Invivyd shares hold Buy as new data and updates bolster COVID-19 strategy

Published 03/09/2024, 14:12
Invivyd shares hold Buy as new data and updates bolster COVID-19 strategy

On Tuesday, H.C. Wainwright maintained a Buy rating on Invivyd Inc. (NASDAQ: IVVD) with a price target of $15.00. The firm's stance comes after Invivyd's announcement on August 27 that its monoclonal antibody, PEMGARDA (pemivibart, VYD222), showed a significant 84% relative risk reduction in symptomatic COVID-19 in an exploratory analysis from its Phase 3 trial. This development is seen as a positive outcome for the company's shareholders.

In addition to the promising trial results, Invivyd reported its second-quarter financials, with revenues reaching $2.3 million. This figure fell short of the anticipated $6.9 million and the consensus estimate of $5.0 million.

However, the management expects revenue growth in the second half of the year. The company also aligned with the FDA on May 31 regarding an accelerated Emergency Use Authorization (EUA) pathway for COVID-19 treatment and prevention, based on streamlined clinical programs.

Further corporate updates included Invivyd's submission on August 14 of an EUA amendment request to the FDA for PEMGARDA's use in treating mild-to-moderate COVID-19 in certain immunocompromised patients. This submission is based on immunobridging analyses and safety data from the CANOPY trial. Previously, on June 14, Invivyd reported that PEMGARDA and VYD2311 maintained in vitro neutralization activity against emerging SARS-CoV-2 variants in pseudovirus assays.

Lastly, the appointment of Timothy Lee as Chief Commercial Officer on May 31 is expected to bolster Invivyd's commercial strategy. Lee's track record includes successful drug launches and significant revenue generation at his previous company. With these developments, H.C. Wainwright reaffirms its positive outlook on Invivyd's shares.

In other recent news, Invivyd Inc. reported promising results from its Phase 3 trial of PEMGARDA, a monoclonal antibody for COVID-19 prevention. The trial, named CANOPY, showed an 84% reduction in the risk of symptomatic COVID-19 compared to a placebo among a broad population of adults.

The U.S. Food and Drug Administration (FDA) updated the Fact Sheet for PEMGARDA to include this new data, seen as a positive step towards a potential commercial launch of the drug for COVID-19 prevention in 2024.

Invivyd also reported consistent growth for its second quarter of 2024 and anticipates further acceleration in the third quarter. However, the company faces supply constraints affecting its ability to expand in international markets. Despite these constraints, Invivyd remains optimistic about future results and the upcoming respiratory virus season.

H.C. Wainwright reiterated a Buy rating and a $15.00 price target for Invivyd, reflecting confidence in the company's performance. The firm's outlook is buoyed by Invivyd's strategic awareness campaign targeted at healthcare providers nationwide, which, along with the updated FDA documentation, is expected to bolster the introduction of PEMGARDA into the market.

InvestingPro Insights

In light of H.C. Wainwright's endorsement of Invivyd Inc. (NASDAQ: IVVD), a closer examination of the company's financial health and market performance is warranted. According to InvestingPro data, Invivyd holds a market capitalization of $101.55 million. The company's revenue for the last twelve months as of Q2 2024 stands at $2.26 million, with an impressive gross profit margin of 96.11%. Despite these figures, the company's operating income margin is deeply negative at -9326.33%, reflecting substantial losses relative to its revenue.

When it comes to stock performance, Invivyd's price has experienced a significant decline over various time frames, including a 53.03% drop over the last three months. Currently trading near its 52-week low, the price per share is $0.85, which is only 16.36% of its 52-week high. This is in line with one of the InvestingPro Tips, which indicates that the stock has taken a considerable hit recently. Additionally, analysts, as reflected in another InvestingPro Tip, do not expect the company to turn a profit this year, which could be a contributing factor to the stock's poor performance.

For investors seeking more in-depth analysis, there are over 10 additional InvestingPro Tips available, which could provide further guidance on Invivyd's financial stability, cash flow, and market trends. These tips might be especially valuable for those considering the company's long-term potential in light of its current challenges.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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