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AstraZeneca's (AZN) Ultomiris Gets EC Nod for New Indication

AstraZeneca AZN announced that the European Commission has granted marketing approval to long-acting C5 complement inhibitor Ultomiris for a new indication — myasthenia gravis (gMG) — a rare autoimmune neuromuscular disease.

Ultomiris can now be prescribed in Europe as an add-on to standard therapy for treating adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive. With the approval, Ultomiris became the first and only long-acting C5 inhibitor approved for gMG in Europe.

Ultomiris was approved for adults with gMG who are AChR antibody-positive in the United States in April and in Japan in August.

So far this year, AstraZeneca’s shares have declined 6.3% compared with a decrease of 5.6% for the industry.

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The approval was expected as in Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had rendered a positive opinion and recommended marketing authorization of Ultomiris for gMG in July.

gMG is a rare autoimmune disorder which causes loss of muscle function and severe muscle weakness. The approval of Ultomiris for gMG was based on data from the CHAMPION-MG phase III study. In the study, Ultomiris showed improvements in daily activities across broad range of patients, including those with milder symptoms. In the study, Ultomiris was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at week 26 of treatment. MG-ADL is a patient-reported scale that assesses patients’ abilities to perform daily activities

Ultomiris was added to AstraZeneca’s portfolio with the acquisition of Alexion in 2021 and is already approved to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS).

Ultomiris sales were $434 million in the second quarter of 2022, up 31%. Sales benefited from the strong launch uptake in gMG in the United States and expansion into new markets

Zacks Rank and Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked large drugmaker is Sanofi SNY, which has a Zacks Rank of 2 (Buy).

Sanofi’s earnings estimates have gone up from $4.06 per share to $4.14 per share for 2022 and from $4.23 to $4.29 per share for 2023 over the past 60 days. Sanofi’s stock has declined 23.4% this year so far.

Sanofi’s earnings beat estimates in all the last four quarters, witnessing a surprise of 9.37%, on average.

Some better-ranked stocks in the broader biotech space are Morphic MORF and Agenus AGEN, both carrying a Zacks Rank #1 at present.

In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.80. Loss estimates for 2023 have narrowed from $3.91 to $3.62 during the same period. Shares of Morphic have lost 45.1% 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.

Estimates for Agenus’ 2022 bottom line have narrowed from a loss of 89 cents to 70 cents in the past 60 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 33.8% 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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