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Last update 28 Jul 2026
Prasinezumab
Last update 28 Jul 2026
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms Prasinezumab (USAN/INN), 普拉西奈珠单抗, NEOD-002 + [6] |
Target |
Action inhibitors |
Mechanism α-synuclein inhibitors(Synuclein alpha inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Sequence Code 170717L
Source: *****
Sequence Code 9795397H
Source: *****
Related
7
Clinical Trials associated with PrasinezumabNCT07055087
A Randomized, Double-blind, Placebo-controlled, 104-week Proof-of-concept Study to Evaluate the Efficacy of Intravenous Prasinezumab in Participants With Parkinson's Disease Carrying a Severe Mutation in the GBA Gene
This is a proof-of-concept trial to investigate the efficacy of prasinezumab to slow or prevent cognitive decline in people with Parkinson's disease carrying a severe mutation in the GBA (glucocerebrosidase) gene. The duration of the intervention per patient will be 104 weeks with monthly infusions. The investigators plan to enroll 120 participants (60 participants per treatment arm). This study will be conducted across Europe in the following countries: France, Germany, Italy, Luxembourg, Spain, Sweden, UK.
Start Date01 Dec 2025 |
Sponsor / Collaborator- |
NCT07174310
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early-Stage Parkinson's Disease
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
Start Date24 Nov 2025 |
Sponsor / Collaborator |
NCT04777331
A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.
Start Date05 May 2021 |
Sponsor / Collaborator |
100 Clinical Results associated with Prasinezumab
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100 Translational Medicine associated with Prasinezumab
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100 Patents (Medical) associated with Prasinezumab
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21
Literatures (Medical) associated with Prasinezumab01 Jun 2026·CNS Neuroscience & Therapeutics
Progress of Immunotherapies in Parkinson's Disease
Review
Author: Liu, Jia ; Kazuo, Sugimoto ; Du, Miao‐qiao ; Yao, Shun‐yu ; Jiang, Dai‐yi ; Chen, Quan ; Jin, Hong ; Peng, Yong ; Kang, Xu‐hui ; Zhang, Xiuli ; Lin, Lan‐xin
ABSTRACT:
Background:
Immune dysregulation plays a pivotal role in the pathogenesis and progression of Parkinson's disease (PD). Increasing evidence suggests that immunotherapies targeting α‐synuclein (α‐syn) pathology may offer potential disease‐modifying strategies for PD.
Objective:
This review aims to systematically summarize recent advances in α‐syn–targeted immunotherapies for PD and to evaluate the translational challenges and future directions of precision immunotherapy.
Methods:
We critically reviewed the preclinical evidence and clinical trial outcomes of both active immunization strategies, including PD01A and UB‐312, and passive monoclonal antibody therapies, such as prasinezumab and cinpanemab.
Results:
Early‐phase studies demonstrated favorable safety profiles and robust peripheral target engagement for several immunotherapeutic candidates. However, recent Phase II clinical trials, including PASADENA and SPARK, failed to achieve their primary clinical endpoints, highlighting a substantial gap between biological target engagement and meaningful clinical benefit. Emerging strategies aimed at overcoming these limitations include stage‐specific interventions, optimized patient stratification, and differentiated therapeutic approaches.
Conclusion:
Although current α‐syn–targeted immunotherapies have shown limited clinical efficacy, ongoing advances in precision immunotherapy and individualized intervention strategies may help overcome existing therapeutic bottlenecks. This review provides a strategic framework for the future development of disease‐modifying therapies for PD.
01 May 2026·LANCET
Efficacy and safety of intravenous prasinezumab in individuals with early-stage Parkinson's disease on stable symptomatic monotherapy (PADOVA): a phase 2b, multicentre, randomised, double-blind, placebo-controlled study
Article
Author: Pross, Nathalie ; Anzures-Cabrera, Judith ; Kerchner, Geoffrey A ; Respondek, Gesine ; Svoboda, Hanno ; Nikolcheva, Tania ; Postuma, Ronald B ; Kustermann, Thomas ; Trundell, Dylan ; Marek, Kenneth ; Pagano, Gennaro ; Stocchi, Fabrizio ; Seppi, Klaus ; Boak, Lauren ; Monnet, Annabelle ; Bonni, Azad ; Simuni, Tanya ; Rutten-Jacobs, Loes ; Pavese, Nicola ; Brundin, Patrik ; Schlegel, Valerie
BACKGROUND:
Prasinezumab has previously shown potential for reducing the progression of motor signs (Movement Disorder Society-sponsored Revision of the Unified Parkinson's Disease Rating Scale [MDS-UPDRS] Part III) in patients with early-stage Parkinson's disease who were treatment-naive or receiving monoamine oxidase type B (MAO-B) inhibitors. The aim of the PADOVA trial was to evaluate the efficacy and safety of prasinezumab in a broader population of patients receiving stable symptomatic medication.
