Anuncio • Jul 06
Centessa Pharmaceuticals plc Files Form 15 Centessa Pharmaceuticals plc has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Ordinary Shares, nominal value 0.002 per share and American Depositary Shares, each representing one ordinary share under the Securities Exchange Act of 1934, as amended. Anuncio • Jun 26
Centessa Pharmaceuticals plc(NasdaqGM:CNTA) dropped from NASDAQ Composite Index Centessa Pharmaceuticals plc has been dropped from the NASDAQ Composite Index Anuncio • May 04
Centessa Pharmaceuticals plc, Annual General Meeting, Jun 12, 2026 Centessa Pharmaceuticals plc, Annual General Meeting, Jun 12, 2026. Location: sancroft, 10-15 newgate street, ec1a 7az, london United Kingdom New Risk • Apr 02
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shares are highly illiquid. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$208m net loss in 3 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Significant insider selling over the past 3 months (€2.8m sold). Board Change • Mar 31
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 7 experienced directors. No highly experienced directors. CEO & Director Mario Accardi was the last director to join the board, commencing their role in 2026. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Anuncio • Mar 31
Eli Lilly and Company (NYSE:LLY) entered into a definitive agreement to acquire Centessa Pharmaceuticals plc (NasdaqGS:CNTA) from Medicxi Ventures (UK) LLP, Index Ventures SA, General Atlantic Service Company, L.P. and other shareholders for $5.6 billion. Eli Lilly and Company (NYSE:LLY) entered into a definitive agreement to acquire Centessa Pharmaceuticals plc (NasdaqGS:CNTA) from Medicxi Ventures (UK) LLP, Index Ventures SA, General Atlantic Service Company, L.P. and other shareholders for $5.6 billion on March 31, 2026. Under the terms of the transaction agreement, Eli Lilly will acquire all of the issued and to be issued share capital of Centessa (including the American Depositary Shares (ADSs) representing ordinary shares) for $38.00 in cash per share plus one non-transferrable contingent value right (CVR) that entitles the holder to receive up to an aggregate of $9.00 subject to the achievement of three milestones described below, for total potential aggregate per share consideration of up to $47.00. CVR holders would become entitled to receive contingent payments as follows: (i) $2.00 per CVR in cash, upon U.S. FDA approval of cleminorexton (formerly ORX750) or ORX142 for the treatment of narcolepsy type 2 prior to the fifth anniversary of transaction closing; (ii) $5.00 per CVR in cash, upon U.S. FDA approval of cleminorexton (formerly ORX750) or ORX142 for the treatment of idiopathic hypersomnia prior to the fifth anniversary of transaction closing; and (iii) $2.00 per CVR in cash, upon the first U.S. FDA approval of cleminorexton (formerly ORX750) or ORX142 for the treatment of any indication prior to January 1, 2030. The agreement stipulates a $63.06 million termination fee payable by the target to the buyer.
Entities affiliated with Medicxi Ventures, entities affiliated with Index Ventures, and affiliates of General Atlantic have signed voting and support agreements whereby they agree to vote to approve the transaction. The shares subject to the agreements represent a total of approximately 24.1% of Centessa’s outstanding ordinary shares (represented by ADSs). The transaction, which will be effectuated by way of a scheme of arrangement under the laws of England and Wales, subject to approval by Centessa shareholders, sanction by the High Court of Justice of England and Wales and satisfaction of other customary closing conditions, including regulatory and antitrust approvals. The boards of directors of both companies have approved the transaction. The transaction is expected to close in the third quarter of 2026.
