Brepocitinib

First-ever potentially disease-modifying therapy for uncontrolled Graves’ disease patients Of 21 patients who entered the six-month off-treatment follow-up period, ~80% (17/21) demonstrated response, resulting in normal thyroid function (T3 and T4 less than the upper limit of normal) at the end of the six-month follow-up period Of the 17 responders to therapy, ~50% (8/17) achieved anti-thyroid drug (ATD) free remission at six months following end of batoclimab treatment Two potentially registrational trials for IMVT-1402 in Graves’ disease are currently enrolling with topline readouts expected in 2027 Roivant to host investor call to discuss these updates today, September 3, 2025, at 4:30 p.m. EDT NEW YORK, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today shared an abstract with six-month off-treatment data in uncontrolled Graves’ disease (GD) patients treated with batoclimab for 24 weeks, to be presented at the 2025 Annual Meeting of the American Thyroid Association (ATA) on September 11, 2025. “These novel and encouraging results support FcRn blockade as a potentially effective mechanism for the treatment of Graves’ disease, with the six-month remission data providing evidence of potential disease modification,” said George Kahaly, M.D., Ph.D., Lead Principal Investigator. “We are incredibly excited to present these remission data demonstrating strong durability of response and ATD-free remission in previously uncontrolled patients off-treatment for six months,” said Eric Venker, M.D., Pharm.D., CEO of Immunovant. “We believe these data have the potential to be transformative for patients and practice-changing for physicians, if approved by FDA, by addressing a significant unmet need in Graves’ disease.” Graves’ Disease Proof-of-Concept Study Six-month off-treatment data was generated from a proof-of-concept study of batoclimab in Graves’ disease. Batoclimab is Immunovant’s first generation fully human monoclonal antibody targeting FcRn. The study included a 24-week treatment period with a dose step-down (Weeks 0-12 at 680 mg weekly (QW) subcutaneously (SC) and Weeks 12-24 at 340 mg QW SC), followed by a 24-week off-treatment follow-up period. The study included patients with active Graves’ disease as documented by presence of elevated thyrotropin receptor autoantibodies (TRAb) and hyperthyroid despite ATD therapy. The key endpoint of the study is the proportion of participants who achieve normalization of free triiodothyronine (T3) and free thyroxine (T4) or have T3 / T4 below the lower limit of normal (LLN) at Week 24, without an increase in ATD dose from baseline. Graves’ Disease Six-month Remission Data 25 patients were enrolled in the treatment period with 21 patients entering the off-treatment 24-week follow-up period to be assessed for remission: At Week 48, or the end of the six-month follow-up period (patients off-treatment for 24 weeks), ~80% (17/21) patients maintained T3/T4 values ≤ upper limit of normal (ULN), indicating strong durability of response through six months off treatment Of these 17 patients, ~50% (8/17) were in ATD free-remission and an incremental ~30% (5/17) were on ATD doses of 2.5 mg/day following six months off treatment, even with batoclimab’s suboptimal step-down dosing design during the treatment period Safety and tolerability were observed to be consistent with prior batoclimab studies IMVT-1402 Registrational Trial Design Two potentially registrational trials of Immunovant’s lead compound IMVT-1402 in Graves’ disease will evaluate 600 mg dose for up to 52 weeks without a step-down in dose. The two potentially registrational global trials for IMVT-1402 in Graves’ disease are currently enrolling with topline readouts expected in 2027. Investor Conference Call Information Roivant will host a live conference call and webcast at 4:30 p.m. EDT on Wednesday, September 3, 2025, to discuss these Immunovant data. To access the conference call by phone, please register online using this registration link. The presentation and webcast details are available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About Immunovant, Inc. Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. Forward-Looking Statements This presentation contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” "intend," "anticipate," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include Immunovant’s expectations regarding the clinical and therapeutic benefits of its product candidates, including durability of response, efficacy, tolerability and the potential for disease modification and first-in-class potential; patient enrollment, timing, design, progress, scope and results of its existing and planned clinical trials, including the potential registrational trials for IMVT-1402 in Graves’ disease and whether the trial designs will result in improved efficacy data; future development of IMVT-1402 and batoclimab, including the timing and likelihood of expansion into additional indications; the evolution of the treatment paradigm for Graves’ disease in North America; the size and growth of the potential markets for Immunovant's product candidates and indication selections, including any estimated market opportunities; expectations regarding the receipt of regulatory approval for its product candidates; and whether, if approved, IMVT-1402 or batcolimab will be successfully distributed, marketed or commercialized. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: initial results or other preliminary analyses or results of early clinical trials may not be predictive of final trial results or of the results of later clinical trials; results of animal studies may not be predictive of results in humans; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this presentation; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the effect of global factors such as geopolitical tensions and adverse macroeconomic conditions on Immunovant’s business operations and supply chains, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of batoclimab and IMVT-1402; Immunovant is in various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 11, 2025, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit https://roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: Investors Keyur Parekh keyur.parekh@roivant.com Media Stephanie Lee stephanie.lee@roivant.com

iStock, juliannafunk Some of the biggest SPACs from the industry’s pandemic-fueled heyday are no longer on the market. 2021 was a wild year for the biotech public stock market. Across the U.S. and Europe, more than 100 startups went for their initial public offerings while another large batch took a different track—merging with a special purpose acquisition company, also known as the SPAC track. Also called blank-check companies, SPACs work by raising capital via an IPO that they then let sit in trust accounts. Eventually, SPACs can leverage this funding to merge with a promising private company in a deal that not only brings the target company to the public stock market but infuses it with a hefty sum of money. During the heyday of 2021—when the industry was flush with pandemic-driven investments—SPACs presented a quick and comparatively easy way to raise money and go public. SPACs typically come with lower upfront costs than traditional initial public offerings (IPOs) and allow companies to collect even more capital through private investment in public equity (PIPE) placements. IPOs, on the other hand, take longer to complete and are burdened by upfront underwriting and legal fees. But the market has since cooled and contracted . With investors driven away by macro-level uncertainties, dozens of companies have already closed shop while many more are in a precarious position . In this piece, BioSpace checks in on some standout SPACs of 2021, looking at how they’ve fared over the years, and how they’re weathering the current market turbulence. Roivant SPAC Date: October 2021 Value: $611 million Roivant debuted on Nasdaq on Oct. 1, 2021 , via a merger with Montes Archimedes Acquisition Corp. The deal gave the burgeoning biotech access to the blank-check company’s $411 million trust fund and $200 million in a PIPE placement. All told, the SPAC deal put Roivant’s cash position at around $2.5 billion . Roivant has used this money to step-up its subsidiary strategy—forming nimble and focused “ Vants ” dedicated to developing novel therapies. Months after completing its SPAC, for instance, the biotech teamed up with Pfizer and in June 2022 launched Priovant Therapeutics to advance brepocitinib, an orally available and selective TYK2 and JAK1 inhibitor for the treatment of autoimmune disorders such as systemic lupus erythematosus and dermatomyositis. Later that year, Roivant and Pfizer debuted another Vant , this time to work on an anti-TL1A antibody for ulcerative colitis. The subsidiary, dubbed Telavant, was acquired by Roche in October 2023 for $7.1 billion upfront . Also in 2022, Roivant scored its first FDA approval for Dermavant’s VTAMA cream, indicated for plaque psoriasis in adults. Two years later, in September 2024, Organon acquired Dermavant in a potential $1.2 billion agreement. That same month, Roivant launched another subsidiary , called Pulmovant, tasked with working on mosliciguat, an inhalable therapy for pulmonary hypertension associated with interstitial