Abby Hardy, Author at BioTuesdays

Developments

Karyopharm Therapeutics doses first glioblastoma patient in Phase 1/2 selinexor study

Karyopharm Therapeutics (NASDAQ:KPTI) dosed the first patient in a Phase 1/2 clinical study evaluating oral selinexor in patients with newly diagnosed or recurrent glioblastoma (GBM). This global study is expected to...

June 9, 2020

Developments

MD Anderson resumes Phase 1b trial of Soricimed’s SOR-C13

Closely-held Soricimed Biopharma reported that the MD Anderson Cancer Center has resumed its investigator-initiated trial of Soricimed’s SOR-C13. MD Anderson completed the first cohort of the dose escalation phase of...

June 9, 2020

Developments

MacroGenics margetuximab gets FDA orphan drug designation for gastric cancer

MacroGenics’ (NASDAQ:MGNX) margetuximab received FDA orphan drug designation for the treatment of gastric and gastroesophageal junction cancer. Margetuximab is currently being evaluated in a Phase 2/3 trial in...

June 5, 2020

Developments

Tenax posts positive Phase 2 levosimendan data

Tenax Therapeutics (NASDAQ:TENX) reported positive results from a Phase 2 trial evaluating levosimendan for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH...

June 4, 2020

Developments

Idera Pharma reports positive initial Phase 2 data of tilsotolimod in colorectal cancer

Idera Pharma (NASDAQ:IDRA) reported positive preliminary data from its Phase 2 trial of tilsotolimod, in combination with Opdivo and Yervoy, in immunotherapy-naive micro-satellite stable colorectal cancer (MSS-CRC)...

June 4, 2020

Developments

Menlo Therapeutics reports positive data from Phase 2 acne vulgaris trial

Menlo Therapeutics (NASDAQ:MNLO) reported positive results from its Phase 2 trial evaluating FCD105 or the treatment of moderate-to-severe acne vulgaris. The study enrolled 447 patients who received either FCD105, a 3%...

June 4, 2020

Developments

Menlo Therapeutics ZILXI gets FDA approval for rosacea

Menlo Therapeutics’ (NASDAQ:MNLO) ZILXI received FDA approval for the treatment of inflammatory lesions of rosacea in adults. The company noted that ZILXI, a minocycline topical foam, is the first minocycline product of...

May 29, 2020

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

Author - Abby Hardy

Karyopharm Therapeutics doses first glioblastoma patient in Phase 1/2 selinexor study

MD Anderson resumes Phase 1b trial of Soricimed’s SOR-C13

MacroGenics margetuximab gets FDA orphan drug designation for gastric cancer

Tenax posts positive Phase 2 levosimendan data

Idera Pharma reports positive initial Phase 2 data of tilsotolimod in colorectal cancer

Menlo Therapeutics reports positive data from Phase 2 acne vulgaris trial

Menlo Therapeutics ZILXI gets FDA approval for rosacea

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

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