Welcome to our dedicated page for Ani Pharmaceutic news (Ticker: ANIP), a resource for investors and traders seeking the latest updates and insights on Ani Pharmaceutic stock.
ANI Pharmaceuticals Inc. (ANIP) delivers innovative solutions in specialty generics and complex drug formulations, focusing on therapeutic areas with high barriers to entry. This page provides investors and healthcare professionals with timely updates on regulatory milestones, manufacturing developments, and strategic initiatives within controlled substances, oncology, and rare disease therapies.
Discover official press releases covering ANIP’s FDA submissions, product launches, and financial results alongside analysis of its Minnesota-based manufacturing capabilities. Our repository includes updates on niche segments like hormonal therapies and extended-release formulations, reflecting the company’s commitment to addressing unmet medical needs.
Bookmark this page for direct access to ANIP’s latest corporate announcements, partnership details, and therapeutic pipeline progress. Stay informed about developments in cGMP-compliant production and market expansions through verified, up-to-date reporting.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) is set to release its fourth quarter and full year 2021 financial results on March 15, 2022, at 8:30 a.m. ET. The conference call will be hosted by CEO Nikhil Lalwani and CFO Stephen P. Carey. Investors can access the live and replay webcast on the company's website under the “Investors” section. ANI Pharmaceuticals focuses on developing high-quality branded and generic prescription drugs, aiming for sustainable growth through a strong Purified Cortrophin™ Gel franchise and enhanced generics.
ANI Pharmaceuticals (NASDAQ: ANIP) announces the appointments of Mary Pao, M.D., Ph.D., as Chief Medical Officer, and Elizabeth Powell, J.D., as Chief Compliance Officer and Head of Legal for its Rare Disease Business Unit. These executives bring over four decades of pharmaceutical experience, aiming to enhance the commercialization of Purified Cortrophin™ Gel. Dr. Pao joined in October 2021, focusing on clinical strategy, while Ms. Powell has been with ANI since February 2022, overseeing compliance and legal matters.
On February 14, 2022, ANI Pharmaceuticals (NASDAQ: ANIP) announced FDA approval for a generic version of Cystadane® (betaine anhydrous) powder, with shipments starting in early February. This approval grants ANI 180 days of exclusivity under Competitive Generic Therapy. CEO Nikhil Lalwani emphasized the company's commitment to serving underserved rare disease patients and expanding its product lineup, which includes seven additional ANDAs filed with the FDA. This marks ANI's third generic orphan drug launch, enhancing its position in the pharmaceutical market.
ANI Pharmaceuticals has announced the U.S. commercial launch of Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) 80 U/mL, which treats chronic autoimmune disorders like multiple sclerosis and rheumatoid arthritis. This launch is driven by ANI's new rare disease business unit and represents a significant addition to the ACTH treatment category, which has lacked options for over 20 years. ANI aims to ensure access to Cortrophin Gel through support programs for patients, prescribers, and healthcare professionals.
ANI Pharmaceuticals will present virtually at the H.C. Wainwright Bioconnect Conference on January 10, 2022, at 7:00 a.m. ET. The presentation will feature CEO Nikhil Lalwani and CFO Stephen Carey. The webcast will be available on demand starting at the specified time and will remain archived for 90 days on ANI's website. ANI Pharmaceuticals focuses on providing high-quality branded and generic pharmaceutical products, particularly for diseases with unmet medical needs. For more details, visit www.anipharmaceuticals.com.
ANI Pharmaceuticals, Inc. announced FDA approval for its Rifabutin Capsules USP, 150 mg, a generic version of Mycobutin®. The U.S. market for this drug is valued at approximately $16.6 million annually, indicating strong commercial potential. CEO Nikhil Lalwani emphasized the company's robust R&D capabilities and commitment to addressing market needs with limited competition generics. This approval marks a significant step in ANI's strategy to enhance its generics portfolio and drive sustainable growth.
ANI Pharmaceuticals has completed the acquisition of Novitium Pharma, enhancing its generics pipeline and manufacturing capabilities. The combined entity boasts a robust product pipeline with over 20 planned launches in the next 18 months, focusing on Competitive Generic Therapy (CGT) and 505(b)(2) products. Pro-forma revenues for the year to date reached $202.5 million, and new capital structures, including a $75 million equity raise, position ANI for sustainable growth. The acquisition is expected to be immediately accretive to adjusted non-GAAP earnings per share.
ANI Pharmaceuticals will present at the Piper Sandler 33rd Annual Healthcare Conference on November 22, 2021, at 10:00 a.m. ET. CEO Nikhil Lalwani and CFO Stephen Carey will lead the presentation, which will also involve 1x1 meetings by request via Piper Sandler. The webcast will be available on demand for 90 days on the company's website. ANI is a diversified bio-pharmaceutical company focused on developing high-quality branded and generic prescription products for patients with unmet medical needs.
ANI Pharmaceuticals, Inc. announced the FTC's acceptance of the proposed consent order regarding its acquisition of Novitium Pharma. The FTC requires the divestiture of development rights to one generic drug and related assets of another, deemed immaterial to ANI's business. With this decision, ANI has cleared the necessary antitrust hurdles, proceeding to close the acquisition around November 18, 2021, subject to customary conditions. This acquisition is strategic, aiming to enhance ANI's portfolio in the pharmaceutical market.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has successfully completed its underwritten public offering, selling 1,500,000 shares at $50.00 each, generating gross proceeds of $75 million. Underwriters have a 30-day option to buy an additional 225,000 shares. Guggenheim Securities and Raymond James served as book-running managers. The offering was made under a shelf registration statement filed with the SEC. ANI focuses on developing high-quality branded and generic pharmaceuticals, particularly in niche areas such as oncology and controlled substances.