METHODS:
This phase 2b, multicentre, double-blind, parallel-group, placebo-controlled, randomised, superiority trial recruited participants with early-stage Parkinson's disease (age 50-85 years, 3 months to 3 years from diagnosis, Hoehn and Yahr stage 1 or 2) on stable symptomatic medication from 110 centres in nine countries in Europe and North America. Participants were individually randomly assigned (1:1) via permuted blocks (stratified by symptomatic medication [levodopa or MAO-B inhibitor]) to intravenous prasinezumab (1500 mg) or placebo every 4 weeks for at least 76 weeks and until the target number of motor progression events was reached. Participants, investigators, and clinical assessors were masked to group assignment. The primary endpoint was time to a confirmed motor progression event (≥5-point increase in MDS-UPDRS Part III off-medication score), assessed in the full analysis set (all randomly assigned participants according to the treatment to which they were assigned). Safety and tolerability were assessed in all randomly assigned participants who received at least one dose of study drug, with participants grouped according to treatment received. The trial is registered with ClinicalTrials.gov (NCT04777331) and EudraCT (2020-004997-23), and is active, not recruiting.
FINDINGS:
Between May 5, 2021, and March 22, 2023, 787 individuals were screened. 586 were enrolled and randomly assigned (n=293 per group; mean age 64·2 years [SD 7·3]; 214 [37%] female and 372 [63%] male); 550 completed double-blind treatment (prasinezumab, n=277; placebo, n=273). The primary endpoint was not met; the primary analysis showed a non-significant delay in motor progression with prasinezumab versus placebo (hazard ratio 0·84 [95% CI 0·69-1·01]; p=0·066); median time to confirmed motor progression in the prasinezumab group was 61·1 weeks (95% CI 52·3-71·9), compared with 49·7 weeks (40·1-58·1) in the placebo group. The incidence of one or more serious adverse events was similar between groups (prasinezumab, 34 [12%] of 292; placebo, 34 [12%] of 290) and three recorded deaths were unrelated to the study drug (prasinezumab, n=1 [<1%]; placebo, n=2 [1%]).
INTERPRETATION:
Although PADOVA did not meet the primary endpoint, prespecified exploratory evidence suggests clinical activity of prasinezumab in early-stage Parkinson's disease, supporting continued investigation in the ongoing phase 3 PARAISO trial (NCT07174310).
FUNDING:
F Hoffmann-La Roche.
01 May 2026·LANCET
Prasinezumab: what have we learned from PASADENA and PADOVA?
Article
Author: Foltynie, Thomas
77
News (Medical) associated with Prasinezumab28 May 2026
iStock,
rudall30
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
For a while, Gilead Sciences and Arcus Biosciences seemed like they could defy the TIGIT odds.
In November 2023, their monoclonal antibody domvanalimab achieved a
59% overall response rate
when used alongside anti-PD-1 treatment and chemotherapy in a Phase 2 stomach cancer trial. Domvanalimab maintained this efficacy beyond two years, the partners
reported
in 2024, while also demonstrating progression-free survival.
Encouraged by these findings, Gilead and Arcus pushed the asset into Phase 3. But in December last year, the duo announced they were
dropping development
of domvanalimab in gastric and esophageal malignancies after an underwhelming performance—adding another chapter to the long and troubled tale of anti-TIGIT therapies.
TIGIT, short for T cell immunoreceptor with immunoglobulin and tyrosine-based inhibitory motif domain, is a receptor that, when activated, exerts immunosuppressive effects. TIGIT is overexpressed in many malignancies, with cancer cells exploiting its natural function to weaken the body’s anti-cancer response.
Many companies have sought to treat cancer by disrupting the TIGIT pathway, but to date, none have succeeded. GSK, for instance,
teamed up
with Belgian biotech iTeos Therapeutics in 2021 to advance its TIGIT therapy belrestotug. Disappointing mid-stage lung cancer data for the drug eventually forced GSK to
pull the plug
on the program and the partnership in May 2025. Not long after, iTeos
shuttered
its operations.
Merck and Roche have also been thrown by TIGIT. The former was
stymied
by
safety
concerns while the latter
failed to see a survival advantage
in lung cancer.
This dilemma stretches across biopharma: Promising disease targets attract a rush of investments from major drugmakers—only to leave behind a trail of disappointing readouts, discontinued studies and doomed partnerships.
BioSpace
takes a look at four of those targets, digging into the science behind their therapeutic potential and taking stock of the sponsors that have failed to bear these mechanisms out in the clinic.
Immuno-oncology
Four Therapies Hanging On in Troubled TIGIT Space
TIGIT-targeting therapies have largely disappointed in recent months, with failed studies, terminated partnerships and shuttered businesses. Here are five biopharma players staying alive with differentiated candidates against the once promising immuno-oncology target.
July 7, 2025
·
9 min read
·
Tristan Manalac
Read more
Big Pharma runs into RIPK1 rough patch
Last month, Eli Lilly
abandoned
Rigel Pharmaceuticals after struggling failing to crack another difficult drug target: RIPK1.
RIPK1
—short for receptor-interacting serine/threonine-protein kinase 1—is “a central signaling node,” Stuti Mahajan, consulting manager at DelveInsight, told
BioSpace
in an email.
“The target gained major attention after preclinical studies showed that RIPK1 inhibition could suppress inflammatory cell death and reduce tissue damage across conditions such as ALS [amyotrophic lateral sclerosis], multiple sclerosis, rheumatoid arthritis, psoriasis, and inflammatory bowel disease,” she said.
GSK led the industry’s charge, winning the FDA’s
first go-ahead
in 2014 to conduct clinical trials on a RIPK1 candidate. Sanofi and Denali Therapeutics followed soon after with
2018 agreement
to go after the target in neurological and inflammatory diseases. By 2021, Eli Lilly was playing catch-up to its Big Pharma peers,
fronting $125 million
and promising up to $835 million in milestones to collaborate with Rigel.
