The Daily Biotech Pulse: Positive Readouts From Adamas And Ironwood

Sesen Bio To Offer Shares, Stoke Therapeutics Debut

Stocks In Focus Adamas Parkinson's Drug Reduces Frequency And Duration of Daily Episodes of Dyskinesia and OFF

Adamas Pharmaceuticals Inc (NASDAQ: ADMS) announced retrospective data analysis from pooled Phase 3 study of its Gocovri extended release capsules, which showed that the drug reduced both the number and duration of troublesome dyskinesia and OFF episodes relative to placebo such that patients experienced approximately half as many transitions between troublesome dyskinesia and OFF at endpoint vs baseline.

Gocovri is approved by the FDA for treating dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

The stock rose 4.63% to $5.20 in after-hours trading.

Obseva Says Nolasiban Progressing Toward Phase 3 Trial

Following its recent end-of-the Phase 2 meeting with the FDA, Obseva SA (NASDAQ: OBSV) said the regulatory body provided clarification on a number of key development issues for its oral oxytocin receptor antagonist nolasiban. The company said it anticipates beginning its U.S. Phase 3 clinical trial in the fourth quarter of 2019 or early 2020.

Based on the meeting, ObsEva said it anticipates working with FDA regarding certain issues, including timing of randomization and number of previous IVF failures, and expects to submit the IMPLANT 3 trial protocol with an updated IND in the third quarter of 2019.

Ironwood-Allergan's Irritable Bowel Syndrome Drug Aces Late-Stage Trial

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE: AGN) announced positive topline results from a Phase 3b study evaluating Linzess 290 mcg on multiple abdominal symptoms in adult patients with irritable bowel syndrome with constipation, or IBS-C.

"The trial met its primary multi-component endpoint and demonstrated that linaclotide improved the overall abdominal symptoms of bloating, pain and discomfort in adult IBS-C patients compared to placebo," the companies said.

The study also met the secondary endpoints.

Ironwood shares climbed 4.26% to $11.99 in after-hours trading.

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