XLRN’s DART Misses Mark, RGLS Makes Cuts In Pipeline, FDA Snubs CHRS

Today’s Daily Dose brings you news about Acceleron Pharma’s disappointing renal cell carcinoma trial results; Aimmune’s PALISDE progress; reverse stock split of CEL-SCI; the FDA rejection of Coherus’ biosimilar candidate; promising trial results of GTX’s drug candidate in postmenopausal women with stress urinary incontinence and Regulus’ shrinking pipeline.

Read on…

Shares of Acceleron Pharma Inc. (XLRN) were down over 5% in extended trading on Monday, following the failure of its phase II study of Dalantercept in advanced renal cell carcinoma.

In the phase II study, dubbed DART, Dalantercept plus Axitinib did not achieve its primary endpoint of demonstrating a statistically significant increase in progression-free survival in advanced renal cell carcinoma patients.

Based on the lack of efficacy, the Company is discontinuing the development of Dalantercept.

XLRN closed Monday’s trading at $28.23, down 2.79%. In after-hours, the stock was down another 5.24% to $26.75.

Aimmune Therapeutics Inc. (AIMT) on Monday announced that in its ongoing phase III trial of AR101 for desensitization of patients with peanut allergy, over 97 percent of patients currently on study have completed up-dosing.

The study, dubbed PALISADE, is designed to investigate the efficacy and safety of AR101 in peanut-allergic children, adolescents, and adults. A total of 554 peanut-allergic patients, ages 4-49, were randomized to receive either AR101 or placebo for approximately six months of up-dosing followed by six months of maintenance therapy, according to the Company.

The final study visits will be completed around year-end 2017, and top line data are expected to be available in the first quarter of 2018.

AIMT closed Monday’s trading at $17.70, up 0.11%.

Bio-Rad Laboratories Inc. (BIO) has received FDA clearance for its BioPlex 2200 Syphilis Total & RPR assay, a novel one-step universal testing method to aid in the diagnosis of syphilis infection.

Commenting on the development, John Hertia,…

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