AstraZeneca ( AZN Quick Quote AZN - Free Report) announced that a post-marketing study on its drug Andexxa has been stopped early after it met its efficacy endpoint at the planned interim analysis.
Andexxa is a recombinant Factor Xa used to reverse anticoagulation (major bleeds) caused by oral FXa-inhibitor treatments, rivaroxaban and apixaban, commonly referred to as blood-thinners. Andexxa was granted accelerated approval in the United States and is conditionally approved in the EU, Switzerland and UK as Ondexxya. It is also approved as Ondexxya in Japan for FXa inhibitors apixaban, rivaroxaban, or edoxaban.
The ANNEXA-I phase IV study evaluated the efficacy and safety of Andexxa (andexanet alfa) in patients being treated with apixaban and rivaroxaban who experience an intracranial hemorrhage. The study was part of a post-marketing commitment to convert Andexxa’s conditional approval to full approval.
The ANNEXA-I study was stopped early on the recommendation of the independent Data and Safety Monitoring Board (DSMB) following a planned interim assessment of efficacy after 450 patients had been randomized and followed for one month. At the interim analysis, Andexxa showed superior hemostatic efficacy or, in other words, improved control of bleeding with targeted anticoagulation reversal versus usual care.
Based on data from the ANNEXA-I study, AstraZeneca will file regulatory applications to convert Andexxa’s approval from conditional to full approval in the United States and Europe.
AstraZeneca’s shares have risen 7% in the year so far against the
industry’s 0.2% decrease. Image Source: Zacks Investment Research
Andexxa’s total revenues increased 8% at a constant exchange rate (CER) to $44 million in the first quarter of 2023. Andexxa was added to AstraZeneca’s portfolio with the July 2021 acquisition of Alexion. In fact, Andexxa became a part of Alexion’s portfolio with the July 2020 acquisition of Portola Pharmaceuticals.
Zacks Rank & Stocks to Consider
Currently, AstraZeneca has a Zacks Rank #3 (Hold). Some better-ranked large drugmakers are
Novo Nordisk ( NVO Quick Quote NVO - Free Report) Roche ( RHHBY Quick Quote RHHBY - Free Report) and Novartis ( NVS Quick Quote NVS - Free Report) . While Novo Nordisk has a Zacks Rank of 1 (Strong Buy), Roche and Novartis have a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.51 to $5.07 over the past 30 days. Estimates for 2024 have jumped from $5.26 per share to $5.91 in the same timeframe. Novo Nordisk’s stock has risen 16.1% this year so far.
Novo Nordisk beat earnings expectations in two of the trailing four quarters, met estimates in one and missed in the other. The company delivered a four-quarter earnings surprise of 0.35%, on average.
Estimates for Roche’s 2023 earnings per share have increased from $2.62 to $2.72. Estimates for 2024 have jumped from $2.84 per share to $2.94 in the past 60 days. Roche’s stock has risen 3.2% this year so far.
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Novartis beat earnings expectations in each of the trailing four quarters. The company delivered a four-quarter earnings surprise of 5.15%, on average.