Invivyd Stock Price, News & Analysis

Invivyd (Nasdaq: IVVD) announced that the FDA has updated the Emergency Use Authorization (EUA) Fact Sheet for PEMGARDA™ (pemivibart) with accurate SARS-CoV-2 variant susceptibility data. The updated Fact Sheet, dated September 26, 2024, includes in vitro neutralization activity against dominant circulating variants, including KP.3.1.1 and LB.1, which is in line with prior variants represented in the CANOPY Phase 3 clinical trial.

The FDA removed a contested statement about reduced susceptibility to pemivibart for KP.3.1.1, based on data provided by LabCorp's Monogram Biosciences lab. Invivyd emphasizes the importance of relying on validated, scientific studies conducted with authentic pemivibart under industrial-quality conditions for assessing neutralization potency and variant susceptibility.

Invivyd, Inc. (Nasdaq: IVVD) has provided detailed virology data and analysis of SARS-CoV-2 structural biology, predicting anticipated neutralization activity for PEMGARDA™ (pemivibart). Key points include:

• Independent evaluation shows in vitro pseudovirus neutralization potency of PEMGARDA against KP.3.1.1 and LB.1 variants in-line with prior variants tested
• Ongoing SARS-CoV-2 spike analyses demonstrate consistent structural stability of the pemivibart binding site
• Potential emerging variants (XEC and LP.1) encode mutations distal from the pemivibart binding site, not expected to meaningfully alter activity
• Pemivibart potency against contemporary viruses remains in-line with predominant variants since 2022
• Structural analysis shows no meaningful mutational change in the pemivibart binding site since late 2021

The company's ongoing genetic and structural analyses provide the biological rationale for expected neutralization activity of pemivibart against evolving SARS-CoV-2 variants.

Invivyd, Inc. (Nasdaq: IVVD) announces readiness to address the increasing COVID-19 cases with PEMGARDA™ (pemivibart), an FDA-authorized monoclonal antibody for pre-exposure prophylaxis in certain immunocompromised individuals. The CDC reports a continued rise in COVID-19 death rates throughout 2024, with immunocompromised patients at highest risk. PEMGARDA is covered by Medicare and Medicaid and has gained rapid commercial coverage across major health plans.

The Infectious Disease Society of America recommends PEMGARDA for PrEP in moderately to severely immunocompromised adults and adolescents at risk of severe COVID-19. Invivyd has launched a Patient Savings Program to assist eligible commercially insured patients. Recent data shows PEMGARDA's continued neutralizing activity against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1. Invivyd is also developing VYD2311, a next-generation mAb candidate with promising early results.

Invivyd (Nasdaq: IVVD), a biopharmaceutical company focused on protection from serious viral infectious diseases, has announced its participation in three upcoming investor conferences in New York, NY:

• Morgan Stanley 22nd Annual Global Healthcare Conference on September 6, 2024, at 10:00 AM ET
• H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, at 9:30 AM ET
• 2024 Cantor Global Healthcare Conference on September 18, 2024, at 10:55 AM ET

Live webcasts of the fireside chats will be available on Invivyd's investor website and archived for approximately 90 days after the events.

Invivyd (Nasdaq: IVVD) has initiated dosing in the Phase 1 clinical trial of VYD2311, a next-generation monoclonal antibody for COVID-19. This trial, conducted in Australia, will assess safety, tolerability, pharmacokinetics, and immunogenicity in healthy volunteers. VYD2311 has shown high in vitro neutralization potency against post-Omicron variants and will explore intramuscular administration for improved patient convenience.

The company expects preliminary data in Q4 2024, with additional clinical readouts throughout 2025. VYD2311 aims to build on the success of PEMGARDA™ (pemivibart), which recently received FDA Emergency Use Authorization for pre-exposure prophylaxis in certain immunocompromised patients.

Invivyd (IVVD) announces continued neutralizing activity of PEMGARDA™ (pemivibart) against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, as well as other variants of interest. New pseudovirus in vitro neutralization data show:

1. Continued effectiveness against KP.3.1.1, which accounts for 42.2% of circulating variants and is the only major variant increasing nationally.

2. Efficacy against variants containing key mutations like Q493E and S31 deletion.

3. Pemivibart's epitope remains intact across 99.59% of viral sequences since Omicron BA.1.

4. Pipeline candidate VYD2311 also shows promising neutralization potency.

Data submitted to FDA for potential updates to PEMGARDA™ Fact Sheet. This demonstrates Invivyd's ongoing efforts in developing variation-resistant COVID-19 antibody medicines.

Invivyd (Nasdaq: IVVD) announced positive 180-day exploratory clinical efficacy data from its ongoing CANOPY Phase 3 trial of pemivibart, an investigational monoclonal antibody for COVID-19 pre-exposure prophylaxis. In immunocompetent individuals, pemivibart demonstrated an 84% relative risk reduction in symptomatic COVID-19 compared to placebo. The pemivibart group had a 1.9% rate of confirmed symptomatic COVID-19, versus 11.9% in the placebo group. In immunocompromised participants, pemivibart showed a 3% rate of confirmed symptomatic COVID-19. The safety profile remained consistent with previous data. The FDA updated the PEMGARDA Fact Sheet for Healthcare Providers to include these exploratory clinical efficacy data.

Invivyd reported Q2 2024 financial results and business highlights for its COVID-19 antibody PEMGARDA. Key points include:

1. $2.3 million net product revenue from PEMGARDA's commercial launch
2. Accelerating commercial results in early Q3 2024
3. New Chief Commercial Officer, Tim Lee, appointed
4. Achieved Medicare, Medicaid, and commercial insurance coverage
5. Submitted EUA amendment for PEMGARDA treatment of mild-to-moderate COVID-19 in immunocompromised patients
6. VYD2311 first-in-human trial to begin in late August
7. $147.9 million in cash and cash equivalents at Q2 end
8. Projected 2024 year-end cash of at least $75 million
9. Anticipated 2024 net product revenue of $150-$200 million

Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company focused on protecting against serious viral infectious diseases, has announced a conference call scheduled for Wednesday, August 14, 2024, at 8:30 a.m. ET. The call will cover the company's financial results for the second quarter ended June 30, 2024, along with recent business highlights. Interested parties can register for the webcast through a provided link, while analysts who wish to participate in the Q&A session have a separate link available. A replay of the webcast will be accessible on Invivyd's investor website approximately two hours after the call concludes. Participants are advised to join 15 minutes before the start time.