But the modality’s initial promise soon gave out under the weight of clinical reality, Mahajan told
BioSpace
. “Clinical translation has been more difficult than initially expected,” she said, with RIPK1-targeting molecules showing “modest or inconsistent” therapeutic benefits.
GSK’s candidate, dubbed GSK2982772, failed to significantly improve disease severity in a
Phase 2 ulcerative colitis study
, according to an August 2021 paper in
BMJ Open Gastroenterology
. The asset is no longer listed on the pharma’s
pipeline page
.
Sanofi and Denali were also foiled by RIPK1 and were forced in October 2024 to
abandon
a mid-stage multiple sclerosis study after a disappointing performance from their candidate oditrasertib. Sanofi earlier that year also
pulled the plug
on a Phase 2 trial of oditrasertib in ALS, similarly due to underwhelming efficacy.
Roche added to RIPK1’s losing streak in March of this year, electing to end a Phase 2 study for its asset flizasertib for acute kidney injury in patients undergoing cardiac surgery. The drug was “unable to demonstrate a statistically significant clinical benefit,” according to a
federal trials database
.
Business
Sanofi and AstraZeneca Scrap Several Early-Stage Programs in Q1
Sanofi is dropping its Sjögren’s syndrome candidate due to disappointing Phase II efficacy data, while AstraZeneca is stopping work on some early-stage assets amid a portfolio reprioritization.
April 25, 2024
·
2 min read
·
Tyler Patchen
Read more
Myc, crucial cancer driver, remains undruggable
Like TIGIT, myc has long been an attractive but elusive cancer target. Myc refers to a
broad family of transcription factors
that regulate several key cellular processes, such as growth, division and metabolism. Under healthy conditions, the
myc
gene is tightly regulated. But in most—if not all—malignancies, it is highly expressed, leading to deregulated pathways that drive cancer.
In fact,
myc
“holds the distinction of being the first oncogene to be found amplified in tumor cells,” according to a 2024 review article published in the journal
Signal Transduction and Targeted Therapy
.
“MYC is over expressed in 70% of malignancies where it drives cell division at an accelerated pace; promotes a hostile tumor microenvironment; and is responsible for resistance against multiple drug classes,” Peter Smith, executive chairman of Racura Oncology, told
BioSpace
in an email.
Despite its prevalence, however, myc remains a largely undruggable target in cancer, owing largely to its structure—"or lack thereof,” Smith said, pointing to the oncogene’s “basic helix-loop-helix transcription factor.” This overall simple structure makes it nearly impossible for drugs to stick to it, he explained.
“Using the classic lock and key analogy for a drug interacting with its target, MYC simply has no lock, no well-defined tertiary structure for a drug to bind with high affinity,” Smith added.
Currently, there are no small molecule myc inhibitors in development, according to Smith, but that’s not for want of trying. Many drugmakers over the years have tried and failed to advance a myc-directed drug.
Aptose Biosciences, for instance, was banking on an asset called APTO-253, which it had been
testing in an early study
of relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. APTO-253 was designed to suppress the expression of
myc
but was
discontinued in 2021
after “an internal review of the product pro performance” and prioritization of other more advanced assets.
Dicerna Pharmaceuticals also took a crack at myc with its RNA interference therapy DCR-MYC, which was supposed to drive down expression of the problematic gene. The company
shelved
the asset in 2016 when preliminary results failed to meet the company’s expectations for further development.
Faced with a string of failures, “it appears that the majority of major pharmaceutical companies, after decades of research, have simply given up trying,” Smith concluded.
STING stymies immunology, oncology advancements
Another target that has tripped up the industry is STING (stimulator of interferon genes), a protein involved in various immune cascades.
“Activation of the STING pathway induces type I interferon production, dendritic cell activation, and downstream T-cell priming,” Arunima Dabral, assistant project manager, Clinical & Pipeline Analysis at DelveInsight, told
BioSpace
in an email. Preclinical data supported this mechanism, she said, not only showing potential for immune-mediated diseases but also for cancer.
This promise attracted “substantial industry investment,” Dabral said, including from GSK, which in 2022
put $1.4 billion on the line
to partner with Mersana Therapeutics. At the heart of this deal was the biotech’s lead asset XMT-2056, an antibody-drug conjugate (ADC) that activates the STING pathway.
The partners were supposed to develop the molecule for HER2-positive cancers. GSK and Mersana had a hard time with XMT-2056, however, running into a
clinical hold
in March 2023 linked to a death in a Phase 1 study that was deemed related to the asset. That pause was
lifted
in November that year, but that wasn’t enough to make GSK stick around. The pharma ultimately
axed
XMT-2056 in the first quarter of this year.
Policy
FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death
The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose.
November 1, 2023
·
2 min read
·
Tristan Manalac
Read more
Merck has also been stymied by STING. The pharma was working on an oral STING agonist ulevostinag, also called MK-1454, which it
was studying
as a monotherapy or as part of a combo regimen with Keytruda, for solid tumors or lymphomas. Phase 1 data in 2018 showed
no partial or complete responses
in patients given the STING agonist alone. Merck has since
discontinued
the asset.
