Re: Threshold Pharmaceuticals, Inc (THLD): Opiniones
de aqui viene el rumor de que quizas liberen datos financieros en Febrero:
http://www.earningswhispers.com/stocks.asp?symbol=THLD
credibilidad la minima, pero ahi esta
de aqui viene el rumor de que quizas liberen datos financieros en Febrero:
http://www.earningswhispers.com/stocks.asp?symbol=THLD
credibilidad la minima, pero ahi esta
Si por eso, aunque la credibilidad sea la mínima, ahora mismo me muerdo las uñas por no estar dentro, y en función de cómo vea la acción hoy/mañana entro. Porque aunque sea un rumor, y si ocurre, o y si es a mediados/finales de febrero...
Tanto ayer y hoy he tenido más tiempo libre, y estoy como nervioso, pero después de los batacazos de verano/otoño por operar sin rumbo y con resultados de pérdidas abultadas, aunque me cueste, voy a hacer las cosas según mi estrategia. Espero poder recomprar algo más abajo y no perder el tren.
La verdad es que es un place leeros por aquí o nasdaqlandia e intentar poco a poco hacer las cosas por uno solo.
Un saludo!
Que eso si, las otras dos veces subió "sin noticia", pero lo de ayer cambia el asunto, que los resultados del máximo competidor no sean tan buenos no es moco de pavo.
Threshold Pharmaceuticals Announces Initiation of TH-302 Phase 3 MAESTRO Study in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma* Reuters is not responsible for the content in this press release.
Fri Jan 25, 2013 4:00am EST
SOUTH SAN FRANCISCO, CA, Jan 25 (Marketwire) --
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that
Threshold's partner Merck KGaA, Darmstadt, Germany, through its division
Merck Serono, initiated the global Phase 3 MAESTRO study assessing the
efficacy and safety of investigational hypoxia-targeted drug TH-302 in
combination with gemcitabine in patients with previously untreated,
locally advanced unresectable or metastatic pancreatic adenocarcinoma.
The initiation of the Phase 3 MAESTRO study resulted in Threshold earning
a $30 million milestone payment from Merck KGaA pursuant to the terms of
Threshold's license and co-development agreement with Merck KGaA, which
includes an option for Threshold to co-commercialize in the U.S. MAESTRO
stands for TH-302 in the treatment of MetastAtic or unrESectable
pancreaTic adenocaRcinOma.
MAESTRO is a randomized, placebo-controlled, international, multi-center,
double-blind Phase 3 trial of TH-302 plus gemcitabine compared with
placebo plus gemcitabine and is expected to enroll 660 patients. The
primary efficacy endpoint is overall survival; the secondary endpoints
include efficacy measured by progression-free survival (PFS), overall
response rate and disease control rate, as well as assessments of safety
and tolerability, pharmacokinetics and biomarkers. The study is being
conducted under a Special Protocol Assessment (SPA) with the U.S. Food
and Drug Administration (FDA). An SPA is a review conducted by the FDA on
a clinical trial that will form the primary basis of an efficacy claim in
a marketing application. The FDA provided written agreement that the
design and planned analysis of this study could adequately address
objectives in support of a regulatory submission. However, the
determination for drug approval by the FDA is made after a complete
review of a marketing application and is based on the entire data in the
application. The study design was discussed with the FDA also at an End
of Phase 2 meeting and with the European Medicines Agency (EMA) during a
scientific advice procedure.
TH-302 is an investigational hypoxia-targeted drug that is designed to be
activated under severe tumor hypoxic conditions, a hallmark of many
cancers. Areas of low oxygen levels (hypoxia) in solid tumors are due to
insufficient blood supply as a result of aberrant vasculature.
"Initiation of the Phase 3 MAESTRO study is an important advancement in
the overall development of TH-302 for the treatment of patients living
with cancer," said Barry Selick, Ph.D., Chief Executive Officer of
Threshold. "This marks the second Phase 3 study of TH-302 in addition to
the ongoing Phase 3 pivotal trial in patients with soft tissue sarcoma.
In addition, we continue to explore the potential breadth and activity of
TH-302 against a variety of solid tumors and hematological malignancies
in multiple ongoing earlier stage clinical trials."
The Phase 3 MAESTRO study for TH-302 was initiated following results from
a randomized, controlled Phase 2b trial of TH-302 in patients with
pancreatic cancer. At the ESMO 2012 Congress (European Society for
Medical Oncology) updated results were presented confirming a significant
improvement (p=0.008) in PFS associated with 41% reduction of risk for
disease progression or death for patients treated with TH-302 340 mg/m2.
This represented a 2.4-month increase in median PFS for patients
receiving TH-302 340 mg/m2. The 12-month overall survival rates were also
in favor of the TH-302 340 mg/m2 treatment group compared with the
control arm (38% vs 26% (p=0.13)). The most common adverse events were
fatigue, nausea and peripheral edema, and were similar across groups.
