ACAD
Sí, fail en esquizofrenia. Algún dato positivo pero más o menos esperado, es una enfermedad complicada. Cae un 15%, podría irse un poco más abajo.
Yo vendí un tercio y compré las puts para enero para el resto como dije antes de estos resultados. Ahora es la jugada interesante para esperar resultados DRP de la forma más barata posible. Si estos son positivos, subirá mucho. Si son negativos, se va a hundir bastante.
ACAD
En IV alguien ha colgado notas de la CC. Lo de Europa es negativo para mí porque creo que es en Ucrania donde había un buen número de pacientes y yo me fiaría menos de esos datos.
Lo más importante es que si no paran por eficacia el DRP antes de tiempo sacarán una nota. Esa es la ventana, de aquí a algún punto en 2H.
Conference Call Notes
1. Acadia is discontinuing its program in inadequate response/schizophrenia. CEO Davis: "Based upon today's topline results, we do not plan to initiate further clinical development for pimavanserin for inadequate response schizophrenia."
2. According to Davis, if the DRP interim does not lead to a study halt for reasons of efficacy, ACAD will let us know in a press release. The interim analysis is still slated for 2H of the year.
3. The background antipsychotic in the inadequate response trial had nothing to do with the outcome, according to Serge.
4. CEO Davis: "The ADVANCE trial [negative symptoms schizophrenia] is technically a phase 2 study; however, we sized this study and designed this study such that it can be considered a pivotal study if it's positive."
5. Most patients (over 80%) were enrolled in Europe. Just for this population, primary endpoint of study was met (PANSS; p value 0.0234). Key secondary endpoint was met (CGI; p value 0.0214).
6. Improvement was shown in the negative symptoms of patients.
7. Reduction of daytime sleepiness was observed. This finding mirrors what's been found in other studies, especially phase 3 PDP.
8. Safety profile was similar to placebo's. 88% of pimavanserin patients finished the study compared to 96% for placebo.
Conclusion
In time this will be seen as a minor setback.
The result is surely unexpected given a) proof-of-concept success of pimavanserin in schizophrenia; b) studies showing the anti-psychotic effect of pimavanserin to be superior to quetiapine (Seroquel), and one tiny study showing clozapine non-responders improving with pimavanserin; and c) the excellent sales of Nuplazid in the PDP population.
I expect strong earnings will mitigate the harsh reaction from the Street tomorrow.
It's possible, maybe even likely, that Acadia will file a supplemental NDA in negative symptoms/schizophrenia if the upcoming trial (slated for completion in Q4) succeeds. The sNDA will be based on pooled data from the successful phase 2 trial and supportive data from the recently completed trial.
ACAD perspectiva mensual
sin el velon rojo que se va a formar hoy ...
ACHN
Fijaros hasta donde hizo corrección esta pajara, 50% retroceso fibo … entonces good news y patadon pa'rriba
Achillion Pharmaceuticals (NASDAQ: ACHN) announces results from their Phase 1 multiple ascending dose study with ACH-5228 outside U.S. 43 healthy volunteers were enrolled in the study. Subjects received oral doses ranging from 40 mg to 200 mg twice a day (BID) for 14 days. The results demonstrated that ACH-5228, when dosed 120 mg BID or higher, achieved near complete and sustained Alternative Pathway inhibition with a mean value of >95% at steady state concentrations. ACH-5228 was well tolerated over the dose ranges, which include the doses expected to be evaluated in Phase 2 trials. The Company expects to submit an IND application in Q4 2019.
MRKR
Ayer caída moderada, en comparación con la de hace un par de días....
A ver como termina la semana...
En principio, los próximos catalizadores serian AML P2 en Q3, y Ovarian P2 en Q4, más financials, que también se prevén positivos....
A tener en mente:
"Studies in the past have demonstrated statistically significant differences in how a stock performs heading into positive or negative phase 3 data.
Rothenstein and colleagues investigated the public announcements from 23 positive clinical trials, 41 positive FDA regulatory decisions (“winners”), 36 negative clinical trials, and 9 negative FDA regulatory decisions (“losers”) between 2000 and 2009. All the trial results and regulatory decisions were regarding experimental anticancer drugs developed by the companies. The average stock price change from 60 days before the announcement to the actual announcement day was positive for the winners and negative for the losers. After the decision, the stock price increased on average for the winners and decreased for the losers (Rothenstein, Tomlinson et al. 2011). Overgaard and colleagues analysed the stock price anticipation of biotechnology stocks to 98 phase III trial decisions and 49 FDA regulatory decisions between 1990 and 1998. The average stock price change from 120 to 3 days before public announcement was significantly higher for the winners compared to the losers (Overgaard, van den Broek et al. 2000).
Source: Ghent University
Researchers, typically, attribute the price changes to insider selling and hedge funds obtaining "insider information" prior to data. Whatever the cause, it happens. I am always more cautious towards stocks trading poorly heading into phase 3 data, no matter the amount of conviction I have in the science, because that's what research has shown."
Sacado de un artículo de hoy sobre una farmacia concreta que no seguimos:
«Después de nada, o después de todo/ supe que todo no era más que nada.»
Biogen
Acaba de presentar resultados, bate previsiones y parece que se lo toma bien. A ver la letra pequeña....
MRKR
Nueva caída con un mínimo en 5,52$, y recuperando ahora mismo....veamos si cierra en verde....
RSI en 30....
La caída sigue sin tener una explicación objetiva, ya que los resultados publicados son buenos, con independencia de la prudencia que debe tenerse con una Fase I, que incluye muy pocos pacientes, debiendo añadirse que son resultados provisionales, y no definitivos...
Añado 800 títulos más aprovechando la caída y me coloco en una media de 6,81....
Un saludo
Segun he entendido el estudio dice que 60 días antes de un anuncio positivo las acciones suelen subir, y luego seguir subiendo, y bajan previamente y despues si el anuncio es malo¿ me lío un poco
NTEC yo la seguía, la presenté aquí a 5,15 tras un offering, tras unos meses de dolor se fué a 9-10$ y luego debacle hasta el anuncio hace dos días, ahora esta por los 0,55$, que miedo..
AERI no se si fuiste tu que entró, sigues ahí o te bajaste? he estado desconectado estos ías
saludos!
