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SAN DIEGO - Teva’s investigational once-monthly subcutaneous long-acting injectable olanzapine (TEV-749) showed no suspected or confirmed Post-injection Delirium/Sedation Syndrome (PDSS) events through week 56 in the Phase 3 SOLARIS trial, according to data presented at the 2025 Psych Congress. The technology provider MedinCell, with a market capitalization of $826 million, has seen its stock surge 41% over the past six months on growing confidence in its drug delivery platform.
The long-term safety profile of the treatment was consistent with other olanzapine formulations, with the most common treatment-emergent adverse events including weight increase (36%), injection site reactions such as induration (12%) and pain (12%), and somnolence (7%).
The data supports Teva’s plans to submit a New Drug Application for the treatment in the U.S. in the fourth quarter of 2025. If approved, it would be the second product using MedinCell’s co-polymer technology (licensed to Teva as SteadyTeq) following UZEDY, which received FDA approval in April 2023. According to InvestingPro data, MedinCell has demonstrated impressive revenue growth of 132% in the last twelve months, with a healthy current ratio of 2.7 indicating strong short-term financial stability.
The SOLARIS trial included an 8-week randomized, double-blind, placebo-controlled period followed by an open-label safety period of up to 48 weeks in participants aged 18-64 with schizophrenia. The study involved 675 participants and included 3,470 total injections.
Long-term effectiveness data demonstrated maintained clinical effectiveness with stable changes in Positive and Negative Syndrome Scale total scores and Clinical Global Impression-Severity scale scores. The treatment also improved patient functioning scores, with a 4.6-point mean increase in Personal and Social Performance Scale score.
Weight and metabolic analysis found that participants who received the treatment for at least 48 weeks experienced a mean weight increase of 5.6kg, comparable to that reported for oral and intramuscular olanzapine formulations.
The absence of PDSS events could represent a significant advancement, as this complication has been a barrier to widespread use of existing long-acting injectable olanzapine formulations. With MedinCell trading near its 52-week high, InvestingPro subscribers can access 11 additional exclusive tips and comprehensive financial metrics to evaluate the company’s growth potential. Get deeper insights into biotechnology stocks and discover similar investment opportunities with InvestingPro’s advanced screening tools.
The information in this article is based on a press release statement from MedinCell.
In other recent news, Medincell announced the appointment of three new independent board members during its General Assembly. The newly appointed members are Dr. Sharon Mates, Dr. Charles Kunsch, and Dr. Pascal Touchon. Dr. Mates is notable for her role as co-founder and former CEO of Intra-Cellular Therapies, which Johnson & Johnson acquired for $14.6 billion earlier this year. Dr. Kunsch brings his experience as a former Managing Director at AbbVie Ventures. Dr. Touchon has held leadership roles at Novartis Oncology and Atara Biotherapeutics. These appointments reflect Medincell’s focus on strengthening its leadership with seasoned biotech professionals. These developments are part of Medincell’s ongoing efforts to enhance its strategic direction.
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