FDA sets a PDUFA target action date of March 20, 2025 Resubmission is supported by the final survival analysis of CARES-310 study, presented at ASCO 2024 FORT LEE, NEW JERSEY, Oct. 21, 2024 – Elevar Therapeutics, Inc., a majority-owned subsidiary of
FORT LEE, NEW JERSEY, Sept. 23, 2024 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug
FORT LEE, NEW JERSEY, Sept. 12, 2024 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the presentation of three posters at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, Sept. 13-17. “The results
FORT LEE, NEW JERSEY, Aug. 1, 2024 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the European Medicines Agency (EMA) granted Orphan Medicinal Product Designation for rivoceranib in combination with camrelizumab as a first-line treatment
FDA confirmed resubmission can occur without delay FDA confirmed additional GMP and/or BIMO inspections may occur after resubmission Elevar plans to resubmit as soon as possible FORT LEE, NEW JERSEY, July 9, 2024 – Elevar Therapeutics, Inc. (Elevar), a
Phase 3 CARES-310 study found combination of camrelizumab and rivoceranib continued to show sustained long-term survival compared with sorafenib as a first-line treatment for uHCC Final analysis reported the longest median overall survival for any treatment in a global
A post hoc analysis found the efficacy of camrelizumab plus rivoceranib was superior to sorafenib regardless of baseline liver function as measured by both albumin-bilirubin grade and Child-Pugh class Another analysis, of patient-reported outcomes during CARES-310, demonstrated the combination
Fort Lee, N.J., Oct. 23, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today
In May, Elevar and Hengrui Pharma submitted an NDA and BLA for the combination of rivoceranib and camrelizumab as a first-line therapy for uHCC, with FDA PDUFA dates in May 2024 Fort Lee, N.J., and Princeton, N.J., Oct. 17, 2023
Fort Lee, New Jersey, Sept. 21, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options,
Fort Lee, New Jersey, September 19, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options,
Fort Lee, N.J., Aug. 15, 2023 — Elevar Therapeutics, Inc., majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced
Fort Lee, New Jersey, August 3, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options,
In CARES 310, camrelizumab plus rivoceranib demonstrated statistically significant and clinically meaningful prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib, a standard first-line treatment for uHCC Fort Lee, New Jersey, July 24, 2023 – Elevar Therapeutics,
With a standard review, FDA set a PDUFA target action date of May 16, 2024 FORT LEE, NEW JERSEY, July 17, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. And a fully integrated biopharmaceutical company dedicated to
FORT LEE, NEW JERSEY, June 1, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options,
Fort Lee, N.J., May 17, 2023 – Elevar Therapeutics, Inc., a wholly owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options,
Orlando, Fla., April 18, 2023 – Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that a comparative biochemical analysis identified rivoceranib, its
Fort Lee, N.J., March 16 – Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced it had a poster accepted for presentation at
Fort Lee, N.J., March 7, 2023 – Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the opening of its new corporate headquarters
SALT LAKE CITY (Oct. 11, 2022) – Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced a positive pre-New Drug Application (NDA) meeting
PARIS, Sept. 8 – Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced top-line results from the Phase 3 study of its drug
Salt Lake City, (August 25, 2022) – Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that initial data from the Phase 3
SALT LAKE CITY, Aug. 22, 2022 -- Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the appointment of Wade Smith as chief
SALT LAKE CITY, June 28, 2022 -- Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the hiring of Gordon Schooley, Ph.D., as
Elevar Therapeutics has reported the Phase II clinical trial results of its small-molecule tyrosine kinase inhibitor (TKI) rivoceranib in progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC) patients. The open-label Study RM-202 of the orally administered TKI was carried out at 11
CHICAGO, June 06, 2022 — Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today detailed the results of its Phase 2 clinical trial (Study
SALT LAKE CITY, June 2, 2022 — Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the hiring of Dr. David E. Lilienfeld as
SALT LAKE CITY, USA., May 26, 2022 — Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced its Phase 2 clinical trial (Study RM-202)
SALT LAKE CITY, USA., May 23, 2022 — Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the hiring of Paul Friel as
SALT LAKE CITY, USA., March 14, 2022 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the
SALT LAKE CITY, USA., January 18, 2022 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the extension of
SALT LAKE CITY, USA., January 5, 2022 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the appointment of
SALT LAKE CITY, USA., November 11, 2021 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the U.S.
