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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.
Synlogic, Inc. (SYBX) reported promising Phase 2 results for its PKU treatment, indicating robust plasma Phe reduction. The company plans to initiate Phase 3 trials in H1 2023. Financially, Synlogic ended Q3 2022 with $91.7 million in cash, enough to fund operations into 2024. However, Q3 revenue dropped to $0.7 million from $0.9 million year-over-year. The net loss widened to $17.9 million or $0.25 per share, compared to a $16.0 million loss in the same period of 2021. Upcoming milestones include significant data releases for other pipeline products in H2 2022.
Synlogic, Inc. (Nasdaq: SYBX) announced positive top-line data from its Phase 2 Synpheny-1 study, which evaluated SYNB1934 for phenylketonuria (PKU). The study showed a 60% response rate and an average 42% reduction in plasma Phe among responders. Both SYNB1934 and SYNB1618 demonstrated significant reductions in fasting plasma Phe levels, particularly SYNB1934, at -34%. Based on these results, SYNB1934 will advance to a Phase 3 registrational study expected in H1 2023. All adverse events reported were mild to moderate.
Synlogic, Inc. (Nasdaq: SYBX) has received a milestone payment from Roche for meeting success criteria in their research collaboration to develop a novel Synthetic Biotic targeting inflammatory bowel disease (IBD). This collaboration aims to discover a Synthetic Biotic for an undisclosed target, with Roche having exclusive licensing options post-research. Synlogic also has a pipeline of synthetic biology-based drugs, including a Phase 3 study for phenylketonuria planned in early 2023.
Synlogic, Inc. (Nasdaq: SYBX), a biotechnology company, announced that the FDA granted Fast Track designation for SYNB1353, aimed at treating homocystinuria (HCU). This designation supports expedited drug development for serious conditions, allowing for ongoing dialogues with the FDA and potential early submission for approval. SYNB1353, an orally-administered drug, is currently in a Phase 1 study. HCU is a serious inherited disorder characterized by elevated homocysteine levels, with limited treatment options available.
Synlogic, Inc. (Nasdaq: SYBX) announced the development of SYNB2081, a new Synthetic Biotic drug candidate for treating gout, in collaboration with Ginkgo Bioworks (NYSE: DNA). This marks the second drug candidate to enter clinical development through their partnership, following SYNB1353 for homocystinuria. Gout, characterized by high uric acid levels, currently lacks effective treatments. SYNB2081 aims to address this need. The collaboration highlights the innovation potential of synthetic biology in developing therapeutics for various diseases.
Synlogic, Inc. (NASDAQ: SYBX) reported its Q2 2022 financial results, highlighting $106.8 million in cash to support operations into 2024. Revenue remained low at $0.2 million, unchanged from 2021, primarily from collaborations with Roche. The company incurred a net loss of $15.8 million ($0.22/share), slightly increased from $14.5 million ($0.28/share) in Q2 2021. Upcoming milestones include three clinical data readouts in H2 2022 and a planned Phase 3 trial for phenylketonuria (PKU) starting in H1 2023.
Synlogic, Inc. (Nasdaq: SYBX) announced that it will release its second quarter 2022 financial results on August 11, 2022, before the market opens. Following the release, a conference call will be held at 8:30 A.M. ET, accessible via telephone and webcast, where the company will review financial results and provide a business update. Synlogic is focused on developing medicines for metabolic and immunological diseases using synthetic biology and plans to start a pivotal Phase 3 study for its PKU program in H1 2023.
Synlogic, Inc. (Nasdaq: SYBX) has initiated a Phase 1 clinical trial for its oral therapy, SYNB1353, aimed at treating homocystinuria (HCU). The first healthy volunteer has been dosed, marking a significant milestone in advancing Synlogic's pipeline. SYNB1353 is engineered to lower homocysteine levels, addressing a pressing medical need as current treatment options are limited. Results from this study are expected by the end of 2022. This development reflects the efficiency of Synlogic's Synthetic Biotic platform and contributes to three anticipated clinical readouts for the year.
Synlogic, Inc. (Nasdaq: SYBX) announced the appointment of Brendan St. Amant as General Counsel and Corporate Secretary effective July 1, 2022. St. Amant, who joined the company in 2021 as Vice President, Head of Legal, brings significant legal experience from his previous roles at Ohana Biosciences and Vertex Pharmaceuticals. This leadership change is expected to further strengthen Synlogic's progress towards key clinical and regulatory milestones, notably for its pipeline focusing on metabolic and immunological diseases.
Synlogic, a clinical-stage biotechnology company (Nasdaq: SYBX), will participate in the National PKU Alliance's biennial conference from July 7-10, 2022, in Vancouver, Washington. As an event sponsor, Synlogic will present on emerging therapies for phenylketonuria (PKU) and share research data on dietary protein intake in PKU patients. Key presentations include:
- Transforming Medicine through Synthetic Biology - July 8, 2022, at 3:30 P.M. PT
- Characterization of Dietary Protein Intake in PKU Patients - July 9, 2022, at 3:00 P.M. PT
Synlogic focuses on developing synthetic biology medicines for metabolic diseases.