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PRINCETON, N.J. - ANI Pharmaceuticals, Inc. (Nasdaq:ANIP), a pharmaceutical company showing strong revenue growth of 30% over the last twelve months and currently valued at $1.3 billion, announced Wednesday that its NEW DAY clinical trial for ILUVIEN (fluocinolone acetonide intravitreal implant) in diabetic macular edema (DME) patients showed mixed results. According to InvestingPro analysis, the company appears undervalued based on its Fair Value estimates.
The study’s primary endpoint, measuring the mean number of supplemental aflibercept injections needed, did not reach statistical significance in the intent-to-treat population. Patients in the ILUVIEN arm required 2.4 supplemental injections compared to 2.5 in the aflibercept arm (p=0.756). Despite these mixed results, InvestingPro data shows ANI maintains strong financial health with a current ratio of 2.66, indicating robust liquidity to support ongoing clinical developments.
However, the trial met its secondary endpoint with ILUVIEN patients showing a significantly longer time to first supplemental injection at 185.4 days versus 132.8 days for aflibercept patients (p
A post-hoc analysis of patients without major protocol deviations showed ILUVIEN recipients needed significantly fewer supplemental injections (1.8) compared to aflibercept recipients (2.5), resulting in a total of 2.8 injections versus 7.5 injections, respectively (p=0.029).
The safety profile aligned with previous ILUVIEN clinical trials. In the ILUVIEN arm, 41% of patients experienced treatment-related adverse events, mainly associated with cataracts and increased intraocular pressure, compared to 3% in the aflibercept arm.
"The NEW DAY study provides clinically meaningful data on ILUVIEN’s potential impact on treatment burden," said Dr. Michael Singer, who presented the results at the American Society of Retina Specialists Annual Scientific Meeting.
ILUVIEN is currently indicated for DME patients previously treated with corticosteroids who did not have a clinically significant rise in intraocular pressure.
Secondary endpoints assessing visual acuity and anatomic changes demonstrated non-inferiority between the treatment arms.
The information in this article is based on a company press release statement. Looking ahead, InvestingPro analysts project profitability for ANI Pharmaceuticals this year, with comprehensive analysis available in the Pro Research Report, part of InvestingPro’s coverage of over 1,400 US stocks. Discover more valuable insights and 7 additional ProTips for ANI Pharmaceuticals with an InvestingPro subscription.
In other recent news, ANI Pharmaceuticals reported impressive financial results for the first quarter of 2025. The company achieved earnings per share of $1.70, surpassing the forecasted $1.34. Revenue for the quarter reached $197.1 million, marking a 43% increase compared to the same period last year. These results reflect a strong performance and have garnered positive attention from investors. Additionally, ANI Pharmaceuticals announced significant updates following its Annual Meeting on May 22, 2025. Stockholders approved amendments to the company’s stock incentive and employee stock purchase plans, along with an increase in the number of authorized shares of common stock. The details of these plans were filed with the SEC on May 23, 2025. These developments indicate strategic moves by ANI Pharmaceuticals to enhance its stock plans and expand its financial capabilities.
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