Akebia Therapeutics (AKBA) : safety results for PRO2TECT vadadustat program

• Shares of Akebia Therapeutics (NASDAQ:AKBA) are plunging today, down 72.3% as of 11:15 a.m. EDT, after the company announced results from a late-stage study of vadadustat in treating anemia due to chronic kidney disease (CKD) in adult patients not on dialysis. While the experimental drug met the primary and secondary efficacy endpoints of the study, it didn't meet the primary safety endpoint.

 

The two PRO2TECT studies evaluated the efficacy and safety of vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis. The Company's vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which the Company reported positive top-line data in May.

Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two PRO2TECT studies, demonstrating non-inferiority (NI) to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat did not meet the primary safety endpoint of the PRO2TECT program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke across both PRO2TECT studies.

This week's biggest % winners & losers : Nov 18 - 22, 19 (wk 47)

The following are this week's top percentage gainers and losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top % gainers

• Healthcare: AKBA (4.21 +25.30),      CLVS (8.66 +35.74%), SGRY (12.88 +48.39%), ATRS (4.89 +43.82%), DXCM (221.85 +41.04%), ATNX (16.08 +38.86%), EPZM (16.42 +38.57%), QGEN (41.6 +35.99%), EVH (10.5 +34.62%), MDCO (68.55 +32.28%), MRNA (20.69 +32.12%), TCMD (60.87 +31.3%), DRNA (22.5 +30.51%)
• Industrials: BE (6.25 +87.13%), AAXN (72.09 +37.26%)
• Information Technology: LASR (19.49 +38.23%)
• Financials: TRUP (33.79 +42.27%), LTS (3.47 +32.44%)

This week's top % losers

• Industrials: NVEE (47.62 -35.35%)
• Consumer Discretionary: MOD (7.41 -36.07%), FOSL (7.18 -34.9%)
• Information Technology: PLT (24.9 -38.64%), RBBN (2.81 -37.49%)
• Financials: QD (4.54 -36.24%)
• Energy: GLOG (9.34 -33.71%)

Long trade : Akebia Therapeutics (AKBA) +25% (11/19)

• Nov. 20:  #4, 5, 44, 75 ; vol. 2.5M

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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