Moderna, Inc. reports developments in mRNA medicines, including commercial vaccines, investigational respiratory vaccines, oncology programs and rare-disease candidates. News commonly covers regulatory authorizations and agency interactions for products such as Spikevax, mRESVIA, mNEXSPIKE and mCOMBRIAX, as well as clinical data for seasonal influenza, pandemic influenza and cancer immunotherapy programs including intismeran autogene and mRNA-4359.
Company updates also include quarterly financial results, revenue mix, expense actions, strategic partnerships, scientific meeting presentations and intellectual-property matters tied to Moderna's infectious disease portfolio and broader mRNA technology platform.
Moderna, Inc. (NASDAQ: MRNA) receives an update from the U.S. FDA regarding the review of its investigational RSV vaccine, mRNA-1345. The FDA will not complete the review by the PDUFA date of May 12, 2024, due to administrative constraints but expects to finish it by the end of May 2024. Moderna remains optimistic about the review and is on track for a CDC Advisory Committee meeting in June 2024.
Moderna reported first quarter revenues of $167 million, with a GAAP net loss of $1.2 billion. The company reaffirmed its 2024 expected product sales of approximately $4 billion. Moderna initiated three new clinical studies for cancer treatment, advanced three new vaccine programs, and provided updates on its COVID-19 and RSV vaccine commercial efforts. Financially, the company saw a decline in revenue due to reduced sales of its COVID-19 vaccine, with cost of sales decreasing by 88%. Research and development expenses decreased by 6% while selling, general, and administrative expenses decreased by 10%. Moderna's net loss was $(1.2) billion, with diluted EPS of $(3.07). The company maintains a cash, cash equivalents, and investments position of $12.2 billion as of March 31, 2024. Looking ahead, Moderna reaffirmed its 2024 revenue expectations, with key milestones in its late-stage pipeline, including respiratory vaccines, next-generation COVID-19 vaccine, and various other vaccine and therapeutics programs.
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