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Bayer (BAYRY) Gets a Boost With Product Approvals and Deals

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We issued an updated research report on Bayer AG (BAYRY - Free Report) on Jan 25, 2021.

In the past few months, the company received a few approvals and inked a few collaborations.

In January 2021, the FDA approved soluble guanylate cyclase (sGC) stimulator, vericiguat, under the brand name,Verquvo. The drug  isindicated to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and an ejection fraction less than 45%. The approval is based on the results of the pivotal phase III VICTORIA study and follows the priority review designation granted by the FDA.

Vericiguat is being jointly developed with Merck (MRK - Free Report) . Merck has the commercial rights to vericiguat in the United States and Bayer has the exclusive commercial rights in the rest of the world.

In the same month, the Ministry of Health, Labor and Welfare in Japan approved the use of the oral Factor Xa inhibitor, Xarelto (rivaroxaban), to treat venous thromboembolism (VTE) and prevent VTE recurrence in children, including catheter-related thrombosis, cerebral vein and sinus thrombosis. The use of an oral suspension was also approved.

Xarelto, already indicated for the treatment of VTE and the prevention of recurrence in adult patients, is the first oral Factor Xa Inhibitor approved for pediatric treatment and secondary prevention of VTE.  In the United States, it is marketed byJohnson & Johnson (JNJ - Free Report) .

The pipeline progress has been encouraging too.

Further, Bayer announced that the FDA accepted its new drug application (NDA) and granted Priority Review tofinerenone to treat patients with chronic kidney disease (CKD) and type II diabetes (T2D) in January 2021. This regulatory submission was based on phase III FIDELIO-DKD trial data.

Finerenone is a first-in-class investigational selective mineralocorticoid receptor antagonist (MRA) that demonstrated renal and cardiovascular benefits in patients with CKD and T2D in the phase III FIDELIO-DKD study. Based on these data, which are part of the largest phase III study to date in CKD and T2D, Bayer also submitted Finerenone  for marketing authorization in the European Union (EU) and other countries worldwide.

In January 2021, Bayer and Germany-based biopharmaceutical company, CureVac N.V., announced a collaboration whereby the former will support the latter  for further development, supply and key territory operations of the latter’s COVID-19 vaccine candidate, CVnCoV. Bayer will lend its arm in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information, supply-chain performance and support in selected countries.

In December 2020, Bayer inked an exclusive worldwide license agreement with Atara Biotherapeutics Inc. (ATRA - Free Report) for pipeline candidate, ATA3271, a next-generation allogeneic T-cell immunotherapy, and an autologous version — ATA2271 — for the treatment of high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer. The deal is part of Bayer's new strategy to speed up and support cell and gene therapy development. With this deal, the companyplans to enter the CAR-T cell therapy space and expand its oncology development pipeline with groundbreaking technologies.

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