Imsidolimab

Completed spin-off of First Tracks Biotherapeutics, Inc., its former biopharma operations business Now exclusively manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda Announced appointment of Chris Murphy as CFO Announced appointments of Susannah Gray , former CFO of Royalty Pharma, and Owen Hughes , current CEO of XOMA Royalty, to its Board of Directors SAN DIEGO , May 12, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, today reported financial results for the first quarter ended March 31, 2026 , and provided a business update. “Following the completion of the spin-off of First Tracks Bio in late April, Anaptys now exclusively manages the financial collaborations for Jemperli and imsidolimab, with streamlined operations requiring limited FTEs, minimal operating expenses and delivering an EBIT margin greater than 95%,” said Daniel Faga , president and chief executive officer. “With Chris Murphy joining as CFO, who brings deep business development and investment banking experience, our priority continues to be to protect our two royalty streams and return their value to shareholders.” GSK Jemperli Financial Collaboration GSK announced strong commercial performance for Jemperli ( $313 million /£232 million in Q1 2026 sales, with >40% year-over-year growth1) Anaptys continues to expect to achieve > $390 million in annualized Jemperli royalties payable to Anaptys as early as 2029 at GSK’s peak sales guidance of > $2.7 billion 2 Anaptys estimates Sagard will have accrued ~$275 million in royalties and sales milestones through Q1 2026 and anticipates paydown of the remaining ~$325 million non-recourse debt monetization by the end of Q2 20273 Substantial GSK investment in additional monotherapy and potential combination trials for Jemperli, including: AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer Data expected in H2 2026; U.S. FDA Breakthrough Therapy Designation Received an FDA Commissioner’s National Priority Voucher (CNPV) in Nov. 2025 allowing for only a one to two-month sBLA review timeline for US FDA approval AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer Data expected in 2028 AZUR-4 – Phase 2 – dostarlimab plus chemotherapy versus standard of care (chemotherapy) in untreated stage III MMRp/MSS resectable colon cancer Data expected in Q4 2026 JADE – pivotal Phase 3 – dostarlimab monotherapy versus placebo in locally advanced unresected head and neck squamous cell carcinoma (PD-L1 CPS≥1) post chemoradiation Data expected in 2028 Vanda Imsidolimab Financial Collaboration FDA target action date (PDUFA) of Dec. 12, 2026 for imsidolimab in generalized pustular psoriasis (GPP) Recent Leadership and Board of Directors Appointments Announced appointment of Chris Murphy as Chief Financial Officer (CFO) Mr. Murphy brings >20 years’ experience in business development, commercial operations, corporate strategy and investment banking in the biopharmaceutical industry Announced appointment of industry veterans Susannah Gray and Owen Hughes to Board of Directors Ms. Gray brings >25 years’ experience in both finance and investment banking in the biopharmaceutical industry, formerly CFO of Royalty Pharma Mr. Hughes brings >25 years’ experience as both an operator and investor in the biopharmaceutical industry, currently leading XOMA Royalty as CEO Stock Repurchase Plan Announced a $100.0 million Stock Repurchase Plan in March 2026 . It will expire on Dec. 31, 2026 , may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock First Quarter Financial Results The separation of Anaptys and First Tracks Bio was completed on April 20, 2026 . As a result, in the first quarter of 2026, the financial results include assets, liabilities and expenses related to both companies. Beginning in the second quarter of 2026, Anaptys expects to reclassify historical First Tracks Bio related assets, liabilities and expenses as discontinued operations. Cash, cash equivalents and investments totaled $286.5 million as of March 31, 2026 , compared to $311.6 million as of Dec. 31, 2025 , for a decrease of $25.1 million due primarily to operating activities offset by $14.0 million received from stock option exercises. Collaboration revenue was $25.6 million for the three months ended March 31, 2026 , compared to $27.8 million for the three months ended March 31, 2025 . The decrease in revenue was primarily due to $9.7 million in revenue recognized for the Vanda license agreement for the three months ended March 31, 2025 offset by Jemperli royalties increasing 44% from $17.2 million to $24.7 million for the three months ended March 31, 2026 . Research and development expenses were $34.0 million for the three ended March 31, 2026 , compared to $41.2 million for the three months ended March 31, 2025 . The decrease for the three months ended March 31, 2026 was primarily due to decreased development costs for rosnilimab and ANB032 offset by increased costs relating to the phase 1 trials for ANB033. The R&D non-cash, stock-based compensation expense was $4.6 million for the three months ended March 31, 2026 as compared to $4.4 million in the same period in 2025. General and administrative expenses were $26.2 million for the three months ended March 31, 2026 , compared to $14.1 million for the three months ended March 31, 2025 . The increase was due primarily to legal costs for the separation of the company, ongoing GSK litigation and non-cash stock compensation costs incurred for our former Chief Financial Officer and former Chief Legal Officer. The G&A non-cash, stock-based compensation expense was $9.7 million for the three months ended March 31, 2026 as compared to $4.8 million in the same period in 2025. Net loss was $52.9 million for the three months ended March 31, 2026 , or a net loss per share of $1.84 , compared to a net loss of $39.3 million for the three months ended March 31, 2025 , or a net loss per share of $1.28 . About AnaptysBio Anaptys manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning the value of its royalties to shareholders. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn.Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to whether Anaptys is able to protect its financial collaborations; and its ability to return value to its shareholders. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to protect its financial collaborations and return value to its shareholders, the company’s ability to operate efficiently with a limited staff, and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. This press release also includes a reference to EBIT margin which is a measure not presented in accordance with generally accepted accounting principles in the United States of America (“GAAP”), which Anaptys believes provides important perspective with respect to operational profitability. Non-GAAP financial measures may exclude items that are significant in understanding and assessing Anaptys’ financial results, should not be considered in isolation or as an alternative to GAAP measures, and should be considered only as a supplement to, and not as superior to, GAAP measures. Anaptys cannot predict with certainty the magnitude or scope of certain items that would be included in the most directly comparable GAAP measure to EBIT margin for the relevant future periods, and such items may be significant. Due to these uncertainties, Anaptys cannot provide a quantitative reconciliation of EBIT margin to the most directly comparable GAAP financial measure without unreasonable effort. Investor Contact:Anaptys Investor Relationsinvestors@anaptysbio.com _______________________________________ Source: AnaptysBio, Inc.

