LAPC

FibroGen Reports First Quarter 2024 Financial Results

Retrieved on: 
Montag, Mai 6, 2024
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.

RenovoRx Highlights Recent Presentation of Clinical Data Abstract at the 2024 Society of Interventional Radiology Annual Scientific Meeting

Retrieved on: 
Dienstag, April 16, 2024
Research, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, MVT, Sale, FDA, Pain, Interventional radiology, Patient, Phase, Risk, Ischemia, Pancreatic cancer, Prevalence, Thrombosis, LAPC, Radiology, MD, Venous thrombosis, Columbia University, Society of Interventional Radiology, Vein, SIR, Associate, TAMP, Coronary thrombosis, Medical imaging

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlights a presentation of a clinical data abstract at the recent 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, held March 23-27, 2024 in Salt Lake City, Utah.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlights a presentation of a clinical data abstract at the recent 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, held March 23-27, 2024 in Salt Lake City, Utah.
  • Clinical data was presented by David Sperling, MD, Associate Professor of Radiology at Columbia University Irving Medical Center in New York.
  • The data presentation highlighted that of the 25 patients randomized to the TAMP therapy, 6 failed to complete all 8 planned procedures due to thrombosis of the targeted arterial artery.
  • The first interim analysis in the Phase III TIGeR-PaC study was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study.

RenovoRx Closes $11.1 Million Private Placement, Providing Cash Runway into 2026

Retrieved on: 
Montag, April 15, 2024
Oncology, Health, General Health, Research, Science, Pharmaceutical, Biotechnology, McGuireWoods, Investment, Pancreatic cancer, LAPC, Patient, Standard of care, TAMP, Pharmaceutical industry

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced the closing of its previously announced private placement of approximately $11.1 million in gross proceeds.

Key Points: 
  • RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced the closing of its previously announced private placement of approximately $11.1 million in gross proceeds.
  • Shaun Bagai, Chief Executive Officer of RenovoRx, stated, “We believe our recent financing achievements mark a critical milestone for RenovoRx.
  • Our April and January 2024 private placements, in which we raised $17.2 million in total gross proceeds, strengthen our balance sheet and energize our drive towards knowable value creation events over the next two years.
  • Ellenoff Grossman & Schole LLP acted as legal counsel to RenovoRx, and McGuireWoods LLP acted as legal counsel to Newbridge Securities Corporation.

Galera Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Donnerstag, März 28, 2024
Research, HNC, Symantec Endpoint Protection, Head, Type, Manganese, Chronic kidney disease, Incidence, ASN, CKD, New Drug Application, LAPC, Patient, Layoff, CRL, NDA, Cancer, Galera, Workforce, Pancreatic cancer, Clinical trial, Cisplatin, Society, Therapy, GRECO, File, Food, SOM, FDA, PDUFA, Pharmaceutical industry

We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.

Key Points: 
  • We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.
  • The Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA was August 9, 2023.
  • Research and development expenses were $3.2 million in the fourth quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $2.0 million in the fourth quarter of 2023, compared to $5.0 million for the same period in 2022.

RenovoRx Announces $11.1 Million at Market Private Placement

Retrieved on: 
Montag, April 8, 2024
Biotechnology, Pharmaceutical, Health, Oncology, LAPC, Venture round, TAMP, Pancreatic cancer, Sale, Standard of care, Security (finance)

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced the execution of definitive subscription agreements with accredited investors for a private placement which is expected to result in gross proceeds of approximately $11.1 million to RenovoRx, before deducting offering expenses.

Key Points: 
  • RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced the execution of definitive subscription agreements with accredited investors for a private placement which is expected to result in gross proceeds of approximately $11.1 million to RenovoRx, before deducting offering expenses.
  • The proceeds from this financing, in addition to RenovoRx’s previously announced private placement on January 29, 2024 for gross proceeds of approximately $6.1 million, extend the Company’s cash runway into 2026.
  • The financing allows RenovoRx to advance its lead program, the pivotal Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC), through the second interim readout and towards completion of the trial.
  • Investors will pay a purchase price of $1.4075 for each share and associated Series A Warrant and Series B Warrant, with such price being at the market for purposes of Nasdaq Stock Market rules.

FibroGen Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Montag, Februar 26, 2024
SAN, AstraZeneca, Anemia, Syndrome, Investment, Interest, Pancreatic cancer, Growth, Sale, Pamrevlumab, Risk, CKD, LAPC, Society, CIA, Webcast, Patient, IND, Pharmaceutical industry

Fourth quarter FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $23.5 million compared to $23.4 million in the fourth quarter of 2022.

