RIGL (Rigel Pharmaceutical).

marachita

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Ah ah, te la suoni e te la canti
bravo Claudiano, oggi ti rifai del -80% di celsion di ieri...


Non mi chiamo Claudiano,:no::no:

Mi chiamo Mario. Mario Chitarra..

Esatto quello che dici. D'altronde la borsa come ben sai va giù e va su. Come la pelle degli occhi.:rolleyes:
 

rone52

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Cosa pensate oggi di Rigel? con possibili nuove approvazioni e studio fase 2 di cure covid a 2,50$ e possibile una entrata con speranza di gain?
 

rone52

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Il titolo e' interessante dovrebbero uscire ad aprile i dati di fase III, se fossero positivi penso abbia spazio fino a 7 dollari

Rigel Awarded $16.5 Million from U.S. Department of Defense for Phase 3 Clinical Trial of Fostamatinib in COVID-19 Patients
29 Gennaio 2021 - 08:45PM
PR Newswire (US)
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SOUTH SAN FRANCISCO, Calif., Jan. 29, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced it has been awarded $16.5 million by the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to support Rigel's ongoing Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients. Fostamatinib is marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, and is approved in the U.S., Europe, and Canada as a treatment for adult chronic immune thrombocytopenia (ITP).

"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," said Raul Rodriguez, Rigel's president and CEO. "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."

"The DOD is pleased to support this effort, since repurposing an existing FDA-approved drug product for potential application as a COVID-19 treatment saves time and cost, enabling a much more rapid response to the pandemic," said Dr. Jason Roos, the Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear Defense. "This investment should speed up identification of safe and effective treatments for this formidable pandemic."

The Phase 3 clinical trial will evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors. This multi-center, double-blind, placebo-controlled, adaptive design study is expected to enroll over 300 evaluable patients that will be randomly assigned to either fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1). Treatment will be administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary endpoint of this study is the proportion of subjects who progress to severe/critical disease within 29 days.

About COVID-19 & SYK Inhibition
COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.1 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.2

SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology, such as inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

About TAVALISSE
Indication
TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Please see Homepage | TAVALISSE® (fostamatinib disodium hexahydrate) tablets for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

About Rigel (Home - Rigel Pharmaceuticals)
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product is also commercially available in Europe (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic immune thrombocytopenia in adult patients.

Grazie e condivido il tuo target
 

rone52

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OK quindi promettente pipeline in aggiunta al farmaco approvato anche in europa e già in commercio si spera per il meglio
ciao
 

rone52

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ieri after market a 4,83 se lunedì supera i 5 il rialzo si prospetta molto corposo..........cosa dite ? sono troppo ottimista?
 

rone52

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Lilly and Rigel Enter Strategic Collaboration to Develop RIPK1 Inhibitors for the Potential Treatment of Immunological and Ne...
18 Febbraio 2021 - 12:30PM
PR Newswire (US)
INDIANAPOLIS and SOUTH SAN FRANCISCO, Calif., Feb. 18, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today 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 (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 (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 $125 million. Rigel may also be eligible to receive up to $835 million 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 critical signaling protein implicated in a broad range of key 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.

"At Lilly, our immunology strategy is focused on the pursuit of novel targets that have the potential to develop into best-in-class medicines for patients with autoimmune conditions," said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly. "RIPK1 inhibitors are a promising approach, and R552 is an exciting addition to our immunology pipeline. We look forward to working with Rigel to advance its clinical development."

"We are very excited to form this strategic partnership with Lilly. This collaboration will provide significant resources and expertise to support a broad investigation in multiple disease indications with our RIPK1 inhibitors," said Raul Rodriguez, Rigel's president and CEO. "With Lilly's extensive knowledge in immune and CNS diseases, they are our ideal partner to ensure the clinical and commercial success of our RIPK1 inhibitor program."

This transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly's 2021 non-GAAP earnings per share guidance as a result of this transaction.

