Phase 3
After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aardvark plans to resume testing the candidate next year.
AbbVie is eyeing regulatory filings in 2027 for the skin disease drug lutikizumab after clearing multiple endpoints in a late-stage trial, but the results have disappointed some analysts, raising questions about its commercial prospects.
Brepocitinib is on a roll. After winning approval for an autoimmune skin disease, Roivant Sciences subsidiary Priovant’s drug hit all primary and secondary endpoints in a pair of Phase 3 non-infectious uveitis trials, leading analysts to say the candidate “looked superior to Humira.”
Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession.
Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria were able to spend in the sun and artificial light.
In the wake of a successful IPO and strong stock growth throughout the year, Veradermics now has late-stage data to support a regulatory package for its hair loss pill.
While Oppenheimer doesn’t see the Phase 3 stumble of VQW-765 as highly detrimental to Vanda Pharmaceuticals, the analyst nevertheless believes the stakes are now higher for the company’s planned Q4 readout for Nereus in GLP-1-induced vomiting.
A low-dose win could derisk a regulatory pathway for BMS’ LPA1 antagonist in idiopathic pulmonary fibrosis after a recently reported patient death, but a miss at the higher dose leaves analysts awaiting full data.
Data released by the FDA show that Revolution Medicine’s newly approved pancreatic cancer drug underperformed in a large subgroup of patients, but analysts say the biotech still has a clear winner.
The centerpiece of Bristol Myers Squibb’s 2024 RayzeBio buy has read out, hitting the primary endpoint in a late-stage tumor trial.
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