drugset
Drugs / UPACICALCET
last change Aug 2025 re-read 3 minutes ago

UPACICALCET

also known as SK-1403 · PLS240 · AJT-240 · AJT240 SODIUM · PLS240 SODIUM · SK-1403 SODIUM · UPACICALCET SODIUM

Small molecule

Developed for
secondary hyperparathyroidism of renal origin · secondary hyperparathyroidism
Investigated by
Sanwa Kagaku Kenkyusho Co., Ltd. · Launch Therapeutics · Pathalys Pharma

Trials 5

today NCT05836220 · Ph 3 NCT05832931 · Ph 3 NCT03801980 · Ph 3 NCT03626948 · Ph 3 NCT03226171 · Ph 2
2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT03226171 Jun 2017 → Sep 2018 secondary hyperparathyroidism Sanwa Kagaku Kenkyusho Co., Ltd. Completed No outcome recorded
Phase 34 trials · 1 met primary
Phase 3 NCT05836220 May 2023 → Aug 2025 end stage renal failure, secondary hyperparathyroidism of renal origin Pathalys Pharma Completed No outcome recorded
Phase 3 NCT05832931 Apr 2023 → Jul 2025 end stage renal failure, secondary hyperparathyroidism Pathalys Pharma Completed No outcome recorded
Phase 3 NCT03801980 Jan → Dec 2019 secondary hyperparathyroidism of renal origin Sanwa Kagaku Kenkyusho Co., Ltd. Completed Met primary
Phase 3 NCT03626948 Sep 2018 → Feb 2020 secondary hyperparathyroidism of renal origin Sanwa Kagaku Kenkyusho Co., Ltd. Completed No outcome recorded

Press releases naming this drug 9 releases

DateIssuerRelease
2024-08-20 Pathalys Pharma Pathalys Pharma Secures $105 Million Series B Financing August 20, 2024 Oversubscribed Financing Paves Path to NDA Submission and Pre-commercialization Efforts for upacicalcet RESEARCH TRIANGLE PARK, NC – August 20, 2024 – Pathalys Pharma, Inc., a private biopharmaceutical company in the late stages of developing treatments for kidney disease, has successfully closed a $105 million Series B financing round. The oversubscribed financing was led by TCGX and joined by other notable investors including, JP Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment, JPS Growth Investment Limited Partnership, and included support from Pathalys’ founding investors, Catalys Pacific and DaVita Venture Group. “Since our inception, Pathalys has made significant strides toward our goal of delivering a best-in-class treatment for those with end-stage kidney disease (ESKD), including the near completion of two phase 3 clinical trials for upacicalcet,” said Neal Fowler, Chief Executive Officer at Pathalys Pharma, Inc. “We believe the continued expansion of our syndicate of prominent life science investors, with representative board members, is indicative of the fact that we are on the right path at Pathalys. We are immensely grateful for the continued support of our investors and remain steadfast and confident in our mission to bring upacicalcet forward to patients.” “I am thrilled to support the Pathalys Pharma team in bringing upacicalcet to dialysis patients with ESKD who need improved calcimimetic treatment options,” stated Chen Yu, M.D., Founder and Managing Partner of TCGX. “With both upacicalcet trials on track for early completion, we are hopeful that these efforts will support a near-term NDA filing with the FDA. I am excited to be a part of this journey as a member of the Pathalys board.” The funds raised via this financing will be utilized to finalize the two ongoing upacicalcet clinical trials, execution of the NDA filing process with the U.S. Food and Drug Administration (FDA), and acceleration of preapproval commercialization preparations. Joining the Board of Directors as members will be Dr. Chen Yu and Mr. Joe Siletto, Managing Partner of JP Morgan Life Sciences Private Capital. Additionally, Dr. Roger Zhang, Ph.D. of Samsara BioCapital will join the Board as an observer. “We are excited to have Chen and Joe join our Board and support Pathalys’ efforts to develop innovative medicines aimed to improve the lives of patients with kidney disease. We are confident that their extensive financial markets experience and leadership will further complement our current Board,” commented BT Slingsby, M.D., Ph.D., M.P.H., Co-founder, and Executive Chairperson of Pathalys and Founder of Catalys Pacific. ABOUT PATHALYS PHARMA Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of ESKD. Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT in hemodialysis patients. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys was co-founded by Catalys Pacific and DaVita Venture Group and is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit pathalys.com. ABOUT TCGX TCGX is a healthcare investment firm dedicated to advancing disruptive medicines and supporting companies that can improve the lives of patients. TCGX invests in both private and public companies led by exceptional entrepreneurs focused on developing better treatment options for patients. TCGX has investment teams in Palo Alto and New York City. For more information, please visit www.tcgcrossover.com CONTACT INFORMATION For Pathalys Media and Investor Contact: Patrick Treanor [email protected] pathalys.com ↗
