Replimune Group (NASDAQ: NASDAQ:REPL) has maintained a positive outlook from H.C. Wainwright following a key regulatory development.
The biotechnology firm recently completed a successful pre-Biologics License Application (pre-BLA) meeting with the U.S. Food and Drug Administration (FDA), which supports its plan to submit a BLA for its drug candidate RP1 for the treatment of melanoma that has not responded to anti-PD1 therapy.
The company aims to use the accelerated approval pathway for the submission in the second half of 2024.
The analyst from H.C. Wainwright reiterated a Buy rating on Replimune's stock, with a price target set at $17.00. This endorsement comes after the company's announcement on Monday that it had reached an agreement with the FDA on the design of its Phase 3 IGNYTE-3 trial.
The trial will be a randomized, two-arm study with a defined list of physician's choice treatment options serving as the comparator arm. This study will focus on advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy or are ineligible for anti-CTLA-4 treatment.
In addition, Replimune has made progress in its clinical development by enrolling the first patient in the IGNYTE-3 trial. This marks a significant step in the company's clinical program as it seeks to address the needs of patients with advanced melanoma.
The trial's design, which has been agreed upon with the FDA, aims to provide a clear comparison between RP1 and existing treatment options.
The affirmation of the $17.00 price target over the next 12 months reflects the firm's confidence in Replimune's potential to succeed in its upcoming regulatory and clinical milestones.
The analyst's commentary underscores the importance of the recent FDA meeting and the company's progress in advancing RP1 through the development pipeline.
In other recent news, Replimune Group has made significant strides in the development of its therapeutic candidate, RP1. The company's positive pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) indicates a potential accelerated approval for RP1, particularly for the treatment of melanoma patients who have not responded to anti-PD1 therapies.
Roth/MKM has maintained a Buy rating and a $17.00 price target for Replimune, reflecting confidence in the commercial potential of RP1 and the company's strategic progress.
Replimune has also seen changes in its leadership, with the appointment of Madhavan Balachandran to its Board of Directors. At the company's Annual Meeting of Stockholders, key decisions were made, including the election of three Class III directors and the ratification of PricewaterhouseCoopers LLP as the company's independent registered public accounting firm for the fiscal year ending March 31, 2025.
In addition, the company has shared primary analysis results from the IGNYTE clinical trial, which combined RP1 with nivolumab and showed an overall response rate of 33%.
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