Key Points: 
  • Fourth quarter FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $23.5 million compared to $23.4 million in the fourth quarter of 2022.
  • Fourth quarter total roxadustat net sales in China¹ by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $66.5 million, compared to $53.1 million in the fourth quarter of 2022, an increase of 25%.
  • Total revenue for the fourth quarter of 2023 was $27.1 million, as compared to $34.4 million for the fourth quarter of 2022.
  • At December 31, 2023, FibroGen had $248.1 million in cash - defined as cash, cash equivalents, investments, and accounts receivable.

RenovoRx Highlights Key Leadership Promotions

Retrieved on: 
Freitag, März 8, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, CPA, Strategic planning, Growth, Standard of care, Safety, LAPC, Phase, Controller, Financial management, Research

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlighted the recent key leadership promotions of Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak, CPA to Principal Accounting Officer.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlighted the recent key leadership promotions of Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak, CPA to Principal Accounting Officer.
  • Since joining RenovoRx, Ms. Gentry has demonstrated exemplary leadership and commitment to advancing the Company’s clinical pipeline.
  • Mr. Kocak has been promoted to the position of Principal Accounting Officer and will retain his roles as Vice President and Controller of RenovoRx.
  • In this new leadership role, Mr. Kocak will oversee all financial management, reporting and strategic planning initiatives crucial to furthering the Company’s research and development efforts.

RenovoRx CEO Issues Letter to Shareholders

Retrieved on: 
Dienstag, Februar 6, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Standard of care, LAPC, Pancreatic cancer, IMU, Patient, New Drug Application, FDA, Death, TAMP, Patent Cooperation Treaty, Cancer, Patent, Letter, ASX, Gastrointestinal cancer, System, Pharmaceutical industry

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today provided a letter to shareholders from Chief Executive Officer, Shaun Bagai.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today provided a letter to shareholders from Chief Executive Officer, Shaun Bagai.
  • 2023 was a pivotal year for RenovoRx, and we believe our accomplishments bode well for the achievement of our anticipated 2024 milestones.
  • TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating our lead product candidate, RenovoGem™ for the treatment of LAPC.
  • RenovoGem is a novel oncology drug-device combination product utilizing our TAMP administration technology combined with the FDA-approved cancer drug, gemcitabine.

RenovoRx Closes $6.1 Million Private Placement

Retrieved on: 
Montag, Januar 29, 2024
Biotechnology, FDA, Professional Services, Health, Pharmaceutical, Oncology, Medical Devices, Research, Science, Clinical Trials, Finance, Death, Pancreatic cancer, Patient, Cancer, TAMP, Sarcoma, Glioblastoma, DMC, Standard of care, Cougar, Data monitoring committee, Cholangiocarcinoma, Sale, Lung cancer, LAPC, Investment, Phase, Clinical trial, Gastrointestinal cancer, Pharmaceutical industry

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced that it has closed a private placement (the “private placement” or the “financing”) resulting in gross proceeds of approximately $6.1 million, before deducting offering expenses.

Key Points: 
  • RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced that it has closed a private placement (the “private placement” or the “financing”) resulting in gross proceeds of approximately $6.1 million, before deducting offering expenses.
  • RenovoRx insiders, including members of the management team and Board of Directors, participated in the private placement.
  • The warrants are exercisable at a price equal to the per share price paid by the applicable investor and are exercisable for a period of five years following the closing of the private placement.
  • “I have now chosen to join as an investor in this private placement financing.

Galera Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Dienstag, November 14, 2023
NDA, Cisplatin, Disclosure, Galera, Chronic kidney disease, Annual general meeting, Superoxide dismutase, ASN, ASTRO, Food, Type, SBRT, Head, Incidence, Investment, New Drug Application, Clinical trial, American Society of Nephrology, Insurance, Patient, Workforce, Research, Radiation therapy, Death, FDA, CKD, Neoplasm, LAPC, Therapy, Manganese, Enterocyte, GRECO, Cancer, CRL, Symantec Endpoint Protection, Combination, Superoxide dismutase mimetics, Layoff, Society, HNC, Poster, Pharmaceutical industry

MALVERN, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the third quarter ended September 30, 2023 and provided recent corporate updates.

Key Points: 
  • The Company is exploring potential strategic alternatives, as it is not feasible to conduct an additional trial with the Company’s current resources.
  • Research and development expenses were $6.1 million in the third quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $5.0 million in the third quarter of 2023, compared to $4.9 million for the same period in 2022.
  • As of September 30, 2023, Galera had cash, cash equivalents and short-term investments of $28.4 million.