Hidemaru Yamaguchi

Michael Nedelcovych

Seiji Wakao

Stephen Barker

Shinichiro Muraoka

Tony Ren

Matsubara

Miki Sogi

Kasumi Haruta

Fumiyoshi Sakai

Hiroshi Wada

Hiroyuki Matsubara

Katsura Matsubara

Kazuaki Hashiguchi

Shinichiro Ueda

Steve Barker

- Exelixis announced positive results from a subgroup analysis of the **CABINET phase 3 pivotal trial** evaluating **CABOMETYX** (cabozantinib) in patients with previously treated advanced lung or thymic neuroendocrine tumors (NET).  **[1395064_23a63c34032f4ebcbe8fee318d568d76_0]** 
- In this subgroup, CABOMETYX reduced the risk of disease progression or death by **81%** versus placebo, demonstrating a median progression-free survival of **8.2 months** compared to **2.7 months** with placebo.  **[1395064_23a63c34032f4ebcbe8fee318d568d76_0]** 
- The safety profile of CABOMETYX observed in patients with lung or thymic NET was consistent with its known safety profile, with no new safety signals identified.  **[1395064_23a63c34032f4ebcbe8fee318d568d76_1]** 
- CABOMETYX received regulatory approvals from the U.S. Food and Drug Administration in **March 2025** and the European Commission in **July 2025** for the treatment of previously treated advanced neuroendocrine tumors, including extra-pancreatic NET (epNET).  **[1395064_23a63c34032f4ebcbe8fee318d568d76_1]**

Exelixis Announces Positive Subgroup Analysis Results for CABOMETYX in CABINET Phase 3 Trial

- **Takeda Pharmaceuticals** has expanded its collaboration with Nabla Bio to advance **AI-driven design of protein therapeutics** using Nabla's proprietary Joint Atomic Model (JAM) platform.  **[1395064_06f61852f97e4af9b263ca569b98dc9c]** 
- The deal includes **upfront payments in the double-digit millions** and potential success-based payments **exceeding $1 billion**.  **[1395064_06f61852f97e4af9b263ca569b98dc9c]** 
- This partnership reflects Takeda's strategic shift toward **AI-powered drug discovery**.  **[1395064_06f61852f97e4af9b263ca569b98dc9c]** 
- Nabla Bio anticipates its AI-designed molecules will enter **first-in-human trials within one to two years**.  **[1395064_06f61852f97e4af9b263ca569b98dc9c]**

Takeda Expands AI Protein Therapeutics Collaboration with Nabla Bio

- **Teva Pharmaceuticals' Uzedy** (risperidone) has received U.S. FDA approval as a **once-monthly extended-release injectable suspension** for the maintenance treatment of bipolar I disorder (BD-I) in adults.  **[1395064_e3ad1d2acf6e4412ac1611d46aa9c96f]** 
- This approval makes Uzedy the **first long-acting, subcutaneous risperidone formulation** utilizing Medincell's SteadyTeq technology, ensuring steady drug release and rapid therapeutic blood concentration.  **[1395064_e3ad1d2acf6e4412ac1611d46aa9c96f]** 
- Uzedy is available in **three once-monthly dosing options**: 50 mg, 75 mg, and 100 mg.  **[1395064_e3ad1d2acf6e4412ac1611d46aa9c96f]** 
- Despite expanding its portfolio with this approval, **Teva's financial profile** indicates challenges, including a **negative net margin**, **negative earnings per share**, a **high debt-to-equity ratio**, and a **distressed Altman Z-Score**.  **[1395064_e3ad1d2acf6e4412ac1611d46aa9c96f]**

Teva Pharmaceuticals' Uzedy Approved for Bipolar I Disorder Maintenance

- The **FDA has approved UZEDY® (risperidone)** extended-release injectable suspension for subcutaneous use as monotherapy or adjunctive therapy for the **maintenance treatment of bipolar I disorder (BD-I) in adults**.  **[1395064_48305d5288ca4f9c9c3808316da8e702_0]** 
- This expanded indication builds on UZEDY's prior **2023 approval for schizophrenia** in adults.  **[1395064_48305d5288ca4f9c9c3808316da8e702_0]** **[1395064_48305d5288ca4f9c9c3808316da8e702_1]** 
- UZEDY, developed by Teva and Medincell, is the **first subcutaneous, long-acting risperidone formulation** utilizing SteadyTeq™ technology, offering **once-monthly dosing options** (50 mg, 75 mg, 100 mg) for BD-I.  **[1395064_48305d5288ca4f9c9c3808316da8e702_0]** 
- The approval addresses a significant unmet need, as an estimated **1% (over 3.4 million) of U.S. adults** will develop BD-I, a condition linked to poor long-term outcomes.  **[1395064_48305d5288ca4f9c9c3808316da8e702_0]** **[1395064_48305d5288ca4f9c9c3808316da8e702_1]**

