Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announces top-line results from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs. 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.
Akebia is working to present the full dataset from its global Phase 3 program (INNO2VATE and PRO2TECT) at an upcoming medical conference and publish the data in peer reviewed journals. Akebia plans to submit to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for vadadustat for the treatment of anemia due to CKD in adult dialysis-dependent and non-dialysis dependent patients as early as possible in 2021. Akebia and its collaborator, Otsuka Pharmaceutical Co. Ltd., are working in close collaboration to prepare a Marketing Authorization Application (MAA) for submission to the European Medicines Agency (EMA).
Global Phase 3 PROTECT Program
Akebia’s global PROTECT program is a cardiovascular outcomes program that includes two separate Phase 3 studies (Correction and Conversion), which collectively enrolled 3,476 adult patients not on dialysis with anemia due to CKD. Both PRO2TECT studies are global, multicenter, open label (sponsor blinded), active-controlled (darbepoetin alfa – an injectable erythropoiesis stimulating agent (ESA)), non-inferiority studies. In both studies, patients were randomized 1:1 to receive either vadadustat or darbepoetin alfa. Vadadustat was initiated at a starting oral dose of 300 mg once daily and adjusted over time in increments of 150 mg within the range of 150 to 600 mg daily using a dose adjustment algorithm, while darbepoetin alfa was dosed per the U.S. package insert (USPI) or summary of product characteristics (SmPCs) in appropriate geographies.
The PRO2TECT Correction study evaluated 1,751 patients with anemia due to CKD without recent ESA use (879 and 872 patients randomized to vadadustat and darbepoetin alfa, respectively). The PRO2TECT Conversion study evaluated 1,725 patients with anemia due to CKD on an active ESA treatment (862 and 863 patients randomized to vadadustat and darbepoetin alfa, respectively).
In both PRO2TECT studies, the primary efficacy endpoint was the mean change in Hb between baseline and the primary evaluation period (weeks 24-36). Non-inferiority was achieved if the lower bound of the 95% confidence interval (CI) for the between-group difference of the mean Hb change did not fall below the pre-specified NI margin (-0.75 g/dL). The PRO2TECT program’s primary safety endpoint, MACE, was independently and blindly assessed by the Brigham and Women’s Hospital’s Clinical Endpoint Center (BWH CEC) in Boston, MA, with a comparison of vadadustat to darbepoetin alfa. MACE is defined as the composite endpoint of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke. To assess MACE, a combined analysis of time to first MACE event from the two PRO2TECT studies was performed. NI was achieved if the upper bound of the 95% confidence interval for the hazard ratio of vadadustat to darbepoetin alfa did not exceed the pre-specified NI margin of 1.25.
On 09-03-2k20 (Thursday) Shareholders tracking shares of Akebia Therapeutics, Inc. (AKBA) belongs to Healthcare sector and Biotechnology industry. AKBA flaunted -72.15% to reach at $2.79 during previous trading session. AKBA Inc. has a total market value of 1.40B at the time of writing – representing $136.91M outstanding shares. Turning to other widely-considered trading data, this company’s half yearly performance is observed at 6.61%.
The USA listed company saw a recent price trade of $2.79 and 29,722,719 shares have traded hands in the session. There are 1.29M shares which are traded as an average over the last three months period.
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Trading volume, or volume, is the number of shares or contracts that indicates the overall activity of a security or market for a given period. Trading volume is an important technical indicator an investor uses to confirm a trend or trend reversal. Volume gives an investor an idea of the price action of a security and whether they should buy or sell the security.
Looking performance record on shares of Akebia Therapeutics, Inc. (AKBA) we observed that the stock has seen a move 155.10% over the last 52-week trading period. The stock generated performance of -17.90% tracking last 3 months. Investors will be anxiously watching to see if things will turn around and the stock will start gaining or losing momentum over the next few months. If we look back year-to-date, the stock has performed 58.23%. Shares are at -1.38% over the previous week and -8.59% over the past month.
Fluctuating the focus to what the Wall Street analysts are projecting, we can see that the current consensus target price on shares is $17.14. Analysts often put in a lot of work to study stocks that they cover. Wall Street analysts have a consensus recommendation of 2.10on this stock. This number falls on a one to five scale where a 1 would be considered a strong buy and 5 means a strong sell, 2 shows Buy, 3 Hold, 4 reveals Sell recommendation.
Watching some historical volatility numbers on shares of Akebia Therapeutics, Inc. (AKBA) we can see that the 30 days volatility is presently 5.79%. The 7 days volatility is 4.61%. Following volatility data can help measure how much the stock price has fluctuated over the specified time period. Although past volatility action may help project future stock volatility, it may also be vastly different when taking into account other factors that may be driving price action during the measured time period.
The company has a beta of 1.18. 1.00 indicates that its price is correlated with the market. Less than 1.00 shows less volatility than the market. Beta greater than 1.00 indicates that the security’s price is theoretically more volatile than the market.
The Average True Range (ATR) value reported at 0.59. The average true range (ATR) is a technical analysis indicator that measures volatility by decomposing the entire range of an asset price for that period. A stock experiencing a high level of volatility has a higher ATR, and a low volatility stock has a lower ATR. The ATR may be used by market technicians to enter and exit trades, and it is a useful tool to add to a trading system. It was created to allow traders to more accurately measure the daily volatility of an asset by using simple calculations. The indicator does not indicate the price direction; rather it is used primarily to measure volatility caused by gaps and limit up or down moves. The ATR is fairly simple to calculate and only needs historical price data.
Akebia Therapeutics, Inc. (AKBA) stock positioned -69.34% distance from the 200-day MA and stock price situated -75.76% away from the 50-day MA while located -73.19% off of the 20-day MA.
RSI value sited with reading of 54.55. Relative Strength Index (RSI) is an extremely useful and popular momentum oscillator. The RSI compares the magnitude of a stock’s recent gains to the magnitude of its recent losses and turns that information into a number that ranges from 0 to 100. It takes a single parameter, the number of time periods to use in the calculation. In his book, Wilder recommends using 14 periods.
Observing the Technical Indicators:
Akebia Therapeutics, Inc. institutional ownership is held at 80.20% while insider ownership was 1.50%. As of now, AKBA has a P/S, P/E and P/B values of 4.11, N/A and 3.70 respectively. Its P/Cash is valued at 4.74. The Company’s net profit margin for the 12 months at 0. Comparatively, the gazes have a Gross margin 61.70%.
Looking into the profitability ratios of AKBA stock, an investor will find its ROE, ROA, ROI standing at -94.70%, -49.80% and -59.40%, respectively.
Earnings per Share Details of Akebia Therapeutics, Inc.:
The EPS of AKBA is strolling at -3.01, measuring its EPS growth this year at 4.50%. As a result, the company has an EPS growth of N/A for the approaching year.
Given the importance of identifying companies that will ensure earnings per share at a tall rate, we later obsession to umpire how to identify which companies will achieve high amassing rates. One obvious showing off to identify high earnings per portion count together companies are to locate companies that have demonstrated such build up beyond the p.s. 5 to 10 years.
The payout ratio shows the proportion of earnings paid out as dividends to shareholders, typically expressed as a percentage of the company’s earnings. The payout ratio can also be expressed as dividends paid out as a proportion of cash flow. The payout ratio is also known as the dividend payout ratio. The Company’s payout ratio was N/A and Price to free cash flow remained $N/A.