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XLRN

Acceleron

$53.61 /

+2.33 (+4.54%)

, BMY

Bristol-Myers

$63.88 /

-0.06 (-0.09%)

07:06
01/09/20
01/09
07:06
01/09/20
07:06

Acceleron and Bristol-Myers' Reblozyl achieves primary endpoint in anemia study

Bristol-Myers (BMY) and Acceleron (XLRN) announced that the New England Journal of Medicine has published results from MEDALIST, the pivotal phase 3 study evaluating the use of Reblozyl to treat anemia in patients with very low- to intermediate-risk myelodysplastic syndromes who have ring sideroblasts and require red blood cell transfusions, and who had failed, were intolerant to, or ineligible for/unlikely to respond to treatment with erythropoiesis-stimulating agents. MEDALIST achieved a statistically significant improvement in the primary endpoint of red blood cell transfusion independence for 8 or more weeks during the first 24 weeks of the study. The study also met the key secondary endpoint of RBC-TI for 12 or more weeks during the first 24 or 48 weeks of the study, as well as the additional secondary endpoint of hematologic improvement-erythroid for 8 or more weeks. The most common treatment-emergent adverse events of any grade in greater than 10% of patients in either the treatment or placebo arm were fatigue, diarrhea, asthenia, nausea, dizziness, and back pain. TEAEs of Grade 3 or 4 were reported in 42.5% of patients receiving luspatercept-aamt and 44.7% of patients receiving placebo. Progression to acute myeloid leukemia occurred in three patients receiving luspatercept-aamt and one patient receiving placebo. Five patients receiving luspatercept-aamt - 3.3% - and four patients receiving placebo - 5.3% - experienced one or more TEAE that resulted in death. The FDA is evaluating Reblozyl for the treatment of anemia in adults with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, and has set a target action, date of April 4 for this indication. In Europe, Bristol-Myers Squibb's Marketing Authorization Application for the treatment of anemia in adults with beta thalassemia and MDS is currently under review. Reblozyl is not approved to treat MDS in any geography.

XLRN

Acceleron

$53.61 /

+2.33 (+4.54%)

BMY

Bristol-Myers

$63.88 /

-0.06 (-0.09%)

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XLRN Acceleron
$53.61 /

+2.33 (+4.54%)

01/08/20 Piper Sandler
Acceleron risk/reward into data heavily skewed to upside, says Piper Sandler
12/11/19 Piper Sandler
Piper Jaffray sees strong launch for Acceleron's Reblozyl
11/11/19 H.C. Wainwright
Acceleron price target raised to $88 from $68 at H.C. Wainwright
11/08/19 Piper Sandler
Acceleron approval signifies FDA confidence, says Piper Jaffray
BMY Bristol-Myers
$63.88 /

-0.06 (-0.09%)

01/06/20 Citi
Bristol-Myers upgraded to Buy from Neutral on resumption at Citi
12/18/19 Morgan Stanley
Morgan Stanley upgrades Major Pharmaceuticals sector view to Attractive
12/13/19
Fly Intel: Top five analyst upgrades
12/13/19 Argus
Bristol-Myers upgraded to Buy from Hold at Argus

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