ABBVIE

Aldeyra Therapeutics' FDA-accepted NDA resubmission for reproxalap targets dry eye disease, with a decision expected by April 2, 2025. Following a 2023 CRL, a phase III study met primary endpoints, leading to the resubmission. Aldeyra also expanded its option agreement with AbbVie, sharing pre-commercial costs. Shares rose 11.6% post-announcement.

Biosimilars, nearly identical to original biologics, are revolutionizing the pharma industry by offering significant cost savings, with U.S. healthcare projected to save billions. Despite regulatory hurdles and a need for greater education among patients and providers, the biosimilar market is rapidly expanding globally, driven by patent expirations and supportive policies.

Chemists at Emory University and Caltech synthesized a complex natural molecule, cylindrocyclophane A, using a revolutionary C-H functionalization strategy, marking a significant advancement in organic synthesis. This method transforms inert C-H bonds into reactive sites, enabling the creation of intricate organic compounds from low-cost materials. The synthesis involved 10 C-H functionalization steps, showcasing the potential of this approach in drug development and materials science.

Rapport Therapeutics announces Q3 2024 financial results, appoints new Board members, and updates on RAP-219 trials in focal epilepsy, peripheral neuropathic pain, and bipolar disorder. The company ended Q3 with $320.7 million in cash, expected to fund operations through 2026.

Skyrizi sales surpass Humira for the first time in Q3 2024, with Skyrizi sales up 50.8% to $3.205 billion and Humira down 37.2% to $2.227 billion. This shift is attributed to the rise of Skyrizi and Rinvoq, impacting adalimumab biosimilar market share despite their growth.

In 2024, smaller deals have dominated pharma M&A, with no single deal surpassing $5 billion. Despite this, M&A remains crucial for refilling pipelines and supporting smaller biotechs. Notable deals include Vertex's $4.9 billion acquisition of Alpine Immune Sciences, Eli Lilly's $3.2 billion acquisition of Morphic, and Gilead's $4.3 billion purchase of CymaBay. Oncology and neuroscience have seen significant activity, with Novartis and AstraZeneca leading in oncology, and Bristol Myers Squibb and Lundbeck in neuroscience.

Top 20 biopharmaceutical companies saw a 2% market cap increase in Q3 2024, driven by FDA approvals and strategic alliances. Bristol Myers Squibb led with a 24.6% growth, fueled by Cobenfy's approval and a $3.5bn deal with Prime Medicine. Gilead Sciences and Sanofi also grew significantly due to new drug approvals. Despite some declines, industry recovery is expected, supported by Federal Reserve interest rate cuts.

REGENXBIO reports Q3 2024 financials and operational updates: RGX-202 for Duchenne Muscular Dystrophy advances in Phase I/II AFFINITY DUCHENNE trial; BLA submission for RGX-121 initiated, expected Q1 2025; positive Phase II data supports bilateral administration of subretinal ABBV-RGX-314; End-of-Phase II meeting for ABBV-RGX-314 in diabetic retinopathy accelerated to Q4 2024; conference call at 4:30 p.m. ET.