Tag Archives: Tecartus

Gilead Reports Increased Cell Therapy Revenue; Yescarta and Tecartus Approved in the EU; New Galapagos Asset Added to Gilead’s Pipeline; Viral Vector Manufacturing Plant Receives FDA Approval; Gilead’s Q3 2022 Earnings Call Summary

On Thursday, October 27, Gilead (Kite) held their Q3 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing recent EC approvals for Yescarta and Tecartus (CD19 CAR-Ts). Moreover, Gilead included a new cell therapy asset in its pipeline and confirmed the FDA approval of its new vector manufacturing facility in Oceanside, CA. Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing how recently gained approvals in several geographies could increase the ex-US sales for Yescarta and Tecartus.

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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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New Tecartus Ph2 Trial (ZUMA-25) for R/R Rare B-cell Malignancies

On Tuesday, September 13, a new Gilead / Kite-sponsored Ph2 trial (ZUMA-25) evaluating Tecartus (autologous CD19 CAR-T) in rare B-cell malignancies was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing how Gilead could leverage Tecartus’s indication expansion strategy to differentiate from its main competitors.

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The Celltelligence Team

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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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The EC Grants Tecartus Marketing Authorization for R/R Adult ALL

On Tuesday, September 6, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Tecartus (CD19 CAR-T) in r/r adult (≥26 years) B-ALL. Below, Celltelligence provides insights on Tecartus’s approval in the EU, while comparing it with ARI-0001 (academic CD19 CAR-T) and obe-cel (Autolus’s CD19 CAR-T).

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The Celltelligence Team

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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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Gilead Reports Outstanding Cell Therapy Revenue Growth; Yescarta’s Manufacturing Capacity Scaled to Address Demand; Updated Regulatory Milestones for Yescarta and Tecartus in the EU; Gilead’s Q2 2022 Earnings Call Summary

On Tuesday, August 2, Gilead (Kite) held their Q2 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing EU regulatory milestones for Yescarta and Tecartus (CD19 CAR-Ts). Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing how Gilead’s manufacturing strategy could accommodate Yescarta’s expected increase in demand.

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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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CHMP Adopts Positive Opinion for Tecartus; Yescarta Absent From July’s CHMP Highlights

On Friday, July 22, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Tecartus (Gilead / Kite’s CD19 CAR-T) in r/r adult B-ALL. Additionally, Yescarta (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides thoughts on Tecartus’s positive opinion, while discussing updated EU timelines for Yescarta.

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The Celltelligence Team

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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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Type II Variations for Yescarta and Tecartus Listed in July’s CHMP Agenda

On Monday, July 18, the CHMP agenda for July was released. Of note, Yescarta and Tecartus (Gilead / Kite’s autologous CD19 CAR-Ts) have been listed as ‘For adoption’ under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for 2L LBCL and r/r adult B-ALL, respectively.

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The Celltelligence Team

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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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UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated its CD19 CAR-T indications table for estimated US approvals and submissions following key Q1 2022 earnings presentations and recent press releases (see below for download).

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The Celltelligence Team

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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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Breyanzi Could Receive a CHMP Opinion for 2L LBCL (TI) as Early as September 2022; Yescarta in 2L LBCL and Tecartus in R/R ALL Absent from June’s CHMP Highlights

On Friday, June 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed in June’s CHMP Highlights. Below, the Celltelligence team provides a full analysis of June’s CHMP meeting with updated EU timelines for Breyanzi in 2L LBCL (TI) and Tecartus in r/r ALL.

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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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Breyanzi Starts EMA Assessment in 2L LBCL (TI); Tecartus and Yescarta Absent from June’s CHMP Agenda

On Monday, June 20, the CHMP agenda for June was released. Of note, Breyanzi (BMS’s CD19 CAR-T) was listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ for 2L LBCL transplant-intended (TI) patients. Additionally, Tecartus (Gilead / Kite’s CD19 CAR-T) in r/r adult B-ALL and Yescarta (Gilead / Kite’s CD19 CAR-T) for 2L LBCL were absent from the CHMP agenda.

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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Initial Data from Yescarta’s Ph2 ZUMA-14 Study for R/R LBCL in Combination with Rituximab; Updated Results for Tecartus in ALL and MCL; ASCO 2022 Analysis 2

ASCO 2022 Analysis 2: Gilead (Kite) reported updated clinical data in LBCL, MCL, and adult B-ALL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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