TECX (Tectonic Therapeutic, Inc. Common Stock) PDUFA Date

Jun 10, 2026

Tectonic Therapeutic Completes Enrollment in TX45 APEX Phase 2 Clinical Trial in PH-HFpEF Patients

Tectonic Therapeutic has completed enrollment for its APEX Phase 2 clinical trial, which evaluates the safety and efficacy of TX45 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). The trial enrolled 191 patients across 14 countries, focusing on a severe subtype of the disease. Topline results are anticipated in early Q1 2027.

Tectonic Therapeutic Announces First Quarter 2026 Financial Results and Recent Business Highlights

Tectonic Therapeutic reported its Q1 2026 financial results, highlighting significant progress in its clinical trials, including the nearing completion of patient enrollment for the TX45 APEX Phase 2 trial and the initiation of the TX2100 Phase 1a trial. The company appointed new board members to strengthen governance and reported a cash position of $236.9 million, expected to sustain operations through Q4 2028. However, the company also noted an increase in net loss and R&D expenses compared to the previous year.

Apr 23, 2026

Tectonic Therapeutic Appoints Jessica Chutter to Board of Directors

Tectonic Therapeutic has appointed Jessica Chutter to its Board of Directors, effective June 8, 2026. Chutter, a veteran in healthcare investment banking, is expected to leverage her extensive experience to support Tectonic's strategic initiatives and growth. The company is progressing towards becoming a multi-product clinical entity with a promising pipeline.

Mar 2, 2026

Tectonic Therapeutic to Participate in March Investor Conferences

Tectonic Therapeutic, a clinical-stage biotech firm, will participate in two investor conferences in March 2026. The company's management will host one-on-one meetings and fireside chats, which will be accessible on their website. Tectonic is focused on developing therapeutic proteins and antibodies targeting GPCRs to address unmet medical needs.

Feb 26, 2026

Tectonic Therapeutic Announces Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights • Announced positive topline results from TX45 Phase 1b acute hemodynamic clinical trial in patient

Tectonic Therapeutic announced positive topline results for its TX45 Phase 1b trial in patients with Group 2 Pulmonary Hypertension, showing improvements in heart function and pulmonary hemodynamics. The company also advanced TX2100 into Phase 1a clinical trials and began a Phase 2 trial for TX45 targeting other forms of pulmonary hypertension. With $253.8 million in cash, Tectonic expects a substantial cash runway into late 2028 to support ongoing and future trials. However, the company reported an increased net loss and rising development expenses.

Feb 24, 2026

Tectonic Therapeutic Appoints François Nader, M.D., as Chair and Independent Director of the Board

Tectonic Therapeutic has appointed Dr. François Nader as Chair and Independent Director of its Board, effective April 1, 2026. Dr. Nader, who has over 30 years of experience in biotechnology, will succeed Terry McGuire, who will remain on the board until the 2026 Annual Meeting. This leadership change is expected to enhance Tectonic's strategic direction and growth in GPCR-targeted therapies.

Feb 12, 2026

Tectonic Therapeutic to Host Virtual KOL Event and Discussion of TX2100, a Novel Approach for the Treatment of Hereditary Hemorrhagic Telangiectasia, on February 24, 2026

Tectonic Therapeutic is set to host a virtual KOL event on February 24, 2026, to discuss TX2100, a novel GPCR antagonist for treating Hereditary Hemorrhagic Telangiectasia (HHT). The event will feature Dr. Hanny Al-Samkari, who will provide insights into HHT's clinical context and the preclinical evidence supporting TX2100. Tectonic plans to initiate a Phase 1a trial of TX2100 in early 2026.

Tectonic Therapeutic Announces Third Quarter 2025 Financial Results and Recent Business Highlights • Positive topline data from Part B of the TX45 Phase 1b trial demonstrated improvements in both left heart functi

Tectonic Therapeutic reported positive topline results from Part B of the TX45 Phase 1b trial, showcasing improvements in left heart function and pulmonary hemodynamics for patients with Group 2 Pulmonary Hypertension and Heart Failure. The company plans to initiate TX2100's Phase 1 trial for Hereditary Hemorrhagic Telangiectasia in Q1 2026 and expand TX45's indications with further trials in 2026. Their financial results indicate a net loss increase, yet a solid cash position is expected to sustain operations into 2028.

TX45 Phase 1b (Part B) PH-HFrEF Data Release Single Dose Hemodynamic Trial O c t o b e r 2025 2 DISCLAIMER Statements contained in this presentation regarding matters that are not historical facts are "forward-looking st

The article discusses the positive results from the TX45 Phase 1b (Part B) trial focusing on patients with pulmonary hypertension and heart failure with reduced ejection fraction (PH-HFrEF). TX45 was found to be well tolerated, showing improvements in left ventricular function and pulmonary hemodynamics similar to earlier studies. As a result, further clinical investigations of TX45 are encouraged, particularly with the insights from the ongoing APEX Phase 2 trial. The findings highlight the potential market opportunity for TX45 in treating PH-HFrEF patients, where there are currently no approved therapeutic options.

