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Bayer's Aliqopa Gets Breakthrough Therapy Status by FDA

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Bayer Aktiengesellschaft BAYRY announced that the FDA granted Breakthrough Therapy designation to Aliqopa (copanlisib) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL), who have received at least two prior therapies. MZL is an indolent form of non-Hodgkin’s lymphoma (iNHL) and accounts for about 10% of all non-Hodgkin’s lymphoma in the United States.

The Breakthrough Therapy designation is aimed at accelerating the development and review of drugs intended to treat serious or life-threatening diseases.

Aliqopa is a pan-PI3K inhibitor, with predominant activity against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B-cells, developed by Bayer.

The Breakthrough Therapy designation was based on data from the MZL subgroup of the pivotal phase II CHRONOS-1 study that led to accelerated approval of Aliqopa in the United States for the treatment of adult patients with relapsed follicular lymphoma (FL), who have received at least two prior systemic therapies. The data from the CHRONOS-1 study showed efficacy of the drug in patients with iNHL, who have received at least two prior therapies, including those with relapsed or refractory MZL.

Shares of Bayer have declined 10.8% year to date against the industry’s growth of 0.9%.

Bayer is conducting two additional phase III studies — CHRONOS-3 and CHRONOS-4 — to evaluate the efficacy and safety of Aliqopa in combination with other therapies in iNHL (including MZL) patients, who have relapsed following one or more prior therapies. 

We remind investors that recently, the FDA approved Celgene Corporation’s CELG Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated FL or MZL. This is the first combination regimen for patients with these indolent forms of non-Hodgkin lymphoma (NHL) that does not include chemotherapy.

Bayer Aktiengesellschaft Price

 

Bayer Aktiengesellschaft Price

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Zacks Rank & Stocks to Consider

Bayer currently carries a Zacks Rank #3 (Hold).

Some other better-ranked stocks in the health care sector include Bristol-Myers Squibb Company BMY and Merck and Co., Inc. MRK. While Bristol-Myers carries a Zacks Rank #1 (Strong Buy), Merck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have moved up from $4.78 to $5.03 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 11.85%.         

Merck’s earnings per share estimates have moved up from $4.65 to $4.72 for 2019 and from $5.17 to $5.20 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 5.67%.         

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