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Bristol-Myers Squibb Co (BMY.N)

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Latest Key Developments (Source: Significant Developments)

Bristol-Myers says encouraging response observed with Opdivo plus BMS-986205, in heavily pre-treated patients with advanced cancers in early-stage study
Friday, 10 Nov 2017 07:00am EST 

Nov 10 (Reuters) - Bristol-myers Squibb Co :Encouraging response observed with Opdivo (nivolumab) plus investigational ido1 inhibitor, BMS-986205, in heavily pre-treated patients with advanced cancers in phase 1/2a study ca017-003.Bristol-Myers Squibb Co - ‍In dose escalation phase, maximum tolerated dose (primary endpoint) of BMS-986205 in combination with Opdivo was 200mg​.  Full Article

U.S. Food and Drug Administration expands approval of Sprycel (dasatinib)
Friday, 10 Nov 2017 06:30am EST 

Nov 10 (Reuters) - Bristol-myers Squibb Co ::U.S. Food and Drug Administration expands approval of Sprycel (dasatinib) to include treatment of children with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.Approval based on data from prospective trial in pediatric chronic myeloid leukemia in chronic phase​.Co says ‍continues to explore pediatric applications for investigational oncology agents within its broad development program​.Approval for Sprycel granted under priority review, indication received Orphan Drug Designation from FDA.  Full Article

Bristol-Myers and Five Prime present early-stage data evaluating Cabiralizumab with Opdivo in patients with advanced solid tumors
Thursday, 9 Nov 2017 08:00am EST 

Nov 9 (Reuters) - Five Prime Therapeutics Inc :Bristol-Myers Squibb and Five Prime present phase 1a/1b data evaluating Cabiralizumab (anti-csf-1 receptor antibody) with Opdivo (nivolumab) in patients with advanced solid tumors.Bristol-Myers Squibb - ‍Preliminary results show safety profile of Cabiralizumab plus Opdivo was generally consistent with that of Opdivo monotherapy​.Bristol-Myers Squibb - ‍Early efficacy signal observed in heavily pretreated patients with advanced pancreatic cancer with microsatellite stable disease​.Bristol-Myers Squibb Co - ‍Bristol-Myers Squibb is launching a new study of Cabiralizumab plus Opdivo​.Bristol-Myers Squibb Co - ‍Data show for first time that combining an anti-csf-1 receptor antibody with Opdivo may help restore t cell function​.  Full Article

Bristol-Myers Opdivo plus Yervoy combination delivered overall survival benefit across PD-l1 expression levels
Tuesday, 7 Nov 2017 08:35am EST 

Nov 7 (Reuters) - Bristol-myers Squibb Co :Opdivo plus Yervoy combination delivered overall survival benefit across PD-l1 expression levels in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma.Bristol-Myers Squibb Co - ‍Safety profile of Opdivo plus Yervoy was consistent with that of previous reports​.Bristol-Myers Squibb - ‍Median OS was not reached for Opdivo plus Yervoy cobo or sunitinib for those with PD-l1 levels <1%, and for patients with PD-l1 expression levels ≥1% ​.  Full Article

Calithera Biosciences expands clinical collaboration with Bristol-Myers Squibb
Tuesday, 7 Nov 2017 08:01am EST 

Nov 7 (Reuters) - Calithera Biosciences Inc :Initial results from Phase 2 study of CB-839 in combination with opdivo® (nivolumab) to be presented at the Society for Immunotherapy of Cancer Meeting.Calithera Biosciences Inc - ‍expanding Bristol-Myers Squibb clinical collaboration​.Calithera Biosciences Inc - ‍expanded its existing clinical collaboration with Bristol-Myers Squibb, evaluating CB-839 in combination with opdivo​.Calithera Biosciences Inc - ‍analysis of all safety evaluable patients demonstrated CB-839 was well tolerated when combined with opdivo​.Calithera Biosciences - ‍among 16 evaluable melanoma patients, one patient achieved a complete response and two patients achieved partial responses​.Calithera Biosciences Inc - ‍study will be expanded to enroll additional melanoma patients​.Calithera Biosciences Inc - ‍as part of expanded collaboration, melanoma development costs will be shared​.  Full Article

