J&J Ends Imaavy Development in Rheumatoid Arthritis Post Study Failure

Johnson & Johnson JNJ announced that it is discontinuing the development of an investigational combination therapy involving Imaavy (nipocalimab) in the rheumatoid arthritis (RA) indication.

This decision is based on findings from the phase IIa DAISY proof-of-concept study, which tested Imaavy in combination with an anti-tumor necrosis factor alpha (anti-TNFα) in RA patients with refractory disease. The study results did not show “sufficient evidence” that the combo treatment provided a significant added benefit compared with anti-TNFα therapy alone. J&J did not report any safety concerns in the study.

Imaavy is the first and only neonatal Fc receptor (FcRn) blocker approved by the FDA to treat generalized myasthenia gravis (gMG) in patients aged 12 years and older who are anti-AChR and anti-MuSK antibody positive. This approval was secured by J&J in April.

JNJ Stock Performance

Year to date, the stock has gained 21% against the industry’s nearly 1% decline.

J&J Reiterates $5B+ Sales Potential With Imaavy

Despite the setback in RA indication, the pharma giant assured investors that it still expects Imaavy to be a potential key driver of top-line growth. J&J believes the drug is one of the ten new Innovative Medicine products that have the potential to deliver peak sales of $5 billion. This list of potential blockbusters also includes new cancer drugs like Talvey and Tecvayli, a newly acquired drug, Caplyta and pipeline candidates like TAR-200 and icotrokinra.

J&J is evaluating the drug in an ongoing clinical program across several immunology and neuroscience indications. This includes late-stage studies for chronic inflammatory demyelinating polyneuropathy (CIDP), hemolytic disease of the fetus and newborn (HDFN), warm autoimmune hemolytic anemia (wAIHA) and Sjogren's disease.

Imaavy is also being evaluated in separate mid-stage studies for idiopathic inflammatory myopathy and systemic lupus erythematosus indications.

JNJ’s Zacks Rank

J&J currently carries a Zacks Rank #2 (Buy).

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Other Key Picks Among Biotech Stocks

Some other better-ranked stocks from the sector are ANI Pharmaceuticals ANIP and CorMedix CRMD, 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 $6.51 to $7.25. EPS estimates for 2026 have increased from $7.05 to $7.74 during the same period. Year to date, shares of ANIP have surged over 67%.

ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 22.66%.

Estimates for CorMedix’s 2025 EPS have increased from 93 cents to $1.22 over the past 60 days, while the same for 2026 has increased from $1.64 to $2.12. CRMD shares have soared 77% year to date.

CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.

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This article originally published on Zacks Investment Research (zacks.com).

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