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Dec 29, 2020
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

Aroon Indicator for ALKS shows an upward move is likely

ALKS's Aroon Indicator triggered a bullish signal on June 23, 2026. Tickeron's A.I.dvisor detected that the AroonUp green line is above 70 while the AroonDown red line is below 30. When the up indicator moves above 70 and the down indicator remains below 30, it is a sign that the stock could be setting up for a bullish move. Traders may want to buy the stock or look to buy calls options. A.I.dvisor looked at 211 similar instances where the Aroon Indicator showed a similar pattern. In of the 211 cases, the stock moved higher in the days that followed. This puts the odds of a move higher at .

Price Prediction Chart

Technical Analysis (Indicators)

Bullish Trend Analysis

The Momentum Indicator moved above the 0 level on May 28, 2026. You may want to consider a long position or call options on ALKS as a result. In of 98 past instances where the momentum indicator moved above 0, the stock continued to climb. The odds of a continued upward trend are .

The Moving Average Convergence Divergence (MACD) for ALKS just turned positive on June 22, 2026. Looking at past instances where ALKS's MACD turned positive, the stock continued to rise in of 43 cases over the following month. The odds of a continued upward trend are .

Following a 3-day Advance, the price is estimated to grow further. Considering data from situations where ALKS advanced for three days, in of 284 cases, the price rose further within the following month. The odds of a continued upward trend are .

Bearish Trend Analysis

The RSI Indicator has been in the overbought zone for 2 days. Expect a price pull-back in the near future.

The Stochastic Oscillator has been in the overbought zone for 2 days. Expect a price pull-back in the near future.

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 of 62 cases within the following month. The odds of a continued downward trend are .

ALKS broke above its upper Bollinger Band on June 23, 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.

Fundamental Analysis (Ratings)

The Tickeron PE Growth Rating for this company is (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 Profit vs. Risk Rating rating for this company is (best 1 - 100 worst), indicating low risk on high returns. The average Profit vs. Risk Rating rating for the industry is 84, placing this stock better than average.

The Tickeron Price Growth Rating for this company is (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 SMR rating for this company is (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 (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 (4.380) is normal, around the industry mean (79.619). P/E Ratio (51.133) is within average values for comparable stocks, (97.708). ALKS's Projected Growth (PEG Ratio) (0.000) is slightly lower than the industry average of (1.629). Dividend Yield (0.000) settles around the average of (0.035) among similar stocks. P/S Ratio (4.953) is also within normal values, averaging (96.435).

Notable companies

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

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 3.96B. The market cap for tickers in the group ranges from 2.12K to 63.66B. AGN holds the highest valuation in this group at 63.66B. 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 -1%. For the same Industry, the average monthly price growth was -0%, and the average quarterly price growth was 8%. AQST experienced the highest price growth at 18%, while GELS experienced the biggest fall at -41%.

Volume

The average weekly volume growth across all stocks in the Pharmaceuticals: Generic Industry was -50%. For the same stocks of the Industry, the average monthly volume growth was 12% and the average quarterly volume growth was 55%

Fundamental Analysis Ratings

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

Valuation Rating: 52
P/E Growth Rating: 65
Price Growth Rating: 57
SMR Rating: 87
Profit Risk Rating: 83
Seasonality Score: 14 (-100 ... +100)
Related Portfolios: BIOTECHNOLOGY SECTOR
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General Information

a manufacturer of pharmaceutical products

Industry PharmaceuticalsGeneric

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