Thursday, July 31, 2014

Tuesday Features

Agile readies new confirmatory pivotal trial of contraceptive patch

Agile readies new confirmatory pivotal trial of contraceptive patch

Agile Therapeutics (NASDAQ:AGRX) believes it has addressed the issues raised by the FDA last year about an initial pivotal trial of its Twirla contraceptive patch and is on track to treat the first patient in a new Phase 3 trial in the current quarter. Al Altomari “Following a complete response letter from the FDA in early 2013, we subsequently received... [Read more of this feature]


XTL hopes to begin major lupus trial next year

XTL hopes to begin major lupus trial next year

XTL Biopharmaceuticals (NASDAQ:XTLB; TASE:XTL) is aiming to begin a Phase 2b clinical trial in the first half of 2015 with its hCDR1 peptide to treat patients with systemic lupus erythematosus (SLE). Josh Levine “We are in the process of finalizing our trial design, approaching the FDA and hope to have feedback from the agency before the end of this... [Read more of this feature]


Taking a ride across the BBB with biOasis

Taking a ride across the BBB with biOasis

biOasis (OTCQX:BIOAF; TSX-V:BTI) believes its Transcend family of technologies holds the key to allow drug therapies to penetrate the blood-brain barrier (BBB) – long considered a Holy Grail of neurological medical research – to treat diseases of the central nervous system. Rob Hutchison “Our Transcend breakthrough is a naturally occurring... [Read more of this feature]


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Briefs

Verisante adds Drs. Beer and Werschler to its CAB

Verisante adds Drs. Beer and Werschler to its CAB

Verisante Technology (OTCQX:VRSEF; TSX-V:VRS) has appointed Dr. Kenneth Beer and Dr. Wm. Philip Werschler to the company’s clinical advisory board. “Both Dr. Beer and Dr. Werschler have extensive experience assisting companies with setting up scientific advisory boards, advising with clinical studies and navigating the medical device regulatory... [Read more of this brief]


FDA clears Lorus Therapeutics IND for LOR-253

FDA clears Lorus Therapeutics IND for LOR-253

The FDA has completed its review and cleared Lorus Therapeutics’ (OTC:LRUSF; TSX:LOR) investigational-new-drug application of LOR-253 for the treatment of hematologic malignancies, including acute myeloid leukemia, high-risk myelodysplastic syndromes, lymphomas and multiple myeloma. Clearance of the IND allows Lorus to initiate a Phase 1b, multicenter,... [Read more of this brief]


Roth upgrades Prosensa Therapeutic to buy

Roth upgrades Prosensa Therapeutic to buy

Roth Capital Partners has upgraded Prosensa Therapeutic NV (NASDAQ:RNA) to “buy,” with a $17 price target, reflecting evolving data in the treatment of Duchenne muscular dystrophy (DMD) and a conciliatory regulatory environment. The stock closed at $9.65 on Friday. Prosensa’s drisapersen treatment for DMD failed a Phase 3 trial last fall, prompting... [Read more of this brief]


Roth starts CorMedix at buy

Roth starts CorMedix at buy

Roth Capital Partners has initiated coverage of CorMedix (NYSE:CRMD) with a “buy” rating and $3 price target. The stock closed at $1.94 on Wednesday. “The impetus for our buy rating is the potential of the company’s Neutrolin compound to drive revenues and ultimately profits,” writes analyst Scott Henry. Neutrolin is approved... [Read more of this brief]


HCW sees no impact from IntelGenx management change

HCW sees no impact from IntelGenx management change

H.C. Wainwright says the recent management change at IntelGenx Technologies (OTCQX:IGXT; TSX-V:IGX) poses no impact. In a conference call yesterday, interim CEO, Horst Zerbe, reiterated management’s confidence in the continuation of business activities despite the recent departure of previous CEO, Rajiv Khosla, writes analyst Swayampakula Ramakanth. “With... [Read more of this brief]


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