Prostate cancer

MacroGenics to Participate in Upcoming Investor Conferences

Retrieved on: 
Friday, March 1, 2024

MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a Prostate Cancer Corporate Panel Discussion on Monday, March 4, 2024, at 10:30 am ET.

Key Points: 
  • MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a Prostate Cancer Corporate Panel Discussion on Monday, March 4, 2024, at 10:30 am ET.
  • MacroGenics’ management will also participate in one-on-one meetings.
  • Scott Koenig, M.D., Ph.D., will participate in a fireside chat on Tuesday, March 12, 2024, at 9:20 am ET.
  • Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm .

American Urological Association Releases Salvage Therapy for Prostate Cancer Guideline

Retrieved on: 
Thursday, February 29, 2024

BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.

Key Points: 
  • BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.
  • Understanding the evaluation and appropriate use of salvage therapies for patients with biochemical recurrence is a critical area of prostate cancer care.
  • “Thanks to the incredible expertise of the entire Panel, this guideline helps provide a roadmap that combines the latest advancements with thoughtful recommendations, empowering patients and clinicians alike.”
    This guideline has 30 recommendations and is a useful reference for effective evidence-based care related to salvage therapy for prostate cancer.
  • Salvage therapy for prostate cancer: AUA/ASTRO/SUO guideline part I: introduction and treatment decision-making at the time of suspected biochemical recurrence after radical prostatectomy.

EDAP Announces Record Preliminary Fourth Quarter and Full-Year 2023 Revenues

Retrieved on: 
Thursday, February 29, 2024

Record full-year 2023 preliminary unaudited revenue of EUR 60.4 million ($65.4 million USD), an increase of 9.6% over full-year 2022, driven by 31.7% HIFU growth

Key Points: 
  • Record full-year 2023 preliminary unaudited revenue of EUR 60.4 million ($65.4 million USD), an increase of 9.6% over full-year 2022, driven by 31.7% HIFU growth
    Record Q4 2023 preliminary unaudited revenue of EUR 19.6 million ($21.3 million USD), an increase of 24.8% over for Q4 2022, driven by 38.8% HIFU growth
    LYON, France, February 29, 2024 - EDAP TMS SA (Nasdaq: EDAP), a global leader in robotic energy-based therapies, today announced preliminary unaudited fourth quarter and full-year 2023 revenues.
  • “Our fourth quarter and full-year 2023 revenues each hit record levels driven by increased demand for Focal One Robotic HIFU and solid execution from our capital sales and regional clinical teams,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS.
  • “During the fourth quarter, we saw growing demand for Focal One from both leading academic and community hospitals across global markets.
  • EDAP expects to release final Fourth quarter and Full-year financial results in March.

Merus Announces Financial Results for the Fourth Quarter and Full Year 2023 and Provides Business Update

Retrieved on: 
Wednesday, February 28, 2024

Merus also continues to evaluate patients with untreated advanced PD-L1+ HNSCC treated with petosemtamab 1500 mg in combination with pembrolizumab.

Key Points: 
  • Merus also continues to evaluate patients with untreated advanced PD-L1+ HNSCC treated with petosemtamab 1500 mg in combination with pembrolizumab.
  • Merus plans to report initial interim efficacy and safety data from this cohort in the second quarter of 2024.
  • Merus achieved a milestone and received a payment of $2.5 million related to the advancement of this program in the third quarter of 2023.
  • Merus also achieved an additional milestone of $1 million for candidate nomination in the fourth quarter of 2023.

Arvinas Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 27, 2024

NEW HAVEN, Conn., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Median PFS of 11.1 and 11.0 months in patients with ESR1 wild-type and ESR1 mutant tumors, respectively.
  • Announced the appointment of Randy Teel, Ph.D., Arvinas’ current senior vice president of corporate and business development, to the role of interim chief financial officer and treasurer.
  • The Arvinas Board of Directors has launched a formal search process to identify Mr. Cassidy’s permanent replacement.
  • Revenues: Revenue was $78.5 million and $(43.1) million for the year and quarter ended December 31, 2023 as compared with $131.4 million and $38.0 million for the year and quarter ended December 31, 2022.

