MRNA Moderna Inc.

69.47
+4.3  (+7%)
Previous Close 65.17
Open 65.89
52 Week Low 13.53
52 Week High 95.21
Market Cap $27,411,948,608
Shares 394,586,852
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Enterprise Value $24,862,707,608
Volume 9,233,603
Av. Daily Volume 17,788,174
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Upcoming Catalysts

Drug Stage Catalyst Date
mRNA-1273
COVID-19 vaccine
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
mRNA-3704
Methylmalonic Acidemia (MMA)
Phase 1/2
Phase 1/2
Phase 1/2 enrollment paused due to COVID-19.
mRNA-2416 and durvalumab
Ovarian cancer
Phase 1/2
Phase 1/2
Phase 2 dosing has commenced - noted September 17, 2020.
mRNA-1653
Human Metapneumovirus and Human Parainfluenza Infection (hMPV+PIV3 vaccine)
Phase 1
Phase 1
First 10 pediatric patients dosed in Phase 1 trial.
mRNA-1647
CMV vaccine (Cytomegalovirus Infection)
Phase 2
Phase 2
Phase 2 first interim analysis announced September 17, 2020. Phase 3 trial to commence in 2021.
mRNA-1944
Chikungunya Virus Infection
Phase 1
Phase 1
Phase 1 enrolment has been paused due to COVID-19.
mRNA-2752
Solid tumors, lymphoma
Phase 1
Phase 1
Phase 1 dosing has commenced - noted January 8, 2019.
mRNA-4157 (KEYNOTE-942)
Personalized cancer vaccine
Phase 1
Phase 1
Phase 2 trial has been initiated.
mRNA-5671
KRAS cancer vaccine
Phase 1
Phase 1
Phase 1 dosing has commenced - August 7, 2019.
mRNA-1172
RSV vaccine
Phase 1
Phase 1
Phase 1 dosing has commenced - August 7, 2019.
mRNA-4650
Autologous Cancer
Phase 1/2
Phase 1/2
Phase 1 data presented at ASCO June 1, 2019.
mRNA-1777
RSV vaccine
Phase 1
Phase 1
Development has been paused - May 8, 2019.
mRNA-1440
Influenza vaccine
Phase 1
Phase 1
Phase 1 completed.
mRNA-1851
Influenza vaccine
Phase 1
Phase 1
Phase 1 completed.
mRNA-1388
Chikungunya vaccine
Phase 1
Phase 1
Phase 1 completed.
VEGF-A(AZD8601)
Myocardial ischemia
Phase 1
Phase 1
Phase 1 completed.

Latest News

  1. Canadian Government maintains option for an additional 36 million doses

    Agreement underscores growing global confidence in mRNA platform and progress of Phase 3 study of mRNA-1273

    Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Canadian Government has increased its confirmed order commitment to 20 million doses of Moderna's vaccine candidate against COVID-19, mRNA-1273.

    This updated agreement comes as Moderna's Phase 3 COVE study has enrolled more than 75% of its participants, 11,879 of whom have received their second vaccination as of September 18, 2020. To provide additional transparency…

    Canadian Government maintains option for an additional 36 million doses

    Agreement underscores growing global confidence in mRNA platform and progress of Phase 3 study of mRNA-1273

    Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Canadian Government has increased its confirmed order commitment to 20 million doses of Moderna's vaccine candidate against COVID-19, mRNA-1273.

    This updated agreement comes as Moderna's Phase 3 COVE study has enrolled more than 75% of its participants, 11,879 of whom have received their second vaccination as of September 18, 2020. To provide additional transparency in the context of the pandemic, the Company also made the complete, unredacted protocol for the Phase 3 trial of mRNA-1273 available online on Thursday, September 17.

    "We appreciate the confidence in Moderna's mRNA platform and the progress we are making with mRNA-1273, as demonstrated by the increased order from the Canadian government today," said Stephane Bancel, Moderna's Chief Executive Officer. "This support, along with that of our stakeholders, drives us forward as we scale-up our global manufacturing and distribution network."

