ORION CORPORATION

MSD Expands Opevesostat Clinical Program to Include Breast, Endometrial, and Ovarian Cancers

2 days ago

• MSD has initiated a new Phase 2 clinical trial to evaluate opevesostat (MK-5684) in women's cancers, expanding beyond its current prostate cancer program. • Opevesostat, an oral, non-steroidal and selective CYP11A1 inhibitor discovered by Orion, will be tested for safety and efficacy in breast, endometrial, and ovarian cancers. • The expansion represents a significant broadening of potential therapeutic applications for opevesostat, which is already in Phase 3 trials for metastatic castration-resistant prostate cancer.

Pfizer to Showcase Breakthrough Cancer Therapies at ASCO 2025 with Over 60 Presentations

a month ago

• Pfizer will present data from more than 60 abstracts at ASCO 2025, including 15 oral presentations highlighting advancements across breast, genitourinary, hematologic, thoracic, and colorectal cancers. • Two late-breaking presentations will be featured in ASCO's press program, including pivotal survival data for BRAFTOVI in colorectal cancer and progression-free survival results for vepdegestrant in metastatic breast cancer. • The company will showcase novel antibody-drug conjugate combinations with immunotherapy and present five-year survival data for XTANDI in prostate cancer, supporting Pfizer's goal of delivering eight breakthrough cancer medicines by 2030.

FDA Endorses Expanded Phase 3 Program for Tenax's Novel PH-HFpEF Treatment TNX-103

3 months ago

• Tenax Therapeutics receives FDA approval to expand its ongoing LEVEL study to 230 patients, increasing statistical power to over 95% for their oral levosimendan (TNX-103) trial in PH-HFpEF treatment. • The company secured FDA agreement to initiate LEVEL-2, a second global Phase 3 study, with patient enrollment expected to begin in 2025, strengthening their clinical development program. • Initial blinded data shows promising safety profile with over 95% patient retention and therapy continuation rates, supported by $100 million financing secured in August 2024.

Pipeline Analysis Reveals 85+ Drugs in Development for Metastatic Prostate Cancer Treatment

3 months ago

• DelveInsight's comprehensive analysis identifies over 80 pharmaceutical companies actively developing 85+ pipeline drugs for metastatic prostate cancer treatment. • Novel therapies in development include TAVT-45, a reformulated abiraterone acetate, and Onvansertib, a first-in-class PLK1 inhibitor, demonstrating innovation in treatment approaches. • Multiple clinical trials are underway, including Phase III studies by major players like Bayer, AstraZeneca, and Novartis, evaluating new treatment combinations and targeted therapies.

NUBEQA Shows Strong Efficacy in Metastatic Prostate Cancer Subgroups, New Trial Data Reveals

3 months ago

• New ARANOTE trial data demonstrates NUBEQA plus ADT reduced risk of disease progression by 70% in low-volume metastatic hormone-sensitive prostate cancer patients and 40% in high-volume disease patients. • Subgroup analysis of ARASENS trial confirms NUBEQA's benefits across age groups, showing consistent survival improvements in both patients under and over 75 years old. • Real-world analysis indicates NUBEQA combination therapy results in lower treatment discontinuation rates and better PSA responses compared to alternative treatments.

Global Neuroregeneration Therapy Market Set to Reach $64.8 Billion by 2034, Driven by AI and Stem Cell Innovations

3 months ago

• The neuroregeneration therapy market is projected to grow at a 5.3% CAGR from 2024 to 2034, with North America leading the expansion due to advanced healthcare infrastructure and strong research funding. • Recent breakthroughs include Biogen's promising gene therapy trials for Parkinson's disease and BrainStorm Cell Therapeutics' regulatory approval for stem cell-based ALS treatment. • Artificial intelligence, stem cell research, and gene therapy applications are reshaping the therapeutic landscape, with major pharmaceutical companies forming strategic partnerships to accelerate innovation.

Pfizer to Present Landmark Survival Data for Cancer Therapies at ASCO GU 2025 Symposium

4 months ago

• Pfizer will showcase over 20 abstracts at ASCO GU 2025, including pivotal Phase 3 TALAPRO-2 trial results demonstrating significant overall survival benefits for TALZENNA-XTANDI combination in prostate cancer. • Updated analysis from Phase 3 EV-302 trial confirms sustained survival advantage of PADCEV with pembrolizumab in advanced urothelial cancer, reinforcing its position as a first-line treatment standard. • Novel investigational therapy mevrometostat shows promising progression-free survival data when combined with XTANDI in metastatic castration-resistant prostate cancer, advancing Pfizer's genitourinary cancer pipeline.

DiMe and FDA Collaboration Provides Roadmap for Validating Novel Digital Clinical Measures

4 months ago

• The Digital Medicine Society (DiMe) and the FDA have released resources for analytical validation of novel digital clinical measures, aiding developers in creating regulatory-grade devices. • The resources complement the V3+ Framework, incorporating usability validation to ensure sensor-based digital health technologies are fit for their intended clinical purpose. • The initiative aims to accelerate the adoption of digital endpoints in clinical trials, potentially shortening timelines and providing a significant return on investment for sponsors. • A master roadmap, expected by the end of 2025, will offer an end-to-end process map for implementing digital endpoints, streamlining conversations with regulators and stakeholders.

Bayer Seeks Approval in China for Darolutamide to Treat Metastatic Hormone-Sensitive Prostate Cancer

5 months ago

• Bayer has submitted an application to China's NMPA for darolutamide, seeking its approval in combination with androgen deprivation therapy (ADT) for mHSPC. • The application is based on the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT. • Darolutamide, marketed as Nubeqa®, is already approved in China for mHSPC with ADT and docetaxel, and for nmCRPC at high risk of metastatic disease. • The ARANOTE trial's results showed a significant extension in radiological progression-free survival (rPFS) with darolutamide plus ADT, benefiting various patient subgroups.

