Bristol Myers Squibb ( BMY Quick Quote BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of chimeric antigen receptor (CAR) T cell immunotherapy, Abecma.
The committee recommended granting Conditional Marketing Authorization to Abecma (idecabtagene vicleucel; ide-cel), for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
The European Commission (EC) will take the recommendation into account while reviewing the application but is not bound by it.
The EC is expected to give a final decision within 67 days of the receipt of the CHMP opinion.
Abecma, a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy, is approved in the United States for the treatment of adult patients with relapsed or refractory multiple myeloma.
It is being developed in collaboration with
bluebird bio ( BLUE Quick Quote BLUE - Free Report) .
Concurrently, the CHMP also recommended the approval of blockbuster immuno-oncology drug, Opdivo (nivolumab), for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).
The positive opinion is based on encouraging results from the phase III CheckMate -577 study.
It is approved in the United States for the adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received neoadjuvant CRT.
Shares of Bristol Myers have gained 7.1% so far this year compared with the
industry’s growth of 0.5%.
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Approval of additional indications should boost Opdivo sales. The company’s performance in the first quarter of 2021 was dismal as Opdivo’s sales declined facing stiff competition from the likes of
Merck’s ( MRK Quick Quote MRK - Free Report) Keytruda. Moreover, Revlimid sales weren’t impressive.
Nevertheless, the recent approval of new drugs adds a stream of revenues, which should propel growth in the coming quarters.
Last month, the FDA gave a nod to Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately-to-severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).
The EC has granted full Marketing Authorization to Onureg (azacitidine tablets) as a maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed, hematopoietic stem cell transplantation (HSCT).
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is
Repligen Corporation ( RGEN Quick Quote RGEN - Free Report) , which presently carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Repligen’s earnings estimates for 2021 have increased to $2.26 from $1.91 in the past 60 days. The stock price has increased 1.7% in the year so far.
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