2024-08-13 Pathalys Pharma Pathalys Pharma Appoints Dr. Bastian Dehmel as Chief Medical Officer August 13, 2024 RESEARCH TRIANGLE PARK, NC — August 13, 2024 – Pathalys Pharma, Inc., a private biopharmaceutical company in the late stages of developing treatments for kidney disease, today announced it has appointed Bastian Dehmel, M.D. as its Chief Medical Officer. In this role, Dr. Dehmel will assume responsibility for clinical operations, clinical affairs, clinical sciences, data management/biometrics, and product drug safety. He will report to Neal Fowler, Pathalys CEO, and will serve on the Senior Leadership Team. “We are thrilled to welcome Bastian as Pathalys’ Chief Medical Officer,” said Neal Fowler. “Throughout his career, Bastian has demonstrated exceptional clinical development leadership, and we are confident that his wealth of experience and deep understanding of calcimimetic clinical research and operations will play a crucial role in advancing our lead asset, upacicalcet, towards a successful clinical and regulatory outcome.” Dr. Dehmel brings 20 years of global biotechnology and pharmaceutical industry experience, spanning all phases of drug development, clinical operations, biostatistics, and regulatory across multiple therapeutic areas and international markets. He joins Pathalys from Oculis S.A. where he served as Chief Development Officer. Previously, Dr. Dehmel served as Chief Medical Officer of OxThera AB and prior to that had roles of increasing responsibility at Amgen, last serving as Global Development Executive Medical Director. Dr. Dehmel added, “I am honored to join the leadership team at Pathalys at a very important time in the company’s history. As demonstrated by the tremendous progress Pathalys has made with the phase 3 program for upacicalcet, this company is driven and focused on their mission of transforming patient lives. I sincerely look forward to being a part of this team and to contributing to bringing upacicalcet to dialysis patients in need” Dr. Dehmel holds a Doctor of Medicine (M.D.) from Free University Berlin Medical School and received his clinical training in Internal Medicine at Charité University in Berlin, Germany as well as Tulane Medical School, New Orleans, United States. ABOUT PATHALYS PHARMA Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of ESKD. Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT in hemodialysis patients. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys was co-founded by Catalys Pacific and DaVita Venture Group and is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit pathalys.com . CONTACT INFORMATION For Pathalys Media and Investor Contact: Patrick Treanor [email protected] pathalys.com ↗
2023-05-31 Pathalys Pharma Pathalys Pharma and Launch Therapeutics Announce First Patient Enrolled Ahead of Schedule in Pivotal Phase 3 Program for Upacicalcet in Patients Receiving Hemodialysis May 31, 2023 Pathalys and LaunchTx leverage recently announced collaboration to accelerate enrollment for the upacicalcet development program. Research Triangle Park, North Carolina and Boston, Massachusetts, May 31, 2023 – Pathalys Pharma, Inc., a private, late-stage biopharma company co-founded by Catalys Pacific and DaVita Venture Group, and Launch Therapeutics (Launch Tx), a clinical development company, today announced that the first patient has been enrolled in the PATH ( P TH Attenuation T rial in H emodialysis) clinical program, consisting of two identical phase 3 trials, to assess upacicalcet for the treatment of secondary hyperparathyroidism (SHPT) in end-stage kidney disease (ESKD) patients on hemodialysis The PATH clinical trial program is the output of Pathalys’ previously disclosed intent to initiate two identical phase 3 clinical trials to evaluate upacicalcet. Upacicalcet is a novel calcimimetic that performed exceptionally well in phase 3 studies in Japan where it was approved in 2021 for the treatment of SHPT in patients on dialysis. As part of its strategic collaboration with Pathalys, Launch Tx has the lead role for operational execution and management of the clinical trials and Pathalys has primary responsibility for PATH study design, manufacturing, FDA regulatory interactions , medical oversight, and commercialization. “We have enrolled our first patient for this program ahead of schedule. With the successful conclusion of this trial, we hope to accelerate upacicalcet toward registration in the U.S. with the goal of making this therapy available for dialysis patients with SHPT.” said Dr. Theodore Danoff, Chief Medical Officer and SVP, Clinical Development at Pathalys. “The advancement of an intravenous calcimimetic like upacicalcet may allow patients on dialysis better control of parathyroid hormone levels in SHPT in a convenient and compliant way while also lowering risk of upper gastrointestinal adverse events and hypocalcemia, which continue to be an issue with