AMGN Stock Falls Despite Upbeat Data on Immunology Drugs: Here's Why

Shares of Amgen AMGN fell by more than 5% on Wednesday after it reported top-line data on two different drugs in the autoimmune disease space. While the studies did meet their respective primary endpoints, Wall Street termed the results ‘lackluster’ and ‘underwhelming’.

At a conference call on Tuesday, Amgen posted top-line data from two late-stage studies — HORIZON and MINT. The HORIZON study evaluated an investigational anti-OX40 therapy rocatinlimab in atopic dermatitis (AD or eczema) indication. In the MINT study, management evaluated the rare disease drug Uplizna (inebilizumab) for label expansion in generalized myasthenia gravis (gMG) indication.

Amgen’s Eczema Study Results Fell Below Street Expectations

The HORIZON study showed that treatment with rocatinlimab achieved statistically significant improvements in its co-primary and key secondary endpoints. After 24 weeks, 32.8% of patients treated with the drug achieved EASI-75 (at least 75% reduction in disease severity) compared with 13.7% in the placebo group.

Wall Street was not impressed with these results and compared them with Sanofi SNY/Regeneron’s REGN blockbuster immunology drug Dupixent, which is also considered the standard of care in AD indication. While it is difficult to compare the results of two different clinical studies directly, multiple analysts pointed out the huge differences in numbers for EASI-75.

In two late-stage studies that supported the FDA’s approval of Dupixent in AD, 51% and 44% of people taking the SNY-REGN partnered drug achieved EASI-75 compared with 15% and 12%, respectively, in the placebo arm. Based on these results, analysts termed the HORIZON study results ‘modest’ or ‘below expectations’.

Amgen is developing rocatinlimab jointly with Japan-based Kyowa Kirin as part of a collaboration deal signed in 2021. As part of the deal, AMGN made an upfront payment of $400 million to Kyowa

The HORIZON study is one of the eight studies in the ROCKET program evaluating rocatinlimab in AD indication, with results from other studies expected in the coming quarters. Some analysts stated that it was unlikely that rocatinlimab could meet the bar set by the Sanofi/Regeneron drug based on the unfavorable difference in EASI-75 numbers.

AMGN Stock Performance

Year to date, Amgen’s shares have risen 8.6% against the industry’s 1.9% decline.

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Uplizna Study Results Lack Efficacy to Tackle Competition

The MINT study met its primary endpoint — treatment with Uplizna showed clinically meaningful and statistical significance in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scores. After 26 weeks, patients who received the drug showed a 1.9-point improvement over placebo.

Wall Street pointed out that the above results appeared less compelling compared with argenx’s ARGX Vyvgart/Vyvgart Hytrulo and UCB’s Rystiggo, which are some of the few most successful drugs in the gMG space. Per an analyst at Jefferies, treatment with the ARGX drug showed around 3.0-point improvement in MG-ADL scores over placebo, while the UCB drug showed nearly 2.6-point improvement.

Some analysts defended Uplizna, stating that it works in a different way than ARGX’s and UCB’s — Uplizna is designed to target CD19, while Vyvgart/Vyvgart Hytrulo and Rystiggo are FcRn blockers.

Uplizna is currently approved by the FDA to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease. The drug is a part of Amgen’s rare disease franchise and was added to its portfolio last year following the acquisition of Horizon Therapeutics for nearly $28 billion. The deal also added other rare disease drugs like Tepezza and Krystexxa to the company’s portfolio of marketed drugs.

Amgen Inc. Price

Amgen Inc. price | Amgen Inc. Quote

AMGN’s Zacks Rank

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

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