WASHINGTON, Dec. 15, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP). Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36RA regulator commonly seen in GPP patients due to IL36RN gene mutations. GPP is a rare, chronic, life ...

Group 1 - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [2] - The company's pipeline includes rosnilimab, ANB033, and ANB101, with various stages of clinical trials [2] - Anaptys plans to separate its biopharma operations from its royalty assets by year-end 2026 to better align with investor interests [3] Group 2 - Upcoming investor conferences include the Piper Sandler 37th Annual Healthcare Conference and the Evercore 8th Annual Healthcare Conference [1] - Live webcasts of the events will be available on the Anaptys investor website, with replays accessible for at least 30 days [1] - The company is engaging in fireside chats and one-on-one investor meetings on specific dates in December 2025 [4]

Core Viewpoint - AnaptysBio, Inc. has authorized an amended Stock Repurchase Plan allowing for the repurchase of up to $100 million of its common stock, in addition to the remaining $6.4 million from a previous plan [1][2]. Group 1: Stock Repurchase Plan - The amended Stock Repurchase Plan allows AnaptysBio to repurchase up to $100 million of its outstanding common stock, with $6.4 million remaining from the previous $75 million plan [1]. - As of November 20, 2025, AnaptysBio has repurchased a total of 3,443,188 shares, representing 11.2% of shares outstanding before the initiation of the repurchase plan [1]. - The repurchase may occur through open market transactions or other means, with the plan set to expire on March 31, 2026, and can be suspended or discontinued at any time [3]. Group 2: Financial Position - AnaptysBio anticipates ending 2025 with approximately $300 million in cash, cash equivalents, and investments, which includes a one-time $75 million commercial sales milestone expected in Q4 2025 from GSK [2]. Group 3: Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases, with a pipeline that includes several candidates in various stages of clinical trials [4]. - The company has out-licensed therapeutic antibodies, including a PD-1 antagonist to GSK and an IL-36R antagonist to Vanda Pharmaceuticals [4]. - AnaptysBio plans to separate its biopharma operations from its royalty assets by the end of 2026, allowing investors to align their investment strategies with each entity's objectives [5].

Core Viewpoint - AnaptysBio, Inc. has authorized an amended Stock Repurchase Plan allowing for the repurchase of up to $100 million of its common stock, in addition to the remaining $6.4 million from the previous plan [1][2] Group 1: Stock Repurchase Plan - The amended Stock Repurchase Plan allows AnaptysBio to repurchase up to $100 million of its outstanding common stock, with $6.4 million remaining from the previous $75 million plan [1] - As of November 20, 2025, AnaptysBio has repurchased a total of 3,443,188 shares, representing 11.2% of shares outstanding before the initiation of the repurchase plan [1] - The new plan will expire on March 31, 2026, and the timing and number of shares repurchased will depend on market conditions and other factors [3] Group 2: Financial Position - AnaptysBio anticipates ending 2025 with approximately $300 million in cash, cash equivalents, and investments, which includes a one-time $75 million commercial sales milestone expected in Q4 2025 from GSK [2] Group 3: Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases, with a pipeline that includes several candidates in various stages of clinical trials [4] - The company plans to separate its biopharma operations from its royalty assets by the end of 2026, allowing investors to align their investment strategies with each entity's objectives [5]

Core Viewpoint - AnaptysBio has filed a Verified Complaint against Tesaro and GSK, alleging material breaches of their Collaboration Agreement and seeking legal remedies [1][2]. Group 1: Legal Disputes - Anaptys claims that Tesaro breached the Collaboration Agreement by participating in clinical trials with competing PD-1 antagonists and failing to use reasonable efforts to maximize commercial returns for Jemperli [2]. - Tesaro has initiated its own lawsuit against Anaptys, alleging that Anaptys improperly claimed breaches of the Collaboration Agreement [4]. - The parties are seeking an expedited trial schedule in Delaware Chancery Court, with a trial expected in July 2026 [5]. Group 2: Financial Implications - Anaptys is entitled to royalties from Jemperli sales, structured as 8% for net sales below $1 billion, 12% for sales between $1 billion and $1.5 billion, 20% for sales between $1.5 billion and $2.5 billion, and 25% for sales above $2.5 billion [7]. - A one-time $75 million commercial sales milestone is anticipated once Jemperli achieves $1 billion in worldwide net sales [7]. - Anaptys estimates that Sagard will accrue $250 million in royalties and sales milestones through the end of 2025, with full paydown expected between Q2 2027 and Q2 2028 [9]. Group 3: Background of the Collaboration - The Collaboration Agreement was established in March 2014, allowing Tesaro to develop Jemperli for various solid tumor indications [6]. - Anaptys previously filed a complaint against GSK in 2020 regarding breaches related to GSK's clinical trial of Zejula, which resulted in a settlement that included cash payments and increased royalties on Jemperli [3]. Group 4: Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases, with a pipeline that includes multiple therapeutic candidates [10]. - The company plans to separate its biopharma operations from its royalty assets by the end of 2026 to better align with investor interests [11].