current calcimimetics.” Jessica Kendrick, MD, MPH, the principal investigator (PI) for the studies, commented, “Advancing upacicalcet will be a very meaningful step for patients and enrolling the first patient ahead of schedule is promising given that the sooner we can dose our first patient, the closer we will be to obtaining the needed data for FDA review and hopefully approval.” “The combination of Pathalys Pharma and Launch Therapeutics is already demonstrating immense value with respect to the speed and efficiency of this program. I firmly believe that the operational expertise and immediate resources provided by the Launch Tx team has contributed to meeting this key milestone ahead of schedule.” said Elisha Talley-Roithner, Head of Operations at Launch Tx. The PATH study program is designed to assess the efficacy of upacicalcet as measured by its ability to reduce intact parathyroid hormone (iPTH) by 30 percent or more in participants with secondary hyperparathyroidism (SHPT) and currently on hemodialysis. Each trial will randomize approximately 375 patients (2:1) to upacicalcet or placebo. Eligible patients will be adults receiving in-center hemodialysis three times weekly and whose iPTH values are 450 pg/mL or greater. Upacicalcet will be titrated based on iPTH and serum corrected calcium (cCa) levels with dose steps between 25 and 300 mcg as a bolus IV injection given at the end of a dialysis session. Doses will be titrated to maintain iPTH in the range of 150-300 pg/mL. About Pathalys Pharma Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of ESKD. Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT in hemodialysis patients. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys was co-founded by Catalys Pacific and DaVita Venture Group and is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit pathalys.com . About Launch Therapeutics Launch Therapeutics (Launch Tx) is a clinical development company with a mission to disrupt the late-stage development paradigm, accelerate timelines to regulatory success, and bring new medicines to patients faster. Launch Tx offers pharmaceutical and biotech companies a variety of innovative models that combine access to capital with deep drug development, medical, clinical operations, regulatory, and commercialization expertise. These models include significant risk financing, clinical co-development, and full in-licensing, all of which offer partners an aligned and efficient approach to realizing the potential of late-stage clinical programs across any therapeutic area. Founded in 2022, Launch Tx is backed by leading investors, Carlyle and its life sciences franchise, Abingworth, and is led by a committed, experienced team with an enthusiastic passion to fulfill its mission. For more information, visit launchtx.com and follow us on LinkedIn . Contact Information For Pathalys Media and Investor Contact: Patrick Treanor [email protected] For Launch Tx Media Contact: Elizabeth Kuronen [email protected] pathalys.com ↗
2023-01-18 Pathalys Pharma Pathalys Pharma Raises $150 Million in Secured Product Financing and Equity led by Abingworth; Forms Strategic Collaboration with Launch Therapeutics to Advance Upacicalcet through Pivotal Phase 3 Studies January 18, 2023 Abingworth, a leading transatlantic life sciences investment firm and part of global investment firm Carlyle (NASDAQ: CG), led financings and was joined by Carlyle, OrbiMed, and Pathalys’ founding investors Catalys Pacific and DaVita Venture Group Transaction is expected to fully fund upacicalcet through pivotal phase 3 studies and pre-commercialization activities Collaboration leverages clinical development experience of Launch Tx and Pathalys’ extensive dialysis expertise to advance the upacicalcet development program Research Triangle Park, North Carolina and Boston, Massachusetts, January 18, 2023 — Pathalys Pharma, Inc., a private, late-stage biopharma company co-founded by Catalys Pacific and DaVita Venture Group, and Launch Therapeutics (Launch Tx), a clinical development company, today announced a collaboration to advance phase 3 clinical trials for upacicalcet (designated PLS240 for clinical trials) for the treatment of secondary hyperparathyroidism (SHPT) in patients on hemodialysis. Launch Tx is backed by funds managed by global investment firm Carlyle (NASDAQ: CG) and its life sciences franchise Abingworth. Pathalys also announced it has raised $150 million through a combination of secured product financing and equity to support the two phase 3 clinical trials, registration efforts and pre-commercialization activities for upacicalcet. Abingworth led both financings and was joined by Carlyle and OrbiMed, along with Pathalys’ founding investors Catalys Pacific and DaVita Venture Group. Pathalys retains worldwide commercial rights to upacicalcet, outside Japan and Asia, and has the option to prepay its obligations in full at any time. “Pathalys is very excited to