    Moderna remains on track to be able to deliver up to 56 million doses of its COVID-19 vaccine to help protect Canadians beginning in 2021. The Canadian vaccine supply will be sourced from Moderna's European production capacity with its strategic manufacturing partner Lonza of Switzerland, and ROVI of Spain for fill-finish services.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company's development of a potential vaccine against the novel coronavirus, the potential for mRNA-1273 to prevent COVID-19 disease and slow the spread of SARS-CoV-2, plans for expansion into the Canadian market, the supply of mRNA-1273 to the Canadian government, and plans for the manufacturing and distribution of mRNA-1273. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could", "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

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  2. Positive interim analysis from Phase 2 study of CMV vaccine candidate (mRNA-1647); Phase 3 study to begin in 2021

    Phase 3 COVE study of COVID vaccine candidate (mRNA-1273) has enrolled 25,296 participants to date; Phase 3 protocol now available online

    Moderna to enter seasonal flu business given the high medical need for more effective flu vaccine

    Two-dose regimen of Chikungunya antibody (mRNA-1944) demonstrates the platform's ability for safe repeat dosing

    Next generation MMA candidate (mRNA-3705) announced

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced progress across its portfolio of pipeline…

    Positive interim analysis from Phase 2 study of CMV vaccine candidate (mRNA-1647); Phase 3 study to begin in 2021

    Phase 3 COVE study of COVID vaccine candidate (mRNA-1273) has enrolled 25,296 participants to date; Phase 3 protocol now available online

    Moderna to enter seasonal flu business given the high medical need for more effective flu vaccine

    Two-dose regimen of Chikungunya antibody (mRNA-1944) demonstrates the platform's ability for safe repeat dosing

    Next generation MMA candidate (mRNA-3705) announced

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced progress across its portfolio of pipeline assets being presented at the Company's annual R&D Day today.

    "The Moderna team has made significant progress since our last R&D Day 12 months ago. The pipeline has matured with our COVID-19 vaccine in a Phase 3 study and four candidates in Phase 2 studies. We are actively preparing for a potential commercial launch of mRNA-1273, our COVID-19 vaccine, and we continue to expand the breadth of Moderna's platform," said Stéphane Bancel, Moderna's Chief Executive Officer. "We are announcing that we are increasing our investment in vaccines and we will develop a seasonal flu vaccine given the unmet need for highly effective vaccines. In our systemic secreted & cell surface therapeutics core modality, we are sharing positive interim data for repeat dosing of our systemic mRNA therapeutic against chikungunya, which is important progress for our therapeutics modalities, particularly in rare diseases. With our second collaboration with Vertex, we are entering the field of gene editing using Moderna's technology. As we continue to scale for commercialization, we are more committed than ever to our mission to deliver on the promise of mRNA medicines to treat or prevent serious diseases."

    Presentation highlights from Moderna's R&D Day include:

    Infectious Diseases

    • COVID vaccine candidate (mRNA-1273) Phase 3 COVE study of 30,000 volunteers in the U.S. being conducted with NIH and BARDA has enrolled 25,296 participants as of September 16, 2020; 10,025 participants have received their second vaccination to date; to provide additional transparency in context of pandemic, Phase 3 protocol now available online
    • Positive interim analysis from Phase 2 study of CMV vaccine candidate (mRNA-1647); Phase 3 study of mRNA-1647 to begin in 2021 at 100 μg dose
    • The U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for the Company's pediatric RSV vaccine (mRNA-1345) and allowed it to proceed to the clinic
    • First 10 pediatric patients dosed in Phase 1 study of hMPV/PIV3 vaccine (mRNA-1653)
    • Moderna plans to enter the seasonal flu business

    Oncology

    Rare Diseases

    • Positive data from additional cohorts of Phase 1 study evaluating escalating doses of antibody against the chikungunya virus (mRNA-1944) administered via intravenous infusion in healthy adults
    • New next generation MMA candidate (mRNA-3705) protocol revision to enhance operational performance and improve outreach to the patient community
    • New protocol amendment for Phase 1/2 study of propionic acidemia (PA) candidate (mRNA-3927)

    Moderna currently has 23 mRNA development candidates in its portfolio with 14 in clinical studies. Across Moderna's pipeline, more than 27,000 healthy volunteers and patients have been enrolled in clinical studies including the Phase 3 study of mRNA-1273. The Company's updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 50 peer-reviewed papers.

    About Moderna's R&D Day Presentation

    Core Modalities

    Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company's global public health portfolio is focused on epidemic and pandemic diseases for which funding has been sought from governments and non-profit organizations.

    • Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive interim data from Phase 2 study assessing the safety, reactogenicity, and immunogenicity of different dose levels of mRNA-1647 are now available. mRNA-1647 was generally safe and well tolerated. After the first vaccination, injection site pain was the most commonly reported solicited local adverse reaction (AR). The most common solicited systemic ARs were headache, fatigue, and myalgia in both CMV-seronegative and CMV-seropositive mRNA-1647 treatment groups. No serious adverse events (SAEs) were reported and no unsolicited events leading to study discontinuation occurred. After the 2nd vaccination, the rate and severity distribution of solicited ARs in the CMV-seronegative and CMV-seropositive mRNA-1647 treatment groups were generally similar. In CMV-seronegative participants, neutralizing antibody titers against epithelial cell infection were boosted to at least 12-fold over the baseline geometric mean titer (GMT) of CMV-seropositive participants. Neutralizing antibody titers against fibroblast infection were generally equivalent to the baseline GMT in CMV-seropositive participants. In CMV-seropositive participants, neutralizing antibody titers in the epithelial cell infection were boosted to GMTs at least 20-fold to greater than 32-fold over the respective baseline GMT after the 2nd vaccination. Neutralizing antibody titers against fibroblast infection boosted to levels at least 2-fold over the respective baseline GMT. Based on the interim analysis of the Phase 2 study, the 100 μg dose has been chosen for the Phase 3 pivotal study, expected to begin in 2021. Moderna owns worldwide commercial rights for mRNA-1647.
    • COVID-19 vaccine (mRNA-1273): As of Wednesday, September 16, 2020, 25,296 participants have been enrolled in the Phase 3 COVE study and approximately 28% of participants enrolled cumulatively are from diverse communities. 10,025 participants have received their second vaccination. The protocol for the study being conducted in collaboration with the NIH and BARDA is now publicly available. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study evaluating a two-dose vaccination schedule of mRNA-1273 across three dose levels (25, 100, 250 µg) in 45 healthy adults ages 18-55 years was published in The New England Journal of Medicine and shows mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2. mRNA-1273 was generally safe and well tolerated with no SAEs reported through Day 57. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of mRNA-1273 with federal funding under Contract no. 75A50120C00034. A summary of the Company's work to date on COVID-19 can be found here.
    • Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): The first 10 seropositive pediatric participants (12-36 months of age) in the Phase 1 study of hMPV/PIV3 study (mRNA-1653) were dosed prior to the COVID-19 related study disruption. Sites have re-opened and are actively recruiting participants. Moderna owns worldwide commercial rights to mRNA-1653.
    • Pediatric respiratory syncytial virus (RSV) vaccine (mRNA-1345): The FDA has completed its review of the Investigational New Drug (IND) application for mRNA-1345 and allowed it to proceed to clinic. mRNA-1345 is a vaccine against RSV in young children encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. The Company intends to combine mRNA-1345 with mRNA-1653, its vaccine against hMPV and PIV3, to create a combination vaccine against RSV, hMPV and PIV3. There is no approved vaccine for RSV. Moderna owns worldwide commercial rights to the combined mRNA-1345/mRNA-1653 vaccine.
    • Seasonal influenza (flu): Moderna is entering the seasonal flu business. Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on healthcare systems. Currently approved vaccines are ~40-60% effective and face significant challenges from strain mismatch1; high-risk groups would benefit from higher efficacy, which the Company believes its mRNA platform may be capable of delivering.

    Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.

    • Antibody against the chikungunya virus (mRNA-1944): Positive interim data from the Phase 1 study evaluating escalating doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication cohort and two doses of 0.3 mg/kg (without steroid premedication) given one week apart cohort are now available. mRNA-1944 was generally safe and well tolerated. No SAEs were reported; the most common adverse events were headache, nausea, myalgia, dizziness and chills. Administration of mRNA-1944 resulted in dose-dependent increases in levels of antibody against chikungunya (CHKV-24). Neutralizing antibodies were observed at all dose levels, indicating functional antibody production by mRNA-1944. Safety and increased CHKV-IgG production in the two-dose regimen shows the platform's ability for repeat dosing.

    Exploratory Modalities

    Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

    • OX40L (mRNA-2416): The Phase 1/2 study of mRNA-2416 alone and in combination with durvalumab (IMFINZI®) is ongoing. The Phase 2 dose expansion study of mRNA-2416 in combination with durvalumab in ovarian cancer patients is enrolling and the first patients have been dosed. Data from the Phase 1 study evaluating mRNA-2416 as a monotherapy were presented at the American Association for Cancer Research Annual Meeting and show mRNA-2416 is well tolerated when given as monotherapy at all dose levels studied with no dose-limiting toxicities reported. The observations of broad pro-inflammatory activity and beneficial changes in the tumor microenvironment with upregulation of PD-L1 support the evaluation of combination intratumoral mRNA-2416 with the anti-PD-L1 inhibitor durvalumab in solid tumors, which is ongoing in Part B of this study with a focus on advanced ovarian carcinoma. Moderna owns worldwide commercial rights to mRNA-2416.

    Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

    • Methylmalonic acidemia (MMA) (mRNA-3704): Due to the COVID-19 pandemic, Moderna paused new enrollment and new site initiation for the Phase 1/2 study of mRNA-3704 to ensure the safety of these pediatric patients and their caregivers. During the pause, the Company implemented changes that the Company believes will ultimately help to accelerate clinical development including the introduction of a new drug product with better pharmacology (designated mRNA-3705) as well as a protocol revision to enhance operational performance and reflecting input from the patient and caregiver community. The Company plans to file new IND and CTA applications for mRNA-3705 and will focus development efforts on that candidate going forward. mRNA-3705 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3705.
    • Propionic acidemia (PA) (mRNA-3927): Due to the COVID-19 pandemic, Moderna paused new enrollment and new site initiation for its Phase 1/2 study of mRNA-3927 to ensure the safety of these pediatric patients and their caregivers. During the pause, the Company implemented changes that the Company believes will ultimately help to accelerate clinical development including a protocol amendment implementing a novel design to identify the optimal dose in the most efficient manner and to make the study less burdensome on patients, their families and clinical partners. mRNA-3927 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3927.

    Corporate Updates

    • Moderna announced a new research collaboration with Vertex to discover potential treatment of cystic fibrosis using gene editing enabled by Moderna's mRNA and lipid technologies
    • Moderna announced a collaboration with Chiesi Group to discover and develop mRNA therapeutics for pulmonary arterial hypertension (PAH)

    Investor Call and Webcast Information

    Moderna will host the virtual R&D Day beginning at 8:00 a.m. ET on Thursday, September 17, 2020. A live webcast will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's website for one year following the presentation.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: expected timing of enrollment completion for the Phase 3 study of mRNA-1273; the timing and design of the Phase 3 study of mRNA-1647; the Company's intention to create a combination therapy with mRNA-1345 and mRNA-1653 against RSV, hMPV and PIV3; the Company's plans to file new IND and CTA applications for mRNA-3705; the Company's intentions regarding resumption of enrollment and the implementation of changes for paused clinical studies; the probability of success of the Company's vaccines individually and as a portfolio; the Company's intention to enter the seasonal flu business; the Company's development of mRNA-3705 as a next generation MMA candidate; and the ability of the Company to accelerate the research and development timeline for any individual product or the platform as a whole. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to or in the clinic; no commercial product using mRNA technology has been approved and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in clinical trials, preclinical work, overall operations, regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    1 Centers for Disease Control and Prevention. Vaccine Effectiveness: How Well Do the Flu Vaccines Work? Available at: https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm.

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  3. Second collaboration between Moderna and Vertex based on Moderna's proprietary mRNA and LNP technology

    Collaboration will leverage Vertex's investments and capabilities in genetic technologies for CF

    Moderna to receive $75 million upfront, with potential for additional development, regulatory and commercial milestones and royalty payments

    Moderna, Inc. (NASDAQ:MRNA) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) announced today a new strategic research collaboration and licensing agreement aimed at the discovery and development of lipid nanoparticles (LNPs) and mRNAs for the delivery of gene-editing therapies for the treatment of cystic fibrosis (CF). The three-year research collaboration initially will focus on the discovery and…

    Second collaboration between Moderna and Vertex based on Moderna's proprietary mRNA and LNP technology

    Collaboration will leverage Vertex's investments and capabilities in genetic technologies for CF

    Moderna to receive $75 million upfront, with potential for additional development, regulatory and commercial milestones and royalty payments

    Moderna, Inc. (NASDAQ:MRNA) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) announced today a new strategic research collaboration and licensing agreement aimed at the discovery and development of lipid nanoparticles (LNPs) and mRNAs for the delivery of gene-editing therapies for the treatment of cystic fibrosis (CF). The three-year research collaboration initially will focus on the discovery and optimization of novel LNPs and mRNAs that can deliver gene-editing therapies to cells in the lungs, enabling functional cystic fibrosis transmembrane conductance regulator (CFTR) protein to be produced.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200916005915/en/

    "We are pleased to enter into this second collaboration with Vertex aimed at delivering potentially novel treatments for patients with cystic fibrosis using gene editing," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our first collaboration with Vertex to deliver mRNA coding for cystic fibrosis protein in lung cells is advancing well and this second collaboration aims at using Moderna's technologies to explore the use of gene editing in lung cells."

