Tag Archives: Carvykti

Carvykti Sales Flatten while Preparing for Launch in 2L MM; JNJ’s Q1 2024 Earnings Call Summary

On Tuesday, April 16, JNJ held its Q1 2024 earnings call (press release / presentation) mentioning Carvykti’s (BCMA CAR-T) revenue remained approximately flat. Additionally, management remarked on Carvykti approval by the FDA and the CHMP positive opinion for the treatment of 2L MM patients. Below, Celltelligence provides insights on Carvykti’s underperforming revenue during this quarter while discussing its upcoming launch in 2L MM.

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Carvykti and Abecma Receive FDA Approval for Early Lines of MM

On Friday, April 5, JNJ (press release) and Legend (press release) announced that the FDA approved Carvykti (BCMA CAR-T) for the treatment of adult patients with r/r MM who have received at least one prior LoT, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.

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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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Thoughts on the FDA ODAC Recommending Carvykti and Abecma in Earlier Lines of MM

On Friday, March 15, JNJ (press release) and Legend (press release) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (BCMA CAR-T) for the treatment of adult patients with r/r MM who have received at least one prior LoT including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and are refractory to lenalidomide.

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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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Poseida to Present Updated Clinical Results at AACR 2024; Legend Further Expands its Manufacturing Capacity; Poseida and Legend Q4 2023 Earnings Call Summary

On Thursday, March 7, Poseida released its Q4 and FY 2023 business updates (press release) highlighting clinical results from its lead asset P-BCMA-ALLO1’s (allogeneic BCMA CAR-T) Ph1 trial in r/r MM and an initial readout from its P-MUC1C-ALLO1’s Ph1 trial in advanced or metastatic solid tumors will be presented at AACR 2024.

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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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CHMP Adopts Positive Opinion for Carvykti in ≥2L MM; February CHMP Highlights

On Friday, February 23, the CHMP meeting highlights were released, including the positive opinion of the CHMP for Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥2L MM.

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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 Receive a Positive Opinion in Q1 2024? February CHMP Agenda

On Monday, February 19, the CHMP agenda for February was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥2L MM.

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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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CHMP Adopts Positive Opinion for Abecma in ≥3L MM; January CHMP Highlights

On Friday, January 26, the CHMP meeting highlights were released, including the positive opinion of the CHMP for Abecma (BMS’s BCMA CAR-T) in ≥3L MM.

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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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Sales of Carvykti Continue to Grow; FDA and EMA Advisory Committees Will Review Carvykti Applications for Early MM; JNJ Considers Entering in Autoimmune Diseases; JNJ’s Q4 2023 Earnings Call Summary

On Tuesday, January 23, JNJ held its Q4 and FY2023 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T) revenue growth. On the same day, Legend disclosed (SEC filing) that advisory committees of the FDA and the EMA will meet to discuss the applications for using Carvykti in ≥2L MM.

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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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Could Abecma Receive a CHMP Positive Opinion on Friday?; January’s CHMP Agenda

On Monday, January 22, the CHMP agenda for January was released including Abecma (BMS / 2seventy bio’s BCMA CAR-T) in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥3L MM, while the Carvykti (JNJ / Legend’s BCMA CAR-T) Type II Variation for ≥2L MM was absent from the agenda.

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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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JPM 2024 Analysis Day 2: Legend, AstraZeneca, and BioNTech

On the second day of JPM 2024, Celltelligence covered presentations by Legend (presentation / webcast), AstraZeneca (presentation / webcast), and BioNTech (presentation / webcast). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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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