Tectonic Therapeutic Announces Second Quarter 2025 Financial Results and Recent Business Highlights TX45 PH-ILD Phase 2 clinical trial is planned to initiate in 2026 to evaluate TX45 s safety and hemodynamic effects in s

Tectonic Therapeutics reported its financial results for Q2 2025 and discussed advancements including the upcoming Phase 2 trial for TX45 targeting pulmonary hypertension associated with interstitial lung disease (PH-ILD). The announcement highlights recent progress in clinical trials, including completed enrollment for TX45's Phase 1b trial and expected topline results. Despite financial losses, the company remains focused on addressing critical medical needs with TX45's innovative approach.

Tectonic Therapeutic Presents Complete Results for Positive Phase 1b Clinical Trial of TX45 in Patients with Group 2 Pulmonary Hypertension in HFpEF in Late-Breaking Presentation at ESC Heart Failure 2025 Data confirmed

Tectonic Therapeutic reported complete results from its Phase 1b clinical trial for TX45, demonstrating positive outcomes in patients with Group 2 Pulmonary Hypertension in HFpEF. The trial showed a significant reduction in pulmonary capillary wedge pressure, indicating potential improvements in exercise capacity and overall health. TX45 was found to be well tolerated, with no serious adverse events. The positive results pave the way for further investigations, including topline data from a related study expected later in 2025.

Tectonic Therapeutic Announces First Quarter 2025 Financial Results and Recent Business Highlights • Interim analysis from the TX45 Phase 1b Part A trial demonstrated meaningful improvements in both left ventricul

Tectonic Therapeutic has announced its financial results for Q1 2025, showcasing significant progress in its clinical development, particularly for TX45 in treating Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF). The interim analysis from the TX45 Phase 1b Part A trial showed meaningful improvements in key patient metrics, with full results to be unveiled at the ESC Heart Failure Congress in May. The company maintains a strong cash position, anticipated to support operations through late 2028, despite experiencing an increased net loss in the quarter.

Mar 20, 2025

Tectonic Therapeutic Announces Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights • TX45 Phase 1b trial interim analysis demonstrated meaningful improvements in both left ventricula

Tectonic Therapeutic recently announced encouraging fourth quarter and full year 2024 financial results, highlighting positive interim findings from their TX45 Phase 1b trial for patients with Group 2 Pulmonary Hypertension. The trial showed meaningful improvements in left ventricular function and pulmonary hemodynamics, reinforcing confidence in ongoing research. Notably, the company's financial outlook is bolstered by significant cash reserves and recent funding efforts, positioning them well for upcoming clinical developments. The APEX Phase 2 trial is set to continue advancing with topline results expected in 2026.

Feb 3, 2025

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Tectonic Announces $185 Million Private Placement

Tectonic Therapeutic has announced a $185 million private placement aimed at funding the clinical development of their product candidates and advancing their discovery platform. The offering includes shares priced at $50.00 for general investors and at $54.14 for insiders. The financing involved participation from a range of new and existing investors, demonstrating confidence in Tectonic's growth prospects. Proceeds are expected to enhance Tectonic's capabilities in developing therapeutic proteins and antibodies targeting G-protein coupled receptors.

Jan 30, 2025

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TX45 Phase 1b PH-HFpEF Interim Data Release for Single Dose Hemodynamic Trial January 2025 2 DISCLAIMER Statements contained in this presentation regarding matters that are not historical facts are "forward-looking state

Tectonic TX (TECX) has reported positive interim data from its Phase 1b clinical trial for TX45, a treatment aimed at Group 2 Pulmonary Hypertension associated with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). The trial achieved all hemodynamic goal targets, supporting the compound's potential as a best-in-class therapy. TX45 shows promise in addressing a significant patient population in the U.S. with no approved therapies and a high mortality rate. The company aims to expand its addressable patient population by also evaluating TX45 for PH with Reduced Ejection Fraction (PH-HFrEF).

Innovating GPCR-Targeted Therapies to Reach Large Untapped Market Opportunities JANUARY 2025 2 DISCLAIMER Statements contained in this presentation regarding matters that are not historical facts are "forward-looking sta

Tectonic Therapeutics Inc. (TECX) is advancing GPCR-targeted therapies with a focus on TX45, a long-acting relaxin currently in Phase 2 trials aimed at addressing Group 2 Pulmonary Hypertension associated with heart failure. The company is well-capitalized with approximately $159 million in cash, expected to sustain operations into mid-2027. Along with TX45, TECX is developing TX2100 for Hereditary Hemorrhagic Telangiectasia (HHT), with a Phase 1 trial initiation expected by early 2026. Despite significant market potential due to unmet needs, several risks and uncertainties could impact the development and regulatory approval of these therapies.

Nov 7, 2024

Tectonic Therapeutic Announces Third Quarter 2024 Financial Results and Recent Business Highlights • Patient enrollment in the Phase 1b hemodynamic trial remains ahead of expectation, with topline results now expe

Tectonic Therapeutic reported its financial results for Q3 2024, highlighting progress in its clinical trials, particularly for lead candidate TX000045. Patient enrollment in a hemodynamic trial for TX45 is exceeding expectations, and the company has initiated the APEX Phase 2 clinical trial. Additionally, Tectonic has selected TX2100 as a development candidate for treating Hereditary Hemorrhagic Telangiectasia. While the company has a strong cash reserve to fund operations, it recorded a higher net loss compared to the previous year.