Skin and mucosal toxicities, predominantly Grade 1 and 2, and
myelosuppression, were the most common adverse events related to TH-302
and did not result in increases in treatment discontinuation. Adverse
events leading to discontinuation of study treatment as well as serious
adverse events were balanced across all treatment arms. Severe (Grade
3/4) myelosuppression was more frequent compared to gemcitabine alone.
All other severe adverse events were generally below 10%.
It is estimated that approximately 277,000 cases of pancreatic cancer are
diagnosed worldwide every year, accounting for 2.2% of all cancers.
Pancreatic cancer is the eighth most common cancer in Europe and the
eleventh most common in the United States. Almost 67% of cases are
diagnosed in people aged 65 and over; it is uncommon in people under the
age of 40. Pancreatic cancer has a low survival rate regardless of stage
of disease, with almost 95% of patients dying from their disease within 5
years. It is estimated that there are around 266,000 deaths from
pancreatic cancer worldwide each year.
About TH-302
TH-302 is an investigational hypoxia-targeted drug that is designed to be
activated under severe tumor hypoxic conditions, a hallmark of many
cancers. Areas of low oxygen levels (hypoxia) in solid tumors are due to
insufficient blood supply as a result of aberrant vasculature. Similarly,
the bone marrow of patients with hematological malignancies has also been
shown, in some cases, to be severely hypoxic.
TH-302 is currently under evaluation in two Phase 3 trials: one in
combination with doxorubicin versus doxorubicin alone in patients with
soft tissue sarcoma (STS), and the other in combination with gemcitabine
versus gemcitabine and placebo in patients with advanced pancreatic
cancer. Both Phase 3 trials are being conducted under a Special Protocol
Assessment with the U.S. Food and Drug Administration (FDA). The FDA and
the European Commission have granted TH-302 Orphan Drug Designation for
the treatment of STS. TH-302 is also being investigated in hematological
malignancies and combination trials in solid tumors.
Merck KGaA signed a global license and co-development agreement for
TH-302 with Threshold in February 2012, which includes an option for
Threshold to co-commercialize in the U.S.
About Threshold Pharmaceuticals, Inc.
Threshold Pharmaceuticals, Inc., is a biotechnology company focused on
the discovery and development of drugs targeting tumor hypoxia, the low
oxygen condition found in the microenvironments of most solid tumors as
well as the bone marrows of some patients with hematologic malignancies.
This approach offers broad potential to treat a variety of cancers. By
selectively targeting tumor cells, we are building a pipeline of drugs
that hold promise to be more effective and less toxic to healthy tissues
than conventional anticancer drugs. For additional information, please
visit our website (www.thresholdpharm.com).
Forward-Looking Statements
Except for statements of historical fact, the statements in this press
release are forward-looking statements, including statements regarding
the potential therapeutic uses and benefits of TH-302 to treat patients
with pancreatic cancer, soft tissue sarcoma or other cancers. These
statements involve risks and uncertainties that can cause actual results
to differ materially from those in such forward-looking statements.
Potential risks and uncertainties include, but are not limited to, the
ability to enroll or complete anticipated clinical trials, the time and
expense required to conduct such clinical trials and analyze data,
whether later trials confirm the results of earlier trials, whether the
Phase 3 trial data is sufficient to support regulatory approval to market
TH-302, and issues arising in the regulatory or manufacturing process and
the results of such clinical trials (including product safety issues and
efficacy results). Further information regarding these and other risks is
included under the heading "Risk Factors" in Threshold's Quarterly Report
on Form 10-Q, which has been filed with the Securities and Exchange
Commission on November 2, 2012 and is available from the SEC's website
(www.sec.gov) and on our website (www.thresholdpharm.com) under the
heading "Investors." We undertake no duty to update any forward-looking
statement made in this news release.
Threshold Pharmaceuticals anuncia la iniciación de la TH-302 Fase 3 Estudio MAESTRO en pacientes con adenocarcinoma de páncreas localmente avanzado o metastásico
+30 millones... En teoría hoy subiremos un 10% por lo menos, a no ser que ya esté descontado.
Recordad
La caja se valora entre 2-y 3 veces en phase II-III (Price to cash to extend 2-3 x times EV)
Si inyectan 30 kilos por milestones , vamos a poner en el caso malo son 60 kilos en valoración
Si la compañía en 5 $ capitaliza 300 aprox
con x $ capitaliza 360 aprox
Hoy debería estar en 6
+ short squeeze igual 7 , que es el precio medio (VWAP que os he hablado todo el año 6.70$)
o Dividen´.....360 millones de $ entre nº de acciones en circulación
Después es una binominial 1/0 para los resultados del TH302, pero el que abraxane falle le da pista libre para 1.Buscar a Celgene alianzas con Threshold, o las misma THLD aliarse con otra.
Fidelity sabe que THLD es el ancla para multiproducto.
Felicidades a los que sigan dentro.
VWAP en 6.70