Moderna says over 26,500 participants received second shot in study » 09:5310/2210/22/20
Moderna said that to…
Moderna says partner PPD 'essential' in Phase 3 Covid study » 09:5110/2210/22/20
Moderna (MRNA) said its…
Moderna completes enrollment in 30,000 person Phase 3 Covid study » 09:4810/2210/22/20
Moderna announced that it…
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Eli Lilly hires advisor to review plant producing C-19 treatment, CNBC reports » 08:2610/2110/21/20
Eli Lilly has hired an…
Eli Lilly has hired an outside advisor to review a plant that had been cited for a variety of issues by the Food and Drug Administration, CNBC reports. The plant had been producing the drugmaker's experimental Covid-19 treatment. The company has not received a warning letter from the FDA following inspections at the plant which were first reported by Reuters last week and had received an Official Action Indicated notice from the FDA in relation to issues at the plant. Reference Link
Moderna sees Covid-19 interim vaccine results in November, WSJ reports » 06:3210/2010/20/20
Moderna (MRNA) CEO…
Moderna (MRNA) CEO Stephane Bancel says the federal government could authorize emergency use of the company's experimental Covid-19 vaccine in December if the company gets positive interim results in November from a large clinical trial, The Wall Street Journal's Peter Loftus reports, citing comments made during the publication's annual Tech Live conference. However, the CEO cautioned that if sufficient interim results from the study takes longer to get, government authorization of the vaccine may not occur until early next year. Pfizer (PFE) said last week it expects to seek U.S. authorization of emergency use of its vaccine by late November. Reference Link
Eli Lilly price target raised to $200 from $190 at JPMorgan » 08:4910/1610/16/20
JPMorgan analyst Chris…
JPMorgan analyst Chris Schott raised the firm's price target on Eli Lilly to $200 from $190 and keeps an Overweight rating on the shares. The analyst remains constructive on U.S. Major Pharma sector heading into Q3 earnings reports. Most franchises are showing continued recovery for their COVID-19 impacted franchises and currency should represent a tailwind with a lower U.S. dollar, Schott tells investors in a research note. The stocks have underperformed year-to-date despite an "attractive" new product cycle, continued pipeline momentum, and multiple product catalysts ahead, says the analyst.
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Eli Lilly to acquire Disarm Therapeutics for upfront payment of $135M » 09:2110/1510/15/20
Eli Lilly and Company…
Eli Lilly and Company announced a definitive agreement to acquire Disarm Therapeutics, a privately-held biotechnology company creating a new class of disease-modifying therapeutics for patients with axonal degeneration. Disarm has discovered novel, potent SARM1 inhibitors and is advancing them in preclinical development, with the goal of delivering breakthrough treatments to patients with peripheral neuropathy and other neurological diseases such as amyotrophic lateral sclerosis and multiple sclerosis. Under the terms of the agreement, Lilly will acquire Disarm for an upfront payment of $135M. Disarm equityholders may be eligible for up to $1.225B in additional future payments for potential development, regulatory and commercial milestones should Lilly successfully develop and commercialize new medicines resulting from the acquisition. This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles. There will be no change to Lilly's 2020 non-GAAP earnings per share guidance as a result of this transaction.
Eli Lilly supports DSMB decision to pause enrollment in ACTIV-3 clinical trial » 09:1610/1410/14/20
Eli Lilly issued a…
Eli Lilly issued a statement on the NIAID decision to pause enrollment in the ACTIV-3 clinical trial, stating in part: "Since the beginning of the COVID-19 pandemic, Lilly has brought the full force of our scientific capabilities to fight this new disease, collaborating with the U.S. government and industry partners to discover potential treatments. Together, we have sought to learn about the potential impact of neutralizing antibodies across the broadest set of patients even as we were still evolving in our understanding of SARS-CoV-2 virus pathology. As always, we have remained deeply committed to patient safety. As of last evening, Lilly continued to be in communication with the trial sponsor regarding the recommendation from the independent data safety monitoring board, DSMB, of the ACTIV-3 clinical trial to pause enrollment of the study. ACTIV-3, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab, LY-CoV555, as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases, NIAID, part of the National Institutes of Health, NIH. At this time, only the DSMB has reviewed the data from the trial, and NIH leadership and Lilly remain blinded to the ongoing trial results. Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study. Importantly, the DSMB also considered the impact of the ACTIV-3 study pause on ACTIV-2 and did not recommend any changes to that study's design or enrollment." Reference Link
Eli Lilly risk/reward favorable into tirzepatide readout, says JPMorgan » 08:2310/1410/14/20
JPMorgan analyst Chris…
JPMorgan analyst Chris Schott sees a favorable risk/reward on Eli Lilly shares into the Phase 3 tirzepatide SURPASS-1 data expected in Q4. Tirzepatide is poised to become Lilly's largest product and further extend its GLP-1 franchise with a potential best-in-class product profile if the drug can replicate Phase 2 efficacy results while improving high-dose tolerability, Schott tells investors in a research note Expectations on tirzepatide have come down recently but remain fairly high into this readout, says the analyst. He sees 5%-10% share upside on "clean" Phase 3 safety and efficacy results across all doses.
Moderna receives confirmation that mRNA-1273 is eligible for EMA MAA submission » 08:0810/1410/14/20
Moderna announced that it…
Moderna announced that it has received written confirmation from the European Medicine Agency, or EMA, that mRNA-1273, the company's vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency's centralized procedure. Confirmation of eligibility was given in response to the submission of a letter of intent enabling Moderna to evaluate the opportunity for submitting a Marketing Authorization Application, or MAA, for mRNA-1273 with the EMA. This submission follows positive results from a preclinical viral challenge study and the positive interim analysis of the Phase 1 study of mRNA-1273 in healthy adults and older adults published in the New England Journal of Medicine. In Europe, the company is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside of the United States. This is a dedicated supply chain to support Europe and countries other than the United States that enter into purchase agreements with Moderna. The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. In the 18-55 age group, neutralizing antibody titers were observed in 100% of evaluated participants and at the 100 microgram dose level selected for Phase 3, the geometric mean titers were above those seen in convalescent sera. Similarly, mRNA-1273 induced consistently high levels of pseudovirus neutralization antibody titers in all participants in the 56-70 and 71+ age groups. In addition, vaccination with mRNA-1273 elicited Th1-biased CD4 T cell responses in all age groups. MRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 microgram dose level in the U.S. As of Friday, October 9, the Phase 3 COVE study has enrolled approximately 28,618 participants with more than 22,194 having received their second vaccination.