Several challenges prevent STING-targeted drugs from succeeding in the clinic, Dabral explained. “Managing the toxicity associated with systemic immune activation, ensuring effective delivery to tumor sites, and overcoming tumor heterogeneity and resistance mechanisms are critical hurdles,” she said.
Nevertheless, “the STING field remains active,” Dabral continued, with newer players incorporating novel technologies such as nanoparticle delivery and more selective pathway targeting. Daiichi Sankyo, for instance, is leveraging its ADC platform to advance the STING-targeting DS3610, which in November last year
entered Phase 1 testing
. The asset seeks to achieve more “precise tumor targeting,” Ken Takeshita, global head of R&D, said in a statement at the time.
Alpha-synuclein aggravates in neuro
Outside of cancer and immunology, there’s alpha-synuclein, which, owing to its central role in the pathology, is “one of the leading targets” in Parkinson’s disease, DelveInsight’s Mahajan said.
Alpha-synuclein
(α-syn) is a protein found in neurons that, under healthy conditions, plays a critical role in regulating the secretion of neurotransmitters. In certain neurodegenerative diseases, however, α-syn is wrongly folded, forming toxic clumps that ultimately trigger the destruction of neurons.
“Aggregated alpha-synuclein is a defining pathological hallmark of Parkinson’s disease” and related conditions, such as dementia with Lewy bodies and multiple system atrophy, Mahajan explained.
Because of its central role in neurodegenerative diseases, many of the industry’s biggest players have invested heavily α-syn-targeting approaches, but results have been mixed. Biogen, for instance,
shelled out $32.5 million
—and promised $395 million in contingent payments—in December 2010 to acquire a Neurimmune subsidiary, gaining an α-syn-targeting antibody that would later be named cinpanemab.
But more than a decade later, in February 2021, Biogen
scrapped
cinpanemab following a disappointing mid-stage performance. The asset, the company said at the time, failed to show significant benefit in patients with Parkinson’s and “did not achieve proof-of-concept.”
Before being discontinued, Biogen was setting cinpanemab up to compete with Roche and Prothena Biosciences’ prasinezumab, another antibody designed to target α-syn. This latter asset, however, did not fare much better. In December 2024, the partners announced that prasinezumab
failed
the Phase 2b PADOVA study, showing no significant benefit on motor progression.
Still, Roche and Prothena are pushing the asset forward to
Phase 3
, buoyed by signals of efficacy in the mid-stage study, such as positive trends in biomarker outcomes.
Parkinson’s disease
Roche, Prothena Push Parkinson’s Drug to Phase III Despite Mid-Stage Fail
Analysts at Jefferies give Roche and Prothena’s Phase III study just a 25% to 40% probability of success.
June 16, 2025
·
2 min read
·
Tristan Manalac
Read more
A major stumbling block for drugmakers, Mahajan explained, is the “difficulty of targeting intracellular pathogenic aggregates using extracellular antibodies”—the modality of choice for both Biogen and Roche/Prothena.
The result, she continued, is that most therapies target α-syn found outside the cells, whereas it’s the intracellular aggregates that drive disease.
The good news is that
α-syn development
“remains highly active,” Mahajan said, as the industry continues to refine its strategies toward earlier-stage intervention and better targeting mechanisms.
Phase 2Phase 3Clinical ResultImmunotherapyPhase 1
07 May 2026
Net cash provided by operating and investing activities was $28.9 million for the first quarter of 2026; quarter-end cash and restricted cash position was $330.3 million Prothena updates projected full year 2026 net cash used in operating and investing actives to be $18 to $23 million (versus prior guidance $50 to $55 million) and expects to end the year with approximately $273 million (midpoint) in cash, cash equivalents and restricted cash Novo Nordisk obtained Fast Track designation from the U.S. FDA for coramitug (PRX004) for the treatment of ATTR amyloidosis with cardiomyopathy and paid Prothena a $50 million clinical milestone payment related to Phase 3 enrollment Roche presented several clinical updates supporting the potential of prasinezumab for the treatment of Parkinson’s disease at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2026) Prothena has completed the Phase 1 study for PRX019. Prothena could potentially earn a $55 million clinical milestone payment if Bristol Myers Squibb decides to advance the program; BMS decision expected by year-end 2026 Prothena initiated a share repurchase program to be conducted in 2026 for up to $100 million if deemed appropriate
DUBLIN--(BUSINESS WIRE)-- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today reported financial results for the first quarter of 2026 and provided business highlights.
“In the quarter we were encouraged by updates on our partnered Phase 3 clinical programs. Roche delivered several presentations highlighting the potential of prasinezumab for Parkinson’s disease at AD/PD 2026, including a ‘time saved’ analysis demonstrating approximately two years in delay of disease progression over a five year period from the PASADENA open-label extension study, longer-term data from the PADOVA open-label extension study showing a sustained effect of prasinezumab on disease progression, and exploratory biomarker analyses of the PADOVA trial suggesting that prasinezumab may impact the underlying disease biology. Novo Nordisk recently obtained Fast Track designation from the U.S. FDA for coramitug in ATTR-CM and delivered $50 million to Prothena upon achievement of a Phase 3 clinical milestone,” said Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. “In addition, we are engaged in multiple research collaborations with industry partners exploring the potential of our CYTOPE® technology. Finally, our team continues to explore additional research collaborations and licensing partnerships to further advance our programs.”
