Thursday, June 20, 2019
FDA OKs Quidel’s Triage TOX drug screen, 94600 test
Quidel (NASDAQ:QDEL) has received 510(k) clearance from the FDA to market the Quidel Triage TOX Drug Screen, 94600, a fluorescence immunoassay for the qualitative determination of the presence of drug and/or metabolites in human urine of up to 9 drug assays.
The test is to be used with Quidel’s Triage MeterPro instrumented system.
Verastem announces leadership changes
Verastem’s (NASDAQ:VSTM) President and Chief Executive Officer (CEO), Robert Forrester has decided to step down from his position.
COO Dan Paterson will take over the president role. He will also take charge of the executive team until a new CEO is found.
Rob Gagnon, Chief Financial Officer, will also assume the role of Chief Business Officer.
Also, the Company is reiterating its previous FY19 guidance. Net product revenue from the sales of COPIKTRA is expected in the range of $10M to 12M.
Edesa gets green light to start EB01 Phase 2b trial
Edesa Biotech (NASDAQ:EDSA) gets the go-ahead from the U.S. Food and Drug Administration for its clinical investigation of EB01, a sPLA2 inhibitor, which Edesa is developing for chronic allergic contact dermatitis.
The FDA “safe to proceed” letter formally approves the company’s Phase 2b clinical protocol and authorizes the company to begin its clinical investigation.
Edesa expects the first patient to be enrolled in the coming quarter after the manufacturing of its drug candidate.
Unlike steroids and other anti-inflammatory drugs, like ibuprofen, the topical treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. In two previous clinical studies, EB01 has demonstrated significant improvement of multiple symptoms in contact dermatitis patients.
Arbutus cleared to start early-stage AB-729 trial
Arbutus Biopharma (NASDAQ:ABUS) has received regulatory clearance to initiate a Phase 1a/1b clinical trial of AB-729, a subcutaneously-administered RNA interference (RNAi) agent.
The Company was requested to complete its ongoing 3- and 6-month toxicology studies before commencing this trial. Based on further interaction with the regulatory authority, a revised protocol was submitted and Arbutus has received clearance to begin the Phase 1a/1b clinical trial.
AB-729-001 is a single and multiple dose clinical trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-729 administered by subcutaneous injection to healthy subjects and patients with chronic hepatitis B infection.
Alexion application for Ultomiris gets priority review
Allscripts gains on Cowen’s LBO speculation
Cowen says Allscripts Healthcare Solutions (NASDAQ:MDRX) is an attractive LBO target and the potential deal could generate a 21% IRR in five years even with an offer as low as $16/share.
The firm says the buyer could see an exit multiple of 12x, which Cowen sees as modest considering Veradigm’s 15-25% growth rate and high-margin profile.
Cowen reiterates an Outperform rating and $14 price target.
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