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Rigel Reports Second Quarter 2022 Financial Results and Provides Business Update
August 02 2022 - 04:02PM
PR Newswire (US)
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Second quarter TAVALISSE® net product sales of $18.6 million and total revenues of $29.8 million
Expanded Rigel's hematology-oncology portfolio by entering into an exclusive license agreement with Forma Therapeutics, Inc. for olutasidenib with an expected launch in 2023
Enrollment completed in Rigel's pivotal Phase 3 clinical trial in high-risk patients hospitalized with COVID-19 with top-line data expected year-end
Management to host a conference call and webcast today at 4:30 p.m. Eastern Time and will be joined by Key Opinion Leader and olutasidenib Phase 2 clinical trial investigator, Jorge E. Cortes, M.D.
SOUTH SAN FRANCISCO, Calif., Aug. 2, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the second quarter ended June 30, 2022, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
"The second quarter of 2022 was a significant one for Rigel, marked by the highest quarterly net product sales for TAVALISSE in ITP since launch. We are also excited about the strategic expansion of our hematology-oncology portfolio to include olutasidenib, and the synergy it provides. We believe the addition of olutasidenib will broaden the reach of the Rigel field force by providing a potential new therapy for mIDH1 relapsed or refractory acute myeloid leukemia and other malignancies," said Raul Rodriguez, Rigel's president and CEO. "I am pleased with our progress, and believe Rigel is well-positioned to continue driving momentum for TAVALISSE in ITP and prepare for the potential launch of olutasidenib in 2023."
Business Update
In the second quarter of 2022, TAVALISSE net product sales were $18.6 million, representing the highest net product sales since launch and an increase of 9% compared to the second quarter of 2021.
Today, Rigel announced an exclusive license agreement with Forma Therapeutics, Inc. (Forma) to develop, manufacture and commercialize olutasidenib, an oral, small molecule inhibitor of mutant isocitrate dehydrogenase-1 (mIDH1) for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML) and other malignancies. The U.S. Food and Drug Administration (FDA) has accepted Forma's New Drug Application (NDA) for olutasidenib. The Prescription Drug User Fee Act (PDUFA) target action date is February 15, 2023. Olutasidenib is highly synergistic with Rigel's existing hematology-oncology focused commercial infrastructure and if approved, would be Rigel's second commercial product in this space.
On June 8, 2022, Rigel announced topline efficacy and safety data from the FORWARD Phase 3 clinical trial of fostamatinib in patients with warm autoimmune hemolytic anemia (wAIHA). The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. The safety profile was consistent with prior clinical experience, and no new safety issues were identified. Rigel is conducting an in-depth analysis of this data to better understand differences in patient characteristics and outcomes and expects to discuss these findings with the FDA to determine the path forward in wAIHA.
In July, Rigel completed enrollment, with 280 patients, in its pivotal Phase 3 clinical trial evaluating fostamatinib in high-risk patients hospitalized with COVID-19. The trial had originally targeted a total of 308 patients; however, Rigel determined the trial would be sufficiently powered with 280 patients to potentially provide a clinically meaningful result and determine the efficacy and safety of fostamatinib in COVID-19. Rigel expects to report top-line results in Q4 2022 and if the data is positive, file an Emergency Use Authorization with the FDA.
In May, Rigel entered into a commercial license agreement with Knight Therapeutics International SA (Knight) for the commercialization of TAVALISSE in all indications in Latin America. Rigel received a $2.0 million upfront payment in the second quarter of 2022, with potential for up to an additional $20.0 million in regulatory and sales-based commercial milestone payments, and will receive twenty- to mid-thirty percent, tiered, escalated net sales-based royalty payments for products sold in the Knight territory.
In April, Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) announced that an NDA was submitted to Japan's Pharmaceuticals and Medical Devices Agency for fostamatinib in chronic ITP. During the second quarter, Rigel received a $5.0 million regulatory milestone in connection with the filing of the NDA.
Financial Update
For the second quarter of 2022, Rigel reported a net loss of $13.5 million, or $0.08 per basic and diluted share, compared to a net loss of $13.8 million, or $0.08 per basic and diluted share for the same period of 2021.
