Tag Archives: LEADING COMPANIES

Carvykti Appears in the CHMP Agenda; September’s CHMP Agenda

On Monday, September 11, the CHMP agenda for September 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, while Abecma’s (BMS’s BCMA CAR-T) Type II Variation for ≥3L MM was absent from the agenda.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Thoughts on BMS Joining Cellares’s Technology Adoption Partnership Program to Evaluate the Automated Production of One of Its Key CAR-Ts; Could Cellares’s Cell Shutter Become a Competitive Advantage for BMS?

On Monday, August 28, Cellares announced (press release) that BMS joined its Technology Adoption Partnership (TAP) program, entering into a proof-of-concept transfer process for the manufacturing of one of its CAR-Ts using Cellares’s proprietary Cell Shuttle platform. Below, Celltelligence provides insights into the features of Cellares’s end-to-end automated process for cell therapy production while discussing the potential competitive advantage that this partnership could represent for BMS.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Yescarta Sales Continue to Increase While Tecartus Revenue Plateaus; Gilead Considers Entry into Autoimmune Diseases; Gilead’s Q2 2023 Earnings Call Summary

On Thursday, August 3, Gilead (Kite) held its Q2 2023 earnings call (press release / presentation) highlighting the increased sales for Yescarta and the regulatory milestones of its cell therapy franchise. Additionally, the company reaffirmed its confidence in the therapeutic potential of CART-ddBCMA (KITE-772; BCMA CAR-T), developed in collaboration with Arcellx, despite the FDA’s clinical hold on its Ph2 iMMagine-1 trial in ≥4L MM. Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase ex-US, while discussing the potential entrance of the company in the autoimmune disease space.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Abecma Sales Decrease While Breyanzi Revenue Keeps Growing; Plans to Start a BMS-986393 Registrational Trial; BMS Invests in Immatics; BMS’s Q2 2023 Earnings Call Summary

On Thursday, July 27, BMS held its Q2 2023 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) sales increase while reporting a revenue decrease for Abecma (BCMA CAR-T). Furthermore, the company underscored clinical and regulatory milestones of its cell therapy assets, disclosing a new potentially registrational trial for BMS-986393 (CC-95266; GPRC5D CAR-T). Finally, on Monday, July 24, Immatics announced a $35M equity investment from BMS (press release). Below, Celltelligence provides insights on how Abecma and Breyanzi sales compare to key competitors while discussing the main clinical milestones achieved by BMS’s marketed cell therapy assets in Q2 2023 and the company’s regulatory plans for its CAR-T programs.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Carvykti’s Revenue Increases Over +60% QoQ; JNJ Q2 2023 Earnings Call Summary

On Thursday, July 20, JNJ held its Q2 and H1 2023 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T) remarkable revenue growth. Below, Celltelligence provides insights on the increase in Carvykti sales, while discussing JNJ / Legend’s ongoing strategies to improve CAR-T manufacturing capacity and analyzing Carvykti’s supply limitations ex-US.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Kymriah Sales Continue to Slowly Decrease; No Updates of T-Charge Programs; Novartis’s Q2 2023 Earnings Call Summary

On Tuesday, July 18, Novartis held its Q2 and H1 2023 earnings call (press release / presentation) reporting $129M in Kymriah’s (CD19 CAR-T) WW sales while the company did not provide any clinical or regulatory updates on its cell therapy programs. Below, Celltelligence provides insights on Kymriah’s Q2 2023 revenue while discussing if Kymriah’s approvals in ≥3L FL in several markets would be enough to offset the declining sales in the future.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

No Cell Therapy-Related Updates in July’s CHMP Agenda

On Monday, July 17, the CHMP Agenda for July was released. Of note, no cell therapy-related updates were observed and both Type II Variations applications (T2V) for Abecma (BMS’s BCMA CAR-T) and Carvykti (JNJ / Legend’s BCMA CAR-T) in r/r MM were absent from the agenda.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

The FDA Clears Poseida’s P-CD19CD20-ALLO1 IND in B-Cell Malignancies

On Wednesday, July 5, Poseida announced (press release) that the FDA has approved the IND for P-CD19CD20-ALLO1 (allogeneic CD19 x CD20 dual CAR-T) in B-cell malignancies. Below, Celltelligence provides insights on P-CD19CD20-ALLO1’s IND clearance while discussing the potential competition that P-CD19CD20-ALLO1 could face.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Abecma’s T2V Receives an RSI; When Could Abecma and Carvykti Receive a CHMP Positive Opinion? June CHMP Highlights

On Friday, June 23, the CHMP meeting highlights were released. Of note, Abecma (BMS’s BCMA CAR-T) was absent from the CHMP highlights implying that it has received a Request for Supplementary Information (RSI) for its assessment in ≥3L MM. Moreover, recall that Carvykti (JNJ / Legend’s BCMA CAR-T) was listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ to expand its label to ≥2L MM on Monday’s CHMP agenda. Below, Celltelligence provides insights on the June CHMP meeting with updated EU regulatory timelines for both cell therapies.

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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.