SYNLOGIC


Associated tags: Genetic engineering, Gout, Synthetic biology, Probiotic, IBD, Inflammatory bowel disease, Roche, PKU, Homocystinuria, Phenylketonuria, HCU, Uric acid, AbbVie, Pharmaceutical industry, Therapy, Patient, FDA, Research

Locations: NEW YORK CITY, LOS ANGELES, INN, CULVER CITY, CA, CAMBRIDGE, MA, US, CALIFORNIA, UNITED STATES, ROCHE, BOSTON, CANADA

Synlogic Reminds Stockholders of 2023 Annual General Meeting Details

Retrieved on: 
Thursday, June 8, 2023

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.

Key Points: 
  • 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.
  • Stockholders should allow ample time for check-in procedures before the meeting begins.
  • Whether or not stockholders plan to virtually attend the Annual Meeting, Synlogic urges them to vote and submit their proxy in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting.

Synlogic Announces Initiation of Synpheny-3 Global, Pivotal Phase 3 Study Evaluating SYNB1934 for Treatment of Phenylketonuria

Retrieved on: 
Monday, June 5, 2023

CAMBRIDGE, Mass., June 05, 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 initiation of Synpheny-3, a global, pivotal Phase 3 study evaluating the efficacy and safety of SYNB1934 as a potential treatment for phenylketonuria (PKU).

Key Points: 
  • Synpheny-3 is a randomized, placebo-controlled, global, multi-center, pivotal Phase 3 clinical trial designed to evaluate the efficacy and safety of SYNB1934 as a treatment for PKU.
  • The final trial design incorporates feedback from global regulatory agencies including the U.S. Food and Drug Administration (FDA).
  • The global study will enroll approximately 150 patients with plasma phenylalanine (Phe) levels at baseline of >360 μM.
  • The study has been designed for patient convenience, and offers opportunities to participate in person, or in a virtual or hybrid format.

Synlogic Announces Data Presentations at the 2023 Synthetic Biology: Engineering, Evolution & Design (SEED) Conference

Retrieved on: 
Wednesday, May 24, 2023

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.

Key Points: 
  • 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.
  • “The data being presented by our team at SEED this year showcases the extraordinary progress our Synthetic Biotic platform has achieved across multiple therapeutic categories,” said Dave Hava, Chief Scientific Officer and Head of Research and Development at Synlogic.

Synlogic to Present at the Jefferies Global Healthcare Conference

Retrieved on: 
Tuesday, May 23, 2023

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.

Key Points: 
  • 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.
  • To access the webcast of the presentation, please click here
    A replay of the presentation will be available for 90 days.
  • Recorded presentations, if available, can be found on the Archived Events section of the Synlogic website.

Synlogic Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, May 11, 2023

CAMBRIDGE, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today reported financial results for the first quarter ended March 31, 2023, and provided an update on its pipeline programs.

Key Points: 
  • Revenue was $0.2 million for each of the three months ended March 31, 2023 and March 31, 2022.
  • Research and development expenses were $12.5 million for the three months ended March 31, 2023, compared to $11.7 million for the corresponding period in 2022.
  • General and administrative expenses were $4.0 million for the three months ended March 31, 2023, compared to $4.3 million for the corresponding period in 2022.
  • Synlogic leadership will attend the Jefferies Global Healthcare Conference being held June 7-9, 2023, in New York City.

Synlogic Receives Orphan Drug Designation from FDA for SYNB1934 for Treatment of Phenylketonuria

Retrieved on: 
Tuesday, May 9, 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).

Key Points: 
  • 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).
  • “We are very pleased that SYNB1934 has been granted another regulatory designation, further validating the need for new treatment options for those living with PKU,” said Aoife Brennan M.B.
  • Ch.B., Synlogic President and Chief Executive Officer.
  • ODD granted therapies entitle companies to development incentives including tax credits for qualified clinical trials, user fee exemptions, and the potential for seven years of market exclusivity after approval.

Synlogic Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Updates

Retrieved on: 
Wednesday, March 29, 2023

   CAMBRIDGE, Mass., March 29, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today reported financial results for the fourth quarter and full year ending December 31, 2022 and provided a business update.

Key Points: 
  • “Last year was a tremendous year for Synlogic and our Synthetic Biotic platform given our three positive clinical readouts in three different diseases in the fourth quarter alone,” said Aoife Brennan, M.B.
  • As of December 31, 2022, Synlogic had cash, cash equivalents, and short-term marketable securities of $77.6 million.
  • Revenue was $0.1 million for the three months ended December 31, 2022, compared to $0.6 million for the corresponding period in 2021.
  • Revenues were $1.2 million for the year ended December 31, 2022, compared to $1.8 million for the same period in 2021.

Synlogic Receives Positive Opinion on Orphan Designation from the European Medicines Agency for SYNB1934 for the Treatment of Phenylketonuria

Retrieved on: 
Tuesday, March 28, 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).

Key Points: 
  • 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).
  • “We are pleased that the EMA has issued a positive opinion for orphan designation for SYNB1934, in recognition of the urgent need for new treatment options for people living with this devastating disease,” said Aoife Brennan, M.B.
  • Ch.B., Synlogic President and Chief Executive Officer.
  • “This designation also comes at a pivotal time as we prepare to begin our Phase 3 trial for PKU in the first half of this year.”
    SYNB1934 has also been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration (FDA).

Synlogic Announces Data Presentations at the Society for Inherited Metabolic Disorders (SIMD) 44th Annual Meeting

Retrieved on: 
Monday, March 20, 2023

In separate poster presentations, the company also presented clinical data and preclinical data related to its homocystinuria (HCU) program.

Key Points: 
  • In separate poster presentations, the company also presented clinical data and preclinical data related to its homocystinuria (HCU) program.
  • “We were delighted to review these encouraging findings from our two rare metabolic disease programs among the expert metabolic clinicians who attend the SIMD meeting,” said Dave Hava, Chief Scientific Officer and Head of Research and Development at Synlogic.
  • Clinical data presented included positive data from the Phase 1 study evaluating SYNB1353 in healthy volunteers using a dietary model of HCU.
  • Posters presented at the SIMD meeting are posted on the Publications page of the Synlogic website.

Synlogic to Present at the Oppenheimer 33rd Annual Healthcare Conference

Retrieved on: 
Wednesday, March 8, 2023

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.

Key Points: 
  • 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:
    Webcast: Register for the presentation here.
  • Recorded presentations, if available, can be found on the Events section of the Synlogic website.