lung disease. Since debuting, Roivant’s shares have increased 28% with a market cap of $8.36 billion. EQRx SPAC Date: August 2021 Value: $1.8 billion EQRx launched in 2020 with $200 million in series A money and a lofty goal: change the drug discovery process to develop medicines that are more affordable. In August 2021, CM Life Sciences III, Inc threw its weight behind this mission with a hefty SPAC deal , not only carrying EQRx to the public stock exchange but also providing a $1.8 billion cash infusion. The problems started over a year later, in November 2022, when development plans for the PD-L1 blocker sugemalimab hit a rough patch. In talks with the FDA, EQRx was told that interim findings from its Phase III GEMSTONE-302 trial, conducted in China, would not be enough to support a regulatory filing for U.S. approval. The company at the time decided that there was “no commercially viable path” for sugemalimab in the U.S. EQRx was forced to abandon plans for a test in stage IV non-small cell lung cancer. A few months later, in February 2023, in an effort to “increase . . . operational efficiencies and streamline expenses,” EQRx downsized by 18% , a move that the company expected to generate $18 million in annualized savings. The company ramped up the restructuring process in May that same year with a sweeping business reset , laying off half its headcount and junking another cancer asset. Most notably, EQRx shifted focus to become a more cookie-cutter drug development company, “developing clinically differentiated, high-value medicines,” then-CEO Melanie Nallicheri said in a statement at the time. But even this pivot failed to turn EQRx’s business around. In August 2023, EQRx was absorbed by Revolution Medicines and is no longer trading on Nasdaq. 23andMe SPAC Date: June 2021 Value: $592 million The last few months have been difficult for DNA testing company 23andMe. In March, the company filed for Chapter 11 bankruptcy , seeking for court supervision as it sells its business. This is a far cry from four years earlier, when 23andMe debuted on the public stock market in a SPAC deal with VG Acquisition Corp in June 2021. The agreement raised a gross of $592 million for the consumer genetics company and bumped up its value to $3.5 billion . Shortly after landing on Nasdaq, 23andMe hit its peak market value of approximately $6 billion . Things soon went south, however, as 23andMe struggled to cope with rising interest rates and sales slumps. By the end of fiscal year 2022, the company hit a $184 million net loss , which ballooned to $312 million in 2023 . To stanch the cash bleed, 23andMe in November 2024 put in motion a sweeping restructuring initiative , involving a 40% layoff and a pivot away from drug development efforts. The company at the time expected these measures to generate $35 million in savings annually. Aside from a capital crunch, 23andMe was beset with privacy problems. In October 2023, hackers breached the company’s system and were able to access data of some 6.9 million people. In June this year, 23andMe and its sale were at the heart of a Senate Oversight Committee hearing that highlighted “serious national security” concerns over Americans’ genetic data. That same month, the company was finally acquired for $305 million by the nonprofit TTAM Research Institute, owned by Anne Wojcicki, 23andMe’s former CEO. Wojcicki has pledged to comply with 23andMe’s privacy policies and has made “binding commitments” to add certain safeguards to further protect customers and their genetic data. After being bought by TTAM, 23andMe is no longer on the public stock market. Tango Therapeutics SPAC Date: August 2021 Value: $342 million Tango Therapeutics danced into the public stock market almost four years ago when it merged with BCTG Acquisition Corp. The deal gave the Massachusetts-based biotech $342 million, including $156 million from BCTG’s trust account and roughly $186 million from a PIPE placement. At the time of its Nasdaq debut, Tango’s cash position was at $515 million. In the years since, the biotech has worked on its pipeline of precision cancer therapies, though this effort has not been without its stumbles. In May 2024, Tango shelved the USP1 inhibitor TNG348, which was being testing in early-stage studies for solid tumors. The decision to scrap the asset was driven by grade 3 and 4 liver function abnormalities, which Tango detected in patients who had been on the trial for more than eight weeks. Tango planned to assess TNG348 as a monotherapy and as part of a combination regimen with AstraZeneca and Merck’s PARP inhibitor Lynparza, though the company never had the chance . A few months later, in