Drugs / COV2
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | COVID-19 | 2020-10-15 | “REGN-COV2, a potentially preventative and therapeutic investigational medicine for COVID-19 that has been recently submitted to the FDA for an emergency use authorization (EUA).” regeneron.com ↗ “Regeneron has submitted a request to the FDA for an Emergency Use Authorization (EUA) for REGN-COV2.” roche.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07416539 | Feb → Nov 2026 expected | COVID-19 | Rokote Laboratories Finland Oy | Recruiting | No outcome recorded |
| Phase 1 | NCT06851611 | Jan → Jun 2025 | COVID-19 | Rokote Laboratories Finland Oy | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2025-06-04 | GeoVax, Inc. | Results GeoVax to Showcase Innovative COVID 19 Vaccine Data at the Keystone Symposia on Vaccinology geovax.com ↗
MVA‑vectored multi‑antigen COVID‑19 vaccines induce protective immunity against SARS‑CoV‑2 variants spanning Alpha to Omicron in preclinical animal models. |
| 2023-08-31 | Shionogi | Regulatory Notice Regarding the Inclusion of Nasal Vaccine Research and Development for Influenza Virus and SARS-COV2 / New Modality Research and Development Project by AMED shionogi.com ↗ |
| 2023-05-24 | Dompé Farmaceutici S.p.A | Results New Data Reveal Role of SARS-Cov-2 Spike protein in Covid-19 associated coagulopathy dompe.com ↗
Dompé farmaceutici announced today new peer-reviewed data demonstrating that small changes in the SARS-CoV-2 Spike (S)-protein sequence can eliminate its effect in inducing coagulation [1]. |
| 2022-06-03 | Vaxart | Results New Preclinical Data Demonstrate Two of Vaxart’s COVID-19 Vaccine Candidates Protect Against Omicron vaxart.com ↗
These findings demonstrate that in this preclinical model both vaccine candidates protect against the Omicron variant. |
| 2022-04-05 | HDT Bio | Results HDT Bio Demonstrates RNA Vaccines Matched to SARS-CoV2 Variants Protect Against Infection of Upper Airways, Important for Preventing Transmission hdt.bio ↗
In addition, the animal studies showed that even when not matched against variants, HDT Bio’s RNA vaccine protects against lower respiratory tract infection and disease regardless of viral strain. |
| 2022-02-21 | Zambon SpA | Results COVID-19. A probiotic formula reduces symptom duration and viral load, increases antibodies, and improves remission rate among patients with mild symptoms zambon.com ↗
After administering the probiotic formulation, complete remission from COVID-19 was achieved by 53.1% of patients in the probiotic group within 30 days, compared to 28.1% of patients in the placebo group. |
| 2022-01-12 | AB Biotics, SA | Results AB21 demonstrates benefit in COVID-19 outpatients ab-biotics.com ↗
A newly published clinical trial in Gut Microbes – a top journal reporting the latest science in microbiota – has confirmed that Kaneka Group / AB-Biotics’ AB21® probiotic formulation exhibits significant positive effects in COVID-19 outpatients. |
| 2021-12-21 | Akston Biosciences Corporation | Results Akston Biosciences Announces Positive Top-Line Data from Phase II Study of COVID-19 Vaccine in the Netherlands akstonbio.com ↗
The interim analysis showed a robust overall 98% seroconversion response after either two 45μg doses (100%), or a single 90μg dose (96%) in healthy adults at 56 days. |
| 2021-11-24 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson COVID-19 Vaccine Fully Approved by Health Canada to Prevent COVID-19 in Individuals 18 years and Older jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canadahas approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. |
| 2021-09-02 | Imunon | Results Celsion Reports T-cell and B-cell Response from In Vivo Studies with its PLACCINE DNA Vaccine Platform imunon.com ↗
Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced results from preclinical in vivo studies showing production of antibodies and cytotoxic T-cell response specific to the spike antigen of SARS-CoV-2 when immunizing BALB/c mice with the Company’s next-generation PLACCINE DNA vaccine platform. |
| 2021-06-09 | Adaptive Biotechnologies | Results New Study Published in Nature Provides Further Evidence that COVID-19 Vaccine Induced T-Cell Response Targets Known SARS-CoV-2 Variants of Concern adaptivebiotech.com ↗
Post-vaccination, results showed that the levels of neutralizing antibodies were diminished against the variants, but that the T-cell immune response was preserved, suggesting T cells may provide protection against these emerging strains. |
| 2021-05-30 | Theravectys S.A. | Results Lenti-Covid: robust answer addressing long-term immunity and emerging variants theravectys.com ↗
Pre-clinical studies of TheraVectys Sars-Cov2 lentiviral vector vaccine candidate administered by nasal route have demonstrated its strong efficacy. |
| 2021-04-20 | Mateon Therapeutics | Results ONCOTELIC THERAPEUTICS, INC. ANNOUNCES POSITIVE TOP LINE DATA FOR ARTI-19 CLINICAL TRIAL EVALUATING PULMOHEAL™ VERSUS COVID-19. oncotelic.com ↗
Oncotelic Therapeutics, Inc. (" Oncotelic " or the "Company") (OTCQB:O TLC) , a leading developer of TGF-β therapeutics for oncology and COVID-19, reports positive top line data from its COVID-19 clinical trial, ARTI-19, evaluating PulmoHeal ™ against COVID-19 in India. |
| 2021-03-12 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization jnj.com ↗ |
| 2021-03-11 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission jnj.com ↗
We are thrilled with today’s Conditional Marketing Authorization by the European Commission, which enables our single-dose vaccine to reach many more communities in need, as we continue to do everything we can to help bring an end to this pandemic. |
| 2021-03-11 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces its Single-Shot COVID-19 Vaccine Candidate Receives Positive CHMP Opinion jnj.com ↗
