low bar. I remain optimistic that the drug will prove quite superior to the placebo injection. The safety studies have also uniformly been favorable. I am optimistic for an easy FDA approval
Iam a hematologist and attended an American society of hemaology review session provided by the Dana-Farber Cancer Institute physicians. They were quite optimistic about this unique drug. A positivee ph3 study and rapid uptake by the hematology community seemshighly likely
Sentiment: Strong Buy
I am a hematologist and attended a review course sponsored by Dana Farber Cancer institute this past Saturday. Jakafi(Incyte) has become a huge success for treating myelofibrosis; however, it exacerbates the low platelet count which frequently accompanies myelofibrosis. The studies to date suggest that Pacritinib is equally efficacious WITHOUT causing a reduction in platelets. I see great potential for pacritinib to displace Jakafi. Jakafi has propelled INCY to a market cap of 5 billion!
In multiple phase2 studies, CPX-351, an emulsified preparation of daunorubicin and cytosine arabinoside in a 5:1 fixed molar concentration, has shown superiority over conventional daunorubicin and cytosine arabinoside(3 + 7) in the Rx of adults with AML. This superiority is even more pronounced in patients with secondary AML(AML following chemotherapy for solid malignancies, AML evolving out of myelodysplastic syndrome). Hence, for its ph3 FDA study, the company wisely selected the more limited indication of secondary AML; the chances of success in secondary AML based on prior experience seems excellent. Assuming success with ph3, the company will have a long time window under its orphan drug status to get the drug approved for conventional AML. Studies are also underway in pediatric AML and adult myelodysplastic syndrome. A potential big market for a company with a tiny market cap.