Arcutis Biotherapeutics-What Awaits These 4 Biotech Stocks That More Than Doubled in 2024

Industry Overview - The drug and biotech sector experienced a turbulent year in 2024, starting strong but losing momentum in the second half due to disappointing third-quarter earnings, reduced guidance, and pipeline setbacks [1] - Despite challenges, the demand for cutting-edge medical innovations ensures the sector remains a focal point for investors [1] - Innovation continues to be a key growth driver, particularly in high-potential areas like obesity and oncology treatments [19] - The sector's robust fundamentals and expectations of strong M&A activity in 2025 indicate a promising outlook [19] Arcutis Biotherapeutics (ARQT) - Zoryve witnessed strong uptake, with Arcutis recording product revenues of $97 million in the first nine months of 2024, up more than 500% from the year-ago quarter [2] - The stock price rally was driven by FDA approval of Zoryve cream 0.15% for mild to moderate atopic dermatitis (AD) in July 2024 [15][16] - Arcutis plans to submit an sNDA for Zoryve cream 0.05% to treat mild to moderate AD in children two to five years old and has another sNDA for Zoryve foam 0.3% under FDA review for scalp and body psoriasis [17] - Shares of Arcutis have shot up 364.1% year-to-date compared with the industry's 12.8% decline [13] Mesoblast Limited (MESO) - Shares of Mesoblast have skyrocketed 673.6% year-to-date compared with the industry's 12.8% decline [4] - The stock price rally was driven by FDA approval of remestemcel-L (Ryoncil) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children [6] - Mesoblast is expanding Ryoncil's label to include adult patients with SR-aGVHD and evaluating it for inflammatory bowel disease indications [7] - The FDA supports an accelerated approval pathway for rexlemestrocel-L in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) [8] - Estimates for MESO's 2025 loss per share have narrowed from 57 cents to 52 cents in the past 60 days [20] Monopar Therapeutics (MNPR) - Shares of Monopar have gained 1196.3% year-to-date compared with the industry's 12.8% decline [24] - The stock price rally was fueled by a licensing agreement with AstraZeneca for ALXN-1840, an investigational oral medicine for Wilson disease [25] - Monopar is focusing on developing ALXN-1840 for patients with more severe Wilson disease symptoms and evaluating several other candidates for various oncology indications [9][18] - Estimates for MNPR's 2025 loss per share have narrowed from$ 1.82 to $1.48 in the past 60 days [23] Kodiak Sciences (KOD) - Shares of Kodiak have rallied 224.7% year-to-date compared with the industry's 12.8% decline [12] - Kodiak is advancing KSI-501 into phase III development for wet AMD and has rebooted the development program of tarcocimab following positive phase III results from the GLOW study [10][12] - The company initiated the GLOW2 study in late 2023 to further investigate tarcocimab for diabetic retinopathy (DR) [12] - Estimates for KOD's 2025 loss per share have narrowed from$ 3.90 to $3.82 in the past 60 days [28]