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AstraZeneca's (AZN) Ultomiris Gets FDA Nod for New Indication
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AstraZeneca (AZN - Free Report) announced that the FDA has approved its drug Ultomiris for a new rare neurological disease.
The approval for long-acting C5 complement inhibitor Ultomiris is for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). The approval makes Ultomiris the first and the only long-acting C5 complement inhibitor approved for AQP4 Ab+ NMOSD.
Patients with NMOSD experience unpredictable relapses, which can involve the onset of new neurological symptoms or the exacerbation of existing ones. These relapses tend to be severe and recurrent, often leading to permanent disability in affected individuals.
The approval of Ultomiris for AQP4 Ab+. NMOSD was based on data from the CHAMPION-NMOSD phase III study, which demonstrated that Ultomiris led to unprecedented relapse risk reduction in NMOSD patients. Zero relapses were observed among Ultomiris patients with a median treatment duration of 73 weeks.
In September last year, the FDA issued a complete response letter (CRL) to its supplemental biologics license application (sBLA) seeking approval for Ultomiris for the treatment of adult patients with AQP4 Ab+. NMOSD. However, the FDA did not request any additional analyses of data from the CHAMPION-NMOSD phase III study. It also did not raise any concerns about the efficacy and safety data from the study. The CRL rather requested modifications in the Ultomiris Risk Evaluation and Mitigation Strategy (REMS) safety program.
In the past year, the stock has declined 4.2% against the industry’s 26.9% rise.
Image Source: Zacks Investment Research
Ultomiris is already approved for the AQP4 Ab+ NMOSD indication in the EU and in Japan.
In the United States, Ultomiris is presently approved for treating three indications — generalized Myasthenia Gravis (gMG), paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Ultomiris was added to AstraZeneca’s portfolio with the July 2021 acquisition of Alexion. The drug recorded sales of $2.97 billion in 2023, up 52% at constant exchange rates. Ultomiris sales are benefiting from label expansion for the gMG indication, expansion into new markets and continued conversion from Alexion’s older drug, Soliris.
Zacks Rank & Stocks to Consider
Currently, AstraZeneca has a Zacks Rank #3 (Hold).
In the past 60 days, 2024 estimates for Vanda Pharmaceuticals have narrowed from a loss of 46 cents to earnings of 1 cent. For 2025, loss estimates have narrowed from 94 cents to 48 cents per share in the past 60 days. In the past year, shares of VNDA have declined 43.3%.
Vanda Pharmaceuticals delivered a three-quarter average earnings surprise of 92.88%.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 92.5%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.
In the past 60 days, estimates for MorphoSys’ 2024 loss per share have narrowed from $2.26 to $2.08. Estimates for 2025 have narrowed from a loss of $1.09 per share to a loss of 89 cents per share. In the past year, shares of MOR have risen 357.2%.
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AstraZeneca's (AZN) Ultomiris Gets FDA Nod for New Indication
AstraZeneca (AZN - Free Report) announced that the FDA has approved its drug Ultomiris for a new rare neurological disease.
The approval for long-acting C5 complement inhibitor Ultomiris is for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). The approval makes Ultomiris the first and the only long-acting C5 complement inhibitor approved for AQP4 Ab+ NMOSD.
Patients with NMOSD experience unpredictable relapses, which can involve the onset of new neurological symptoms or the exacerbation of existing ones. These relapses tend to be severe and recurrent, often leading to permanent disability in affected individuals.
The approval of Ultomiris for AQP4 Ab+. NMOSD was based on data from the CHAMPION-NMOSD phase III study, which demonstrated that Ultomiris led to unprecedented relapse risk reduction in NMOSD patients. Zero relapses were observed among Ultomiris patients with a median treatment duration of 73 weeks.
In September last year, the FDA issued a complete response letter (CRL) to its supplemental biologics license application (sBLA) seeking approval for Ultomiris for the treatment of adult patients with AQP4 Ab+. NMOSD. However, the FDA did not request any additional analyses of data from the CHAMPION-NMOSD phase III study. It also did not raise any concerns about the efficacy and safety data from the study. The CRL rather requested modifications in the Ultomiris Risk Evaluation and Mitigation Strategy (REMS) safety program.
In the past year, the stock has declined 4.2% against the industry’s 26.9% rise.
Image Source: Zacks Investment Research
Ultomiris is already approved for the AQP4 Ab+ NMOSD indication in the EU and in Japan.
In the United States, Ultomiris is presently approved for treating three indications — generalized Myasthenia Gravis (gMG), paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Ultomiris was added to AstraZeneca’s portfolio with the July 2021 acquisition of Alexion. The drug recorded sales of $2.97 billion in 2023, up 52% at constant exchange rates. Ultomiris sales are benefiting from label expansion for the gMG indication, expansion into new markets and continued conversion from Alexion’s older drug, Soliris.
Zacks Rank & Stocks to Consider
Currently, AstraZeneca has a Zacks Rank #3 (Hold).
AstraZeneca PLC Price and Consensus
AstraZeneca PLC price-consensus-chart | AstraZeneca PLC Quote
Some top-ranked stocks in the healthcare sector are Vanda Pharmaceuticals (VNDA - Free Report) , ADMA Biologics (ADMA - Free Report) and MorphoSys , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, 2024 estimates for Vanda Pharmaceuticals have narrowed from a loss of 46 cents to earnings of 1 cent. For 2025, loss estimates have narrowed from 94 cents to 48 cents per share in the past 60 days. In the past year, shares of VNDA have declined 43.3%.
Vanda Pharmaceuticals delivered a three-quarter average earnings surprise of 92.88%.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 92.5%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.
In the past 60 days, estimates for MorphoSys’ 2024 loss per share have narrowed from $2.26 to $2.08. Estimates for 2025 have narrowed from a loss of $1.09 per share to a loss of 89 cents per share. In the past year, shares of MOR have risen 357.2%.