Glenmark Pharmaceuticals’ shares increased by up to 1.8% to Rs 1,431.25 on the BSE on Tuesday. The rise followed the announcement that its innovation division, Ichnos Glenmark Innovation (IGI), secured ‘fast track’ designation from the US Food and Drug Administration (FDA) for its investigational therapy, ISB 2001. This designation is for adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously undergone at least three treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
ISB 2001 is a tri-specific antibody therapy targeting BCMA, CD38 on myeloma cells, and CD3 on T cells, facilitating a targeted immune response against cancer. It is presently in a Phase 1 dose expansion clinical study. Ichnos Glenmark Innovation recently concluded the dose escalation phase of its Phase 1 trial in patients with heavily pre-treated multiple myeloma.
Initial study results, presented in an oral session at the American Society of Hematology (ASH) Annual Meeting in December 2024, showed a high overall response rate (ORR), durable responses, and a favorable safety profile. Complete results from the dose escalation phase will be shared at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2025.
The FDA’s fast track designation aims to expedite the development and review of drugs that treat serious conditions and address unmet medical needs, making new treatments available to patients more quickly. Drugs with fast track status may have more frequent FDA meetings and communications, as well as a rolling review of any marketing application. ISB 2001 had been granted ‘orphan drug’ designation by the FDA in July 2023.
According to Trendlyne data, the average target price for Glenmark Pharmaceuticals’ stock is Rs 1,691, indicating a potential 20% increase from its current level, with a ‘Buy’ consensus recommendation from 12 analysts.
Glenmark Pharma shares closed 2.2% higher at Rs 1,405.7 on the BSE on Monday, while the benchmark Sensex rose 0.37%. The stock has declined 13% year-to-date but gained 155% over the previous two years, with a current market capitalization of Rs 39,670 crore.
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