BRISTOL MYERS SQUIBB

Climb Bio appoints Douglas E. Williams, Ph.D., as Chair of its Board of Directors, succeeding Andrew Levin, who remains a director. Dr. Williams brings over 30 years of biotech leadership experience, including roles at Sana Biotechnology, Codiak BioSciences, and Biogen. His expertise in immunology drug development is expected to aid Climb Bio's mission to treat immune-mediated diseases.

The global biotechnology market is projected to reach $550.83 billion in 2024 and $2667.36 billion by 2034, driven by advancements in synthetic biology, CRISPR, and genomic sequencing. North America is expected to lead, with a revenue of $231.68 billion in 2024, due to established agricultural biotechnology and a robust GMO framework. Key players include Johnson & Johnson, Roche, Pfizer, and Novartis.

Autolus secures FDA approval for Aucatzyl, a CD19-targeting CAR-T therapy for relapsed or refractory B-cell precursor ALL, with no REMS requirement. Aucatzyl achieved 42% complete remission in the FELIX trial, with low rates of CRS and neurotoxicity. Competing with Novartis' Kymriah and Gilead/Kite's Tecartus, Aucatzyl aims to capture market share in the US, targeting around 3,000 patients.

Adlai Nortye (ANL) is developing Buparlisib, a PI3K inhibitor for recurrent/metastatic HNSCC post-anti-PD(L)1 treatment, with a phase III trial (BURAN) underway. Expected OS data in Q1 2025. ANL also has two other clinical drugs, AN4005 and AN0025, and a cash position of $98M as of June 2024.

Roflumilast cream 0.15% showed high efficacy in treating mild to moderate atopic dermatitis in patients aged 6 years and older, with more patients achieving a validated IGA-AD score of 0/1 and minimal application site irritation.

The biopharmaceutical sector rebounded in Q3 2024, with top 20 companies seeing a 2% increase in market capitalization to $4.3 trillion. Bristol-Myers Squibb led with a 24.6% surge, driven by FDA approval of Cobenfy. Gilead Sciences rose 22.1% due to accelerated approvals for Livdelzi and Trodelvy. Sanofi's market cap jumped 19.2% on Dupixent's success. AbbVie gained 15.2% from immunology drugs. Alnylam Pharmaceuticals and Roche Holdings also saw significant growth. Novo Nordisk, Eli Lilly, and Merck faced declines.

Sehgal et al reported nivolumab plus ipilimumab activity in aggressive thyroid carcinoma, with objective responses in 9.4% of radioiodine-refractory DTC, 30% in ATC, and 0% in MTC. NRAS variants correlated with poorer survival. No treatment-related deaths occurred.

The Lupus Research Alliance launched the DREAM platform, a knowledge-exchange tool for researchers and lupus patients, completing the Lupus Nexus program aimed at accelerating precision medicine in lupus.

Kura Oncology reports Q3 2024 financial results, expecting topline results from ziftomenib trial in R/R NPM1-mutant AML in early 2025. The company plans to present data from 100 patients in the Phase 1a study at ASH, with the Phase 1b expansion study enrolling at 600 mg. Preclinical data supports ziftomenib's potential in GIST, with a proof-of-concept study expected in 1H 2025. Kura also dosed the first patient in the KO-2806 and adagrasib study in KRASG12C-mutated NSCLC. The company reported a net loss of $54.4 million for Q3 2024, with R&D expenses at $41.7 million and G&A expenses at $18.2 million. Kura holds $455.3 million in cash, cash equivalents, and investments, expected to fund operations into 2027.