Tag Archives: Gilead

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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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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You May Have Missed: Are Cell Therapy Leaders Losing Their Innovative Edge?

During July, the Celltelligence team published a six-part series discussing the pipeline, manufacturing technology, and novel platforms from Novartis, BMS, and Gilead (Kite):

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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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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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Are Cell Therapy Leaders Losing Their Innovative Edge? Final Analysis

In our previous six-part series, the Celltelligence team discussed the pipeline, manufacturing technology, novel platforms, and potential strategy to maintain an innovative clinical program for Novartis, BMS, and Gilead (Kite):

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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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on Gilead (Blast 5/6)

As the cell therapy field continues to grow and evolve, companies are developing innovative strategies to overcome the current challenges that the field is facing. In our Spotlight blasts 1-2 and 3-4, the Celltelligence team discussed Novartis’s and BMS’s pipeline, manufacturing technology, novel platforms, and potential strategy for maintaining an innovative clinical program:

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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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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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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 Included in the NCCN Guidelines for the Treatment of 2L DLBCL

On Tuesday, July 12, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-Cell Lymphomas were updated (NCCN Guidelines in B-Cell Lymphoma) to include Breyanzi’s (BMS’s CD19 CAR-T) treatment in 2L DLBCL. Of note, Breyanzi is now recommended as a 2L therapy for patients who have primary refractory disease or have relapsed within 12 months, as well as patients who are non-candidates for transplant. Below, Celltelligence provides insights on Breyanzi’s inclusion in the NCCN Guidelines, while discussing how Yescarta’s (Gilead / Kite’s CD19 CAR-T) NCCN recommendation.

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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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight Series on Novartis, BMS, and Gilead (Kite)

Since the first US CAR-T approval in 2017, the cell therapy field has rapidly evolved with 5 additional CAR-Ts receiving FDA approval. Nevertheless, challenges surrounding TATs, cost, and patient access still remain. As such, companies are developing innovative strategies to overcome the challenges that the field is currently facing. In the upcoming six-part series, the Celltelligence team will analyze different innovative strategies which the cell therapy leaders (Novartis, BMS, and Gilead) are utilizing to remain competitive in this dynamic space. At the end of the series, Celltelligence will present a semi-qualitative analysis comparing the innovative strategies from Novartis, BMS, and Gilead (Kite).

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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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).

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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The EC Grants Yescarta Marketing Authorization for ≥4L R/R FL

On Tuesday, June 28, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Yescarta (CD19 CAR-T) in ≥4L r/r FL. Below, Celltelligence provides insights on Yescarta’s approval in the EU, while comparing it with key competitor Kymriah (Novartis’s CD19 CAR-T).

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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