    "Vertex's CFTR modulator therapies have the potential to treat the vast majority of CF patients and address the underlying cause of their disease. However, approximately 10 percent of patients do not produce any CFTR protein and so are unlikely to benefit from our existing medicines. Over the past 5 years, we have made important progress in our research efforts aimed at the creation of genetic therapies for CF, with the delivery of such therapies remaining the most significant technological and scientific challenge," said David Altshuler, M.D., Ph.D., Vertex's Executive Vice President, Global Research and Chief Scientific Officer. "The combination of Moderna's unique expertise in the discovery and manufacturing of novel LNP delivery systems and mRNA technologies, combined with Vertex's scientific, clinical and regulatory capabilities in CF, will accelerate the development of groundbreaking genetic therapies for people with CF and supports our commitment to developing therapies for all people living with CF."

    Under the terms of the agreement, Moderna will conduct research activities to discover and optimize novel LNPs for the delivery of gene-editing therapies to lung cells for the treatment of CF. Moderna will receive $75 million upfront and will be eligible to receive up to $380 million in development, regulatory and commercial milestones, plus tiered royalties on any products that result from the collaboration. Moderna will be responsible for the discovery and manufacturing of LNPs and mRNA constructs encoding gene-editing endonucleases. Vertex will be responsible for providing other components of the gene-editing therapies to be formulated into LNPs, as well as subsequent preclinical and clinical development and potential commercialization efforts. This new collaboration adds to the existing relationship between Moderna and Vertex in their recently extended collaboration aimed at the discovery and development of mRNA therapeutics for the treatment of CF.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years.

    About Vertex Pharmaceuticals

    Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

    Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 10 consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes.

    Special Note Regarding Forward-looking Statements

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, Mr. Bancel's statements in the second paragraph of the press release, Dr. Altshuler's statements in the third paragraph of the press release, and the information provided regarding the future development of therapies to treat the underlying cause of CF, and the potential commercialization opportunities from those therapies. While Vertex and Moderna each believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the companies' beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data may not support further development of the therapies subject to the collaboration due to safety, efficacy or other reasons, and other risks listed under the heading "Risk Factors" in Vertex's annual report and subsequent quarterly reports filed with the Securities and Exchange Commission (SEC) and available through Vertex's website at www.vrtx.com and on the SEC's website at www.sec.gov, as well as those risks listed under the heading "Risk Factors" in Moderna's most recent quarterly report on Form 10-Q filed with the SEC and in subsequent filings made by Moderna with the SEC, which are available on Moderna's website at www.modernatx.com and on the SEC's website at www.sec.gov. Except as required by law, Vertex and Moderna each disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.

    (VRTX – GEN)

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  4. Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients and Chiesi Farmaceutici S.p.A., an international research-focused healthcare group (Chiesi Group), today announced a collaboration aimed at the discovery and development of mRNA therapeutics for the treatment of pulmonary arterial hypertension (PAH), a rare disease with an incidence of 2-5 per million adults1. PAH is a progressive disorder characterized by high blood pressure in the arteries of the lungs with concomitant right heart failure2. There is an unmet medical need for novel treatments that could delay, or reverse, the disease progression in patients.

    Under…

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients and Chiesi Farmaceutici S.p.A., an international research-focused healthcare group (Chiesi Group), today announced a collaboration aimed at the discovery and development of mRNA therapeutics for the treatment of pulmonary arterial hypertension (PAH), a rare disease with an incidence of 2-5 per million adults1. PAH is a progressive disorder characterized by high blood pressure in the arteries of the lungs with concomitant right heart failure2. There is an unmet medical need for novel treatments that could delay, or reverse, the disease progression in patients.

    Under the terms of the agreement, Moderna will lead discovery efforts, leveraging its leading mRNA technology and delivery platforms along with Chiesi's expertise in the field of PAH biology. Chiesi Group will lead development and worldwide commercialization activities and will fund all expenses related to the collaboration. Moderna will receive $25 million upfront and is eligible for more than $400 million in development, regulatory, and commercial milestones, as well as tiered double-digit royalties on net sales.

    "We are excited to begin this collaboration with Chiesi Group, which provides the opportunity to further leverage our mRNA and delivery technology," said Stephen Hoge, M.D., President of Moderna. "This new relationship continues our commitment to partner with companies that have unique expertise in serious diseases, and who share our vision of using mRNA therapeutics to address the unmet needs of patients."