For the second quarter of 2022, total revenues were $29.8 million, consisting of $18.6 million in TAVALISSE net product sales and $11.3 million in contract revenues from collaborations. TAVALISSE net product sales of $18.6 million increased by 9%, compared to $17.1 million in the second quarter of 2021. Contract revenues from collaborations during the second quarter of 2022 consisted of $7.5 million in revenue from Kissei related to a milestone payment and delivery of fostamatinib supply, $2.0 million in revenue related to the license agreement with Knight, $1.4 million in revenue from Grifols related to the delivery of fostamatinib supply and performance of certain research and development services pursuant to the collaboration agreement, and $0.3 million in revenue related to the license agreement with Eli Lilly.
For the second quarter of 2022, total costs and expenses were $42.8 million, compared to $39.3 million for the same period of 2021. The increase in costs and expenses was primarily due to increased commercial activities related to the sales force expansion, and increased research and development costs for the IRAK1/4 inhibitor program, partially offset by decreased research and development costs related to the Phase 3 clinical trial for wAIHA and the ongoing Phase 3 clinical trial in high-risk hospitalized patients with COVID-19.
For the six months ended June 30, 2022, Rigel reported a net loss of $40.9 million, or $0.24 per basic and diluted share, compared to a net income of $25.7 million, or $0.15 per basic and diluted share, for the same period of 2021.
For the six months ended June 30, 2022, total revenues were $46.6 million, consisting of $34.7 million in TAVALISSE net product sales and $11.8 million in contract revenues from collaborations. TAVALISSE net product sales of $34.7 million increased by 18% compared to $29.4 million in the same period of 2021. Contract revenues from collaborations for the six months ended June 30, 2022 consisted of $7.6 million in revenue from Kissei primarily related to a milestone payment and delivery of fostamatinib supply, $2.0 million in revenue related to the license agreement with Knight, $1.7 million in revenue from Grifols related to the delivery of fostamatinib supply and performance of certain research and development services pursuant to the collaboration agreement, and $0.5 million in revenue related to the license agreement with Eli Lilly.
For the six months ended June 30, 2022, total costs and expenses were $85.8 million, compared to $78.6 million for the same period of 2021. The increase in costs and expenses was primarily due to increased commercial related activities related to the sales force expansion, and increased research and development costs for the IRAK1/4 inhibitor program, partially offset by decreased research and development costs related to the Phase 3 clinical trial for wAIHA and the ongoing Phase 3 clinical trial in high-risk hospitalized patients with COVID-19.
As of June 30, 2022, Rigel had cash, cash equivalents and short-term investments of $89.2 million, compared to $125.0 million as of December 31, 2021. In July 2022, Rigel accessed an additional $10.0 million term loan through its credit agreement with MidCap Financial Trust (MidCap) and amended the terms of the credit agreement which, among other things, allows Rigel to defer the loan principal payment by one year and extends the maturity date for the term loans.
Conference Call and Webcast Today at 4:30 p.m. Eastern Time, with Key Opinion Leader and olutasidenib Phase 2 clinical trial investigator, Jorge E. Cortes, M.D.
Rigel will host a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss financial results, and provide an update on the business, including the license agreement with Forma. The conference call will also feature a presentation of the olutasidenib Phase 2 interim results by Jorge E. Cortes, M.D., Director, Georgia Cancer Center at Augusta University, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator.
Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.
About ITP
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
About AML
Acute myeloid leukemia (AML) is a cancer that starts in a person's bone marrow but often quickly moves into the blood. AML develops from immature blood cells, known as myeloid cells, that are supposed to mature into white blood cells. However, the diseased myeloid cells do not function properly. They instead multiply rapidly, which causes normal blood cell production to fail. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that in the United States alone, there will be about 20,050 n
Hi folks just found this one and bought a small stake. Here are a couple articles I found.
https://pennystocks.com/featured/2021/07/06/top-biotech-penny-stocks-buy-week-9-watch/
https://pennystocks.com/featured/2021/06/28/top-penny-stocks-buy-july-7-know-about/
* * $RIGL Video Chart 05-12-2021 * *
Link to Video - click here to watch the technical chart video
In April 2021, Rigel reported positive topline data from the multi-center, Phase 2 clinical trial evaluating the safety of fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized patients with COVID-19. The trial 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. The trial was conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and Inova Health System. The NHLBI is expected to publish a full analysis of the trial data in a peer-reviewed journal. Rigel is discussing these results with health authorities, including the U.S. Food and Drug Administration (FDA), and intends to apply for Emergency Use Authorization (EUA) for fostamatinib for the treatment of hospitalized COVID-19 patients.
