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CAMBRIDGE, Mass. - Seres Therapeutics, Inc. (NASDAQ:MCRB), a biotechnology firm specializing in live biotherapeutics with a market capitalization of $130 million, has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its clinical development strategy for SER-155, an investigational treatment for patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). According to InvestingPro data, the company’s stock has shown significant volatility, trading between $0.54 and $1.53 over the past 52 weeks. The FDA has endorsed the primary efficacy endpoint proposed by Seres—a reduction in bloodstream infections (BSIs) 30 days post-transplantation.
The company, which recently engaged in a Type B Breakthrough Therapy meeting with the FDA, is considering the design for its next study, which could be a Phase 2 or a combined Phase 2/3 trial. InvestingPro analysis indicates the company is quickly burning through cash, with a negative EBITDA of $36.4 million in the last twelve months. This decision will be informed by further feedback from the FDA, expected in the coming weeks. Seres plans to submit the study protocol in the second quarter of this year, incorporating the FDA’s guidance.
Seres’ CEO, Eric Shaff, expressed satisfaction with the FDA’s input, which supports the company’s aim to provide SER-155 to allo-HSCT patients. The FDA’s feedback aligns with the benefits of the Breakthrough Therapy designation and aims to streamline the regulatory process.
SER-155 is designed to prevent bacterial bloodstream and antimicrobial resistant infections, as well as other negative clinical outcomes, by decolonizing gastrointestinal pathogens, enhancing epithelial barrier integrity, and inducing immune tolerance. The treatment has shown promise in a Phase 1b placebo-controlled trial, demonstrating a 77% relative risk reduction in BSIs, a decrease in systemic antibiotic use, and a lower incidence of febrile neutropenia.
The company, which has previously succeeded in developing and gaining approval for the first FDA-approved orally administered microbiome therapeutic, is now seeking a development partner for SER-155 in allo-HSCT. While analysts maintain mixed views on the stock’s prospects, InvestingPro data suggests the stock is currently undervalued based on its Fair Value model. For deeper insights into Seres Therapeutics’ financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
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In other recent news, Seres Therapeutics has received a $50 million payment from Nestlé Health Science as part of the transition obligations following the sale of its VOWST business. The company anticipates an additional $25 million installment in July 2025, which will aid in financing operations into the first quarter of 2026. Additionally, the FDA granted Breakthrough Therapy designation to Seres’ investigational drug SER-155, aimed at reducing bloodstream infections in patients undergoing allogeneic hematopoietic stem cell transplants. This designation follows a Phase 1b study showing a significant reduction in infection risk compared to placebo.
In a move to strengthen its leadership, Seres Therapeutics appointed Dr. Hans-Juergen Woerle as a new director to its Board, expanding it to nine members. This appointment follows a rights agreement with Nestlé, which holds a significant stake in the company. Dr. Woerle’s role will include participation in the Science and Clinical Development Committee. These recent developments reflect Seres Therapeutics’ ongoing efforts to enhance its leadership and advance its pipeline of biotherapeutic products.
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