Re: Farmas USA
P/E, precio y evolución me llamo la atención.
La conocíais? Por lo que he visto es bastante grande
P/E, precio y evolución me llamo la atención.
La conocíais? Por lo que he visto es bastante grande
AUPH
Comunica elección de CRO y ensayo y sube por artículo del Bastardo donde afirma que no va a haber más muertes en el ensayo.
Aurinia Selects Worldwide Clinical Trials as its CRO for Phase 3 Lupus Nephritis Trial
With support from Worldwide, Aurinia will proceed with conducting a randomized, placebo-controlled, double-blind global 52-week trial in approximately 320 patients. The primary endpoint as in the Phase 2b AURA trial is renal response (complete remission), at 24 weeks. In addition to the assessment of renal response, a key marker of clinical benefit in this population is the duration of proteinuria improvement. Therefore, secondary endpoints will include the duration of renal response at 52 weeks (48 weeks in AURA), an efficacy measure which delineates durability of renal response (remission), an important parameter in evaluating long-term outcomes for the treatment of LN.
Del Bastardo sobre AUPH de ahora:
Aurinia Pharmaceuticals (AUPH) has an opportunity to ease investor concerns about the safety of its experimental lupus nephritis drug voclosporin when a 48-week update from the phase II study is announced later this quarter (likely in the middle of February.)
Lupus nephritis is a chronic disease (and a form of lupus) in which a person's own immune system attacks their kidneys, causing inflammation that progressively destroys kidney function. There are no drugs approved today specifically to treat lupus nephritis, so doctors use a combination of immunosuppressive drugs and steroids with mixed results.
As a reminder, Aurinia shares sold off hard last August when the 24-week results from the voclosporin study were announced. The primary endpoint of the study was met with 33% of low-dose voclosporin patients achieving complete remission compared to 19% of placebo patients, with statistical significance. Key secondary efficacy endpoints were also met in vocolosporin's favor. [There was a high dose of voclosporin in the study but it was less effective.]
Investors freaked out over an imbalance in patient deaths in the phase II study. Ten patients in the low-dose voclosporin died compared to one patient in the placebo arm and two patients in the high-dose voclosporin arm.
You can understand why investors were concerned.
Since August, Aurinia has dug into the study's safety data and believes strongly that voclosporin did not cause the patient deaths. Their argument, explained to me by Aurinia Vice President, Clinical Affairs Rob Huizinga in San Francisco during the J.P. Morgan Healthcare Conference, makes sense.
If voclosporin was contributing to the deaths, the rate of overall adverse events in the study, including deaths, would be higher. They were not. The overall adverse-event rate and the mortality rate in Aurinia's study were consistent with safety results from other lupus nephritis studies.
So, why did so many patients in the low-dose voclosporin arm die? Because through a fluke in the study's randomization by geography, patients from less developed Asian countries like Bangladesh, the Philippines Sri Lanka were placed into the low-dose voclosporin arm, Huizinga notes. These patients had more severe disease at baseline than other patients entered into the study and they also had poorer access to quality healthcare.
Seven of the 10 patients in the low-dose voclosporin arm who died came from Bangladesh, Aurinia discovered. They all died within 60 days of starting the study.
The most reassuring data point to rule out voclosporin's role in the patient deaths would be no more deaths. As of early January, when I met with Huizinga, there had been zero additional deaths in the phase II study. The company receives daily updates on adverse events, including mortality, from study monitors.
Aurinia continues to follow lupus nephritis patients in the study and will report 48-week data.
No additional patient deaths will be good news for voclosporin. Investors also want to see the rate of complete remission seen with the drug at 24 weeks extend out to 48 weeks.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
DVAX
Feo em gráfico diario, cierre de ayer muy casi en 52WL
Semanal ....
MACD y su histograma cruzando al alza
RSI en sobreventa
--
Blackrock aumenta posicion un 16%,y ya acumula un 6.5 del total 83 % de institucionales
Robert Janssen Vice Presidente se gasta mas de 24,000 usd a 4.05 usd para aumentar posición
Institutional Holdings 83.03%
Total Number of Holders 143
Total Shares Held 31,990,312
Total Value of Holdings 121,563,186
Net Activity (248,919)
Short Interest decreciendo cada vez mas-
Read more: http://www.nasdaq.com/symbol/dvax/ownership-summary#ixzz4Wy4zy1PV
Para los interesados en células y CRISPR, estudio sobre quimeras:
«Después de nada, o después de todo/ supe que todo no era más que nada.»
HZNP
QUEDA 1 mes
Horizon Pharma plc to Host Fourth-Quarter 2016 Conference Call and Webcast on February 27, 2017
DUBLIN, Ireland, Jan. 27, 2017 (GLOBE NEWSWIRE) -- Horizon Pharma plc (Nasdaq:HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced today that its fourth-quarter 2016 financial results will be released on Monday, February 27, 2017. Following the announcement, Horizon's management will host a live conference call and webcast at 8 a.m. Eastern Time to review the Company's financial and operating results.
athx
abajo, quizas oportunidad.
Form 424B5
Prospectus Filed Pursuant to Rule 424
Filed Jan 26, 2017
http://www.athersys.com/secfiling.cfm?filingid=1193125-17-19946&CIK=1368148
ATHX
Edito: 19.8M common a 1,01
Athersys Announces Proposed Public Offering of Common Stock
https://finance.yahoo.com/news/athersys-announces-proposed-public-offering-212851510.html
PS: David, paso de largos ;)
«Después de nada, o después de todo/ supe que todo no era más que nada.»
Ana, el PR de AUPH me parece un bluff. No tienen además fondos para hacer todo el fase 3. X eso mi interés ya que si los datos q salen en breve son buenos, es un candidato a BO