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BioWorld - Saturday, June 20, 2026
Home » Topics » Clinical

Clinical
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Moderna signage

Moderna’s cytomegalovirus vaccine fails a phase III

Oct. 23, 2025
By Lee Landenberger
No Comments
Moderna Inc. stopped its efforts to develop mRNA-1647 as a vaccine for preventing congenital cytomegalovirus infection, the most common infectious cause of birth defects in the U.S. The pivotal and placebo-controlled phase III CMVictory study of mRNA-1647 missed the primary efficacy endpoint, which was preventing the infection in seronegative females ages 16 to 40.
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PRIMA implant

Science Corp.'s Prima implant enables blind patients to read

Oct. 22, 2025
By Annette Boyle
Interim results from the PRIMAVERA study published in the New England Journal of Medicine demonstrated that Science Corp.'s Prima retinal implant restored vision, enabling 80% of patients to read at 12 months. Participants had age-related macular degeneration-related geographic atrophy resulting in total loss of central vision.
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Red arrow pointing downward on a stock market ticker

Alector stock and staff halved after phase III fail in dementia

Oct. 22, 2025
By Lee Landenberger
No Comments
The failure of Alector Inc.’s phase III study of latozinemab in treating dementia halved the company’s stock on Oct. 22. That is also about the same percentage of staff that Alector is letting go after the clinical trial stumble.
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Illustration of liver with DNA double helixes
ESMO 2025

Delcath’s Chemosat plus ICIs triples PFS in uveal melanoma

Oct. 21, 2025
By Annette Boyle
While positive results from the investigator-led phase II CHOPIN trial at ESMO 2025 failed to get investors dancing, they were no doubt music to management’s ears, particularly with Delcath Systems Inc.’s third quarter earnings report missing a beat.
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ESMO 2025

Celcuity nears NDA filing with gedatolisib breast cancer win

Oct. 21, 2025
By Karen Carey
No Comments
Detailed Viktoria-1 results of Celcuity Inc.’s gedatolisib positions the pan-PI3K/mTORC1/2 inhibitor as a top contender for second-line treatment of HR+/HER2- PIK3CA wild-type advanced breast cancer – a multibillion-dollar indication in need of new treatments.
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Woman in crowd with anxiety

With a phase III loss, Neuphoria halts its social anxiety program

Oct. 21, 2025
By Lee Landenberger
No Comments
Neuphoria Therapeutics Inc.’s phase III study of social anxiety disorder has missed its primary and secondary endpoints, prompting the company to stop the program’s development and hold a full strategic review of its operations and portfolio. It’s the second stumble for lead candidate BNC-210, a negative allosteric modulator of alpha7 nicotinic acetylcholine receptor, in the indication.
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Illustration of liver with DNA double helixes

Delcath’s Chemosat plus ICIs triples PFS in uveal melanoma

Oct. 20, 2025
By Annette Boyle
While positive results from the investigator-led phase II CHOPIN trial at the 2025 European Society of Medical Oncology (ESMO) Annual Congress being held in Berlin failed to get investors dancing, they were no doubt music to management’s ears, particularly with Delcath Systems Inc.’s third quarter earnings report missing a beat.
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Cancer tumor in breast illustration
ESMO 2025

Olema slides despite positive breast cancer data with palazestrant

Oct. 20, 2025
By Lee Landenberger
No Comments
Despite a recent stock surge, Olema Oncology Inc. shares (NASDAQ:OLMA) slipped 17% on Oct. 20 to close at $7.77 each in the wake of updated and positive phase Ib/II results for palazestrant, the company’s metastatic breast cancer drug.
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Colorectal cancer illustration
ESMO 2025

Exelixis plans NDA for zanzalintinib on colorectal cancer data

Oct. 20, 2025
By Jennifer Boggs
No Comments
Much-awaited detailed data from Exelixis Inc.’s phase III Stellar-303 study of zanzalintinib, presented at the European Society for Medical Oncology meeting, showed the third-generation, oral tyrosine kinase inhibitor in combination with Tecentriq (atezolizumab, Roche AG) reduced the risk of death by 20% vs. Stivarga (regorafenib, Bayer AG) in patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer and are expected to pave the way for an NDA filing later this year.
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Galleri instruction booklet on blood draw chair
ESMO 2025

Grail's DNA blood test improves early cancer detection sevenfold

Oct. 20, 2025
By Nuala Moran
No Comments

Grail LLC has presented data showing that when added to standard screening procedures for breast, cervical, colorectal and lung cancers, its Galleri circulating tumor DNA test led to a sevenfold increase in the number of cancers detected.


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