Business Highlights and Upcoming Milestones
Active Clinical Development Portfolio
Prasinezumab, a potential first-in-class antibody for the treatment of Parkinson’s disease that is designed to target a key epitope within the C-terminus of alpha-synuclein and is the focus of a worldwide collaboration with Roche.
Partner Roche presented several clinical updates from the Phase 2b PADOVA trial and open-label extension (OLE) and the PASADENA OLE study supporting the potential of prasinezumab for the treatment of Parkinson’s disease at AD/PD™ 2026Oral Presentation – Modeling Parkinson’s Disease Progression to Quantify Long-Term Treatment Effects via the Concept of ‘Time Saved’ Oral Presentation – Prasinezumab in Early-Stage Parkinson’s Disease: Additional Data from the PADOVA Study Poster Presentation – Prasinezumab’s Impact on Neuromelanin- and Iron-Sensitive MRI Biomarkers in Parkinson’s Disease: Findings from the PADOVA Phase IIb Study Poster Presentation – Sustained Effect on Prasinezumab on Parkinson’s Disease Motor Progression in the Open-Label Extension of the PASADENA Trial, 5-Year Update Poster Presentation – Digital Health Technology Detects Group Differences in Practically-Defined OFF L-DOPA State: Results of PADOVA Phase IIb Study of Prasinezumab Roche is conducting the Phase 3 PARAISO clinical trial in approximately 900 participants with early-stage Parkinson's disease; primary completion expected in 2029 ( NCT07174310) Roche has stated that prasinezumab has peak sales potential greater than $3.5 billion (unadjusted) and could be the first disease-modifying treatment for a condition that affects 10 million people worldwide
Oral Presentation – Modeling Parkinson’s Disease Progression to Quantify Long-Term Treatment Effects via the Concept of ‘Time Saved’ Oral Presentation – Prasinezumab in Early-Stage Parkinson’s Disease: Additional Data from the PADOVA Study Poster Presentation – Prasinezumab’s Impact on Neuromelanin- and Iron-Sensitive MRI Biomarkers in Parkinson’s Disease: Findings from the PADOVA Phase IIb Study Poster Presentation – Sustained Effect on Prasinezumab on Parkinson’s Disease Motor Progression in the Open-Label Extension of the PASADENA Trial, 5-Year Update Poster Presentation – Digital Health Technology Detects Group Differences in Practically-Defined OFF L-DOPA State: Results of PADOVA Phase IIb Study of Prasinezumab
Coramitug (formerly PRX004), a potential best-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM) designed to deplete the pathogenic, non-native forms of the transthyretin (TTR) protein, is being developed by Novo Nordisk as part of its up to $1.2 billion acquisition of Prothena’s ATTR amyloidosis business and pipeline.
Novo Nordisk is conducting the Phase 3 CLEOPATTRA clinical trial in approximately 1280 participants with ATTR-CM; primary completion expected in 2029 ( NCT07207811) Coramitug granted Fast Track designation from the U.S. FDA for the treatment of ATTR-CM Novo Nordisk initiated an open-label study to evaluate the biodistribution of 89Zr-coramitug and investigate the effects of coramitug on depleting TTR amyloid deposits in myocardial tissues using PET/CT imaging in participants with ATTR-CM; primary completion expected in 2027 ( NCT07448623) Prothena received a $50 million clinical milestone payment related to Phase 3 enrollment
BMS-986446 (formerly PRX005), a potential best-in-class antibody for the treatment of Alzheimer’s disease that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in the causal pathophysiology of Alzheimer’s disease.
Bristol Myers Squibb is conducting the Phase 2 TargetTau-1 clinical trial in approximately 310 patients with early Alzheimer’s disease; primary completion expected in 1H 2027 ( NCT06268886) Bristol Myers Squibb conducted a Phase 1 open-label single-dose clinical trial to assess a subcutaneous administration ( NCT06955741) BMS-986446 granted Fast Track designation by U.S. FDA as a treatment for Alzheimer’s disease
PRX019, a potential treatment of neurodegenerative diseases in development in collaboration with Bristol Myers Squibb.
Prothena has completed a Phase 1 study to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of single ascending and multiple doses in healthy adults Prothena could potentially earn a $55 million clinical milestone payment if Bristol Myers Squibb decides to advance the program; BMS decision expected by YE 2026
Active Preclinical Development Portfolio
TDP-43 CYTOPE®, a wholly-owned proprietary preclinical program for precision intracellular targeting of TDP-43 pathology, a defining pathogenic feature of ALS and other TDP-43 proteinopathies. TDP-43 CYTOPE preclinical data demonstrates the potential of Prothena’s CYTOPE® technology to target intracellular disease pathways.
Prothena presented a poster at Neuroscience 2025 (Society for Neuroscience) and the International Symposium of ALS/MND demonstrating the potential of TDP-43 CYTOPE in multiple preclinical models
PRX012-TfR, a wholly-owned preclinical program combining PRX012, our single-injection, once-monthly antibody delivered subcutaneously with proprietary transferrin receptor technology to potentially improve its product profile.
Preclinical studies ongoing to support potential efficacy of PRX012-TfR
Upcoming Investor Conference
Members of the senior management team will participate in 1 on 1 investor meetings at the following upcoming investor conference:
H.C. Wainwright 4th Annual BioConnect Investor Conference on Tuesday, May 19, 2026 in New York, NY
First Quarter of 2026 Financial Results
For the first quarter of 2026, Prothena reported net income of $32.7 million, as compared to a net loss of $60.2 million for the first quarter of 2025. Basic net income per share was $0.61 and fully dilutive net income per share was $0.60 for the first quarter of 2026, as compared to a basic and dilutive net loss per share of $1.12 for the first quarter of 2025.
