IMVT Unlikely to Pursue Batoclimab for MG & CIDP Despite Success

Immunovant IMVT announced top-line data from a late-stage study of its investigational candidate, batoclimab, for myasthenia gravis (MG) and initial results from Period 1 of a mid-stage study of the same candidate for chronic inflammatory demyelinating polyneuropathy (CIDP).IMVT’s Batoclimab Shows Superior Efficacy in MG PatientsThe phase III study is evaluating the efficacy and safety of batoclimab in adult patients with moderate to severe MG. Per the data readout, the study met its primary endpoint of mean change from baseline in the MG Activities of Daily Living (MG-ADL) score, used to determine the impact of weekly or bi-monthly doses of batoclimab, in acetylcholine receptor antibody positive (AChR+) patients after 12 weeks.Immunovant reported that MG patients who received the weekly 680mg subcutaneous dose of batoclimab achieved a 5.6-point improvement in MG-ADL and a 4.7-point improvement was observed in patients receiving the 340mg dose compared to a 3.6-point improvement in the placebo group at week 12. Please note that the MG-ADL score is an 8-item scale that measures the impact of MG symptoms on daily activities like chewing, speaking and breathing.MG is a chronic autoimmune neuromuscular disorder that causes muscle weakness and fatigue due to disrupted communication between nerves and muscles. It commonly affects the eyes, face, throat, and limbs, worsening with activity and improving with rest. It is often marked by elevated Immunoglobulin G (IgG) levels. In the phase III study, participants receiving the higher batoclimab doses experienced an average 74% reduction in IgG, while those on the lower dose observed a 64% reduction.Year to date, shares of Immunovant have plunged 23.8% against the industry’s 6.3% growth.Image Source: Zacks Investment ResearchIMVT’s CIDP Study Results of Batoclimab in DetailThe phase IIb study is evaluating batoclimab in CIDP patients whose disease had worsened during standard-of-care treatment. CIDP is a rare autoimmune neurological disorder that causes progressive muscle weakness and sensory loss due to damage to the peripheral nerves.The initial data readout, encompassing pooled data from 73 CIDP patients across all batoclimab dosing cohorts for the run-in Period 1 of the mid-stage study, showed a 1.8-point improvement in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score from baseline at week 12. Notably, 84% of patients with 70% IgG reduction or more, met the response criteria of ≥1-point aINCAT improvement.IMVT’s Next Plans in Developing a Product for MG and CIDPImmunovant reported that batoclimab demonstrated an acceptable safety and tolerability profile, consistent with that observed in prior clinical studies, in both MG and CIDP studies.Despite the encouraging data readout, IMVT announced that it does not intend to pursue regulatory approval for batoclimab in MG or CIDP. Instead, the company plans to use insights from the batoclimab studies to advance its lead candidate, IMVT-1402, programs. IMVT-1402 is a next-generation FcRn inhibitor.Immunovant will defer a final decision on batoclimab regulatory submissions until results from the ongoing phase III studies in thyroid eye disease are available.The company is currently gearing up to initiate potential registrational studies of IMVT-1402 for MG and CIDP, having already received the FDA’s thumbs up for both indications as previously disclosed. Per Immunovant, while the available anti-FcRn class of therapeutics has shown meaningful benefits for MG and CIDP patients, a significant unmet need remains. IMVT-1402, positioned as a potential best-in-class therapy, aims to provide deeper and longer-lasting clinical responses for MG, CIDP and other complex autoimmune diseases.Immunovant, Inc. Price and Consensus Immunovant, Inc. price-consensus-chart | Immunovant, Inc. QuoteZacks Rank & Stocks to ConsiderImmunovant currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks from the sector are Gilead Sciences GILD, Dynavax Technologies Corporation DVAX and Arvinas 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 30 days, Gilead Sciences’ earnings estimate for 2025 has improved from $7.80 to $7.87 per share. During the same timeframe, the estimate for earnings per share for 2026 has improved from $8.12 to $8.27. Year to date, shares of Gilead Sciences have gained 16.4%.GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.In the past 30 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. Year to date, shares of DVAX have gained 6.8%.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 30 days, estimates for Arvinas’ loss per share have widened from $3.73 to $3.75 for 2025. During the same time, loss per share has narrowed from $3.67 to $3.65 for 2026. Year to date, shares of ARVN have plunged 54.6%.ARVN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 32.56%.Zacks Names #1 Semiconductor StockIt's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.See This Stock Now for Free >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Dynavax Technologies Corporation (DVAX): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report Arvinas, Inc. (ARVN): Free Stock Analysis Report Immunovant, Inc. (IMVT): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks