STOCK TITAN

Invivyd, Inc. - IVVD STOCK NEWS

Welcome to our dedicated page for Invivyd news (Ticker: IVVD), a resource for investors and traders seeking the latest updates and insights on Invivyd stock.

Invivyd, Inc. (Nasdaq: IVVD) is a clinical-stage biopharmaceutical company committed to the innovation, development, and commercialization of antibody-based therapies aimed at combating infectious diseases with pandemic potential. The company is primarily focused on developing antibodies that can provide superior protection against viral threats, starting with COVID-19.

Invivyd’s lead program, ADG20, is in clinical stages for both treatment and prevention of COVID-19, showcasing a broad spectrum of activity against various SARS-CoV-2 variants. Another promising candidate, VYD222, is engineered to ensure high potency and prolonged action in an evolving viral landscape. These efforts reflect Invivyd’s strategic approach of leveraging best-in-class antibody discovery capabilities to create multiple, non-competing antibodies with distinct targets, thereby minimizing the risk of viral escape.

In recent developments, Invivyd has achieved notable milestones including the receipt of Emergency Use Authorization (EUA) for PEMGARDA™ (pemivibart) for the pre-exposure prophylaxis of COVID-19 in moderately to severely immunocompromised individuals. PEMGARDA is the first mAb to receive EUA utilizing a rapid immunobridging trial design, indicating its potential to meet urgent medical needs. The company is positioned to launch PEMGARDA in the U.S., targeting key healthcare practitioners and institutions caring for high-risk populations.

The company’s proprietary INVYMAB™ platform integrates advanced viral surveillance, predictive modeling, and antibody engineering to generate new monoclonal antibodies (mAbs) swiftly and serially. This approach ensures that Invivyd remains at the forefront of addressing evolving viral threats. In addition to PEMGARDA, Invivyd is planning to advance VYD2311 into clinical development, further expanding its innovative pipeline.

Financially, Invivyd has projected a robust performance with net product revenue guidance for PEMGARDA ranging from $150 million to $200 million for the full year 2024. The company’s recent strategic review has optimized operational efficiencies, improving the projected year-end cash position to at least $75 million. These financial strategies ensure that Invivyd is well-positioned to sustain its development efforts and commercial initiatives.

Looking ahead, Invivyd plans to seek authorization for PEMGARDA for the treatment of mild to moderate symptomatic COVID-19 in immunocompromised individuals using an aligned, rapid immunobridging pathway. This underscores the company’s mission to deliver effective antibody-based treatments that continually adapt to the changing viral landscape.

Overall, Invivyd, Inc. exemplifies a relentless commitment to protecting vulnerable populations from serious viral infections through pioneering therapeutic advancements and strategic financial stewardship.

