Moderna

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.

Lykos Therapeutics CEO Amy Emerson steps down, interim CEO Michael Mullette appointed. Emerson to remain as senior advisor. Lykos faces FDA rejection for MDMA therapy, plans resubmission. Company also names David Hough as CMO and lays off 75% of workforce.

Mpox, caused by monkeypox virus (MPXV), re-emerged in 2024 with clade I strains spreading faster and being deadlier. A new study led by researchers from the United States Army Medical Research Institute of Infectious Diseases, the National Institutes of Health, Boston University, and Moderna, published in *Cell*, demonstrated that mRNA-based vaccines, like mRNA-1769, could be more effective than the modified vaccinia Ankara (MVA) vaccine in protecting against severe mpox disease in macaques. The mRNA-1769 vaccine, targeting four MPXV antigens, showed tenfold fewer lesions and reduced viral load compared to MVA, highlighting the potential of mRNA technology to combat MPXV-like viruses.

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EMA's CHMP recommends Moderna's updated Covid-19 vaccine, Spikevax, targeting JN.1 variant for potential authorisation in 2024-2025. The recommendation is based on comprehensive data, following EMA's ETF guidance. The vaccine has been approved in Taiwan, Japan, and the UK, with ongoing reviews globally. Moderna participates in EU's mRNA vaccine procurement.

Levi & Korsinsky, LLP notifies Moderna investors of a class action securities lawsuit alleging false statements and concealed issues with mRNA-1345 vaccine, seeking recovery of losses between January 18, 2023, and June 25, 2024. Investors have until October 8, 2024, to request lead plaintiff status. No cost or obligation to participate.

Moderna's updated COVID-19 mRNA vaccine, Spikevax, targeting SARS-CoV-2 variant JN.1, received a positive recommendation from the European Medicines Agency's CHMP. The vaccine is intended for individuals aged six months and above, expected for the 2024-2025 vaccination season. Moderna also participates in HERA's tendering procedure for mRNA COVID-19 vaccines.

Lykos Therapeutics CEO Amy Emerson to step down after FDA rejection of MDMA therapy aid approval. Michael Mullette appointed interim CEO. Company plans to cut 75% of workforce and resubmit MDMA approval application.

Faruqi & Faruqi, LLP's James (Josh) Wilson encourages investors who suffered losses exceeding $100,000 in Moderna between January 18, 2023, and June 25, 2024, to contact him directly to discuss their options. The firm is investigating potential claims against Moderna and reminds investors of the October 8, 2024, deadline to seek the role of lead plaintiff in a federal securities class action. The complaint alleges Moderna and its executives violated federal securities laws by making false and/or misleading statements regarding mRNA-1345's efficacy.