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IMVT Ends Cutaneous Lupus Erythematosus Program, Stock Down
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Key Takeaways
IMVT halted its CLE program after IMVT-1402 failed to meet statistical significance on the primary endpoint.
IMVT-1402 was generally well-tolerated, with a favorable safety profile consistent with prior studies.
IMVT-1402's other autoimmune disease programs remain on track, with key data expected in 2027 and 2028.
Immunovant (IMVT - Free Report) announced top-line data from a proof-of-concept study that evaluated its lead and sole pipeline asset, IMVT-1402 (imeroprubart), a next-generation neonatal fragment crystallizable receptor (FcRn) inhibitor, for the treatment of cutaneous lupus erythematosus (CLE).
CLE is a rare, chronic skin disease that causes inflammation, rashes, painful lesions, itching, burning and hair loss, often triggered by sun exposure.
IMVT’s CLE Study Misses Primary Endpoint
The randomized, double-blind, placebo-controlled global study (NCT06980805) assessed the safety and efficacy of IMVT-1402 versus placebo over a 12-week treatment period in 57 adults with CLE. The primary endpoint was the percent change in the cutaneous lupus erythematosus disease area and severity index activity score at week 12 from baseline.
The study failed to achieve statistical significance on the primary endpoint. However, positive trends were observed across multiple efficacy measures, with greater reductions in IgG antibody levels associated with improved clinical outcomes.
IMVT-1402 was generally well-tolerated and demonstrated a favorable safety profile, consistent with findings from previous clinical studies.
Despite these encouraging trends, the results did not meet Immunovant’s internal criteria to support further development of IMVT-1402 in CLE. Consequently, the company stopped the program.
The decision to discontinue the CLE program disappointed investors and contributed to a 7.4% decline in IMVT shares on Wednesday.
Year to date, the stock has gained 35.9% compared with the industry’s 9.5% growth.
Image Source: Zacks Investment Research
Immunovant’s Broader Pipeline Remains on Track
The timeline for Immunovant’s other clinical development programs remains on track.
The company is evaluating IMVT-1402 across multiple autoimmune diseases, including Graves’ disease (GD), difficult-to-treat rheumatoid arthritis, myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren's disease (SjD).
Top-line data from potentially registrational clinical studies evaluating IMVT-1402 for the treatment of patients with GD and MG are anticipated in 2027. The company expects to report data from the registrational studies of IMVT-1402 in CIDP and SjD in 2028.
IMVT’s Zacks Rank & Stocks to Consider
Immunovant currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have gained 78% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 9.9% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 74% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
View the Zacks #1 Rank List
Image: Bigstock
IMVT Ends Cutaneous Lupus Erythematosus Program, Stock Down
Key Takeaways
Immunovant (IMVT - Free Report) announced top-line data from a proof-of-concept study that evaluated its lead and sole pipeline asset, IMVT-1402 (imeroprubart), a next-generation neonatal fragment crystallizable receptor (FcRn) inhibitor, for the treatment of cutaneous lupus erythematosus (CLE).
CLE is a rare, chronic skin disease that causes inflammation, rashes, painful lesions, itching, burning and hair loss, often triggered by sun exposure.
IMVT’s CLE Study Misses Primary Endpoint
The randomized, double-blind, placebo-controlled global study (NCT06980805) assessed the safety and efficacy of IMVT-1402 versus placebo over a 12-week treatment period in 57 adults with CLE. The primary endpoint was the percent change in the cutaneous lupus erythematosus disease area and severity index activity score at week 12 from baseline.
The study failed to achieve statistical significance on the primary endpoint. However, positive trends were observed across multiple efficacy measures, with greater reductions in IgG antibody levels associated with improved clinical outcomes.
IMVT-1402 was generally well-tolerated and demonstrated a favorable safety profile, consistent with findings from previous clinical studies.
Despite these encouraging trends, the results did not meet Immunovant’s internal criteria to support further development of IMVT-1402 in CLE. Consequently, the company stopped the program.
The decision to discontinue the CLE program disappointed investors and contributed to a 7.4% decline in IMVT shares on Wednesday.
Year to date, the stock has gained 35.9% compared with the industry’s 9.5% growth.
Image Source: Zacks Investment Research
Immunovant’s Broader Pipeline Remains on Track
The timeline for Immunovant’s other clinical development programs remains on track.
The company is evaluating IMVT-1402 across multiple autoimmune diseases, including Graves’ disease (GD), difficult-to-treat rheumatoid arthritis, myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren's disease (SjD).
Top-line data from potentially registrational clinical studies evaluating IMVT-1402 for the treatment of patients with GD and MG are anticipated in 2027. The company expects to report data from the registrational studies of IMVT-1402 in CIDP and SjD in 2028.
IMVT’s Zacks Rank & Stocks to Consider
Immunovant currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have gained 78% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 9.9% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 74% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.