Replimune Stock Hits 1-Year High In After-hours As Small-Cap Biotech Files For FDA Approval Of Skin Cancer Combo Therapy: Retail Upbeat

Replimune, Inc. ($REPL) shares spiked higher in Thursday’s after-hours session after the small-cap biopharma developing oncolytic immunotherapies, provided a key regulatory update for its combo therapy candidate to treat skin cancer, lifting retail sentiment.

The Woburn, Mass.-based clinical-stage biopharma said after the market closed that it has submitted a biologic license application (BLA) for RP1, aka vusolimogene oderparepvec, -  its lead immulytic product candidate, in combination with Bristol-Myers Squibb Co.’s ($BMY) Opdivo, for advanced melanoma patients who have been previously treated with anti-PD1 therapies.

Anti-PD1 therapy is currently the standard of care for several types of cancer.

RP1 is based on a proprietary new strain of the Herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

The regulatory filing has been done under the accelerated approval pathway, which expedites approval for drugs to treat unmet needs based on a “surrogate endpoint,” rather than a direct measure of clinical benefit.

The combo therapy also received FDA’s breakthrough therapy designation (BTD) based on the safety and clinical activity observed in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial.

A BTD designation is meant to expedite drug development for treating life-threatening and serious medical conditions by allowing increased FDA interactions and intensive guidance from the agency.

Sushil Patel, CEO of Replimune, said, "Today is an important milestone for Replimune and for the melanoma community as we are one step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD1 containing regimens.”

The biopharma said patients are currently being enrolled for the confirmatory late-stage study, dubbed IGNYTE-3 trial.

REPL sentiment and message volume November 22, 2024, as of 3:25 am ET | Source: Stocktwits

On Stocktwits, retail sentiment inflected higher from ‘neutral’ (46/100) a day ago to ‘bullish’ (57/100), with message volume rising to ‘extremely high.’

Replimune stock climbed 19.37% in Thursday’s after-hours session to $13.19, its highest level in a little over a year. The stock has gained 31.08% for the year-to-date period.