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Sanofi (SNY) Hemophilia A Drug BLA Gets FDA Priority Tag

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Sanofi (SNY - Free Report) announced that the FDA has granted priority review to its biologics license application (BLA) seeking approval of its novel recombinant factor VIII therapy, efanesoctocog alfa (BIVV001), for the treatment of people with hemophilia A. The FDA’s decision on the BLA is expected on Feb 28, 2023.

Sanofi is collaborating with Swedish Orphan Biovitrum (Sobi) for the development and commercialization of efanesoctocog alfa.

Sanofi stock has declined 18.8% this year so far compared with the industry’s decrease of 1.6%.

The BLA filing was based on data from the XTEND-1 pivotal phase III study evaluating efanesoctocog alfa in previously treated adults and adolescents with severe hemophilia A, a rare genetic disorder. The study showed that treatment with efanesoctocog alfa led to clinically meaningful prevention of bleeds and showed superiority to prior factor prophylaxis based on an intra-patient comparison. In the study, efanesoctocog alfa led to reduced annualized bleeding rates.

Efanesoctocog alfa enjoys the FDA’s Breakthrough Therapy designation as well as Orphan Drug designation. In Europe, a regulatory application is expected to be filed next year, following the availability of data from an ongoing pediatric study — XTEND-Kids.

Apart from efanesoctocog alfa, Sanofi has another pipeline candidate, fitusiran, which is being studied in late-stage studies for rare genetic disorders, hemophilia A and B.

Xenpozyme/olipudase alfa was approved to treat patients with non-Central Nervous System manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease in Europe in June. Xenpozyme is already approved in Japan for ASMD. An application seeing approval for olipudase alfa is under review in the United States, with a decision expected in a couple of months.

Zacks Rank & Stocks to Consider

Sanofi currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the same sector are Morphic (MORF - Free Report) , Sesen Bio and Agenus (AGEN - Free Report) , all carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.75. Loss estimates for 2023 have narrowed from $3.91 to $3.77 during the same period. Shares of Morphic have lost 41% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average.

Sesen Bio’s loss estimates for 2023 have narrowed from 27 cents per share to 1 cent per share over the past 30 days. Shares of Sesen Bio have declined 19% this year so far.

Earnings of Sesen Bio beat estimates in all the last four quarters, delivering a four-quarter surprise of 89.49%, on average.

Agenus’ loss per share estimates for 2022 have narrowed from 89 cents to 70 cents in the past 30 days. Loss estimates for 2023 have narrowed from 64 cents per share to 60 cents per share over the same time frame. Agenus’ stock is down 17.4% in the year-to-date period.

Earnings of Agenus beat estimates in three of the last four quarters while missing in one. The stock delivered a four-quarter average negative surprise of 12.02%.


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