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Bayer Seeks FDA Approval for New Formulation of Nifurtimox

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Bayer AG BAYRY announced that it has submitted an application to the FDA for a new formulation of nifurtimox to improve the body-weight adjusted dosing in pediatric Chagas patients. The application was supported by positive phase III data from the CHICO study, which is the largest clinical study to date in pediatric patients with Chagas disease.

Bayer filed the application on the World Neglected Tropical Diseases (NTDs) Day, which is part of Bayer’s Sustainability Strategy launched in December 2019.

The CHICO study evaluated the efficacy, safety and pharmacokinetics of nifurtimox in 330 pediatric patients with acute or chronic Chagas disease.

Chagas disease is caused by the protozoan parasite, Trypanosoma cruzi. The new formulation will improve dosing for newborns, infants and children suffering from Chagas disease and be a significant contribution in controlling the disease.

Shares of the company have gained 6.3% in the past year compared with the industry’s growth of 10.9%.

In a separate release, the company also announced results from the preplanned final overall survival analysis of the phase III ARAMIS study that evaluated darolutamide, a non-steroidal androgen receptor inhibitor (ARi), in men with non-metastatic castration-resistant prostate cancer (nmCRPC). The results showed a statistically significant improvement in overall survival (OS) in patients receiving darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

We remind investors that darolutamide is approved in the United States, under the brand name Nubeqa, for the treatment of patients with nmCRPC. In January, the Ministry of Health, Labor and Welfare (MHLW) in Japan also approved darolutamide for the treatment of patients with nmCRPC. It is under review in the EU for the same. It is also being investigated in a phase III study (ARASENS) in metastatic hormone-sensitive prostate cancer.


Zacks Rank and Stocks to Consider

Bayer currently has a Zacks Rank #4 (Sell).

A few better-ranked stocks from the healthcare space are Pfizer, Inc. (PFE - Free Report) , Eli Lilly & Co. LLY and Roche Holding AG RHHBY. While Pfizer sports a Zacks Rank #1 (Strong Buy), Lilly and Roche carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Pfizer’s earnings per share estimates have moved up from $2.56 to $2.69 for 2019 and from $2.73 to $2.81 for 2020 in the past 90 days. The company delivered a positive earnings surprise of 7.46%, on average, in the last four quarters.

Lilly’s earnings per share estimates have increased from $5.79 to $5.80 for 2019 and from $6.56 to $6.77 for 2020 in the past 60 days. The company delivered a four-quarter positive earnings surprise of 1.20%, on average.

Roche’s earnings per share estimates have increased from $2.61 to $2.66 for 2019 and from $2.82 to $2.90 for 2020 in the past 60 days.

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