Rigel Pharmaceuticals Inc (RIGL) News

RIGL under $2

Just published, "Olutasidenib in post-venetoclax patients with mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML)". The results of this phase 2 study support data from registrational cohort demonstrating that Olutasidenib works well in patients previously treated with venetoclax.
https://pubmed.ncbi.nlm.nih.gov/38538632/

Good read on Olutasidenib
https://journals.lww.com/oncology-times/fulltext/2024/03000/olutasidenib_as_a_breakthrough_for_r_r_midh1_aml.25.aspx
Important further research: 1) studying whether olutasidenib can eliminate the stem cell fraction within each patient's IDH1-mutant AML; 2) characterization of synthetic lethality involving olutasidenib in IDH1-mutant AML.

Rigel Pharmaceuticals Acquires U.S. Rights to GAVRETO®
FEBRUARY 22, 2024 7:50AM EST
GAVRETO® (pralsetinib) is an FDA approved targeted therapy for the treatment of RET fusion-positive metastatic non-small cell lung cancer and advanced or metastatic thyroid cancer
Acquisition of established U.S. marketed product further expands Rigel's portfolio and leverages Rigel's existing infrastructure in both the institutional and community settings
GAVRETO generated ~$28M in U.S. net product sales in 2023

Rigl should be VTGN (Today) one day.

Yeah. Should be good Q.

Hopefully, the inducement grants are being used to hire qualified talent, rather than pad the wallets of friends and relatives.

Better be good.

Ugly.

nice

nice

base

What a shoot! Amazing.

The next quarter fin should include the rev for TAVALISSE. "In April, Rigel's partner Kissei announced the launch of TAVALISSE in Japan for the treatment of chronic ITP."
1. What else should we expect as for the rev?
2. Result of phase 3 of Fostamatinib3 COVID 19?
3. Status of Fostamatinib-ACTIV4 COVID 19?
4. Partnered Programs?

nice fins

gem

gem

easy

Nice spike AH today.

Higher low higher low.... next leg is North.

https://www.barchart.com/stocks/quotes/RIGL/technical-chart?plot=BAR&volume=total&data=I:120&density=H120&pricesOn=1&asPctChange=0&logscale=0&im=120&indicators=EXPMA(9);SMA(20);BBANDS(20,2);MACD(12,26,9)&sym=RIGL&grid=1&height=500&studyheight=100

https://www.barchart.com/stocks/quotes/RIGL/technical-chart?plot=BAR&volume=total&data=I:120&density=H120&pricesOn=1&asPctChange=0&logscale=0&im=120&indicators=EXPMA(9);SMA(20);BBANDS(20,2);MACD(12,26,9)&sym=RIGL&grid=1&height=500&studyheight=100

acting wild atm, but still healthy.

nice

Nice & Healthy.

quite the dip

ready

ready

red to green

red to green

Wonderful!

beauty

nice

Expect Q4 filing this week?

Be seeing that. Lot of 1.95 transactions so far

Revenue potential appears good. SP is slowly rising, and looks like it has been in accumulation for the past few weeks.

SP should be a lot higher since the Q4 revenue is more than double from last year...

Apparently insider buying reported on ST. Take it for what it’s worth.

RIGL news out

Looks like it will poke thru & bye bye 1 today.

Just like ABQQ. Right?

You are 1/2 way there!!!!

Wow - BOOM - we just went over a dollar - next step $10.00 - DON'T MISS OUT!!

This is a $10.00 per share stock in the very near future - EASILY!!

I just bought in. Seems like a good run could come in the near future.

Consolidating nicely on Continuation from last week!

LOL!

GIVE ME MY $2DOLLAS…YA BUM

Rigel Announces U.S. FDA Approval of REZLIDHIA™ (olutasidenib) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation
December 01 2022 - 05:03PM
PR Newswire (US)
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REZLIDHIA is a potentially market-leading, oral, mutant isocitrate dehydrogenase-1 (mIDH1) inhibitor

Phase 2 registrational data supporting the approval showed a 35% CR+CRh rate in mIDH1 R/R AML patients with a median duration of response of 25.9 months

Conference call and webcast to be held today at 6:30 p.m. ET

SOUTH SAN FRANCISCO, Calif., Dec. 1, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the U.S. Food and Drug Administration (FDA) has approved REZLIDHIA™ (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. REZLIDHIA is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells.

"REZLIDHIA is a novel, non-intensive monotherapy treatment in the relapsed/refractory AML setting demonstrating a CR+CRh rate of 35% in patients with over 90% of those responders in complete remission. The 25.9 months median duration of CR+CRh is a clinically meaningful improvement for AML patients and appears to be longer than currently available treatment options," said Jorge E. Cortes, M.D., Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator. "Given the limited treatment options for adult patients with mIDH1 R/R AML, who typically have a poor prognosis, REZLIDHIA may provide an effective, new treatment option with a well characterized safety profile."

The FDA approval was supported by data from the open-label Phase 2 registrational study evaluating REZLIDHIA monotherapy at a dose of 150 mg twice daily in 153 mIDH1 R/R AML patients. The efficacy-evaluable population was 147 patients who initiated REZLIDHIA at least six months prior to the interim analysis cutoff date of June 18, 2021, and who had a centrally confirmed IDH1 mutation. The primary endpoint was a composite of a complete remission (CR) plus a complete remission with partial hematological recovery (CRh). CRh is defined as less than 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and absolute neutrophil count >500/microliter).

Results from the trial demonstrated a 35% (51/147) CR+CRh rate in mIDH1 R/R AML patients, with a median duration of response of 25.9 months. The median time to CR or CRh was 1.9 months. Of the patients who achieved the primary endpoint of CR+CRh, 92% (47/51) were CR with a median duration of response of 28.1 months. REZLIDHIA was well tolerated in the study with an adverse event profile largely characteristic of symptoms or conditions experienced by patients with AML undergoing treatment. Differentiation syndrome was observed in 16% of patients and was manageable in most cases with dose interruption and corticosteroids. Hepatotoxicity, presenting as increases in liver function parameters, occurred in 23% of patients and most cases were manageable with dose modifications.

"We are delighted by the approval of REZLIDHIA based on the strength of data supporting the efficacy and safety of the product," said Raul Rodriguez, Rigel's president and CEO. "REZLIDHIA provides a new and important, oral therapy option for patients who typically have a poor clinical outcome. Additionally, this approval greatly strengthens and expands Rigel's commercial hematology-oncology portfolio. I would like to extend our sincerest thanks to all the patients, their families and caregivers, the doctors, the FDA, and our team members who have all contributed to the approval of REZLIDHIA."

In August 2022, Rigel and Forma Therapeutics, Inc. announced they entered an exclusive, worldwide license agreement to develop, manufacture and commercialize REZLIDHIA. Under the terms of the agreement, Rigel will be responsible for the launch and commercialization of REZLIDHIA in the U.S., and intends to work with potential partners to further develop and commercialize the product outside the U.S.

Conference Call and Webcast Today at 6:30PM Eastern Time
Rigel will hold a live conference call and webcast today at 6:30 p.m. Eastern Time (3:30 p.m. Pacific Time) to discuss the FDA approval of REZLIDHIA.

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 AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. 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 new cases, most in adults, in 2022.1

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.2 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.3 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About REZLIDHIA™
INDICATION
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME

Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment.
Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney
injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected,
withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic
monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome is associated

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