https://secfilings.nasdaq.com/filingFrameset.asp?FilingID=14927567&RcvdDate=5/5/2021&CoName=RIGEL%20PHARMACEUTICALS%20INC&FormType=8-K&View=html
https://www.outsourcedpharma.com/doc/navigating-the-fda-s-emergency-use-authorization-process-0001
of so many upcoming catalysts...as of right now this is my #1 position on this afterhours selloff
$$$$$$$$$$$$$$
Analyst Ratings
RIGEL PHARMACEUTICALS (NASDAQ:RIGL) PRICE TARGET AND CONSENSUS RATING
4 Wall Street analysts have issued ratings and price targets for Rigel Pharmaceuticals in the last 12 months. Their average twelve-month price target is $8.33, predicting that the stock has a possible upside of 125.84%. The high price target for RIGL is $11.00 and the low price target for RIGL is $6.00. There are currently 1 hold rating and 3 buy ratings for the stock, resulting in a consensus rating of "Buy
On April 13, 2021, Rigel Pharmaceuticals, Inc. (“Rigel”) announced positive topline results from a multi-center, Phase 2 clinical trial to evaluate the safety of fostamatinib, its oral spleen tyrosine kinase inhibitor, for the treatment of hospitalized patients with COVID-19. A copy of Rigel’s press release, titled “Positive Topline Data Shows Fostamatinib Meets Primary Endpoint of Safety in Phase 2 Clinical Trial in Hospitalized Patients with COVID-19,” is attached as Exhibit 99.1 to this Current Report and is incorporated by reference herein.
* * $RIGL Video Chart 04-13-2021 * *
Link to Video - click here to watch the technical chart video
Rigel Pharma shares surge as fostamatinib meets primary endpoint of safety in COVID-19
Source: Seeking Alpha
Nice! "...Based on these data, Rigel plans to discuss the potential for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) of fostamatinib as a treatment for hospitalized patients with COVID-19..."
$RIGL is climbing after the company announced positive data from a Phase 2 COVID-19 therapeutic clinical trial. https://cnafinance.com/rigel-pharmaceuticals-rigl-stock-climbs-on-covid-19-news/
$RIGL Positive Results, next step EUA -
https://finance.yahoo.com/news/positive-topline-data-shows-fostamatinib-110000249.html
RIGL 3.27 - added here...Top line data from NIH/NHLBI-sponsored Phase 2 trial of fostamatinib in COVID-19 patients expected in April 2021
https://secfilings.nasdaq.com/filingFrameset.asp?FilingID=14765212&RcvdDate=3/2/2021&CoName=RIGEL%20PHARMACEUTICALS%20INC&FormType=8-K&View=html
Never mind, This is by far one of ClayTraders favorite stock to short!
Why this stock in particular? It’s not a lot of volume here. Almost feeling like this Is the ultimate shorts trap!
Agree 100 percent. Really wish the Reddit crowd would take a run at this. The Institutions need to be taught a lessen.
There’s some major manipulation going on here. This doesn’t add up fundamentally. Companies don’t post positive news and plummet like this... you would at minimum expect some slight upward momentum????
Tired of them selling shares: OS as of February 23, 2021, there were 170,041,848 shares of the registrant’s common stock outstanding.
Had been around 168 million. They get $125 million from Lily and for some reason still feel the need to issue shares. Starting to piss me off.
Holy Mackerel! This news is huge!
Looks like they may finally let $RIGL move a bit closer to it's true value.
I have been on $RIGL for a few years. Wondered why nobody was here.
Rigel Awarded $16.5 Million from U.S. Department of Defense for Phase 3 Clinical Trial of Fostamatinib in COVID-19 Patients
https://ih.advfn.com/stock-market/NASDAQ/rigel-pharmaceuticals-RIGL/stock-news/84206472/rigel-awarded-16-5-million-from-u-s-department-o
Just nod if you can hear me
Is there anybody home
Five newly licensed medicines have been accepted for use on NHS Scotland by the Scottish Medicines Consortium (SMC) following its first meeting of 2021 - including Tavlesse from Grifols.
Things adding up for $RIGL
http://www.pharmatimes.com/news/smc_kicks_of_the_new_year_by_accepting_five_new_medicines_for_nhs_use_1361518
Looks like a bigger breakout could be setting up, perhaps some big news is coming, and as usual only insiders know about it.