Sep 19, 2024

Tectonic Therapeutic Announces Favorable Phase 1a Safety, Tolerability and PK/PD Results for Lead Program TX45 TX45 was well-tolerated with no observed immunogenicity, and demonstrated a favorable PK/PD relationship whic

Tectonic Therapeutic has announced positive Phase 1a results for its lead program TX45, which is being developed to treat Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF). The study showed that TX45 was well-tolerated and displayed no immunogenicity, alongside promising pharmacokinetic and pharmacodynamic relationships that will inform dosage for upcoming Phase 2 trials. The company will present additional findings at the American Heart Association Scientific Sessions in November 2024, with topline results expected in 2026.

Aug 14, 2024

Tectonic Therapeutic Announces Second Quarter 2024 Financial Results and Recent Business Highlights TX45 advances into Phase 2 clinical trial for patients with Group 2 PH-HFpEF with first site activated and screening ope

Tectonic Therapeutic, Inc. announced its second quarter 2024 financial results, highlighting significant developments including its transition to a public company and the commencement of a global Phase 2 clinical trial for TX45 in patients with Group 2 PH-HFpEF. The company reported the expected topline results from the Phase 1a trial in healthy volunteers in September. TX45 is aimed at addressing a major unmet medical need in the treatment of heart failure patients. Tectonic remains cautious about various external risks that could impact its progress.

Jul 30, 2024

Tectonic Therapeutic Announces US IND Clearance for Lead Program, TX45 TX45 is an Fc-relaxin fusion protein being evaluated in patients with Group 2 Pulmonary Hypertension (PH) due to Heart Failure with Preserved Ejectio

Tectonic Therapeutics has announced the FDA's clearance of its Investigational New Drug application for TX45, an Fc-relaxin fusion protein aimed at treating Group 2 pulmonary hypertension due to heart failure with preserved ejection fraction. The company plans to initiate a Phase 2 clinical trial in the third quarter of 2024 with topline results expected in 2026. TX45 is designed to address significant physiological challenges in this patient population, potentially improving exercise capacity. The lead program highlights the growing focus on innovative therapies in a market with no current approved treatments for this specific condition.

Jun 26, 2024

Transforming and Innovating the Discovery and Development of Novel, Class Leading GPCR-Targeted TherapiesJ u n e 2 0 2 4 Transforming and Innovating the Discovery and Development of Novel, Class Leading GPCR-Targeted The

Tectonic Therapeutics is advancing the discovery and development of GPCR-targeted therapies, particularly focusing on TX45 for Group 2 Pulmonary Hypertension and a program for hereditary hemorrhagic telangiectasia. The company is well-capitalized with $181 million to support operations through mid-2027. While demonstrating promising early clinical data, they acknowledge significant risks associated with their forward-looking statements, including potential challenges in regulatory approval and market competition. A robust team with a history of successful drug discovery is positioned to navigate these challenges as they work towards innovative therapeutic solutions.

Jun 21, 2024

Tectonic Therapeutic Announces Closing of Merger with AVROBIO as well as Concurrent Private Placement of $130.7 Million Tectonic will be focused on advancing a pipeline of novel G-protein-coupled receptor ( GPCR ) target

Tectonic Therapeutic announced the completion of its merger with AVROBIO and a concurrent private placement that raised $130.7 million. The combined company will focus on developing novel therapies, including TX45 for Group 2 Pulmonary Hypertension and a program for Hereditary Hemorrhagic Telangiectasia. With a strong cash position of approximately $181 million post-transaction, Tectonic aims to initiate pivotal clinical trials through 2026 while planning to commence trading under the ticker symbol TECX on June 21, 2024.

Jan 30, 2024

Transforming the Discovery of Novel GPCR- Targeted Therapies J A N U A R Y 2 0 2 4 DISCLAIMER This communication contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Sec

This article discusses the proposed merger between AVROBIO and Tectonic, highlighting the uncertainties surrounding the merger's completion, including necessary shareholder approvals and regulatory permissions. It outlines the potential risks associated with managing expenses and the anticipated operational strategies of the combined company. Additionally, the article addresses the uncertainties linked to the clinical development of product candidates and the broader financial outlook for the combined entity. Investors are urged to rely on future filings for comprehensive details related to the merger.

Jan 30, 2024

AVROBIO and Tectonic Therapeutic Announce Merger Combined company to be Nasdaq-listed, clinical-stage biopharmaceutical company focused on advancing Tectonic s novel GPCR-targeted therapeutic proteins $130.7 million in p

AVROBIO and Tectonic Therapeutic have announced a merger to create a combined company focused on developing GPCR-targeted therapeutic proteins, to be listed on Nasdaq. The merger is supported by $130.7 million in private financing commitments, with the combined entity expected to have $165 million in cash upon closing. This funding will aim to advance Tectonic's lead asset TX45 and other clinical programs. The transaction is set to close in the second quarter of 2024, subject to shareholder approval and customary conditions.