    "Chiesi Group is at the forefront of innovation and discovery of novel therapies for people affected by diseases with high unmet medical need," said Ugo Di Francesco, Chief Executive Officer of Chiesi Group. "The agreement with Moderna, a leader in mRNA science and delivery, confirms our commitment to better serve patients and healthcare professionals with transformative solutions."

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC, Merck & Co., Inc. and Vertex Pharmaceuticals, Inc. as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    About Chiesi Group

    Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK and Sweden to advance Chiesi's pre-clinical, clinical and registration programs. Chiesi employs nearly 6,000 people. Chiesi Group is a certified Benefit corporation. For more information, please visit www.chiesi.com.

    Moderna's Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the Company's collaboration with Chiesi Farmaceutici to develop and discover mRNA therapeutics for the treatment of pulmonary arterial hypertension and the potential commercialization opportunities from such efforts. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could", "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, the fact that there has never been a commercial product utilizing mRNA technology approved for use, and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

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    1 Lancet Resp Medicine, Vol. 4, issue 4, p. 306-322, 2016

    2 https://www.ajmc.com/view/subpopulations-pulmonary-hypertension

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  5. Dan Staner appointed as Vice President and Managing Director, Switzerland

    Reinforces Moderna's commitment to Europe

    Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the appointment of Dan Staner as Vice President and General Manager, Switzerland, effective today. Switzerland is the first country outside of North America to host a Moderna regional hub and commercial organization.

    Mr. Staner is responsible for Moderna's presence and activities in Switzerland, building a team to cover a range of functions – medical, regulatory, pricing, reimbursement, market access, government affairs and commercial…

    Dan Staner appointed as Vice President and Managing Director, Switzerland

    Reinforces Moderna's commitment to Europe

    Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the appointment of Dan Staner as Vice President and General Manager, Switzerland, effective today. Switzerland is the first country outside of North America to host a Moderna regional hub and commercial organization.

    Mr. Staner is responsible for Moderna's presence and activities in Switzerland, building a team to cover a range of functions – medical, regulatory, pricing, reimbursement, market access, government affairs and commercial operations – for the Swiss market. As Moderna builds its European footprint, Mr. Staner will work in close collaboration with Mr. Nicolas Chornet who was recently appointed as SVP International Manufacturing, Europe, based in Basel.

    Recently, the Swiss Federal Government concluded an agreement with the Company for the procurement of 4.5 million vaccine doses of mRNA-1273, its investigational vaccine against COVID-19. In May 2020, Moderna and Lonza, a Swiss-based company, also announced a strategic collaboration to enable larger scale global manufacture by Lonza of mRNA-1273 and additional Moderna products in the future.

    "I am first and foremost honored to have joined Moderna. I am very excited to have the responsibility for building Moderna's first commercial organization outside of North America," said Mr. Staner. "I look forward to working with Switzerland's healthcare stakeholders as we face the immediate challenge of COVID-19. This is a wonderful opportunity for Switzerland to continue its leading role in innovation and biopharmaceuticals for the benefit of society globally."

    "Switzerland is a leader in life-sciences, with a dynamic pool of industry talent, scientists, research organizations, investors and global health policymakers," said Stéphane Bancel, CEO of Moderna. "Since Moderna's founding, Switzerland has played an important role in Moderna's development thanks to the long-term support of our Swiss investors and their business advice. Opening our first subsidiary outside North America in Switzerland is a natural step for Moderna. I am pleased to welcome Dan Staner to the Moderna team. I had the chance to work with Dan at Lilly and I know that he has a proven track record in building and leading global biopharmaceutical commercial teams in Switzerland and around the world."

    Mr. Staner brings over 25 years of experience in the global pharmaceutical industry, principally with Eli Lilly. His previous leadership roles have included finance, marketing, strategy, global product development. and general management. His geographic responsibilities at different times covered Switzerland, Europe, USA, Middle East, Africa, and South Asia. He is a Swiss national and holds an MSc in Economics and Business Management from H.E.C. University of Lausanne.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., with a European headquarters in Basel, Switzerland, Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company's development of a potential vaccine against the novel coronavirus, the potential for mRNA-1273 to prevent COVID-19 disease and slow the spread of SARS-CoV-2, the Company's international expansion and staffing efforts, and plans to increase and scale production of mRNA-based medicines. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could", "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

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