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Home » Topics » Clinical

Clinical
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Vim’s vigor in TGCT verified in phase III as Deciphera ‘pex’ at Daiichi’s heels

Oct. 31, 2023
By Randy Osborne
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
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Test tubes, capsules, dropper
Biopharma clinical updates September 2023

Clinical trial data show 1.79% growth year-on-year through Q3 2023

Oct. 31, 2023
By Amanda Lanier
Clinical trial data from January-September 2023 was up 1.79% compared to the same time period last year. In the first three quarters of this year, BioWorld reported on 2,611 drugs in phase I-III, compared to 2,565 in Q1-Q3 2022. The number of trial updates is down 13.74% from 3,027 in 2021 and also down from the 2,738 in 2020, but up from 2,251 updates noted in 2019.
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Lianbio says hit-and-miss for co-primary endpoints in Xdemvy’s China trial

Oct. 31, 2023
By Marian (YoonJee) Chu
Lianbio Co. Ltd. announced mixed phase III top-line results on Oct. 30 for its in-licensed Demodex blepharitis treatment called TP-03, with the U.S. FDA-approved eyedrop hitting just one co-primary endpoint in the Libra trial on Chinese patients.
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Conceptual image for brain cancer treatment

Kintara shifts its focus after disappointing glioblastoma data

Oct. 31, 2023
By Lee Landenberger
Disappointing preliminary top-line data from Kintara Therapeutics Inc.’s phase II/III study of VAL-083 (dianhydrogalactitol) is causing the company to shift its attention and resources to another cancer program. In the meantime, the results wreaked havoc on the stock and sent the company on a mission to look at its options.
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Stock chart, red down arrow

Sarepta sinks as Elevidys misses DMD endpoint in confirmatory trial

Oct. 31, 2023
By Karen Carey
Failing to meet the primary endpoint in its confirmatory phase III Embark trial, Sarepta Therapeutics Inc.’s gene therapy, Elevidys (delandistrogene moxeparvovec), which received accelerated approval in June and was priced at $3.2 million, has one of three fates in its future, all of which are dependent on how the U.S. FDA perceives the data. Based on secondary endpoints showing statistical significance and a recent positive meeting with the agency, Sarepta could continue to market Elevidys under its current label for 4- and 5-year-old ambulatory Duchenne muscular dystrophy (DMD) patients; Sarepta is filing the postmarketing requirement needed to transition from accelerated to full approval.
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Vim’s vigor in TGCT verified in phase III as Deciphera ‘pex’ at Daiichi’s heels

Oct. 30, 2023
By Randy Osborne
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
Read More
Psychiatric disorders illustration

Reviva’s brilaroxazine hits phase III schizophrenia endpoint, propels stock upward

Oct. 30, 2023
By Lee Landenberger
The pivotal phase III study of brilaroxazine from Reviva Pharmaceuticals Holdings Inc. for adults with schizophrenia hit its primary endpoint and two key secondary endpoints, following positive phase II data in 2021. The serotonin-dopamine signaling modulator, the company’s lead candidate, is a once-daily treatment. Results from the study showed brilaroxazine demonstrated reductions in all major symptom domains for the patients and the secondary endpoints at week 4 when comparing the 50-mg dose with placebo.
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Esophageal cancer

Oncolys esophageal cancer drug Telomelysin hits phase II endpoints

Oct. 27, 2023
By Tamra Sami
Oncolys Biopharma Inc.’s lead compound Telomelysin (suratadenoturev, OBP-301) met the primary endpoint of exceeding the predefined threshold of local complete response, confirming clinical benefit in a phase II study in locally advanced esophageal cancer combined with radiation.
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Female reproductive system and cancer cells

ESMO 2023: Latest advances in gynecological cancer

Oct. 25, 2023
By Mar de Miguel
The Congress of the European Society of Medical Oncology (ESMO) held in Madrid from Oct. 20 to 24, 2023, could well add the letter W to its acronym after the four sessions on gynecological cancer that could represent a milestone in the lives of all women who suffer from cervical, ovarian, or endometrial cancer.
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Prostate cancer cells

Novartis’ Pluvicto continues to show data and sales muscle

Oct. 24, 2023
By Lee Landenberger
Novartis AG’s radioligand therapy, Pluvicto, a bestseller for the company that has been restructuring itself, continues to show strong growth in the third quarter of 2023, according to its most recent financial results. Sales were up 217% from the same quarter in 2022 at $256 million. Analysts are predicting blockbuster sales. Adding to the momentum were new data from the phase III PSMAfore study of Pluvicto (lutetium [177Lu] vipivotide tetraxetan), in second-line cancer, hitting its primary endpoint of radiographic progression-free survival in treating prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer after treatment with androgen receptor pathway inhibitor therapy.
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