collaborate with Launch Tx and to have the backing of such an esteemed group of healthcare investors. Through this collaboration and transaction, Pathalys expects to be fully funded through the completion of its planned phase 3 trials, and pre-commercialization efforts for upacicalcet.” said Neal Fowler, Chief Executive Officer at Pathalys. “We look forward to working closely with Launch Tx to advance upacicalcet toward registration in the U.S. with the goal of making this important product candidate available for dialysis patients with SHPT.” The co-development agreement creates a collaboration that combines the exceptional clinical development resources available through Launch Tx and the extensive dialysis expertise of Pathalys to advance the upacicalcet clinical development program. Launch Tx will have the lead role in the operational execution and management of the planned clinical trials and Pathalys will retain primary responsibility for manufacturing, FDA regulatory interactions and commercialization. Anshul Thakral, CEO of Launch Tx, commented, “We are thrilled to collaborate with Pathalys to advance upacicalcet. Launch Tx will bring deep clinical and operational resources to this phase 3 program to accelerate the path to regulatory approval. We offer a unique approach that helps both pharma and biotech companies develop their late-stage therapies and plan to demonstrate that approach through our collaboration with Pathalys.” Earlier this year, Pathalys disclosed its plans to initiate two phase 3 clinical trials to evaluate upacicalcet as a treatment alternative to currently available calcimimetics. Upacicalcet is a novel calcimimetic that performed exceptionally well in phase 3 studies in Japan where it was approved last year for the treatment of SHPT in patients on dialysis. An intravenous calcimimetic like upacicalcet may allow patients on dialysis better control of serum parathyroid hormone levels in SHPT in a convenient and compliant way, without increasing their calcium-phosphorus production while, more importantly, lowering their risk for vascular calcifications. About Upacicalcet Upacicalcet is an intravenously administered investigational small molecule calcimimetic that may control intact parathyroid hormone (iPTH) levels in patients with secondary hyperparathyroidism (SHPT) receiving hemodialysis. Upacicalcet was granted Marketing Authorization in Japan in 2021, under the brand name UPASITA®, based on a phase 3, 24-week double-blind, placebo-controlled dose-titration study and a second phase 3, 52-week open-label, dose-titration study. In these studies, upacicalcet was shown to significantly reduce iPTH and maintain long-term iPTH suppression, as well as demonstrate the potential for fewer adverse events (AEs) than currently available therapies. About Pathalys Pharma Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of end-stage kidney disease (ESKD). Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT in hemodialysis patients. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys was co-founded by Catalys Pacific and DaVita Venture Group and is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit pathalys.com . About Launch Therapeutics Launch Therapeutics (Launch Tx) is a clinical development company with a mission to disrupt the late-stage development paradigm, accelerate timelines to regulatory success, and bring new medicines to patients faster. Launch Tx offers pharmaceutical and biotech companies a variety of innovative models that combine access to capital with deep drug development, medical, clinical operations, regulatory, and commercialization expertise. These models include significant risk financing, clinical co-development, and full in-licensing, all of which offer partners an aligned and efficient approach to realizing the potential of late-stage clinical programs across any therapeutic area. Founded in 2022, Launch Tx is backed by leading investors, Carlyle and its life sciences franchise, Abingworth, and is led by a committed, experienced team with an enthusiastic passion to fulfill its mission. For more information, visit launchtx.com and follow us on LinkedIn . Contact Information For Pathalys Media and Investor Contact: Patrick Treanor [email protected] For Launch Tx Media Contact: Elizabeth Kuronen [email protected] ©Pathalys Pharma, Inc., All Rights Reserved. pathalys.com ↗
2022-06-03 Pathalys Pharma Pathalys Pharma to Present at Jefferies Healthcare Conference June 3, 2022 RESEARCH TRIANGLE PARK, N.C., June 2, 2022 – Pathalys Pharma, Inc., a private, late-stage biopharma company committed to the development and commercialization of a range of best-in-class therapies for patients with end stage kidney disease (ESKD), today announced that Neal Fowler, Chief Executive Officer, will present a company overview at the Jefferies Healthcare Conference on Friday, June 10 at 10:30 AM ET. Pathalys will also be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Pathalys management team should contact their Jefferies representative. About Pathalys Pharma, Inc. Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of ESKD. Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT in hemodialysis patients. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit www.pathalys.com . Contact Information Media Contact: Michael Parks 484.356.7105 Investor Contact: Patrick Treanor [email protected] pathalys.com ↗
