Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I have been long PSDV for more than a year (before Iluvien´s approval) and to be honest, yesterday´s data was better than expected. with the p value showed, they could even expect for FDA approval of Medidur even without the second phase III. Nevertheless I have to say I sold at today´s high, because knowing this company, it is likely they don't hold their gains so for the moment it is better to trade it and wait for lower prices to get back in.
I think ACHN has a chance, validated after J&J deal. I remain long ACHN. Also you have to add the factor D platform with is a plus
------------------------
" Problem is, simeprevir isn't quite as potent, not effective on RAV's and isn't pangenotypic. "
-------------------------
I guess J&J knew this and still decided to do the deal with ACHN
PSDV up 40% pre market
Phase 3 study shows pSivida's Medidur effective in preventing recurrence of posterior uveitis; shares up 37% premarket
Top-line results from a 129-subject Phase 3 clinical trial assessing pSivida's (NASDAQ:PSDV) Medidur injectable insert for the treatment of chronic noninfectious posterior uveitis (PU) showed the product was highly effective in preventing recurrence of disease at six months in the intent-to-treat population.At month six, 18.4% of Medidur-treated eyes experienced a recurrence of PU compared to 78.6% of eyes treated with a sham injection (p<0.00000001). 23.0% of Medidur eyes showed an improvement in visual acuity of at least 15 letters from baseline compared to 4.9% for sham (p=0.011).In 65 subjects receiving systemic therapy, only 18.2% of the Medidur cohort were still on systemic treatment at month six compared to 52.4% in the control group (<0.01).27.6% of the Medidur group experienced an increase in intraocular pressure (IOP) above 21 mmHg for at least one observation versus 16.7% of the control group (normal range: 12 - 22 mmHg). Through the most recent follow-up, 3.4% of Medidur-treated eyes required an incision to reduce IOP compared to 2.4% of the eyes treated with control.Out of the 64 eyes with a natural lens at baseline, 9.5% of those treated with Medidur required cataract surgery compared to 4.8% for control.Assuming favorable results from a second Phase 3 study, the company expects to file a New Drug Application (NDA) with the FDA in H1 2017.Medidur is an injectable micro insert designed for the long-term treatment of posterior uveitis by providing sustained release flucinolone acetonide, a corticosteroid, for three years.Posterior uveitis is a chronic non-infectious inflammatory condition affecting the posterior segment of the eye, often involving the retina. It is the third leading cause of blindness in the U.S.Shares are up 37% premarket on robust volume.
The AL-335, ACH-3102 and Simeprevir triplet study results, will be released in Q1 2016.
CPRX: Both CP115 good data (yesterday) http://finance.yahoo.com/news/inplay-briefing-com-055139997.html#cprx
and today´s News on Firdapse NDA were expected (the Jacobus nonsense was IMO to bash the stock) and I thought the price would be after both positive news at least at $5, as It was last summer.
Looks like the stock at least has bottomed
ARRY is more than 33% premarket on news, good on them. I hold shares at low $4s. Surprisingly, the stock has been down so i was concerned the NEMO (melanoma) trial was a failure. This is great news. Now they have 2 studies for 2 indications and presumably positive too
But Acerta's new drug's label is limited in scope to Xalkori intolerant or nonresponding patients so even if they may see potential in other indications, I think that price is too high
Thanks, interesting. How does this affect other companies in the field such as TGTX?
At ASH, they presented 1303 Doublet and TGR1202 single agent
GILD has been lower and lower since last earnings ($111 before released news). i sold there and might consider to get back in if they go back to $90
Investors don't seem very happy with the deal. It was up pre market and now is red
RDUS: anyone investing or following Radius? They are presenting New data for RAD1901 (breast cancer). What is likehood of good data? market cap is priced for abaloparatide alone imo. If the breast cancer drug is promising it should merit a higher market cap
See their website, under investors relations. ASH Investor Event Slides Designed v14 6 Dec 15FINALwebcst_v2-2.pdf
I mean that not total cure was already known, hence should be priced in ( $200 to $80) and multiple myeloma data looks promising
my point is that reducing is not something new that was learned by today´s presentation. The ONLY real news is that they are doing a separate trial for a smaller subset.
What high expectations? By who? at this point? This was already expected. Who was expecting 1 shot equals all cured? some articles look they just want to confuse people.
Looks less enthusiastic than before.
Thanks. I think data looks promising. As it has been discussed, it is not serious and nobody should expect 1 shot= all cure. Anyway, at this point nobody is expecting that.
ZIOP: And why is down 13% ?