Prothena reported total revenue of $51.1 million for the first quarter of 2026, as compared to total revenue of $2.8 million for the first quarter of 2025. Total revenue for the first quarter of 2026 was primarily from $50.0 million in milestone payment from Novo Nordisk related to ongoing Phase 3 clinical trial for coramitug and collaboration revenue from Bristol Myers Squibb related to the partial performance of our PRX019 Phase 1 clinical trial obligation. Total revenue for the first quarter of 2025, was primarily from collaboration revenue from Bristol Myers Squibb related to the partial performance of our PRX019 Phase 1 clinical trial obligation.
Research and development (R&D) expenses totaled $12.6 million for the first quarter of 2026, as compared to $50.8 million for the first quarter of 2025. The decrease in R&D expenses for the first quarter of 2026 compared to the same periods in the prior year was primarily due to lower clinical trial expenses, lower personnel expenses, lower manufacturing expenses and lower consulting expenses. R&D expenses included non-cash share-based compensation expense of $2.0 million for the first quarter of 2026, as compared to $4.8 million for the first quarter of 2025.
General and administrative (G&A) expenses totaled $12.7 million for the first quarter of 2026, as compared to $17.6 million for the first quarter of 2025. The decrease in G&A expenses for the first quarter of 2026 compared to the same periods in the prior year was primarily due to lower consulting expenses and lower personnel expenses. G&A expenses included non-cash share-based compensation expense of $4.9 million for the first quarter of 2026, as compared to $6.1 million for the first quarter of 2025.
Prothena recorded an aggregate restructuring credit of approximately $4.2 million for the three months ended March 31, 2026 primarily related to a reduction in contract termination costs associated with one or more third-party vendors.
Total non-cash share-based compensation expense was $6.9 million for the first quarter of 2026, as compared to $10.9 million for the first quarter of 2025.
As of March 31, 2026, Prothena had $330.3 million in cash, cash equivalents and restricted cash, and no debt.
As of April 30, 2026, Prothena had approximately 52.4 million ordinary shares outstanding.
2026 Financial Guidance
Prothena is updating its projected full year 2026 net cash used in operating and investing actives, and expects it to be $18 to $23 million (versus prior guidance $50 to $55 million) and expects to end the year with approximately $273 million (midpoint) in cash, cash equivalents and restricted cash, representing an increase of $18 million from prior guidance of $255 million (midpoint). This increase in cash position is primarily driven by a $50 million milestone payment from Novo Nordisk related to the advancement of coramitug offset by cash utilized as part of share repurchase program activities of approximately $15 million through April 30, 2026, the settlement of liabilities related to discontinued programs, and an increased investment in our preclinical programs. The updated estimated full year 2026 net cash used from operating and investing activities is primarily driven by an updated estimated net loss of $25 to $30 million (versus prior guidance of $67 to $72 million), which includes an estimated $26 million of non-cash share-based compensation expense. This financial guidance does not include the potential to earn a $55 million clinical milestone payment in 2026 related to the advancement of PRX019 for neurodegenerative diseases by Bristol Myers Squibb or additional cash utilized as part of a share repurchase program.
1Q 2026 Share Repurchase Program
Prothena repurchased a total of 788,990 ordinary shares with $7.3 million, exclusive of commissions and expenses, as of March 31, 2026, from its up to $100.0 million share repurchase program, which expires December 31, 2026.
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including Parkinson’s disease, ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Amyotrophic lateral sclerosis (ALS) and a number of other neurodegenerative diseases. Prothena is developing and applying CYTOPE®, a novel technology that incorporates a cell-internalizing domain to drive efficient cytosolic delivery with highly specific marcomolecular effectors. For more information, please visit the Company’s website at www.prothena.com and follow the Company on X (formerly Twitter) @ProthenaCorp.
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to fund advancement of our pipeline and completion of our ongoing clinical trials; the continued advancement of our preclinical and clinical pipeline, including the potential and advancement of our CYTOPE technology and expected milestones in 2026, 2027, and beyond; the treatment potential, designs, proposed mechanisms of action, and potential administration of prasinezumab, coramitug, BMS-986446, PRX019, TDP-43 CYTOPE, and PRX012-TfR; plans for ongoing and future clinical trials of prasinezumab, coramitug, BMS-986446, and PRX019; the expected timing of reporting data from preclinical studies and clinical trials; projections regarding peak sales and patient population for prasinezumab; timing of and amounts we may receive under our collaborations with Novo Nordisk and Bristol Myers Squibb; our anticipated net cash burn from operating and investing activities for 2026 and expected cash balance at the end of 2026; our estimated net loss and non-cash share-based compensation expense for 2026; and the potential to return capital to shareholders via a share repurchase program or other permissible means. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2026, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.
PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)
Three Months Ended
March 31,
2026
2025
Collaboration revenue
$
1,034
$
2,778
Revenue from license and intellectual property
50,050
50
Total revenue
51,084
2,828
Operating expenses:
Research and development
12,627
50,811
General and administrative
12,666
17,598
Restructuring costs
(4,244
)
—
Total operating expenses
21,049
68,409
Income (loss) from operations
30,035
(65,581
)
Other income, net
2,687
4,208
Income (loss) before income taxes
32,722
(61,373
)
Provision for (benefit from) income taxes
1
(1,178
)
Net income (loss)
$
32,721
$
(60,195
)
Basic net income (loss) per ordinary share
$
0.61
$
(1.12
)
Diluted net income (loss) per ordinary share
$
0.60
$
(1.12
)
Shares used to compute basic net income (loss) per share
53,708
53,827
Shares used to compute diluted net income (loss) per share
54,109
53,827
PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
March 31,
December 31,
2026
2025
Assets
Cash and cash equivalents
$
329,462
$
307,531
Prepaid expenses and other current assets
9,739
7,662
Total current assets
339,201
315,193
Property and equipment, net
1,960
2,144
Operating lease right-of-use assets
7,391
8,125
Restricted cash, non-current
860
860
Other non-current assets
482
482
Total non-current assets
10,693
11,611
Total assets
$
349,894
$
326,804
Liabilities and Shareholders’ Equity
Accrued research and development
$
4,611
$
4,329
Deferred revenue, current
1,630
2,664
Restructuring liability
8,585
13,303
Lease liability, current
2,893
2,886
Other current liabilities
14,798
17,661
Total current liabilities
32,517
40,843
Lease liability, non-current
4,761
5,487
Total non-current liabilities
4,761
5,487
Total liabilities
37,278
46,330
Total shareholders’ equity
312,616
280,474
Total liabilities and shareholders’ equity
$
349,894
$
326,804
Mark Johnson, CFA Senior Vice President, Head of Investor Relations and Corporate Communications 650-837-8550 IR@prothena.com Media@prothena.com
06 May 2026
Dr. Doody joins from Senior Leadership in Neurodegeneration at F. Hoffman-LaRoche LTD and biotech Axxium Life
ATLANTA and BOSTON, May 06, 2026
(GLOBE NEWSWIRE)
-- ABLi Therapeutics (“ABLi”), a biotechnology company developing therapeutics to address diseases that arise from activation of Abelson Tyrosine Kinases (c-Abl kinases), announces the appointment of world renowned industry veteran in clinical development of neurodegeneration therapeutics, Rachelle S. Doody, MD, PhD, to the ABLi Board of Directors.
Dr. Doody has over 10 years of pharmaceutical leadership experience in clinical development of therapeutics to fight neurodegenerative diseases, including Alzheimer’s and Parkinson’s disease. She was Global Head of Neurodegeneration in late stage Neuroscience at F. Hoffman-LaRoche (Roche) where she led the development of the monoclonal antibodies Crenezumab and Gantenerumab for familial and sporadic AD; led the late stage development for Tominersin, an antisense oligonucleotide for Huntington’s Disease, and led the late-stage development program for Prasinezumab, an anti-alpha synuclein monoclonal antibody for Parkinson’s disease that is now in Phase 3 development. After leaving Roche in 2024, she joined the biotechnology company Axxium Life as Chief Medical Officer and Director of Development, where she oversees a pipeline of active immunotherapy medications directed against chronic and neurodegenerative diseases.
Prior to her tenure at Roche, Dr. Doody was the Effie Marie Cain Chair in Alzheimer’s Disease research at Baylor College of Medicine and is presently a Distinguished Emeritus Professor in Neurology.
Dr. Doody trained in internal medicine at McGill University, the Royal Victoria Hospital and the Montreal Neurological Hospital and Institute and did her residency in Neurology at Baylor where she honed her interests and expertise in Alzheimer’s Disease. Her PhD work in cognitive anthropology was completed at Rice University.
“The appointment of Dr. Doody brings to the ABLi Board an industry leader in the development of neurodegenerative disease therapeutics,” said Dr. Milton Werner, ABLi’s Chairman and Chief Executive Officer. “Dr. Doody will advise the company on management best practices and clinical trial design as we prepare to launch our Phase 3 programs for Parkinson’s, Multiple System Atrophy (MSA) and Dementia with Lewy Body (DLB).”
“Patients with neurodegenerative diseases need more and better treatments than what is available today. I am pleased to join the Board at ABLi to extend my assistance to another promising biotechnology company with the potential to really impact the synucleinopathies, such as Parkinson’s disease, MSA and DLB.”
About Risvodetinib (ABLi-148009)
Risvodetinib is a potent, selective small-molecule inhibitor of the non-receptor c-Abl kinases, designed for once-daily oral use that targets the underlying biological mechanisms driving Parkinson’s disease initiation and progression. Risvodetinib has been demonstrated to modify the PD pathophysiologic pathway and shown to impact the neurodegenerative and neuroinflammatory disease processes in humans as a once-per-day oral therapy. All marketed therapeutic approaches to treat Parkinson’s disease help manage symptoms, but there are currently no available treatments to slow or stop the disease’s relentless progression. Recently, risvodetinib was the first monotherapy to improve patient quality of life in a randomized, placebo-controlled clinical trial (NCT NCT05424276) and simultaneously reduced the underlying disease pathology and suppressed the underlying disease process in patients with untreated Parkinson’s disease. Risvodetinib currently has intellectual property protection beyond 2036.
