IDEAYA Biosciences, Inc., a synthetic lethality-focused precision medicine oncology company, focuses on the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. The company's product candidate is IDE196, a protein kinase C inhibitor that is in Phase I/II clinical trial for genetically defined cancers having GNAQ or GNA11 gene mutations. Its preclinical pipeline includes various synthetic lethality programs targeting IDE397, a methionine adenosyltransferase 2a inhibitor for patients with solid tumors having MTAP deletions; PARG inhibitor in tumors for patients having tumors with a defined biomarker based on genetic mutations and/or molecular signatures; Pol Theta inhibitors in tumors with BRCA or other homologous recombination deficiency mutations; and WRN inhibitors in high microsatellite instability tumors. The company has a research collaboration agreement with Cancer Research UK and the University of Manchester to develop small molecule inhibitors of Poly (ADP-ribose) glycohydrolase; and a clinical trial collaboration and supply agreement with Pfizer Inc. for Phase I/II study in metastatic uveal melanoma, skin melanoma, and other solid tumors, as well as a strategic partnership with GlaxoSmithKline plc. IDEAYA Biosciences, Inc. was incorporated in 2015 and is headquartered in South San Francisco, California.
IPO Year: 2019
Exchange: NASDAQ
Website: ideayabio.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
11/18/2024 | $51.00 | Overweight | Stephens |
11/5/2024 | $27.00 | Outperform → Market Perform | Leerink Partners |
10/24/2024 | $50.00 | Buy | UBS |
10/15/2024 | Overweight | Cantor Fitzgerald | |
7/8/2024 | $50.00 | Outperform | Mizuho |
3/8/2024 | $55.00 | Buy | BTIG Research |
8/8/2023 | $33.00 | Outperform | SVB Securities |
5/24/2023 | $32.00 | Buy | Goldman |
4/24/2023 | $18.00 → $24.00 | Hold → Buy | Stifel |
3/23/2023 | $26.00 | Buy | Berenberg |
S-8 - IDEAYA Biosciences, Inc. (0001676725) (Filer)
10-K - IDEAYA Biosciences, Inc. (0001676725) (Filer)
SCHEDULE 13G/A - IDEAYA Biosciences, Inc. (0001676725) (Subject)
8-K - IDEAYA Biosciences, Inc. (0001676725) (Filer)
8-K - IDEAYA Biosciences, Inc. (0001676725) (Filer)
8-K - IDEAYA Biosciences, Inc. (0001676725) (Filer)
10-Q - IDEAYA Biosciences, Inc. (0001676725) (Filer)
8-K - IDEAYA Biosciences, Inc. (0001676725) (Filer)
8-K - IDEAYA Biosciences, Inc. (0001676725) (Filer)
8-K - IDEAYA Biosciences, Inc. (0001676725) (Filer)
4 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
4 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
4 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
4 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
4 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
4 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
4 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
3 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
4 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
3 - IDEAYA Biosciences, Inc. (0001676725) (Issuer)
Designation enables expedited development and priority regulatory reviewBTD application was supported by updated clinical data from Ph2 neoadjuvant UM trial that we are targeting to present at medical conferences in mid-2025 and H2 2025Targeting to initiate a Ph3 registrational study in neoadjuvant UM in H1 2025Neoadjuvant UM has a projected annual incidence of ~12k patients, and is a high unmet medical with no FDA approved systemic therapiesSOUTH SAN FRANCISCO, Calif., March 31, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the U.S. Food and Drug Adm
