Raghuram Selvaraju

Charles Duncan

Andrew Tsai

Lin Tsai

Matthew Barcus

Olivia Breyer

- Vanda Pharmaceuticals Inc. reported **total net product sales of $56.3 million** for Q3 2025, an **18% increase** year-over-year, driven by a **31% increase in Fanapt sales**.  **[0001347178_2212813_1]** **[0001347178_2212813_5]**  For the first nine months of 2025, total revenues reached **$158.9 million**, a **9% increase** compared to the same period in 2024.  **[0001347178_2212813_1]** **[0001347178_2212813_4]** 
- The company updated its 2025 financial guidance, narrowing total revenue expectations from Fanapt, Helios, and PONVORY to between **$210 million and $230 million** (previously $210 million to $250 million).  **[0001347178_2212813_8]**  Year-end 2025 cash guidance was also lowered to between **$260 million and $290 million** (previously $280 million to $320 million).  **[0001347178_2212813_8]** 
- Vanda has several near-term regulatory milestones, including a PDUFA target action date of **December 30, 2025**, for the tradipitant NDA for motion sickness, and **February 21, 2026**, for the Visanti NDA for bipolar I disorder and schizophrenia.  **[0001347178_2212813_1]** **[0001347178_2212813_2]**  The imsidolimab BLA for generalized pustular psoriasis is anticipated for submission in **Q4 2025**.  **[0001347178_2212813_1]** **[0001347178_2212813_2]** 
- Commercial efforts for Fanapt included expanding the sales force to approximately **300 representatives** by Q3 2025, resulting in a **35% increase in total prescriptions** compared to Q3 2024.  **[0001347178_2212813_1]** **[0001347178_2212813_7]**

Vanda Pharmaceuticals Inc. Announces Q3 2025 Results and Updates 2025 Guidance

- Vanda Pharmaceuticals Inc. reported **total net product sales of $56.3 million** in the third quarter of 2025, an **18% increase** compared to the third quarter of 2024, while recording a **net loss of $22.6 million** for the same period.  **[1347178_0001628280-25-047112_vnda8-k10292025exhibit991.htm:0]** 
- For the first nine months of 2025, total net product sales reached **$158.9 million**, a **9% increase** year-over-year, with a **net loss of $79.3 million**.  **[1347178_0001628280-25-047112_vnda8-k10292025exhibit991.htm:1]** 
- The company updated its **2025 financial guidance**, revising total revenues to **$210 to $230 million** and year-end 2025 cash to **$260 to $290 million**.  **[1347178_0001628280-25-047112_vnda8-k10292025exhibit991.htm:2]** 
- Vanda has multiple regulatory milestones approaching, including PDUFA target action dates for Bysanti on **February 21, 2026**, and tradipitant on **December 30, 2025**, and expects to submit the imsidolimab BLA in **Q4 2025**.  **[1347178_0001628280-25-047112_vnda8-k10292025exhibit991.htm:0]** **[1347178_0001628280-25-047112_vnda8-k10292025exhibit991.htm:1]**

Vanda Pharmaceuticals Inc. Reports Q3 2025 Financial Results and Updates Guidance

- Vanda Pharmaceuticals reported **total net product sales of $56.3 million** in the third quarter of 2025, an **18% increase** compared to Q3 2024, and a **net loss of $22.6 million** for the same period.  **[1347178_20251029PH10452:0]** 
- **Fanapt net product sales increased by 31% to $31.2 million** in Q3 2025, while HETLIOZ net product sales were **$18.0 million** and PONVORY net product sales were **$7.0 million**.  **[1347178_20251029PH10452:0]** 
- The company has multiple near-term regulatory milestones, including PDUFA target action dates for **Bysanti (February 21, 2026)** and **Tradipitant (December 30, 2025)**, and an expected BLA submission for **Imsidolimab in Q4 2025**.  **[1347178_20251029PH10452:0]** 
- Vanda updated its **full-year 2025 financial guidance**, revising total revenues to **$210 to $230 million** and year-end 2025 cash to **$260 to $290 million**.  **[1347178_20251029PH10452:1]**

Vanda Pharmaceuticals Reports Third Quarter 2025 Results and Updates 2025 Guidance

