Roche's (RHHBY) sBLA for Xolair Gets FDA Priority Review Tag
Roche Holding AG RHHBY announced that the FDA has accepted the supplemental biologics license application (sBLA) seeking a label expansion for Xolair (omalizumab) to address a new indication.
The sBLA is seeking approval for Xolair for reducing allergic reactions, including anaphylaxis in adults and pediatric patients aged one year and above with food allergy following an accidental exposure to one or more foods.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected in the first quarter of 2024.
The FDA accepted the sBLA based on positive data from the interim analysis of the National Institutes of Health (NIH)-sponsored pivotal phase III OUtMATCH study, which evaluated Xolair in patients allergic to peanuts and at least two other common foods.
The OUtMATCH study is being conducted by Roche and Novartis NVS.
If approved, Xolair will become the first medicine to be approved for reducing allergic reactions associated with multiple foods following an accidental exposure. However, people who are taking Xolair still need to avoid certain foods that they are allergic to.
Roche shares have declined 11.2% in the past year against the industry’s increase of 4.9%.
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We note that Xolair is currently approved for the treatment of moderate to severe persistent allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in the United States.
In the United States, Roche co-develops and co-promotes Xolair with Novartis and shares a portion of the operating income. NVS does not record any U.S. sales of Xolair. However, outside the United States, Novartis records all sales of Xolair.
Xolair generated sales worth CHF 1.6 billion in the first nine months of 2023.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Entrada Therapeutics, Inc. TRDA and Puma Biotechnology, Inc. PBYI, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have decreased 11.7%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. In the past year, shares of PBYI have lost 19.8%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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