SOUTH SAN FRANCISCO, Calif., March 28, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that, on March 27, 2025, the Compensation Committee of IDEAYA's Board of Directors granted non-qualified stock options to purchase an aggregate of 17,600 shares of the Company's common stock to a newly hired employee. The stock options were granted under the IDEAYA Biosciences, Inc. 2023 Employment Inducement Incentive Award Plan (2023 Inducement Plan) as an inducement material to such individual entering into employment with IDEAYA in accordance with Nasdaq Listing Rule 5
4 IDEAYA/GSK presentations of IDE275 (GSK959) and 4 additional presentations across IDE397/MAT2A, IDE161/PARG, PRMT5, and KAT6/7 programs at AACR 2025IDE275 (GSK959) has demonstrated a potential best-in-class preclinical profile in the MSI-H setting, with a unique binding mode from previously reported WRN inhibitorsPhase 1 dose escalation trial ongoing in MSI-H solid tumors with GSKMSI-H prevalence has been reported at approximately 31%, 20%, and 19% in endometrial, colorectal, and gastric cancers, respectivelySOUTH SAN FRANCISCO, Calif., March 26, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a leading precision medicine oncology company, today announced the publication of ab
SOUTH SAN FRANCISCO, Calif., March 3, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced a research collaboration with ATTMOS as part of its efforts to build a physics-based computational small molecule discovery platform that rapidly unlocks what are currently perceived as undruggable oncology targets. The collaboration will integrate IDEAYA's differentiated and proven capabilities in structural biology and pharmaceutical drug discovery across m
SOUTH SAN FRANCISCO, Calif., Feb. 28, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that, on February 27, 2025, the Compensation Committee of IDEAYA's Board of Directors granted non-qualified stock options to purchase an aggregate of 125,600 shares of the Company's common stock to four newly hired employees. The stock options were granted under the IDEAYA Biosciences, Inc. 2023 Employment Inducement Incentive Award Plan (2023 Inducement Plan) as an inducement material to such individuals' entering into employment with IDEAYA in accordance with Nasdaq Listi
Over 230 patients enrolled in potential registration-enabling trial in 1L HLA-A2-negative MUM, and median PFS readout targeted by year-end 202595 patients enrolled in neoadjuvant UM trial and targeting clinical data and regulatory update(s) in H1 2025, including vision data in plaque brachytherapy patientsTargeting median OS readout in ~40 1L MUM patients in 2025Targeting expansion of study in Q1 2025 of IDE397 in combination with Trodelvy® (sacituzumab govitecan-hziy) in MTAP-deletion UC and clinical data update in 2025; expanded clinical study collaboration into NSCLCTargeting to enable wholly owned IDE397 and IDE892 (IDEAYA PRMT5) clinical combination in H2 2025; IDEAYA and Amgen mutually
Entered into an additional clinical study collaboration and supply agreement with Gilead to evaluate IDE397, IDEAYA's MAT2A inhibitor, in combination with Trodelvy, Gilead's Trop-2 directed ADC, in MTAP-deletion NSCLCThe potential first-in-class clinical combination of IDE397 and Trodelvy targets two mechanistically distinct and complementary nodes of MTAP-deletion in solid tumorsMTAP-deletion prevalence in NSCLC is estimated to be approximately 15%SOUTH SAN FRANCISCO, Calif., Feb. 13, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced it has entered into an addition
SOUTH SAN FRANCISCO, Calif., Feb. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced the appointment of Joshua Bleharski, Ph.D. as Chief Financial Officer. Dr. Bleharski joins IDEAYA from J.P. Morgan, where he spent nearly 17 years advising clients in the biopharma sector on capital markets transactions, corporate strategy and other investment banking services. IDEAYA anticipates that Dr. Bleharski will complete the transition into his new role by early May.
