Akebia Therapeutics (AKBA) : positive top-line results from two pivotal Phase 3 studies

Akebia Therapeutics (AKBA) : Positive Top-Line Results from Two Pivotal Phase 3 Studies of Vadadustat in Japanese Patients with Anemia Due to Chronic Kidney Disease 

• Co announced positive top-line results from two phase 3 active-controlled pivotal studies evaluating vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in Japanese subjects with anemia due to chronic kidney disease (CKD).
• These studies were conducted by Akebia's development and commercialization collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation (MTPC).
• Each study, one in non-dialysis dependent subjects and one in hemodialysis-dependent subjects, met its primary endpoint.
• In addition, results from two phase 3 single-arm studies conducted by MTPC in peritoneal dialysis subjects and hemodialysis subjects further support vadadustat's potential in these indications.
• MTPC expects to submit a Japanese New Drug Application in 2019.

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Akebia Therapeutics (AKBA) began trading on the NASDAQ on 20 March 2014

Biotech IPOs this week: Akebia Therapeutics (AKBA), Versartis (VSAR), MediWound (MDWD)

Three biotechnology IPOs are coming up this week that might be worth watching, given how well that most of those launched in the last few months have done….

First on the list is Akebia Therapeutics, whose symbol will be AKBA. IPO Renaissance Capital says the strike price should be somewhere between $14 to $17 a share, with 4.9 million shares expected to hit the market.

Akebia specializes in treating anemia through a rather unusual method — adopting the mountain life. That’s an oversimplification, but the company has discovered that simulating high-altitude conditions can increase red blood cell production and stabilize iron supply in bone marrow. That, in turn, helps to fight anemia.

The second making its debut is Versartis Inc., going by the symbol VSAR. A total 4.6 million shares are to be filed at $16 to $19 apiece. It is developing an orphan drug consisting of a hormone designed to treat pediatric growth deficiency.

IPO Boutique sent out a note Tuesday increasing its rating on the shares on word that the upcoming listing is getting “a great deal of attention from the Street.”  On Monday, IPO Boutique said the offering is “multiple times oversubscribed.”

Finally, the third is Israeli-based MediWound Ltd., whose symbol will be MDWD. A total 5 million shares are up for grabs at $14 to $16 apiece.

This company makes an agent known as NexoBrid, used to remove dead skin left from severe burns. It has already been approved for use by the European Medicines Agency. That was enough for CNBC’s Jim Cramer to declare the stock a standout from the other two on his “Mad Money” program this week.