The Big Biotech and partner Acceleron say that blood disease drug luspatercept, a blockbuster hopeful, has been given a series of FDA passes: First up is a priority review for the erythroid maturation agent’s potential indication in beta-thalassemia (with an action date of Dec. 4), followed by a PDUFA date of April 4 for its myelodysplastic syndromes (MDS) indication.

Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) announced on 4/5/19 that Celgene has submitted a Biologics License Application (BLA) for luspatercept, an erythroid maturation agent, for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions.

A pair of clinical trial wins for Celgene’s luspatercept at the American Society of Haematology (ASH) meeting have set up a filing for the new drug in mid-2019.

The American Society of Hematology (ASH) begins its 60th annual meeting on Dec. 1, and this year's going to be one to remember. Acceleron Pharma Inc. (NASDAQ:XLRN), bluebird bio (NASDAQ:BLUE), and Amgen Inc. (NASDAQ:AMGN) are all scheduled to present highly anticipated results from experimental cancer therapies that could be worth billions. Here's what investors need to watch out for.

After a couple of pipeline setbacks, Celgene has said it is preparing to file five new products between now and the end of 2020 that analysts say will reduce its reliance on cancer cash-cow Revlimid.

Shares of Acceleron Pharma (NASDAQ: XLRN) lost over 10% last month, according to data provided by S&P Global Market Intelligence, but it's not nearly as bad as it looks. Investors simply adjusted the company's market valuation following a huge one-day surge of 42% at the end of June, when the biopharma announced positive results for a phase 3 trial evaluating its lead drug candidate.

Just days after hitting its first set of marks in a critically important Phase III study, Acceleron $XLRN and its partners at Celgene $CELG say that their prospective blockbuster luspatercept has rung all the right bells in a pivotal study for beta thalassemia.

Acceleron Pharma said Thursday that its experimental drug luspatercept significantly reduced the need for blood transfusions in patients with the blood disease myelodysplastic syndrome, meeting the primary goal of a Phase 3 clinical trial.

It's been a tough year for Celgene Corp. (NASDAQ:CELG) investors, but upcoming phase 3 data on luspatercept from Acceleron Pharma (NASDAQ:XLRN) could rekindle interest in Celgene's stock price.