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Synlogic, Inc. (Nasdaq: SYBX) is a clinical-stage biopharmaceutical company at the forefront of synthetic biology and microbiome research. The company is pioneering the development of Synthetic Biotics™, which are engineered probiotic bacteria designed to perform specific therapeutic functions. These innovative biotherapeutics target a range of metabolic and rare genetic diseases, addressing unmet medical needs.
Using its proprietary Synthetic Biotics™ platform, Synlogic engineers probiotics to correct metabolic dysfunctions linked to various diseases. These therapeutics are primarily delivered orally, acting from the gut microbiome to address systemic issues. The company’s lead programs include treatments for rare genetic metabolic disorders such as phenylketonuria (PKU) and homocystinuria (HCU). Synlogic's pipeline also targets conditions like enteric hyperoxaluria, gout, and cystinuria.
One of Synlogic's flagship projects, labafenogene marselecobac (SYNB1934), is currently in a global, pivotal Phase 3 study for PKU, known as Synpheny-3. Additional candidates, such as SYNB1353 for HCU, are also progressing through clinical stages. The company collaborates with notable partners including Roche for inflammatory bowel disease (IBD) research and Ginkgo Bioworks for synthetic biology advancements.
Synlogic's commitment to innovative medicine is further demonstrated by its recent achievements. In December 2023, the company announced that SYNB1353, a potential treatment for HCU, would be presented at the International Conference on Microbiome Engineering. Additionally, Synlogic secured a $1 million subcontract from the Air Force Research Lab to develop a manufacturing process for a potential live probiotic product, extending a project initiated in 2020.
The company’s approach leverages well-characterized probiotics, such as Escherichia coli Nissle 1917, ensuring consistency, safety, and non-colonizing properties, which simplify oral administration and storage. Synlogic continues to expand its pipeline and research capabilities, driving forward its mission to transform the care of serious diseases through groundbreaking synthetic biology technologies.
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.
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