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Glenmark Pharmaceuticals shares climbed arsenic overmuch arsenic 1.8% connected Tuesday to Rs 1,431.25 connected the BSE aft the institution 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 big patients with relapsed oregon refractory aggregate myeloma (RRMM) who person received astatine slightest 3 anterior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
ISB 2001 is simply a tri-specific antibody therapeutic designed to people BCMA and CD38 connected myeloma cells, arsenic good arsenic CD3 connected T cells, enabling a targeted immune effect against cancer. The therapy is presently being evaluated successful a Phase 1 dose enlargement objective study.
Ichnos Glenmark Innovation precocious completed the dose escalation information of its Phase 1 objective proceedings successful patients with heavy pre-treated aggregate myeloma.
Initial results from the study, presented during an oral league astatine the American Society of Hematology (ASH) Annual Meeting successful December 2024, demonstrated a precocious wide effect complaint (ORR), durable responses, and a favorable information profile.
Complete results from the dose escalation information volition beryllium presented successful a accelerated oral league astatine the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting connected Monday, June 2, 2025.
The FDA’s accelerated way designation is intended to facilitate the improvement and accelerate the reappraisal of drugs that dainty superior conditions and code unmet aesculapian needs, with the extremity of making important caller treatments disposable to patients sooner.
A cause granted accelerated way presumption whitethorn beryllium eligible for much predominant meetings and communications with the FDA, arsenic good arsenic rolling reappraisal of immoderate selling application.
It whitethorn besides suffice for precedence reappraisal if definite criteria are met. Notably, ISB 2001 was antecedently granted 'orphan drug' designation by the FDA successful July 2023.
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Glenmark Pharma: Price Target
According to Trendlyne data, the mean people terms for the banal is Rs 1,691, indicating an upside of 20% from existent levels. The statement proposal from 12 analysts is simply a 'Buy'.
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Glenmark Pharma: Share terms performance
On Monday, Glenmark Pharma shares closed 2.2% higher astatine Rs 1,405.7 connected the BSE, portion the benchmark Sensex roseate 0.37%. The banal has declined 13% year-to-date but has surged 155% implicit the past 2 years. Its existent marketplace capitalisation stands astatine Rs 39,670 crore.
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