| Tuesday | ||||
After Rigel… After Rigel Pharmaceuticals announced topline results from its Phase 2 clinical trial to evaluate the safety of fostamatinib for the treatment of hospitalized patients with COVID-19, Piper Sandler analyst Christopher Raymond said the results of the 60 patient study were "pretty dramatic" despite the small number of patients. He sees "a strong signal" supporting fostamatinib's utility in severe COVID-19, "barring any surprises in the full publication," Raymond tells investors. He keeps an Overweight rating and $8 price target on Rigel shares. | ||||
Rigel Pharmaceuticals… Rigel Pharmaceuticals announced positive topline results from a multi-center, Phase 2 clinical trial to evaluate the safety of fostamatinib, its oral spleen tyrosine kinase, or SYK, inhibitor, for the treatment of hospitalized patients with COVID-19. The trial, being conducted in collaboration with the National Heart, Lung, and Blood Institute, or NHLBI, part of the National Institutes of Health, or NIH, and Inova Health System, met its primary endpoint of safety. Fostamatinib reduced the incidence of Serious Adverse Events, or SAEs, by half. By day 29, there were three SAEs in the fostamatinib plus standard of care, or SOC, group of thirty patients compared to six SAEs in the placebo plus SOC group of twenty-nine patients. Of these, there was a reduction for the disease related SAE of hypoxia in the fostamatinib group compared to placebo. | ||||
| Over a week ago | ||||
Rigel Pharmaceuticals… Rigel Pharmaceuticals (RIGL) has closed its license agreement with Eli Lilly (LLY), following the expiration of the waiting period under the HSR Act. Rigel and Lilly entered a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 inhibitor, for all indications including autoimmune and inflammatory diseases. Pursuant to the collaboration, Lilly will also lead all clinical development of penetrating RIPK1 inhibitors in central nervous system diseases. Rigel has received the $125M upfront cash payment due under the terms of the agreement from Lilly. | ||||
Healthcare Analyst Yang,… Healthcare Analyst Yang, along with Dr. Paritosh Prasad, discuss Rigel Pharmaceuticals' Tavalisse for COVID-19 pneumonia--first human Efficacy Phase 2 data in April 2021 on an Analyst/Industry conference call to be held on March 24 at 12 pm. | ||||
| Over a month ago | ||||
Rigel Pharmaceuticals… Rigel Pharmaceuticals completed patient enrollment in a multi-center Phase 2 clinical trial to evaluate the safety of fostamatinib, Rigel's oral spleen tyrosine kinase inhibitor, for the treatment of hospitalized COVID-19 patients. The study is sponsored by the National Heart, Lung, and Blood Institute - NHLBI - , part of the National Institutes of Health, in collaboration with Inova Health System. Fostamatinib is marketed in the U.S. as Tavalisse tablets, and is approved in the U.S., Europe, and Canada as a treatment for adult chronic immune thrombocytopenia. This is a Phase 2 clinical trial that randomly assigned fostamatinib plus standard of care or matched placebo plus SOC to 58 evaluable patients who are requiring supplemental oxygen via nasal canula or non-invasive ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation. The primary endpoint of this study is cumulative incidence of serious adverse events through day 29, with multiple secondary endpoints designed to assess the early efficacy and clinically relevant endpoints of disease course. The NHLBI and Rigel expect to report topline data from this clinical trial in April 2021. | ||||
Reports Q4 revenue… Reports Q4 revenue $18.5M, consensus $18.1M. As of December 31, 2020, Rigel had cash, cash equivalents and short-term investments of $57.3 M, compared to $98.1M as of December 31, 2019. "Our team has shown its resilience as we continue to execute on our mission to serve patients who have diseases where few or no approved treatment options exist," said Raul Rodriguez, Rigel's president and CEO. "Despite the challenges brought on by 2020, we successfully expanded our global ITP reach and positioned ourselves for potential success in wAIHA, announced a major collaboration with Lilly to develop RIP1 inhibitors, and launched a comprehensive COVID-19 clinical program which has gained the support from the NIH, DOD, and several universities. Importantly, we also continued to explore opportunities in immunology, and more recently heme-onc, with our IRAK 1/4 inhibitor program." | |
