Farmas USA

RGLS

Lgonber, estoy fijándome que es bajista en todos los plazos. Sé que eres experta en las pharmas, te puedo pedir que me / nos expliques qué te hace estar larga en el valor?

Sinceramente, sin mirar al pipeline en detalle, es simplemente un “bounce play” ya que apuesto a que no van a hacer un contrasplit ni a sacar el valor del Nasdaq y por lo menos la devolverán al 1$. En este caso tengo varios indicadores. Es mi opinión

ACAD

De lo que ha presentado en AAN estos días

ACADIA Pharmaceuticals Announces Presentation of Clinical Experience Data for NUPLAZID (Pimavanserin) at 2018 American Academy of Neurology (AAN) Annual Meeting

Two Independent Data Sets Confirm NUPLAZID Is Well-Tolerated and Efficacious in Treating Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis

https://www.businesswire.com/news/home/20180427005270/en/ACADIA-Pharmaceuticals-Announces-Presentation-Clinical-Experience-Data

ACAD

Clinical Experience with Pimavanserin for Treatment of Parkinson’s Disease Psychosis
(Poster #040)

Eighty eight of these patients began treatment with NUPLAZID and 14 patients never started treatment. About two-thirds of patients had tried and failed prior antipsychotic therapy. Data from the study show:

• >70% of all patients treated with NUPLAZID reported clinical improvement, while 88% of patients treated longer than four weeks improved.
• 67% of patients have remained on NUPLAZID for an average of 10+ months.
• Only 11% of patients were unable to tolerate NUPLAZID due to adverse events.
• NUPLAZID was effective in both treatment naïve and prior antipsychotic failure patients.
  • For those who failed NUPLAZID, improvement with a subsequent antipsychotic was uncommon.
• There was no increase in mortality detected in users of NUPLAZID.
  • 6 of the 88 patients treated with NUPLAZID died (compared to 5 out of 14 in the group that never started NUPLAZID).

Pimavanserin Use in a Movement Disorders Clinic: a Single Center Experience (Poster #065)

This assessment of real-life experience in 16 patients diagnosed with PD Psychosis and taking NUPLAZID

• 65% reported improvement of hallucinations with NUPLAZID.
• Six of the nine patients originally prescribed an earlier generation antipsychotic (either quetiapine or olanzapine) were able to discontinue those drugs following NUPLAZID initiation and remained on NUPLAZID monotherapy.
• No major side effects were reported.

Hoy toca up up up
ACAD

ACADIA Pharmaceuticals Issues Statement Reaffirming Benefit/Risk Profile of NUPLAZID

NUPLAZID® (pimavanserin) is the only medicine approved in the United States to treat hallucinations and delusions associated with Parkinson’s disease psychosis. NUPLAZID was approved by the FDA based on a pivotal Phase 3 study that demonstrated clinically robust and highly statistically significant efficacy, combined with other supportive studies.

on April 10, 2018, the FDA stated, “The FDA continues to monitor adverse events reported with NUPLAZID that are submitted to the FDA Adverse Event Reporting System (FAERS). We have noted that the cases typically involve geriatric patients with advanced-stage Parkinson’s disease, as well as numerous medical conditions, who are frequently taking concomitant medications with risks for serious adverse events, including death. Based on these data, the FDA has, at this time, not identified a specific safety issue that is not already adequately described in the product labeling.”

On April 25, 2018, the FDA stated that its evaluation does not mean the Agency has determined the medicine has a new risk and does not suggest healthcare providers should not prescribe it nor that patients should stop taking the medication. The Agency also has confirmed this statement does not represent a change from the safety review and monitoring activities the FDA referred to in its statement of April 10. As always, we will continue to work with the FDA and medical community to answer any questions related to NUPLAZID.

ACADIA collects and analyzes postmarketing events for NUPLAZID as part of our ongoing commitment to monitor the medication’s safety profile. These events are submitted to the FDA and incorporated into the FDA’s FAERS public reporting system. Because NUPLAZID is distributed through a specialty distribution channel, we have frequent (in most cases monthly) contact with patients and caregivers through our distribution partners. This increased interaction naturally results in dramatically higher adverse event collection and reporting compared to products without such a distribution method. Approximately 93 percent of the reported adverse events associated with NUPLAZID are considered “solicited” due to this direct interaction with patients and caregivers, while only approximately 7 percent of these events are considered “spontaneous” reports, which are voluntary reports originating from consumers or healthcare professionals. In contrast, most other antipsychotics are distributed through retail channels, which rely almost entirely on “spontaneous” reporting.

(Como resumen me ha quedado poco resumido :) )

http://ir.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&ID=2345257

REGN , en barrena ... un dia mas ... el dineral que voy a perder aqui ... 

ACAD

200 cromos más a 16.15