DiaMedica files pre-IND bid for DM-199 trial

DiaMedica (TSX:DMA) has submitted a pre-Investigational New Drug application with the FDA in preparation for an upcoming clinical trial with its DM-199 drug candidate for Type 1 diabetes. The company also has filed additional patents on DM-199 composition of matter and its uses, and developed a proprietary, high-yield manufacturing process for the recombinant protein. In [...]

Protected: FDA completes review of Sunshine Heart C-Pulse data

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Cynapsus arranges $1.07-million debenture offering

Cynapsus Therapeutics (TSX-V:CTH) has arranged a financing of secured Series E5 10% debentures in the principal amount of $1,075,865, maturing Feb. 28, 2013. The latest financing “allows us to continue to execute on our plan and complete a dose escalation study in preparation for the Investigational New Drug Application to the FDA for a clinical [...]

Intellipharmaceutics to raise $5 Million

Intellipharmaceutics International (NASDAQ:IPCI; TSX:I) is raising approximately $5 million (U.S.) in a registered direct common share offering of 1,818,182 common shares at a price of $2.75 each. After placement agent fees and estimated offering expenses, the company expects to receive net proceeds of approximately $4.4 million. The offering is expected to close on March 14, 2012, subject [...]

Non-profit ALS group readying Phase 2 trial

The ALS Therapy Development Institute, a non-profit organization working to discover and develop effective treatments for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), is gearing up to conduct its first ever Phase 2 clinical trial, using a drug introduced last year by Novartis to treat multiple sclerosis. “This is the furthest compound we’ve had in [...]

Craig-Hallum starts TearLab at buy

Craig-Hallum Capital has initiated coverage of TearLab (NASDAQ:TEAR; TSX:TLB) with a “buy” rating and 12-month price target of $5, calling the company a “unique diagnostics opportunity with ophthalmology.” The stock was changing hands at $2 Monday afternoon. Analyst Steven Crowley writes that TearLab’s Osmolarity System offers optometrists and ophthalmologists a unique point-of-care diagnostic tool for [...]

In Conversation with Matt Dolan

As a senior research analyst focused on medical technology: (devices and diagnostics) with ROTH Capital Partners, Matt Dolan’s investment views have been cited by a “Who’s Who” of publications on Wall Street. Prior to joining Roth in 2003, Mr. Dolan, a graduate of Northwestern University, formed a trading group at the Chicago Board of Trade [...]

Navidea to seek approval for Lymphoseek in Europe

Navidea Biopharmaceuticals (AMEX:NAVB) intends to file a Marketing Authorization Application (MAA) in the EU for Lymphoseek, its radioactive diagnostic tracing agent, based on clinical data accumulated from completed pivotal studies and supporting clinical literature. Navidea also has been advised by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use that it has [...]

Roth upgrades Antares Pharma to buy

Roth Capital Partners has upgraded Antares Pharma (AMEX:AIS) to “buy” from “neutral” and raised its 12-month price target to $3.50 from $2, saying the balance sheet is strong and the company could become cash flow positive this year. “The solid financial position, platform opportunities, and potential for advancement of key products make the stock attractive [...]

Navidea signs option to license PD imaging agent

Navidea Biopharmaceuticals (AMEX:NAVB), formerly Neoprobe,  has entered into a six-month option agreement with Alseres Pharmaceuticals to license [123I]-E-IAFCT Injection, also called Altropane, an Iodine-123 radio-labeled imaging agent, being developed as an aid in the diagnosis of Parkinson’s disease and movement disorders. “Should we exercise the option, [123I]-E-IAFCT would provide us not only with another strong [...]

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