BioKnow: By the Time We Diagnose Parkinson's, We've Already Lost the Window
Parkinson’s disease has no licensed disease-modifying therapies, and clinical trials repeatedly fail to find success. Scientists cannot agree on a cause or even a mechanism of progression, but the issue at the heart of this is that Parkinson’s is being diagnosed too late.
Parkinson’s diagnoses typically occur at the point of obvious symptom development, but these often only appear when a patient has already lost a significant proportion of dopaminergic neurons in their brain. In fact, researchers estimate that neuronal loss may begin up to seven years pre-diagnosis, with an initial decrease in dopaminergic activity as much as 17 years pre-diagnosis1. So are patients entering clinical trials too late? If significant degeneration has already occurred, resulting in symptoms, treatments to slow degeneration are of limited use for truly preserving neurological function.
The key to success in clinical trials may be in the earlier diagnosis of Parkinson’s disease. Parkinson’s has multiple well-documented prodromal features that remain underutilized in diagnosis and clinical trial recruitment: REM sleep behaviour disorder (RBD), where as many as 66% of patients are thought to develop Parkinsons’s or a similar synucleinopathy within 8 years2; hyosmia, seen in 50-90% of early-stage Parkinson’s disease3; and chronic constipation, a known risk factor for Parkinson’s and potential predictor of cognitive decline4. These conditions are commonly overlooked in clinical practice, meaning that the prodromal window is repeatedly missed. Systematically screening, recruiting, and investigating people experiencing these symptoms may prove crucial to the early diagnosis of Parkinson’s disease and the future success of clinical trials. The prodromal window may be the most important therapeutic opportunity in Parkinson's research. We are missing it.
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Redx Pharma closes $36M series A funding round to fund Crohn’s Disease Trial
Redx has secured a $125M financing package in connection with its pending merger with Skye Bioscience to form Fibrx Therapeutics, a Nasdaq-listed company led by Redx’s management team. Supported by investors including Abingworth and Redmile, the funding extends the combined entity's cash runway to 2029. The company will focus on advancing RXC008, a gut-restricted ROCK inhibitor designed to treat gastrointestinal fibrosis in Crohn's disease patients as an alternative to surgery, while minimizing systemic side effects. Topline Phase 2 data for RXC008 is expected in the second half of 2028.
FDA expands approval for GSK’s Tivicay to HIV-affected newborns
The FDA has approved GSK’s Tivicay PD (dolutegravir) as an HIV treatment for newborns weighing at least 2 kg. Designed to be used alongside other antivirals, the integrase strand transfer inhibitor (INSTI) works by inhibiting an essential enzyme HIV requires to replicate. It is indicated for both treatment-naïve and treatment-experienced newborns, except those with prior INSTI exposure. Lead trial investigator Dr. Diana Clarke emphasized that HIV-affected infants have historically lacked specialized, well-studied treatment options despite the critical importance of early intervention.
This approval marks a key milestone in Tivicay’s expansion. First approved 13 years ago for patients aged 12 and older, Tivicay PD oral suspension tablets were authorized in 2020 for infants as young as 4 weeks weighing at least 3 kg. The latest FDA clearance significantly lowers the weight and age thresholds, providing a tailored option for vulnerable newborns.
Huawei’s William Zhang signals intent to expand AI partnerships with domestic pharma companies
Huawei is signaling an intention to broaden its artificial intelligence collaborations across China's pharmaceutical sector, according to statements made by William Zhang, president of the Huawei’s healthcare business unit. The planned expansion aims to cover stages spanning drug discovery, clinical trials, and manufacturing implementation, primarily serving domestic drugmakers. The initiative highlights Huawei's ongoing strategy to anchor domestic healthcare workflows onto its sovereign hardware stack, notably its Ascend AI processors and Kunpeng CPUs.
A May deal involving state-owned Guangzhou Pharmaceutical Holdings validated Beijing-based StoneWise's AI drug design models adapted to run natively on Ascend and Kunpeng chips. The project serves primarily as a proof-of-concept for running drug discovery workloads on non-US silicon. Huawei continues to leverage its Pangu drug molecule model, originally released in 2021 in partnership with the Chinese Academy of Sciences and pre-trained on 1.7 billion compound structures to predict target binding affinity.
The company maintains a 2022 cooperation agreement with botanical drugmaker Yunnan Baiyao, supplying cloud and AI infrastructure to analyze natural compound libraries. To date, neither collaboration has yielded a named candidate entering human clinical trials. With biopharmaceuticals highlighted in China's national government work reports and US export controls limiting international adoption of Ascend hardware, Huawei is positioning itself as the core infrastructure provider for China's localized AI drug discovery ecosystem.
Cellares CEO announces restructuring due to loss of client
Automated cell therapy manufacturer Cellares is restructuring its workforce after losing a major commercial client. Co-founder and CEO Fabian Gerlinghaus announced the downsizing via LinkedIn over the weekend, noting that the unnamed partner's departure was due to the client's changing portfolio strategy. While exact headcount numbers were withheld, the South San Francisco-based company confirmed that the operational reduction aims to reallocate core internal resources toward remaining active commercial and clinical programs.
Despite the client exit, Cellares maintains that its underlying technological platform and financial position remain solid. Built around its proprietary end-to-end automated manufacturing platform, the Cell Shuttle, and automated quality control unit, Cell Q, the company has secured major collaborations with biopharma leaders including Bristol Myers Squibb (in a deal valued up to $380M) and Gilead Sciences’ Kite Pharma. Recent commercial milestones include a 10-year supply agreement with Cabaletta Bio for its CAR-T therapy, a manufacturing partnership with Sonoma Biotherapeutics, and selection for the FDA's PreCheck Pilot Program at its Bridgewater, New Jersey manufacturing site. Management emphasized that the customer base has doubled since early 2026 as the company continues executing on clinical-stage production.
