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FDA Panel to Review Perrigo's (PRGO) OTC Birth Control Pill

Perrigo Company plc PRGO announced that the FDA scheduled a joint advisory committee meeting in November 2022 to review its regulatory application. The application seeks to make Opill, a progestin-only daily birth control pill, available as an over-the-counter (“OTC”) drug.

A joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) will take place on Nov 18, 2022, to review Perrigo’s application.

The application, filed by Perrigo’s wholly-owned subsidiary HRA Pharma in July, seeks an Rx-to-OTC switch for Opill, Perrigo’s daily oral contraceptive. The drug is being marketed in the United States as a prescription drug. If the FDA approves PRGO’s application, Opill will become the first daily birth control pill made available OTC without a prescription in the country

Shares of Perrigo have increased 4.6% so far this year against the industry’s decline of 42.0%.

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Zacks Investment Research


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Removing a prescription requirement for Opill would help American women get easy access to a contraceptive method that is more effective at preventing pregnancy than all current OTC methods.

Though contraceptives like Opill have been available for decades, their demand is likely to increase following the overturning of the Roe v. Wade decision by the U.S. Supreme Court earlier this June. As a result of the overturning of this judgment, abortion is illegal in most of the states in the country.

Owing to abortions becoming illegal, demand for birth control pills is likely to increase in the upcoming days as these are safe for most women to use. Though not a substitute for abortions, birth control pills do help prevent pregnancy.

Increasing easy access to an OTC birth control pill will likely provide women with better control of their reproductive life without facing unnecessary barriers. Approval of non-prescription birth control pills has been advocated by health experts for some time. They feel these pills should be available easily over the counter. An approval of Opill as an OTC drug will likely increase the demand for the drug but, at the same time, may also help Perrigo in generating additional product revenue from the drug’s sales.

Perrigo Company plc Price

 

Perrigo Company plc Price
Perrigo Company plc Price

Perrigo Company plc price | Perrigo Company plc Quote

 

Zacks Rank & Stocks to Consider

Perrigo carries a Zacks Rank #4 (Sell) at present.

Some better-ranked stocks in the overall healthcare sector include Kamada KMDA, Morphic MORF and Sesen Bio SESN, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Kamada’s 2022 earnings per share have risen from 1 cent to 26 cents. Shares of Kamada have lost 24% in the year-to-date period.

The earnings of Kamada missed estimates in three of the last four quarters and beat the mark just once, witnessing a negative surprise of 212.50%, on average. In the last reported quarter, KMDA’s earnings beat estimates by 450%.

In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.80. Loss estimates for 2023 have narrowed from $3.96 to $3.62 during the same period. Shares of Morphic have lost 36.4% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.

Estimates for Sesen Bio’s 2023 bottom line have narrowed from 27 cents to 1 cent in the past 60 days. Share prices of Sesen Bio have fallen 19.6% in the year-to-date period.

Earnings of Sesen Bio beat estimates in each of the last four quarters, the average surprise being 89.49%. In the last reported quarter, Sesen Bio delivered an earnings surprise of 61.54%.


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