Associated tags: AAV, Gene editing, Disease, PNH, Patient, PKU, Hunter syndrome, Phenylketonuria, Paroxysmal nocturnal hemoglobinuria, Antibody, MLD, Therapy, Pharmaceutical industry, Vaccine, Safety, Failure, COVID-19, JumpStart
Locations: MASSACHUSETTS, BEDFORD, MA, US
Failure,
600 (number),
Growth,
Form,
Risk,
COVID-19,
Form S-4,
XXV,
Security (finance),
Nature,
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Annual report,
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CVR BEDFORD, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX) today announced that it declared a distribution to its common stockholders of record as of the close of business on March 21, 2024 of the right to receive one contingent value right (CVR) for each outstanding share of Homology common stock held by such stockholder as of such record date.
Key Points:
- BEDFORD, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX) today announced that it declared a distribution to its common stockholders of record as of the close of business on March 21, 2024 of the right to receive one contingent value right (CVR) for each outstanding share of Homology common stock held by such stockholder as of such record date.
- The payment date for such distribution is expected to be March 27, 2024 (three business days after the expected closing of the merger on March 22, 2024).
- Certain statements contained in this filing may be considered forward-looking statements within the meaning of the U.S.
- Homology can give no assurance that the conditions to the proposed transaction will be satisfied.
Failure,
600 (number),
Risk,
XV,
Form,
File,
Common stock,
Calendar,
COVID-19,
Nature,
Form S-4,
Letter,
Growth,
XXV,
Indian stock exchange,
Security (finance),
Auction BEDFORD, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX) today announced that it received notification (“Nasdaq Notification”) from The Nasdaq Stock Market LLC (“Nasdaq”) on December 29, 2023 indicating that, for the last thirty (30) consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Global Select Market (Nasdaq Listing Rule 5450(a)(1)).
Key Points:
- Homology Medicines has an initial 180-day period through June 26, 2024 to regain compliance with Minimum Bid Price Requirement
BEDFORD, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX) today announced that it received notification (“Nasdaq Notification”) from The Nasdaq Stock Market LLC (“Nasdaq”) on December 29, 2023 indicating that, for the last thirty (30) consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Global Select Market (Nasdaq Listing Rule 5450(a)(1)).
- The Nasdaq Notification has no immediate effect on the listing of the Common Shares on the Nasdaq Capital Market.
- In accordance with the Nasdaq Notification, Homology has a compliance period of 180 calendar days from the date of the notification letter from Nasdaq, or until June 26, 2024, to regain compliance with the requisite minimum bid price requirement.
- If, at any time before June 26, 2024, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of ten (10) consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement.
Bristol Myers Squibb,
ANCA,
AA,
Clinical trial,
Patient,
Alopecia areata,
Atopic dermatitis,
Therapy,
Q32,
OrbiMed,
Trial of the century,
TSLP,
IL-7,
System,
Autoimmunity,
AAV,
OUP,
Vaccine,
Pharmaceutical industry WALTHAM, Mass. and BEDFORD, Mass., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Q32 Bio Inc., a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Homology Medicines, Inc. (Nasdaq: FIXX), today announced they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on advancing Q32 Bio’s wholly owned clinical development candidates for the treatment of autoimmune and inflammatory diseases. Upon completion of the merger, the combined company will operate as Q32 Bio, headquartered in Waltham, Massachusetts, and is expected to trade under the Nasdaq ticker symbol “QTTB”.
Key Points:
- and BEDFORD, Mass., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Q32 Bio Inc., a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Homology Medicines, Inc. (Nasdaq: FIXX), today announced they have entered into a definitive merger agreement to combine the companies in an all-stock transaction.
- The combined company will focus on advancing Q32 Bio’s wholly owned clinical development candidates for the treatment of autoimmune and inflammatory diseases.
- Upon completion of the merger, the combined company will operate as Q32 Bio, headquartered in Waltham, Massachusetts, and is expected to trade under the Nasdaq ticker symbol “QTTB”.
- “The proposed merger with Homology Medicines and concurrent private placement is expected to provide Q32 Bio with the capital to drive development of our autoimmune and inflammatory pipeline through multiple clinical milestones,” said Jodie Morrison, Chief Executive Officer of Q32 Bio.
