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Centessa Pharmaceuticals plc (NASDAQ: CNTA) is a next-generation biopharmaceutical company based in Cambridge, Massachusetts, dedicated to transforming the traditional drug development model. By leveraging an asset-centric R&D approach at scale, Centessa is advancing a robust pipeline of highly validated programs led by industry-leading teams. Each program is managed by a Centessa subsidiary and supported by a centralized infrastructure and executive management team.
The company’s clinical-stage assets include:
- SerpinPC - A novel treatment for Hemophilia A and B, currently in Phase 2b trials. SerpinPC is a subcutaneously administered inhibitor of APC, aiming to provide effective treatment irrespective of severity or inhibitor status.
- LB101 - A cutting-edge PD-L1xCD47 LockBody, targeting solid tumors. LB101 is currently in a Phase 1/2a clinical trial, designed to selectively drive potent effector functions to the tumor micro-environment while minimizing systemic toxicity.
- ORX750 - An orally administered, highly selective orexin receptor 2 (OX2R) agonist for Narcolepsy Type 1 (NT1) and other sleep disorders, currently in its Phase 1 clinical study.
- MGX292 - Targeting Pulmonary Arterial Hypertension (PAH).
- Undisclosed programs targeting solid tumors.
Recent Achievements include:
- Phase 2b study PRESent-3 of SerpinPC showing promising preliminary results.
- FDA Fast Track designation for SerpinPC in treating Hemophilia B.
- Progress in LB101's Phase 1/2a clinical trial.
- Launch of the Phase 1 study for ORX750, with initial proof-of-concept data in sleep-deprived healthy volunteers expected later this year.
Centessa’s innovative approach and comprehensive pipeline aim to deliver transformational medicines to patients, setting a new standard of care. For more information, visit their official website at http://www.centessa.com/.
Centessa Pharmaceuticals (CNTA) announced promising preclinical results for LB101, a PD-L1xCD47 LockBody, at the 2022 ASCO Annual Meeting. The data showed that LB101, delivered systemically as a single-agent, resulted in significant tumor regressions in a mouse model, with 26 out of 32 tumors eradicated. Importantly, no toxicity was observed, suggesting a favorable safety profile. The company plans to advance LB101 into clinical trials by late 2022, aiming to transform immuno-oncology treatments.
Centessa Pharmaceuticals (Nasdaq: CNTA) announced the discontinuation of lixivaptan's development for Autosomal Dominant Polycystic Kidney Disease (ADPKD) due to safety concerns, specifically elevated ALT/AST levels observed in the ALERT Study. This strategic move is expected to significantly decrease cash burn and extend the company’s financial runway into 2026. Centessa aims to focus on its rare disease and immuno-oncology pipeline, anticipating multiple clinical proof of concept readouts in the next 12 to 24 months.
Centessa Pharmaceuticals (CNTA) has outlined its progress in advancing its rare disease and immuno-oncology pipeline toward its '4x24' goal, aiming for four registrational programs in 2024. Key updates include the ongoing registrational ACTION Study for lixivaptan targeting ADPKD and a Phase 1 study for ZF874 in AATD. As of March 31, 2022, Centessa reported cash and cash equivalents of $544.5 million, ensuring operational funding through mid-2024. The first quarter saw R&D expenses of $36.9 million and a net loss attributable to ordinary shareholders of $54.5 million.
Scorpion Therapeutics has appointed Dr. Saurabh Saha to its Board of Directors. Dr. Saha, CEO of Centessa Pharmaceuticals, has over 20 years of experience in biopharmaceutical research. This strategic appointment aligns with Scorpion's Precision Oncology 2.0 strategy, aiming to enhance cancer treatment development. Dr. Saha's expertise is expected to be pivotal as the company prepares for investigational new drug applications for its lead programs in the upcoming year.
Centessa Pharmaceuticals (NASDAQ: CNTA) reported a net loss of $60.8 million for Q4 2021 and $381.1 million for the full year, primarily driven by $220 million in R&D expenses from acquisitions. The company holds $595.1 million in cash as of December 31, 2021, aimed to fund operations into early 2024.
The company focuses on rare diseases and immuno-oncology, with SerpinPC registrational studies planned for Hemophilia B in 2H 2022, and Lixivaptan in a Phase 3 trial for ADPKD. Centessa's '4x24' goal aims for four registrational programs by 2024.
Centessa Pharmaceuticals (Nasdaq: CNTA) announced that CEO Saurabh Saha will present at the Guggenheim Genomic Medicines & Rare Disease Day on March 31, 2022, at 11:00 AM ET. Investors can access the live webcast and archived recordings on the company’s investor relations website.
This presentation aligns with Centessa's mission to develop impactful medicines across various therapeutic areas, including oncology, hematology, and neuroscience. For more details, visit Centessa's website.
Centessa Pharmaceuticals (Nasdaq: CNTA) announced the appointment of Antoine Yver, MD, MSc, as Executive Vice President and Chairman of Development, and Javad Shahidi, MD, MSc, as Chief Medical Officer. Dr. Yver will oversee overall development strategy, while Dr. Shahidi will manage clinical development teams. CEO Saurabh Saha emphasized the recruitment of talent amid plans for registrational trials and entry of multiple assets into clinical phases. Dr. Shahidi's previous role at Daiichi Sankyo involved leading significant oncology programs.
Centessa Pharmaceuticals (Nasdaq: CNTA) and its subsidiary Palladio Biosciences have initiated dosing in the pivotal Phase 3 ACTION Study, evaluating lixivaptan for Autosomal Dominant Polycystic Kidney Disease (ADPKD). This trial aims to enroll ~1,350 participants across 200 sites in over 20 countries, with completion expected in H2 2023. Positive results may lead to a New Drug Application (NDA) submission post the double-blind study phase. Lixivaptan's unique profile may mitigate liver toxicity issues associated with existing ADPKD therapies, enhancing its therapeutic potential.
Centessa Pharmaceuticals (CNTA) has initiated the global ACTION Study, a pivotal Phase 3 clinical trial investigating lixivaptan as a treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). With up to 1,350 subjects, the double-blind trial aims to assess lixivaptan's efficacy in slowing renal function decline over 52 weeks. Initial safety data from four subjects in the ALERT Study show successful titration of lixivaptan without liver toxicity, while a new patent protects lixivaptan use in ADPKD until 2038. The first subject is expected to be dosed in Q1 2022.
Centessa Pharmaceuticals (Nasdaq: CNTA) announced its upcoming addition to the NASDAQ Biotechnology Index, effective December 20, 2021. This index includes companies classified as Biotech or Pharma that meet specified criteria. The announcement reflects Centessa's innovative, asset-centric model aimed at developing impactful medicines across multiple therapeutic areas such as oncology and immunology. This addition may enhance Centessa's visibility and investor interest, potentially influencing its stock performance positively.
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