SOUTH SAN FRANCISCO, Calif., Jan. 31, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that, on January 30, 2025, the Compensation Committee of IDEAYA's Board of Directors granted non-qualified stock options to purchase an aggregate of 62,800 shares of the Company's common stock to two newly hired employees. The stock options were granted under the IDEAYA Biosciences, Inc. 2023 Employment Inducement Incentive Award Plan (2023 Inducement Plan) as an inducement material to such individuals' entering into employment with IDEAYA in accordance with Nasdaq Listing
SOUTH SAN FRANCISCO, Calif., Jan. 27, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the upcoming investor relations events. Oppenheimer 35th Annual Healthcare Life Sciences ConferenceTuesday, February 11th, 2025 at 1:20 PM ET Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Matthew Biegler, Executive Director and Senior AnalystCiti's 2025 Virtual Oncology Leadership SummitWednesday, February
SC 13G/A - IDEAYA Biosciences, Inc. (0001676725) (Subject)
SC 13G/A - IDEAYA Biosciences, Inc. (0001676725) (Subject)
SC 13G/A - IDEAYA Biosciences, Inc. (0001676725) (Subject)
SC 13G/A - IDEAYA Biosciences, Inc. (0001676725) (Subject)
SC 13G - IDEAYA Biosciences, Inc. (0001676725) (Subject)
SC 13G - IDEAYA Biosciences, Inc. (0001676725) (Subject)
SC 13G/A - IDEAYA Biosciences, Inc. (0001676725) (Subject)
SC 13G/A - IDEAYA Biosciences, Inc. (0001676725) (Subject)
SC 13G/A - IDEAYA Biosciences, Inc. (0001676725) (Subject)
SC 13G - IDEAYA Biosciences, Inc. (0001676725) (Subject)
Stephens initiated coverage of IDEAYA Biosciences with a rating of Overweight and set a new price target of $51.00
Leerink Partners downgraded IDEAYA Biosciences from Outperform to Market Perform and set a new price target of $27.00
UBS initiated coverage of IDEAYA Biosciences with a rating of Buy and set a new price target of $50.00
Cantor Fitzgerald initiated coverage of IDEAYA Biosciences with a rating of Overweight
Mizuho initiated coverage of IDEAYA Biosciences with a rating of Outperform and set a new price target of $50.00
BTIG Research initiated coverage of IDEAYA Biosciences with a rating of Buy and set a new price target of $55.00
SVB Securities initiated coverage of IDEAYA Biosciences with a rating of Outperform and set a new price target of $33.00
Goldman initiated coverage of IDEAYA Biosciences with a rating of Buy and set a new price target of $32.00
Stifel upgraded IDEAYA Biosciences from Hold to Buy and set a new price target of $24.00 from $18.00 previously
Berenberg initiated coverage of IDEAYA Biosciences with a rating of Buy and set a new price target of $26.00
SOUTH SAN FRANCISCO, Calif., Feb. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced the appointment of Joshua Bleharski, Ph.D. as Chief Financial Officer. Dr. Bleharski joins IDEAYA from J.P. Morgan, where he spent nearly 17 years advising clients in the biopharma sector on capital markets transactions, corporate strategy and other investment banking services. IDEAYA anticipates that Dr. Bleharski will complete the transition into his new role by early May.
Brings over 20-year global commercialization experience in oncology with leading biopharmaceutical companies Gilead Sciences and Bristol Myers Squibb, including leadership of multiple commercial launches for products including Trodelvy® and Opdivo®SOUTH SAN FRANCISCO, Calif., Nov. 18, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced the appointment of Stu Dorman as Chief Commercial Officer. Mr. Dorman has a track record of commercial success in numerous specialty disease areas with over 20 years of oncology and hematology experience.
Over 25 years of legal experience with leading healthcare organizations, including GW Pharmaceuticals, Actelion Pharmaceuticals, Eisai, GSK, and the U.S. FDASOUTH SAN FRANCISCO, Calif., Sept. 18, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that Douglas B. Snyder, joined the company as its Senior Vice President, General Counsel on September 18, 2024. "Doug brings a broad legal background in the healthcare field spanning biotechnology, pharm
Over 18-years at leading life sciences and strategy consulting companies, including Revolution Medicines, Guardant Health, Onyx Pharmaceuticals, and McKinsey & CompanySOUTH SAN FRANCISCO, Calif., May 28, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that Daniel A. Simon, will join the company as its Chief Business Officer in August 2024. "We are thrilled to welcome Daniel to IDEAYA Biosciences. His extensive expertise in corporate strategy
- Dr. Karlene Cimprich, Ph.D. (Stanford University), is a leading scientist in replication stress mechanisms and regulation of DNA Damage Repair pathways - Dr. Kornelia Polyak, M.D., Ph.D. (DFCI, Harvard University) is a renowned physician-scientist focused on breast cancer clinical management and tumor biology SOUTH SAN FRANCISCO, Calif., Dec. 19, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the appointment of Dr. Karlene Cimprich, Ph.D., and Dr. Kornelia Polyak, M.D., Ph.D., to its Scientific Advisory Board.
