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BioWorld - Monday, December 22, 2025
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Australian coins and bills

Opthea raising AU$227M, enters final phase III stretch for OPT-302

June 12, 2024
By Tamra Sami
Opthea Ltd. announced it plans to raise up to AU$227.3 million (US$150 million) to extend its cash runway through the data readout for its two phase III pivotal trials of sozinibercept (OPT-302) in wet age-related macular degeneration.
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NLRP3 inflammasome

Nodthera's NLRP3 inflammasome inhibitor targets cardiometabolic space

June 12, 2024
By Nuala Moran
After delivering animal data to show that inhibiting the NLRP3 inflammasome induces weight loss in mice, Nodthera Ltd. has now demonstrated this effect translates to humans. In a phase Ib/II study of NT-0796, an orally available, brain-penetrant drug, subjects in both the active and placebo arms all lost weight, due to the calorie-restricted diet they received in the 28-day trial.
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Person holding weight with assistance

Avidity shares rise on FSHD data, plans for registrational study

June 12, 2024
By Jennifer Boggs
Shares of Avidity Biosciences Inc. hit a 52-week high on reports of promising data from the first efficacy cohort of its phase I/II Fortitude study testing delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD), including impressive biomarker results that could indicate a path for potential accelerated approval.
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3D rendering of CAR T therapy in cell
Cancer

Acepodia’s antibody cell conjugation platform could disrupt CAR Ts

June 12, 2024
By Tamra Sami
Acepodia Inc.’s antibody cell conjugation platform could change the way CAR T-cell therapies are manufactured, clearing the way for an off-the-shelf model to treat numerous cancers that is safer and cheaper than current CAR Ts, Acepodia CEO Sonny Hsiao told BioWorld.
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Acepodia’s antibody cell conjugation platform could disrupt CAR Ts

June 11, 2024
By Tamra Sami

Acepodia Inc.’s antibody cell conjugation platform could change the way CAR T-cell therapies are manufactured, clearing the way for an off-the-shelf model to treat numerous cancers that is safer and cheaper than current CAR Ts, Acepodia CEO Sonny Hsiao told BioWorld.


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Syringe in front of Moderna logo

Moderna’s combo flu/COVID-19 vaccine hits phase III endpoints

June 10, 2024
By Jennifer Boggs
Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing, not only demonstrating noninferiority to individually licensed competitor vaccines but also eliciting statistically significant higher immune responses.
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Eye and financial charts

Skye writing off glaucoma post-phase II, airs obesity plan

June 10, 2024
By Randy Osborne
After the phase IIa failure at lowering intraocular pressure to a statistically significant degree with SBI-100, Skye Bioscience Inc. is dropping work with the ophthalmic emulsion, meant to treat primary open-angle glaucoma or ocular hypertension. Resources are turning to the firm’s metabolic program, which includes nimacimab, targeting the cannabinoid 1 receptor, due to start a phase II trial in obesity during the third quarter of this year.
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3D rendering of an antibody drug conjugate

Developers hop to it, make TROP2 do it – some more than others

June 6, 2024
By Randy Osborne
Trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugates became a topic of talk during the recent American Society of Clinical Oncology meeting in Chicago.
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Skin exam with dermatoscope

Replimune ignites its stock with phase I/II data in melanoma

June 6, 2024
By Lee Landenberger
In an indication with few treatment options for patients who are running out of time, Replimune Group Inc. revealed positive top-line results of its lead candidate, RP-1 (vusolimogene oderparepvec), in anti-PD-1-failed melanoma. Data from the phase I/II Ignyte study of RP-1 plus Opdivo (nivolumab, Bristol Myers Squibb Co.) showed the treatment hit the primary endpoint with a 12-month overall response rate of 33.6% and a median duration of response of more than 35 months.
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Amgen’s inebilizumab succeeds in phase III IgG4-RD trial

June 5, 2024
By Jennifer Boggs
Amgen Inc. is looking to position inebilizumab as the first therapeutic specifically for treating immunoglobulin G4-related disease (IgG4-RD), a rare, immune-mediated condition that can affect multiple organs, after yielding what Leerink Partners analyst David Risinger called “exceptional” phase III results.
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