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Roche's (RHHBY) Flu Candidate Gets Priority Review by the FDA

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Roche’s (RHHBY - Free Report) member Genentech announced that the FDA has accepted a new drug application (NDA) and granted priority review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. 

A decision is expected by Dec 24, 2018.

Priority Review designation from the FDA is granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.

We note that, Baloxavir marboxil is a medication developed by Roche and Shionogi Co., a Japanese pharmaceutical company, for treatment of influenza A and influenza B. Roche holds worldwide rights to baloxavir marboxil excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd. The drug was approved for use in Japan in February 2018.

The NDA was supported by results from the phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu. In the study, baloxavir marboxil met its primary and secondary endpoints compared to placebo. Baloxavir marboxil significantly reduced the duration of flu symptoms by more than one day. It also considerably reduced the duration of fever by nearly a day and reduced the levels of virus in the nose and throat from 24 hours through 120 hours.

The NDA included supporting data of results from a placebo-controlled phase II study in otherwise healthy people with the flu.

Year to date, shares of Roche have declined 13.2% compared with the industry’s decline of 4.9%.

We remind investors that in January 2018, GlaxoSmithKline plc (GSK - Free Report) received approval from the FDA’s Center for Biologics Evaluation and Research for the label expansion of influenza vaccine — FluarixQuadrivalent. The vaccine has been approved for infants six months or older. 

Roche Holding AG Price

Zacks Rank & Stock to Consider

Roche carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Aeglea BioTherapeutics, Inc. (AGLE - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both Aeglea and ANI Pharmaceuticals carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Aeglea’s loss per share estimates have narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 96.3% so far this year.

ANI Pharmaceuticals’earnings per share estimates have moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 5.4% so far this year.

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