SALT LAKE CITY, USA., October 26, 2021 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that Yang Gon
SALT LAKE CITY, USA., September 27, 2021 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced key additions to
SALT LAKE CITY, USA., July 20, 2021 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the Board
SALT LAKE CITY, USA., July 8, 2021 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the expansion of
SALT LAKE CITY, May 18, 2021 -- Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the presentation of data from a
SALT LAKE CITY, USA., February 8, 2021 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the U.S.
SALT LAKE CITY, USA., December 28, 2020 — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that it has
SALT LAKE CITY, USA., November 19, 2020 -- Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced new clinical results
SALT LAKE CITY, USA., Nov. 17, 2020 – Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the Company met its
SALT LAKE CITY, USA., Oct 05, 2020 -- Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that it has entered
SALT LAKE CITY, Utah and CHARLOTTE, N.C. USA, July 27, 2020 -- Elevar Therapeutics, Inc. (“Elevar”), a late-stage biopharmaceutical company focused on developing and commercializing promising therapies to address unmet needs in cancer, and Tanner Pharma Group (“Tanner”), a global provider of integrated specialty access solutions,
SALT LAKE CITY, USA, March 25, 2020 Elevar Therapeutics, Inc., a fast-growing biopharmaceutical company focused on promising therapies for unmet medical needs in cancer, announced today an agreement with Swedish-based Oasmia Pharmaceutical AP to obtain global rights for Apealea®, except in Nordics,
March 9, 2020 SALT LAKE CITY, USA. Elevar Therapeutics, a late stage biopharmaceutical company focused on promising therapies for unmet medical needs in cancer, announced today the initiation of a pivotal trial for the treatment of adenoid cystic cancer (ACC) with
September 29, 2019 SALT LAKE CITY, USA. Elevar Therapeutics announced data from the ANGEL trial, a randomized phase 3 study of rivoceranib (also known as apatinib) plus best supportive care in patients with gastric or gastroesophageal junction cancer who have failed
SALT LAKE CITY, USA, September 16, 2019 Elevar Therapeutics is pleased to announce the addition of a new member to the Board of Directors, Paul Chen. “We are very excited to have Paul join our Board of Directors,” said Alex Kim, Elevar
SALT LAKE CITY, USA. The Board of Directors of Elevar Therapeutics has appointed Mr. Alex Kim to the position of Chief Executive Officer to succeed Dr. Sung Chul Kim as the head executive of the Company effective August 31, 2019. Dr. Sung Chul
SALT LAKE CITY, USA. LSK BioPharma is pleased to announce its new company name, Elevar Therapeutics, effective immediately. “In the last year the Company has made significant strides towards making rivoceranib available to patients worldwide,” said Alex Kim, Elevar Therapeutics’
SALT LAKE CITY, USA, June 30, 2019 LSK BioPharma (or “LSKB”), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or “Hengrui”), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, today announced the first
LSK BioPharma Announces Preliminary Review of Top-Line Results from ANGEL Study SALT LAKE CITY, USA, June 27, 2019 – LSK BioPharma (LSKB) has completed the unblinding and preliminary review of topline data from its ANGEL Study, a Phase III clinical trial for
SALT LAKE CITY, USA, and SHANGHAI, CHINA, April 8, 2019 -- LSK BioPharma (or “LSKB”), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or “Hengrui”), one of the largest and most innovative fully-integrated biopharmaceutical companies based in
SALT LAKE CITY, USA, Feb 12, 2019 -- LSK BioPharma (LSKB, Company) announced that it has reached the pre-specified number of events required for unblinding and analysis of the primary endpoint of overall survival in the ANGEL study, a global
SALT LAKE CITY, USA, Feb 2nd, 2019 – In order to accommodate rapid growth, LSK BioPharma (LSKB, Company) has relocated its corporate headquarters to 2825 E Cottonwood Pkwy, Suite 180, Salt Lake City, Utah 84121 USA. The new offices will
JOB DESCRIPTION Responsible for compliance with applicable procedures. This position will play a key role in preparing US and international regulatory filings. Individual coordinates and supports technical and scientific regulatory activities, researches regulations and guidelines, and maintains and organizes key information
SALT LAKE CITY, USA, Oct 29th, 2018 -- LSK BioPharma (LSKB, Company) announced that it has completed patient enrollment in its pivotal Phase 3 trial, ANGEL, which is evaluating the efficacy and safety of rivoceranib plus Best Supportive Care (BSC)
Director Clinical Strategic Development LSK Biopharma South San Francisco, CA Director Clinical Strategic Development (CSD) provides critical expertise and leadership in the design and planning of integrated development plans for multiple disease indications. CSD drives adoption of innovative approaches and strategic thinking in
SALT LAKE CITY, USA, and SHANGHAI, CHINA, October 21, 2018 -- LSK BioPharma (or “LSKB”), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or “Hengrui”), one of the largest and most innovative fully-integrated biopharmaceutical companies based in
SALT LAKE CITY, USA, Oct 1st, 2018 -- LSK BioPharma (LSKB, Company) announced that the South Korean Ministry of Food and Drug Safety (MFDS) has approved a Phase I/IIa study protocol to investigate the combination of rivoceranib and paclitaxel, “A
Ensure that global regulated clinical studies are compliant and that clinical trials are conducted with company goals, SOPs, Ethics, ICH GCP and global regulatory guidelines. Provide operations management for the planning, execution and reporting of Phase III global clinical trials.
