RIGL (Rigel Pharmaceutical).

rone52

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bene bene prossimi giorni importanti anche per incontri con gli analisti e considerazioni sul work in process della nuova molecola finanziata da Lilly - la quotazione dovrebbe lievitare speriamo bene (almeno per noi)
 

ilovepablo

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bene bene prossimi giorni importanti anche per incontri con gli analisti e considerazioni sul work in process della nuova molecola finanziata da Lilly - la quotazione dovrebbe lievitare speriamo bene (almeno per noi)

Io ne ho poche, ma se riesco aumento un pochino... :sperem:
 

rone52

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Venerdì si sono mosse bene a 4,53$ a mio avviso i 5$ sono ormai a portata
 

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Fostamatinib Selected for NIH ACTIV-4 COVID-19 Clinical Trial
29 Giugno 2021 - 01:30PM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., June 29, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that fostamatinib, the Company's novel oral spleen tyrosine kinase (SYK) inhibitor, has been selected for a National Institutes of Health (NIH) ACTIV-4 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) trial in hospitalized patients with COVID-19.

The ACTIV-4 Host Tissue trial is a large, multi-site trial funded by the National Heart, Lung, and Blood Institute (NHLBI) of the NIH and coordinated by Vanderbilt University Medical Center (VUMC). The trial is evaluating treatments, including fostamatinib, that aim to protect and heal host tissues in hospitalized patients with COVID-19.

This study follows a recently completed NHLBI/NIH-sponsored Phase 2 study (NCT04579393), with positive topline results, that evaluated fostamatinib in hospitalized adults with COVID-19. The study met its primary endpoint of safety and showed broad and consistent improvement in numerous efficacy endpoints including mortality, ordinal scale assessment, and number of days in the ICU. These data were submitted as part of a request for an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for fostamatinib in hospitalized patients diagnosed with COVID-19. These data have also been submitted for publication in a peer-reviewed medical journal.

"Despite welcome advances in some areas, COVID-19 and its variants will remain a real public health threat for the foreseeable future, particularly for those with pre-existing conditions," said Raul Rodriguez, Rigel's president and CEO. "The teams at the NIH and VUMC are ideally positioned to continue to advance clinical efforts for COVID-19 related lung injuries, including the study of fostamatinib's potential to treat and prevent conditions caused by an overactive immune system in COVID-19 patients," he added.

"Fostamatinib will be the fourth arm of our ACTIV-4 Host Tissue trial. The drugs tested on this platform offer an opportunity to better understand both the central pathways of disease progression and better ways to protect and heal the host tissues damaged by COVID-19," said Dr. Sean P. Collins, MD, MSc, ACTIV-4 Host Tissue Principal Investigator and Professor of Emergency Medicine at VUMC.

ACTIV-4 Host Tissue Phase 3 Clinical Study Design
The Collaborative Network of Networks for Evaluating COVID-19 Therapeutic Strategies (CONNECTS) Master Protocol for Clinical Trials Targeting Macro-, Micro-immuno-thrombosis, Vascular Hyperinflammation, and Hypercoagulability and Renin-angiotensin-aldosterone System (RAAS) in Hospitalized Patients With COVID-19 (ACTIV-4 Host Tissue) is a multi-site, randomized, placebo-controlled trial of therapies, including fostamatinib, targeting the host response to COVID-19 in hospitalized patients. The Master Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Each active arm will include approximately 300 patients. Eligible participants will include patients hospitalized for COVID-19 with laboratory confirmed SARS-CoV-2 infection on oxygen therapy. The primary outcome is oxygen free days through day 28. Secondary outcomes include hospital mortality, use of mechanical ventilation, and WHO scale scores. More detail on the study can be found on clinicaltrials.gov: NCT04924660.

The study is part of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), initiated and funded by the NHLBI, part of the NIH. ACTIV is a public-private partnership that unites partners from government, industry, academic and non-profit organizations to prioritize and speed development of the most promising COVID-19 treatments.

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 pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

About Rigel
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.

Fostamatinib is currently being studied in a Phase 3 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)7; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with mild-to-moderate COVID-197; and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London. An NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of hospitalized patients with COVID-19, in collaboration with Inova Health System, was recently completed.

Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

Ottimo vediamo oggi
 

rone52

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come per VBI vaccines anche Rigel nonostante le ottime news di oggi (almeno a mio avviso) le quotazioni o arretrano VBI o restano ferme Rigel. Bohhhhh!!!!!
Il titolo di questo thread è proprio azzeccato. Saluti a tutti
 

rone52

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Anche questa come VIBV mai un bel giorno da +20% o +30% salgono bene sempre i titoli che non hai
 

rone52

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Ma non lo ca..ga più nessuno questo titolo ? e a me che sembra un gioiello di sicuro non ne capisco niente
 

rone52

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Rigel Announces Conference Call and Webcast to Report Second Quarter 2021 Financial Results and Business Update
27 Luglio 2021 - 01:30PM
PR Newswire (US)
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SOUTH SAN FRANCISCO, Calif., July 27, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that it will report its second quarter 2021 financial results after market close on Tuesday, August 3, 2021. Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at Rigel Pharmaceuticals, Inc. (RIGL). The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

About Rigel (Rigel Pharmaceuticals, Inc. (RIGL))
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.

