WALTHAM, Mass. - Invivyd, Inc. (NASDAQ: IVVD), a biopharmaceutical company, announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) has issued new HCPCS codes for the reimbursement of its drug PEMGARDA. The Q code (Q0224) and M code (M0224) will be used for product reimbursement and administration coverage, respectively, effective retroactively from March 22, 2024.
PEMGARDA, which received emergency use authorization (EUA) on the aforementioned date, is intended for pre-exposure prophylaxis of COVID-19 in individuals 12 years and older with moderate-to-severe immune compromise. It targets the SARS-CoV-2 spike protein to prevent virus attachment to host cells. The drug is not approved for treatment or post-exposure prophylaxis of COVID-19.
Jeremy Gowler, Interim CEO of Invivyd, expressed optimism about the CMS codes facilitating access to PEMGARDA for a significant portion of the target population. He also noted early commercial interest in the drug, which is available through a network of authorized specialty distributors and by prescription.
PEMGARDA's efficacy for pre-exposure prophylaxis is based on an immunobridging approach, comparing its serum virus neutralizing titer with other neutralizing human monoclonal antibodies against SARS-CoV-2. Still, the variability in cell-based assays and limitations related to pharmacokinetic data affect the precision of protective titer range estimates.
The company's INVYMAB platform aims to rapidly generate new monoclonal antibodies to keep pace with evolving viral threats. Invivyd's mission is to deliver antibody-based therapies to protect vulnerable individuals from serious viral diseases, starting with SARS-CoV-2.
The information in this article is based on a press release statement from Invivyd. It is important to note that the emergency use of PEMGARDA is only authorized for the duration of the COVID-19 pandemic declaration, unless terminated or revoked sooner.
InvestingPro Insights
As Invivyd, Inc. (NASDAQ: IVVD) forges ahead with its immunotherapeutic solutions, the financial landscape presents a mixed bag of indicators. The company's market capitalization stands at a modest $351.7 million, reflecting the market's measured confidence in its potential.
Despite not turning a profit over the last twelve months, with an adjusted P/E ratio of -1.76, investors have witnessed a substantial return with a 161.54% increase in the stock price over the past year.
Two InvestingPro Tips that stand out for Invivyd include the company's strong cash position in comparison to its debt, suggesting a degree of financial stability. Still, it is also important to note that the company is rapidly burning through its cash reserves, which could be a cause for concern.
Moreover, with analysts not expecting profitability this year and a notable weakness in gross profit margins, the financial outlook requires cautious optimism.
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