Phase 3
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.
Argenx shares have fallen more than 13% after the surprise futility finding, which overshadowed a mid-stage celiac disease win for a separate asset acquired in the company’s $2.2 billion Forte Biosciences buy.
After one patient death prompted an FDA hold this spring, Newron Pharmaceuticals has now shared that a total of four fatalities have been recorded among participants receiving its schizophrenia candidate. A fifth death was recorded among those taking the placebo.
The Takeda spinout showed that a high dose of solengepras can shorten the periods during which difficult Parkinson’s disease symptoms like involuntary movements and sleepiness.
ArriVent BioPharma’s Phase 3 lung cancer trial was clouded by stronger-than-expected data for patients receiving chemotherapy, prompting analysts to pivot focus to a late-stage test of the tyrosine kinase inhibitor in a different type of lung cancer and to the biotech’s antibody-drug conjugate pipeline.
PRESS RELEASES