FDA approves roll-over combination study of BriaVax with pembrolizumab
Monday, 30 Oct 2017 08:30am EDT 

Oct 30 (Reuters) - Briacell Therapeutics Corp :FDA approves the roll-over combination study with checkpoint inhibitor immunotherapies to allow continued access to BriaVax in patients with advanced breast cancer.Briacell Therapeutics - ‍FDA approved roll-over combination study of BriaVax with pembrolizumab or ipilimumab.Briacell- ‍FDA approved roll-over combination study for patients previously treated with BriaVax from Phase I/IIa clinical trial in advanced breast cancer​.  Full Article

Bristol-Myers Squibb reports Q3 earnings per share $0.51
Thursday, 26 Oct 2017 06:59am EDT 

Oct 26 (Reuters) - Bristol-Myers Squibb Co ::Q3 GAAP earnings per share $0.51; Q3 non-GAAP earnings per share $0.75; Q3 revenues up 7 percent to $5.3 billion.Decreasing 2017 GAAP earnings per share guidance range from $2.66 - $2.76 to $2.36 - $2.46.Increasing 2017 non-GAAP earnings per share guidance range from $2.90 - $3.00 to $2.95 - $3.05.Sees 2017 gross margin as a percentage of revenue to be about 71.5 percent for GAAP.Sees 2017 research and development expenses increasing about 25 pct - 30 pct compared to 2016 for GAAP.Qtrly Opdivo worldwide revenues $1,265 million versus $920 million last year.Qtrly Sprycel worldwide revenues $509 million versus $472 million last year.Qtrly Yervoy worldwide revenues $323 million versus $285 million last year.Qtrly Eliquis worldwide revenues $1,232 million versus $884 million last year.FY2017 earnings per share view $2.99 -- Thomson Reuters I/B/E/S.Q3 earnings per share view $0.77, revenue view $5.20 billion -- Thomson Reuters I/B/E/S.  Full Article

FDA accepts Bristol-Myers Squibb’s application for Opdivo
Monday, 16 Oct 2017 04:15pm EDT 

Oct 16 (Reuters) - Bristol-Myers Squibb Co :U.S. Food and Drug Administration (fda) accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma and grants priority review.  Full Article

Bristol-Myers Squibb extends strategic partnership with Target Pharmasolutions
Thursday, 12 Oct 2017 09:00am EDT 

Oct 12 (Reuters) - Target Pharmasolutions::Says BMY extended strategic partnership for TARGET-NASH to multi-year agreement​.Says Bristol-Myers squibb extends strategic partnership with Target Pharmasolutions for TARGET-NASH.  Full Article

Infinity Pharmaceuticals and Bristol-Myers Squibb expand clinical collaboration
Monday, 25 Sep 2017 08:02am EDT 

Sept 25 (Reuters) - Bristol-Myers Squibb Co :Infinity Pharmaceuticals and Bristol-Myers Squibb expand clinical collaboration evaluating ipi-549 in combination with Opdivo (nivolumab).Infinity Pharmaceuticals Inc - ‍combination dose-escalation is also ongoing, and combination expansion is expected to begin in second half of 2017​.Infinity Pharmaceuticals Inc - ‍patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing​.Infinity Pharmaceuticals- deal expands Phase 1/1b study to include patients with triple negative breast cancer who havent been previously exposed to anti-PD-1/anti-PD-l1 therapy​.  Full Article

BRIEF-Ono Pharmaceutical enters into license agreement with Bristol-Myers Squibb for Prostaglandin E2 receptor antagonists

* Says it entered into license agreement with Bristol-Myers Squibb Company (BMS)for Prostaglandin E2 receptor antagonists relating to Immuno-Oncology programs