Jul 12, 2023

AVROBIO to Explore Strategic Alternatives CAMBRIDGE, Mass.--(BUSINESS WIRE)

AVROBIO, a clinical-stage gene therapy company, announced the suspension of its program developments to evaluate strategic alternatives for maximizing shareholder value. The company will consider options like mergers or acquisitions but does not guarantee a successful transaction. A timetable for this evaluation process has not been set, and further updates will only be provided if necessary. This decision reflects ongoing challenges within the biotechnology sector.

Jun 12, 2023

UNAUDITED PRO FORMA FINANCIAL INFORMATION On

AVROBIO, Inc. has entered an Asset Purchase Agreement with Novartis Pharma AG, involving the sale of its cystinosis gene therapy program, AVR-RD-04. This transaction, which closed on June 9, 2023, includes a cash payment of $87.5 million to AVROBIO. As part of the agreement, AVROBIO has granted Novartis an exclusive license for certain intellectual property related to this therapy, which may enhance Novartis's portfolio. The company is prohibited from entering into activities that compete with the cystinosis business for five years.

May 22, 2023

AVROBIO Announces Agreement to Sell Cystinosis Gene Therapy Program for $87.5 Million All-cash transaction, with full $87.5 million to be paid at closing Proceeds expected to extend cash runway into Q4 2024

AVROBIO has announced an agreement to sell its cystinosis gene therapy program to Novartis for $87.5 million in cash, which will be paid at closing. This transaction is expected to extend AVROBIO’s cash runway into Q4 2024, allowing the company to focus on its remaining gene therapy programs for diseases such as Gaucher and Hunter syndrome. The deal includes the transfer of specific assets and a license of intellectual property related to the cystinosis program. Financial advisors for the transaction include TD Cowen and Wells Fargo Securities, LLC.

May 18, 2023

AVROBIO Announces Positive Data from Phase 1/2 Clinical Trial of Investigational Gene Therapy for Cystinosis at the ASGCT 26 th Annual Meeting All patients remain off oral cysteamine up to 36 months post gene therapy Sus

AVROBIO, Inc. announced promising results from a Phase 1/2 clinical trial of their investigational gene therapy for cystinosis. The data reveal that all patients remained off oral cysteamine for up to 36 months, with a notable reduction in leukocyte cystine levels. The therapy appears well tolerated, with no adverse drug-related events, and it shows potential to improve clinical outcomes for patients. Additionally, AVROBIO has received positive feedback from regulatory agencies in both the US and UK regarding their therapy's development path.

May 11, 2023

AVROBIO Reports First Quarter 2023 Financial Results and Provides Business Update On track to initiate registrational global Phase 2/3 clinical trial for Gaucher disease type 3 (GD3) in second half 2023, subject to regul

AVROBIO, Inc. reported its financial results for the first quarter of 2023, highlighting a net loss of $25 million, an improvement from the previous year's loss. The company is set to initiate a global, registrational Phase 2/3 clinical trial for Gaucher disease type 3 in the latter half of the year, along with advancements in clinical trials for Hunter syndrome and cystinosis. Additionally, Erik Ostrowski has been appointed as interim CEO following the departure of the founding CEO, as the company emphasizes its gene therapy development strategy. AVROBIO maintains a focus on building upon recent positive data and collaborations.

May 1, 2023

AVROBIO Announces Leadership Transition Current CFO Erik Ostrowski named interim CEO, replacing Founding President and CEO Geoff MacKay Cambridge, Mass.

AVROBIO, a clinical-stage gene therapy company, announced a leadership transition with Erik Ostrowski taking over as interim CEO from Geoff MacKay, who is leaving for a new opportunity. The Board of Directors has started the search for a permanent CEO as the company prepares for late-stage development in two significant clinical programs. Ostrowski, who will continue as CFO, has been with AVROBIO for four years and is recognized for his operational leadership. This transition reflects a commitment to stability while advancing the company's strategic goals.

Mar 23, 2023

AVROBIO Reports Fourth Quarter and Fiscal Year 2022 Financial Results and Provides Business Update Following positive regulatory feedback, plan to initiate registrational global Phase 2/3 clinical trial for Gaucher disea

AVROBIO, Inc. reported its fourth quarter and full-year financial results for 2022, highlighting a net loss of $25 million in Q4. The company plans to initiate a global Phase 2/3 trial for Gaucher disease type 3 and has completed patient dosing in a Phase 1/2 trial for cystinosis. Despite positive regulatory feedback and plans for future trials, AVROBIO's financial position is challenged, with a decrease in cash reserves compared to the previous year. Continued progress in clinical programs is expected amid these financial considerations.