Former Senior Vice President and Head of Early Oncology Development and Clinical Research at Pfizer will lead IDEAYA's clinical development efforts as Chief Medical OfficerOver twenty-five years of experience in clinical development and translational research, including at leading pharmaceutical companies and major research institutionsSOUTH SAN FRANCISCO, Calif., Nov. 28, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that Darrin M. Beaupre, M.D., Ph.D., has joined the company as its Chief Medical Officer, effective November 21, 2022.
- Dr. Mackey formerly served as Senior Vice President of Pfizer Worldwide Research and Development and as Director of Pfizer's La Jolla Laboratories SOUTH SAN FRANCISCO, Calif., April 6, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the appointment of Catherine Mackey, Ph.D., to its Board of Directors. Dr. Mackey brings over 30 years of life sciences research, development and operational experience to IDEAYA. As Senior
SOUTH SAN FRANCISCO, Calif., Jan. 4, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the appointment of Frank McCormick, Ph.D., FRS, to Chair of the IDEAYA Scientific Advisory Board. Dr. McCormick is a Professor at the University of California at San Francisco's (UCSF) Helen Diller Family Comprehensive Cancer Center and holds the David A. Wood Chair of Tumor Biology and Cancer Research at UCSF. Prior to joining UCSF,
SOUTH SAN FRANCISCO, Oct. 18, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that Michael White, Ph.D., will join the company as its Chief Scientific Officer, effective November 1, 2021. "We are thrilled to welcome Dr. White, and we believe his deep industry experience as CSO and Head of Tumor Biology at Pfizer, and extensive knowledge in cancer biology developed during a prolific academic career at UT Southwestern, wil
SOUTH SAN FRANCISCO, Calif., Feb. 17, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the appointment of Susan Kelley, M.D., to its Board of Directors. Dr. Kelley brings over 25 years of experience in oncology drug research and development to IDEAYA. Most recently she served as Chief Medical Officer of the Multiple Myeloma Research Consortium (MMRC) where she led the strategic design and management of clinical trials in North America. Prior to the MMRC, she held positions of increasing responsibility at Bayer Healthcare Pharmaceutica
Phase 2 company-sponsored and IST neoadjuvant uveal melanoma (UM) clinical data update in 49 evaluable patients, demonstrates ~49% of patients with >30% tumor shrinkage by product of diameters, and ~61% eye preservation rate for enucleation patientsTargeting to initiate Phase 3 randomized registrational trial in neoadjuvant UM following finalization of the clinical protocol with FDAClinical endpoints supportive of full approval based on FDA guidance: Eye preservation rate as the primary endpoint for enucleation patients. Time to vision loss as the primary endpoint for plaque brachytherapy patients. No detriment to Event-Free-Survival (EFS) in the treatment arms is a secondary endpointDiscuss
SOUTH SAN FRANCISCO, Calif., Sept. 22, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, September 23, 2024, at 8:00 a.m. ET to report interim Phase 2 data for darovasertib and provide a regulatory update from FDA Type C meeting in neoadjuvant uveal melanoma (UM). Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic UM.
