Healthcare Review: NewLink Genetics, Cellular Biomedicine, Bioanalytical Systems, Allergan, Amgen Print E-mail
By Staff and Wire Reports   
Thursday, 14 August 2014 13:21

The U.S. stock market crept higher Thursday following a mixed batch of corporate news. In Europe, investors brushed aside more worrying news on the economy and nudged markets up.

The Standard & Poor's 500 index was up six points, or 0.3 percent, to 1,953. The Dow Jones industrial average gained 41 points, or 0.3 percent, to 16,697 while the Nasdaq composite climbed 11 points, or 0.3 percent, to 4,445.

Citing the U.S. Defense Threat Reduction Agency ($DTRA) desire to "move quickly" on validating an Ebola vaccine, NewLink Genetics ($NLNK) says it has enough doses of its vaccine candidate to launch a safety trial in 20 -100 healthy volunteers in a matter of weeks. CEO Dr. Charles Link says he has lined up two (possibly three) contract manufacturers that could produce tens of thousands of doses within a month or two. NewLink subsidiary BioProtection Systems received $1M from DTRA to fund more pre-clinical toxicology studies and stepped-up manufacturing to allow human trials to start quickly.

Cellular Biomedicine Group ($CBMG) Q2 results: Revenues: $0.1M; Operating Expenses: $2.5M (+8.6%); Net Loss: ($6.7M) (-166.5%); Loss Per Share: ($0.29) (+25.6%); Quick Assets: $13.6M (+88.9%); Cash Burn (1H): ($4.7M) (-2.4%).

Bioanalytical Systems ($BASI) fiscal Q3 results: Revenues: $6.0M (+7.7%); Operating Expenses: $1.7M (+8.4%); Net Income: $143K (-75.6%); EPS: $0.02 (-71.4%); Quick Assets: $736K (-43.6%).

Allergan ($AGN) acquires the worldwide rights to Taris Biomedicals' lead program, LIRIS, currently in Phase 2 clinical trials for the treatment of  interstitial cystitis/bladder pain syndrome. LIRIS' value proposition is the ability to continuously deliver lidocaine to the bladder over an extended period. It accomplishes this by incorporating three proven drug delivery strategies: osmotic delivery, shape memory technology and implant retention.

Amgen's ($AMGN) Kyprolis (carfilzomib) failed to achieve its primary endpoint of improving overall survival (OS) in a 315-patient Phase 3 clinical trial (FOCUS) evaluating the safety and efficacy of the product in patients with relapsed and advanced refractory multiple myeloma compared to an active control regimen of low-dose dexamethasone (or equivalent corticosteroids) plus optional cyclophosphamide.




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