RESEARCH TRIANGLE PARK

AskBio receives FDA Fast Track Designation for AB-1002 investigational gene therapy program in congestive heart failure

Retrieved on: 
Thursday, April 18, 2024
FDA, Phase, Bayer, Priority review, Safety, Food, Heart, Research and development, Doctor of Philosophy, Fast track (FDA), Protein phosphatase 1, Therapy, Accelerated approval (FDA), Patient, Gene, CHF, Clinical trial, Heart failure, Pharmaceutical industry

Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the AB-1002 program.

Key Points: 
  • Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the AB-1002 program.
  • AB-1002 is an investigational one-time gene therapy that is administered to the heart with the intention of helping to promote the production of a constitutively active form of protein inhibitor 1 (I-1c) designed to block the action of protein phosphatase 1.
  • “The Fast Track Designation for AB-1002 emphasizes the need to rapidly advance new therapeutic modalities such as gene therapy for people living with congestive heart failure,” said Christian Rommel, PhD, Head of Research and Development at Bayer’s Pharmaceuticals Division.
  • AskBio is currently enrolling patients in the Phase II GenePHIT (Gene PHosphatase Inhibition Therapy) trial of AB-1002 (also known as NAN-101) for the treatment of CHF.4

G1 Therapeutics to Release First Quarter 2024 Financial Results and Provide Business Update on May 1, 2024

Retrieved on: 
Wednesday, April 17, 2024
G1 Therapeutics, Webcast, Event, Therapy, PIN

RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, will host a webcast and conference call to provide a financial and corporate update for the first quarter of 2024 on Wednesday May 1, 2024, at 8:30 a.m.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, will host a webcast and conference call to provide a financial and corporate update for the first quarter of 2024 on Wednesday May 1, 2024, at 8:30 a.m.
  • While not required, it is recommended that you join 10 minutes prior to the start of the event.
  • A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com .
  • The webcast will be archived on the same page for 90 days following the event.

AskBio presents 18-month Phase Ib trial results of AB-1005 gene therapy for patients with Parkinson’s disease

Retrieved on: 
Tuesday, April 16, 2024
American Academy, Șaeș, Political moderate, Bayer, Safety, Patient, Aes, Putamen, Clinical trial, PD, Pharmaceutical industry

These included headache, tremor, dyskinesia, arthralgia, musculoskeletal chest pain, fatigue, COVID-19, and magnetic resonance imaging (MRI) abnormalities.

Key Points: 
  • These included headache, tremor, dyskinesia, arthralgia, musculoskeletal chest pain, fatigue, COVID-19, and magnetic resonance imaging (MRI) abnormalities.
  • Bilateral infusions of AB-1005 within the putamen (up to 1.8 mL) were well tolerated, with no SAEs associated with the investigational gene therapy or contrast agent.
  • Neurosurgical delivery of AB-1005 resulted in putamen coverage of 63% ± 2%, exceeding the goal of greater than 50% coverage with AB-1005.
  • “While much remains to be done, we recognize with increasing confidence the potential of AB-1005 to provide a transformative impact for patients in the future.”

AskBio Names Mansuo Shannon Chief Scientific Officer

Retrieved on: 
Tuesday, April 9, 2024
Eli Lilly, Alzheimer's disease, Gene editing, Princeton University, MIT, Research, Bayer, Chugai Pharmaceutical Co., Doctor of Philosophy, Samulski, Therapy, Eli Lilly and Company, CSO, Molecular biology, Management

Shannon joins AskBio from Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

Key Points: 
  • Shannon joins AskBio from Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
    Co-Founder and former Chief Scientific Officer R. Jude Samulski to remain member of AskBio Board of Directors
    Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, announced today that on April 8, 2024, Mansuo Shannon, PhD, was named the company’s next Chief Scientific Officer (CSO).
  • Shannon joins AskBio from Prevail Therapeutics, where she also served as CSO.
  • Reporting to Gustavo Pesquin, Chief Executive Officer (CEO), Shannon will be a member of AskBio’s Executive Leadership Team and head its R&D organization.
  • As part of her role as CSO at AskBio, Shannon will develop and implement the company’s future R&D strategy.

G1 Therapeutics to Participate in the 23rd Annual Needham Virtual Healthcare Conference

Retrieved on: 
Thursday, April 4, 2024
G1 Therapeutics, Conference, Therapy

RESEARCH TRIANGLE PARK, N.C., April 04, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that G1’s Chief Executive Officer Jack Bailey will provide a corporate presentation during the 23rd Annual Needham Virtual Healthcare Conference on Thursday, April 11, 2024, at 8:45 AM ET.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., April 04, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that G1’s Chief Executive Officer Jack Bailey will provide a corporate presentation during the 23rd Annual Needham Virtual Healthcare Conference on Thursday, April 11, 2024, at 8:45 AM ET.

