Raghuram Selvaraju

Charles Duncan

Andrew Tsai

Lin Tsai

Matthew Barcus

Olivia Breyer

- **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]**

Vanda Pharmaceuticals announces positive HETLIOZ® study results for insomnia

- Vanda Pharmaceuticals reported a strong financial position, ending the second quarter of 2025 with approximately **$325 million in cash** and **no debt**.  **[1347178_tx_380811_1]** **[1347178_tx_380811_4]** 
- The company provided full-year 2025 revenue guidance of **$210 million to $250 million** (midpoint **$230 million**) and expects to end the year with **$280 million to $320 million** in cash.  **[1347178_tx_380811_1]** **[1347178_tx_380811_3]** **[1347178_tx_380811_4]** 
- Vanda has several key regulatory milestones approaching, including PDUFA dates for **Tradipitant** (motion sickness) on **December 30**, and **Basanti** (bipolar disorder and schizophrenia) in **February 2026**.  **[1347178_tx_380811_1]** **[1347178_tx_380811_4]** 
- Commercial efforts for **Fanapt** have led to significant revenue growth in Q2 2025, with the company doubling its sales force to approximately **300 representatives** to further drive growth and prepare for the potential **Basanti** launch.  **[1347178_tx_380811_4]** **[1347178_tx_380811_6]** 
- The potential launch of **Basanti** is expected to offer a more favorable gross-to-net dynamic compared to Fanapt, potentially increasing net revenue for the same volume.  **[1347178_tx_380811_7]**

Vanda Pharmaceuticals Discusses Strong Financial Position and Upcoming Regulatory Milestones at Cantor Global Healthcare Conference

- Vanda Pharmaceuticals announced on **August 28, 2025**, that the FDA granted **Orphan Drug Designation** for **VGT-1849B**, its novel and selective candidate for the treatment of **polycythemia vera (PV)**.  **[1347178_20250828PH60962:0]** 
- VGT-1849B is a **JAK2 inhibitor** that aims to provide **targeted efficacy** with an **improved safety profile** by selectively reducing JAK2 protein production, unlike other available JAK inhibitors.  **[1347178_20250828PH60962:0]** 
- Polycythemia vera is a chronic myeloproliferative disorder estimated to affect **44 to 57 per 100,000 people** in the United States.  **[1347178_20250828PH60962:0]** 
- Orphan Drug Designation is granted by the FDA for investigational therapies addressing rare medical conditions and provides **benefits to drug developers**.  **[1347178_20250828PH60962:0]**