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IMVT Stock Falls 2.4% as Batoclimab Misses Late-Stage Study Endpoints
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Key Takeaways
Immunovant's phase III GO trials of batoclimab in TED miss their primary endpoints.
IMVT shares fell 2.4% on April 2 following the disappointing trial results.
Batoclimab showed consistent safety and better proptosis improvement in the high-dose phase.
Immunovant (IMVT - Free Report) reported top-line results from two phase III studies, known as the GO trials, evaluating batoclimab as an investigational treatment for adult patients with active, moderate-to-severe thyroid eye disease (TED). Both studies failed to achieve their primary endpoint. Shares fell 2.4% on April 2 following the announcement.
Under the HanAll Agreement, Immunovant is developing batoclimab in partnership with HanAll Biopharma. Per the deal, Immunovant holds exclusive rights to develop and commercialize batoclimab in key global markets, while HanAll remains the originator of the molecule and retains rights outside the licensed territory.
Year to date, Immunovant shares have lost 3.6% against the industry’s 5.7% growth.
Image Source: Zacks Investment Research
Key Highlights of IMVT’s Phase III Batoclimab Studies for TED
Based on the pre-specified statistical analysis plan, neither study evaluating batoclimab for TED patients met the primary endpoint of a 2 millimeters or greater proptosis responder rate at week 24, after 12 weeks of high-dose followed by 12 weeks of low-dose batoclimab treatment.
Despite the setback, the therapy demonstrated a safety profile consistent with prior studies, with no new safety concerns identified.
Notably, patients experienced greater improvements in proptosis from baseline during the initial 12-week high-dose treatment phase compared to the subsequent 12-week low-dose period, underscoring the potential advantage of achieving deeper IgG suppression.
Among hyperthyroid patients in the TED studies, thyroid hormone normalization rates were consistent with those observed in the phase II study of batoclimab in Graves’ disease (GD), reinforcing the therapy’s biological activity in this population.
Immunovant intends to review future development plans for batoclimab with its partner HanAll Biopharma and provide an update at a later date.
The company remains focused on advancing IMVT-1402, its investigational FcRn blocker, across multiple autoimmune diseases, with GD identified as a key strategic priority. Top-line data from potentially registrational IMVT-1402 studies in GD are expected in 2027.
IMVT’s Zacks Rank & Stocks to Consider
Immunovant currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. CPRX shares have gained 5.8% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. INDV shares have lost 15.1% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $8.14 to $8.99 for 2026. Year to date, shares of ANIP have declined 6%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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IMVT Stock Falls 2.4% as Batoclimab Misses Late-Stage Study Endpoints
Key Takeaways
Immunovant (IMVT - Free Report) reported top-line results from two phase III studies, known as the GO trials, evaluating batoclimab as an investigational treatment for adult patients with active, moderate-to-severe thyroid eye disease (TED). Both studies failed to achieve their primary endpoint. Shares fell 2.4% on April 2 following the announcement.
Under the HanAll Agreement, Immunovant is developing batoclimab in partnership with HanAll Biopharma. Per the deal, Immunovant holds exclusive rights to develop and commercialize batoclimab in key global markets, while HanAll remains the originator of the molecule and retains rights outside the licensed territory.
Year to date, Immunovant shares have lost 3.6% against the industry’s 5.7% growth.
Image Source: Zacks Investment Research
Key Highlights of IMVT’s Phase III Batoclimab Studies for TED
Based on the pre-specified statistical analysis plan, neither study evaluating batoclimab for TED patients met the primary endpoint of a 2 millimeters or greater proptosis responder rate at week 24, after 12 weeks of high-dose followed by 12 weeks of low-dose batoclimab treatment.
Despite the setback, the therapy demonstrated a safety profile consistent with prior studies, with no new safety concerns identified.
Notably, patients experienced greater improvements in proptosis from baseline during the initial 12-week high-dose treatment phase compared to the subsequent 12-week low-dose period, underscoring the potential advantage of achieving deeper IgG suppression.
Among hyperthyroid patients in the TED studies, thyroid hormone normalization rates were consistent with those observed in the phase II study of batoclimab in Graves’ disease (GD), reinforcing the therapy’s biological activity in this population.
Immunovant intends to review future development plans for batoclimab with its partner HanAll Biopharma and provide an update at a later date.
The company remains focused on advancing IMVT-1402, its investigational FcRn blocker, across multiple autoimmune diseases, with GD identified as a key strategic priority. Top-line data from potentially registrational IMVT-1402 studies in GD are expected in 2027.
IMVT’s Zacks Rank & Stocks to Consider
Immunovant currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals (ANIP - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. CPRX shares have gained 5.8% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. INDV shares have lost 15.1% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $8.14 to $8.99 for 2026. Year to date, shares of ANIP have declined 6%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.