2022-04-09 Pathalys Pharma Pathalys Pharma to Present at the 21st Annual Needham Virtual Healthcare Conference April 9, 2022 Research Triangle Park , N.C., April 8, 2022 – Pathalys Pharma, Inc., a private, late-stage biopharma company committed to the development and commercialization of a range of best-in-class therapies for patients with end stage kidney disease (ESKD), today announced that the company will participate in the 21 st Annual Needham Virtual Healthcare Conference, taking place April 11-14, 2022. Presentation Details: Conference – 21 st Annual Needham Virtual Healthcare Conference Date / Time – Tuesday, April 12th, 11:00 AM ET Presenter – Neal Fowler, Chief Executive Officer at Pathalys Pharma Format: – Virtual presentation Pathalys will also be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Pathalys management team should contact their Needham representative. About Pathalys Pharma, Inc. Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of ESKD. Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT in hemodialysis patients. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit www.pathalys.com . Contact Information Media Contact : Michael Parks 484.356.7105 Investor Contact: Patrick Treanor [email protected] pathalys.com ↗
2022-04-07 Pathalys Pharma Pathalys Pharma Announces Phase 3 Program for Upacicalcet April 7, 2022 – Plans for Phase 3 Program Presented at National Kidney Foundation’s Annual Spring Clinical Meeting – Research Triangle Park , N.C., April 7, 2022 – Pathalys Pharma, Inc., a private, late-stage biopharma company committed to the development and commercialization of a range of best-in-class therapies for patients with end stage kidney disease (ESKD), today announced plans for a phase 3 program to support the application of upacicalcet (designated PLS240 for clinical trials), globally. Pathalys holds exclusive rights for the development and commercialization of upacicalcet, a novel calcimimetic, worldwide outside of Japan and Asia. “This is a very exciting time for Pathalys as we set out to further understand the full clinical potential of upacicalcet in patients with ESKD through two phase 3 studies that will form the basis for our applications for approval,” said Dr. Theodore Danoff, Chief Medical Officer and SVP, Clinical Development at Pathalys. “Upacicalcet is a novel calcimimetic that performed exceptionally well in phase 3 studies in Japan where it was recently approved for the treatment of SHPT in patients on dialysis. We look forward to the opportunity to demonstrate its effectiveness for patients in the US and other markets globally.” In a poster presented today at the National Kidney Foundation’s Annual Spring Clinical Meeting (SCM22), the company disclosed its plans to initiate two phase 3 clinical trials in 2022 to evaluate upacicalcet as a treatment alternative to currently available calcimimetics. The two identically designed phase 3 clinical trials will assess the efficacy of upacicalcet in reducing intact parathyroid hormone (iPTH) by 30 percent or more in participants with secondary hyperparathyroidism (SHPT) and currently on hemodialysis. Each trial will randomize approximately 375 patients (2:1) to upacicalcet or placebo. Eligible patients will be adults receiving in-center hemodialysis three times weekly and whose iPTH values are 450 pg/mL or greater. Upacicalcet will be titrated based on iPTH and serum corrected calcium (cCa) levels with dose steps between 25 and 300 µg as a bolus IV injection given at the end of a dialysis session. Upacicalcet starting dose will be 50 µg if cCa is 9.0 mg/dL or greater or 25 µg if cCa is below 9.0 mg/dL. Doses will be titrated to maintain iPTH in the range of 150-300 pg/mL. Japanese Approval and Clinical Trial: Upacicalcet was approved last year in Japan (under the brand name UPASITA®) based in part on a randomized, double-blind, placebo-controlled phase 3 study in hemodialysis patients with SHPT. The study evaluated upacicalcet when administered three times weekly with a starting dose of 25 or 50 μg IV based on cCa levels and was titrated from 25 to 300 μg over 24 weeks. The primary endpoint was the proportion of patients with a mean iPTH between 60 and 240 pg/mL over weeks 22 to 24 and was achieved in 69 of 103 patients (67.0 percent) in the upacicalcet group and 4 of 50 patients (8.0 percent) in the placebo group (difference of 59.0 percent, p<0.001). A 30 percent or greater reduction in mean iPTH over weeks 22 to 24 was achieved by 80.6 percent in the upacicalcet group compared to 8.0 percent in the placebo group (difference of 72.6 percent; p<0.001). Upper gastrointestinal disorder adverse drug reactions (ADRs) were reported in two of 103 patients (1.9 percent) in the upacicalcet group and in three of 50 patients (6.0 percent) in the placebo group. The incidence of calcium less than 7.5 mg/dL was low with 2 events (1.9 percent). About Pathalys Pharma, Inc. Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of ESKD. Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT in hemodialysis patients. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit www.pathalys.com . Contact Information Media Contact : Michael Parks 484.356.7105 Investor Contact: Patrick Treanor [email protected] pathalys.com ↗
2022-03-30 Pathalys Pharma Pathalys Pharma Announces Executive Team Appointments March 30, 2022 – Executive Leadership Team Brings Diverse Skills and Broad Expertise to New Venture – RESEARCH TRIANGLE PARK, N.C., March 30, 2022 – Pathalys Pharma, Inc., a private, late-stage biopharma company committed to the development and commercialization of a range of best-in-class therapies for patients with chronic kidney disease (CKD), today announced the executive leadership team for the newly formed company. Pathalys officially launched on March 1, 2022. “It is my privilege to announce Pathalys’ executive team. This robust and highly capable team of leaders has extensive experience in building companies and a demonstrated track record of delivering results in their respective areas,” said Neal Fowler, Chief Executive Officer at Pathalys Pharma, Inc. “I am confident that this group of accomplished leaders, along with our distinguished board, can deliver on our mission to successfully advance upacicalcet and other enhanced therapeutics with the expressed goal of transforming the lives of CKD patients.” The following individuals have joined the Pathalys Executive Team reporting to Mr. Fowler: Dr. Ashwin Ram – Co-founder and Senior Vice President, Operations Patrick Treanor – Chief Operating Officer David Banks – Senior Vice President, Technical Operations Dr. Theodore Danoff – Chief Medical Officer and Senior Vice President, Clinical Development Greg Klatt – Vice President, Finance Executive Leadership Team Ashwin Ram, M.D., is a Pathalys co-founder and the Senior Vice President, Operations. Dr. Ram is a physician-scientist, biotechnology entrepreneur, and investor at Catalys Pacific. He is the founder and chair of Jupiter Therapeutics, Inc., and previously worked at Genentech in early clinical development. Dr. Ram is a board-certified radiation oncologist who completed his medical degree at the University of Michigan Medical School with Alpha Omega Alpha honors and residency training at The Johns Hopkins Hospital. He completed a graduate degree in bioengineering at Caltech and a postdoctoral fellowship at Stanford University as an NIH/NCI Cancer Translational Nanotechnology Fellow. Patrick Treanor, M.B.A., is the Chief Operating Officer. Prior to his appointment, Mr. Treanor was President, U.S. for Vifor Pharma, an international pharmaceutical company focused on nephrology. Mr. Treanor started his career with large pharmaceutical organizations such as Johnson & Johnson (NYSE: JNJ) and Abbott Laboratories (NYSE: ABT) over 25 years ago but found his niche building early-stage commercial organizations at companies such as Oscient Pharmaceuticals, AMAG Pharmaceuticals and Relypsa. Mr. Treanor holds a B.S. in Management from Bryant University and an M.B.A. from Rensselaer Polytechnic Institute. David Banks, M.B.A., is the Senior Vice President, Technical Operations. Mr. Banks has more than 30 years of manufacturing, supply chain, and quality experience in the pharmaceutical industry, having held positions of increasing responsibility at several companies, including GSK (NYSE: GSK), Roche (as Syntex), Johnson & Johnson (as Alza), and Gilead (NASDAQ: GILD). Mr. Banks earned a B.S. in Engineering from Tennessee Tech University, a M.B.A. from East Tennessee State University, and a M.S. in Finance from the University of San Francisco. Theodore Danoff, M.D., Ph.D., is the Chief Medical Officer and Senior Vice President, Clinical Development . Dr. Danoff is a graduate of the Medical Scientist Training Program at the University of Chicago with a Ph.D. in Immunology. He completed his residency in internal medicine and fellowship in nephrology at the Hospital of the University of Pennsylvania and then served on the faculty as an Assistant Professor in the Renal Division in the Department of Medicine. He has worked in the pharmaceutical industry for more than 20 years at organizations, including GlaxoSmithKline (NYSE: GSK), Endo Pharmaceuticals (NASDAQ: ENDP), Clarus Therapeutics (NASDAQ: CRTX), and Complexa Inc. He has co-authored more than 40 peer-reviewed publications, five book chapters, and has two issued patents. Greg Klatt, C.P.A., is the Vice President, Finance . Previously, Mr. Klatt was Assistant Controller at Aravive, Inc. (NASDAQ: ARAV), a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life-threatening diseases, including cancer and fibrosis. Before Aravive, he held positions at Alvarez & Marsal, as well as Ernst & Young. Mr. Klatt earned his B.S. at the University of Oregon and holds his license as a C.P.A. in the State of California. About Pathalys Pharma, Inc. Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of end stage kidney disease (ESKD). Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT in hemodialysis patients. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit www.pathalys.com . Contact Information Media Contact: Michael Parks 484.356.7105 Investor Contact: Patrick Treanor [email protected] pathalys.com ↗
2022-03-01 Pathalys Pharma Pathalys Pharma, Inc. Launches with Mission to Address High Priority Needs in Chronic Kidney Disease March 1, 2022 – Company Acquires License to EA Pharma’s Upacicalcet Worldwide Outside of Japan and Asia – – Industry Veteran Neal Fowler Named Chief Executive Officer of New Venture – RESEARCH TRIANGLE PARK, N.C., March 1, 2022 – Pathalys Pharma, Inc., a private, late-stage biopharma company committed to the development and commercialization of a range of best-in-class therapies for patients with chronic kidney disease (CKD), today announced its formation made possible through initial seed financing from DaVita Venture Group, part of DaVita Inc. (NYSE: DVA), and Catalys Pacific. Pathalys launches with a novel clinical-stage asset, upacicalcet, that was acquired through a license granted by EA Pharma for exclusive rights to the development and commercialization of the product, worldwide outside of Japan and Asia. “We are excited about this opportunity to join forces with DaVita, a recognized leader in kidney care, in an effort to advance multiple best-in-class therapies for patients with CKD who are in need of better treatments – beginning with upacicalcet,” said BT Slingsby, M.D., Ph.D., M.P.H., founder and Executive Chairman of Pathalys and Managing Partner, Catalys Pacific. Upacicalcet is an intravenously administered investigational small molecule calcimimetic that may control intact parathyroid hormone (iPTH) levels in patients with secondary hyperparathyroidism (SHPT) receiving hemodialysis (HD). Upacicalcet was granted Marketing Authorization in Japan in 2021, under the brand name UPASITA®, based on a phase 3, 24-week double-blind, placebo-controlled dose-titration study and a second phase 3, 52-week open-label, dose-titration study. In these studies, upacicalcet was shown to significantly reduce iPTH and maintain long-term iPTH suppression, as well as demonstrate the potential for fewer adverse events (AEs) than currently available therapies. In anticipation of a submission to the U.S. Food and Drug Administration (FDA), Pathalys intends to conduct two identical phase 3 clinical trials designed as randomized, double-blind, placebo-controlled studies with 27-week individualized dose titration periods in patients with SHPT due to end-stage kidney disease (ESKD) on maintenance HD. “DaVita’s support of Pathalys Pharma underscores our commitment to bringing to market innovations that may help improve the health and quality of life of kidney care patients,” said Mahesh Krishnan, M.D., M.PH., M.B.A., F.A.S.N., Pathalys director, and Group Vice President of Research and Development at DaVita. “By combining the unique development strengths of Catalys Pacific with DaVita’s kidney care expertise, we believe Pathalys can be a platform for delivering a range of novel products and solutions that help improve patient lives.” Chief Executive Officer and Board Appointments Joining BT Slingsby and Mahesh Krishnan on the Pathalys Board of Directors are Jay Shepard, Pathalys co-founder and Venture Partner at Catalys Pacific; and Takeshi Takahashi, M.B.A., Pathalys co-founder and Managing Partner at Catalys Pacific. Additionally, Neal Fowler, a seasoned industry veteran and former Chief Executive Officer (CEO) at Liquidia Corporation (NASDAQ: LQDA) has been appointed CEO at Pathalys and will serve on the company’s board of directors. BT Slingsby continued, “We are very pleased to welcome Neal to Pathalys as CEO and member of the Pathalys Board of Directors. Neal is a proven business leader with significant experience and success in the biopharmaceutical industry and at all stages of a company’s life cycle. We are delighted to have a leader of his caliber and unwavering commitment to success lead this new venture.” While at Liquidia, Mr. Fowler also co-founded and served as CEO of Envisia Therapeutics (acquired), an ophthalmology therapeutics company. Prior to Liquidia, Neal worked for seven years with Johnson & Johnson (NYSE: JNJ), serving as President of Centocor, Inc., a global multi-billion-dollar subsidiary focused on biomedicines, and President of Ortho-McNeil