Morgan Stanley & Co. LLC acted as financial advisor for Eli Lilly and Company. Sarkis Jebejian, Keri Schick Norton, Steven M. Choi of Kirkland & Ellis LLP and Dipak Bhundia, Bonian Wu of Kirkland & Ellis International LLP acted as legal advisor for Eli Lilly and Company. Centerview Partners LLC and Jefferies LLC acted as financial advisors for Centessa Pharmaceuticals plc. Stuart M Cable, Lisa R Haddad, Blake Liggio of Goodwin Procter LLP acted as legal advisor for Centessa Pharmaceuticals plc. Anuncio • Jun 18
Centessa Pharmaceuticals plc Announces Clearance of Investigational New Drug Application for ORX142 Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has cleared the IND to initiate a Phase 1 clinical study of ORX142 in healthy volunteers. ORX142 is an investigational, novel, highly potent and selective OX2R agonist being developed for the treatment of select neurological and neurodegenerative disorders. ORX142 is the second drug candidate from the Company’s multi-asset orexin franchise. The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX142 in healthy volunteers. In parallel to the SAD, a placebo-controlled crossover pharmacodynamic (PD) assessment will be performed utilizing the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS) in acutely sleep-deprived healthy adult subjects. The Company plans to initiate the first-in-human Phase 1 clinical study imminently, with clinical data expected 2025. Anuncio • Apr 23
Centessa Pharmaceuticals plc, Annual General Meeting, Jun 20, 2025 Centessa Pharmaceuticals plc, Annual General Meeting, Jun 20, 2025. Location: offices of goodwin procter (uk) llp at sancroft, 10-15 newgate street, london, ec1a 7az, United Kingdom Anuncio • Jan 08
Centessa Pharmaceuticals Announces Appointment of Stephen Kanes as Chief Medical Officer Centessa Pharmaceuticals plc announced the appointment of Stephen Kanes MD PhD, as Chief Medical Officer (CMO). Dr. Kanes is a neuropsychiatrist, with a career in neuroscience, clinical psychiatry, and neuroscience drug development spanning more than 30 years. Dr. Kanes served as Chief Medical Officer of Sage Therapeutics from 2013 to 2021, where he led the successful clinical development of ZULRESSO® (brexanolone), the first-ever treatment approved for Postpartum Depression (PPD), along with the buildout of the development organization and Sage Therapeutics' broad neuroscience portfolio. Most recently, Dr. Kanes was Chief Executive Officer of EmbarkNeuro, a neuroscience focused biotech company. Earlier in his career, Dr. Kanes was Executive Director in Clinical Development in the Inflammation, Neuroscience and Respiratory therapeutic areas at AstraZeneca, and a faculty member of the University of Pennsylvania Department of Psychiatry where he explored both the genetics and physiology of severe mental illness. He has authored or co-authored more than 60 peer-reviewed publications in behavioral neuroscience, behavioral pharmacology, genetics, brain imaging, clinical trials, and health economics and serves as an ad hoc reviewer for multiple journals including Neuropsychopharmacology andThe American Journal of Medical Genetics and Biological Psychiatry. Dr. Kanes received his BA from the University of Pennsylvania in the Biological Basis of Behavior and both his PhD in Molecular and Cellular Pharmacology and MD from the Stony Brook University Renaissance School of Medicine. He completed his psychiatry residency at Yale-New Haven Medical Center and a neuropsychiatry postdoctoral fellowship at the University of Pennsylvania. Anuncio • Nov 13
Centessa Pharmaceuticals Initiates Phase 2 Trial with ORX750, a Novel Orexin Receptor 2 (OX2R) Agonist Nxera Pharma Co. Ltd. announced that Centessa Pharmaceuticals has initiated a Phase 2 trial of ORX750, an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) antagonist for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia. The achievement of this milestone results in a payment of USD 3.5 million to Nxera pursuant to its research collaboration with Centessa. This will be recognised as revenue in Fourth Quarter Fiscal Year 2024. ORX750 was designed using Nxera technology to directly target the underlying pathophysiology of orexin neuron loss in NT1, with potential applicability to NT2, idiopathic hypersomnia, and other sleep- wake disorders with normal orexin levels. Anuncio • Sep 12
Centessa Pharmaceuticals plc has filed a Follow-on Equity Offering in the amount of $150 million. Centessa Pharmaceuticals plc has filed a Follow-on Equity Offering in the amount of $150 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock) Anuncio • Sep 10
Centessa Pharmaceuticals plc Announces Positive Interim Phase 1 Clinical Data with Its Novel Orexin Receptor 2 (OX2R) Agonist, Orx750, in Acutely Sleep-Deprived Healthy Volunteers Centessa Pharmaceuticals plc announced positive interim data from an ongoing Phase 1 trial of its highly potent and selective orexin receptor 2 (OX2R) agonist, ORX750, in acutely sleep-deprived healthy volunteers. ORX750 showed clinically meaningful and statistically significant improvements in mean sleep latency at the first two doses evaluated (1.0 mg and 2.5 mg) in the Maintenance of Wakefulness Test (MWT) compared to placebo. More specifically, the 2.5 mg dose was shown to restore normative wakefulness2 with a mean sleep latency of 32 minutes as measured by the MWT. ORX750 was also shown to have a favorable safety and tolerability profile with no observations of frequently reported on-target adverse events (AEs) associated with other OX2R agonists, and no cases of hepatotoxicity or visual disturbances across all three dose levels tested (1.0 mg, 2.0 mg, and 2.5 mg), as of the data cutoff date.1 Based on the interim data, the Company plans to rapidly advance ORX750 into Phase 2 studies in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) beginning in the fourth quarter of 2024. The Phase 1 clinical study is an ongoing first-in-human, randomized, placebo-controlled study designed to evaluate the safety, tolerability and pharmacokinetics (PK) of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects. In parallel to the SAD, a placebo-controlled cross-over pharmacodynamic (PD) assessment is being performed utilizing the MWT and Karolinska Sleepiness Scale (KSS) in acutely sleep-deprived healthy adult subjects with the goal of rapidly generating early efficacy data to inform dosing for planned studies in patients. As of September 10, 2024, the study has completed three SAD cohorts of healthy volunteers (27 active, 9 placebo) with doses of 1.0 mg, 2.0 mg, and 2.5 mg, and has advanced through two cohorts within the cross-over assessment of acutely sleep-deprived healthy volunteers with doses of 1.0 mg (n=8) and 2.5 mg (n=8), administered as a single oral dose. Dosing in the MAD portion of the study is also ongoing. Board Change • Jun 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 7 experienced directors. No highly experienced directors. Independent Non-Executive Director Mathias Hukkelhoven was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Anuncio • Apr 23
Centessa Pharmaceuticals plc Announces Open IND for ORX750 Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human, clinical trial of ORX750 for the treatment of narcolepsy. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1), with potential applicability to narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other sleep-wake disorders with normal orexin levels. The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects. In parallel to the SAD, a cross-over pharmacodynamic (PD) assessment will be performed utilizing the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS) in acutely sleep-deprived healthy adult subjects which is intended to provide proof-of-concept data to enable dose selection for NT1, NT2 and IH indications. The study has a maximum exposure limit specified by the FDA which the Company believes significantly exceeds the predicted efficacious doses of ORX750 in indications associated with or without orexin loss; therefore, the Company does not expect this limit to affect any of the planned clinical development activities for ORX750. The Company expects to commence dosing of the Phase 1 study in healthy volunteers imminently, and proof-of-concept data are anticipated in the second half of 2024. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1). ORX750 has been shown to potently activate the OX2R with an in vitro EC50 of 0.11 nM and 9,800-fold selectivity over the human orexin receptor (hOX1R). ORX750 is Centessa’s first orexin product candidate being developed for the treatment of narcolepsy with potential expansion into narcolepsy type 2 (NT2), idiopathic hypersomnia (IH) and other sleep-wake disorders. Anuncio • Dec 11
Centessa Pharmaceuticals plc Announces New Data from an Additional 52-Weeks of Continuous Treatment from Third Year (Part 5) of Ongoing Phase 2A Study of Serpinpc for the Treatment of Hemophilia Centessa Pharmaceuticals plc announced new data from an additional 52-we weeks of continuous treatment from the third year (Part 5) of the ongoing Phase 2a study of SerpinPC for the treatment of hemophilia. The data were shared in a poster presentation at the American Society of Hematology (ASH) Annual Meeting on December 10, 2023. During treatment with SerpinPC all breakthrough bleeds were treated on-demand w ith usual clotting factor concentrate, without dose reduction and without limitation of number of infusions. Data from Part 5 were presented at the ASH Annual Meeting in a poster titled: SerpinPC in persons with severe hemophilia (PwH): Updated results from a multi-center, multi-part, first-in-human study. Anuncio • Nov 01
Centessa Pharmaceuticals plc Announces Dosing of First Subject in Registrational Present-3 Study Evaluating Serpinpc for the Treatment of Hemophilia B with Inhibitors Centessa Pharmaceuticals plc announced the dosing of the first subject in its registrational Present-3 study of SerpinPC for the treatment of hemophilia B with inhibitors. The dosing phase of Present-3 follows a minimum 12-week observation period during which prospective baseline data of the subject's disease status under their current therapy are collected to support regulatory review of the benefit and risk profile of SerpinPC. SerpinPC is a subcutaneously administered novel inhibitor of APC being developed as a potential treatment for hemophilia, regardless of severity or inhibitor status, and which may also be developed to prevent bleeding associated with other bleeding disorders. The registrational program for SerpinPC in hemophilia B includes a set of clinical studies with multiple components. Present-5 is an observational feeder study to collect prospective observational data for minimum defined periods before switching to dosing subjects in the interventional studies. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC for the treatmentof hemophilia B, with or without inhibitors. SerpinPC is an investigational agent that has not been approved by the FDA or any other regulatory authority. Anuncio • Oct 26
