Eli Lilly completes acquisition of Prevail Therapeutics » 08:5601/2201/22/21
Eli Lilly and Company…
Eli Lilly and Company (LLY) announced the successful completion of its acquisition of Prevail Therapeutics (PRVL). The acquisition establishes a new modality for drug discovery and development at Lilly, extending Lilly's research efforts through the creation of a gene therapy program that will be anchored by Prevail's portfolio of clinical-stage and preclinical neuroscience assets. The impact of this transaction will be reflected in Lilly's 2021 financial results according to Generally Accepted Accounting Principles. There will be no change to Lilly's 2021 financial guidance for research and development expense or non-GAAP earnings per share as a result of this transaction.
Humanigen announces expansion of CRADA for lenzilumab development » 07:0301/2201/22/21
Humanigen announced an…
Humanigen announced an expansion to the Cooperative Research and Development Agreement, or CRADA, that the company had previously entered into with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, or JPEO-CBRND, to gain access to manufacturing capacity reserved by the Biomedical Advanced Research and Development Authority, or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response, or ASPR, at the U.S. Department of Health and Human Services. The agreement supports development of lenzilumab in advance of a potential Emergency Use Authorization, or EUA, for COVID-19. The amended CRADA, now co-signed by BARDA, provides Humanigen with access to manufacturing capacity reserved by BARDA for fill-finish product to accelerate the drug product manufacturing of lenzilumab. The initial agreement, originally signed in November 2020, complements Humanigen's development efforts for lenzilumab by providing access to a full-scale, integrated team of manufacturing and regulatory subject matter experts and statistical support in anticipation of applying for EUA and subsequently a biologics license application, or BLA, for lenzilumab as a potential treatment for COVID-19. Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19.
Fly Intel: Wall Street's top stories for Thursday » 16:4001/2101/21/21
UAL, TRV, LLY, ABCL, CTVA, CLGX, CSGP, DBD, TAL, UAA, UA, DYN, INMB
Stocks on Wall Street…
Fly Intel: Wall Street's top stories at midday » 12:1401/2101/21/21
DBD, UAL, TRV, LLY, ABCL, UAA, UA, TAL, DYN, INMB
The major averages are…
AbCellera-discovered antibody prevented COVID-19 in nursing homes, reduced risks » 08:3101/2101/21/21
AbCellera (ABCL) announced that bamlanivimab, LY-CoV555, a human antibody discovered by AbCellera and developed with Eli Lilly and Company (LLY) , significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. Lilly's Phase 3 BLAZE-2 COVID-19 prevention trial was conducted in partnership with the National Institute of Allergy and Infectious Diseases, NIAID, part of the National Institutes of Health , NIH, and the COVID-19 Prevention Network, CoVPN. bamlanivimab. "The data from the Phase 3 BLAZE-2 trial show that bamlanivimab provides effective protection against COVID-19 infection, with the greatest impact on the most vulnerable patients," said Carl Hansen, Ph.D., CEO and President of AbCellera. "Furthermore, data obtained from the treatment group are completely consistent with what was observed in the BLAZE-1 trial. This reinforces the importance of efforts to ensure high-risk patients get access to antibody therapy early in COVID-19 infection. We believe bamlanivimab can save lives if delivered early."
Eli Lilly: LY-CoV555 prevented Covid-19 at nursing homes in Blaze-2 trial » 08:0501/2101/21/21
Bamlanivimab, or LY-CoV555, significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, Eli Lilly and Company announced. The Phase 3 BLAZE-2 COVID-19 prevention trial - conducted in partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health and the COVID-19 Prevention Network - enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the U.S. The 965 participants who tested negative for the SARS-CoV-2 virus at baseline were included in the analysis of primary and key secondary endpoints for assessing prevention, while the 132 participants who tested positive for the virus at baseline were included in exploratory analyses for assessing treatment, adding to the growing body of evidence for treatment with bamlanivimab. All participants were randomized to receive either 4,200 mg of bamlanivimab or placebo. After all participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 in the bamlanivimab treatment arm versus placebo. Results for all key secondary endpoints also reached statistical significance in both the overall and resident populations. Among the 299 residents in the prevention group, there were 4 deaths attributed to COVID-19 at the time of death, and all occurred in the placebo arm. There were no COVID-19 attributed deaths in the bamlanivimab arm. Among the 41 residents in the treatment group, there were 4 deaths, and all occurred in the placebo arm with none in the bamlanivimab arm. Over the entire trial, there were a total of 16 deaths reported, including deaths not related to COVID-19, and all deaths were residents.
Jefferies reads Humanigen COVID-19 trial change as 'sign of confidence' » 09:2801/2001/20/21
After Humanigen disclosed…
After Humanigen disclosed that the company has changed the primary endpoint of its ongoing Phase 3 clinical trial of lenzilumab in hospitalized patients with COVID-19 to ventilator-free survival through day 28, previously one of several secondary endpoints, Jefferies analyst Kelly Shi said that switching to the "more challenging" primary endpoint is "a positive sign for trial outcome" and a "sign of confidence." The analyst, who thinks lenzilumab will be viewed "as a game changer if the trial succeeds," would use the "panic selling post-market" as a buying opportunity. Shi keeps a Buy rating and $27 price target on Humanigen shares.
Humanigen changes primary endpoint of lenzilumab trial in COVID-19 patients » 09:2401/2001/20/21
In a regulatory filing…
In a regulatory filing last night, Humanigen noted that the company provided an update on its ongoing Phase 3 clinical trial of lenzilumab in hospitalized patients with COVID-19. "As of January 19, 2021, more than 500 patients have been enrolled in the trial. In response to the rapidly evolving therapeutic landscape, the primary endpoint of the trial has been changed to ventilator-free survival through day 28, previously one of several secondary endpoints. Time to recovery will be one of several secondary endpoints. The company believes this change in the primary endpoint represents a more meaningful endpoint for patients, health-care providers, and payors given the current standard of care for hospitalized and hypoxic COVID-19 patients. The protocol and statistical analysis plan for the Phase 3 trial have been updated to reflect these changes. These changes have been reviewed and discussed with FDA and are expected to be posted to clinicaltrials.gov (NCT04351152). The company remains blinded to the results of this ongoing trial," Humanigen said.
Citi opens 'positive Catalyst Watch' on Eli Lilly into Alzheimer's data » 06:3701/2001/20/21
Citi analyst Andrew Baum…
Citi analyst Andrew Baum opens a opening a "positive Catalyst Watch" on Eli Lilly ahead of presentation of donanemab data at March 13 conference. The analyst keeps a Neutral rating on the shares with a $210 price target. While market expectations have "materially increased" following Lilly's top-line data release earlier this month, Lilly will showcase clinically significant slowing on both cognition and function across subgroups, Baum tells investors in a research note.
Merus price target raised to $32 from $19 at Roth Capital » 10:5001/1901/19/21
Roth Capital analyst Tony…
Roth Capital analyst Tony Butler raised the firm's price target on Merus (MRUS) to $32 from $19 and keeps a Buy rating on the shares after the company announced a research collaboration with Eli Lilly (LLY) to develop up to three CD3-engaging bispecific antibodies. Merus is getting $60M in total upfront payment as well as potential milestone payments and royalties. CD3-engaging biologics have been successful in treating hematologic malignancies, Butler tells investors in a research note.