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Pfizer Inc (PFE.N)

PFE.N on New York Stock Exchange

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19 Sep 2017
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Latest Key Developments (Source: Significant Developments)

Transgene says first patient treated in a phase 1B/2 trial of TG4001
Tuesday, 19 Sep 2017 11:45am EDT 

Sept 19 (Reuters) - TRANSGENE SA ::TRANSGENE: FIRST PATIENT TREATED IN A PHASE 1B/2 TRIAL OF TG4001 IN COMBINATION WITH AVELUMAB IN HPV-POSITIVE CANCERS.‍FIRST RESULTS EXPECTED IN 2018​.  Full Article

Astellas Pharma and Pfizer say positive top-line results from phase 3 prosper trial of XTANDI (enzalutamide)
Thursday, 14 Sep 2017 05:17am EDT 

Sept 14 (Reuters) - Astellas Pharma Inc <4503.T>:Co and Pfizer Inc <<>> announced that the Phase 3 PROSPER trial evaluating XTANDI®(enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic (M0) CastrationResistant Prostate Cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS) .The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of XTANDI in previous clinical trials.  Full Article

Pfizer, Astellas report positive top-line results from phase 3 PROSPER trial of XTANDI
Thursday, 14 Sep 2017 05:00am EDT 

Sept 14 (Reuters) - Pfizer Inc ::Pfizer and Astellas announce positive top-line results from phase 3 prosper trial of XTANDI (enzalutamide) in patients with non-metastatic castration-resistant prostate cancer.Phase 3 prosper trial met its primary endpoint​.Preliminary safety analysis of PROSPER trial appears consistent with safety profile of XTANDI in previous clinical trials​.In study of patients taking XTANDI who earlier received docetaxel, 1% of XTANDI patients versus 0.3% of placebo patients died from infections or sepsis​.In study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death​.In placebo-controlled patients taking XTANDI who earlier got docetaxel, grade 3 or higher adverse reactions reported among 47% of XTANDI patients​.In placebo-controlled study of chemotherapy-naïve patients, grade 3-4 adverse reactions were reported in 44% of XTANDI patients​.In bicalutamide-controlled study of chemotherapy-naïve patients, grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients​.Hypertension occurred in 11% of xtandi patients and 4% of placebo patients in two placebo-controlled trials​.No patients experienced hypertensive crisis​.  Full Article

Pfizer receives FDA approval for MYLOTARG (gemtuzumab ozogamicin)
Friday, 1 Sep 2017 11:38am EDT 

Sept 1 (Reuters) - Pfizer Inc ::Pfizer receives FDA approval for MYLOTARG (gemtuzumab ozogamicin).  Full Article

U.S. FDA approves Pfizer's Mylotarg for treatment of acute myeloid leukemia
Friday, 1 Sep 2017 11:11am EDT 

Sept 1 (Reuters) - U.S. Food and Drug Administration::U.S. FDA approves Pfizer's Mylotarg for treatment of acute myeloid leukemia.Prescribing information for Mylotarg includes a boxed warning that severe or fatal liver damage occurred in some patients who took mylotarg​.Also approved Mylotarg for patients aged 2 years, older with CD33-positive AML experiencing relapse/ who have not responded to initial treatment​.  Full Article

Pfizer says U.S. FDA and EMA accept regulatory submissions for bosuliffor
Tuesday, 29 Aug 2017 07:00am EDT 

Aug 29 (Reuters) - Pfizer Inc :U.S. FDA and European Medicines Agency accept regulatory submissions for Bosulif® (bosutinib) for the treatment of patients with newly diagnosed Ph+ chronic myeloid leukemia.Says ‍prescription drug user fee act (PDUFA) goal date for a decision by FDA is in December 2017​.  Full Article

Pfizer and Sangamo updates on early stage trial on its blood disorder therapy
Friday, 25 Aug 2017 08:00am EDT 

Aug 25 (Reuters) - Pfizer Inc ::Sangamo and Pfizer announce first patient receives treatment in Phase 1/2 clinical trial evaluating SB-525 investigational gene therapy for Hemophilia A.  Full Article

Pfizer receives FDA approval for BESPONSA (inotuzumab ozogamicin)
Thursday, 17 Aug 2017 01:57pm EDT 

Aug 17 (Reuters) - Pfizer Inc :Pfizer receives U.S. FDA approval for BESPONSA (inotuzumab ozogamicin).  Full Article

U.S. FDA approves Pfizer's leukemia drug Besponsa ‍​
Thursday, 17 Aug 2017 01:40pm EDT 

Aug 17 (Reuters) - U.S. Food and Drug Administration: :U.S. FDA approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia ‍​.FDA granted the approval of Besponsa to Pfizer Inc.‍​.Prescribing information for Besponsa includes a boxed warning that severe liver damage occurred in some patients who took Besponsa‍​.Boxed warning also includes an increased risk of death for patients who take Besponsa after receiving a certain type of stem cell transplant.  Full Article

Soros Fund Management dissolves share stake in Tesla, Pfizer, ConocoPhillips
Monday, 14 Aug 2017 06:15pm EDT 

Aug 14 (Reuters) - Soros Fund Management::Soros Fund Management dissolves share stake in Tesla Inc - SEC filing.Soros Fund Management dissolves share stake in Pfizer Inc.Soros Fund Management dissolves share stake in ConocoPhillips.Soros Fund Management: Change in holdings are as of June 30, 2017 and compared with the previous quarter ended as of March 31, 2017.  Full Article

BRIEF-Pfizer announces outcome of FDA advisory committee meeting for Sutent

* Pfizer announces outcome of FDA advisory committee meeting for Sutent in patients at high risk of recurrent renal cell carcinoma after surgery