Fostamatinib is currently being studied in a Phase 3 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with mild-to-moderate COVID-191; an NIH/NHLBI-sponsored Phase 3 clinical trial for the treatment of COVID-19 in hospitalized patients on oxygen therapy, and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London. An NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of hospitalized patients with COVID-19, in collaboration with Inova Health System, was recently completed.

Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

For further information, visit Rigel Pharmaceuticals, Inc. (RIGL) or follow us on Twitter or LinkedIn.
 

rone52

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Come lo vedete voi questo titolo possibile che piaccia solo a me? Gradirei qualche commento da chi conosce l'azienda o che in passato h seguito le quotazioni e la pipeline
 

rone52

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Cucumber in the ass?

Rigel Pharmaceuticals Provides Update on COVID-19 Program
13 Agosto 2021 - 01:30PM
PR Newswire (US)
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SOUTH SAN FRANCISCO, Calif., Aug. 13, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib to treat hospitalized patients suffering from COVID-19 are insufficient for an emergency use authorization (EUA) at this time. The FDA noted in their response that they remain committed to working with Rigel in the development of fostamatinib for COVID-19 as the Company is currently conducting a larger Phase 3 clinical trial evaluating fostamatinib in hospitalized patients with COVID-19.

"With new virus variants spreading and vaccination rates plateauing, there remains a need for therapies that can improve outcomes for hospitalized patients, particularly patients suffering from hyperinflammatory COVID-19-related complications," said Raul Rodriguez, president and CEO of Rigel. "The Rigel team continues to focus on enrolling our Phase 3 clinical trial, which we anticipate completing later this year, and we look forward to providing further safety and efficacy data from this larger, 308-patient trial of fostamatinib in COVID-19 patients. If this trial meets its endpoints, we plan to resubmit our EUA application with this additional data."

Fostamatinib Clinical Development Program in COVID-19
The broader clinical development program for fostamatinib is comprised of three ongoing studies and a recently completed Phase 2 study. These studies are evaluating a wide range of hospitalized patients, including those not on oxygen therapy, who are experiencing mild to severe COVID-19-related complications:

Rigel-led Phase 3 Trial. This ongoing 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 study will enroll ~308 evaluable patients to either fostamatinib plus SOC or matched placebo plus SOC (1:1). The primary endpoint of this study is the proportion of patients who progress to severe/critical disease within 29 days. The study has enrolled ~176 patients as of August 12, 2021, and enrollment is expected to be complete by year-end. More detail on the study can be found on clinicaltrials.gov: NCT04629703.
ACTIV-4 Host Tissue Phase 3 Trial. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) study, initiated and funded by the National Heart Lung and Blood Institute (NHLBI), part of the National Institutes of Health, is a multi-site, randomized, placebo-controlled trial of therapies, including fostamatinib, targeting the host response to COVID-19 in hospitalized patients. The Master Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Each active arm will include approximately 300 patients. Eligible participants will include patients hospitalized for COVID-19 with laboratory-confirmed SARS-CoV-2 infection on oxygen therapy. The primary outcome is oxygen-free days through day 28. Secondary outcomes include hospital mortality, use of mechanical ventilation, and WHO scale scores. The study enrolled its first patient on July 22, 2021. More detail on the study can be found on clinicaltrials.gov: NCT04924660.
Imperial College of London IST. The Imperial College London Investigator-Sponsored Trial (IST) is a two-stage, open-label, controlled clinical trial of patients randomized (1:1:1) to fostamatinib, ruxolitinib, or SOC. The primary objective will be to determine the efficacy of fostamatinib and the efficacy of ruxolitinib compared to SOC to reduce the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia. Rigel is providing support for this trial along with Novartis. More detail on the study can be found on clinicaltrials.gov: NCT04581954.
NIH/NHLBI-sponsored Phase 2 Trial. This randomized, double-blind, placebo-controlled study, which has been completed, evaluated the safety of fostamatinib plus SOC and matched placebo plus SOC (1:1) in hospitalized patients with COVID-19 requiring supplemental oxygen. The primary endpoint was the cumulative incidence of serious adverse events (SAEs) by Day 29. As previously announced, the study met its primary endpoint of safety and provided evidence of broad and consistent improvement in numerous secondary endpoints including mortality, time to sustained recovery, change in ordinal scale assessment, number of days on oxygen, and number of days in the ICU. Results from this study have been submitted for publication in a peer-reviewed medical journal. More details on the study can be found on clinicaltrials.gov: NCT04579393.
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

Spleen tyrosine kinase (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 pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

For more information on Rigel's comprehensive clinical program in COVID-19, go to: COVID-19 :: Rigel Pharmaceuticals, Inc. (RIGL)

Porca tr*** per non accontentarsi mai.
 

ilovepablo

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Cucumber in the ass?

