The data review of phase III trial of Rocapuldencel-T in metastatic renal cell carcinoma, conducted by Argos Therapeutics Inc.'s (ARGS) seems to be breathing new life for the study.
The trial, dubbed ADAPT, evaluated Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of metastatic renal cell carcinoma. In February of this year, the Independent Data Monitoring Committee, based on its planned interim data analysis, recommended that the study be discontinued as it was unlikely to meet the endpoints.
However, the Company continued to keep the ADAPT trial open while it conducted data review. A post-hoc subgroup analysis of overall survival in the first one third of patients enrolled in the study, for whom generally the longest follow-up data was available, the estimated median overall survival for the combination arm was 30.1 months compared to 22.2 months for the control arm.
It should be noted that at the time of the interim analysis by the Independent Data Monitoring Committee in February of this year, the estimated median overall survival for the combination arm was 27.7 months compared to 32.4 months for the control arm.
Based on the data it has reviewed, the Company is of the view that the ADAPT trial should be continued until completion.
Argos plans to meet with the FDA in May 2017.
ARGS closed Tuesday's trading at $0.39, down 5.55%. In after-hours, the stock was up 68.75% to $0.66.
Shares of Nivalis Therapeutics Inc. (NVLS) jumped more than 21% in extended trading on Tuesday after it agreed to merge with privately-held Alpine Immune Sciences Inc.
The merger is expected to close in the third quarter of 2017.
Following the merger, current Alpine shareholders will own approximately 74 percent of the combined company and current Nivalis shareholders will own approximately 26 percent of the combined company.
The exchange ratio is based on a valuation of Nivalis equal to $50 million, which includes approximately $44 million in cash expected to be held by Nivalis at the time of closing. The combined company is expected to have approximately $90 million in cash and cash equivalents at the closing of the transaction, according to a Press Release by Nivalis.
NVLS closed Tuesday's trading at $0.39, down 5.55%. In after-hours, the stock was up 68.75% to $0.66.
Prima BioMed Ltd (PBMD) has been given the go-ahead for the third cohort of its phase I clinical trial for IMP321 in combination with Merck's KEYTRUDA being conducted in Australia. The third cohort will recruit six patients with unresectable or metastatic melanoma.
The first patient cohort results were released in December 2016. The data showed that IMP321 at the 1mg dose level is safe and well tolerated.
PBMD closed Tuesday's trading at $2.42, down 2.81%.
Shares of Ultragenyx Pharmaceutical Inc. (RARE) were up more than 18% in extended trading on Tuesday, following positive 24-week data from its phase III study of Burosumab (KRN23) in adults with X-linked hypophosphatemia.
X-linked hypophosphatemia, or XLH, is a rare, hereditary renal phosphate-wasting disorder characterized by hypophosphatemia, rickets and/or osteomalacia, and diminished growth.
The study, which had enrolled 134 patients, met the primary endpoint of serum phosphorus response and key secondary endpoint of stiffness improvement.
RARE closed Tuesday's trading at $60.08, down 2.23%. In after-hours, the stock was up 18.92% to $71.45.
by RTT Staff Writer
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