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Thanks, no doubt of potential big acquisition by GILD this year.
If we are talking of a really big one, in the list are INCY and even BMY. any other thoughts?
I tend to think is going to be an oncology company in any case.
Thanks. BTW sold half of my ESPR yesterday at $20.05 from $13s. Second time I trade this stock with profits. I will buy back that half if goes down again. Still think is possible a BO for this asset. Only oral non statin
I meant at what price was AQB trading first day, to know what was the price the XON holders got them. So for example if they want to sell them today, are they up or down. Someone told me AQB shares to XON holders were given at $10 other tell me $16.
At what price were given the AQB shares to XON holders when the spin out happened? Thanks
is anyone on statins using Crestor (Rosuvastatin). my both parents take them (10mg) as they don't increase liver enzymes. Does this one have the Potential CNS adverse events mentioned in some statins?
BMY
• A Phase 2 clinical trial, EffiKIR, assessing Bristol-Myers Squibb's (NYSE:BMY) lirilumab as monotherapy for the maintenance treatment of elderly patients with acute myeloid leukemia (AML) in its first complete remission failed to achieve its primary endpoint of leukemia-free survival (LFS).
• There were no significant differences in LFS or any other efficacy endpoints in either arm of the study between the test groups and placebo. One treatment arm, 1 mg/kg once per month, was discontinued in March 2015 based on the recommendation from the Data Safety Monitoring Board (DSMD). The data analysis in ongoing. Complete results will be presented at a future medical conference.
• Bristol is investigating lirilumab in six studies in a range of solid tumors and blood cancers.
• Lirilumab is a fully human monoclonal antibody that is designed to help the immune system attack tumors by acting as a checkpoint inhibitor by blocking the interaction between inhibitory receptors called KIR2DL-1, -2 and -3 and their ligands.
• Bristol-Myers licensed lirilumab from Innate Pharma (OTCPK:IPHYF) in 2014.
• BMY is up a fraction premarket.
Not sure. Still too early IMO. Not in yet.
at least NVAX had good data in Phase II for their RSV vaccine. this one is much worse.
AUPH: Regardless of AE rates and whatever explanation they give, I feel uncomfortable with such an imbalance, so I have decided to stay away of the stock and look at other opportunities. Good luck to the longs and thank you all for your input and thoughts.
As per Adam F article, he spoke recently with AUPH CEO and accepted the explanation of deaths in less developed countries. Are you still reluctant after explanation CEO gives to Adam F?
Also, Steve Goldman author of SA article talked to COO Jan 24 and was told there were no more deaths at 48 wk. Have you read that article?
really? what is the purpose to have this amount of retweets and who was behind it? ...really odd
Agree. Mi sense is they announced the CRO, showing they are ready for a phase 3, showing confidence in the fact that the phase 2b is going to be positive...and to give a push to the share price.News showed The FDA has already agreed to a single arm Phase 3 trial and both the primary and secondary end points set out in the Phase 3 trial are favorable.
In my view, in light of the Phase 2B results to date as well as the very favorable FDA phase 3 trial design and endpoints, voclosporin has become substantially more de-risked. The recent run up of the stock is also because they released the interim results and the recent CEO stock purchase, CEO and Director, acquired 99,566 Common Shares on a direct ownership basis at prices ranging from US$2.133 to US$2.148 between January 3rd and 4th, 2017. The insider also acquired 434 Common Shares on a direct ownership basis at a price of $2.148 on January 5th, 2017. This represents a $285,652 investment into the company's shares and an account share holdings change of 42.6%.
well, I guess WS is expecting no more deaths and a BO to possibly Japanese company such as Astellas in the future. Although they just released they have pointed the CRO to conduct the Phase III, it is very unlikely they will conduct all the trials as they have no money to do so. That is why don't get the PR last week announcing the CRO. By contrary, if the data to be released shows any concern regarding safety, it will fall much down. The CMO said on 20th of january that there were no more deaths reported. Given the lack of transparency you mention, it is difficult to place a bet in such a binary event.
