ALIMERA SCIENCES INC

ANI Pharmaceuticals launched Prucalopride Tablets, a generic version of Motegrity®, after FDA approval. The product has a Competitive Generic Therapy designation with 180-day exclusivity. U.S. annual sales for Prucalopride Tablets are approximately $168.0 million. ANI focuses on rare diseases, generics, and established brands.

ANI Pharmaceuticals received FDA approval for Prucalopride Tablets, the first generic of Motegrity®, with 180-day CGT exclusivity, targeting a $168.0 million U.S. market.

ANI Pharmaceuticals launched Prucalopride Tablets, a generic of Motegrity®, with FDA approval and 180-day exclusivity, targeting a $168M U.S. market. This move highlights ANI's R&D strength and generics market position, despite regulatory and competition risks.

ANI Pharmaceuticals launched generic Prucalopride Tablets after FDA approval, gaining 180-day market exclusivity. Targeting a $168M U.S. market, this move showcases ANI's R&D strength in generics and rare diseases, aiming to improve patient lives.

The global retinal vein occlusion (RVO) market, valued at USD 2.8 billion in 2023, is projected to grow at a 6.7% CAGR, reaching over USD 5.5 billion by 2034. Growth is driven by advancements in treatments like anti-VEGF drugs, laser therapies, and surgical interventions, alongside increasing RVO prevalence and research investments. Key players include Bayer AG, Novartis AG, and Regeneron Pharmaceuticals, focusing on innovation and accessibility. Emerging trends include AI in diagnostics, combination therapies, and personalized treatments, aiming for better patient outcomes and market expansion.

ANI Pharmaceuticals reported Q3 2024 net revenues of $148.3 million (+12.5% YoY) and Purified Cortrophin® Gel net revenues of $52.6 million (+76.8% YoY). The company posted a net loss of $(24.2) million and adjusted non-GAAP EBITDA of $35.1 million. Diluted GAAP loss per share was $(1.27), and adjusted non-GAAP diluted earnings per share were $1.34. ANI completed the acquisition of Alimera Sciences, Inc., implemented a new capital structure reducing annual interest expense by $39.0 million, and increased 2024 guidance to $594 million to $602 million in net revenues.

ANI Pharmaceuticals launched Estradiol Gel, 0.06% after FDA approval, aiming to provide a limited-competition product with annual U.S. sales of $16.7 million.

ANI Pharmaceuticals launched Ketoconazole Shampoo, 2% after FDA approval, aiming to address patient needs with limited competition products.