Novavax (NVAX): Un Nuevo Comienzo

Pues si , parece haber vuelto el control...

Novavax RSV F Vaccine Phase 2 Clinical Trial Data in Women of Child Bearing Age Published in Vaccine

Trial demonstrated a reduction of RSV infection in vaccinated women of greater than 50%, suggesting potential benefits to the mother, pregnancy outcomes and her infant

GAITHERSBURG, Md., June 7, 2017 /PRNewswire/ -- Novavax, Inc., (Nasdaq:NVAX) today announced that data from the second of two Phase 2 trials of its RSV F protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in women of child bearing age have been published in the journal  Vaccine (the data contained in this publication have been shared in prior scientific conferences). The Company previously announced  top line results from this trial in April 2014. Novavax is developing the RSV F Vaccine with the goal of protecting infants from RSV disease.

The manuscript describes the randomized, observer-blinded, placebo-controlled dose-ranging trial which evaluated the safety and immunogenicity of the RSV F Vaccine with and without varying doses of aluminum-phosphate adjuvant. The trial enrolled 720 women of child bearing age (18-35 years) at 10 clinical trial sites in the United States who received either one or two intramuscular injections of vaccine (at 60 or 120 µg doses) or placebo at study days 0 and 28.

The manuscript documents the significant antibody response elicited by the RSV F Vaccine, including 11.6 to 12.7-fold increases in anti-F IgG responses in women receiving a single dose of 120 µg RSV F Vaccine with 0.2 or 0.4 mg of aluminum. These antibody responses peaked 14 days post-vaccination and persisted at significantly elevated levels for the 3 month period during which immunogenicity was evaluated. Palivizumab-competing antibody (PCA) levels were low or undetectable at day 0 but increased to 341-423 µg/mL on day 14 for the 120 µg 1-dose regimens. While baseline levels of RSV/A and RSV/B microneutralizing titers did not vary in the placebo group, they more than doubled at day 28 against both RSV strains for the 120 µg, 0.4 mg aluminum formulation, which the Company selected for further development.

Importantly, confirming  results from the Company's prior trial in a similar population, serologic evidence of a new RSV infection by Western Blot was present in 21% (18/84) of placebo recipients, compared to only 10% (36/352) of vaccinees, a 52% (p=0.009) overall reduction of infection.

"The Western Blot finding from this trial, which demonstrates a reduction in recent RSV infections of approximately 52% in the vaccine relative to the placebo arms, is consistent with the Western Blot data we reported from a comparable trial and population in September of 2015.  Together, these data suggest that the RSV F Vaccine provided protection against RSV infection in controlled trials of over 1,000 women," said Gregory Glenn, M.D., President, Research and Development. "The results from this trial not only demonstrate significant increases in anti-F IgG, PCA and microneutralizing antibody titers in response to a 120 µg dose of the RSV F Vaccine with 0.4 mg aluminum, the same dose and regimen used in our global Phase 3 trial, Prepare, they are consistent with the immunogenicity results reported in our prior trial in women of child bearing age. While it was not the primary endpoint in the trial, the Western Blot data suggest the potential to protect both the pregnant mothers and their infants from RSV disease."

Cómo lo ves?

Que se dejen de gañanadas y que liberen datos intermedios del fase 3...y rapidito que cojo un vuelo a los Estados Juntitos en menos que canta un gallo si es necesario

Edito: Como pumpeo diario vale y con las ganas de noticias que hay a ver a dónde la quieren llevar hoy...

NVAX

Me la pela esa new, asi lo veo, pero si vale para que rompa los 1,07 por mi bienvenido sea

Manda güevos... anuncian que una revista ha publicado un "refrito" de datos que ya eran de dominio público.

Un +13% en PM con una no-noticia... supongo que en mercado abierto, corregirá, porque si no, qué venga alguien y me lo explique.

nada que explicar, si buscas razonamiento te arruinas, aquí es toque de corneta cuando los que lo llevan quieren, tanto arriba como abajo.

así es este tinglao trileros

A mi me va a venir de perlas para soltar las que llevo a 1$ y a esperar la parte del "dump"

1,18 ya :D 

si rope 1.20 volará algo más si en apertur no los supera los 1.19 puede volverse, a saber

No habla del MATRIX-M, que si está en la fase 3. Estos datos ya se conocian.

Supongo que debe ser para mantenerla fuera del 1$ y que los cortos no se apropien de ella.

Por eso voy a vender, porque no veo ningún motivo para que rompa los 1,19 y se vaya a los 1,30 o más.

Aunque luego va a pasar cualquier cosa menos la idea que tengo en mente...

Es que carece de toda lógica... un 1% o un 2%, todavía, pero esto...

Pues la misma lógica cuando ves un sell off desproporcionado cada vez que un directivo vende un puñado de cromitos, o se hunde con unos resultados porque "no tiene beneficios" (como si eso fuese una sorpresa). No le busques lógica, solo intenta aprovecharlo cuando va a tu favor.

Leyendo a fondo he visto que es una segunda parte de la fase II, y lo que habian publicado anteriormente era parte 1 de fase2.

No sé , parecen iguales los resultados , esto indica que van por buen camino, yo sigo pensando que el exito o no vendrá con el MATRIX-M, si al aplicarlo da mas de un 52% de eficacia entonces la de ancianos tendrá mas posibilidades,

Que pensais?