Tonix Pharmaceuticals stock halted ahead of FDA approval news
On Thursday, Enlivex Therapeutics (NASDAQ:ENLV), currently trading at $0.92 with a market cap of $21.8 million, received a reiteration of a Buy rating and a $7.00 price target from H.C. Wainwright analysts. According to InvestingPro data, analyst targets range from $7.00 to $13.00, suggesting significant upside potential from current levels. The endorsement comes as Enlivex announced the completion of patient enrollment for the Phase 2 segment of its Phase 1/2 trial for Allocetra in treating moderate-to-severe knee osteoarthritis (OA). The trial successfully randomized and treated 133 patients in this stage.
The Phase 2 stage of the trial is characterized by a double-blind, randomized, placebo-controlled, multi-center design, which aims to assess the safety and efficacy of Allocetra injections. While the company maintains a strong financial position with more cash than debt and a healthy current ratio of 6.84, InvestingPro analysis indicates the company is rapidly burning through its cash reserves. This follows a Phase 1 safety run-in, open-label dose escalation phase that reported positive interim efficacy data at three and six months for the initial 12 patients, with significant improvements in all key efficacy endpoints without safety concerns.
The trial includes an interim statistical evaluation by an independent third party, which is blinded to Enlivex, to consider the potential benefits of enrolling additional patients beyond the original target size. This evaluation is intended to determine the impact on the statistical significance of the overall group or specific sub-groups. An independent data safety and monitoring board (DSMB) is in place to review safety data at predetermined intervals.
Key efficacy endpoints of the trial will compare joint pain and joint function against a placebo at three months, six months, and at various post-treatment stages, including a 12-month follow-up. Enlivex anticipates the release of top-line data from the Phase 2 stage, including complete three-month endpoints, by August of the current year.
The reaffirmation of the Buy rating and the price target reflects the analysts’ outlook on Enlivex’s stock potential, based on the progress and anticipated outcomes of the ongoing Allocetra trial. With the stock trading below its Fair Value according to InvestingPro models, investors seeking deeper insights can access additional ProTips and comprehensive financial metrics through an InvestingPro subscription.
In other recent news, Enlivex Therapeutics has made notable strides in its intellectual property portfolio. The China National Intellectual Property Administration has issued a notice of allowance for Enlivex’s patent application concerning its therapy, Allocetra, for treating osteoarthritis. This development is expected to strengthen Enlivex’s intellectual property rights in China through at least 2040, with the patent anticipated to be officially granted in the first half of 2025. Analyst Raghuram Selvaraju from H.C. Wainwright responded to this development by raising the price target for Enlivex to $7.00 from $6.00, maintaining a Buy rating on the stock. Selvaraju highlighted the potential of the Chinese market, noting the large number of osteoarthritis cases in China, which is considered a promising market for treatment. Osteoarthritis affects over 300 million individuals globally, with significant prevalence in China and the United States. Enlivex’s progress in securing this patent is seen as a significant step forward for the company. The decision to raise the price target reflects optimism about Enlivex’s future prospects in a key international market.
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