Glenmark Pharma shares up 2% after FDA grants fast track status to cancer drug

Glenmark Pharmaceuticals shares climbed as much as 1.8% on Tuesday to Rs 1,431.25 on the BSE after the company announced that its innovation arm, Ichnos Glenmark Innovation (IGI), has received ‘fast track’ designation from the US Food and Drug Administration (FDA) for its investigational therapy ISB 2001.

The designation applies to adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

ISB 2001 is a tri-specific antibody therapeutic designed to target BCMA and CD38 on myeloma cells, as well as CD3 on T cells, enabling a targeted immune response against cancer. The therapy is currently being evaluated in a Phase 1 dose expansion clinical study.

Ichnos Glenmark Innovation recently completed the dose escalation portion of its Phase 1 clinical trial in patients with heavily pre-treated multiple myeloma.

Initial results from the study, presented during an oral session at the American Society of Hematology (ASH) Annual Meeting in December 2024, demonstrated a high overall response rate (ORR), durable responses, and a favorable safety profile.

Complete results from the dose escalation portion will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2, 2025.

The FDA’s fast track designation is intended to facilitate the development and accelerate the review of drugs that treat serious conditions and address unmet medical needs, with the goal of making important new treatments available to patients sooner.

A drug granted fast track status may be eligible for more frequent meetings and communications with the FDA, as well as rolling review of any marketing application.

It may also qualify for priority review if certain criteria are met. Notably, ISB 2001 was previously granted 'orphan drug' designation by the FDA in July 2023.

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Glenmark Pharma: Price Target

According to Trendlyne data, the average target price for the stock is Rs 1,691, indicating an upside of 20% from current levels. The consensus recommendation from 12 analysts is a 'Buy'.

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Glenmark Pharma: Share price performance

On Monday, Glenmark Pharma shares closed 2.2% higher at Rs 1,405.7 on the BSE, while the benchmark Sensex rose 0.37%. The stock has declined 13% year-to-date but has surged 155% over the past two years. Its current market capitalisation stands at Rs 39,670 crore.

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