Cosa pensate di questo accordo del 18-2-2021. quota $ 4,40 - considerando anche la corposa pipeline e in fasi abbastanza avanzate, secondo voi può essere un buon investimento? grazie per eventuali suggerimenti
 

rone52

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Il prezzo attuale si colloca ai valori di Rigel del 2013 - resistenza importante
 

rone52

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Secondo me è un deciso strong buy.........poi la prossima settimana sarò subito smentito di solito a me capita così
 

ilovepablo

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Notizia di una settimana fa interessante.

Rigel Pharma shares surge as fostamatinib meets primary endpoint of safety in COVID-19

Rigel Pharmaceuticals (NASDAQ:RIGL) soars 19% premarket in reaction to positive topline results from Phase 2 trial evaluating the safety of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized patients with COVID-19.

Key findings from the Phase 2 clinical data readout include:
At Day 29, in the overall population, deaths in the fostamatinib group were (0/30) compared to (3/29) in the placebo (p=0.07).
In more severe patients, the difference was (0/19) patients compared to (3/17) patients (p=0.049), respectively.

There were four intubated patients in the trial on mechanical ventilation. Two patients treated with fostamatinib showed improvement within 7 days and came off the ventilator, while both patients in the placebo group deceased.
Fostamatinib was superior to placebo in accelerating improvement in clinical status by day 15 (mean change -3.6 compared to -2.6, p=0.035) and by day 29 (mean change -4.2 compared to -3.3, p=0.12).

The median number of days in ICU was reduced by 4 days, from 7 days in the placebo group to 3 days in the fostamatinib group (p=0.07).
Fostamatinib reduced the incidence of Serious Adverse Events (SAEs) by half compared to placebo.
Investigators will conduct full and detailed analyses in the coming weeks.

Based on these data, Rigel plans to discuss the potential for emergency use authorization (EUA) with the FDA of fostamatinib as a treatment for COVID-19.
Rigel will hold a live conference call and webcast today to discuss the Phase 2 trial results at 8:00 am ET.
 

rone52

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Notizia di una settimana fa interessante.

Rigel Pharma shares surge as fostamatinib meets primary endpoint of safety in COVID-19

Rigel Pharmaceuticals (NASDAQ:RIGL) soars 19% premarket in reaction to positive topline results from Phase 2 trial evaluating the safety of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized patients with COVID-19.

Key findings from the Phase 2 clinical data readout include:
At Day 29, in the overall population, deaths in the fostamatinib group were (0/30) compared to (3/29) in the placebo (p=0.07).
In more severe patients, the difference was (0/19) patients compared to (3/17) patients (p=0.049), respectively.

There were four intubated patients in the trial on mechanical ventilation. Two patients treated with fostamatinib showed improvement within 7 days and came off the ventilator, while both patients in the placebo group deceased.
Fostamatinib was superior to placebo in accelerating improvement in clinical status by day 15 (mean change -3.6 compared to -2.6, p=0.035) and by day 29 (mean change -4.2 compared to -3.3, p=0.12).

The median number of days in ICU was reduced by 4 days, from 7 days in the placebo group to 3 days in the fostamatinib group (p=0.07).
Fostamatinib reduced the incidence of Serious Adverse Events (SAEs) by half compared to placebo.
Investigators will conduct full and detailed analyses in the coming weeks.

Based on these data, Rigel plans to discuss the potential for emergency use authorization (EUA) with the FDA of fostamatinib as a treatment for COVID-19.
Rigel will hold a live conference call and webcast today to discuss the Phase 2 trial results at 8:00 am ET.

In effetti questa ulteriore notizia positiva aggiunta ad una estesa pipeline in fase 2 e 3 e alle numerose partnership il titolo potrebbe veramente esplodere basta pazientare
 

rone52

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Forza Rigel domani 4$ e poi %$ e poi..........
 

rone52

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Si ripropongono i 4 $ con tante buone premesse e un'interessante pipeline -qualcuno segue ancora il titolo - cosa ne pensate?