#110665
#110666
Re: Farmas USA
#110667
Re: Farmas USA
New opinions from EMA advisor CHMP
Sep. 21, 2018 10:07 AM ET|By: Douglas W. House, SA News Editor
Opinions released today from the European Medicines Agency's advisory group CHMP.
Positive:
Takeda's ( OTCPK:TKPHF)( OTCPK:TKPYY) Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC previously treated with Pfizer's XALKORI (crizotinib).
Mylan's ( MYL +0.7%) Fulphila (pegfilgrastim), a biosimilar of Amgen's Neulasta, to reduce the duration of neutropenia and febrile neutropenia due to chemotherapy.
Novartis' ( NVS -0.9%) Gilenya (fingolimod) in highly active relapsing/remitting MS in pediatric patients at least 10 years old.
Roche's ( OTCQX:RHHBY +0.4%) RoActemra (tocilizumab) for active systemic juvenile idiopathic arthritis in patients at least one year old who have failed to respond adequately to previous therapy with NSAIDs and systemic corticosteroids.
Negative:
CHMP has agreed to re-examine its negative opinion (issued on July 27) on Amgen's ( AMGN) Blincyto for B-precursor ALL.
CHMP has agreed to re-examine its July 27 negative opinion on Bristol-Myers Squibb's ( BMY +0.3%) Opdivo (nivolumab) + Yervoy (ipilimumab) for kidney cancer
https://seekingalpha.com/news/3392135-new-opinions-ema-advisor-chmp
#110668
Re: Farmas USA
Acadia Receives A Rubber Stamp From FDA On Nuplazid Risk-Benefit Profile
Summary
The FDA issues a press release reaffirming that the risk-benefit profile for Nuplazid remains solid despite safety concerns.
Nuplazied sales reached $57.1 million in Q2 2018, which is a 17% increase from the prior quarter.
Nuplazid failed to achieve its main study goal for a phase 2 Alzheimer's psychosis study, therefore, Acadia chose to go after a broad psychosis disease population.
Nuplazid targeting a broad range of psychosis diseases is highly promising because the FDA has already given it Breakthrough Therapy Designation.
Conclusion
The FDA pretty much has cleared up the safety issues that have plagued Acadia for a very long time now. I believe that this should get the biotech back on track. It produced a good amount of sales for Nuplazid in the most recent quarter. For the second quarter of 2018 Nuplazid net sales hit $57.1 million, which is an increase of 17% from the first quarter of 2018. In addition, the net sales of the drug increased by 87% year over year. It is good news for now and a risk that remains is if anything seems to pop up again related to the safety of Nuplazid. In that case, the stock could take another hit again. However, I believe that the risk-benefit profile has been established quite well by the FDA. The other risk relates to the pivotal phase 3 study targeting a broad range of psychosis indications. While a bit riskier than a study with a single target indication, positive results for this endeavor would be groundbreaking. All these reasons are why I believe Acadia Pharmaceuticals is a strong buy.
#110669
Re: Farmas USA
#110670
Re: Farmas USA
#110671
Re: Farmas USA
#110672
Re: Farmas USA
Perdón, pero hoy es de esos días (para mi por suerte son muy pocos) que me he visto totalmente sobrepasado psicológicamente por la bolsa. No por la pasta, porque anda que no he palmado pastizales en otras bichas, si no por exponer una cantidad importante de cash por error sin ningún plan o estrategia. Y fuera de casa y con solo el mobil, y con la cuenta del broker tiritando...
En fin, que gracias por los apoyos/comentarios. Seguro que no hay para tanto, pero he pasado un mal rato de cojones. Solo quería compartirlo.