Today - Friday, March 7, 2014
10:23 AM| Comment!
- AstraZeneca (AZN) says Nexium is safe despite an FDA-imposed ban on US shipments on a key ingredient's manufacturer.
- Ranbaxy Laboratories was slapped with the ban in January because it was allegedly retesting QC-failed products in order to get acceptable results. AZN switched suppliers to Minakem SAS in France shortly thereafter.
- It has no plans to withdraw the $4B product from the marketplace.
- Mindray Medical International Ltd (MR) will pay its recently-declared $.50/share dividend on or around April 8 to shareholders of record March 8.
- Columbia Laboratories (CBRX) purchases 1.4M shares of its common stock from Actavis (ACT) at $6.08/share, a supposed 10.75% discount to yesterday's closing price. In reality, the price was a 2% premium to the close of $5.96.
- The CEO calls it a "unique opportunity to acquire Actavis' large block of shares at an advantageous price". No word on shareholders reaction to this one-in-a-lifetime use of 41% the company's $20.7M of cash and equivalents.
- Consensus 2014 estimates are earnings of $.33/share on revenues of $32M.
- EPS for 2013 was $.73 on revenues of $29.2M.
9:06 AM| Comment!
- Shares of Northwest Biotherapeutics (NWBO) are poised for a strong up move at the open in response to its announcement that the Data Safety Monitoring Board recommends the continuation of its DCVax-L Phase 3 GBM trial.
- The unblinded review was conducted in response to shareholder inquiries.
- Prices have been on a roller coaster of late. In November, shares doubled, retraced, then shot up almost 150% to a February 27 peak of $7.92 before correcting. Shares closed yesterday at $5.96.
- Achillion Pharmaceuticals (ACHN) plans to complete the Phase 1 drug-drug interaction study evaluating ACH-3102 in combination with ACH-2684 in the second quarter. A Phase 2 trial will begin shortly thereafter.
- A Phase 1 trial evaluating ACH-3422 will begin ex-US in the second quarter with proof-of-concept results expected by Q3.
- A data package addressing the clinical hold of sovaprevir by the FDA will be submitted shortly. The firm expects a response in the first half.
- Quick assets totaled $159M at years end. The company expects to burn $60M - $65M in 2014. Net loss will be ~$.70/share.
- Press release
- Shares of NewLink Genetics (NLNK) are poised for a down move at the open in apparent reaction to the company's announcement of the continuation of the phase 3 IMPRESS clinical trial of algenpantucel-L for patients with surgically resected pancreatic cancer.
- The interim analysis was conducted after the predetermined midpoint 222 patient events. A second interim analysis will be done after 333 patient events and, if necessary, a final analysis after 444 patient events.
- The trial will involve as many as 722 patients.
- Omeros (OMER) announces that it achieved 50% higher plasma concentrations in its phase 2a trial of OMS824, the firm's phosphodiesterase 10 (PDE10) inhibitor without additional side effects.
- The product inhibits PDE10, an enzyme expressed in the brain that is linked to diseases that affect cognition (Huntington's, schizophrenia).
- The results indicate that OMS824 can be administered with standard antipsychotic medication at a concentration that can achieve a high degree of PDE10 interaction.
- The FDA designated Orphan Drug status to OMS824 for Huntington's disease. A Fast Track application is currently under agency review.
- Press release
8:02 AM| 1 Comment
- Citi and Cantor Fitzgerald both upgrade Cross Country Healthcare (CCRN) to Buy. The latter sets a price target of $10.
- Yesterday, the stock plunged 28% on 5.5 times normal volume after the company reported results Wednesday evening that fell short of expectations.
- Shares are up 5% premarket.
- Consensus estimates for Q1 and 2014 are $.01/share on revenues of $118M and $.13/share on revenues of $484M, respectively.
- 213 mutual funds have positions, up from 188 a year earlier.
- Harvard Apparatus Regenerative Technology's (HART) Q4 loss per share was $0.34 vs $0.25 a year earlier.
- Company recognizes revenue of $22,000.
- HART's net loss was $2.6M vs $2M a year earlier.
- In December, a fifth successful regenerated human trachea transplant surgery took place.
- Early this year, HART held a meeting with the FDA to help the company towards starting trials for its regenerated trachea. The firm has also requested orphan biologics status for the product.
- HART had cash on hand of $14M at the end of 2013 and no debt.
- HART was spun off from Harvard Bioscience on November 1. (PR)