Dec 7, 2022

AVROBIO Announces New Positive Clinical Data and Outlines Clinical Development Plan Following Regulatory Discussions for its Gaucher Disease Gene Therapy New compelling clinical data from first-ever Gaucher disease type

AVROBIO Announces New Positive Clinical Data and Outlines Clinical Development Plan Following Regulatory Discussions for its Gaucher Disease Gene Therapy New compelling clinical data from first-ever Gaucher disease type 3 (GD3) patient and four Gaucher disease type 1 (GD1) pat

Nov 8, 2022

AVROBIO Reports Third Quarter 2022 Financial Results and Provides Business Update Patient dosing completed in collaborator-sponsored Phase 1/2 clinical trial for cystinosis Rare pediatric disease designations received fo

AVROBIO Reports Third Quarter 2022 Financial Results and Provides Business Update Patient dosing completed in collaborator-sponsored Phase 1/2 clinical trial for cystinosis Rare pediatric disease designations received for Gaucher disease and cystinosis investigational gene the

Aug 9, 2022

AVROBIO Reports Second Quarter 2022 Financial Results and Provides Business Update Presented positive data from first five patients in Phase 1/2 cystinosis trial 1 showing systemic gene therapy effect at the American Soc

AVROBIO Reports Second Quarter 2022 Financial Results and Provides Business Update Presented positive data from first five patients in Phase 1/2 cystinosis trial1 showing systemic gene therapy effect at the American Society of Gene and Cell Therapy Annual Meeting; all five pat

Jun 29, 2022

Disclaimer This presentation has been prepared by AVROBIO, Inc. ("AVROBIO") for informational purposes only and not for any other purpose. Certain information contained in this presentation and statements made orally dur

JUNE 2022 Corporate Presentation Disclaimer This presentation has been prepared by AVROBIO, Inc. ("AVROBIO") for informational purposes only and not for any other purpose. Certain information contained in this presentation and statements made orally during this presentation rel

May 18, 2022

AVROBIO Announces Preclinical Gene Therapy Data for Pompe Disease at American Society of Gene and Cell Therapy (ASGCT) annual meeting Genetically modified hematopoietic stem cells lead to supraphysiological levels of the

AVROBIO Announces Preclinical Gene Therapy Data for Pompe Disease at American Society of Gene and Cell Therapy (ASGCT) annual meeting Genetically modified hematopoietic stem cells lead to supraphysiological levels of therapeutic protein in a mouse model of Pompe disease sustai

May 17, 2022

AVROBIO Reports Positive Data from Phase 1/2 Clinical Trial of Investigational Gene Therapy for Cystinosis, including New Interim Data on Neurocognitive Measures New early data show key visual motor integration, visual p

AVROBIO Reports Positive Data from Phase 1/2 Clinical Trial of Investigational Gene Therapy for Cystinosis, including New Interim Data on Neurocognitive Measures New early data show key visual motor integration, visual perception and motor coordination measures impacted by cyst

May 10, 2022

AVROBIO Reports First Quarter 2022 Financial Results and Provides Business Update Phase 1/2 collaborator-sponsored 1 clinical trial in cystinosis fully enrolled New interim cystinosis clinical data to be presented at the

AVROBIO Reports First Quarter 2022 Financial Results and Provides Business Update Phase 1/2 collaborator-sponsored1 clinical trial in cystinosis fully enrolled New interim cystinosis clinical data to be presented at the 25th annual meeting of the American Society of Gene and

Mar 17, 2022

AVROBIO Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Update Provided interim data at WORLDSymposium 2022 that showed sustained engraftment across first three patients 1 + year post-

AVROBIO Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Update Provided interim data at WORLDSymposium 2022 that showed sustained engraftment across first three patients 1+ year post-gene therapy in Phase 1/2 clinical triali for cystinosis;

Feb 9, 2022

AVROBIO Reports Interim Data from Phase 1/2 Clinical Trial of Investigational Gene Therapy for Cystinosis Sustained engraftment observed across first three patients 1+ year post-gene therapy; all remain off oral cysteami

AVROBIO Reports Interim Data from Phase 1/2 Clinical Trial of Investigational Gene Therapy for Cystinosis Sustained engraftment observed across first three patients 1+ year post-gene therapy; all remain off oral cysteamine to date Reduction in number of cystine crystals as me

Jan 4, 2022

AVROBIO Reprioritizes Pipeline Programs Fabry disease program to be deprioritized, shifting focus to other clinical-stage programs in lysosomal disorder pipeline Data updates for cystinosis and Gaucher disease type 1 pro

AVROBIO Reprioritizes Pipeline Programs Fabry disease program to be deprioritized, shifting focus to other clinical-stage programs in lysosomal disorder pipeline Data updates for cystinosis and Gaucher disease type 1 programs planned for 1H 2022, with regulatory interactions

Nov 4, 2021

AVROBIO Reports Third Quarter 2021 Financial Results and Provides Business Update Provided comprehensive safety update on AVROBIO s lentiviral gene therapy platform and programs at ESGCT 2021 Received FDA feedback on CMC

AVROBIO Reports Third Quarter 2021 Financial Results and Provides Business Update Provided comprehensive safety update on AVROBIO s lentiviral gene therapy platform and programs at ESGCT 2021 Received FDA feedback on CMC requirements for anticipated Fabry disease registration

