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) has announced that CEO Nikhil Lalwani and CFO Stephen Carey will present at the H.C. Wainwright BioConnect Investor Conference on May 2, 2023, at 12:00 p.m. ET in New York City. The event will be available via webcast.
Investors can access the live presentation by clicking here. The recorded version will be available on demand starting May 3, 2023, at 7:00 a.m. ET for 90 days.
ANI Pharmaceuticals focuses on developing, manufacturing, and marketing high-quality pharmaceutical products, including those for unmet medical needs.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has received FDA approval for its Nitrofurantoin Oral Suspension (25 mg/5 ml), a generic version of Furadantin®, addressing a market worth approximately $55.5 million annually. This approval aligns with ANI's strategy to expand its generics portfolio by providing limited-competition products to benefit patient populations in need. CEO Nikhil Lalwani emphasized the company's commitment to launching new products as a priority for growth.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has received FDA approval for its Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g, a generic version of Colestid®.
This market is valued at approximately $81.3 million annually in the U.S., according to IQVIA/IMS Health. CEO Nikhil Lalwani noted the launch expands their generics portfolio, emphasizing the limited suppliers for this product.
ANI aims to enhance its growth through access to high-quality medicines and strengthening its generics business.
ANI Pharmaceuticals (ANIP) reported a strong performance in Q4 2022, achieving net revenues of $94.2 million—a 54.7% increase year-over-year. However, the company incurred a net loss of $(4.7) million, translating to a diluted GAAP loss per share of $(0.28). For full-year 2022, total net revenues reached $316.4 million, alongside a net loss of $(49.5) million. The company anticipates 2023 net revenue guidance of $360 million to $385 million, with adjusted EBITDA expected between $78 million and $88 million. ANI is focusing on its Rare Disease segment, particularly the Cortrophin Gel, and projects substantial revenue growth in this area.
Cosette Pharmaceuticals has announced the acquisition of US marketing rights for Betaine Anhydrous for Oral Solution from ANI Pharmaceuticals (ANIP), beginning immediate shipping to customers. This product provides an important treatment option for patients suffering from homocystinuria, a rare genetic disorder. The CEO of Cosette,
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will announce its fourth quarter and full year 2022 financial results on March 9, 2023, before the market opens. The call will include insights from Nikhil Lalwani, CEO, and Stephen P. Carey, CFO, at 8:30 a.m. ET. Interested parties can participate via a conference call at 800-343-5172 or through a webcast available on the ANI website. Following the call, a replay will be accessible for two weeks. ANI Pharmaceuticals focuses on developing high-quality branded and generic pharmaceuticals, particularly in addressing high unmet medical needs.
ANI Pharmaceuticals (NASDAQ: ANIP) has received FDA approval for its Levocarnitine Tablets USP, 330 mg, a generic version of the branded drug Carnitor®. The U.S. market for Levocarnitine Tablets is valued at approximately $10 million annually. This launch aligns with ANI's mission to enhance patient access to affordable medicines and reinforces its commitment to limited-competition products. The company aims for sustainable growth through its generics and innovative product lines, leveraging its manufacturing capabilities.
ANI Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, 20 mg/5 mL, a generic version of Prozac®. This generic drug targets a U.S. market estimated at $14.6 million, according to IQVIA/IMS Health. CEO Nikhil Lalwani emphasized ongoing commitment to affordable generics, showcasing the company's focus on enhancing its generics business. The approval may potentially boost ANI's sales and market presence, reflecting its strategic growth in the pharmaceutical sector.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has received FDA approval for its Abbreviated New Drug Application for Trimethoprim Tablets USP, 100 mg. This product is a generic version of the established Trimethoprim Tablets, targeting an annual U.S. market worth approximately $16.8 million according to IQVIA/IMS Health. CEO Nikhil Lalwani highlighted ANI's commitment to bringing niche products to market while expanding its generics portfolio.
ANI Pharmaceuticals reported third-quarter 2022 net revenues of $83.8 million, marking a 61% year-over-year growth. However, the net loss available to common shareholders stood at $(9.0 million), with a diluted GAAP loss per share of $(0.55). Adjusted non-GAAP EBITDA reached $19.6 million. The company reiterated its full-year 2022 guidance for net revenues between $295 million and $315 million. Key product Cortrophin generated $12.6 million in sales, with substantial gains in patient cases initiated and prescriber engagement.