- AnaptysBio announced positive late-breaking data from its **Phase 2b trial of rosnilimab** for rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) Convergence 2025.  **[1347178_d0efa7a940654b27b31bb6935f71ea73_0]** 
- The trial demonstrated **deepening clinical responses** and **durable clinical benefit** of rosnilimab in RA patients, with efficacy maintained for at least three months off drug.  **[1347178_d0efa7a940654b27b31bb6935f71ea73_0]** 
- Rosnilimab was **well-tolerated** through Week 38, showing no treatment-related serious adverse events or malignancies.  **[1347178_d0efa7a940654b27b31bb6935f71ea73_0]** 
- AnaptysBio also announced its intent to **separate its biopharma operations** from its royalty assets by year-end 2026.  **[1347178_d0efa7a940654b27b31bb6935f71ea73_2]**

AnaptysBio Announces Positive Phase 2b Rosnilimab Trial Results for Rheumatoid Arthritis

- **AnaptysBio** announced that complete data from the **Phase 2b trial of rosnilimab** in rheumatoid arthritis (RA) was accepted for a late-breaking oral presentation.  **[1347178_489e916c51654e6f81263c753f35c842_0]** 
- The presentation will occur at the **ACR Convergence 2025** in Chicago, IL, from **October 24-29, 2025**, with the specific session on **Wednesday, October 29, 2025**, from **8:00am – 9:30am CT**.  **[1347178_489e916c51654e6f81263c753f35c842_0]** 
- The trial data showed rosnilimab delivered a **compelling safety and tolerability profile** and **JAK-like efficacy** through six months, which was durable for at least three months off-drug.  **[1347178_489e916c51654e6f81263c753f35c842_0]** 
- **Rosnilimab** is a novel therapeutic antibody designed to **selectively and potently deplete pathogenic T cells** while preserving nonpathogenic T cells to maintain overall immune function.  **[1347178_489e916c51654e6f81263c753f35c842_1]**

AnaptysBio Announces Late-Breaking Oral Presentation of Rosnilimab Phase 2b Data

- **Vanda Pharmaceuticals** and the FDA have reached an agreement to resolve longstanding disputes regarding Vanda’s drugs **Hetlioz** and **tradipitant**.  **[1347178_22af54b85ad04a539a07c2bf6fcc012f]** 
- The FDA will conduct expedited re-reviews of the jet lag indication for Hetlioz by **January 7, 2026**, and the partial clinical hold on long-term studies of tradipitant for motion sickness by **November 26**.  **[1347178_22af54b85ad04a539a07c2bf6fcc012f]** 
- The existing **December 30, 2025**, target decision date for tradipitant's new drug application will be maintained.  **[1347178_22af54b85ad04a539a07c2bf6fcc012f]** 
- In exchange for these expedited reviews, Vanda will **pause ongoing litigation** against the FDA.  **[1347178_22af54b85ad04a539a07c2bf6fcc012f]** 
- Analysts maintain **mixed views** on Vanda’s stock, balancing the regulatory progress with ongoing financial and operational challenges.  **[1347178_22af54b85ad04a539a07c2bf6fcc012f]**

Vanda Pharmaceuticals Resolves FDA Disputes, Expediting Drug Reviews

- Vanda Pharmaceuticals Inc. (VNDA) has agreed on a **collaborative framework** with the U.S. Food and Drug Administration (FDA) to resolve certain disputes regarding its drugs, **HETLIOZ®** (tasimelteon) and **tradipitant**.  **[1347178_0001628280-25-043489_vnda8-k1012025exhibit991.htm:0]** **[1347178_0001628280-25-043489_vnda-20251001.htm:1]** 
- The FDA will conduct an **expedited re-review** of the partial clinical hold preventing long-term clinical studies of **tradipitant** for motion sickness by **November 26, 2025**, with the existing PDUFA target action date for the New Drug Application (NDA) being **December 30, 2025**.  **[1347178_0001628280-25-043489_vnda8-k1012025exhibit991.htm:0]** 
- An **expedited re-review** of Vanda's supplemental NDA for **HETLIOZ®** for the treatment of jet lag disorder will be conducted by the FDA by **January 7, 2026**.  **[1347178_0001628280-25-043489_vnda8-k1012025exhibit991.htm:0]** 
- The agreement includes a **temporary pause** in several ongoing administrative proceedings and lawsuits, and Vanda will **dismiss certain lawsuits** challenging FDA actions related to these drugs.  **[1347178_0001628280-25-043489_vnda8-k1012025exhibit991.htm:0]**

