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Análisis de Bayer: ¿Buen momento para entrar en Bayer AG (BAY)?

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Análisis de Bayer: ¿Buen momento para entrar en Bayer AG (BAY)?
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Análisis de Bayer: ¿Buen momento para entrar en Bayer AG (BAY)?
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#162

Re: Análisis de Bayer: ¿Buen momento para entrar en Bayer AG (BAY)?

Bayer ha anunciado hoy que el Servicio de Alimentos y Administración de Drogas (FDA) ha otorgado la designación de Revisión Prioritaria para la Nueva Droga Aplicación (NDA) para copanlisib para el tratamiento de la recaída o refractario folicular Linfoma (FL) pacientes que han recibido al menos dos terapias anteriores.

Copanlisib es un Inhibidor de fosfatidilinositol-3-quinasa intravenosa de clase I (PI3K) con predominio Actividad inhibidora contra PI3K-α y PI3K-δ isoformas. FL es el subtipo más común de Linfoma no Hodgkin indolente (iNHL).

#165

Re: Análisis de Bayer: ¿Buen momento para entrar en Bayer AG (BAY)?

Poquito a poco se va acercando a los máximos históricos, ya toca los 118 euros

#166

Re: Análisis de Bayer: ¿Buen momento para entrar en Bayer AG (BAY)?

Bayer Receives FDA Priority Review For Investigational Anti-Cancer Compound Copanlisib

Regulatory submission based on data from the Phase II CHRONOS-1 study, in which copanlisib showed objective response rate of 59% and a manageable safety profile in patients with follicular lymphoma (FL) / Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant activity against PI3K-α and PI3K-δ isoforms / Copanlisib granted Fast Track and Orphan Drug Designation in the U.S. for FL

Berlin, May 17, 2017 - Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies. Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. FL is the most common subtype of indolent non-Hodgkin's lymphoma (iNHL).

"Patients with relapsed or refractory follicular lymphoma have a poor prognosis, and new treatment options which are well tolerated and effective are needed to prolong progression-free survival and improve quality of life for these patients," said Martin Dreyling, Professor of Medicine at the University of Munich Hospital in Grosshadern and lead investigator of the CHRONOS-1 study. "Based on the CHRONOS-1 results, where copanlisib showed durable efficacy with a manageable and distinct safety profile, the compound may have the potential to address this unmet medical need."

"Bayer is advancing one of the most diverse oncology portfolios and pipelines and our first priority is to deliver new treatments to cancer patients as quickly and prudently as possible," said Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer. "With this milestone, we are one step closer to making copanlisib available in the U.S. to the community of doctors and patients facing a very difficult-to-treat disease in follicular lymphoma. We look forward to continuing to work with the FDA throughout the review process."

The FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions, when compared to standard applications. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months (compared to 10 months under standard review).
 

#167

Re: Análisis de Bayer: ¿Buen momento para entrar en Bayer AG (BAY)?

Continua el rally buscando los máximos históricos, ya toca los 122 euros

#168

Re: Análisis de Bayer: ¿Buen momento para entrar en Bayer AG (BAY)?

Bayer places 8.5 percent of Covestro's shares and EUR 1 billion bonds exchangeable into Covestro shares

Leverkusen, June 7, 2017 - Bayer AG has reduced its direct holding in Covestro from 53.3 percent to 44.8 percent. This was achieved by selling 17.25 million of Covestro shares at a price of EUR 62.25 per share via an accelerated bookbuilding procedure. The planned deposit in Bayer Pension Trust e. V. will reduce Bayer AG's stake in Covestro by a further 4 percentage points.

In addition, Bayer AG placed bonds exchangeable into Covestro shares maturing in 2020 in an aggregate principal amount of EUR 1 billion. The bonds bear interest at a rate of 0.05 percent per annum. The issue price was fixed at 105.25 percent of the principal amount and the initial exchange price at EUR 80.93. Upon exchange of the bonds, Bayer will have the flexibility to settle the bonds in cash, by delivery of Covestro shares or by a combination thereof.

The accelerated bookbuilding and the offering of the exchangeable bonds took place Tuesday evening after market close and were addressed to institutional investors only. In the context of the placements, Bayer has agreed to a lock-up period of 90 days.

The transactions offer Bayer the opportunity to further reduce its holding in Covestro. Covestro will continue to be fully consolidated in Bayer's financial statements since Bayer should continue to hold the majority at a Covestro annual stockholders meeting after these transactions are completed. As previously announced, Bayer aims to achieve full separation from Covestro in the medium term.
 

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