Welcome to our dedicated page for Synlogic news (Ticker: SYBX), a resource for investors and traders seeking the latest updates and insights on Synlogic stock.
Synlogic, Inc. (SYBX) pioneers synthetic biology solutions targeting rare metabolic disorders through its innovative engineered probiotics. This dedicated news hub provides investors and industry observers with essential updates on clinical developments, regulatory milestones, and strategic partnerships.
Access timely reports on Synlogic's synthetic biotics platform progress, including trial results for phenylketonuria (PKU) therapies and microbiome research breakthroughs. Our curated collection features earnings announcements, patent filings, and scientific collaborations that shape the company's trajectory in biopharmaceutical innovation.
Key updates include FDA designations, partnership agreements with leading research institutions, and advancements in oral therapeutic delivery systems. Bookmark this page for streamlined access to verified information about Synlogic's novel approach to metabolic disease treatment.
On March 28, 2023, Synlogic, Inc. (Nasdaq: SYBX) announced that the European Medicines Agency (EMA) granted a positive opinion for the orphan designation of SYNB1934, aimed at treating phenylketonuria (PKU).
This designation highlights the urgent need for new PKU treatments and positions Synlogic to commence a Phase 3 trial in mid-2023. Additionally, SYNB1934 has received Rare Pediatric Disease Designation from the FDA. The EMA’s orphan designation provides financial and regulatory benefits, including a decade of marketing exclusivity following product approval.
SYNB1934 is designed to lower phenylalanine levels using engineered probiotics, offering a promising therapeutic option for PKU patients.
Synlogic, Inc. (Nasdaq: SYBX) presented positive findings from its Phase 2 Synpheny-1 Study for phenylketonuria (PKU) at the SIMD Annual Meeting in Utah. Results showed that SYNB1934 significantly reduced plasma phenylalanine (Phe) levels by 53% in responders, indicating strong proof-of-concept. The study successfully met its primary endpoint, with reductions of -33.8% and -42.9% for SYNB1618 and SYNB1934 respectively. Synlogic also provided updates on its homocystinuria (HCU) program, highlighting the promising Phase 1 data for SYNB1353. This demonstrates the company’s progress toward initiating a Phase 3 trial for PKU in the first half of 2023.
Synlogic, the leader in synthetic biology therapeutics, announced a presentation at the Oppenheimer 33rd Annual Healthcare Conference from March 13-15, 2023. The CEO, Aoife Brennan, and her team will present on March 13, 2023, from 3:20 to 3:50 p.m. ET. Attendees can register for the webcast here.
A replay will be available for 90 days. Synlogic's pipeline focuses on treatments for metabolic diseases, including phenylketonuria (PKU), with plans for a Phase 3 study in 2023.
Synlogic, Inc. (Nasdaq: SYBX) announced its participation at the SIMD 44th Annual Meeting in Salt Lake City on March 19, 2023. The company will present a podium presentation on Phase 2 data for its PKU treatment, SYNB1618 and SYNB1934, led by Dr. Jerry Vockley. Additionally, two poster presentations will showcase findings on SYNB1353 for homocystinuria. The presentations underscore Synlogic's commitment to developing innovative therapies for inborn metabolic disorders. Dr. Dave Hava expressed enthusiasm for sharing new data that may alleviate burdens faced by patients and caregivers.
Synlogic, Inc. (Nasdaq: SYBX) recently announced its participation in two major upcoming conferences: the BIO CEO & Investor Conference from February 6-9, 2023, in New York City, and the SVB Securities Global Biopharma Conference from February 14-16, 2023. Chief Business Officer Molly Harper and Chief Financial Officer Michael Jensen will present at the BIO conference, with Harper's in-person presentation scheduled for February 6 at 4:15 p.m. ET. Synlogic's President and CEO Aoife Brennan will present virtually on February 16 at 12 p.m. ET at the SVB conference. More details and recorded presentations will be available on Synlogic's website.
Synlogic (Nasdaq: SYBX) announced that the FDA has granted Rare Pediatric Disease Designation (RPDD) for its drug SYNB1934, targeting phenylketonuria (PKU). This designation underscores the urgent need for PKU treatments, particularly for children. The pivotal Phase 3 study, Synpheny-3, is set to begin in the first half of 2023. Additionally, Synlogic previously received RPDD for SYNB1353 in December 2022 for homocystinuria (HCU). RPDD can lead to a pediatric priority review voucher if the drug is approved, enhancing the potential market value for new therapeutic options.
Synlogic, Inc. (Nasdaq: SYBX) announced key accomplishments for 2022 and future milestones. The company plans to initiate a pivotal Phase 3 trial for SYNB1934 in phenylketonuria (PKU) in H1 2023. Additionally, SYNB1353 has received Rare Pediatric Disease Designation for homocystinuria (HCU) from the FDA. Synlogic expects its cash runway to last into H2 2024. Major 2022 achievements include positive Phase 2 data for PKU and proof of concept for SYNB1353 and SYNB8802. Upcoming milestones include advancing SYNB1353 to Phase 2 and presenting full Phase 2 data for PKU.
Synlogic, Inc. (Nasdaq: SYBX) has appointed Dr. Dave Hava as Head of Research and Development effective January 1, 2023. Previously Chief Scientific Officer, Dr. Hava will oversee the integration of research and clinical development, aiming to advance various programs, including SYNB1353 for homocystinuria and SYNB2081 for gout. Synlogic's pipeline includes potential treatments for metabolic disorders, with a Phase 3 study for phenylketonuria planned for 2023. The company collaborates with Roche to develop Synthetic Biotics, enhancing treatment options for patients.
Synlogic, Inc. (Nasdaq: SYBX) announced positive results from its Phase 1b study of SYNB8802, demonstrating a 38% reduction in urinary oxalate in Roux-en-Y gastric bypass patients compared to placebo. This reduction exceeds the 20% threshold associated with lower kidney stone risks. The treatment was well tolerated with no serious adverse events reported. The study involved 11 patients, showing a significant dose-related effect. Synlogic's CEO highlighted this as their third positive clinical data readout this year, underscoring the urgent need for treatments for enteric hyperoxaluria.
Synlogic announced positive top-line results from its Phase 1 study for SYNB1353, designed to lower methionine levels in patients with homocystinuria (HCU). The drug achieved proof of mechanism, showing a significant plasma methionine reduction post-administration and was well tolerated by participants. Additionally, SYNB1353 received Orphan Drug Designation from the FDA, enhancing its development incentives. The company plans to continue advancing its clinical research, including expected proof-of-concept data for SYNB8802 by year-end and the initiation of a Phase 3 study for SYNB1934 in early 2023.
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