Centessa Pharmaceuticals plc Announces Preclinical Data Supporting Orx750's Potential as A Best-In-Class Oral Ox2r Agonist for the Treatment of Narcolepsy and Other Sleep-Wake Disorders Centessa Pharmaceuticals plc announced a robust set of new preclinical data from in vivo and in vitro studies of its investigational, novel orexin receptor 2 (OX2R) agonist, ORX750, that support its potential best-in-class profile for the treatment of narcolepsy and other sleep- wake disorders. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (ox2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1). ORX750 is Centessa's first orexin product candidate being developed for the treatment of narcolpsy with potential expansion into other sleep- wake disorders.ORX750 is currently undergoing IND-enabling activities and has not been administered as an investigational drug to humans in any jurisdiction. Any such statements that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to: the Company's ability to deliver transformational medicines to patients; the activity significance of low doses in highly predictive, translational models of narcolepsy type 1 ("NT1") including maximal wake times and suppressed cataplexy at the lowest oral dose tested; the Company's expectations on the timing of Ind-enabling studies of ORX750 in narcolepsy and other Sleep- wake disorders; the ability of management team and board to drive execution of the Company's portfolio of programs; asset-centric business model and the intended advantages and benefits thereof; the scope, progress, results and costs of developing product candidates or any other future product candidates; current expectations concerning, amongst other things, the development and therapeutic potential and benefits of product candidates, including ORX750 and other OX2R agonists; strategy; regulatory matters, including the timing and likelihood of initiating clinical trials, reporting clinical trial results, ability to initiate or continue clinical trials or market any products; and the market size and opportunity for product candidates. Based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set out in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the safety and tolerability profile of product candidates including ORX750; ability to protect and maintain intellectual property position; business (including commercial viability), regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing product candidates and technologies; ability to obtain adequate financing, including through financing facility with Oberland, to fund planned clinical trials and other expenses; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; future expenditures risks related to asset-centric corporate model; the risk that any one or more of product candidates will not be successfully developed and/or commercialized; and the risk that the results of non-clinical studies or clinical studies will not be predictive of future results. Anuncio • Aug 25
World Sleep Congress Releases an Abstract Submit by Centessa Pharmaceuticals plc On August 22, 2023, the World Sleep Congress 2023 released an abstract submitted by Centessa Pharmaceuticals Plc. containing preclinical data on ORX750, the company's orally administered, selective orexin receptor 2 (OX2R) agonist in development for the treatment of narcolepsy and other sleep disorders. The company will present the abstract in an oral presentation on October 25, 2023. Introduction: Narcolepsy Type 1 (NT1) is a rare neurological disease caused by the profound loss of orexin-producing neurons. Orexin (also called hypocretin) is a neurotransmitter that regulates wakefulness, arousal, and energy homeostasis via activation of Orexin Receptor-1 (OX1R) and -2 (OX2R). Orexin agonists are designed to directly address the underlying disease pathology of NT1 to restore orexin neurotransmission in the brain. The orexin/ataxin-3 (Atax) mouse model of NT1 recapitulates key features of the human disorder, such as orexin loss, inability to sustain wakefulness, and cataplexy (emotionally triggered, transient loss of muscle tone). Here it present ORX750, a novel, orally available, brain penetrant, OX2R selective agonist. ORX750 was developed using structure-based drug design with an OX2R stabilized receptor (StaR®) protein and high-resolution protein crystallography. Materials and Methods: In vitro calcium mobilization (FLIPR), ß-arrestin recruitment, and inositol-phosphate accumulation assays were performed in Chinese hamster ovary (CHO) cells stably expressing human recombinant OX1R or OX2R. Electrophysiological recordings were performed on slices of the ventral tuberomammillary nucleus (TMN) from mouse hypothalamus; effects on membrane potential were measured in the presence of 1 micromolar tetrodotoxin to block neuron firing. In vivo efficacy for enhancing wakefulness was evaluated in wild type (WT) and Atax mice during their