Immunovant, Inc. (NASDAQ:IMVT) is one of the best biotech stocks with high potential. On September 30, JPMorgan analyst Brian Cheng lowered the firm’s price target on Immunovant, Inc. (NASDAQ:IMVT) to $33 from $37 while keeping an Overweight rating on the shares. Is Immunovant, Inc. (IMVT) The Most Undervalued Stock With Smart Money Ratings? Immunovant, Inc. (NASDAQ:IMVT) reported that its cash and cash equivalents totaled approximately $598.9 million in the quarter ending June 30, 2025, providing runway ...

Core Insights - Roivant Sciences Ltd and Priovant Therapeutics announced positive results from the Phase 3 VALOR study for brepocitinib in treating dermatomyositis, marking a significant advancement in targeted therapy for this chronic autoimmune disorder [1][4]. Group 1: Study Results - Brepocitinib 30 mg showed a statistically significant improvement on the primary endpoint with a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006) [2][3]. - The treatment demonstrated clinically meaningful improvements across all nine key secondary endpoints, including skin and muscle disease metrics, steroid-sparing effects, and rapidity of onset [2][4]. Group 2: Patient Background and Outcomes - Approximately 75% of patients in the VALOR study were on background steroids, with a mean baseline dose of 12.2 mg/day in the brepocitinib group and 11.3 mg/day in the placebo group [5]. - Among those on steroids, 62% of brepocitinib patients reduced their steroid dose to ≤2.5 mg/day by the end of the study, compared to 34% for placebo, and 42% of brepocitinib patients were able to discontinue steroids entirely, versus 23% for placebo [5]. Group 3: Safety and Future Plans - The safety profile of brepocitinib 30 mg was consistent with previous clinical trials, indicating a favorable safety outcome [6]. - Priovant plans to file a New Drug Application (NDA) for brepocitinib in dermatomyositis in the first half of 2026 [6].

Group 1 - Roivant has been recognized as one of the 2025 Fortune Best Workplaces in BioPharma, ranking 28th in the small & medium category, marking its first appearance on this prestigious list [1][3] - The award is based on survey responses from nearly 40,000 employees at Great Place To Work Certified companies in the biotechnology and pharmaceutical industry, reflecting a comprehensive picture of workplace experiences [2][4] - The selection process involved over 1.3 million survey responses from employees across the U.S., with rankings derived from 60 employee experience questions within the Great Place To Work Trust Index™ Survey [5] Group 2 - The recognition highlights Roivant's commitment to fostering an empowering, high-performance, and talent-oriented culture, as stated by the CEO [3] - The Best Workplaces in BioPharma list is highly competitive, with companies evaluated on their ability to provide positive outcomes for employees across various demographic identifiers [4][5] - Roivant is a biopharmaceutical company focused on accelerating the development and commercialization of impactful medicines, with a diverse pipeline targeting various medical conditions [10][11]

Core Viewpoint - Immunovant, Inc. has seen a 7.8% increase in share price since the last earnings report, outperforming the S&P 500, but there are concerns about whether this positive trend will continue leading up to the next earnings release [1]. Financial Performance - For Q1 fiscal 2026, Immunovant reported an adjusted net loss of $0.60 per share, which was narrower than the Zacks Consensus Estimate of a loss of $0.69 per share, and consistent with the loss reported in the same quarter last year [2]. - Research and development expenses reached $101.2 million, a 34% increase from the previous year, primarily due to clinical studies for IMVT-1402 and increased personnel costs, partially offset by lower costs related to batoclimab studies [3]. - General and administrative expenses were $26 million, up 38% year-over-year, mainly due to higher personnel-related expenses [4]. - As of June 30, 2025, Immunovant had a cash balance of $598.9 million, down from $714 million as of March 31, 2025, with expectations to fund clinical activities through 2027 [4]. Market Sentiment and Estimates - There has been a downward trend in fresh estimates for Immunovant over the past month [5]. - The company currently holds a Zacks Rank of 3 (Hold), indicating expectations for an in-line return in the coming months [7]. Industry Comparison - Immunovant operates within the Zacks Medical - Biomedical and Genetics industry, where competitor Alkermes (ALKS) has seen a 1.5% gain over the past month [8]. - Alkermes reported revenues of $390.66 million for the last quarter, reflecting a year-over-year decline of 2.1%, with an expected EPS of $0.41 for the current quarter, down 43.8% year-over-year [9].

Core Insights - Immunovant, Inc. (IMVT) shares increased by 10.8% following the announcement of six-month off-treatment results from a proof-of-concept study for batoclimab in patients with uncontrolled Graves' disease (GD) [1][4] - The study demonstrated that approximately 80% of patients maintained normalized thyroid hormone levels during the follow-up period, indicating strong durability of response [3][4] Study Details - The proof-of-concept study involved patients with active GD who had elevated thyroid hormone levels despite antithyroid drug (ATD) therapy. The primary endpoint was the normalization or reduction of thyroid hormone levels without increasing ATD dosage at week 24 [2] - Among the responders, about half achieved ATD-free remission, while 30% required only minimal ATD doses of 2.5 mg/day [6] Implications and Future Plans - The findings suggest that FcRn blockade may provide a promising therapeutic approach for GD, with potential for disease modification as several patients achieved durable remission after treatment withdrawal [7] - Immunovant plans to leverage the batoclimab data to expedite the development of its lead candidate, IMVT-1402, which is also aimed at treating GD [8] - The company has initiated two global studies for IMVT-1402, evaluating a 600 mg dose for up to 52 weeks, with top-line results expected in 2027 [9]

