Articles from Synlogic, Inc.

WINCHESTER, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a biopharmaceutical company advancing novel therapeutics to transform the care of serious diseases, today reported financial results for the third quarter 2024 and provided a corporate update.

WINCHESTER, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a biopharmaceutical company advancing novel therapeutics to transform the care of serious diseases, today reported financial results for the second quarter 2024 and provided a corporate update.

CAMBRIDGE, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a biopharmaceutical company advancing novel therapeutics to transform the care of serious diseases, today reported financial results for the first quarter 2024 and provided a corporate update.

CAMBRIDGE, Mass., March 19, 2024 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a biopharmaceutical company advancing novel therapeutics to transform the care of serious diseases, today reported financial results for the fourth quarter and full year ending December 31, 2023.

Engages Ladenburg Thalmann as financial advisor to assist with previously announced strategic review process

Decision to end trial follows internal review of initial data indicating study unlikely to meet primary endpoint

Findings support positive proof of mechanism, through successful degradation of methionine, precursor to homocysteine, using dietary disease model in preclinical models and healthy volunteer study

- Data review from pivotal Synpheny-3 study in PKU expected in H1 2024, with potential to expand study population to patients aged 12-17 years of age -

- Selection of Synlogic reflects Company’s leadership in process development and manufacturing of therapeutics based on synthetic biology -

- Poster presentation on SYNB1353 program for homocystinuria includes findings from process improvements to improve activity of methionine degradation -

- Underwritten public offering of $21.0 million and earned $2.5 million milestone payment from Roche have extended cash runway into the first half of 2025 -

CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, announced today that it has achieved its third pre-specified research milestone and earned a third milestone payment of $2.5 million due under its collaboration agreement with Roche for the research and pre-clinical development of a Synthetic Biotic for the treatment of inflammatory bowel disease (IBD).

CAMBRIDGE, Mass., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced the closing of its previously announced underwritten public offering.

CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced the pricing of an underwritten public offering of (i) 7,394,363 shares of common stock (or common stock equivalents in lieu thereof) and (ii) accompanying common warrants to purchase up to an aggregate of 7,394,363 shares of common stock. The combined effective offering price to the public of each share of common stock (or pre-funded warrant) and accompanying warrant is $2.84. The accompanying warrants will have an exercise price of $3.408 per share, will be exercisable immediately, and will expire five years from the initial exercise date. All of the securities are being offered by Synlogic, Inc. The Company expects to receive total gross proceeds of approximately $21.0 million, before deducting underwriting discounts, commissions and offering expenses. The offering is expected to close on or about October 3, 2023, subject to satisfaction of customary closing conditions.

CAMBRIDGE, Mass., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced the publication of results from its Synpheny-1 Phase 2 study of its drug candidates, labafenogene marselecobac (SYNB1934) and SYNB1618 in patients with phenylketonuria (PKU) in the journal Nature Metabolism.

CAMBRIDGE, Mass., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced that it will implement a 1-for-15 Reverse Stock Split of its common stock (Reverse Stock Split), effective at 5:00 p.m. Eastern Time on Wednesday, September 27, 2023. The Reverse Stock Split, which was approved by shareholders at the company’s Annual Meeting of Stockholders on September 21, 2023, is primarily intended to bring the company into compliance with the minimum bid price requirement for maintaining its listing on The Nasdaq Capital Market. Beginning with the opening of trading tomorrow, Thursday, September 28, 2023, the company’s common stock will trade on the Nasdaq Capital Market on a split-adjusted basis under the existing symbol “SYBX” and a new CUSIP number 87166L 209.

CAMBRIDGE, Mass., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced its management team will participate in Chardan’s 7th Annual Genetic Medicines Conference, being held in New York, October 2-3, 2023. In addition to one-on-one meetings with investors, Synlogic CEO Dr. Aoife Brennan will participate in a Fireside Chat on Monday, October 2 at 4:30 p.m. Eastern Time.

CAMBRIDGE, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced that CEO Aoife Brennan, M.B. Ch.B., has been honored as a PharmaVoice 100 winner, a list recognizing the most inspiring people in the life sciences industry.

Recent milestones include initiation of the pivotal Phase 3 trial, Synpheny-3, and receipt of Fast Track designation for labafenogene marselecobac as a potential treatment for PKU

CAMBRIDGE, Mass., July 11, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to labafenogene marselecobac (previously known as SYNB1934) for the treatment of phenylketonuria (PKU). Labafenogene marselecobac has also received Rare Disease Designation (RPDD) and Orphan Drug Designation (ODD) by the FDA and orphan designation from the European Medicines Agency (EMA).

The World Health Organization has approved “labafenogene marselecobac”

CAMBRIDGE, Mass., June 27, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced that its management team will participate in the SVB Securities Healthcare Therapeutics Forum, being held in New York, July 11-12, 2023. The Synlogic team will be available for one-on-one investor meetings. To register for the conference or request one-on-one meetings, please contact your SVB Securities representative.

CAMBRIDGE, Mass., June 08, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today reminded stockholders that it will hold its 2023 Annual General Meeting of Stockholders on Thursday, June 15, 2023 at 8:00 a.m. EST. The Annual Meeting will be held in a virtual meeting format only.

Registrational study designed to support BLA submission of first-in-class biotherapeutic

CAMBRIDGE, Mass., May 24, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced its planned presentations at the 2023 Synthetic Biology: Engineering, Evolution & Design (SEED) conference being held May 30 – June 2, 2023 in Los Angeles, CA. The company’s oral presentation focuses on Synlogic’s development of a Synthetic Biotic drug candidate for the potential treatment of homocystinuria (HCU), a rare metabolic disease caused by an inborn error of metabolism. The company’s poster presentations highlight preclinical and clinical data. Presentation details are provided below.

CAMBRIDGE, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that Aoife Brennan, M.B. Ch.B., President and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference being held in New York, NY, June 7-9, 2023.

- Phenylketonuria (PKU) program on track for Phase 3 trial initiation in first half of 2023 –

CAMBRIDGE, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to SYNB1934 for the treatment of phenylketonuria (PKU).

– Phenylketonuria (PKU) program on track for Phase 3 trial initiation in first half of 2023 –

CAMBRIDGE, Mass., March 28, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that the European Medicines Agency (EMA) issued a positive opinion on the Company’s application for orphan designation for SYNB1934 for the treatment of phenylketonuria (PKU).

Presentations included full data from both the Phase 2 Synpheny-1 Study in phenylketonuria and Phase 1 Study for SYNB1353 as a potential treatment for homocystinuria

CAMBRIDGE, Mass., March 08, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer, and members of the leadership team, will provide a company presentation at the Oppenheimer 33rd Annual Healthcare Conference being held virtually from March 13-15, 2023. Presentation details are provided below:

– Podium presentation on Phase 2 phenylketonuria (PKU) data –

CAMBRIDGE, Mass., Jan. 24, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced it will participate in the following upcoming investor and industry conferences:

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 potential treatment of phenylketonuria (PKU).

Pivotal Phase 3 for SYNB1934 in phenylketonuria (PKU) to initiate in H1 2023

Results include -38% reduction in urinary oxalate compared to placebo in Roux-en-Y gastric bypass patients

Top-line Phase 1 data in healthy volunteers show that SYNB1353 reduces plasma methionine by consuming methionine in the GI tract

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

Positive results include clinically meaningful Phe reductions, with a 60% response rate and 42% reduction in plasma Phe among responders across the study population