Mirati Therapeutics Inc. posted new data for its highly anticipated KRAS cancer fighter, adagrasib (MRTX-849), showing mixed results compared to its already-marketed competition, Lumakras (sotorasib) from Amgen Inc. The new data came from a cohort of patients with KRAS-G12C non-small-cell lung cancer enrolled in Mirati’s registration-enabling phase II Krystal-1 study. Each had received at least one prior systemic therapy, most with a PD-1/L1 inhibitor following or in combination with chemotherapy.
Nurix Therapeutics Inc. has started its first phase Ib expansion cohort for treating chronic lymphocytic leukemia with NX-2127 but it is facing the headwind of a drop in share price. Shares (NASDAQ:NRIX) of the San Francisco-based company closed 22.7% lower at $7.88 each on May 26. Share prices in the past 12 months have drifted lower since their crest of $26.69 each on Sept. 9, 2021.
Solid phase III top-line results from a study in India for treating stroke with PMZ-1620 (sovateltide) have prodded Pharmazz Inc. to rethink its path to the clinic in the U.S. While the privately held company plans to apply for marketing authorization from the Indian Central Drugs Standard Control Organization, it also had planned to talk to the FDA about launching a phase II study. But since the new data are so solid, it may ask for an IND for a phase III study in the U.S., with the expectation that the number of participants would jump from 158 in the Indian study to as many as 400 to 500 participants in the U.S. and Europe, Anil Gulati, Pharmazz’s CEO and founder, told BioWorld.
Dermavant Sciences Inc. has received its first FDA approval with the agency’s blessing of Vtama (tapinarof) for treating plaque psoriasis in adults. The treatment is also the first FDA-approved, steroid-free topical medication in its class in addition to being the first psoriasis novel topical chemical entity introduced to the market in the past 25 years.
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress. The WHO’s director general, Tedros Adhanom Ghebreyesus, emphatically agreed on May 18, saying he was taken aback by data showing COVID-19 cases rose in four out of the six WHO regions just in the past week.
The U.S. FDA sent a refuse to file letter to Nymox Pharmaceutical Corp. regarding its NDA for fexapotide triflutate, a pro-apoptotic protein intended for treating benign prostatic hyperplasia. The letter noted that more long-term safety data was needed for the application, the company said.
In the wake of a patient’s death, the U.S. FDA has placed a partial clinical hold on Foghorn Therapeutics Inc.’s phase I study of FHD-286 in treating relapsed and/or refractory acute myelogenous leukemia (r/r AML) and myelodysplastic syndrome.
Respiratory syncytial virus (RSV) continues to be a tough indication. Enanta Pharmaceuticals Inc.’s phase IIb study of otherwise healthy adults treated with EDP-938, an N-protein inhibitor, missed its primary endpoint of reduction in total symptom score compared to placebo. It also missed the study’s secondary antiviral endpoints.
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress.
It was a patient-reported outcome, one that could actually be seen in the mirror, that alerted researchers they might be on track in their phase I/II study of cystinosis. The patient noticed that for the first time in his life his hair had become darker, like his brother’s. It was all because the rare disease inhibiting the pigment in his body was being impacted by the treatment. “It’s a secondary issue, but I find it fascinating,” Avrobio Inc.’s CEO, Geoff MacKay, told BioWorld. “When you run trials like this, you stumble upon some fascinating results.”
