Celgene (NASDAQ:CELG) and Acceleron Pharma (NASDAQ:XLRN) have announced that Celegene has submitted a biologics license application for luspatercept, which is to treat adult patients with low to intermediate risk myelodysplastic syndromes with ring sideroblasts and need red blood cell transfusions, and for treatment of patients with beta thalassemia-associated anemia that require red blood cell transfusions. …

Celgene (NASDAQ:CELG) and Acceleron Pharma (NASDAQ:XLRN) have announced that Celegene has submitted a biologics license application for luspatercept, which is to treat adult patients with low to intermediate risk myelodysplastic syndromes with ring sideroblasts and need red blood cell transfusions, and for treatment of patients with beta thalassemia-associated anemia that require red blood cell transfusions.

As quoted in the press release:

The submission is based on the safety and efficacy results of the pivotal phase 3 studies MEDALIST and BELIEVE, both recently presented at the American Society of Hematology annual meeting, where MEDALIST was included in the plenary session.

“There remains a high unmet medical need for patients with MDS or beta-thalassemia who suffer from the effects of their disease-related anemia. The primary treatment option for these patients currently is chronic transfusion of red blood cells which can be associated with complications such as iron overload,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “New treatment options are urgently needed for these patients. With this submission, we look forward to working with the Agency to deliver luspatercept to patients with these serious blood diseases.”

The companies also plan to submit a marketing application to the European Medicines Agency in the second quarter of 2019.

Click here to read the full press release.

Featured
ClaimsFiler, a FREE shareholder information service, reminds investors of pending deadlines in the following securities class action lawsuits: Bristol-Myers Squibb Company Class: Investors who received Contingent Value Rights in exchange for their shares of Celgene Corporation pursuant to Bristol-Myers’ acquisition of Celgene on November 20, 2019 Lead Plaintiff Motion Deadline: December 6, 2021 MISLEADING ...

ClaimsFiler, a FREE shareholder information service, reminds investors of pending deadlines in the following securities class action lawsuits:

Bristol-Myers Squibb Company (BMY)
Class: Investors who received Contingent Value Rights ("CVRs") (BMY.RT) in exchange for their shares of Celgene Corporation (CELG) pursuant to Bristol-Myers' acquisition of Celgene on November 20, 2019
Lead Plaintiff Motion Deadline: December 6, 2021
MISLEADING PROSPECTUS
To learn more, visit https://claimsfiler.com/cases/nyse-bmy-3/

read more Show less
Amgen today announced that it has been named to the Dow Jones Sustainability World Index for the eighth consecutive year, reflecting the company's enduring commitment to environmental, social, and governance issues. Amgen also was named to the DJSI North America Index for the ninth straight year. The DJSI Indices are among the best indicators of a company's ESG performance due to the breadth of companies evaluated ...

Amgen (NASDAQ:AMGN) today announced that it has been named to the Dow Jones Sustainability World Index for the eighth consecutive year, reflecting the company's enduring commitment to environmental, social, and governance (ESG) issues. Amgen also was named to the DJSI North America Index for the ninth straight year.

The DJSI Indices are among the best indicators of a company's ESG performance due to the breadth of companies evaluated – nearly 11,000 this year – and the rigorous nature of the annual assessment process. The DJSI World Index recognizes the top 10% of companies in the S&P Global Broad Market Index for performance on ESG issues, which S&P Global considers critical to generating long-term stakeholder value.

read more Show less
ASCENT Subgroup Analysis Provides Insights on Treatment Outcomes for Black Patients with Metastatic TNBC – – Separate ASCENT Post Hoc Analysis Examines Outcomes in Patients Who Discontinue Treatment Due to Progressive Disease – Gilead Sciences, Inc. will present additional data from the Phase 3 ASCENT study of Trodelvy ® during the upcoming San Antonio Breast Cancer Symposium being held from December 7-10. ...

ASCENT Subgroup Analysis Provides Insights on Treatment Outcomes for Black Patients with Metastatic TNBC –

Separate ASCENT Post Hoc Analysis Examines Outcomes in Patients Who Discontinue Treatment Due to Progressive Disease

read more Show less

MARKETS

Markets
TSX21149.00+23.10
TSXV954.26+10.21
DOW35135.94+236.60
S&P 5004655.27+60.65
NASD15782.83+291.18
ASX7239.80-39.50

COMMODITIES

Commodities
Gold1792.95+6.33
Silver22.93+0.01
Copper4.32-0.03
Palladium1797.00+8.08
Platinum965.00-0.99
Oil68.63-1.32
Heating Oil2.11-0.04
Natural Gas4.76-0.09