Autolus Therapeutics

FDA approves AUCATZYL, a CAR T therapy for adult r/r B-ALL, based on FELIX trial results showing 63% overall complete remission. AUCATZYL is the first CAR T therapy approved without a REMS program. Conference call on Nov 11 to discuss approval.

FDA to decide on Journey's rosacea drug DFD-29, Merus' bispecific antibody for NSCLC and PDAC, PTC's gene therapy Upstaza for AADC deficiency, and Autolus' CAR T therapy obe-cel for ALL by November 4, 6, 13, and 16 respectively.

October saw FDA approvals for Pfizer's Hympavzi, Astellas' Vyloy, and Iterum's Orlynvah, targeting hemophilia, gastric cancers, and UTIs respectively. November anticipates FDA decisions on drugs like Journey Medical's DFD-29 for rosacea, Merus' Zenocutuzumab for NRG1+ cancers, and PTC Therapeutics' Upstaza for AADC deficiency, among others, highlighting significant advancements in treatment options.

Resolution Therapeutics, co-founded by Syncona in 2020, raised £63.5 million in Series B financing to progress RTX001, an engineered autologous macrophage cell therapy for end stage liver disease. The company plans to start a phase 1/2 EMERALD trial in the UK and Spain by year-end, aiming to regenerate liver tissue and explore other regenerative therapies.

Autolus Therapeutics' obe-cel, an autologous CAR-T cell therapy for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia, awaits FDA approval on November 16, 2024. The therapy targets CD-19 and has shown a 78% ORR in the FELIX study, with potential peak revenues of ~$300m. Despite a 25% share price drop, Autolus holds $700m in cash and has partnerships with BioNTech, Moderna, and Bristol Myers Squibb, positioning it for future growth.

The article highlights 12 undervalued biotech stocks favored by hedge funds, focusing on companies like MEI Pharma, Ocuphire Pharma, and Voyager Therapeutics. It discusses the biotech industry's growth, driven by innovation, M&A activity, and FDA approvals, with a positive outlook for 2024 despite challenges like drug pricing and regulatory scrutiny.

CAR-T cell therapy, a groundbreaking immunotherapy, modifies patient T-cells to target and destroy cancer cells, acting as 'living drugs.' With 11 products commercialized, including 7 FDA-approved, the therapy shows promise in treating blood cancers. Challenges include expanding to solid tumors, reducing 'vein-to-vein' time, and improving reimbursement. The industry is advancing through gene-transfer techniques, partnerships, and 'on-off' switches in CAR-T cells to enhance efficacy and safety.