Associated tags: MDS, Therapy, Patient, Dialysis, Duchenne, IPF, Biology, LAPC, Roxadustat, Pancreatic cancer, CIA, DMD, CTGF, Duchenne muscular dystrophy, CKD, Anemia, Research, Syndrome, Idiopathic pulmonary fibrosis, SAN, Pharmaceutical industry
Locations: NEW ORLEANS, LA, LOUISIANA, CALIFORNIA, UNITED STATES, NORTH AMERICA, LOS ANGELES, LONDON, CHICAGO, PARIS, TEL AVIV, SM, VIRGINIA, SAN FRANCISCO, CA, US, MA, EGYPT, CHINA, GOLDMAN, FLORIDA, EUROPE, JAPAN
SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression.
Key Points:
- SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression.
- “The FDA’s IND clearance is an important achievement for us, and we are pleased to advance another product from our promising oncology pipeline into the clinic,” said Thane Wettig, Chief Executive Officer of FibroGen.
- “To date, FG-3165 has demonstrated anti-tumor activity with improved survival in combination with other immune modulatory therapies in mouse cancer models and has shown excellent tolerability in nonclinical safety studies.
- The trial is anticipated to begin enrollment in the second half of 2024.
PD-1,
Lymphocyte,
IND,
Patient,
Trial of the century,
SAN,
Clinical trial,
CCR8,
NK,
Investigational New Drug,
Food,
FDA,
Regeneron Pharmaceuticals,
Pharmaceutical industry “We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
Key Points:
- “We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
- “We believe that the mechanisms of action for both FG-3165 (anti-Gal9) and FG-3175 (anti-CCR8) have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients.
- Under the clinical study collaboration and supply agreement, Regeneron will provide drug supply to FibroGen, who will be the sponsor of each Phase 1 monotherapy and combination trial.
- Each company retains all rights to their respective compounds, including as a monotherapy or as combination therapies.
SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that Thane Wettig, Chief Executive Officer, will participate in a Fireside Chat at Goldman Sachs 45th Annual Global Healthcare Conference to be held in Miami, Florida on Monday, June 10, 2024, from 10:00-10:35 AM Eastern Time.
Key Points:
- SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that Thane Wettig, Chief Executive Officer, will participate in a Fireside Chat at Goldman Sachs 45th Annual Global Healthcare Conference to be held in Miami, Florida on Monday, June 10, 2024, from 10:00-10:35 AM Eastern Time.
- Company management will also participate in one-on-one meetings with investors during the conference.
- A live audio webcast of the event will be available to investors and other interested parties on the “ Events & Presentations ” section of the FibroGen Investor webpage at www.fibrogen.com.
- A replay will be available for 90 days.
Patient,
MTD,
Food,
Neutropenia,
University,
CDT,
FDA,
ABW,
SAN,
Castration,
ADC,
Peripheral neuropathy,
Prostate cancer,
MMAE,
Spacecraft,
CD46,
ASCO,
Enza,
Fatigue,
Society,
Weight loss,
Arsis,
Principal,
Annual general meeting,
Pharmaceutical industry “We are excited to announce that FG-3246 in combination with enzalutamide in patients with mCRPC demonstrated clinically meaningful early signals of efficacy,” commented Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
Key Points:
- “We are excited to announce that FG-3246 in combination with enzalutamide in patients with mCRPC demonstrated clinically meaningful early signals of efficacy,” commented Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
- Over 70% of the patients in the study received at least two prior ARSIs, which included prior enzalutamide treatment.
- The primary endpoint was determination of the maximally tolerated dose (MTD) of FG-3246 in combination with enzalutamide.
- The MTD was established at 2.1 mg/kg ABW, with primary G-CSF prophylaxis, in combination with enzalutamide 160 mg/day.
SAN FRANCISCO, May 07, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the company’s management will participate in the following investor conferences:
Key Points:
- SAN FRANCISCO, May 07, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the company’s management will participate in the following investor conferences:
The live audio webcast of the H.C. Wainwright Fireside Chat will be available to investors and other interested parties on the “ Events & Presentations ” section of the FibroGen Investor webpage at www.fibrogen.com .