Fanapt® net product sales rose 26% to $29.6 million; total prescriptions increased 32% and new-to-brand prescriptions surged 76% NEREUS™ (tradipitant) launched via nereus.us, an innovative direct-to-consumer platform – the first new prescription medicine in more than 40 years for the prevention of vomiting induced by motion, with convenient online ordering and rapid direct home delivery Full-year 2026 revenue guidance raised to $240-$290 million, including $10-30 million from newly launched NEREUS™ BYSANTI™ (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026 Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026 WASHINGTON, May 6, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2026. "Vanda delivered strong commercial execution in the first quarter, highlighted by 26% growth in Fanapt sales, the groundbreaking U.S. launch of NEREUS with its pioneering direct-to-consumer platform at nereus.us, and the FDA approval of BYSANTI," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We believe that these achievements, combined with meaningful pipeline progress and our raised 2026 revenue guidance, position the company for continued growth and value creation." Financial Highlights Total net product sales reached $51.7 million in Q1 2026, a 3% increase compared to $50.0 million in Q1 2025. Fanapt® net product sales were $29.6 million, up 26% year-over-year. HETLIOZ® net product sales were $15.9 million, down 24% year-over-year. PONVORY® net product sales were $6.2 million, up 10% year-over-year. Loss before income taxes was $48.4 million compared with $37.4 million in Q1 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $202.3 million as of March 31, 2026, representing a decrease to Cash of $61.5 million in Q1 2026, which included a one-time payment of a $10.0 million milestone to Eli Lilly due upon approval of NEREUS™ (tradipitant). Key Commercial Highlights Fanapt® saw continued strong momentum with total prescriptions (TRx)1 up 32% and new-to-brand prescriptions (NBRx)1 up 76% versus Q1 2025. In April 2026, weekly TRx for Fanapt® reached an 11-year high of over 2,600 prescriptions for the week ending April 24, 2026. NEREUS™ is now commercially available nationwide through nereus.us, Vanda's innovative direct-to-consumer platform. This pioneering patient-centric model enables convenient ordering online with rapid direct delivery, eliminating traditional pharmacy barriers and providing a seamless, modern access experience. As the first new prescription therapy approved for the prevention of vomiting induced by motion in adults in more than 40 years, NEREUS™ represents a breakthrough in both science and patient access. Key Regulatory & Clinical Development Highlights BYSANTI™ (milsaperidone) received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia. BYSANTI™ is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. Vanda's ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including: The Phase III study of BYSANTI™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in Q1 2027. The Thetis Phase III study of NEREUS™ for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026. The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected by the end of 2026. The FDA accepted the Biologics License Application (BLA) for imsidolimab in Generalized Pustular Psoriasis (GPP) with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026. The results of the pivotal clinical study were published in the April 28, 2026 issue of the New England Journal of Medicine (NEJM) Evidence2. Corporate Highlight On April 22, 2026, Vanda appointed Charles Duncan, Ph.D. to its Board of Directors. The Board now consists of seven directors, six of whom are independent. GAAP Financial Results Net loss was $48.6 million (diluted loss per share of $0.82) in Q1 2026 compared with a net loss of $29.5 million (diluted loss per share of $0.50) in Q1 2025. 2026 Financial Guidance Vanda is raising its full-year 2026 total revenue guidance to reflect the contribution of the newly launched NEREUS™ while maintaining prior ranges for Fanapt® and other products: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 6, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2026 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 8051722. A replay of the call will be available on Wednesday, May 6, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, May 13, 2026 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 8051722. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2026 Financial Guidance" above and statements regarding Vanda's plans for pursuit of FDA approval of imsidolimab for the treatment of GPP, and the related timeline for approval; Vanda's expectations with respect to its continued growth and ability to create value; Vanda's clinical development plans and expected timelines for BYSANTITM for the treatment of MDD, NEREUSTM in the prevention of vomiting induced by GLP-1 therapies, and VQW-765 in the treatment of adults with social anxiety disorder; and Vanda's expectations with respect to the strength of its business are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; the FDA's ability to complete its review of, and reach a decision with respect to, the BLA for imsidolimab by December 12, 2026; Vanda's ability to successfully execute the commercial launches of NEREUSTM for the prevention of vomiting induced by motion and BYSANTI™ for the treatments of bipolar I disorder and schizophrenia; Vanda's ability to continue to advance its late-stage clinical development programs and to obtain regulatory approval for, and successfully commercialize, the late-stage products in development; Vanda's ability to complete the clinical study for BYSANTITM for the treatment of MDD and receive results in in the first quarter of 2027; Vanda's ability to complete the Thetis study and receive results in 2026; and Vanda's ability to complete the clinical study for VQW-765 in the treatment of adults with social anxiety disorder and receive results by the end of 2026. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo