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) operates in the specialty pharmaceutical sector, where news typically involves product development milestones, regulatory approvals, manufacturing updates, and financial performance. As a company focused on controlled substances, oncology medications, and complex formulations, developments in clinical trials, FDA interactions, and product launches carry particular significance for understanding the company's business trajectory.
This news resource tracks earnings reports, product commercialization announcements, clinical trial results, regulatory submissions, and material corporate events affecting ANI Pharmaceuticals. Pharmaceutical companies operating in niche therapeutic categories generate news around FDA approval decisions, manufacturing capacity expansions, product supply developments, and strategic partnerships that shape their competitive position.
For ANI Pharmaceuticals, investors and industry observers watch for updates on the company's Cortrophin development program, generic product launches in high-barrier categories, and financial results that reflect performance across branded and generic product lines. News coverage includes quarterly earnings that break down revenue contributions from different product categories, announcements of new product approvals that expand the company's portfolio, and material events disclosed through SEC filings.
Following ANI Pharmaceuticals news provides insight into how the company navigates the specialty pharmaceutical market, manages its manufacturing operations, advances product development initiatives, and responds to competitive dynamics in markets for controlled substances and complex formulations. Bookmark this page to track developments as they emerge.
ANI Pharmaceuticals (NASDAQ:ANIP) reported exceptional Q2 2025 results with record-breaking performance across key metrics. The company achieved total net revenues of $211.4 million, representing 53.1% year-over-year growth. Their Rare Disease segment, led by Cortrophin Gel with $81.6 million in revenue (66% YoY growth), was a major contributor.
The company's Generics business generated $90.3 million in revenue, up 22.1% YoY. ANI delivered record quarterly adjusted EBITDA of $54.1 million, a 62.8% increase, and achieved adjusted non-GAAP diluted EPS of $1.80.
Based on strong performance, ANI raised its 2025 guidance, now expecting total revenues of $818-843 million and adjusted non-GAAP EBITDA of $213-223 million. Rare Disease revenues are projected to represent approximately 50% of total company revenues in 2025.
ANI Pharmaceuticals (NASDAQ: ANIP) has scheduled its second quarter 2025 financial results announcement for Friday, August 8, 2025, before market open. The company will host a conference call at 8:30 a.m. ET to discuss the results.
Key executives participating in the call include CEO Nikhil Lalwani, CFO Stephen P. Carey, Head of Rare Disease Chris Mutz, and Chief Medical Officer Mary Pao, M.D., Ph.D. Investors can access the call via toll-free number 800-343-4136 using conference ID 5034065. A webcast will be available on the company's website under the Investors section.
ANI Pharmaceuticals (NASDAQ:ANIP) announced results from the NEW DAY clinical trial evaluating ILUVIEN® for diabetic macular edema (DME) treatment. The study compared ILUVIEN to aflibercept in treatment-naïve patients.
The trial's primary endpoint of reducing supplemental aflibercept injections was not met in the intent-to-treat population (2.4 vs 2.5 injections, p=0.756). However, a secondary endpoint showed significantly longer time between treatments with ILUVIEN (185.4 vs 132.8 days, p<0.001). A post-hoc analysis of patients without protocol deviations showed significant reduction in supplemental injections for the ILUVIEN group (1.8 vs 2.5, p=0.029).
Safety data showed ILUVIEN was well-tolerated but had higher treatment-related adverse events (41%) compared to aflibercept (3%), mainly related to cataracts and increased intraocular pressure.
ANI Pharmaceuticals (NASDAQ:ANIP) announced its participation in the upcoming Leerink Partners Therapeutics Forum, focusing on I&I and Metabolism. The company's President and CEO, Nikhil Lalwani, will be conducting one-on-one meetings with investors during the event, which takes place on July 8, 2025, in Boston, MA.
ANI Pharmaceuticals (NASDAQ: ANIP) has announced that CEO Nikhil Lalwani will present at the upcoming 2025 Jefferies Global Healthcare Conference in New York City. The presentation is scheduled for Wednesday, June 4, 2025, at 2:35 PM ET.
Investors can access the live and archived webcast through ANI Pharmaceuticals' website at www.anipharmaceuticals.com in the Investors section under Events and Presentations. The webcast replay will be available for 60 days after the event. Interested parties can schedule one-on-one meetings with the company by contacting their Jefferies representative.
ANI Pharmaceuticals (NASDAQ: ANIP) has announced its participation in the upcoming H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ. The company's presentation is scheduled for Tuesday, May 20, 2025, at 1:30pm ET. CEO Nikhil Lalwani and CFO Stephen Carey will represent the company at the conference.
Investors can access the presentation through a live webcast on ANI's website under the Investors section. The webcast recording will remain available for 90 days after the event. One-on-one meetings with management can be arranged through meetings@hcwco.com.
ANI Pharmaceuticals (NASDAQ: ANIP) presented preclinical data on Purified Cortrophin® Gel in an experimental autoimmune uveitis (EAU) mouse model at the ARVO 2025 annual meeting. The study demonstrated that Cortrophin Gel showed a significant dose-dependent effect in suppressing EAU across all tested doses (4, 40, 160, and 400 U/kg), with the strongest suppression at 400 U/kg.
Key findings revealed that the treatment suppressed inflammatory cytokine production and reduced retinal damage caused by EAU, comparable to α-MSH treatment versus placebo. The research supports the company's understanding of Cortrophin Gel's mechanism of action and demonstrates ANI's commitment to expanding clinical research for their products.
ANI Pharmaceuticals (NASDAQ: ANIP) has scheduled its first quarter 2025 financial results announcement for Friday, May 9, 2025, before market opening. The company will host a conference call at 8:00 a.m. ET to discuss the results.
Key executives participating in the call include President and CEO Nikhil Lalwani, SVP Finance and CFO Stephen P. Carey, and Head of Rare Disease Chris Mutz. Investors can access the call via toll-free number 800-225-9448 using Conference ID 4921902.
The webcast will be available live and for replay on the company's website under the Investors section. A replay option will be accessible for two weeks by calling 800-753-8591 with access code 4921902.
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