The progression-free survival metric has helped shepherd many products across the regulatory finish line. Experts say the FDA’s new emphasis on overall survival will be felt especially by small biotechs.
Tag Archive for: biotech
Kyverna Therapeutics will debut on the Nasdaq Global Select Market under the ticker symbol KYTX after announcing that it is putting up for sale 14.5 million shares of its common stock for $22 apiece in an upsized initial public offering.
According to the announcement, the firm’s mission is to create and build companies developing innovative treatments that could “cure or transform the clinical management” of life-threatening diseases.
The Swiss pharma’s dealmaking momentum continues in early 2024 with the acquisition of German biotech MorphoSys in an effort to strengthen its oncology portfolio.
Alto Neuroscience and Fractyl Health provided further momentum to the recent spate of biotech initial public offerings, with both companies going public on Friday morning in respective $128 million and $110 million IPOs.
The bladder cancer-focused company’s larger-than-expected Nasdaq debut on Thursday opens this year’s batch of planned initial public offerings, which include at least half a dozen biotechs.
The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
The collaboration is focused on the evaluation of Vivtex’s unique and proprietary GI-ORIS™ (“Gut on a chip” and AI) screening and formulation platform technology to support the development of novel, oral versions of a therapeutic candidate provided by Astellas.
The deal will bolster nthye French company’s drug development portfolio with an experimental treatment for a rare genetic disease.
The biotech announced a restructuring plan as its humanized IgG1 antibody lirentelimab failed two Phase II studies in atopic dermatitis and chronic spontaneous urticaria.