H.C. Wainwright analyst… H.C. Wainwright analyst Joseph Pantginis raised the firm's price target on Rigel Pharmaceuticals (RIGL) to $11 from $8 and keeps a Buy rating on the shares after the company entered into an exclusive worldwide license with Eli Lilly (LLY) for its RIPK1 inhibitor candidates, which includes the Phase 2-ready R552, for all indications. The analyst is "impressed" with the overall terms of the deal and believes that Rigel remains undervalued solely on the Tavalisse/Tavlesse commercial traction in immune thrombocytopenia. | |
Piper Sandler analyst… Piper Sandler analyst Christopher Raymond keeps an Overweight rating on Rigel Pharmaceuticals (RIGL) with an $8 price target after the company announced a strategic collaboration for its RIPK1 program with Eli Lilly (LLY), bringing in $125M upfront. While the collaboration comes a bit later than expected, the valuation is on par with Sanofi's 2018 Denali deal for two of the company's RIPK1 inhibitors, Raymond tells investors in a research note titled "RIPK1 Partnership Just What the Doctor Ordered." He sees a "distinctly positive" setup for Rigel shares and would be a buyer up to $8. | |
Eli Lilly (LLY) and Rigel… Eli Lilly (LLY) and Rigel Pharmaceuticals (RIGL) announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1, or RIPK1, inhibitor, for all indications including autoimmune and inflammatory diseases. Pursuant to the collaboration, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system, or CNS, diseases. Rigel's lead RIPK1 inhibitor, R552, has completed Phase 1 clinical trials and will begin Phase 2 clinical trials in 2021 as part of the collaboration. Rigel also has ongoing pre-clinical activities with its lead CNS penetrant RIPK1 inhibitor candidates. Under the terms of the agreement, Lilly will pay an upfront cash payment to Rigel of $125M. Rigel may also be eligible to receive up to $835M in potential development, regulatory, and commercial milestone payments, as well as tiered royalties ranging from the mid-single digit to high-teens that will vary depending upon Rigel's clinical development investment. Lilly and Rigel will co-develop R552 at specified contribution levels. Lilly will be responsible for all costs of global commercialization for R552, and Rigel will have the right to co-commercialize R552 in the U.S. Lilly will be solely responsible for all clinical development and commercialization of brain penetrating RIPK1 inhibitors in CNS indications. RIPK1 is a signaling protein implicated in a broad range of inflammatory cellular processes including necroptosis, a type of regulated cell death, and cytokine production. In necroptosis, cells rupture leading to the dispersion of cell contents which can trigger an immune response and enhance inflammation. Inhibiting RIPK1 may be a new approach to treating various autoimmune, inflammatory, and neurodegenerative disorders. In pre-clinical studies, Rigel's R552 demonstrated prevention of joint and skin inflammation in a RIPK1-mediated murine model of inflammation and tissue damage. This transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. 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 2021 non-GAAP earnings per share guidance as a result of this transaction. | |
Rigel Pharmaceuticals… Rigel Pharmaceuticals announced it has been awarded $16.5M by the U.S. Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense to support Rigel's ongoing Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients. "We are grateful to receive this funding from the DOD and for their demonstrated commitment towards finding safe and effective treatments for COVID-19 patients. These additional resources will contribute significantly to the advancement of our Phase 3 trial. Data from this trial, coupled with findings from the NIH-sponsored Phase 2 trial, which is anticipated to report topline results in April 2021, could potentially facilitate an EUA filing for a much needed therapy for hospitalized COVID-19 patients in the U.S," said Raul Rodriguez, Rigel's president and CEO. |