rest phase using PiezoSleep, a rapid, non-invasive method for classifying sleep and wakefulness by unsupervised machine learning on physiologically relevant readouts, including body movement and breath rate. Electroencephalogram (EEG), electromyogram (EMG), and video recordings were used in Atax mice during their active phase to evaluate effects at 0.3-10 mg/kg on arousal states and cataplexy. Results: ORX750 behaved as a potent full agonist at human OX2R (EC50=0.11 nM) relative to the native ligand orexin A (OXA; EC50=0.035 nM) and showed 9,800-fold selectivity over human OX1R (EC50=1100 nM) in the FLIPR assay. Biased agonism was not detected by measurement of b-arrestin recruitment at OX2R in comparison to OXA. ORX750 depolarized membrane potential (EC50=5.0 nM, max DmV=9.5) in whole cell current-clamp recordings in the TMN. In the PiezoSleep assay, in which wakefulness readouts are highly correlated with EEG/EMG-defined wakefulness, ORX750 increased time awake and the consolidation of wakefulness vs. vehicle in a dose-related manner when administered to WT and Atax mice during the rest phase. Increased sensitivity to these wake-promoting effects was observed in Atax vs. WT mice. In Atax mice, ORX750 increased time awake; consolidated wakefulness; increased EEG gamma power during wakefulness; reduced cataplexy occurrences; and increased latencies to sleep and cataplexy in a dose-related manner during the active phase using the EEG/EMG/video assay. At the lowest dose tested (0.3 mg/kg) and compared to vehicle, the latency to sleep was 2.3 h vs. 0.69 h and the latency to cataplexy was 2.7 h vs. 1.3 h. Conclusions: ORX750 is an oral, highly potent, and selective OX2R agonist with the potential to treat patients with primary symptoms of NT1, as well as reduce excessive sleepiness in those presenting sleep/wake disorders with normal orexin levels. Anuncio • Jul 12
Centessa Pharmaceuticals Announces Dosing of First Subject in Registrational PRESent-2 Study Evaluating SerpinPC for the Treatment of Hemophilia B Without Inhibitors Centessa Pharmaceuticals plc announced the dosing of the first subject in its registrational PRESent-2 study of SerpinPC for the treatment of hemophilia B without inhibitors. The dosing phase of PRESent-2 follows a minimum 12-week observation period during which prospective baseline data of the subject’s disease status under their current therapy are collected to support regulatory review of the benefit and risk profile of SerpinPC. SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) being developed as a potential treatment for hemophilia B, with or without inhibitors. The PRESent-2 study (AP-0102) is a Phase 2b, global, open-label, seamless adaptive design study to investigate the efficacy and safety of subcutaneous dosing of SerpinPC every week, every 2 weeks, or every 4 weeks in approximately 120 adult (aged 18 to =65 years) or adolescent (aged =12 to <18 years) male subjects with severe hemophilia A (with or without inhibitors) or moderately severe to severe hemophilia B (without inhibitors). PRESent-2 consists of 3 parts: a 24-week randomized dose-justification phase (Part 1), a 24-week dose-confirmatory phase (Part 2), and a further 24-week extension phase (Part 3) for subjects who complete either Part 1 or Part 2. Subjects must have undergone a minimum period of prospective observation (at least 12 weeks for Part 1 or 24 weeks for Part 2) under their current therapy (either on-demand or prophylaxis factor replacement) before switching to SerpinPC treatment. The primary efficacy endpoint for the study is the rate of treated bleeds (expressed as an annualized bleeding rate (ABR)) in the observation period compared to the first 24 weeks treated with SerpinPC. The Company expects to begin dosing in its registrational PRESent-3 (AP-0103) study for subjects with hemophilia B with inhibitors this year. Board Change • Jun 23
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. No experienced directors. No highly experienced directors. Independent Non-Executive Chairman of the Board Francesco de Rubertis is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Anuncio • May 23
Centessa Pharmaceuticals Receives Fast Track Designation from the U.S. FDA for Serpinpc for Hemophilia B Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors. According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval, Priority Review, or Rolling Review. Anuncio • Jan 27
Centessa Pharmaceuticals Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of LB101, First LockBody® Candidate, for Solid Tumors Centessa Pharmaceuticals plc announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a first-in-human, clinical trial of LB101 for the treatment of solid tumors. LB101, a conditionally tetravalent PD-L1xCD47 LockBody® bispecific monoclonal antibody targeting solid tumors, is the first product candidate developed using the Company’s proprietary LockBody technology which is designed to selectively drive potent effector function activity, such as CD47, in the tumor microenvironment (TME) while avoiding systemic toxicity. Board Change • Jan 06
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. No experienced directors. No highly experienced directors. Independent Chairman of the Board Francesco de Rubertis is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. 
