Replimune Group Inc. (REPL)
Summary
Replimune: Stock Buoyant On Third Try At RP1 Approval - FDA AdCom May Be Crucial
Replimune Group, Inc. faces a pivotal FDA AdCom for RP1 after two prior rejections, with a final FDA approval decision expected August 2, 2026. RP1 demonstrated a 34% ORR and median overall survival of 32.9 months in anti-PD-1-failed melanoma, but trial design concerns persist. REPL stock has surged over 135% since April as FDA leadership changes and collaborative dialogue opened a path for BLA resubmission.
REPL Stock Soars on Plans of BLA Resubmission for Melanoma Combo Drug
Replimune stock surges after the company aligned with the FDA on plans to resubmit its BLA for RP1 plus Opdivo in advanced melanoma.
How Replimune's drug got a third chance after the White House intervened
Replimune representatives met with White House officials in early May and by the end of month, the Food and Drug Administration was planning to review the melanoma medication again.
Replimune Group Inc. Investors
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
| CE Curtis Ellergodt Rothschild Investment LLC | 9 | $37.73 | $93.96 | $56.23 | 149.03% |
| BG Bart Gancher Intech Investment Management LLC | 18,125 | $214,905.44 | $189,950 | -$24,955.44 | -11.61% |
 John H. Burbank III Passport Capital LLC | 11.05M | $148.52M | $115.76M | -$32.77M | -22.06% |
 Joseph Castro Nuveen LLC | 57,614 | $561,736.56 | $606,099.28 | $44,362.72 | 7.9% |
 Bobby Adusumilli SJS Investment Consulting Inc. | 17 | $130.05 | $180.54 | $50.49 | 38.82% |
Replimune Group Inc. Analysts
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
 Robert Driscoll Wedbush | 992.56 | $3,067.73 | $10,158.86 | $7,091.13 | 231.15% |
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Replimune Group Inc. Profile
| Biotechnology Industry | Healthcare Sector | Sushil Patel CEO | NASDAQ (NGS) Exchange | 76029N106 CUSIP |
| US Country | 465 Employees | - Last Dividend | - Last Split | 20 Jul 2018 IPO Date |
Overview
Replimune Group, Inc. is recognized as a clinical-stage biotechnology firm that is dedicated to the creation of oncolytic immunotherapies aimed at combating cancer. With its foundation laid in 2015 and based in Woburn, Massachusetts, the company leverages its specialized knowledge to develop innovative treatments that stimulate the immune system's response to cancer. Focusing primarily on the intersection of immunotherapy and the unique characteristics of oncolytic viruses, Replimune Group endeavors to transform cancer treatment paradigms and provide new hope to patients affected by various forms of solid tumors.
Products and Services
Replimune Group, Inc. has established a portfolio of oncolytic immunotherapy product candidates, each designed with the objective of activating the immune system's natural ability to fight cancer. These include:
- RP1: Representing Replimune's lead product candidate, RP1 is a select form of the herpes simplex virus type 1 (HSV-1), modified to selectively replicate within tumors and express the GALV-GP R(-) and human granulocyte-macrophage colony-stimulating factor (GM-CSF). This candidate is currently being evaluated across a range of solid tumors in Phase I/II clinical trials and has completed a Phase II clinical trial for the treatment of cutaneous squamous cell carcinoma. The pioneering approach of RP1 offers the dual benefit of direct oncolytic destruction of tumor cells and the stimulation of a systemic anti-tumor immune response.
- RP2: As an extension of Replimune's innovative research, RP2 is another significant product candidate under clinical development. This therapy is designed to express an anti-CTLA-4 antibody-like protein, with the purpose of disrupting the inhibition of the immune response typically instigated by CTLA-4. Currently in Phase I clinical trials, RP2 embodies the company's commitment to advancing immune checkpoint blockade strategies within the realm of oncolytic immunotherapy.
- RP3: Further exemplifying Replimune's broad pipeline is RP3, a product candidate in Phase I clinical trials. RP3 is engineered to express multiple immune-activating proteins intended to stimulate T cells, which play a crucial role in the immune system's ability to recognize and combat cancer cells. This innovative approach positions RP3 as a potential catalyst for further enhancing the efficacy of cancer immunotherapy.