Rigel Pharmaceuticals Provides Update on COVID-19 Program
13 Agosto 2021 - 01:30PM
PR Newswire (US)
Alert
Stampa
Share On Facebook
SOUTH SAN FRANCISCO, Calif., Aug. 13, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib to treat hospitalized patients suffering from COVID-19 are insufficient for an emergency use authorization (EUA) at this time. The FDA noted in their response that they remain committed to working with Rigel in the development of fostamatinib for COVID-19 as the Company is currently conducting a larger Phase 3 clinical trial evaluating fostamatinib in hospitalized patients with COVID-19.

"With new virus variants spreading and vaccination rates plateauing, there remains a need for therapies that can improve outcomes for hospitalized patients, particularly patients suffering from hyperinflammatory COVID-19-related complications," said Raul Rodriguez, president and CEO of Rigel. "The Rigel team continues to focus on enrolling our Phase 3 clinical trial, which we anticipate completing later this year, and we look forward to providing further safety and efficacy data from this larger, 308-patient trial of fostamatinib in COVID-19 patients. If this trial meets its endpoints, we plan to resubmit our EUA application with this additional data."

Fostamatinib Clinical Development Program in COVID-19
The broader clinical development program for fostamatinib is comprised of three ongoing studies and a recently completed Phase 2 study. These studies are evaluating a wide range of hospitalized patients, including those not on oxygen therapy, who are experiencing mild to severe COVID-19-related complications:

Rigel-led Phase 3 Trial. This ongoing 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 study will enroll ~308 evaluable patients to either fostamatinib plus SOC or matched placebo plus SOC (1:1). The primary endpoint of this study is the proportion of patients who progress to severe/critical disease within 29 days. The study has enrolled ~176 patients as of August 12, 2021, and enrollment is expected to be complete by year-end. More detail on the study can be found on clinicaltrials.gov: NCT04629703.
ACTIV-4 Host Tissue Phase 3 Trial. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) study, initiated and funded by the National Heart Lung and Blood Institute (NHLBI), part of the National Institutes of Health, is a multi-site, randomized, placebo-controlled trial of therapies, including fostamatinib, targeting the host response to COVID-19 in hospitalized patients. The Master Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Each active arm will include approximately 300 patients. Eligible participants will include patients hospitalized for COVID-19 with laboratory-confirmed SARS-CoV-2 infection on oxygen therapy. The primary outcome is oxygen-free days through day 28. Secondary outcomes include hospital mortality, use of mechanical ventilation, and WHO scale scores. The study enrolled its first patient on July 22, 2021. More detail on the study can be found on clinicaltrials.gov: NCT04924660.
Imperial College of London IST. The Imperial College London Investigator-Sponsored Trial (IST) is a two-stage, open-label, controlled clinical trial of patients randomized (1:1:1) to fostamatinib, ruxolitinib, or SOC. The primary objective will be to determine the efficacy of fostamatinib and the efficacy of ruxolitinib compared to SOC to reduce the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia. Rigel is providing support for this trial along with Novartis. More detail on the study can be found on clinicaltrials.gov: NCT04581954.
NIH/NHLBI-sponsored Phase 2 Trial. This randomized, double-blind, placebo-controlled study, which has been completed, evaluated the safety of fostamatinib plus SOC and matched placebo plus SOC (1:1) in hospitalized patients with COVID-19 requiring supplemental oxygen. The primary endpoint was the cumulative incidence of serious adverse events (SAEs) by Day 29. As previously announced, the study met its primary endpoint of safety and provided evidence of broad and consistent improvement in numerous secondary endpoints including mortality, time to sustained recovery, change in ordinal scale assessment, number of days on oxygen, and number of days in the ICU. Results from this study have been submitted for publication in a peer-reviewed medical journal. More details on the study can be found on clinicaltrials.gov: NCT04579393.
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

Spleen tyrosine kinase (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 pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

For more information on Rigel's comprehensive clinical program in COVID-19, go to: COVID-19 :: Rigel Pharmaceuticals, Inc. (RIGL)

Porca tr*** per non accontentarsi mai.

Io per fortuna me be soon disfato giorni fa... invece l'ho presa in quel posto anche peggio con SPPI
 

rone52

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Comunque rileggendo con più calma il comunicato forse non proprio male come pensavo perchè FDA non boccia Rigel ma dice di fare ulteriori verifiche (anche in collaborazione con stessa FDA) per l'approvazione e il resto della pipeline è molto promettente e con partner di alto rango perciò tengo duro sperando in un veloce recupero vediamo se sbaglio anche questa volta. Se avete considerazioni da fare tanto per tenere aperto il thread - ciao a tutti
 

rone52

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Qui non c'è più nessuno? Pere tutte le speranze per un buon gain? Rispondete per favore
 

rispi

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ocio
:cool:
habemus FDA
grana fino a settembre 2023
e un grafico mica male