Core Viewpoint - AnaptysBio has filed a Verified Complaint against Tesaro and GSK, alleging material breaches of their Collaboration Agreement and seeking legal remedies [1][2]. Group 1: Legal Dispute - The Complaint asserts that Tesaro breached the Collaboration Agreement by engaging in clinical trials with competing PD-1 antagonists, including Keytruda, and failed to use reasonable efforts to maximize commercial returns for Jemperli [2]. - Anaptys previously filed a complaint against GSK in 2020 for similar breaches related to GSK's clinical trial of Zejula in combination with Keytruda, which resulted in a settlement that included cash payments and increased royalties on Jemperli [3]. - Tesaro has initiated its own lawsuit against Anaptys, claiming that Anaptys has breached the Collaboration Agreement, which Anaptys contends is without merit [4]. Group 2: Collaboration Agreement Details - The Collaboration Agreement, established in March 2014, involves Tesaro developing Jemperli for various solid tumor indications [6]. - Anaptys is entitled to royalties from Jemperli sales, structured as 8% for net sales below $1 billion, 12% for sales between $1 billion and $1.5 billion, 20% for sales between $1.5 billion and $2.5 billion, and 25% for sales above $2.5 billion [7]. - A one-time $75 million commercial sales milestone is anticipated once Jemperli achieves $1 billion in worldwide net sales [7]. Group 3: Financial Implications - The royalty term under the Collaboration Agreement extends until the expiration of composition of matter coverage, which is set to expire in 2035 in the U.S. and 2036 in the EU [8]. - Anaptys estimates that Sagard will have accrued $250 million in royalties and sales milestones through the end of 2025, with full paydown of $600 million expected between Q2 2027 and Q2 2028 [9]. Group 4: Future Developments - The parties have agreed to an expedited schedule with the Delaware Chancery Court, with a trial anticipated in July 2026 [5]. - Milestone and royalty payment obligations to Anaptys will continue during the legal proceedings [5].

Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Focus**: Development of biologics or antibodies for autoimmune diseases - **Clinical Programs**: Three clinical stage programs including Rosnilimab, AMV033, and AMV101 [1][2] Key Clinical Programs Rosnilimab - **Type**: Selective and potent depleter of pathogenic T cells - **Recent Development**: Positive phase 2b trial readout in arthritis with plans to advance into phase 3 trials for rheumatoid arthritis (RA) [1][24] - **Trial Details**: Robust study with 424 patients, showing high tolerability and sustained responses off-drug [24][30] AMV033 - **Type**: CD122 antagonist blocking IL-15 and IL-2 signaling - **Current Status**: Phase 1b trial initiated for celiac disease, with plans for a second indication in 2026 [1][2][7] - **Mechanism**: Designed to target autoimmune cells, particularly CD8 T cells in diseases like celiac disease and eosinophilic esophagitis (EOE) [8][20] AMV101 - **Current Status**: In phase 1a trials with results expected next year [1][32] Royalty Management Business - **Separation Announcement**: Company plans to separate into two businesses: biopharma operations and royalty management [2] - **Key Products**: - **Jemperli**: PD-1 antagonist with expected run rate of $1.4 billion to $1.5 billion; AnaptysBio anticipates substantial royalties based on sales tiers [3][4] - **Imsidolimab**: IL-36 receptor antagonist partnered with Vanda Pharmaceuticals, expected approval next year [6] Financial Overview - **Cash Position**: Expected $300 million cash at the end of the year [2] - **Royalty Structure**: Royalties range from 8% to 25% based on sales thresholds, with potential for significant revenue [4][6] Market Opportunity - **Celiac Disease**: Estimated 2 million patients in the US, with 250,000 potentially eligible for biologics by the 2030s [19] - **EOE Market**: Dupilumab, the only approved therapy, has generated $2 billion in sales, indicating a growing market for new therapies [20][23] Competitive Landscape - **Competitors**: Other companies like Novartis and Teva are also developing therapies targeting similar pathways in autoimmune diseases [9][10] - **Differentiation**: AnaptysBio's approach targets both inflammation and the underlying autoimmune response, which may provide advantages over existing therapies [15][22] Conclusion - **Future Plans**: AnaptysBio aims to advance AMV033 into further trials and move Rosnilimab into phase 3 next year, with a focus on addressing significant unmet needs in autoimmune diseases [31][32]