- A replay will be available for 30 days.
Pamrevlumab,
Sale,
Investment,
Peripheral neuropathy,
Pancreatic cancer,
Neutropenia,
RECIST,
LAPC,
CD46,
Weight loss,
MD,
PSA,
Webcast,
Growth,
IND,
ASCO,
CKD,
Patient,
Fatigue,
Neoplasm,
SAN,
AstraZeneca,
Anemia,
CIA,
Interest,
Pharmaceutical industry Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024.
Key Points:
- Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024.
- Total revenue for the first quarter of 2024 was $55.9 million, as compared to $36.2 million for the first quarter of 2023, an increase of 55% year over year.
- At March 31, 2024, FibroGen reported $214.7 million in cash - defined as cash, cash equivalents, investments, and accounts receivable.
- FibroGen will host a conference call and webcast today, Monday, May 6, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update.
Retrieved on:
Wednesday, April 24, 2024
SAN FRANCISCO, April 24, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that clinical data from the dose escalation portion of the Phase 1b/2 study of FG-3246 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer have been selected for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4, 2024 in Chicago, Illinois.
Key Points:
- SAN FRANCISCO, April 24, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that clinical data from the dose escalation portion of the Phase 1b/2 study of FG-3246 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer have been selected for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4, 2024 in Chicago, Illinois.
- Details for the poster presentation are as follows:
Session: Poster Session – Genitourinary Cancer – Prostate, Testicular, and Penile
Title: A Phase 1b dose escalation study of FOR46, a novel antibody-drug conjugate targeting a tumor-specific epitope of CD46, in combination with enzalutamide (Enza) in patients with metastatic castration resistant prostate cancer (mCRPC).
Neutropenia,
Prostate cancer,
Survival,
RECIST,
Prostate-specific antigen,
Patient,
SAN,
Neoplasm,
MMAE,
Weight loss,
Publishing,
Peripheral neuropathy,
University,
CD46,
Spacecraft,
Society,
Safety,
ASCO,
Adenocarcinoma,
Fatigue,
ADC,
PSA,
FDA,
Fortis,
Lead,
Food,
Pharmaceutical industry “We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
Key Points:
- “We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
- In the dose-expansion arm of the trial, patients were treated at the 2.7 mg/kg adjusted body weight dosing (AjBW) until disease progression.
- The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts.
- These findings warrant further investigation and hold promise for addressing the therapeutic needs of patients with CD46 positive prostate cancer.
SAN FRANCISCO, March 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that Thane Wettig, Chief Executive Officer, will participate in a corporate presentation at the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, from 3:00-3:40 PM Eastern Time.
Key Points:
- SAN FRANCISCO, March 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that Thane Wettig, Chief Executive Officer, will participate in a corporate presentation at the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, from 3:00-3:40 PM Eastern Time.
- Company management will also participate in virtual one-on-one meetings with investors during the conference.
- The live audio webcast of the event will be available to investors and other interested parties on the “ Events & Presentations ” section of the FibroGen Investor webpage at www.fibrogen.com .
- A replay will be available for 30 days.
PLEASE DO NOT CONTACT THE COURT, THE CLERK'S OFFICE, DEFENDANTS, OR DEFENDANTS' COUNSEL REGARDING THIS NOTICE, THE PROPOSED SETTLEMENT, OR THE CLAIMS PROCESS.
Key Points:
- PLEASE DO NOT CONTACT THE COURT, THE CLERK'S OFFICE, DEFENDANTS, OR DEFENDANTS' COUNSEL REGARDING THIS NOTICE, THE PROPOSED SETTLEMENT, OR THE CLAIMS PROCESS.
- You cannot ask the Court to order a different settlement; the Court can only approve or reject the Settlement.
- If the Court denies approval, no settlement payments will be sent out, and the lawsuit will continue.
- 21-cv-02623) and include all information required by the Court as detailed in the Notice.
