Tag Archives: LB1908

Carvykti’s sBLA in 2L MM Did Not Receive Priority Review; JNJ / Legend Continue To Improve Manufacturing Capacity; Updates on Solid Tumor Programs; Legend’s Q2 2023 Earnings Call Summary

On Tuesday, August 15, Legend held its Q2 2023 earnings call (press release) highlighting that the FDA set a PDUFA date for Carvykti’s (BCMA CAR-T) sBLA in ≥2L MM on April 5, 2024. Moreover, management listed measures that the company is taking to improve its manufacturing capacity and reported updates on its solid tumor programs. Below, Celltelligence provides insights on the FDA’s standard review of Carvykti’s sBLA while discussing future development for Carvykti and the company’s solid tumor programs.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Could Carvykti be Approved in 2L MM by 2023? Legend Introduces New γδ CAR-T Program; Updates to Solid Tumor Programs; Thoughts on Legend’s R&D Day 2022

On Monday, October 3, Legend Biotech held their R&D Day (webcast), highlighting Carvykti’s (BCMA CAR-T) LCM initiatives, while providing updates on Legend’s pipeline platforms and programs. Below, Celltelligence provides insights on Carvykti’s ongoing competition with Abecma (BMS’s BCMA CAR-T), while evaluating the strength of Legend’s pipeline compared to its competitors.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Gracell to Open an R&D Facility in the US; JPM 2022 Days 2 & 3: Legend, Allogene, and Autolus

A series of cell therapy-related news items have been observed:

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Cilta-cel’s Potential Off-Label Use in the US; Could BMS’s KarMMa-3 Trial Design Limit Abecma’s Targetable Population? Legend / JNJ Pivot to Earlier Lines; Legend Explores Allogeneics, CAR-NKs, and Novel Solid Tumor Targets; Legend’s R&D Day

On Monday, October 18, Legend held an R&D day (presentation) detailing preclinical and clinical assets across their BCMA, allogeneic, and solid tumors programs. Below, Celltelligence provides insights on Legend’s LCM strategy for cilta-cel (BCMA CAR-T) and possible ‘off-label’ usage in the US, while discussing the company’s allogeneic and solid tumors platforms.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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