Neurologics, a company focused on neurological disorders. Mr. Fowler started his career with Eli Lilly and Company, working for 13 years in a variety of sales, marketing, and business development roles in both the pharmaceutical and medical device divisions. Mr. Fowler is the current chair of both NCBIO and the UNC Eshelman School of Pharmacy Foundation. He is a native of Raleigh, North Carolina and earned his B.S. degree in Pharmacy and M.B.A., both from the University of North Carolina at Chapel Hill. “I am honored to have the opportunity to lead Pathalys, a company formed by industry leaders with a passion to improve the lives of patients living with CKD. I am very optimistic about the future of our organization and our lead asset, upacicalcet, as well as the other opportunities that exist to expand our portfolio,” said Mr. Fowler. “I look forward to announcing additional members of our Executive Team soon, and to working with them and members of the Pathalys Board of Directors to bring meaningful change to the lives of CKD patients and value to our stakeholders.” About Pathalys Pharma, Inc. Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of advanced therapeutics that address unmet needs in the management of ESKD. Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit www.pathalys.com . About Catalys Pacific Catalys Pacific is an independent venture capital firm focusing on early-stage investments in life sciences. The firm’s mission is to focus on providing healthcare solutions for patients worldwide through the creation of and investment in biotech companies. Catalys Pacific is led by a global team versed in working closely with its partners in academia, biotech, venture capital and the pharmaceutical industry in Japan and worldwide. The firm maintains offices in Tokyo and Kanagawa (Shonan Health Innovation Park), Japan and in San Francisco, California. For more information about Catalys Pacific, please visit www.catalyspacific.com . About DaVita DaVita (NYSE: DVA) is a comprehensive kidney care provider focused on transforming care to improve the quality of life for patients globally. The company is one of the largest providers of kidney care services in the U.S. and has been a leader in clinical quality and innovation for more than 20 years. DaVita is working to help increase equitable access to care for patients at every stage and setting along their kidney health journey—from slowing progression of kidney disease to streamlining the transplant process, from acute hospital care to dialysis at home. As of December 31, 2021, DaVita served 203,000 patients at 2,815 outpatient dialysis centers in the U.S. The company operated an additional 339 outpatient dialysis centers in ten countries worldwide. DaVita has reduced hospitalizations, improved mortality and worked collaboratively to propel the kidney care community to adopt an equitable, high-quality standard of care for all patients, everywhere. To learn more, visit DaVita.com/About . About EA Pharma Co., Ltd. EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd., was established in April 2016 by integration of the gastrointestinal business unit with more than 60 year’s history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a gastrointestinal specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing. For further information on EA Pharma Co., Ltd., please visit www.eapharma.co.jp/en . DaVita Inc. Forward-Looking Statements Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties. These forward-looking statements are based on management’s current expectations. Various important factors could cause actual results to differ materially from these forward-looking statements, including the risks identified in our U.S. Securities and Exchange Commission filings. DaVita disclaims any obligation to update any forward-looking statement contained in this press release, except as may be otherwise required by law. Contact Information Media Contact: Michael Parks 484.356.7105 Investor Contact: Patrick Treanor [email protected] pathalys.com ↗

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as UPACICALCET ChEMBL registry synonym — accepted as the source's own label CHEMBL6068421 ↗
Known as AJT-240 ChEMBL registry synonym — accepted as the source's own label CHEMBL6068421 ↗
Known as AJT240 SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL6068421 ↗
Known as PLS240 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05832931 ↗
1

NCT05836220 ↗
Known as PLS240 SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL6068421 ↗
Known as SK-1403 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03226171 ↗
2

NCT03801980 ↗

NCT03626948 ↗
Known as SK-1403 SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL6068421 ↗
Known as UPACICALCET SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL6068421 ↗
Modality Small molecule — CHEMBL6068421 ↗
Route Intravenous “administered by intravenous bolus injection” NCT03626948 ↗