Core Insights - Immunovant's shares increased nearly 11% following positive laboratory results, outperforming the S&P 500's 0.5% rise [1] Group 1: Clinical Study Results - Immunovant presented data from a proof-of-concept study for its investigational drug batoclimab, targeting Grave's disease, an autoimmune disorder characterized by excessive thyroid hormone production [2] - The study lasted almost one year, with 17 out of 21 patients maintaining normal thyroid function six months post-treatment, and 8 of these patients no longer requiring anti-thyroid medications [4] Group 2: Management and Future Prospects - CEO Eric Venker stated that the data could be transformative for patients and practice-changing for physicians if approved by the FDA, addressing a significant unmet need in Grave's disease [5] - Batoclimab is being explored for other conditions, including Sjögren's syndrome, indicating the drug's potential flexibility and broader application [5]

Core Insights - Immunovant, Inc. presented six-month off-treatment data for batoclimab in uncontrolled Graves' disease patients, indicating potential disease modification and strong durability of response [1][2][3] Study Details - The proof-of-concept study involved a 24-week treatment with batoclimab, followed by a 24-week off-treatment follow-up, focusing on patients with active Graves' disease [3][4] - Key endpoint was the normalization of free triiodothyronine (T3) and free thyroxine (T4) levels at Week 24 without increasing anti-thyroid drug (ATD) doses from baseline [3] Remission Data - Out of 21 patients in the follow-up, approximately 80% (17/21) maintained normal thyroid function after six months off treatment [6][7] - Among responders, about 50% (8/17) achieved ATD-free remission, while an additional 30% (5/17) were on low ATD doses [6][7] Future Trials - Two potentially registrational trials for IMVT-1402 in Graves' disease are currently enrolling, with topline readouts expected in 2027 [5][6]

Core Insights - Immunovant, Inc. presented six-month off-treatment data for batoclimab in uncontrolled Graves' disease patients, indicating potential disease modification and strong durability of response [1][2][3] Study Details - The proof-of-concept study involved a 24-week treatment with batoclimab, followed by a 24-week off-treatment follow-up, focusing on patients with active Graves' disease [3][4] - The key endpoint was the normalization of free triiodothyronine (T3) and free thyroxine (T4) levels without increasing anti-thyroid drug (ATD) doses from baseline [3] Remission Data - Out of 21 patients in the follow-up period, approximately 80% (17/21) maintained normal thyroid function at the end of six months [6][7] - Among the responders, about 50% (8/17) achieved ATD-free remission, while an additional 30% (5/17) were on low ATD doses [6][7] Future Trials - Two potentially registrational trials for Immunovant's lead compound IMVT-1402 in Graves' disease are currently enrolling, with topline readouts expected in 2027 [5][6]

Core Insights - Immunovant, Inc. reported a first-quarter fiscal 2026 adjusted net loss of $0.60 per share, which is narrower than the Zacks Consensus Estimate of a loss of $0.69 and matches the loss from the same quarter last year [1][4] Financial Performance - Research and development expenses reached $101.2 million, reflecting a 34% increase from the previous year, driven by clinical study activities for IMVT-1402 and higher personnel costs, partially offset by reduced costs in batoclimab studies [2] - General and administrative expenses were $26 million, up 38% year over year, primarily due to increased personnel-related expenses [3] - As of June 30, 2025, the company had a cash balance of $598.9 million, down from $714 million as of March 31, 2025, with expectations to fund clinical activities through 2027 [3] Pipeline Developments - IMVT-1402 is the lead drug candidate, being studied for six indications, with key data readouts expected through 2027 [4][6] - The company plans to initiate clinical studies for IMVT-1402 in a total of 10 indications by March 31, 2026, leveraging existing data from batoclimab studies for financial efficiencies [5] - During the first quarter of fiscal 2026, Immunovant initiated a second potentially registrational study of IMVT-1402 for Graves' disease and a study for Sjögren's disease [7] Upcoming Milestones - In 2026, the company plans to share open-label data from its difficult-to-treat rheumatoid arthritis study and top-line results from the cutaneous lupus erythematosus proof-of-concept study [7] - Top-line results from potentially registrational studies in difficult-to-treat rheumatoid arthritis, Graves' disease, and myasthenia gravis are expected in 2027 [7] Additional Candidates - Immunovant is also evaluating batoclimab in mid-late-stage studies for Graves' disease and thyroid eye disease, with new proof-of-concept data expected to be reported in September 2025 [8][10]

Business Highlights - Roivant completed a $1.5 billion share repurchase program in June 2025, repurchasing approximately 149 million shares at an average price of $10.09, reducing the share count by over 15%[23] - The company expanded its pipeline by initiating 6 potentially registrational studies and 3 proof-of-concept (POC) studies[23] - Roivant increased shareholder exposure to clinical and litigation catalysts over the next 36 months[23] Brepocitinib Program - Topline data from the Phase 3 VALOR study of brepocitinib in dermatomyositis (DM) is expected in the second half of 2025[20, 27] - The VALOR study enrolled 241 adults with active DM, with 38% from the US, 32% from the EU, and 30% from the rest of the world[35] - Approximately 40% of subjects taking oral corticosteroids (OCS) at baseline in the VALOR study were able to eliminate OCS entirely by the end of the study[45] LNP Litigation - Summary judgment phase is ongoing in the US Moderna case, with a jury trial scheduled for March 2026[18, 27, 52] - Ongoing progress is expected in the Pfizer/BioNTech case following the Markman hearing, with a decision potentially in 2025[18, 27, 52] Financial Update - Research and development (R&D) expense was $153 million, with an adjusted R&D expense of $141 million (non-GAAP)[58] - General and administrative (G&A) expense was $134 million, with an adjusted G&A expense of $63 million (non-GAAP)[58] - Roivant had $4.5 billion in cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2025[58]