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Dec 29, 2020
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Alkermes'(ALKS, $21.13) resubmission of  schizophrenia drug application accepted by FDA

Alkermes'(ALKS, $21.13) resubmission of  schizophrenia drug application accepted by FDA

On Tuesday, Alkermes Plc. announced that the U.S. Food and Drug Administration (FDA) accepted the company's resubmission of its new drug application for its treatment of schizophrenia or bipolar 1 disorder. 

The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) issued in November 2020. Last month, the FDA had  turned away Alkermes’ ALKS 3831 candidate, since it had concerns  with conditions related to the tablet-coating process.

Alkermes said it will continue to work closely with the FDA as it completes its review of ALKS 3831.

The pharma company said that it wants to make the treatment available to patients as soon as possible. 

Related Ticker: ALKS

ALKS's MACD Histogram crosses above signal line

The Moving Average Convergence Divergence (MACD) for ALKS turned positive on October 05, 2026. Looking at past instances where ALKS's MACD turned positive, the stock continued to rise in 36 of 43 cases over the following month. The odds of a continued upward trend are 84%.

Price Prediction Chart

Technical Analysis (Indicators)

Bullish Trend Analysis

The RSI Indicator points to a transition from a downward trend to an upward trend -- in cases where ALKS's RSI Indicator exited the oversold zone, 15 of 21 resulted in an increase in price. Tickeron's analysis proposes that the odds of a continued upward trend are 71%.

The Momentum Indicator moved above the 0 level on October 19, 2026. You may want to consider a long position or call options on ALKS as a result. In 73 of 102 past instances where the momentum indicator moved above 0, the stock continued to climb. The odds of a continued upward trend are 72%.

ALKS moved above its 50-day moving average on October 26, 2026 date and that indicates a change from a downward trend to an upward trend.

The 10-day moving average for ALKS crossed bullishly above the 50-day moving average on October 30, 2026. This indicates that the trend has shifted higher and could be considered a buy signal. In 14 of 20 past instances when the 10-day crossed above the 50-day, the stock continued to move higher over the following month. The odds of a continued upward trend are 70%.

Following a +2.37% 3-day Advance, the price is estimated to grow further. Considering data from situations where ALKS advanced for three days, in 201 of 276 cases, the price rose further within the following month. The odds of a continued upward trend are 73%.

Bearish Trend Analysis

The Stochastic Oscillator demonstrated that the ticker has stayed in the overbought zone for 8 days. The longer the ticker stays in the overbought zone, the sooner a price pull-back is expected.

Following a 3-day decline, the stock is projected to fall further. Considering past instances where ALKS declined for three days, the price rose further in 50 of 62 cases within the following month. The odds of a continued downward trend are 65%.

ALKS broke above its upper Bollinger Band on October 20, 2026. This could be a sign that the stock is set to drop as the stock moves back below the upper band and toward the middle band. You may want to consider selling the stock or exploring put options.

The Aroon Indicator for ALKS entered a downward trend on October 23, 2026. This could indicate a strong downward move is ahead for the stock. Traders may want to consider selling the stock or buying put options.

Fundamental Analysis (Ratings)

The Tickeron PE Growth Rating for this company is 1 (best 1 - 100 worst), pointing to outstanding earnings growth. The PE Growth rating is based on a comparative analysis of stock PE ratio increase over the last 12 months compared against S&P 500 index constituents.

The Tickeron Price Growth Rating for this company is 40 (best 1 - 100 worst), indicating steady price growth. ALKS’s price grows at a higher rate over the last 12 months as compared to S&P 500 index constituents.

The Tickeron Profit vs. Risk Rating rating for this company is 42 (best 1 - 100 worst), indicating well-balanced risk and returns. The average Profit vs. Risk Rating rating for the industry is 83, placing this stock slightly better than average.

The Tickeron SMR rating for this company is 85 (best 1 - 100 worst), indicating slightly better than average sales and a considerably profitable business model. SMR (Sales, Margin, Return on Equity) rating is based on comparative analysis of weighted Sales, Income Margin and Return on Equity values compared against S&P 500 index constituents. The weighted SMR value is a proprietary formula developed by Tickeron and represents an overall profitability measure for a stock.

The Tickeron Valuation Rating of 100 (best 1 - 100 worst) indicates that the company is significantly overvalued in the industry. This rating compares market capitalization estimated by our proprietary formula with the current market capitalization. This rating is based on the following metrics, as compared to industry averages: P/B Ratio (4.206) is normal, around the industry mean (8.346). ALKS has a moderately high P/E Ratio (113.350) as compared to the industry average of (-1.638). ALKS's Projected Growth (PEG Ratio) (21.570) is very high in comparison to the industry average of (2.152). Dividend Yield (0.000) settles around the average of (0.044) among similar stocks. P/S Ratio (4.638) is also within normal values, averaging (178.797).

Notable companies

The most notable companies in this group are Teva Pharmaceutical Industries Limited (NYSE:TEVA), ZOETIS (NYSE:ZTS), Elanco Animal Health (NYSE:ELAN), Bausch Health Companies (NYSE:BHC), BioCryst Pharmaceuticals (NASDAQ:BCRX), Tilray Brands Inc. (NASDAQ:TLRY), Canopy Growth Corp (NASDAQ:CGC), Aurora Cannabis (NASDAQ:ACB), Journey Medical Corp (NASDAQ:DERM).

Industry description

A generic drug contains the same chemical substance as a drug that was originally protected by patents. Generic drugs are generally sold at cheaper price points, compared to name-brand pharmaceuticals, after patents for the more expensive drugs lapse. The generic drug industry has created a major market, thanks to the lower pricing. According to the Center for Justice and Democracy at New York Law School, 80 percent of all drugs prescribed are generic, and generic drugs are chosen 94 percent of the time when they are available. But their manufacturers must be able to prove to the FDA that they can be effective substitutes for the original drugs. Some of the major generic drug makers include Zoetis, Inc., Allergan plc and Mylan N.V.

Market Cap

The average market capitalization across the Pharmaceuticals: Generic Industry is 4.3B. The market cap for tickers in the group ranges from 2.12K to 68.49B. MKGAF holds the highest valuation in this group at 68.49B. The lowest valued company is CANQF at 2.12K.

High and low price notable news

The average weekly price growth across all stocks in the Pharmaceuticals: Generic Industry was -0%. For the same Industry, the average monthly price growth was -9%, and the average quarterly price growth was 3%. BHC experienced the highest price growth at 27%, while UPC experienced the biggest fall at -65%.

Volume

The average weekly volume growth across all stocks in the Pharmaceuticals: Generic Industry was 29%. For the same stocks of the Industry, the average monthly volume growth was -19% and the average quarterly volume growth was 7%

Fundamental Analysis Ratings

The average fundamental analysis ratings, where 1 is best and 100 is worst, are as follows

Valuation Rating: 43
P/E Growth Rating: 59
Price Growth Rating: 60
SMR Rating: 87
Profit Risk Rating: 83
Seasonality Score: 6 (-100 ... +100)
Related Portfolios: BIOTECHNOLOGY SECTOR
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A.I.Advisor
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A.I. Advisor
published General Information

General Information

a manufacturer of pharmaceutical products

Industry PharmaceuticalsGeneric

Industry
Biotechnology
Address
1 Burlington Road
Phone
+353 17728000
Employees
2050
Web
https://www.alkermes.com
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