~39% Overall Response Rate (ORR): 1 CR and 6 PRs (2 awaiting confirmation) by RECIST 1.1 out of 18 evaluable MTAP-deletion urothelial and NSCLC patients~94% Disease Control Rate (DCR): 1 CR and 6 PRs and 10 SD by RECIST 1.1~78% of Patients with Tumor Shrinkage: 14 patients observed tumor shrinkage~81% ctDNA Molecular Response Rate (MRR): 13 of 16 patients with > 50% ctDNA reductionAE Profile: ~5.6% drug-related grade >3 AEs and no drug-related SAEs or discontinuations at 30 mg once-a-day expansion doseIDE397 expansion dose of 30 mg once-a-day achieved target drug coverage and plasma SAM pharmacodynamic reduction associated with preclinical tumor regressions~48k U.S. annual incidence of MTAP-
Confirmed overall response rate (ORR) of 45%, disease control rate (DCR) of 90% and median PFS of ~7 months in 20 evaluable First-Line MUM patientsBased on FDA meeting, initiating Phase 2/3 registrational trial in Q2 2023 in First-Line HLA-A2 negative MUM, with median PFS as primary endpoint for potential accelerated approvalConfirmed overall response rate (ORR) of 30%, disease control rate (DCR) of 87% and median PFS of ~7 months in 63 evaluable Any-Line MUM patientsConfirmed overall response rate (ORR) of 35%, disease control rate (DCR) of 100% and median PFS of ~11 months in 20 evaluable Hepatic-Only MUM patientsHistorical % ORR and median PFS by other therapies in MUM have been low, rang
Confirmed partial responses by RECIST observed in 4 of 8 (50% ORR) evaluable First-Line MUM patients and in 11 of 35 (31% ORR) evaluable Any-Line MUM patientsTumor shrinkage observed in 31 of 35 (89%) Any-Line MUM patientsMedian PFS not yet reached and >5 months in evaluable First-Line MUM patients; observed median PFS of ~5 months in evaluable Any-Line MUM patientsHistorical % ORR and median PFS by other therapies in MUM have been low, ranging from ~0% to 5% ORR and ~2 to 3 months median PFSProof-of-concept for use in (neo)adjuvant UM with tumor shrinkage in 5 of 5 ocular lesions, including reductions of ~-74% and -67%, each with improved visual symptomsTotal UM and MUM annual incidence in
SAN FRANCISCO, May 3, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in investor conferences in May 2022. 2022 JP Morgan Conference Call SeriesMonday, May 16 at 10:00am ETFireside chat with Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences, hosted by Anupam Rama, Managing Director US SMID Biotechnology Equity Research Virtual Guggenheim Synthetic Lethality Day Monday, May 16 at 12:00pm ETFireside
Observed preclinical complete suppression (~95-100%) of tumor SDMA in multiple MTAP-deleted patient derived xenograft (PDX) models across indications Interim IDE397 clinical data demonstrates robust plasma pharmacodynamic modulation, exceeding target of >60% reduction of plasma SAM across all evaluated cohorts Observed clinical exposure-dependent reduction of tumor pharmacodynamic biomarker SDMA in target tumor types, including 95% reduction of tumor SDMA No drug-related Serious Adverse Events (SAEs) observed through Cohort 5 Enrolling into Cohort 6 of the dose escalation Phase 1 evaluating IDE397; have not yet determined the maximum tolerated dose (MTD) through Cohort 5 Targeting initiation
SOUTH SAN FRANCISCO, Calif., March 8, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced plans to issue a pre-market press release and host an Investor Webcast on Tuesday, March 15, 2022 to discuss interim clinical data for IDE397, a potential best-in-class MAT2A inhibitor being evaluated in a Phase 1 Clinical Trial (NCT 04794699) in patients having tumors with MTAP deletion. IDEAYA will host a conference call and webcast
SOUTH SAN FRANCISCO, Calif., Dec. 7, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, provided a clinical data update for the Phase 1/2 trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma (MUM) patients. "The partial responses, percentage of patients with tumor shrinkage and disease control rate observed from the darovasertib and crizotinib synthetic lethal combination in heavily pr
SOUTH SAN FRANCISCO, Calif., Nov. 29, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its plans for a clinical data update on December 7, 2021, including plans to issue a pre-market press release and host a conference call and webcast to discuss clinical data from the ongoing Phase 1/2 trial evaluating darovasertib and crizotinib combination in patients with metastatic uveal melanoma (MUM) (ClinicalTrials.gov Identifier: NCT03947385).