In our global healthcare weekly, we focus on identifiying key stock catalysts for biotech companies this week.

Atara Biotherapeutics (NASDAQ: ATRA) with a market cap of around $41.8 million, focuses on developing T-cell immunotherapies for cancers and autoimmune diseases. The firm’s lead candidate, tabelecleucel (tab-cel), is under development for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease. Tabelecleucel’s clinical development remains a priority.

The FDA has set a PDUFA priority review date for January 15, 2025. Tabelecleucel has breakthrough therapy designation (BTD) for this rare indication, and approval could solidify Atara’s presence in the cell therapy space, potentially leading to broader applications in EBV-related conditions.

Axsome Therapeutics Inc. (NASDAQ: AXSM) is a late-stage biopharmaceutical company with a market cap of $3.88 billion, developing treatments for central nervous system disorders. The firm has one approved product (Auvelity for depression), and it is progressing with multiple candidates across Alzheimer’s, migraine, and narcolepsy. Axsome is generating increasing revenue from Auvelity, positioning itself for future growth.

A key upcoming catalyst is the PDUFA decision for AXS-07, a combination of meloxicam and rizatriptan for the treatment of migraines, expected on January 31, 2025. AXS-07 has shown potential for superior efficacy compared to current migraine treatments, and a positive decision could substantially expand Axsome’s commercial portfolio and market presence.

SpringWorks Therapeutics Inc. (NASDAQ: SWTX) with a market cap of about $1.93 billion, is focused on targeted oncology therapies. Its pipeline includes investigational treatments for rare diseases and cancers, including mirdametinib, a MEK inhibitor. Financially, the company is supported by a healthy cash balance, though it remains in a development stage with no major product revenue.

Mirdametinib is being developed for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas, a rare genetic disorder. The FDA has granted priority review with a PDUFA date of February 28, 2025. The trial data released thus far are positive, and this late-stage regulatory decision is a significant catalyst that could potentially drive the company’s valuation.

Mesoblast Limited (NASDAQ: MESO) is a regenerative medicine company focused on developing cellular therapies. With a market cap of approximately $1.05 billion, the firm is working to commercialize RYONCIL (remestemcel-L), primarily for treating pediatric acute graft versus host disease (aGVHD) following allogeneic hematopoietic stem cell transplants.

A key upcoming catalyst is the PDUFA date for RYONCIL, scheduled for January 7, 2025. The FDA accepted the resubmission of the BLA on July 23, 2024. This product, if approved, could address a major unmet need for aGVHD in pediatric patients, potentially driving significant commercial success for Mesoblast.