Johnson & Johnson JNJ announced that the FDA has granted a Fast Track designation (“FTD’) to its investigational drug, nipocalimab, for treating adult patients with moderate-to-severe Sjögren’s disease (“SjD”), a chronic autoimmune disease.

Currently, there are no advanced therapies approved by the FDA for the given indication.

The Fast Track designation from the FDA facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.

Besides SjD, the FDA has granted FTD to nipocalimab in three other indications, hemolytic disease of the fetus and newborn (“HDFN”) and warm autoimmune hemolytic anemia (wAIHA), generalized myasthenia gravis (gMG) and fetal neonatal alloimmune thrombocytopenia.

The FDA granted Breakthrough Therapy designation to nipocalimab for SjD in November 2024. In February this year, J&J announced positive top-line data from a phase II study in SjD. Nipocalimab met the primary endpoint of the phase II DAHLIAS dose-ranging study in SjD. J&J is now enrolling patients in the phase III DAFFODIL study.

JNJ Stock's Performance

In the past year, J&J’s shares have gained 5.4% against the industry’s decline of 4.3%.

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JNJ's Nipocalimab Nearing Potential Approval for gMG

A biologics license application (“BLA”) seeking approval for nipocalimab is currently under review for treating gMG.

The FDA accepted J&J’s regulatory filing seeking approval for nipocalimab in gMG indication in January 2025.

The BLA has been granted priority review by the FDA. We expect a final decision from the regulatory body in the third quarter of 2025.

The filing is supported by data from the phase III Vivacity-MG3 study, gMG is an autoantibody-driven neuromuscular disease marked by fluctuating muscle weakness.

JNJ's Nipocalimab Development Plans

Besides gMG and SjD, J&J is also developing nipocalimab in separate mid to late-stage clinical studies for treating autoantibody-driven rare diseases.

The company is evaluating nipocalimab in late-stage studies for chronic inflammatory demyelinating polyneuropathy, HDFN and wAIHA. The candidate is also being evaluated in separate mid-stage studies for idiopathic inflammatory myopathy and systemic lupus erythematosus.

Nipocalimab was added to J&J’s pipeline following the acquisition of Momenta Pharmaceuticals in 2020.

JNJ's Zacks Rank & Stocks to Consider

J&J currently carries a Zacks Rank #3 (Sell).

Some better-ranked stocks in the biotech sector are Gilead Sciences, Inc. GILD, Dynavax Technologies Corporation DVAX and Arvinas Inc ARVN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.56 to $7.87 for 2025. During the same time, earnings per share have increased from $7.76 to $8.27 for 2026. In the past year, shares of GILD have rallied 49%.

GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.

In the past 60 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share have increased from 49 cents to 57 cents for 2026. In the past year, shares of DVAX have rallied 14.9%.

DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.

In the past 60 days, estimates for Arvinas’ loss per share have narrowed from $4.42 to $3.75 for 2025. During the same time, loss per share has narrowed from $4.19 to $3.65 for 2026. In the past year, shares of ARVN have plunged 80.9%.

ARVN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 32.56%.

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