Abby Hardy, Author at BioTuesdays

Developments

Myovant Sciences updates positive data from Phase 3 prostate cancer trial

Myovant Sciences’ (NASDAQ:MYOV) reported additional positive results from its Phase 3 HERO study of once-daily, oral relugolix in men with advanced prostate cancer. In the primary endpoint responder analysis, 97% of men...

May 29, 2020

Developments

AVEO Oncology reports positive overall survival results from Phase 3 RCC study

AVEO Oncology (NASDAQ:AVEO) reported positive final overall survival results from its Phase 3 TIVO-3 trial comparing tivozanib to sorafenib in third- and fourth-line renal cell carcinoma (RCC). The trial met the...

May 29, 2020

Developments

Cardiff Oncology onvansertib gets FDA fast track designation for colorectal cancer

Cardiff Oncology’s (NASDAQ:CRDF) onvansertib received FDA fast track designation for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). The company is currently assessing...

May 28, 2020

Developments

Zynerba Pharmaceuticals reports positive topline results from Phase 2 trial of Zygel in ASD

Zynerba Pharmaceuticals (NASDAQ:ZYNE) reported positive topline data from its Phase 2 trial of Zygel for the treatment of autism spectrum disorder (ASD). Zygel is a cannabidiol-based gel that provides controlled...

May 27, 2020

Developments

IntelGenx schedules meeting with the FDA to discuss RIZAPORT NDA

The FDA has granted IntelGenx Technologies’ (TSXV:IGX; OTCQX:IGXT) request for a Type A meeting to discuss the company’s RIZAPORT VersaFilm program. The meeting is scheduled for June 10, 2020. On March...

May 27, 2020

Developments

Protara gets FDA fast track designation for intestinal failure-associated liver disease

Protara Therapeutics’ (NASDAQ:TARA) IV choline chloride received FDA fast track designation for the treatment of intestinal failure-associated liver disease (IFALD). IFALD occurs in patients who have been receiving...

May 26, 2020

Developments

TransMedics reports positive topline results from liver transplant trial

TransMedics Group’s (NASDAQ:TMDX) pivotal Organ Care System (OCS) liver trial, called PROTECT, achieved its primary and secondary effectiveness and safety endpoints. TransMedics’ OCS technology addresses the major...

May 26, 2020

Developments

Cidara doses first patient in Phase 3 rezafungin trial

Cidara Therapeutics (NASDAQ:CDTX) dosed the first patient in its Phase 3 trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation. The...

May 21, 2020

Developments

Passage Bio gets rare pediatric disease designation for gangliosidosis

Passage Bio’s (NASDAQ:PASG) PGBM01 received FDA rare pediatric disease designation for the treatment of GM1 gangliosidosis. GM1 gangliosidosis is a rare genetic disease where mutations in the GLB1 gene impair...

May 21, 2020

Developments

Kadmon reports positive topline results from pivotal GvHD trial

Kadmon Holdings (NYSE:KDMN) reported positive topline results from its pivotal trial of KD025 (belumosudil) in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of...

May 21, 2020

Author - Abby Hardy

Myovant Sciences updates positive data from Phase 3 prostate cancer trial

AVEO Oncology reports positive overall survival results from Phase 3 RCC study

Cardiff Oncology onvansertib gets FDA fast track designation for colorectal cancer

Zynerba Pharmaceuticals reports positive topline results from Phase 2 trial of Zygel in ASD

IntelGenx schedules meeting with the FDA to discuss RIZAPORT NDA

Protara gets FDA fast track designation for intestinal failure-associated liver disease

TransMedics reports positive topline results from liver transplant trial

Cidara doses first patient in Phase 3 rezafungin trial

Passage Bio gets rare pediatric disease designation for gangliosidosis

Kadmon reports positive topline results from pivotal GvHD trial

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