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 received FDA approval for its Clorazepate Dipotassium Tablets, a generic version of Tranxene®. The U.S. market for this product is approximately $25.8 million, as reported by IQVIA/IMS Health. CEO Nikhil Lalwani highlighted this launch as part of ANI's commitment to expanding access to essential therapeutics. The Company continues to focus on sustainable growth through new product launches and strengthening its generics portfolio.
ANI Pharmaceuticals and Veeva Systems have partnered to enhance commercial strategies for ANI's Rare Disease Business Unit, utilizing Veeva's data-driven tools. This collaboration aims to launch ANI's first product, Purified Cortrophin Gel, in the U.S. The companies emphasize agility and precision in addressing rare disease patients' needs. ANI has adopted Veeva Commercial Cloud solutions to strengthen its sales and marketing capabilities. This partnership is expected to refine customer engagement and optimize sales interactions, marking a significant step in ANI's mission to improve patient access.
ANI Pharmaceuticals plans to cease operations at its Oakville, Ontario manufacturing plant by Q1 2023 as part of cost-competitiveness efforts following its acquisition of Novitium Pharma in November 2021. This move is expected to enhance profitability and cash flow by $7 million to $8 million annually. Products from the Oakville site will be transitioned to U.S. facilities, ensuring supply continuity. The company remains committed to treating employees respectfully and is exploring potential buyers for the Oakville site.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has received FDA approval for its Abbreviated New Drug Application (ANDA) for Fludrocortisone Acetate Tablets USP, 0.1 mg, a generic version of Florinef®. The U.S. market for these tablets is valued at approximately
ANI Pharmaceuticals (NASDAQ: ANIP) announced that CEO Nikhil Lalwani and CFO Stephen Carey will present at two key conferences. The first, the H.C. Wainwright Global Investment Conference, is a virtual event on May 24, 2022 at 7:00 a.m. ET. The second is the Jefferies Healthcare Conference in New York City on June 9, 2022 at 11:30 a.m. ET. Webcasts will be available on the company's website, enhancing transparency and investor engagement.
ANI Pharmaceuticals reported first quarter 2022 net revenues of $64.5 million, a 17.6% increase from Q1 2021. However, the company faced a net loss of $(20.1) million, equating to a diluted GAAP loss per share of $(1.27). Adjusted non-GAAP EBITDA was $4.3 million. The company provided revenue guidance for Cortrophin Gel of $35 million to $40 million and total net revenue guidance of $295 million to $315 million for 2022. Strong physician demand for Cortrophin Gel has resulted in over 250 new cases initiated. ANI's ongoing R&D efforts led to several new product launches and six new ANDA applications.
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will release its Q1 2022 financial results on May 10, 2022. A conference call will follow at 8:30 a.m. ET to discuss these results. The call can be accessed via a toll-free number and a webcast available on their website. ANI focuses on developing, manufacturing, and marketing high-quality branded and generic pharmaceuticals, aiming for sustainable growth through its Purified Cortrophin™ Gel franchise and enhanced generics business.
ANI Pharmaceuticals has launched Misoprostol Tablets in 100 mcg and 200 mcg strengths, positioned as the generic counterpart to Cytotec®.
The U.S. market for these tablets is valued at approximately $15.3 million. The product holds an AB rating, ensuring its bioequivalence to the reference drug, which enhances its competitive edge amidst a recent market shortage.
ANI aims to fulfill the demand for limited market competition in generics, emphasizing its commitment to patient needs and sustainable growth.
ANI Pharmaceuticals has appointed Renee P. Tannenbaum, Pharm.D., MBA, to its Board of Directors, increasing the board size to nine members. Dr. Tannenbaum brings over 35 years of experience in the pharmaceutical sector and will enhance the company's strategy as it launches Purified Cortrophin Gel. She has held senior roles at major firms like AbbVie and Elan Pharmaceuticals and looks forward to contributing to ANI's growth trajectory, especially post the recent acquisition of Novitium Pharma LLC.
ANI Pharmaceuticals, Inc. reported fourth quarter net revenues of $60.9 million, with a net loss of $24.1 million (diluted loss per share of $1.72). For the full year 2021, revenues reached $216.1 million, and the net loss stood at $42.6 million. The company launched Purified Cortrophin™ Gel for chronic autoimmune disorders and acquired Novitium Pharma, integrating it to enhance their generics business. ANI projects 2022 revenues between $260 million and $275 million, indicating a growth of 20%-27% year-over-year.
