SNDX Rises On Entinostat Data, Kalydeco Gets FDA Nod, Concert Fails To Enthrall

Today’s Daily Dose brings you news about Avita Medical’s ReCell device trial results; Blueprint’s upcoming event to watch out for; Concert Pharma’s phase II alopecia areata trial; GlycoMimetics’ acute myeloid leukemia drug candidate; Repros’ public offering; Syndax’ ENCORE 601 trial results; FDA approval for expanded use of Vertex Pharma’s Kalydeco and Ziopharm’s phase I glioblastoma trial.

Read on.

Avita Medical Ltd.’s (AVMXY.OB) pivotal trial of ReCell device to treat severe burns has achieved both co-primary endpoints.

The Company noted that it is on track to file a Premarket Approval application for the ReCell Autologous Cell Harvesting device with the FDA in mid-2017.

AVMXY.OB closed Wednesday’s trading at $1.34, up 2.29%.

Blueprint Medicines Corp. (BPMC) is scheduled to present new data from its ongoing phase 1 clinical trial of BLU-285 for the treatment of advanced gastrointestinal stromal tumors on June 5, 2017 at the 2017 American Society of Clinical Oncology Annual Meeting.

BPMC closed Wednesday’s trading at $38.70, down 6.34%.

The FDA has placed a clinical hold on Concert Pharmaceuticals Inc.’s (CNCE) Phase 2a clinical trial of CTP-543 for alopecia areata, also known as spot baldness.

The regulatory agency has informed the Company that a review of certain recently completed non-clinical toxicology studies is required before CTP-543 can advance to phase IIa trial. Safety concerns are not the reason for the FDA’s decision to impose the clinical hold, the Company noted.

CNCE closed Wednesday’s trading at $14.85, down 7.48%.

Shares of GlycoMimetics Inc. (GLYC) surged more than 37% in extended trading on Wednesday after being granted Breakthrough Therapy Designation by the FDA for its drug candidate GMI-1271 for the treatment of adult relapsed/refractory acute myeloid leukemia.

GMI-1271 is currently under phase 2 portion of a Phase 1/2 clinical trial in patients with acute myeloid leukemia.

GLYC closed Wednesday’s trading at $5.37, unchanged from the previous day’s…

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