News
Rhea-AI Summary
Invivyd, Inc. appoints Jeremy Gowler as Interim CEO to lead the company's growth phase focused on monoclonal antibody therapies for COVID-19. The company aims to unlock value creation with novel pipeline candidates and a strong balance sheet.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-3.44%
Tags
none
-
Rhea-AI Summary
Invivyd, Inc. announces the commercial availability of PEMGARDA for pre-exposure prophylaxis of COVID-19 in immune-compromised individuals in the U.S. The company expects significant revenue in 2024 and ends the year with at least $55 million in cash. PEMGARDA received emergency use authorization from the FDA and is now available for purchase.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-7.82%
Tags
none
-
Rhea-AI Summary
Invivyd, Inc. (IVVD) receives emergency use authorization for PEMGARDA™, a monoclonal antibody for COVID-19 pre-exposure prophylaxis. The company's cash position is strong at $200.6 million. Recent At-the-Market share sales raised $40.5 million. The company is focusing on commercial launch plans for PEMGARDA and developing VYD2311, the next anti-SARS-CoV-2 candidate.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
11%
Tags
Rhea-AI Summary
Invivyd, Inc. announces interim exploratory COVID-19 clinical event data for VYD222, an investigational monoclonal antibody for pre-exposure prophylaxis. The data from the Phase 3 CANOPY trial show a potential signal of clinical protection from symptomatic COVID-19. The company plans to further analyze the relationship between serum virus neutralizing antibody titers and clinical efficacy in future trials.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
41.1%
Tags
-
Rhea-AI Summary
Invivyd, Inc. (IVVD) receives emergency use authorization for PEMGARDA, a monoclonal antibody for COVID-19 prevention in immunocompromised individuals. The company anticipates product availability soon, with a strong financial position and ongoing clinical trials supporting its efficacy and safety.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
41.1%
Tags
covid-19
-
Rhea-AI Summary
Invivyd, Inc. (IVVD) CEO to present at Guggenheim Healthcare Talks 6th Annual Biotechnology Conference to discuss the company's mission to protect against viral infectious diseases and host investor meetings. The live webcast will be available on the company's website.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.61%
Tags
conferences
Rhea-AI Summary
Invivyd, Inc. (Nasdaq: IVVD) requests Emergency Use Authorization (EUA) from the FDA for VYD222, a monoclonal antibody candidate for pre-exposure prevention of COVID-19 in immunocompromised individuals. The submission is based on positive results from the CANOPY Phase 3 trial and in vitro neutralization activity against SARS-CoV-2 variants, including JN.1. If authorized, VYD222 could provide a new preventive option for vulnerable individuals.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.01%
Tags
acquisition covid-19
-
Rhea-AI Summary
Invivyd, Inc. (IVVD) announced positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial of VYD222, a monoclonal antibody candidate for the prevention of symptomatic COVID-19. VYD222 demonstrated high serum virus neutralizing antibody titer levels in immunocompromised participants, favorable safety and tolerability profile, and continued in-vitro neutralization activity against major SARS-CoV-2 variants.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
120.25%
Tags
clinical trial covid-19
-
Rhea-AI Summary
Invivyd, Inc. (IVVD) completed enrollment in the CANOPY Phase 3 clinical trial for VYD222, aiming to prevent symptomatic COVID-19. They plan to submit an application for Emergency Use Authorization (EUA) in the U.S. and expect initial primary endpoint data by late 2023 or early Q1 2024. The company also continues to advance INVYMABTM, its proprietary platform approach for generating new antibodies addressing viral threats. With $264.9 million in cash, cash equivalents, and marketable securities, they expect to support operations into Q4 2024, excluding potential commercial product revenue contribution.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
Tags
Rhea-AI Summary
Invivyd, Inc. (Nasdaq: IVVD) will host a conference call on November 9, 2023, at 4:30 p.m. ET to discuss its financial results for the quarter ended September 30, 2023, and recent business highlights. Listeners can register for the webcast via the provided link. Analysts can participate in the Q&A session using a separate link. A replay of the webcast will be available on the company's website. Join 15 minutes prior to the start time.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.94%
Tags
conferences earnings

FAQ

What is the current stock price of Invivyd (IVVD)?

The current stock price of Invivyd (IVVD) is $0.4439 as of December 20, 2024.

What is the market cap of Invivyd (IVVD)?

The market cap of Invivyd (IVVD) is approximately 50.2M.

What is Invivyd, Inc.?

Invivyd, Inc. is a clinical-stage biopharmaceutical company focused on developing antibody-based therapies for infectious diseases with pandemic potential, starting with COVID-19.

What are Invivyd’s lead product candidates?

Invivyd's lead product candidates include ADG20 for the treatment and prevention of COVID-19 and VYD222, a monoclonal antibody designed for high potency and prolonged action against various SARS-CoV-2 variants.

What recent achievements has Invivyd accomplished?

Invivyd recently received Emergency Use Authorization for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis of COVID-19 in certain high-risk populations.

What is Pemgarda?

PEMGARDA™ (pemivibart) is a half-life extended monoclonal antibody authorized for emergency use in the U.S. for the pre-exposure prophylaxis of COVID-19 in immunocompromised individuals.

How does Invivyd ensure the effectiveness of its antibodies?

Invivyd uses its proprietary INVYMAB™ platform for viral surveillance, predictive modeling, and advanced antibody engineering to rapidly generate effective monoclonal antibodies.

What are Invivyd’s financial projections for 2024?

Invivyd projects net product revenue for PEMGARDA to be between $150 million and $200 million, with an improved year-end cash position of at least $75 million.

What is the future plan for PEMGARDA?

Invivyd plans to submit an EUA application for PEMGARDA for the treatment of mild to moderate symptomatic COVID-19 in immunocompromised individuals.

What distinguishes INVYMAB™ platform?

The INVYMAB™ platform combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, facilitating the rapid, serial generation of new monoclonal antibodies.

Who should use PEMGARDA?

PEMGARDA is intended for adults and adolescents (12 years and older, weighing at least 40 kg) with moderate-to-severe immune compromise who are unlikely to respond adequately to COVID-19 vaccination.

What measures is Invivyd taking to expand its therapeutic offerings?

Invivyd is advancing clinical development of new antibody candidates like VYD2311 and seeking rapid pathways for future EUA applications to address evolving viral threats.

Invivyd, Inc.

Nasdaq:IVVD

IVVD Rankings

IVVD Stock Data

50.24M
96.19M
18.17%
79.25%
6.93%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States of America
WALTHAM