BRISTOL MYERS SQUIBB

Arbutus Biopharma reported Q3 2023 earnings in line with expectations, with a reported EPS of $-0.12. The company is focusing on developing a functional cure for chronic hepatitis B virus (HBV) through its clinical assets, imdusiran and AB-101, with data readouts expected next year. Arbutus announced a 24% workforce reduction to streamline operations, maintaining a strong financial position with $145 million in cash. CEO Bill Collier announced his retirement, with Mike McElhaugh set to succeed him as interim CEO.

Bristol Myers Squibb's repotrectinib, a next-gen TKI, seeks EMA approval for treating ROS1-positive NSCLC and NTRK-positive solid tumors. Based on TRIDENT-1 and CARE studies, it showed robust responses. FDA approved it as Augtyro for NSCLC. BMY aims to diversify its portfolio amid generic competition, with Opdivo already approved for NSCLC and plans to acquire Mirati Therapeutics for $5.8B, adding Krazati to its oncology portfolio.

Seattle Children's launches BrainChild Bio, Inc. to advance CAR T-cell therapies for CNS tumors, focusing on pediatric brain tumors like DIPG. With exclusive license to novel CAR T-cell technology, BrainChild Bio aims to accelerate clinical programs, leveraging Seattle Children’s Therapeutics' expertise and initial funding, to develop safer, effective treatments for children globally.

Seattle Children's Hospital launches BrainChild Bio, a biotech startup focusing on CAR-T cell therapies for pediatric brain tumors, leveraging technology and funding from the hospital. With prior clinical testing and plans for future trials, BrainChild aims for accelerated approval, despite FDA scrutiny over CAR-T therapy's safety risks.

The global sickle cell disease (SCD) treatment market, valued at USD 2.5 billion in 2022, is projected to reach USD 50.45 billion by 2032, growing at a CAGR of 35.1%. North America led with a 36% market share in 2022. Growth factors include market expansion in developing regions, innovative therapies, and global health initiatives. Key treatments involve blood transfusion and bone marrow transplant, with hospitals and specialty clinics as primary end-users. Advances in genetic research and personalized medicine are driving market evolution, despite challenges like economic barriers and inadequate infrastructure in developing regions.

Phase III trials for Aravive’s batiraxcept in ovarian cancer and Travere’s Filspari in FSGS failed, reducing their LoA. VYNE’s VYN201 showed positive Phase Ib results in vitiligo. Moderna’s MEDI1191, Drug Farm’s DF-006, and Alexion’s ALXN-2220 completed Phase I trials, increasing their PTSR in solid tumors, hepatitis B, and ATTR-CM, respectively.

The global Type 1 Diabetes (T1D) market is projected to grow at a CAGR of 17.2%, reaching US$ 38.63 Bn by 2029. Driven by increased awareness, technological advancements in insulin delivery, and government initiatives, the market faces challenges like high costs and biosimilars. North America leads, with APAC expected to grow significantly.

Paradigm collaborates with Bristol Myers Squibb to create a new clinical trial model, aiming to improve patient access, speed up results, and reduce provider burden. Starting with oncology, the initiative focuses on equitable enrollment and efficient trial operations, leveraging Paradigm's network and software to enhance clinical research accessibility and diversity.

Sarepta Therapeutics received FDA accelerated approval for Elevidys, a gene therapy for DMD in children aged 4-5, pending confirmatory trial results. Bristol Myers Squibb's Camzyos was approved in the EU for treating obstructive HCM. FibroGen's pamrevlumab failed in a phase III IPF study, leading to discontinuation of related trials. Intercept Pharmaceuticals faced FDA rejection for its NASH treatment, prompting restructuring. MoonLake Immunotherapeutics reported positive phase II results for sonelokimab in treating HS.