OK, thanks. I didn't follow AUPH but came across recently to a bullish article from AdamF. Also they might probably release the 48 week data at a conference so was thinking the odds of positive data would be good. I will avoid it for the moment as I don't like much to play binaries. As you think their possibility of approval is null, are you forecasting the 48 week data release next month will be disappointing?
thanks
Are you Long AUPH? Do you think is Possible that AUPH has the 48 wk results by Feb 16 at Leerink Conference? Are you optimistic of the results they would release? Thanks
Very much expected news, but still important and Action trading 20% on news this morning. The shares have rise 12.57% since it confirmed exclusive talks with J&J on Dec. 21 but are more than 50% higher since takeover speculation first surfaced in late November.
Interesting they are spinning out the R&D, very "creative"
SGYP, yes, this is one of the analyst notes:
Canaccord Genuity analyst John Newman weighed in on Synergy Pharmaceuticals (NASDAQ: SGYP) saying they are skeptical on efficacy, diarrhea for 72 mcg Linzess.
Newman commented, "We are skeptical that the 72 mcg dose of Linzess will show less diarrhea without sacrificing efficacy vs. the approved 145 mcg dose in CIC, based on earlier Phase 2b data for a 75 mcg dose. We also believe that SGYP's Trulance will still have a much lower rate of diarrhea, appealing strongly to doctors and patients. We expect 72 mcg results for Linzess upon potential supplemental FDA approval in early 2017. Interestingly, Phase 3 data for the 72 mcg Linzess dose have been available since October 2015, but have never been presented, making us question the data quality. Importantly, the 72 mcg and 145 mcg doses did show a statistically significant improvement vs. placebo for Complete Spontaneous Bowel Movements (CSBM), and diarrhea was lower in the 72 mcg vs. 145 mcg dose, but details have never been disclosed."
The firm maintained a Buy rating and price target of $13.
TGTX link to the Landenburg report:
https://ladenburg.bluematrix.com/sellside/EmailDocViewer?encrypt=ae4ecb9f-7bf3-4b1d-a5c5-29723dcdc992&mime=pdf&co=Ladenburg&id=DHeuring
Have you read the Landenburg report, they have a Bull thesis and PT $28
Ladenburg on $TGTX GENUINE Study: has a high probability of success, given the 95% ORR observed in the Phase 2 TG-1101 +Ibrutinib study.
MYOV. Anyone in this one or following the stock? any feedback/comments are appreciated. thanks.
Their main compound, Relugolix is an oral, once-daily, gonadotropin-releasing hormone (GnRH) receptor antagonist. By inhibiting GnRH receptors in the anterior pituitary gland, relugolix rapidly reduces the circulating gonadotropins luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to the suppression of estrogen in women and testosterone in men. Suppression of these hormones improves the symptoms of uterine fibroids and endometriosis in women and decreases prostate-specific antigen (PSA) levels in men with advanced prostate cancer.
In a double-blind, placebo-controlled Phase 2 clinical trial in 216 patients with uterine fibroids, women who received relugolix experienced a statistically significant reduction in menorrhagia, or heavy menstrual bleeding. In a double-blind, placebo-controlled Phase 2 clinical trial in 487 patients with endometriosis, women who received relugolix experienced statistically significant reductions in non-menstrual and menstrual pelvic pain. In two randomized Phase 2 studies in approximately 228 men with advanced prostate cancer, oral once-daily relugolix suppressed serum testosterone to castrate levels and decreased PSA. Across all phase 2 studies, relugolix was generally well-tolerated and its safety profile was consistent with its mechanism of action. Takeda is currently conducting two Phase 3 studies in women with uterine fibroids in Japan.
Unlike GnRH agonists, relugolix does not cause transient increases in gonadotropin secretion (flare), which can result in an initial worsening of clinical symptoms. Moreover, upon treatment discontinuation, its effects diminish quickly and hormone levels rapidly return to baseline. We believe relugolix, when co-administered with low-dose estrogen and progesterone add-back therapy, will preserve bone mineral density in women and increase tolerability.
SGYP. the approval is pretty clean IMO, I don't see the "label concern". The stock went down on approval when market closed, as it a very manipulated stock, so shorts are allowed to cover. It is now +9% on pre market. The SP should be pushed up on BO rumors. wait also for analysts new PT to hit up the price...these guys just said they want to put the drug on mkt very quickly so they need to partner.