Pfizer,
Safety,
Research,
CDMO,
Workforce,
Investment,
Clinical trial,
Pipeline,
PKU,
Phenylketonuria,
Environment,
Pharmaceutical industry BEDFORD, Mass., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today third quarter 2023 financial results and highlighted recent updates.
Key Points:
- - Continuing to Evaluate Strategic Options for the Company and the Pipeline of Genetic Medicines, including HMI-103 -
BEDFORD, Mass., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today third quarter 2023 financial results and highlighted recent updates.
- There was no collaboration revenue for the quarter ended September 30, 2023, compared to $0.8 million for the quarter ended September 30, 2022.
- Research and development expenses for the quarter ended September 30, 2023 were $17.5 million, compared to $25.9 million for the quarter ended September 30, 2022.
- General and administrative expenses for the quarter ended September 30, 2023 were $6.8 million, compared to $7.8 million for the quarter ended September 30, 2022.
Phenylketonuria,
Gene editing,
PKU,
Plasma,
Medical genetics,
Data monitoring committee,
Pipeline,
Beckman Center for Molecular and Genetic Medicine,
ACMG,
Pharmaceutical industry,
Genomics BEDFORD, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today second quarter 2023 financial results and highlighted recent updates.
Key Points:
- - Evaluating Strategic Options for the Company and Pipeline of Genetic Medicines, including HMI-103 -
BEDFORD, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today second quarter 2023 financial results and highlighted recent updates.
- Also previously announced that Homology will be evaluating strategic options for the Company and its genetic medicines programs, including HMI-103.
- Research and development expenses for the quarter ended June 30, 2023 were $23.0 million, compared to $21.1 million for the quarter ended June 30, 2022.
- General and administrative expenses for the quarter ended June 30, 2023 were $8.2 million, compared to $8.0 million for the quarter ended June 30, 2022.
TD,
Gene editing,
MPS II,
MPS,
AAV,
Sale,
PKU,
Paroxysmal nocturnal hemoglobinuria,
Acquisition,
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Investment,
Family,
Pharmaceutical industry,
Vaccine BEDFORD, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today that it has completed a review of its business, and the Board of Directors has approved a plan to evaluate strategic alternatives to maximize shareholder value. Earlier today, Homology reported encouraging initial data from the first dose level in the Phase 1, dose-escalation trial evaluating gene editing candidate HMI-103 in adults with classical phenylketonuria (PKU), which showed it was generally well-tolerated in all three participants and resulted in a meaningful reduction in plasma phenylalanine (Phe) in two participants as of the data cut-off date of July 26, 2023. Despite these encouraging data, based on the current financing environment and Homology’s anticipated clinical development timelines, Homology will not be further developing its programs and will be instituting a related reduction in force while it explores options for the Company and its assets, including HMI-103. Homology has retained TD Cowen as its strategic financial advisor.
Key Points:
- Homology has retained TD Cowen as its strategic financial advisor.
- Additionally, the Company has a 20 percent stake in Oxford Biomedica Solutions, an AAV manufacturing company based on Homology’s internal process development and manufacturing.
- Strategic options may include but are not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, or other transactions.
- There can be no assurance of completion of any particular course of action or a defined timeline for completion.
BEDFORD, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today encouraging initial clinical data from the first dose cohort in the pheEDIT Phase 1, dose-escalation trial evaluating gene editing candidate HMI-103 in adults with classical phenylketonuria (PKU), the most prevalent and severe form of the disease. As of the data cut-off date of July 26, 2023, HMI-103 has been generally well-tolerated in all three participants. Participant 1 experienced a reduction in plasma phenylalanine (Phe) levels to below the U.S. American College of Medical Genetics and Genomics (ACMG) PKU treatment guideline threshold of
Key Points:
- As of the data cut-off date of July 26, 2023, HMI-103 has been generally well-tolerated in all three participants.
- Participant 2 has experienced a meaningful plasma Phe reduction of 49% at 17 weeks post-dose.
- We are also pleased that the targeted immunosuppression regimen has been effective in the first dose cohort.
