SYBX News and Press, Synlogic Inc. From 01/19/23

The U.S. Food and Drug Administration (FDA) granted rare pediatric disease designation (RPDD) to Synlogic's ( NASDAQ: SYBX ) SYNB1934 to potentially treat phenylketonuria (PKU). PKU is a rare inherited disorder which causes an amino acid called phenylalanine to build up in the bod...

CAMBRIDGE, Mass., Jan. 19, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that SYNB1934 was granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the pote...

Pivotal Phase 3 for SYNB1934 in phenylketonuria (PKU) to initiate in H1 2023 Rare Pediatric Disease Designation received for SYNB1353 for homocystinuria (HCU) Cash runway expected into H2 2024 CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX...

CAMBRIDGE, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced the appointment of Dr. Dave Hava to H...

Results include -38% reduction in urinary oxalate compared to placebo in Roux-en-Y gastric bypass patients Favorable safety and tolerability, with frequency and severity of adverse events similar across placebo and active arms Synlogic to host webcast today at 8:30 am. ET with D...

Top-line Phase 1 data in healthy volunteers show that SYNB1353 reduces plasma methionine by consuming methionine in the GI tract SYNB1353 has been granted Orphan Drug Designation (ODD) from the FDA for the treatment of homocystinuria (HCU) Company confirms expectations for proof...

Synlogic press release ( NASDAQ: SYBX ): Q3 GAAP EPS of -$0.25 misses by $0.02 . Revenue of $0.7M (-22.2% Y/Y) beats by $0.61M . For further details see: Synlogic GAAP EPS of -$0.25 misses by $0.02, revenue of $0.7M beats by $0.61M

Top-line Phase 2 data for phenylketonuria (PKU) demonstrated robust plasma Phe reduction and high response rate; Phase 3 study initiation planned for H1 2023 Clinical readouts for SYNB1353 for homocystinuria (HCU) and SYNB8802 for enteric hyperoxaluria (EH) expected in 2022 ...

Summary The standard of care treatments for PKU have safety issues and/or limited efficacy. Recent data showed meaningful efficacy for SYNB1934 in PKU and the company will proceed to phase 3 testing. PTC Therapeutics, a competitor has a phase 3 study underway in PKU. PKU i...

The clinical-stage biotech Synlogic, Inc. ( NASDAQ: SYBX ) jumped ~10% on Tuesday after the company reported top-line data from the Phase 2 trial for experimental oral drugs SYNB1934 and SYNB1618 in rare genetic condition phenylketonuria (PKU). PKU is characterized b...