About ABLi Therapeutics
ABLi Therapeutics (“ABLi”) applies innovative medicinal chemistry and a deep understanding of disease biology to develop small molecule therapeutics that target the cause of diseases that arise from activation or dysfunction of the Abelson Tyrosine Kinases (c-Abl). Leveraging its expertise in drug design, ABLi utilizes clinically validated data of kinase inhibitors to design and develop novel product candidates with enhanced penetration into the brain, greater potency and target selectivity, and improved safety to treat diseases in which Abl kinase activation or dysfunction is implicated. The Company’s primary focus is on developing therapeutics for the treatment of neurodegenerative diseases like Parkinson’s disease and the Parkinson’s-related neurodegenerative diseases Multiple System Atrophy and Dementia with Lewy Body that are all associated with Abl kinase activation or dysfunction. For more information visit
or follow us on
LinkedIn
and X.
Contacts:
For ABLi Therapeutics
Milton H Werner PhD
Chairman & CEO
info@ablitherapeutics.com
Investor/Media
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
100 Deals associated with Prasinezumab
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Parkinson Disease | Phase 3 | United States | 24 Nov 2025 | |
| Parkinson Disease | Phase 3 | China | 24 Nov 2025 | |
| Parkinson Disease | Phase 3 | Australia | 24 Nov 2025 | |
| Parkinson Disease | Phase 3 | Australia | 24 Nov 2025 | |
| Parkinson Disease | Phase 3 | Austria | 24 Nov 2025 | |
| Parkinson Disease | Phase 3 | Austria | 24 Nov 2025 | |
| Parkinson Disease | Phase 3 | Brazil | 24 Nov 2025 | |
| Parkinson Disease | Phase 3 | Brazil | 24 Nov 2025 | |
| Parkinson Disease | Phase 3 | Canada | 24 Nov 2025 | |
| Parkinson Disease | Phase 3 | Canada | 24 Nov 2025 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2 | 586 | levodopa or MAO-B inhibitor + Prasinezumab | ctrvnxwjlp(akbqtwlayz) = lwvrvkauti qawnrcglkt (yqazghqptn ) View more | Negative | 01 May 2026 | ||
levodopa or MAO-B inhibitor + Placebo | ctrvnxwjlp(akbqtwlayz) = mezqstsfxy qawnrcglkt (yqazghqptn ) View more | ||||||
Phase 2 | 586 | placebo+prasinezumab (DBT Period: Placebo) | tpibvbieab(unfvbbkehx) = gkjxcgihrm rzxngnvnrb (zopjejseom, cuvqeyeziq - zyqjqmstvs) View more | - | 02 Dec 2025 | ||
(DBT Period: Prasinezumab) | tpibvbieab(unfvbbkehx) = smrrsfnuut rzxngnvnrb (zopjejseom, bmxifzcukk - xkjdkvgdmd) View more | ||||||
Phase 2 | 589 | eevahfsxuz(llpnjnjdeo): Difference in adjusted means = -2.18 (95.0% CI, -3.87 to -0.49), P-Value = 0.0117 View more | Positive | 05 Oct 2025 | |||
Placebo | |||||||
Phase 2 | 586 | ipstcxzqta(jitcvhjvql): HR = 0.84 (95% CI, 0.69 - 1.01), P-Value = 0.0657 Not Met | Negative | 18 Dec 2024 | |||
Placebo | |||||||
Phase 2 | Parkinson Disease alpha-synuclein | 316 | gdtcaoglxo(fxumctjxke) = objaneetih mryjcvhhha (vjazkzrxrs ) View more | - | 25 Apr 2023 | ||
Placebo+Prasinezumab 1500 mg | gdtcaoglxo(fxumctjxke) = lxbadrjhfw mryjcvhhha (vjazkzrxrs ) View more | ||||||
Phase 2 | Parkinson Disease α-synuclein | - | nuaojwkexg(xpyixeedmm) = oudlksnqxw dokjysyfcy (esxmwpksyl ) View more | - | 15 Sep 2022 | ||
nuaojwkexg(xpyixeedmm) = abwgnqxinb dokjysyfcy (esxmwpksyl ) View more | |||||||
Phase 2 | Parkinson Disease α-synuclein | 316 | huloiefvpf(dqxxgashpt) = infusion reactions occurred in 19.0% and 34.0%, respectively isltwaqexn (zdfgjuqkvy ) View more | Negative | 04 Aug 2022 | ||
Phase 2 | 316 | Placebo (Part 1: Placebo) | vpxszivexl(stgiramtef) = wyqpnzwuum aacuzxuuay (iepneoozdf, 1.221) View more | - | 08 Feb 2021 | ||
(Part 1: RO7046015 Low Dose) | vpxszivexl(stgiramtef) = uhmagzgvhg aacuzxuuay (iepneoozdf, 1.225) View more | ||||||
Phase 2 | 316 | xhfqxykqim(endvuspivh) = ffyhykbhcs rnitufpucv (tbkxcvpxio ) | - | 01 Jan 2021 | |||
xhfqxykqim(endvuspivh) = ofjxtpbwtg rnitufpucv (tbkxcvpxio ) | |||||||
Phase 1 | 80 | ccrlffrskq(ygjyfxzmue) = ubizpmfrdz rdtsdsengf (iimxkvzuok ) View more | Positive | 01 Oct 2018 | |||
Placebo | ccrlffrskq(ygjyfxzmue) = gyfeqliapw rdtsdsengf (iimxkvzuok ) |
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