Farmas USA

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Farmas USA
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Farmas USA
14.523 / 16.994

Re: Farmas USA


Dentro a 280

Re: Farmas USA

Enhorabuena investing! 

Re: Farmas USA


Ahora RVNC es la que me queda de mis 3 principales posiciones (tras la recuperación de RDUS) por darse la vuelta.

A ver si le toca pronto y pillamos una buena subida (que si no me equivoco estabas también). Y por qué no un BO, que ya llevas mucho sin uno ;).

Re: Farmas USA


Colgado en IV. Los datos (lo poco que se sabe ya que es un interim parado por una empresa externa) pintan muy bien realmente.
A Harmonious Beginning to the Fall for ACAD

Price: $23.80

06 Sep 2019

Biotechnology – Large Cap

Cory Kasimov

Gavin Scott

Matthew T Holt, Ph.D.

Neena M Bitritto-Garg, CFA

J.P. Morgan Securities LLC

We view the Phase 3 HARMONY trial stopping for positive efficacy as a clear win for

ACAD. We liked the risk/reward into this planned interim analysis (note here) given

our confidence in the relapse-prevention trial design and its historic success rate, even

if not specifically for dementia related psychosis (DRP). While data details are limited

(not surprising as this was an interim look), we expect this result to support Nuplazid's

approval in DRP (a commercial drug with BTD and no approved therapies for this

indication) and drive this product to “blockbuster” status (DRP 10x > PDP).

Importantly, we also see multiple additional positive read-throughs from today’s

development beyond DRP, including 1) it further validates the current PDP indication

/ Nuplazid’s safety profile and could drive greater traction in that setting; 2) it adds to

our confidence in MDD, which has more supportive data and is also being evaluated

in a straightforward trial; and 3) it may greatly add to ACAD’s scarcity value now that

the company has a clearer path to billion-dollar-plus sales with a wholly owned CNS

asset. Reiterate Overweight rating.

Quick Takes from the Conference Call

· Not surprisingly, details on the call were limited as this was an interim analysis and

thus the company does not yet have the full data set.

· In terms of stopping criteria, Nuplazid achieved statistical superiority over placebo

in time to relapse of dementia-related psychosis (DRP) at the planned interim

analysis (p < 0.0033).

· Response rates in the open-label portion of the study exceeded the company’s

assumptions (based on prior ADP and PDP response rates).

· Roughly 20% of patients in the open-label run in that made it to 8 weeks of

treatment did not meet the response criteria to be eligible for randomization at 12

weeks. A small % of patient discontinued for other reasons.

· The subtypes of DRP matched the overall epidemiology of the disease: ~67% ADP,

15% PDP, 10% vascular dementia, <10% dementia with lewy bodies, and <5%

frontotemporal dementia.

· Approximately 90% of patients were on the 34mg dose of Nuplazid and 10% dose

titrated down to the 20mg dose.

· Safety in the open label portion was consistent with prior data, and no concerns were

observed in the blinded safety reviews post randomization.

· Full data will be presented at an upcoming medical meeting that’s TBD (we suspect

CTAD in Dec or one of the many neuro/psych meetings in 1H). It's also possible that

ACAD updates investors in the interim as they analyze the data.

· It will take a few months for the company to shut down the trial and clean/analyze

all the data. Pending a meeting with the FDA, mgmt expects to submit a sNDA in

2020; we expect on the earlier side of the year (recall this is a supplemental filing

and key items such as CMC are already established).

· It’s also worth restating that the product has breakthrough therapy designation

(BTD) and that there are no approved therapies for DRP.

· DRP represents a blockbuster opportunity in the US alone, with 1.2M patients...or

about 10x larger than the currently approved PDP indication.

· ACAD’s EU strategy for Nuplazid remains TBD. We continue to suspect that they

will ultimately use DRP or MDD as the trigger to file overseas. 


Re: Farmas USA


Te sigo 1 pavo por debajo. Gracias por el aviso.

«Después de nada, o después de todo/ supe que todo no era más que nada.»


Re: Farmas USA

NVAX. " On September 9, 2019, Novavax, Inc. (the “Company”) was informed that the Company would be receiving written notification that the European Medicines Agency (“EMA”) had concluded that, based on the data package provided under the scientific advice request, the Company would not be able to utilize the conditional marketing authorization pathway for ResVax in the European Union.
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