|Healthcare Review: Tekmira Pharmaceuticals, Symmetry Medical, ANI Pharmaceuticals, Amgen, Insmed|
|By Mary Davila|
|Monday, 04 August 2014 15:44|
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.