Cambridge, Mass. and Seoul, Korea – December 3, 2015 -- bluebird bio, Inc. (Nasdaq: BLUE) and ViroMed Co., Ltd. today announced that they have entered into an exclusive license agreement to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using ViroMed’s proprietary humanized antibody to an undisclosed cancer target for solid tumors.
Under the terms of the agreement, ViroMed will provide bluebird bio exclusive rights to its novel humanized antibody to the target, and bluebird bio will leverage its proprietary lentiviral gene therapy platform and CAR T capabilities to deve lop CAR T therapies against the target. Financial terms of the agreement include a $1 million upfront payment and subsequent milestone payments to ViroMed, which together could total over $48 million per licensed product if certain development and regulatory milestones are achieved. ViroMed is also eligible to receive tiered royalties on product sales. bluebird bio will conduct and fund clinical development as well as regulatory and commercial activities.
“Over the course of 2015, bluebird has continued to expand its immuno-oncology research and preclinical programs, building a broad pipeline of multiple targets in solid and hematologic malignancies. We are pleased to enter this agreement with ViroMed and add their novel target to our growing pipeline,” said Rob Ross. M.D., head of oncology, bluebird bio. “We believe that this target, combined with our lentiviral vector and manufacturing expertise, position us as a leader in delivering potentially transformative T cell-based immunotherapies to patients.”
“CAR T technology has been gaining worldwide attention in recent years as an innovative technology backed by highly promising results from recent clinical studies,” said Seung Shin Yu, Ph.D., director of new business planning, ViroMed. “bluebird bio owns critical technologies for the development of CAR T therapeutics as well as manufacturing capabilities and know-how for commercialization, making them an ideal partner for us. This agreement is a testament to ViroMed’s competitive edge in innovative gene therapy technologies like CAR T technology.”
BLUE new deal: License agreement with ViroMed for CAR-T.
Thanks. No doubt they are on the right track to succeed in new ways to treat diseases. Will follow closely at ASH
Not unexpected at all
" currently treated patients are receiving a different vector from what earlier patients received, so BLUE is already on at least its second iteration of LentiGlobin."
As per my previous message what I mean is that there is a continuous improvement and I don't see that as a negative thing but the normal in R&D
I don't see that as negative. It is common in R&D companies to improve their platform technologies. Obviously, the first iteration of LentiGlobin will not be the last.
Piper just reiterated their Overweight rating and $204 price target.
back in BLUE at $87.4 for ASH. I sold my whole position at $160 last summer
If there is nothing more to be done why J&J, the second bigest pharma worldwide, has entered this summer in a deal with ACHN to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir. ????
Congrats, Astellas buying $OCAT for $8.50 per share, that is a 90% premium to Monday’s close. I think many on this board hold this stock. Good pick
Thanks. For what I could see these past year, this seems one of the few stocks AF is possitive. Dont mean he is pumping it but I tend to think he always have a hide reason to speak on a particular stock.
Results from 55 response-evaluable patients showed treatment with AG-120 reduced the tumor metabolite 2HG in plasma and tumor tissue. Seven of 11 IDH1+ chondrosarcoma patients had stable disease, five for at least six months. One IDH1+ IHCC patient experienced a partial response while 11 had stable disease, five for at least six months. The partial responder also showed the effect for at least six months. 10 of 20 IDH1+ glioma patients showed stable disease, four for at least six months.
Is data so disappointing to justify the selloff (-12%) ? No position.
Thanks all for the dip explanations. I got very surprised with the reaction today. Although INCY is one of my biggest holdings, it is an old investment and I don't follow it very close.
INCY: Anyone has any news on why is down 10% ?
CNAT is up 9% today. so unpredictable stock
congrats. What took you to invest in CLLS in stead for example in JUNO? . I am currently holding JUNO since $37
Do you think they will raise money before early 2016 data?
Thanks, the strategy makes sense,phase 2B with lots of shots on goal. So i guess next catalyst is early 2016 data. I don't get why the apps is so depressed.
Should be passing $40s upon approval. GL
ACAD: Bear in mind that all bios are up today even in no news. In my portfolio I have NVAX up 14%, CEMP 10%, ENTA 13%, ZIOP 7%...on no news, so as ACAD had positive news, I would hold it. Now that they have priority review they could even get approval by March IMO. Disclose: I don't own ACAD. GL
yes, my CEMP add at $16 is also a 50%. I wish I added both ;)
Dew, congrats in your ENTA addition. I Wasn't quick enough and missed it. At least I got the CEMP dip. GL