Core Insights - AnaptysBio announced that rosnilimab was safe and well tolerated but failed to meet primary and key secondary endpoints in a Phase 2 trial for moderate-to-severe ulcerative colitis, leading to the discontinuation of the trial and an estimated savings of at least $10 million [1][6][9] Group 1: Trial Results - The Phase 2 trial enrolled 136 patients with a baseline mean modified Mayo Score (mMS) of 6.7, who had inadequate responses to prior therapies [2][3] - At Week 12, clinical remission was achieved by 7% of patients receiving rosnilimab, compared to 5% and 4% for endoscopic remission [3][4] - Blood biomarker data indicated ~90% depletion of pathogenic T cells at Week 12, consistent with previous studies [4][6] Group 2: Future Plans - The company remains optimistic about advancing rosnilimab in rheumatoid arthritis (RA) and plans to provide updates in H1 2026, with funding expected from strategic sources without diluting royalties [2][6] - AnaptysBio intends to separate its biopharma assets from its royalty assets by 2026, which includes Jemperli royalties projected to exceed $390 million annually [2][11] Group 3: Safety Profile - Rosnilimab demonstrated a favorable safety profile, with adverse events primarily mild to moderate, including nasopharyngitis and dizziness [7][13] - No serious adverse events or malignancies were reported, and the ongoing safety profile remains consistent with previous studies [8][13]

Company Overview - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [2] - The lead program, rosnilimab, has completed a Phase 2b trial for rheumatoid arthritis and is currently in a Phase 2 trial for ulcerative colitis [2] - The pipeline includes ANB033, a CD122 antagonist in a Phase 1b trial for celiac disease, and ANB101, a BDCA2 modulator in a Phase 1a trial [2] - Anaptys has out-licensed multiple therapeutic antibodies, including a PD-1 antagonist to GSK and an IL-36R antagonist to Vanda Pharmaceuticals [2] Upcoming Events - Daniel Faga, CEO, and other executives will participate in several investor conferences, including the TD Cowen Immunology & Inflammation Summit and the Jefferies Global Healthcare Conference [1] - Live webcasts of the events will be available on the investor section of the Anaptys website, with replays accessible for at least 30 days [1] Strategic Developments - Anaptys plans to separate its biopharma operations from its royalty assets by the end of 2026, allowing investors to align their investment strategies with the distinct opportunities of each entity [3]

Core Insights - AnaptysBio, Inc. reported strong financial results for Q3 2025, with a net income of $15.1 million for the quarter, marking a significant improvement compared to a net loss of $32.9 million in Q3 2024 [14][23]. - The company announced its intent to separate its biopharma operations from its royalty assets by the end of 2026, aiming to unlock potential value for investors [5][16]. Financial Performance - Collaboration revenue for Q3 2025 was $76.3 million, up from $30.0 million in Q3 2024, driven primarily by Jemperli sales exceeding $750 million [17][23]. - Research and development expenses decreased to $31.4 million in Q3 2025 from $42.2 million in Q3 2024, while general and administrative expenses remained relatively stable [17][23]. - Cash and investments totaled $256.7 million as of September 30, 2025, down from $420.8 million at the end of 2024, primarily due to operating activities and share repurchases [17][20]. Business Updates - Jemperli sales grew to $785 million year-to-date in 2025, with a quarter-over-quarter growth of over 16% [5][6]. - Anaptys anticipates a one-time $75 million commercial sales milestone in Q4 2025 from GSK once Jemperli achieves $1 billion in worldwide net sales [5][6]. - The company is on track to report top-line Phase 2 data for rosnilimab in ulcerative colitis in November or December 2025 [5][13]. Strategic Initiatives - The planned separation will create two independent publicly traded companies, allowing investors to align their portfolios with distinct business objectives [6][16]. - The biopharma operations will focus on innovative immunology therapeutics, including rosnilimab, ANB033, and ANB101, while the royalty management company will handle royalties and milestone payments [6][16]. Clinical Development - Rosnilimab's Phase 2b data in rheumatoid arthritis was presented at ACR Convergence 2025, showing promising response rates [13]. - A Phase 1b trial for ANB033 in celiac disease has been initiated, with top-line data expected in Q4 2026 [5][13].