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AMGN Posts Upbeat Data on Uplizna From Myasthenia Gravis Study
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Amgen (AMGN - Free Report) reported the latest data from the phase III MINT study that evaluated the rare disease drug Uplizna (inebilizumab) for label expansion in generalized myasthenia gravis (gMG) indication.
Data from the study showed that treatment with Uplizna ‘demonstrated durable and sustained efficacy’ in AChR-positive (AChR+) gMG patients over 52 weeks. These findings were assessed using the Myasthenia Gravis Activities of Daily Living (MG-ADL) scores, a patient-reported tool that measures the impact of the disease’s symptoms on a person's ability to perform daily activities. Patients treated with Uplizna for a year showed a 2.8-point improvement over placebo. Per Amgen, about 72% of AChR+ patients in the Uplizna group had an improvement of three or more points in the MG-ADL score compared to 45% in the placebo group.
There was also a change in the Quantitative Myasthenia Gravis (QMG) score, a physician assessment tool for quantifying disease severity. 69% of AChR+ patients treated with Uplizna showed an improvement of three or more points in the QMG score compared to nearly 42% in the placebo group.
Based on these results, Amgen intends to submit a regulatory filing for Uplizna with the FDA by the first half of 2025. This drug is currently approved in the country to treat adults with a rare autoimmune disease called neuromyelitis optica spectrum disorder.
A regulatory filing is currently under review with the FDA seeking approval for Uplizna in immunoglobulin G4-related disease (IgG4-RD) indication. A final decision is expected by April 3, 2025.
AMGN Stock Performance
Year to date, Amgen’s shares have risen more than 20% compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
What Makes Amgen’s MINT Study Results Encouraging?
Some Wall Street analysts also pointed out that the 52-week results also give Uplizna an edge over argenx’s (ARGX) Vyvgart/Vyvgart Hytrulo and UCB’s Rystiggo, which are some of the few most successful drugs in the gMG space. Unlike the ARGX and UCB drugs, which require once-weekly dosing, the AMGN drug requires dosing once every six months. Uplizna has also been granted orphan drug designation by the FDA in the gMG indication.
Uplizna is part of Amgen’s rare disease franchise and was added to its portfolio following the acquisition of Horizon Therapeutics for nearly $28 billion in 2023. The deal also added other rare disease drugs like Tepezza and Krystexxa to the company’s portfolio of marketed drugs.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.00 during the same period. Year to date, shares of ANIP have risen 13%.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 17.32%.
In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to earnings of 25 cents. During the same timeframe, estimates for loss per share for 2026 have narrowed from 65 cents to 50 cents. Year to date, shares of CytomX have lost nearly 37%.
CTMX’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 180.70%.
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AMGN Posts Upbeat Data on Uplizna From Myasthenia Gravis Study
Amgen (AMGN - Free Report) reported the latest data from the phase III MINT study that evaluated the rare disease drug Uplizna (inebilizumab) for label expansion in generalized myasthenia gravis (gMG) indication.
Data from the study showed that treatment with Uplizna ‘demonstrated durable and sustained efficacy’ in AChR-positive (AChR+) gMG patients over 52 weeks. These findings were assessed using the Myasthenia Gravis Activities of Daily Living (MG-ADL) scores, a patient-reported tool that measures the impact of the disease’s symptoms on a person's ability to perform daily activities. Patients treated with Uplizna for a year showed a 2.8-point improvement over placebo. Per Amgen, about 72% of AChR+ patients in the Uplizna group had an improvement of three or more points in the MG-ADL score compared to 45% in the placebo group.
There was also a change in the Quantitative Myasthenia Gravis (QMG) score, a physician assessment tool for quantifying disease severity. 69% of AChR+ patients treated with Uplizna showed an improvement of three or more points in the QMG score compared to nearly 42% in the placebo group.
Based on these results, Amgen intends to submit a regulatory filing for Uplizna with the FDA by the first half of 2025. This drug is currently approved in the country to treat adults with a rare autoimmune disease called neuromyelitis optica spectrum disorder.
A regulatory filing is currently under review with the FDA seeking approval for Uplizna in immunoglobulin G4-related disease (IgG4-RD) indication. A final decision is expected by April 3, 2025.
AMGN Stock Performance
Year to date, Amgen’s shares have risen more than 20% compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
What Makes Amgen’s MINT Study Results Encouraging?
The latest MINT study results are a significant improvement over the previous 26-week readout reported from the study last year. At the time, Amgen reported that gMG patients who received the drug for 26 weeks showed a 1.9-point improvement over placebo.
Some Wall Street analysts also pointed out that the 52-week results also give Uplizna an edge over argenx’s (ARGX) Vyvgart/Vyvgart Hytrulo and UCB’s Rystiggo, which are some of the few most successful drugs in the gMG space. Unlike the ARGX and UCB drugs, which require once-weekly dosing, the AMGN drug requires dosing once every six months. Uplizna has also been granted orphan drug designation by the FDA in the gMG indication.
Uplizna is part of Amgen’s rare disease franchise and was added to its portfolio following the acquisition of Horizon Therapeutics for nearly $28 billion in 2023. The deal also added other rare disease drugs like Tepezza and Krystexxa to the company’s portfolio of marketed drugs.
AMGN’s Zacks Rank
Amgen currently carries a Zacks Rank #3 (Hold).
Amgen Inc. Price
Amgen Inc. price | Amgen Inc. Quote
Key Biotech Stock Picks
Some better-ranked stocks from the sector are ANI Pharmaceuticals (ANIP - Free Report) and CytomX Therapeutics (CTMX - Free Report) , each sporting 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 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.00 during the same period. Year to date, shares of ANIP have risen 13%.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 17.32%.
In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to earnings of 25 cents. During the same timeframe, estimates for loss per share for 2026 have narrowed from 65 cents to 50 cents. Year to date, shares of CytomX have lost nearly 37%.
CTMX’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 180.70%.