Oct 19, 2021

AVROBIO Reports New Interim Safety Data Across Investigational Gene Therapies for Fabry and Gaucher Disease Type 1 No adverse events or serious adverse events related to drug product in 14 patients treated in Phase 1 and

AVROBIO Reports New Interim Safety Data Across Investigational Gene Therapies for Fabry and Gaucher Disease Type 1 No adverse events or serious adverse events related to drug product in 14 patients treated in Phase 1 and 2 Fabry disease trials and Phase 1/2 Gaucher disease tri

Aug 5, 2021

AVROBIO Reports Second Quarter 2021 Financial Results and Provides Business Update U.S. Food and Drug Administration granted Fast Track Designation to AVR-RD-04 for cystinosis Company is planning to initiate multiple reg

AVROBIO Reports Second Quarter 2021 Financial Results and Provides Business Update U.S. Food and Drug Administration granted Fast Track Designation to AVR-RD-04 for cystinosis Company is planning to initiate multiple registration trials in 2022 Multiple data and regulatory

May 13, 2021

AVROBIO Reports First Quarter 2021 Financial Results and Provides Business Update Held meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for AVR-RD-01 for Fabry disease Dosing comple

AVROBIO Reports First Quarter 2021 Financial Results and Provides Business Update Held meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for AVR-RD-01 for Fabry disease Dosing completion in ongoing FAB-GT Phase 2 trial reaches 50%, with th

May 3, 2021

AVROBIO Provides Regulatory Update on Investigational AVR-RD-01 for Fabry Disease Anticipates initiating registration trial with kidney biopsy endpoint in mid-2022 to support potential full approval of AVR-RD-01 as first

AVROBIO Provides Regulatory Update on Investigational Anticipates initiating registration trial with kidney biopsy endpoint in mid-2022 to support potential full approval of AVR-RD-01 as first-line therapy, subject to FDA discussion and agreement Two additional patients dosed

Mar 18, 2021

AVROBIO Reports Fourth Quarter and Fiscal Year 2020 Financial Results and Provides Business Update 100% kidney substrate reduction at 12 months post-gene therapy in the first patient dosed with the plato gene therapy pla

AVROBIO Reports Fourth Quarter and Fiscal Year 2020 Financial Results and Provides Business Update 100% kidney substrate reduction at 12 months post-gene therapy in the first patient dosed with the plato gene therapy platform in FAB-GT1 trial for Fabry disease One new patient

Feb 8, 2021

AVROBIO Announces 100% Kidney Substrate Reduction at 12 Months Post-Gene Therapy in First Patient Dosed with plato Gene Therapy Platform in Fabry Disease Phase 2 Trial Consistent with the 87% reduction in the first evalu

AVROBIO Announces 100% Kidney Substrate Reduction at 12 Months Post-Gene Therapy in First Patient Dosed with plato Gene Therapy Platform in Fabry Disease Phase 2 Trial Consistent with the 87% reduction in the first evaluable kidney biopsy, there is complete clearance of Gb3 inc

Nov 19, 2020

AVROBIO Announces Proposed Public Offering of Common Stock

AVROBIO Announces Proposed Public Offering of Common Stock CAMBRIDGE, Mass., Nov. 19, 2020 AVROBIO, Inc. (NASDAQ: AVRO), a leading clinical-stage gene therapy company, today announced that it intends to offer and sell, subject to market and other conditions, $75 million of its

Nov 17, 2020

AVROBIO Announces New Positive Clinical Data and Preclinical Data, as Well as Expanded Leading Lysosomal Disorder Gene Therapy Pipeline Three months post-gene therapy, first patient in Gaucher trial shows reductions in t

AVROBIO Announces New Positive Clinical Data and Preclinical Data, as Well as Expanded Leading Lysosomal Disorder Gene Therapy Pipeline Three months post-gene therapy, first patient in Gaucher trial shows reductions in the toxic metabolite plasma lyso-Gb1 and plasma chitotrios

Nov 5, 2020

AVROBIO Reports Third Quarter 2020 Financial Results and Provides Business Update Expanded ex vivo lentiviral gene therapy pipeline with program for Hunter syndrome Received orphan drug designation from the European Comm

AVROBIO Reports Third Quarter 2020 Financial Results and Provides Business Update Expanded ex vivo lentiviral gene therapy pipeline with program for Hunter syndrome Received orphan drug designation from the European Commission for two lead programs, AVR- RD-01 for Fabry disea

Oct 21, 2020

AVROBIO Appoints Dr. Gail Farfel to its Board of Directors

AVROBIO Appoints Dr. Gail Farfel to its Board of Directors CAMBRIDGE, Mass. Oct. 21, 2020 AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced the appointment of Gail M. Far

Oct 5, 2020

AVROBIO Expands Lentiviral Gene Therapy Pipeline with Program for Hunter Syndrome Investigational gene therapy licensed from The University of Manchester, UK aims to address both physical and CNS manifestations of Hunter

AVROBIO Expands Lentiviral Gene Therapy Pipeline with Program for Hunter Syndrome Investigational gene therapy licensed from The University of Manchester, UK aims to address both physical and CNS manifestations of Expands leading pipeline targeting lysosomal disorders with 5th