In a blink of an eye the corrupted MM shorts here, that have been major manipulators here for many weeks naked shorting it down to these levels could find themselves covering in a squeeze at 50% and higher like not that long ago, when big news hit, just maybe an update on that news is coming, sure is acting that way the past few days.
One thing is for sure, it should be trading a lot higher then where it is right now, the crew of corrupt MM's are responsible for it not being over three bucks.
$RIGL should be making some moves soon with an $8 price target on it...
The reason why this stock pulled back so much and why the corrupt naked shorting MM's could soon end up getting squeezed big time.
COMMENTS
RIGL stock exploded higher last month after instigating an investigator-sponsored trial (IST) with the Imperial College London to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of COVID-19 pneumonia. This was indeed big news and drove shares to over $5.
RIGL stock has since dropped back down on short-selling pressure and weak longs selling. However, we see this selling as a discount entry opportunity for investors looking to pick up cheap exposure to a name with huge potential. In this article, we take a look at why we think RIGL stock has multi-bagger potential and is more than just a Covid-19 play.
?
RIGL Stock Daily Chart
RIGL STOCK
First up, here’s a little background info for those that aren’t familiar with RIGL stock. Rigel Pharmaceuticals is a biotechnology company dedicated to discovering, developing, and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer, and rare diseases.
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 has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other
* * $RIGL Video Chart 09-17-2020 * *
Link to Video - click here to watch the technical chart video
$RIGL $8 usd soon☺️🚀💚 https://t.co/mqz60tbbd5
— Sexy_Rhinna (@S3xyRhinna) September 17, 2020
RIGL SHOULD PUT UP SOME GOOD NUMBERS TODAY BASED ON NIH COLLABORATION NEWS
New article on $RIGL
https://insiderfinancial.com/rigl-stock-gearing-up-for-a-big-move/180289/
* * $RIGL Video Chart 07-15-2020 * *
Link to Video - click here to watch the technical chart video
RiGL is cool move was made yesterday will consolidate for the next week or two.
RVVYF is in Phase 3 for Covid-19 36 million Market cap .20 5 or 6 companies in the world in Phase 3 in the USA
$RIGL
Shares of Rigel Pharmaceuticals (NASDAQ:RIGL) soared more than 90% on Tuesday after the biotech company announced the start of a clinical trial for a potential treatment for COVID-19 pneumonia.
So what
Imperial College London will conduct the trial to evaluate the efficacy of fostamatinib for the treatment of COVID-19 pneumonia. Fostamatinib is Rigel's oral spleen tyrosine kinase (SYK) inhibitor. It's already approved for the treatment of an autoimmune disorder in the U.S. and Europe, which could help to speed the delivery of the drug to COVID-19 patients if it proves effective.
A person in a business suit is drawing an upwardly sloping line.RIGEL PHARMACEUTICALS' STOCK ROCKETED HIGHER ON TUESDAY. IMAGE SOURCE: GETTY IMAGES.
Researchers at Harvard and MIT recently led an effort to screen compounds that reduce a biomarker used to predict the development of lung injuries and respiratory distress in patients. Of the 3,713 compounds they studied, fostamatinib was the only FDA-approved compound that did so.
"Severe COVID-19 pneumonia can lead to acute respiratory distress syndrome, or ARDS, which can often be fatal," Rigel CEO Raul Rodriguez said in a press release. "Given encouraging data from pre-clinical models of fostamatinib, we believe there is potential for SYK inhibition to help treat the severity of the disease for these patients and to prevent ARDS."
Now what
Patients will randomly receive either fostamatinib, Novartis' (NYSE: NVS) chemotherapy ruxolitinib, or standard of care. The goal of the trial is to determine whether these treatments reduce the number of patients who progress from mild or moderate COVID-19 pneumonia to more severe cases.
Rigel and Novartis will provide support for this trial, and Rigel intends to eventually begin a trial of its own design. "We are pleased to be able to support the exciting work being done by our colleagues at Imperial College London," Rodriguez said. "Their efforts will be valuable as we explore fostamatinib in COVID-19 and pursue our plans for a Rigel-led study."
https://www.google.com/amp/s/www.fool.com/amp/investing/2020/07/14/why-rigel-pharmaceuticals-stock-skyrocketed-91-tod.aspx
* * $RIGL Video Chart 07-14-2020 * *
Link to Video - click here to watch the technical chart video
OS is only 168 million shares. Lots of shorting going on here. IMO
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