G1 Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Monday, April 1, 2024
Employment, G1 Therapeutics, RSU, Therapy

RESEARCH TRIANGLE PARK, N.C., April 01, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, today announced the grant of inducement stock options exercisable for 3,000 shares of G1’s common stock and 1,500 restricted stock units (RSUs) to one hired employee under the Amended and Restated G1 Therapeutics, Inc. 2021 Inducement Equity Incentive Plan (the “Amended and Restated 2021 Plan”).

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., April 01, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, today announced the grant of inducement stock options exercisable for 3,000 shares of G1’s common stock and 1,500 restricted stock units (RSUs) to one hired employee under the Amended and Restated G1 Therapeutics, Inc. 2021 Inducement Equity Incentive Plan (the “Amended and Restated 2021 Plan”).
  • These equity awards were granted as an inducement material to the new employee becoming an employee of G1 in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The Amended and Restated 2021 Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of G1 (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with G1, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.
  • The stock options and RSUs are subject to the terms and conditions of the Amended and Restated 2021 Plan.

Opus Genetics Announces Completion of Dosing in First Cohort of Phase 1/2 Trial of Gene Therapy OPGx-LCA5 in Patients with Rare Inherited Retinal Disease LCA5

Retrieved on: 
Tuesday, March 26, 2024
Opus, Retina, Leber congenital amaurosis, University of Pennsylvania, VR, Genetics, LCA5, University, Patient, Ophthalmology, LCA, Penn Presbyterian Medical Center, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., March 26, 2024 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-first, clinical-stage gene therapy company developing treatments for inherited retinal diseases, today announced that the first cohort has completed dosing in its open-label, dose-escalation Phase 1/2 clinical trial evaluating the subretinal delivery of OPGx-LCA5, an adeno-associated virus 8 (AAV8) vector designed to precisely deliver a functional LCA5 gene to the outer retina in patients with Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene (LCA5).

Key Points: 
  • Based on positive safety and efficacy data from the first cohort of three adult patients, the Company will advance OPGx-LCA5 into the next highest dose.
  • Opus anticipates initiating the next cohort mid-2024.
  • There are also future plans to expand the study population to include subjects 13 years or older.
  • “Based on these early clinical data, we’re excited for the potential of OPGx-LCA5 to transform the lives of patients affected by LCA5,” said Ben Yerxa, Ph.D., chief executive officer of Opus.

G1 Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, March 1, 2024
G1 Therapeutics, Therapy, Employment, RSU

RESEARCH TRIANGLE PARK, N.C., March 01, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, today announced the grant of inducement stock options exercisable for 2,100 shares of G1’s common stock and 1,050 restricted stock units (RSUs) to one hired employee under the Amended and Restated G1 Therapeutics, Inc. 2021 Inducement Equity Incentive Plan (the “Amended and Restated 2021 Plan”).

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., March 01, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, today announced the grant of inducement stock options exercisable for 2,100 shares of G1’s common stock and 1,050 restricted stock units (RSUs) to one hired employee under the Amended and Restated G1 Therapeutics, Inc. 2021 Inducement Equity Incentive Plan (the “Amended and Restated 2021 Plan”).
  • These equity awards were granted as an inducement material to the new employee becoming an employee of G1 in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The Amended and Restated 2021 Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of G1 (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with G1, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.
  • The stock options and RSUs are subject to the terms and conditions of the Amended and Restated 2021 Plan.

G1 Therapeutics Provides Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Retrieved on: 
Wednesday, February 28, 2024
G1 Therapeutics, Breast cancer, Carboplatin, Research, PIN, SCLC, Telephone, Update, J. P. Morgan, DMC, Food, Growth, SACT, G1, Trilaciclib, Hospital, ADC, OS, Conjugation, GAAP, Event, Therapy, Webcast, Patent, Patient, Acceleration, Clinical trial, Survival, Oncology, ITT, Pharmaceutical industry

G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.

Key Points: 
  • G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.
  • Operating expenses for the fourth quarter of 2023 were $23.8 million, compared to $41.1 million for the fourth quarter of 2022.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $7.4 million, compared to $16.6 million for the fourth quarter of 2022.
  • The net loss for the fourth quarter of 2023 was $10.9 million, compared to $33.6 million for the fourth quarter of 2022.

G1 Therapeutics to Participate in the TD Cowen 44th Annual Health Care Conference

Retrieved on: 
Tuesday, February 27, 2024
G1 Therapeutics, Therapy, Conference

RESEARCH TRIANGLE PARK, N.C., Feb. 27, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that G1’s Chief Executive Officer Jack Bailey will participate in a Breast & Lung Cancer Corporate Panel Discussion during the TD Cowen 44th Annual Health Care Conference on Wednesday March 6, 2024 at 9:10 AM EST.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Feb. 27, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that G1’s Chief Executive Officer Jack Bailey will participate in a Breast & Lung Cancer Corporate Panel Discussion during the TD Cowen 44th Annual Health Care Conference on Wednesday March 6, 2024 at 9:10 AM EST.