November 2024, Tango was forced to abandon another asset, this time the PRMT5 blocker TNG908. The molecule, designed to get past the blood-brain barrier, was being trialed for glioblastoma, but a Phase I/II study showed that TNG908 “did not meet the pharmacokinetic exposure threshold for clinical efficacy,” according to a company announcement at the time. Discontinuing TNG908 allowed Tango to fully resource its other PRMT5 blocker TNG462, which is now the biotech’s lead asset. The company is developing the asset for pancreatic and lung cancers, as well as other non-CNS malignancies. Phase I/II data are expected later this year, according to Tango’s most recent quarterly report , released last month, after which it expects to launch a registrational trial for pancreatic cancer next year. Since going public, Tango’s stocks have declined 33%. The biotech has a market cap of $745.4 million. Cerevel Therapeutics SPAC Date: July 2020 Value: $440 million Cerevel was a little early to the SPAC party as compared to the other entries on this list, merging in July 2020 with blank-check firm Arya Sciences Acquisition Corp II. The SPAC at the time had $150 million in trust, which Cerevel’s backers—a high-pro including Bain Capital and Pfizer—supplemented with $320 million in a PIPE placement. All told, Cerevel’s public stock debut a few months later was accompanied by a net cash infusion of approximately $440 million . This money helped the Massachusetts biotech establish itself as a leader in the neurology space, anchored by its next-generation antipsychotic schizophrenia drug emraclidine. Phase Ib data published in December 2022 showed that the drug led to “ clinically meaningful and statistically significant improvements ” in positive and negative symptoms after six weeks of treatment, as compared with placebo. These findings, though early, were enough to not only land emraclidine on BioSpace ’s watchlist for neuropsychiatric drugs on August 2023 but also attract the attention of AbbVie. In December that year, the industry giant dropped an eye-watering $8.7 billion to acquire Cerevel, winning emraclidine and the biotech’s rich pipeline of other investigational neuro assets. The bet seemed to pay off quickly, with a Phase III readout in April 2024 showing that its dopamine receptor partial agonist tavapadon elicited significant motor control improvements in patients with Parkinson’s disease. But in November last year, emraclidine returned back-to-back Phase II failures in schizophrenia , delivering a 12% hit to AbbVie’s shares. The pharma has since recalibrated its program for emraclidine and will take the molecule forward as part of an adjunct regimen. AbbVie’s acquisition of Cerevel closed in August 2024 , officially taking the neuro biotech off the public stock exchange just over four years since its debut. Immatics SPAC Date: March 2020 Value: $250 million In two important ways, Immatics’ SPAC journey mirrors that of Cerevel’s: The cancer-focused biotech launched onto the public stock market in 2020, and it did so by merging with an Arya entity. In the case of Immatics, its SPAC was funded by the original Arya Sciences Acquisition Corp., which in March 2020 offered its $148 million trust fund to take the biotech public. The arrangement was completed in July that same year, with Immatics bagging $253 million in total , including proceeds from a PIPE financing. In the years since its Nasdaq debut, Immatics mustered support from many other biopharma companies through partnerships. Chief of these is Bristol Myers Squibb, which in December 2021 paid $150 million upfront and promised up to $770 million in milestones to co-develop the T cell receptor (TCR) bispecific antibody IMA401. Some six months later, in June 2022, BMS doubled down on its commitment to Immatics by paying $60 million to expand their existing arrangement to go after “multiple” off-the-shelf TCR or CAR T programs. Under the expanded contract, Immatics is eligible for up to $700 million per program. In May 2023, BMS exercised its first license option under the Immatics deal, gaining worldwide license to a novel TCR-T product candidate, in turn giving the biotech $15 million in exercise fees. A few months later, the pharma made a $35 million equity investment in Immatics. Aside from BMS, Immatics also struck up an R&D deal with Moderna in September 2023, under which the companies will explore using mRNA technology for the in vivo expression of TCR bispecifics. The collaboration gave Immatics $120 million upfront plus the possibility of more than $1.7 billion in milestones. Since its SPAC, Immatics’ shares have fallen 66%. The company has a market cap of $657 million.