Farmas USA

ONTY

Dimisión del CEO. Se busca sustituto:

http://ir.oncothyreon.com/secfiling.cfm?filingID=1193125-16-425648&CIK=1412067

Suena a que Merck ha querido dar una ultima oportunidad a THLD para mantener el partnership. Para ello han abierto el estudio de la fase 2 de pulmón para ver si realmente hay algo por lo que trabajar. Y nones. incluso detienen el reclutamiento. Es el fin.

Aunque el premarket de un estupido y sin sentido +14%

THLD

Bueno, le queda los 2 estudios que no son Evofosfamide. Si hay algo donde rascar será ahí si consiguen buenos datos, pero ahora mismo queda muy tocada (como si no lo estuviera ya...).

THLD

THLD

Pues otro varapalo más para la maja esta...

A ver cómo se lo toman los usanos, pero creo que hoy veremos otra bajada. Voy a poner órden de venta, a ver si puedo salir dignamente...
ONTY

ya, ya ... hay mas pipeline. Pero si la primera, segunda y tercera joyas de la corona se van al garete pues pffff . Hombre, los caza mamporros tienen donde rascar, por supuesto, los comprados en 0,4x. Pero los comprados por encima de 3$ ... no se ... le veo mas futuro a MNKD fijate lo que te digo ;)

edito: ojo, que tampoco se lo veo , eh? :)

AMARIN , vaya, vaya ... los irlandeses dando un update y ademas aportando guidance ... y previsión de NUMEROS NEGROS PARA 2017 .... que han tomado para desayunar!???

Amarin Reports Preliminary 2015 Net Product Sales and Provides 2016 Revenue and Business Outlook

2015 Net Product Revenue Estimated to Be Approximately $26.0 Million for the Fourth Quarter and $80 Million for the Full Year, Exceeding Prior Guidance; Anticipate Full-Year 2016 Net Product Revenues Between $105 Million and $120 Million, Commercial Operations Positioned to Be Cash Flow Positive Entering 2017

BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 01/11/16 -- Amarin Corporation plc (NASDAQ: AMRN), today provided a business update, including preliminary unaudited fourth quarter and full year 2015 revenue and 2016 revenue outlook. Amarin plans to discuss these results and expectations for the coming year with investors in conjunction with the 34^th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Preliminary (Unaudited) 2015 Revenue and Year-end Cash Results
Fourth quarter 2015: Net product revenue estimated to be approximately $26.0 million, which represents growth of approximately:

• 58% over fourth quarter 2014;
• 22% sequentially over third quarter 2015; and
• 8% over the upper range of Amarin's prior guidance.

Full-Year 2015: Net product revenue is expected to be approximately $80.0 million reflecting growth of approximately:

• 48% compared to 2014; 50% growth compared to 2014 including licensing revenue.

Cash: Cash and cash equivalents at December 31, 2015 were approximately $107.0 million compared to $119.5 million at year-end 2014.

Additional 2015 Operational Progress
REDUCE-IT: Enrollment reached approximately 7,900 patients as of December 31, 2015, representing 99% of the patients targeted for enrollment in this prospective cardiovascular outcomes study, the first such study ever conducted to evaluate the effect of treating patients who despite statin therapy have elevated triglyceride levels and the first cardiovascular outcomes study to test a high, 4-gram per day dose of a pure-EPA omega-3 prescription product.

"Amarin made substantial progress in its commercial growth and outcomes study in 2015, including obtaining the authority to significantly expand the scope of information we can use to promote Vascepa^® (icosapent ethyl) capsules. We intend to build on this progress in 2016 by continuing to educate healthcare professionals regarding the efficacy and safety of Vascepa, growing revenues and executing on our cardiovascular outcomes study," commented John F. Thero, President and Chief Executive Officer. 

2016 Objectives and Financial Outlook
Commercial Operations: Amarin is intently focused on growing revenue in 2016 and anticipates being able to further increase Vascepa product revenues through productivity improvements without expanding its sales force. The company expects total net product revenue (excluding licensing revenue) of between $105 and $120 million in 2016, which is expected to position Amarin to enter 2017 cash flow positive from commercial operations, excluding REDUCE-IT and other research and development (R&D) expenses not required to sustain current commercial operations.

Revenue growth in 2016 is expected to remain variable from quarter to quarter. In particular, as experienced in each of the past two years, revenues in the first quarter of 2016 are expected to be impacted by seasonal factors such as the effect of new year insurance deductibles on consumer behavior regarding prescription refills, particularly for therapies treating asymptomatic, chronic conditions, such as Vascepa. 

REDUCE-IT: The continued progression of REDUCE-IT in a cost-effective manner is a key priority for Amarin heading into 2016. The timing of cumulative primary cardiovascular events in this study continues to track to prior estimates supporting onset of the predefined target (1,612^th) cumulative event in 2017 and publication of results in 2018. 

Based on historical event rates in the study, Amarin expects to attain 60% of the target aggregate number of cardiovascular events during the first half of 2016, triggering a pre-specified interim review by the independent data monitoring committee (DMC) of the trial's efficacy and safety results. After the 60% target has been achieved, additional time is required by the contract research organizations to finish collecting and preparing data for transfer to and analysis by the DMC. As is typical for large-scale, multi-national studies, this process is expected to take several months. Also as is typical for outcomes studies and based on the design of REDUCE-IT, management continues to expect that the study will run to completion rather than being stopped early for overwhelming efficacy at the interim look. Amarin will remain blinded to the interim and ongoing results throughout the study. 

The company anticipates that R&D expenses, excluding non-cash costs in 2016 will remain relatively consistent with 2015 levels with the majority of such spending devoted to the ongoing REDUCE-IT trial.

Amarin plans to provide further details regarding its 2015 results and 2016 outlook in connection with the publication of its 2015 audited financial results in late February.

MNKD tiene una deuda inasumible (200M o por ahí, y sigue gastando mucho más por fabricar Afrezza que lo que ingresa por ventas). THLD está limpia en ese sentido, pero necesita sacar nuevos estudios o que los que tiene sean positivos. Ahora mismo, es mejor no dar ni medio duro por ninguna de las 2.