Profound Medical in Collaboration with Siemens Healthineers to Further Expand Physician and Patient Access to the TULSA Procedure

Retrieved on: 
Tuesday, February 27, 2024

TULSA is a “one-and-done” procedure, performed in a single session that takes a few hours, and no hospital stay is required.

Key Points: 
  • TULSA is a “one-and-done” procedure, performed in a single session that takes a few hours, and no hospital stay is required.
  • At less than 7,700 Lbs and 80 inches high, MAGNETOM Free.Max is the most lightweight, compact whole-body scanner ever offered by Siemens Healthineers.
  • I commend the teams at Siemens Healthineers and Profound as they work to achieve the convergence of their respective diagnostic and interventional MR technologies.
  • We look forward to collaborating with Profound to help expand access to TULSA as well.

Monopar Provides Update on MNPR-101-Zr Radiopharma Clinical Trial

Retrieved on: 
Tuesday, February 27, 2024

“We are very excited to have Professor Hicks as the lead investigator for our MNPR-101-Zr clinical trial,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.

Key Points: 
  • “We are very excited to have Professor Hicks as the lead investigator for our MNPR-101-Zr clinical trial,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.
  • In 2023, Professor Hicks received the Saul Hertz Award from the Society of Nuclear Medicine and Molecular Imaging for his lifetime contribution to radionuclide therapy.
  • “The preclinical data that Monopar announced on this past Thursday encourages us to translate this class of agents into the clinical domain.
  • MNPR-101-Zr is being developed for cancers with very high unmet medical need, such as pancreatic cancer and triple negative breast cancer,” said Professor Hicks.

Celcuity Announces First Patient Dosed in Phase 1b/2 CELC-G-201 Clinical Trial of Gedatolisib for the Treatment of Metastatic Castration Resistant Prostate Cancer

Retrieved on: 
Thursday, February 22, 2024

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).
  • Gedatolisib, the company’s lead therapeutic candidate, is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTORC1/2.
  • “We are excited to begin enrolling patients in our 201 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with prostate cancer,” said Igor Gorbatchevsky, M.D.
  • “As it stands, there are limited options for patients with mCRPC whose disease progressed on or after treatment with an androgen receptor inhibitor.

Curium Announces Submission of the Marketing Authorization Application for PYLCLARI®, an Innovative (18F)-PSMA PET Tracer Indicated in Adults With Prostate Cancer to Swissmedic

Retrieved on: 
Thursday, February 22, 2024

Dr. Michel Wuillemin, Head of Radiopharmaceuticals at b.e.imaging, commented, “b.e.Imaging is proud of the submission of the marketing authorization application for PYLCLARI® to Swissmedic ahead of schedule.

Key Points: 
  • Dr. Michel Wuillemin, Head of Radiopharmaceuticals at b.e.imaging, commented, “b.e.Imaging is proud of the submission of the marketing authorization application for PYLCLARI® to Swissmedic ahead of schedule.
  • We are fully dedicated to improving the situation of prostate cancer patients in Switzerland.”
    Benoit Woessmer, PET Europe CEO at Curium, commented, “The acceptance of the marketing authorization application by Swissmedic for PYLCLARI® is another important milestone for prostate cancer patients in Switzerland.
  • We look forward to providing an improved choice of tools available to physicians for the diagnosis of prostate cancer patients.
  • Marketing authorization for PYLCLARI® (also known as (18F)-DCFPyL) was granted in July 2023 by the European Commission.

Telix 2023 Full Year Results: Inaugural Profit Achieved, Strong Revenue Growth Underpins Investment in Late-stage Pipeline

Retrieved on: 
Thursday, February 22, 2024

MELBOURNE, Australia, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its results for the financial year ended 31 December 2023.

Key Points: 
  • MELBOURNE, Australia, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its results for the financial year ended 31 December 2023.
  • Dr Christian Behrenbruch, Managing Director and Group CEO commented:
    “This is an excellent result which demonstrates the strength of the Telix business model.
  • Full year revenue for 2024 expected range of US$445M to US$465M ($675M to $705M at current exchange rates), representing an approximate 35-40% increase on 2023.
  • Expected additional investment of 40-50% in R&D (compared with 2023), including both external and internal costs funded by operating cash flow and broadly in line with revenue growth.