|Healthcare Review: Northwest Biotherapeutics, Idera Pharaceuticals, Mannkind, Organovo, Aria Pharmaceuticals|
|By Staff and Wire Reports|
|Friday, 28 March 2014 14:09|
Northwest Biotherapeutics ($NWBO) takes predictable exception to The Street's Adam Feuerstein regarding his bearish comments after CEO Linda Powers' DC-Vax presentation on March 27.The company insists that the statistical significance of the phase 3 trial results increases its chances of success not decreases as Mr. Feuerstein asserts. It also disputes his opinion that the trial has been poorly run.
Shares of Idera Pharaceuticals ($IDRA) are up 20% on heavy volume in response to the firm's report of positive phase 2 clinical trial results for it psoriasis drug IMO-8400.The 32-patient study met its primary endpoint of safety and tolerability over a 12-week period. No adverse events, dose reductions or discontinuations occurred. The study also met its secondary endpoint of demonstrating clinical activity as assessed by Psoriasis Area and Severity Index (PASI) scores.IMO-8400 has demonstrated activity in other autoimmune diseases such as lupus and arthritis.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets April 1 to discuss Mannkind's ($MNKD) AFREZZA NDA. The company originally submitted the New Drug Application for its ultra fast-acting inhalable insulin in March 2009. A couple of CRLs and clinical trials later, CEO Al Mann hopes this is the long-awaited breakthrough in light of his $1B+ investment to date. Considering the inherent risk in a binary event such as an Ad comm vote, longs might want to hedge their positions.
Controversial biotech firm Organovo ($ONVO) will conduct an online conference for investors on April 10 at 12:00 pm ET. CEO Keith Murphy will provide an update on the firm's liver tox assay, breast cancer model, R&D and cash position. Shares have been under pressure since hitting a peak of $13.65 on November 18. Yesterday's close was $7.24.The company plans to launch its first product, the liver toxicity assay, later this year.
Shares of Aria Pharmaceuticals ($ARIA) are up 7% on rumors that Jazz Pharmaceuticals (JAZZ) is mulling a buyout for as much as $20/share versus yesterday's close of $7.60. This would value the acquisition at ~$3.6B.Consensus 2014 and 2015 revenue estimates for ARIA are $87.9M and $158.4M, respectively.287 mutual funds own ARIA, down from 505 a year earlier.