Carvykti’s Revenue Increases +31% QoQ; Novartis to Manufacture Carvykti; JNJ Q1 2023 Earnings Call Summary
(Celltelligence is aware of the CARTITUDE-4 abstract leak and will have a thoughts-on analysis after the team returns from AACR.)
(Celltelligence is aware of the CARTITUDE-4 abstract leak and will have a thoughts-on analysis after the team returns from AACR.)
On Tuesday, July 19, JNJ held their Q2 2022 earnings call (press release / presentation) highlighting Carvykti’s (JNJ / Legend’s BCMA CAR-T) US launch in April 2022, and subsequent EC conditional approval for ≥4L MM in May 2022. Below, Celltelligence provides insights on Carvykti’s potential US and EU launch strategy, while comparing it with key competitor Abecma (BMS’s BCMA CAR-T).
On Thursday, April 21, Legend announced (press release) that they have achieved a 50M USD milestone under their collaboration agreement with JNJ for Carvykti (cilta-cel; BCMA CAR-T). Recall that Legend received an upfront payment of 350M USD, with additional milestone payments covering development, production performance, regulatory and sales.
On Thursday, November 18, JNJ held their Pharmaceutical Business Review 2021 Event (website) revealing cilta-cel’s (BCMA CAR-T) brand name as Carvykti, while commenting on their manufacturing and supply strategy to ensure a strong launch for Carvykti. Additionally, management emphasized their plan to quickly advance Carvykti into earlier lines of treatment. Below, Celltelligence provides insights on how JNJ’s manufacturing strategy may ensure a successful launch for Carvykti, while comparing JNJ’s digital platform with key competitors Gilead (Kite) and BMS. Moreover, Celltelligence will comment on the potential challenges JNJ may encounter advancing Carvykti into earlier lines for MM.
During the CAR-TCR European Summit 2021, eight key CAR-T related topics were observed. Six updates covering Cellectis, JNJ (Janssen), Dorian Therapeutics, Antion Biosciences, Prescient Therapeutics, and Avectas are summarized below. Of note, no major clinical updates were presented by Precision BioSciences or Gilead (Kite). Below, Celltelligence provides insights and context for each presentation.
On Friday, August 28, Legend Biotech published their Q2 2020 results (press release). Management confirmed that their BCMA CAR-T, cilta-cel (JNJ-4528), co-developed with Janssen, is expected to be filed with the FDA by YE 2020, the EMA in early 2021, and with China’s NMPA in 2021. Furthermore, by YE 2020, Legend anticipates filing an IND application for LB1901 (a CD4 CAR-T) in r/r T cell lymphoma (TCL). Below, Celltelligence provides thoughts on cilta-cel’s commercial opportunity following the anticipated approval of ide-cel (BMS) around March 2021, and Legend’s market opportunity for LB1901 in the TCL setting.