Latest news with #CD38
Economic Times
06-05-2025
- Business
- Economic Times
Glenmark Pharma shares in focus after FDA grants fast track status to cancer drug
Glenmark Pharmaceuticals shares will be in focus on Tuesday 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. ADVERTISEMENT 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 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 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. ADVERTISEMENT 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. ADVERTISEMENT 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. Also Read:8 Nifty Microcap stocks that can jump 100-230% in the next 12 months ADVERTISEMENT 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'. Also Read: 5 timeless Warren Buffett quotes every investor should know ADVERTISEMENT 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. Also Read: SBI, LIC among 10 large-cap stocks that are below industry PE levels can rally up to 32% (Disclaimer: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times) (You can now subscribe to our ETMarkets WhatsApp channel)
Time of India
06-05-2025
- Business
- Time of India
Glenmark Pharma shares in focus after FDA grants fast track status to cancer drug
Glenmark Pharmaceuticals shares will be in focus on Tuesday 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. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track default , selected Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. 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. Live Events 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. Also Read: 8 Nifty Microcap stocks that can jump 100-230% in the next 12 months 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'. Also Read: 5 timeless Warren Buffett quotes every investor should know 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. Also Read: SBI, LIC among 10 large-cap stocks that are below industry PE levels can rally up to 32% ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
