Shares of Celgene Corporation (CELG - Free Report) have gained 18.6% in the last three months compared with growth of 4.3% for the industry.
After a series of setbacks, things are finally looking good for Celgene.
The company suffered a setback, when a late-stage study on its lead cancer drug Revlimid in combination with Rituxan failed. Celgene suffered a setback when it received a Refusal To File letter from the FDA, regarding the New Drug Application (NDA) for ozanimod in relapsing multiple sclerosis (RMS).
Nevertheless, Celgene’s second-quarter results were encouraging as the company beat on both sales and earnings. Revlimid sales were impressive yet again, along with that of Pomalyst and Otezla. The increase in annual guidance on the back of Revlimid sales was impressive as well.
Meanwhile, Celgene was on the look-out for new deals and acquisitions, given a lacklustre 2017, and hence it acquired Juno Therapeutics in Mar 2018. The acquisition added JCAR017 (lisocabtagene maraleucel; liso-cel) to its lymphoma pipeline. JCAR017 is a best-in-class CD19-directed CAR-T candidate, currently in a pivotal program for relapsed and/or refractory diffuse large B-cell lymphoma.
The candidate is expected to obtain regulatory approval in the United States in 2019 with potential global peak sales of approximately $3 billion. Another candidate for multiple myeloma is JCARH125.
Earlier, Celgene announced a global collaboration with Prothena (PRTA - Free Report) to develop new therapies for a broad range of neurodegenerative diseases, primarily focused on three proteins implicated in the pathogenesis of several neurodegenerative diseases including tau, TDP-43 and an undisclosed target.
The company also has development and co-promotion agreement with bluebird bio, Inc. (BLUE - Free Report) . Both companies entered into a deal to co-develop and co-promote bb2121, an experimental anti-B-cell maturation antigen chimeric antigen receptor CAR-T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States.
Celgene and partner Acceleron Pharma (XLRN - Free Report) recently reported positive results from two phase III studies on luspatercept — BELIEVE and MEDALIST. Luspatercept achieved all primary and key secondary endpoints in the phase III MEDALIST and BELIEVE trials in patients with low-to-intermediate risk myelodysplastic syndromes (MDS) and transfusion-dependent beta-thalassemia, respectively.
Data from both the studies will be submitted to a future medical meeting in 2018. Both the companies intend to submit regulatory applications for luspatercept in the United States and Europe, in the first half of 2019.
The phase III trial named AUGMENT, evaluating Revlimid in combination with rituximab (R2) in patients with relapsed and/or refractory follicular lymphoma and marginal zone lymphoma, met the primary endpoint of progression-free survival (PFS). Global regulatory submissions are planned for the first quarter of 2019.
Hence, we expect a better performance in the second half of 2018 followed by an eventful 2019 for Celgene.
Celgene currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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