SALT LAKE CITY, USA, June 19, 2018 -- LSK BioPharma (LSKB, Company) announced that enrollment has opened for the APPEASE study, “A phase 1/2 open label study of the safety and efficacy of apatinib [rivoceranib] administered to patients with advanced
Position Scope and Summary LSK BioPharma is searching for a qualified candidate to join our preclinical product development team in South San Francisco. The position will be responsible for planning and monitoring preclinical and DMPK-related projects performed by LSK BioPharma’s vendors/contractors. Roles
Overview We are currently seeking a full-time, office-based CMC Product Manager to join LSK Biopharma. This position will manage and guide our CMC activities for our small molecule drug substance and product programs from preclinical through commercial. If you want an
Overview We are currently seeking a full-time, office-based Regulatory Affairs Manager/Director to join LSK Biopharma. This position will work with our clinical and product development teams to contribute to the strategic planning and preparation of regulatory submissions and supports the formatting,
SALT LAKE CITY, April 16, 2018 – LSK BioPharma (LSKB) today will present a poster at the American Association for Cancer Research (AACR) Annual Meeting in Chicago. The poster discloses nonclinical data suggesting a synergistic combination of rivoceranib (apatinib) with
Position has been filled. Responsibilities and Duties Essential Duties & Responsibilities: Primary contact for the site, supervise and monitor clinical trials to ensure adherence to ICH-GCP standards, study protocol, SOPs and regulations. Ensure proper adherence to protocol, Informed consent procedures, source
SALT LAKE CITY, USA, JANUARY 2, 2018. LSKB announced that it has adopted the nonproprietary/generic name “rivoceranib” (pronounced riv” oh ser’ an ib) for its small molecule angiogenesis inhibitor commonly known as apatinib and YN968D1. “Rivoceranib” has been approved as
SALT LAKE CITY, USA, December 27, 2017 -- LSK BioPharma (LSKB, Company) announced that it has enrolled the first patient in a clinical trial studying the combination of apatinib with the immuno-oncology drug nivolumab. This study (designated LSK-AM107) is an
SALT LAKE CITY, USA, December 20, 2017 -- LSK BioPharma (LSKB, Company) has enrolled the first US and European patients in its ongoing, multinational Phase 3 ANGEL Study; a pivotal study assessing the safety and efficacy of apatinib in patients
SALT LAKE CITY, USA, December 10, 2017 -- LSK BioPharma (LSKB, Company) announced a new initiative to study the safety and efficacy of cancer therapies combining apatinib with immunotherapy. The first clinical study, designated LSK-AM107, will take place at the
Responsibilities and Duties Essential Duties & Responsibilities: Assist protocol, IB and CRF development Provide monitoring guidance Plan and assist study start-up activities such as the creation of Site Initiation Presentations, CRF Completion Guidelines and various study tracking and management documents Perform
Position Summary: This position functions as a Clinical Project Manager for global late stage clinical trials within LSK BioPharma (South San Francisco) or within LSK Global CRO (Seoul) as the relevant study/project requires. The Global Clinical Trials Manager (GCTM) works
SALT LAKE CITY, USA, June 19 2017 -- LSK BioPharma (LSKB, Company) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to apatinib for the treatment of gastric cancer. Apatinib, which has been approved and is marketed
SALT LAKE CITY, USA, June 1 2017 -- LSK Biopharma (LSKB Company) will be attending the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA from June 2-6. The Company will be meeting with leading oncologists and key
SALT LAKE CITY, USA, May 16, 2017 – LSK BioPharma (LSKB, Company) announced today that it has started Site Initiation Visits (SIVs) for clinical sites in the United States for its global apatinib phase 3 gastric cancer trial. The Company
SALT LAKE CITY, USA, May 8, 2017 – LSK BioPharma (LSKB, Company) announced today that it has received approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a phase 2 clinical trial of apatinib, the Company’s
