Standard of care

89bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Thursday, February 29, 2024

SAN FRANCISCO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today reported its financial results for the fourth quarter and full year ended December 31, 2023, and provided corporate updates.

Key Points: 
  • ENLIGHTEN-Fibrosis is expected to enroll non-cirrhotic patients with fibrosis stage F2-F3 and ENLIGHTEN-Cirrhosis is expected to enroll NASH patients with compensated cirrhosis (F4).
  • ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis are expected to initiate in the first and second quarter of 2024, respectively.
  • Completed follow-on offering in the fourth quarter of 2023 for $172.5 million in gross proceeds.
  • The foregoing financial information is unaudited and subject to change, and actual results may vary from the foregoing.

Cardiff Oncology Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024

New clinical data from discontinued second-line randomized ONSEMBLE trial provides further evidence of onvansertib’s improvement of the efficacy for standard of care therapy in bev naïve patients.

Key Points: 
  • New clinical data from discontinued second-line randomized ONSEMBLE trial provides further evidence of onvansertib’s improvement of the efficacy for standard of care therapy in bev naïve patients.
  • Contingent upon the results, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent.
  • Full Year 2023 Financial Results:
    As of December 31, 2023, Cardiff Oncology had approximately $75 million in cash, cash equivalents, and short-term investments.
  • Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024.

Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC

Retrieved on: 
Thursday, February 29, 2024

SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today provided a clinical update on the first release of data from its second-line RAS-mutated metastatic colorectal cancer (mCRC) ONSEMBLE trial. Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment. The 23 enrolled patients continued treatment per protocol. The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.

Key Points: 
  • Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment.
  • The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.
  • “The randomized data from the ONSEMBLE trial further validates the opportunity for onvansertib in the first-line RAS-mutated mCRC setting.
  • We look forward to sharing the topline results of our first-line CRDF-004 trial in mid-2024.”
    In August 2023, Cardiff Oncology discontinued enrollment in the second-line ONSEMBLE trial to focus on its new lead program in first-line RAS-mutated mCRC.

Atea Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, February 28, 2024

BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • Enrollment of the remainder of this study is ongoing with topline results anticipated in the second half of 2024,” continued Dr. Sommadossi.
  • Final results from the 60 patient lead-in cohort confirmed a 98% SVR4 rate across GT from 58 of 59 patients.
  • Final SVR12 results from all patients enrolled in the Phase 2 study are anticipated in the second half of 2024.
  • Cash, Cash Equivalents and Marketable Securities: $578.1 million at December 31, 2023 compared to $646.7 million at December 31, 2022.

BioAegis Therapeutics Unveils Upcoming Clinical Study of Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Tuesday, February 27, 2024

Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study.

Key Points: 
  • Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study.
  • The planned primary outcomes are all-cause mortality at Day 28 between treatment groups and incidence, causality, and severity of SAEs in rhu-pGSN vs placebo treatment.
  • Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system.
  • In the U.S. alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions.

Zymeworks Announces Participation in Upcoming Investor Conferences

Retrieved on: 
Tuesday, February 27, 2024

VANCOUVER, British Columbia, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that management will participate in the following upcoming investor conferences:

Key Points: 
  • VANCOUVER, British Columbia, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that management will participate in the following upcoming investor conferences:
    TD Cowen 44th Annual Health Care Conference: Zymeworks’ management will participate in one-on-one meetings and present on March 6th at 11:10 am Eastern Time (ET) in Boston, MA.
  • Barclays 26th Annual Global Healthcare Conference: Zymeworks’ management will participate in one-on-one meetings and a fireside chat on March 14th at 11:45 am ET in Miami, FL.

PolarityTE Announces First Subject Screened in Phase III Pivotal Study Evaluating Investigational New Drug SkinTE® in Diabetic Foot Ulcers

Retrieved on: 
Monday, February 26, 2024

Subjects will be randomized to one of two treatment groups, receiving either SkinTE plus the standard of care (SOC) or the SOC alone.

Key Points: 
  • Subjects will be randomized to one of two treatment groups, receiving either SkinTE plus the standard of care (SOC) or the SOC alone.
  • The primary endpoint is the incidence of DFUs closed at 12 weeks.
  • COVER DFUS II is a pivotal study that PolarityTE will conduct under its open IND for SkinTE.
  • We are excited to evaluate how the optimized healthy cells from the patient in SkinTE can facilitate closure in these difficult-to-treat ulcers.

IR-MED Reports 92% Efficacy for PressureSafe™ in Early, Non-Invasive, Skin Color Agnostic Detection of Pressure Injuries

Retrieved on: 
Tuesday, February 20, 2024

The objective of the study was to evaluate the sensitivity, specificity, and usability of PressureSafe to detect early-stage pressure injuries Stage 1 / suspected deep tissue injuries (sDTI) before skin breakage, compared to standard of care.

Key Points: 
  • The objective of the study was to evaluate the sensitivity, specificity, and usability of PressureSafe to detect early-stage pressure injuries Stage 1 / suspected deep tissue injuries (sDTI) before skin breakage, compared to standard of care.
  • PressureSafe detected biomarkers and changes in tissue structures under the skin’s surface as they relate to pressure injuries.
  • The 14-day efficacy portion of the single arm, bi-center study evaluated 38 patients at high risk of pressure injury development.
  • Based on these data, the study concluded that PressureSafe is a safe, efficient, and valuable method for early detection of pressure injuries.

RenovoRx Highlights Key Leadership Promotions

Retrieved on: 
Friday, March 8, 2024

(“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.

Soleo Health Celebrates 10 Years of Simplifying Complex Care for Patients

Retrieved on: 
Thursday, March 7, 2024

Soleo Health , a national leader in complex specialty pharmacy services, recently marked its 10th anniversary on February 24, 2024.

Key Points: 
  • Soleo Health , a national leader in complex specialty pharmacy services, recently marked its 10th anniversary on February 24, 2024.
  • Led by Chief Executive Officer Drew Walk and Chief Commercial Officer Craig Vollmer, Soleo Health was founded on the commitment to simplify complex care for patients.
  • Over the past decade, Soleo Health has become one of the fastest-growing independent specialty pharmacies, solidifying its position as a leading provider of complex specialty pharmacy services.
  • “Looking ahead, we remain dedicated to defining the unique requirements of complex specialty pharmacy, focusing on patients with complex, rare and ultra-rare diseases,” explained Walk.