Bayer Seeks FDA Approval to Expand Nubeqa's Indication for Metastatic Hormone-Sensitive Prostate Cancer

8 months ago

• Bayer has submitted a supplemental New Drug Application (sNDA) to the FDA for Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT). • The sNDA is seeking approval for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), expanding its current indications. • The submission is based on positive results from the Phase III ARANOTE trial, which were presented at the 2024 ESMO Congress and published in The Journal of Clinical Oncology. • Nubeqa, an oral androgen receptor inhibitor (ARi), is jointly developed by Bayer and Orion Corporation.

Darolutamide sNDA Submitted to FDA and EMA for mHSPC Treatment

8 months ago

• Bayer has submitted applications to the FDA and EMA for darolutamide, seeking approval for use in combination with androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC). • The submissions are based on Phase III ARANOTE trial results, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT. • Darolutamide, already approved for other prostate cancer indications, could offer a new treatment option for mHSPC patients, regardless of chemotherapy use. • The ARANOTE trial showed a favorable safety profile for darolutamide plus ADT, with consistent benefits across secondary endpoints.

ARANOTE Trial: Darolutamide Plus ADT Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer

8 months ago

• The ARANOTE trial demonstrated that darolutamide plus androgen deprivation therapy (ADT) significantly improves radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). • Darolutamide-treated patients experienced a 46% reduction in the risk of radiographic progression or death compared to those receiving ADT plus placebo, with consistent benefits across subgroups. • The combination therapy also delayed time to castration-resistant prostate cancer and pain progression, while showing a favorable safety profile with lower rates of fatigue. • These findings suggest darolutamide plus ADT could become a new standard of care for mHSPC, offering an alternative to chemotherapy-based regimens.

Darolutamide Plus ADT Shows Promise in Metastatic Hormone-Sensitive Prostate Cancer

8 months ago

• Darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% in patients with metastatic hormone-sensitive prostate cancer (mHSPC). • The ARANOTE trial data supports the expanded use of darolutamide in mHSPC patients, both with and without docetaxel, according to Bayer. • Consistent benefits in radiological progression-free survival (rPFS) were observed across patient subgroups, including high- and low-volume mHSPC. • Darolutamide, already approved for certain prostate cancer types, shows a favorable safety profile with low incidences of treatment-emergent adverse events.

NUBEQA® (darolutamide) Plus ADT Significantly Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer

8 months ago

• The Phase III ARANOTE trial demonstrated that NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS). • The trial showed a 46% statistically significant reduction in the risk of progression or death compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001). • NUBEQA plus ADT now demonstrates efficacy in mHSPC both with and without docetaxel, based on the ARANOTE and ARASENS trials, establishing it as a versatile treatment option. • The safety profile of NUBEQA in the ARANOTE trial was consistent with previous findings, with no new safety signals observed, supporting its use in mHSPC.

NUBEQA® (darolutamide) Plus ADT Significantly Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer

8 months ago

• The Phase III ARANOTE trial demonstrated that NUBEQA plus androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) in mHSPC patients. • NUBEQA plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001). • The safety profile of NUBEQA in the ARANOTE trial was consistent with previous studies, with similar rates of serious adverse events between treatment arms.

Darolutamide Improves Survival in Chinese Patients with Metastatic Hormone-Sensitive Prostate Cancer

a year ago

• Darolutamide combined with androgen deprivation therapy (ADT) and docetaxel significantly improved overall survival in Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC). • The addition of darolutamide reduced the risk of death by 36.4% compared to placebo in this patient population. • Darolutamide also delayed time to castration-resistant prostate cancer (CRPC) and PSA progression, with a similar safety profile to placebo. • A significantly higher proportion of patients achieved undetectable PSA levels with darolutamide compared to placebo (71.2% vs 19.4%).

Darolutamide Approved in China for Metastatic Hormone-Sensitive Prostate Cancer

2 years ago

• The Chinese NMPA has approved darolutamide (Nubeqa) plus docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC). • The approval was based on the Phase III ARASENS trial, which showed a 32.5% reduction in mortality risk compared to ADT with docetaxel. • Darolutamide is an oral androgen receptor inhibitor developed by Bayer and Orion Corporation. • This approval provides a new treatment option for mHSPC patients in China, where prostate cancer cases have significantly increased.

MHRA and NHS England Fast-Track Novel Prostate Cancer Treatment Darolutamide Combination Therapy

2 years ago

• A groundbreaking combination therapy of NUBEQA (Darolutamide) with ADT and docetaxel receives accelerated approval from MHRA through Project Orbis for metastatic hormone-sensitive prostate cancer treatment. • Clinical trial data demonstrates significant efficacy with a 32.5% reduced risk of death in metastatic hormone-sensitive prostate cancer patients, based on the Phase 3 ARASENS study of 1,305 participants. • NHS England becomes the first European healthcare system to provide early access to this innovative treatment while NICE assessment is pending, following a commercial agreement with Bayer.

Bayer Seeks Expanded Approval for Darolutamide in Japan and China for Metastatic Hormone-Sensitive Prostate Cancer

3 years ago

• Bayer has submitted applications in Japan and China for darolutamide, seeking approval for metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (ADT). • The submissions are based on the Phase III ARASENS trial, which demonstrated a statistically significant improvement in overall survival for darolutamide plus ADT and docetaxel in mHSPC patients. • Darolutamide, marketed as Nubeqa™, is already approved in multiple markets, including the U.S., EU, Japan, and China, for non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis. • Prostate cancer is a significant health concern in both Japan and China, with a substantial proportion of patients experiencing disease progression, highlighting the need for new treatment options.