Aug 6, 2020

AVROBIO Reports Second Quarter 2020 Financial Results and Provides Business Update New data indicate stable kidney function across the two Fabry disease clinical studies up to 32 months New six-month Phase 2 FAB-201 data

AVROBIO Reports Second Quarter 2020 Financial Results and Provides Business Update New data indicate stable kidney function across the two Fabry disease clinical studies up to 32 months New six-month Phase 2 FAB-201 data from first patient treated using AVROBIO s plato gene th

Jul 6, 2020

AVROBIO Announces New Patients Dosed in Gaucher Disease and Cystinosis Clinical Trials First patient dosed in AVROBIO's global Phase 1/2 clinical trial of AVR-RD-02 for Gaucher disease type 1 Second patient dosed in inve

AVROBIO Announces New Patients Dosed in Gaucher Disease and Cystinosis Clinical Trials First patient dosed in AVROBIO's global Phase 1/2 clinical trial of AVR-RD-02 for Gaucher disease type 1 Second patient dosed in investigator-sponsored Phase 1/2 clinical trial of AVR-RD-04 f

May 14, 2020

Pompe Program Team 3/25/2020 NSG Study What's Important Now Monthly Report Niek van Til is an employee of AVROBIO. Disclaimer This presentation has been prepared by AVROBIO, Inc. ("AVROBIO") for informational purposes on

Session: Musculo-skeletal Diseases II Hematopoietic Stem Cell Gene Therapy Corrects Neuromuscular Manifestations in Preclinical Study of Pompe Mice Niek van Til, PhD AVROBIO, Cambridge, MA USA May 14, 2020 Exhibit 99.1 Pompe Program Team 3/25/2020 NSG Study What's Important No

May 7, 2020

AVROBIO Reports 1Q 2020 Financial Results and Provides Business Update Three oral presentations accepted on new clinical and preclinical data at the American Society of Gene and Cell Therapy (ASGCT) 23rd annual meeting C

AVROBIO Reports 1Q 2020 Financial Results and Provides Business Update Three oral presentations accepted on new clinical and preclinical data at the American Society of Gene and Cell Therapy (ASGCT) 23rd annual meeting Completed two collaboration agreements to reinforce techno

Mar 30, 2020

AVROBIO Outlines Response to COVID-19 and Current Assessment of Business Impact Patient identification for clinical trials continues; dosing temporarily paused as clinical trial sites focus on COVID-19 pandemic Essential

AVROBIO Outlines Response to COVID-19 and Current Assessment of Business Impact Patient identification for clinical trials continues; dosing temporarily paused as clinical trial sites focus on COVID-19 pandemic Essential laboratory and manufacturing activities currently uninter

Mar 16, 2020

AVROBIO Reports Fourth Quarter and Fiscal Year 2019 Financial Results and Provides Business Update Presented positive data at the 16 th Annual WORLDSymposium on AVR-RD-04 for cystinosis and AVR-RD-01 for Fabry disease, a

AVROBIO Reports Fourth Quarter and Fiscal Year 2019 Financial Results and Provides Business Update Presented positive data at the 16th Annual WORLDSymposium on AVR-RD-04 for cystinosis and AVR-RD-01 for Fabry disease, as well as early data on plato -produced drug product and p

Feb 10, 2020

AVROBIO Presents Positive Initial Data for its Investigational Cystinosis Program and plato TM Platform, as well as Positive Data Out to 32 Months for its Ongoing Investigational Fabry Program Early data trends from firs

AVROBIO Presents Positive Initial Data for its Investigational Cystinosis Program and plato TM Platform, as well as Positive Data Out to 32 Months for its Ongoing Investigational Fabry Program Early data trends from first patient dosed in the AVR-RD-04 investigational gene the

Nov 7, 2019

AVROBIO, Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update Dosing of first Fabry patient incorporating plato anticipated for fourth quarter 2019 All Fabry patients who discontinued enzyme rep

AVROBIO, Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update Dosing of first Fabry patient incorporating plato anticipated for fourth quarter All Fabry patients who discontinued enzyme replacement therapy (ERT) following treatment with AVR-RD-01 inve

Aug 8, 2019

AVROBIO Reports Second Quarter 2019 Financial Results and Provides Business Update Reported positive interim results from clinical trials of AVR-RD-01 investigational gene therapy in Fabry disease, including 87% substrat

AVROBIO Reports Second Quarter 2019 Financial Results and Provides Business Update Reported positive interim results from clinical trials of AVR-RD-01 investigational gene therapy in Fabry disease, including 87% substrate reduction in first kidney biopsy at one year post-treat

Jul 16, 2019

AVROBIO Announces Proposed Public Offering of Common Stock CAMBRIDGE, Mass .

AVROBIO Announces Proposed Public Offering of Common Stock CAMBRIDGE, Mass. July 16, 2019 AVROBIO, Inc. (NASDAQ: AVRO) (the Company ), a Phase 2 clinical-stage gene therapy company, today announced that it intends to offer and sell, subject to market and other conditions, $100.

