ALLOGENE THERAP. DL-,001 Aktie

At the Citi Biopharma Summit, Allogene outlined a strategy focused on MRD (minimal residual disease) with cema-cel as its lead program and the autoimmune program ALLO-329 as a second value driver. The company reported positive preliminary MRD-clearance data from the ALPHA3 study and plans a preliminary EFS analysis in mid-2027 and the primary EFS analysis in 2028. Allogene most recently held $420 million in cash to support operations through 2029 and has already begun early commercial preparations for a potential approval. » Mere på de.investing.com

The FDA granted Allogene Therapeutics’ experimental drug cemacabtagene anseledleucel (cema-cel) RMAT designation and accelerated approval for the treatment of adult LBCL patients with minimal residual disease. The decision is based on interim data from the ALPHA3 study, in which 58.3% of patients in the cema-cel arm became MRD-negative versus 16.7% in the observation arm. Cema-cel also showed a median reduction in ctDNA of 97.7% and, as of the data cutoff, had a favorable safety profile with no treatment-related serious adverse events. The stock rose about 2.7% on the day of the announcement. » Mere på de.investing.com

Allogene presented data from the ALPHA3 study at the H.C. Wainwright conference, in which Cema-cel achieved an MRD clearance of 58.3% in the treatment arm versus 16.7% in the observation arm, with no cases of CRS or ICANS. After a capital raise of around $200 million, the company has financial runway through 2029 and sees a market potential for Cema-cel of $2.5–3.5 billion in the US and EU-5. In parallel, Allogene is advancing the autoimmune program ALLO-329 (CD19/CD70) and a BCMA/CD70 program, and is focusing near-term on the regulatory relevance of Cema-cel with an interim EFS analysis due mid-2027. » Mere på de.investing.com