Vanda Pharmaceuticals Establishes Collaborative Framework with FDA to Resolve Disputes

- **Vanda Pharmaceuticals (VNDA)** and the U.S. Food and Drug Administration (FDA) have agreed on a collaborative framework to resolve disputes regarding **HETLIOZ® (tasimelteon)** and **tradipitant**.  **[1347178_20251001PH88778:0]** 
- The FDA will conduct an **expedited re-review** of the partial clinical hold on tradipitant for motion sickness by **November 26, 2025**, with the New Drug Application (NDA) review continuing towards a **December 30, 2025** target action date.  **[1347178_20251001PH88778:0]** 
- An **expedited re-review** of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® for jet lag disorder is also scheduled by the FDA for **January 7, 2026**.  **[1347178_20251001PH88778:0]** 
- As part of the agreement, Vanda will **dismiss several lawsuits** challenging FDA actions, and both parties will seek temporary pauses in other ongoing administrative proceedings and litigation.  **[1347178_20251001PH88778:0]**

Vanda Pharmaceuticals and FDA Agree on Dispute Resolution Framework

- **AnaptysBio, Inc.** announced plans to explore separating its business into two independent, publicly traded companies, "Royalty Management Co" and "Biopharma Co," with completion anticipated by **year-end 2026**.  **[1347178_ddbd812d39b3438c83c0f085af9a1c9b_1]** **[1347178_ddbd812d39b3438c83c0f085af9a1c9b_3]** 
- The **Royalty Management Co** will manage royalties and milestone payments from financial collaborations, including _Jemperli_ with GSK and **imsidolimab with Vanda**.  **[1347178_ddbd812d39b3438c83c0f085af9a1c9b_0]** **[1347178_ddbd812d39b3438c83c0f085af9a1c9b_1]** 
- For **imsidolimab**, the Royalty Management Co would be eligible for up to **$35 million** in future sales milestones and regulatory approvals, including a **$5 million** milestone upon U.S. FDA approval, plus a **10% royalty on net sales**.  **[1347178_ddbd812d39b3438c83c0f085af9a1c9b_2]** 
- **Vanda** anticipates **FDA BLA submission for generalized pustular psoriasis (GPP) in 2H 2025** for imsidolimab.  **[1347178_ddbd812d39b3438c83c0f085af9a1c9b_2]** 
- The **Biopharma Co** will focus on developing immunology therapeutics and is expected to launch with adequate capital to fund operations for at least **two years**.  **[1347178_ddbd812d39b3438c83c0f085af9a1c9b_0]** **[1347178_ddbd812d39b3438c83c0f085af9a1c9b_2]** **[1347178_ddbd812d39b3438c83c0f085af9a1c9b_3]**

AnaptysBio Announces Intent to Separate Biopharma Operations from Royalty Assets

- Vanda Pharmaceuticals announced on **September 25, 2025**, the publication of a study in PLOS One detailing positive results for its melatonin agonist, HETLIOZ® (tasimelteon), in treating primary insomnia.  **[1347178_20250925PH83269:0]** 
- The study, published on **September 24, 2025**, demonstrated that HETLIOZ® significantly improved latency to persistent sleep (LPS) by **44.9 minutes (20 mg)** and **46.3 minutes (50 mg)**, compared to **28.2 minutes for placebo**.  **[1347178_20250925PH83269:0]** 
- Improvements in LPS persisted through follow-up time points, and HETLIOZ® use was not associated with cognitive or mood changes, nor were rebound or withdrawal effects observed after discontinuation.  **[1347178_20250925PH83269:0]** 
- Vanda is continuing to pursue U.S. Food and Drug Administration (FDA) approval for HETLIOZ® in the treatment of insomnia and Jet Lag Disorder, and is developing it for other sleep disorders including Delayed Sleep Phase Disorder (DSPD) and pediatric insomnia.  **[1347178_20250925PH83269:0]** **[1347178_20250925PH83269:1]**