Teva and Medincell: FDA Approves Expanded Indication for UZEDY

- The **FDA has approved UZEDY® (risperidone) extended-release injectable suspension** for the maintenance treatment of **bipolar I disorder (BD-I) in adults**, either as monotherapy or as adjunctive therapy.  **[1395064_d12b47df93024199a6f97aa9ba2f2ebc_0]** **[1395064_d12b47df93024199a6f97aa9ba2f2ebc_1]** 
- This approval expands UZEDY's existing indication for the treatment of **schizophrenia in adults**, which was approved in **2023**.  **[1395064_d12b47df93024199a6f97aa9ba2f2ebc_0]** **[1395064_d12b47df93024199a6f97aa9ba2f2ebc_1]** **[1395064_d12b47df93024199a6f97aa9ba2f2ebc_2]** 
- UZEDY is a **once-monthly subcutaneous injectable** that utilizes Medincell's **SteadyTeq™ copolymer technology**.  **[1395064_d12b47df93024199a6f97aa9ba2f2ebc_1]** 
- For the BD-I indication, UZEDY is approved with **three once-monthly dosing options (50 mg, 75 mg, and 100 mg)**.  **[1395064_d12b47df93024199a6f97aa9ba2f2ebc_1]**

Teva Pharmaceuticals Announces FDA Approval for Expanded UZEDY® Indication

- **Takeda** has decided to **discontinue its cell therapy efforts** as part of a strategic portfolio prioritization process, and will seek an external partner for its cell therapy platform technologies and programs.  **[1395064_0001395064-25-000145_form6k_100125.htm:0]** 
- The company expects to recognize an **impairment loss of approximately JPY 58.0 billion** in the second quarter of the fiscal year ending March 31, 2026 (FY2025), primarily related to intangible assets associated with the gamma delta T-cell therapy platform.  **[1395064_0001395064-25-000145_form6k_100125.htm:0]** 
- The majority of this JPY 58.0 billion impairment is anticipated to be absorbed by the **JPY 50.0 billion of impairment losses** on intangible assets already included in Takeda's full-year consolidated forecast for FY2025, which was announced on May 8, 2025.  **[1395064_0001395064-25-000145_form6k_100125.htm:0]**

Takeda Discontinues Cell Therapy Efforts and Expects Impairment Loss

- **COUR Pharma** announced that the **U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CNP-106** for the treatment of **generalized myasthenia gravis (gMG)**.  **[1395064_e18b08005f3a49faac2d831a3f196b95_0]** 
- **CNP-106** is an investigational therapy, a biodegradable nanoparticle encapsulating acetylcholine receptor (AChR) antigens, designed to induce antigen-specific immune tolerance in anti-AChR antibody positive gMG.  **[1395064_e18b08005f3a49faac2d831a3f196b95_0]** **[1395064_e18b08005f3a49faac2d831a3f196b95_1]** 
- The company is currently enrolling patients aged 18-75 in a **Phase 1b/2a double-blind, randomized, placebo-controlled clinical trial (NCT06106672)** for CNP-106 in gMG.  **[1395064_e18b08005f3a49faac2d831a3f196b95_0]** 
- Receiving Orphan Drug Designation provides benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication.  **[1395064_e18b08005f3a49faac2d831a3f196b95_0]**

COUR Pharma Receives FDA Orphan Drug Designation for CNP-106

- **Takeda** has appointed **Rhonda Pacheco** as President of its U.S. Business Unit, effective **September 29**.  **[1395064_5afbd193614048b380e77b4d171cd58b_0]** 
- Pacheco joins Takeda from **Eli Lilly**, where she most recently served as Group Vice President of U.S. Cardiometabolic Health.  **[1395064_5afbd193614048b380e77b4d171cd58b_0]** 
- She succeeds **Julie Kim**, who was appointed to become Takeda's next Chief Executive Officer (CEO) in **June 2026** and will now focus on preparing for this transition.  **[1395064_5afbd193614048b380e77b4d171cd58b_0]**

TAKEDA PHARMACEUTICAL CO (TAK)