Jul 15, 2019

AVROBIO Announces 87% Substrate Reduction in First Kidney Biopsy and Additional Positive Data from Clinical Trials of AVR-RD-01 Investigational Gene Therapy in Fabry Disease 87% reduction in average number of Gb3 inclusi

AVROBIO Announces 87% Substrate Reduction in First Kidney Biopsy and Additional Positive Data from Clinical Trials of AVR-RD-01 Investigational Gene Therapy in Fabry Disease CAMBRIDGE, Mass. July 15, 2019 AVROBIO, Inc. (NASDAQ: AVRO) (the Company ) today announced the first k

May 13, 2019

AVROBIO, Inc. Reports First Quarter 2019 Financial Results and Provides Business Update Regulatory clearances achieved that enable integration of the plato platform into Fabry FAB-201 and Gaucher GAU-201 clinical trials

AVROBIO, Inc. Reports First Quarter 2019 Financial Results and Provides Business Update Regulatory clearances achieved that enable integration of the plato platform into Fabry FAB-201 and Gaucher GAU-201 clinical trials in the second half of 2019 IND for AVR-RD-01 for the trea

Apr 29, 2019

AVROBIO, Inc. Announces FDA Clearance of Investigational New Drug Application for AVR-RD-01 Gene Therapy for the Treatment of Fabry Disease The plato platform represents a significant advance towards a commercial-stage g

AVROBIO, Inc. Announces FDA Clearance of Investigational New Drug Application for AVR-RD-01 Gene Therapy for the Treatment of Fabry Disease The plato platform represents a significant advance towards a commercial-stage gene therapy solution designed to treat thousands of pati

Mar 25, 2019

AVROBIO, Inc. Reports Fourth Quarter and Fiscal Year 2018 Financial Results and Provides Business Update Recruitment completed in investigator-sponsored Phase 1 Fabry study Phase 1 and Phase 2 clinical data updates for A

AVROBIO, Inc. Reports Fourth Quarter and Fiscal Year 2018 Financial Results and Provides Business Update Recruitment completed in investigator-sponsored Phase 1 Fabry study Phase 1 and Phase 2 clinical data updates for AVR-RD-01 in Fabry disease reported at WORLDSymposium 2019

Feb 6, 2019

AVROBIO, Inc. Announces Updated Clinical Data from Ongoing Phase 1 and Phase 2 Studies for AVR-RD-01 Gene Therapy for Fabry Disease All patients with reported data exhibit AGA enzyme activity above the diagnostic range f

AVROBIO, Inc. Announces Updated Clinical Data from Ongoing Phase 1 and Phase 2 Studies for AVR-RD-01 Gene Therapy for Fabry CAMBRIDGE, Mass. February 6, 2019 AVROBIO, Inc. (Nasdaq: AVRO) (the Company ), a Phase 2 clinical-stage gene therapy company, today announced clinical tr

Jan 7, 2019

AVROBIO, Inc. Appoints Philip J. Vickers to its Board of Directors Industry leader brings global expertise, including as Shire s former Global Head of Research and Development, to help further accelerate momentum and gro

AVROBIO, Inc. Appoints Philip J. Vickers to its Board of Directors Industry leader brings global expertise, including as Shire s former Global Head of Research and Development, to help further accelerate momentum and growth CAMBRIDGE, Mass., Jan. 07, 2019 (GLOBE NEWSWIRE) AVRO

Dec 18, 2018

s AVROBIO, Inc. Expands and Strengthens Leadership Team with Four Senior Management Hires Birgitte Volck, M.D., Ph.D., is appointed President of Research and Development and will oversee clinical, regulatory

AVROBIO, Inc. Expands and Strengthens Leadership Team with Four Senior Management Hires Birgitte Volck, M.D., Ph.D., is appointed President of Research and Development and will oversee clinical, regulatory, research and CAMBRIDGE, Mass., Dec. 18, 2018 (GLOBE NEWSWIRE) AVROBIO,

Nov 13, 2018

AVROBIO, Inc. Reports Third Quarter 2018 Financial Results and Provides Business Update During the quarter, announced updated Fabry clinical data, acceptance of Clinical Trial Application for Gaucher, and continued platf

AVROBIO, Inc. Reports Third Quarter 2018 Financial Results and Provides Business Update During the quarter, announced updated Fabry clinical data, acceptance of Clinical Trial Application for Gaucher, and continued platform optimization CAMBRIDGE, Mass., November 13, 2018 (GLO

Oct 1, 2018

AVROBIO Announces Updated Clinical Data for AVR-RD-01 Gene Therapy in Fabry Disease First two patients in Phase 1 study continue to demonstrate AGA enzyme activity above the diagnostic range for classic Fabry disease 18

AVROBIO Announces Updated Clinical Data for AVR-RD-01 Gene two patients in Phase 1 study continue to demonstrate AGA enzyme activity above the diagnostic range for classic Fabry disease 18 months and six months after receiving AVR-RD-01, respectively; Patient 1 is no longer rec

Aug 9, 2018