Healthcare Review: Tekmira Pharmaceuticals, Symmetry Medical, ANI Pharmaceuticals, Amgen, Insmed Print E-mail
By Mary Davila   
Monday, 04 August 2014 15:44
U.S. stocks pushed higher in choppy trading Monday afternoon, as markets stabilized after last week's abrupt selloff. The Dow Jones Industrial Average rose 34 points, or 0.2%, to 16528. The S&P 500 index gained nine points, or 0.5%, to 1934, and the Nasdaq Composite Index advanced 22 points, or 0.5%, to 4375. The session was calm compared with recent turbulent trading. Last week, the S&P 500 tumbled to its worst weekly loss in more than two years amid worries about the outlook for Federal Reserve policy and global credit-market woes. But those jitters were largely absent from markets Monday.

Tekmira Pharmaceuticals' ($TKMR) Ebola-stoked up move may be stalling. Shares are showing a bearish reversal in early trading. Prices have retreated 15% from the intraday high of $16.87 on a massive 14x surge in volume.The two U.S. aid workers infected with the virus were treated with an experimental drug that was rushed to Africa. One of the workers improved dramatically one hour after dosing. The problem for Tekmira bulls is that the drug was supplied by privately-held Mapp Biopharmaceuticals. Some observers believe this may lessen the FDA's motivation to lift the clinical hold on the company's Phase 1 healthy volunteer trial.

Symmetry Medical ($SMA) Q2 results: Revenue: $101.3M (+2.3%); Gross Profit: $28.2M (+6.0%); Operating Loss: ($2.6M) (-136.1%); Net Loss: ($6.6M) (-656.5%); Loss Per Share: ($0.07) (-275.0%); Quick Assets: $17.3M (+133.8%).

ANI Pharmaceuticals ($ANIP) Q2 results: Net Revenues: $6.6M (+8.0%); Operating Loss: ($2.5M) (+34.8%); non-GAAP EBITDA: $226K (-81.2%); Net Loss: ($2.4M) (+45.5%); Loss Per Share: ($0.21) (+96.5%); Quick Assets: $53.0M (+377.5%).2014 Guidance: Net revenues: $28M - 30M; non-GAAP EPS: $0.90 - 1.00; non-GAAP EBITDA: $14M - 15M; effective 2H tax rate: 15%.

In an interim analysis of results from Amgen's ($AMGN) Phase 3 clinical trial to expand the label of Kyprolis (carfilzomib), the study achieved its primary endpoint of progression-free survival (PFS). The trial, called ASPIRE, evaluated the safety and efficacy of Kyprolis combined with Celgene's (CELG +1.8%) Revlimid (lenalidomide) and dexamethasone compared to Revlimid and dexamethosone alone to treat patients with relapsed multiple myeloma. The median PFS of the Kyprolis cohort was 26.3 months versus the non-Kyprolis cohort's 17.6 months. The results were statistically significant.

Shares of Insmed (NASDAQ:INSM) are off 26% on heavy volume after the company announced its plans for two additional Phase 3 studies evaluating Arikayce (liposomal amikacin for inhalation) dashing expectations (hopes) for an accelerated approval.




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