The European Medicines Agency’s recommendation is a landmark moment for Johnson & Johnson and for the world, |
| 2021-03-11 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission jnj.com ↗
Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission |
| 2021-03-11 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces its Single-Shot COVID-19 Vaccine Candidate Receives Positive CHMP Opinion jnj.com ↗
Johnson & Johnson Announces its Single-Shot COVID-19 Vaccine Candidate Receives Positive CHMP Opinion |
| 2021-02-26 | Hoffmann-La Roche | Regulatory Roche SARS-CoV-2 Rapid Antigen Test receives special approval for at-home patient self-testing using nasal swabs in Germany roche.com ↗
Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has been granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) to offer the SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for patient self-testing in Germany. |
| 2021-02-26 | Hoffmann-La Roche | Regulatory EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19 roche.com ↗
The CHMP’s scientific opinion (under Article 5(3) of Regulation 726/2004) provides a harmonised, EU-level opinion on the efficacy, quality and safety of casirivimab and imdevimab. |
| 2021-02-03 | Vaxart | Results Vaxart Announces Positive Preliminary Data from Phase 1 Clinical Trial Evaluating Its Oral COVID-19 Tablet Vaccine Candidate vaxart.com ↗
VXA-CoV2-1 induced potent CD8+ T-cell responses |
| 2020-12-17 | Regeneron Pharmaceuticals | Results New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19 regeneron.com ↗ |
| 2020-11-24 | ReiThera Srl | Results ReiThera Announces its GRAd-COV2 COVID-19 Vaccine Candidate is Well Tolerated and Induces Clear Immune Responses in Healthy Subjects Aged 18-55 Years Phase 1 Trial to Advance into Elderly Subjects Aged 65-85 Years reithera.com ↗
Preliminary results from this cohort , which was divided into three study arms of 15 subjects, have shown that GR A d-COV2 was well-tolerated and generated spike-binding antibod ies and T-cell responses at all three doses tested. |
| 2020-11-21 | Regeneron Pharmaceuticals | Regulatory Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization regeneron.com ↗ |
| 2020-10-30 | Regeneron Pharmaceuticals | Results REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements regeneron.com ↗ |
| 2020-10-28 | Regeneron Pharmaceuticals | Results Regeneron's COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. |
| 2020-10-15 | Sanofi | Results Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies sanofi.com ↗
Preclinical evaluation of MRT5500, importantly, demonstrated a favorable immune response profile against SARS-CoV-2. |
| 2020-10-15 | Hoffmann-La Roche | Results First nine months of the year with 1% sales growth at constant exchange rates, significant impact of COVID-19 pandemic roche.com ↗
Initial data showed REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalised COVID-19 patients. |
| 2020-09-29 | Regeneron Pharmaceuticals | Results Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. |
| 2020-09-03 | Janssen Research & Development, LLC | Results Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies jnj.com ↗
Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2, the virus that causes COVID-19 in people. |
| 2020-09-01 | deCODE genetics | Results Titers of antibodies against SARS-CoV2 do not decline within four months decode.com ↗
Scientists at deCODE genetics in Iceland, a subsidiary of Amgen Inc , biopharmaceutical company headquartered in California, and their collaborators, have published a study in The New England Journal of Medicine, that shows that antiviral antibodies against SARS-CoV2 do not decline within four months of diagnosis. |
| 2020-07-30 | Janssen Research & Development, LLC | Results Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies jnj.com ↗
Johnson & Johnson (NYSE: JNJ) (the Company) today announced that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies. |
| 2020-07-07 | 7 Hills Pharma, LLC | Results 7 Hills Pharma Announces Positive Data With Oral Immunostimulant to Improve Effectiveness of COVID-19 Vaccines 7hillspharma.com ↗
The data also suggest 7HP349 can be used as an immunostimulant for any COVID-19 vaccine and has the potential not only to augment the vaccines’ effectiveness, but also accelerate immune system response, allow for dose sparing and reduce or eliminate the need for boosters. |
| 2020-06-11 | Regeneron Pharmaceuticals | Results Two Science Publications Highlight Potential of REGN-COV2 Anti-Viral Antibody Cocktail to Protect Against SARS-CoV-2 Escape Mutants regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Science has accepted for publication two papers describing the creation of its novel two-antibody cocktail, REGN-COV2, and its potential to diminish risk of viral escape by effectively binding to the virus's critical spike protein in two separate, non-overlapping locations. |
| 2020-05-05 | Corat Therapeutics Gmbh | Results Fully neutralising antibodies to SARS-CoV-2 corat-therapeutics.com ↗ |
| 2020-05-03 | Hoffmann-La Roche | Regulatory Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA)1 for its new Elecsys® Anti-SARS-CoV-2 antibody test. |
All press releases naming this drug 49 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | COV2 | “COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing modified SARS-CoV-2 spike protein.” NCT07416539 ↗1“COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing the SARS-CoV-2 spike protein.” NCT06851611 ↗ |
| Modality | Vaccine | “COV2 is a nasal, investigational vaccine against COVID-19” NCT07416539 ↗ |
| Route | Intranasal | “COV2 is a nasal, investigational vaccine against COVID-19” NCT06851611 ↗ |