Month: December 2019

Stock Analysts

Pfizer/Astellas Xtandi Gets Nod in China for Prostate Cancer (Revised)

December 4, 2019 0

Pfizer, Inc.’s PFE partner Astellas announced that the Chinese regulatory authority has approved their cancer drug Xtandi. The drug was approved by China National Medical Products Administration (NMPA) on Nov 18 to treat men with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic and had disease progression despite androgen deprivation therapy (ADT). The new drug application (NDA) seeking approval in China was based on data from an Asian multinational phase III study (Asian PREVAIL) involving Asian patients of which approximately 200 were Chinese […]

Momentum Stocks

Bear of the Day: Alcoa Corporation (AA)

December 4, 2019 0

Alcoa Corporation ( AA ) stock has fallen over 25% in 2019 as the broader global economic slowdown hampers demand for aluminum and drags prices down. The company’s near-term outlook appears rough and the recent U.S.-China trade war setback hardly helps Alcoa’s situation. What’s Going On […]

Stock Analysts

Epizyme Announces FDA Committee Review of Tazemetostat NDA

December 3, 2019 0

Epizyme, Inc . EPZM announced that the Oncologic Drugs Advisory Committee (ODAC) of the FDA is scheduled to review data supporting the New Drug Application (NDA), seeking accelerated approval of the lead candidate, tazemetostat, on Dec 18. The proposed indication for tazemetostat, to be discussed at this upcoming ODAC meeting, is metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. […]