TGTX: Agree with you Rockrat. good chance that this happens.
yes, the SPA was lost and thought it will be reinstated but did not happen. I also expected ASH presentations to be a catalyst but didn't. There are chances that Genuine trial is a failure...
thanks. EOM
TGTX; ROckRat, my understanding is KOLs like the drug. But the stock trading action is not good. If bear case is a possibility, would you consider to sell before P3 results are out?
Thanks. I am also reluctant to add too. I have also concerns with management. I don't trust them at this point. Don't trust either the analysts with High PTs on this one, ignoring the issues reused lately.
TGTX is almost at 52 week lows. On the other side Ladenburg just gave a $28 PT
Looks odd when sell analysts give high PTs and the stock goes down...Although they give a good summary, they don't spend a word trying to explain the price declive. It is also odd TGTX released positive news recently and after every spike, the stock gets sold again and new lows. dot know if it is because of the ATM financing they have in place.
A spate of class-action litigations has been filed against $TGTX in the last few days. Although Clinically and scientifically the pipeline looks good, what is the explanation for the price decline? what are issues surrounding the company?
Next catalysts are (1) The genuine phase 3 combo trial results will be out in H1 (2) Asco presentations June 2-9.
Any thoughts on TGTX lately?
thanks
IMO if you want to hedge your bio portfolio, I would buy BIS for say 25% of your total bio investment portfolio, in stead of LABD which is less liquid and with more abrupt movements. LABD is IMO a vehicle more useful for daily traders.
it is good idea to keep in portfolio companies with short term catalysts as you said. In that direction I bought RGLS for short term hoping for a hold lift in 1-2 months time. I keep also other long term positions with potential to grow in the long term and super long term I never sell such as INCY. Good luck. L.
How can you ask pharma to manufacture in USA (in stead of India, México...) and at the same time ask for lower drug prices?
INCY, I remember around a year ago, when INCY was at $130. I still hold all my shares for many years ago. Merck collaboration extension looks good. INCY around 10% up today and possibly on its way back to that $130...
Following both EDIT and NTLA as I am interested in CRISPR for a long term position. looking still from the sidelines as both are too expensive considering all in preclinical but might buy at the right price.
CEMP. With this 2 CRLs and asking for a 9K patient safety study in CABP patients, FDA has put things very difficult for soli approval IMO. I believe future relies on what Europe will do and also what are the probability of Gono indication approval. What are the real chances of Soli to be approved in Europe? will EMA follow FDA or will approve with restrictions (bear in mind Ketek is used in Europe in several indications). Also what are the possibilities of Soli to be approved for Gono given it is only one dose and safety issues are mitigated for this indication? These are the 2 key factors for CEMP IMO.
If Soli is approved n Europe and Japan and if gone indication is successful, there is hope, if not...
Any comments? thanks
Nice version. Love it too. Merry Christmas to you and all the posters and bio investors of this site.
L.??
CNAT. Agree with your analysis on the deal. I haven't sold after the big spike on news. holding long since 2 years ago. Good luck
CNAT: Nice! Definitely my 2 investments this year in NASH (TBRA and CNAT) were a great idea!
BLUE offering: And CELG is buying a big stake of the offering:
Celgene Corporation, our strategic collaboration partner, has indicated an interest in purchasing approximately $50 million of shares of our common stock in this offering at the public offering price and on the same terms as the other purchasers in this offering.
bluebird bio (NASDAQ:BLUE) prices a 3.3M share offering at $76/share.
• The offering was upsized to $250M from a previously disclosed $200M.
• Goldman Sachs, BofA Merrill Lynch and Cowen & Co. are joint book-running managers of the offering. Wells Fargo Securities and Wedbush PacGrow are co-managers.
• BLUE closed at $78.95.
ARWR. not surprised at all. This one was an easy short (no position). Let's see how it goes for ABUS.
ESPR Here, the paper on bempedoic acid MoA
http://www.nature.com/articles/ncomms13457
On the other hand, there is a wide use of statins that are "supposed" to produce as secondary effect dementia-like disorders in some individuals...
Looking at statistics for the past 10 years. 90% approval chance.
In this case they will have to conduct pharmacovigilance study post marketing for CAP and next year it will be approved for GOno which is huge mkt. At $7 was a great buy. I took advantage of the sell ratings issued by analysts downgrades that prompted the selloff after the adcom docs, they didn't care to wait 2 days for adcom recommendations. Really bad job of analysts again. But thank them for the manipulation...