SALT LAKE CITY, USA, March 13, 2017 – LSK BioPharma (LSKB, Company) announced today enrollment of the first patient in a global, multicenter phase 3 trial to evaluate apatinib in patients with advanced or metastatic gastric cancer. This first patient was
SALT LAKE CITY, USA, March 1, 2017 – LSK BioPharma (LSKB, Company) today announced that it has received notification that the European Commission has designated apatinib as an orphan medicinal product for the treatment of gastric cancer in the European
SALT LAKE CITY, January 6, 2017 – LSK BioPharma (LSKB) today announced that it received approval for its apatinib phase 3 protocol under the Korean Ministry of Food and Drug Safety (MFDS). South Korea will be a part of the
SALT LAKE CITY, September 21, 2016 – LSK BioPharma (LSKB) announced that it will release data from its phase 2 apatinib clinical trial in a poster at the 2016 ESMO Congress in Copenhagen, Denmark October 7-11, 2016. This data comes from
SALT LAKE CITY, September 21, 2016 – LSK BioPharma (LSKB) today announced receiving advice from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) supporting its plan to recruit European patients in its global phase 3
FDA meeting clears pathway to initiation of pivotal phase 3 study SALT LAKE CITY, July 26, 2016 -- LSK BioPharma (LSKB) today announced the successful completion and positive outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug
Position Summary: Responsible for assisting with the planning and implementation of business development activities (out-license and in-license research, valuations/models and other value driving documentation, competitive and prospective client research, and relationship building) and participating in developing infrastructure to support current and
LSK BioPharma is pleased to announce the opening of its west coast office in San Bruno, California at 1001 Bayhill Dr. on the 2nd Floor. This office will handle business development for LSKB’s products and product development partnerships in Asia.
LSKB is a privately-held biopharmaceutical company based in Salt Lake City, Utah. We are opening an office in the Bay Area. The Company specializes in the early clinical development of promising therapies for unmet medical needs in cancer. LSKB is
LSKB has scheduled an End-of-Phase 2 meeting with US FDA on July 20, 2016 to discuss clinical development plans for apatinib. The FDA guidance from this meeting will assist LSKB in finalizing the design of a pivotal Phase 3 study
LSKB is attending Bio International Convention June 6-9th in San Francisco at the Moscone Center - We are discussing product license and co-development opportunities. Schedule a meeting with us through the bio partnering system, or send us a message at
LSKB is attending ASCO in Chicago at the McCormick Center June 2-7th. We will be meeting with key leading oncologists from across the globe to discuss late stage development of apatinib mesylate in gastric cancer, colorectal cancer, and hepatocellular carcinoma.
LSKB is attending Bio Europe Spring in Stockholm - schedule a meeting with us through the partnering system, or send us a message at alexkim@lskbiopharma.com
LSK BioPharma (LSKB), which is currently developing two promising cancer drugs, announced that it has entered into a strategic alliance with the largest CRO in Korea, LSK Global PS. The strategic alliance will initially focus on the clinical development of
Salt Lake City– LSK BioPharma (LSKB) and the University of Utah’s Huntsman Cancer Institute (HCI) today announced an exclusive license agreement for LSKB to develop and commercialize HCI-1401, an orally bioavailable, small molecule, irreversible inhibitor of Bruton’s tyrosine kinase (BTK).
Dr. Sunil Sharma and Dr. Yoon Koo Kang in front of the Apatinib poster at ASCO 2015. Read The Abstract
Salt Lake City, UT, June 6, 2012 - LSK BioPartners today announced the initiation of a Phase 1/2A dose escalation and safety trial of apatinib mesylate (YN968D1) with the enrollment of the first three patients of the first dose cohort.
