In January, a Wall Street analyst predicted the U.S. FDA’s rejection of Eli Lilly and Co.’s application seeking accelerated approval of amyloid beta-targeting Alzheimer’s candidate, donanemab, would be a “mere footnote” in the drug’s development, a forecast confirmed in the wake of positive top-line phase III data showing donanemab significantly slowed cognitive and functional decline in people with early symptomatic disease.
Immunogen Inc. scored a major win in top-line data from the confirmatory phase III trial called Mirasol evaluating the approved antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx, “mirv”) vs. chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer (PROC). The victory led shares of the Waltham, Mass.-based firm to close May 3 at $12.26, a rise of $7.06, or 135%.
Using direct current to stimulate a chronic wound can help it to heal up to three times faster, researchers from Chalmers Institute of Technology, Sweden, and the University of Freiburg, Germany, found. Working from a well-known hypothesis that the skin is electrostatic, the researchers engineered a microfluidic biochip on which skin cells were cultured. They then made tiny wounds in two cells. One was allowed to heal naturally while the other was stimulated with electricity.
Saddled with disappointing results from a phase III trial with Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), officials of Travere Therapeutics Inc. stressed the differences between that disorder and IgA nephropathy (IgAN) – for which the drug was cleared by the U.S. FDA in February. Two-year IgAN efficacy data are due in the fourth quarter of this year.
A precancerous condition caused by the human papillomavirus (HPV) affects up to 300,000 American women who are diagnosed each year, and yet there are no treatments, just preventive vaccines introduced in 2006 – targeted to younger generations prior to the first sexual encounter. That leaves a large proportion of the female population stuck with a “wait-and-see” approach that involves continuous monitoring of their HPV infection through pap smears to detect cellular changes that could lead to cervical cancer. South San Francisco-based Antiva Biosciences Inc. is seeking to find a better response to this condition known as high-grade cervical intraepithelial neoplasia (CIN2,3) with its lead topical therapeutic, ABI-2280, a prodrug of an acyclic nucleoside phosphonate that is currently in phase I trials.
Despite posting positive phase IIa data, Pliant Therapeutics Inc. stock (NASDAQ:PLRX) took a punch May 1 as shares closed 21% downward at $22.31 each. Still, the stock is in far better shape than it was a year ago when shares were going for about $5 each.
Xeltis AG reported the first-in-human results for its fully synthetic electrospun vascular access graft, showing 100% patency at six months in 20 patients with end stage renal disease who were not suitable for arteriovenous (AV) fistula creation.
Touting what’s been so far the “cleanest safety profile that’s been presented with genetic medicine in the eye,” deemed “a game changer for this field,” 4D Molecular Therapeutics Inc. CEO David Kirn said phase III planning will begin in later this year to test gene therapy 4D-150 in wet age-related macular degeneration (AMD).
Positive phase III results from Surmount-2 of Eli Lilly and Co.’s Mounjaro (tirzepatide) showed overweight and obese type 2 diabetes patients receiving the highest dose lost up to 34.4 pounds, with the majority achieving at least a 5% decrease in overall body weight. The results will help the Indianapolis-based company complete its rolling supplemental NDA with the U.S. FDA targeting an approval for obese and overweight adults with weight-related co-morbidities.
The Memed BV test, developed by Memed Diagnostics Ltd. to distinguish between bacterial and viral infections, offers an accurate diagnosis of the infection in children, and reduces the unnecessary prescription of antibiotics by physicians, according to a study published in the journal, PLOS One.