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Inhibitor,
Neutralizing antibody,
Hemolysis,
Gene,
NOD,
MLD,
PAH,
Serum,
SCID,
Phenylketonuria,
Trabecular meshwork,
Gene editing,
Gene expression,
FIX,
Publication,
Metachromatic leukodystrophy,
Messenger,
PKU,
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Genome,
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Cell,
Retinal pigment epithelium,
NHP,
Poster,
RPE,
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Identification,
Virus,
ARSA,
Society,
Vaccine,
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Mouse,
IND,
C5 BEDFORD, Mass., May 16, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today six presentations supporting its gene editing, gene therapy and GTx-mAb programs at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting, including the first data from IND-enabling studies with HMI-104, the anti-C5 GTx-mAb development candidate for paroxysmal nocturnal hemoglobinuria (PNH). These preclinical data demonstrated that a one-time administration of HMI-104 resulted in sustained expression of C5 monoclonal antibody (C5mAb) levels, supporting the use of a one-time vectorized approach for PNH to enable continuous antibody production.
Key Points:
- These preclinical data demonstrated that a one-time administration of HMI-104 resulted in sustained expression of C5 monoclonal antibody (C5mAb) levels, supporting the use of a one-time vectorized approach for PNH to enable continuous antibody production.
- Additionally, Homology highlighted methods to identify genomic sites with improved homologous-recombination (HR)-based gene editing integration, which could be used to enhance and streamline development of future product candidates.
- These data support the immunosuppression regimen used in Homology’s ongoing gene editing and gene therapy clinical trials.
- In the poster, “Gene Therapy Candidate for Metachromatic Leukodystrophy (MLD): Optimization of HMI-202 Leading to HMI-204 Nomination,” Homology highlighted preclinical data on its optimized HMI-204 gene therapy candidate for MLD.
Gene,
Phenix,
MLD,
Paroxysmal nocturnal hemoglobinuria,
Phenylketonuria,
Gene editing,
Methodology,
Research,
OXB,
Sale,
PKU,
Congress,
Investment,
Annual general meeting,
PNH,
Cell,
Upcoming,
Collaboration,
Immunosuppression,
IND,
Potential,
Society,
Pfizer,
Pharmaceutical industry,
Vaccine,
Cryptocurrency BEDFORD, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today financial results for the first quarter ended March 31, 2023, and highlighted recent accomplishments.
Key Points:
- - First Presentations of Preclinical Data with GTx-mAb Development Candidate HMI-104 for PNH, and Potential for Re-Dosing with AAVHSCs, at Upcoming ASGCT Meeting -
BEDFORD, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today financial results for the first quarter ended March 31, 2023, and highlighted recent accomplishments.
- Research and development expenses for the quarter ended March 31, 2023 were $20.0 million, compared to $24.3 million for the quarter ended March 31, 2022.
- General and administrative expenses for the quarter ended March 31, 2023 were $8.3 million, compared to $14.1 million for the quarter ended March 31, 2022.
- Based on current projections, Homology expects cash resources to fund operations into the fourth quarter of 2024.
Abstract,
Gene,
Publication,
AAV,
Immunosuppression,
Annual general meeting,
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Cell,
Virus,
Society,
Treatment,
Neutralizing antibody,
Vaccine,
Communications satellite,
Mouse BEDFORD, Mass., May 03, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today the first presentation of results from IND-enabling studies with HMI-104, the anti-C5 GTx-mAb development candidate for paroxysmal nocturnal hemoglobinuria (PNH). These data demonstrated that a one-time administration of HMI-104 resulted in sustained expression of functional C5 monoclonal antibody (C5mAb) levels in multiple preclinical models. Homology will also present for the first time non-clinical data that show the potential for AAVHSC re-dosing across different clades of viruses. These presentations, alongside additional data supporting the Company’s gene editing and gene therapy programs, will be featured at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting from May 16-20, 2023.
Key Points:
- BEDFORD, Mass., May 03, 2023 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today the first presentation of results from IND-enabling studies with HMI-104, the anti-C5 GTx-mAb development candidate for paroxysmal nocturnal hemoglobinuria (PNH).
- These data demonstrated that a one-time administration of HMI-104 resulted in sustained expression of functional C5 monoclonal antibody (C5mAb) levels in multiple preclinical models.
- Homology will also present for the first time non-clinical data that show the potential for AAVHSC re-dosing across different clades of viruses.
- These presentations, alongside additional data supporting the Company’s gene editing and gene therapy programs, will be featured at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting from May 16-20, 2023.
