Shares of Amicus Therapeutics, Inc. (FOLD Quick QuoteFOLD - Free Report) have rallied 27.9% in the past three months compared with the industry’s increase of 10.7%.

In late September 2023, the FDA approved Pombiliti + Opfolda, a two-component therapy for treating late-onset Pompe disease (LOPD) in adults who weigh more than 40 kg and are not improving on their current enzyme replacement therapy.

The approval for Pombiliti + Opfolda in the United States is a huge boost and provides a significant commercial opportunity for Amicus in 2024. This could have been one of the factors driving the stock’s rise in the said time frame.

Earlier in 2023, Pombiliti + Opfolda was approved in Europe, including the United Kingdom, for treating LOPD in adults.

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Amicus’ lead drug, Galafold (migalastat), is the first and only approved oral medicine for patients living with Fabry disease, having amenable genetic variants. The drug has shown solid uptake since its launch.

Sales of Galafold have been rising consistently over the past years. In the first nine months of 2023, the drug generated sales worth $281.2 million, increasing 16.6% on a year-over-year basis.

Earlier this month, Amicus announced encouraging preliminary results for the fourth quarter of 2023. The company also provided a strategic outlook for 2024.

For the fourth quarter of 2023, preliminary total revenues were approximately $115.1 million. The Zacks Consensus Estimate for fourth-quarter revenues stands at $110.6 million.

Galafold net sales were around $106.6 million in the fourth quarter.

Newly approved product, Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat), generated sales of roughly $8.5 million in the fourth quarter of 2023.

Amicus aims to deliver Galafold revenue growth of 11-16% at CER in 2024. The company is also looking to ensure the successful global launch of Pombiliti + Opfolda for Pompe disease. Launches are currently underway in the United States, EU and United Kingdom.

Also, the company targets to achieve full-year profitability on a non-GAAP basis in 2024.

The strong uptake of Galafold and the successful launch of Pombiliti + Opfolda should continue the upward momentum for Amicus in 2024, as both Fabry disease and Pompe disease are rare diseases.

Zacks Rank & Stocks to Consider

Amicus currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector are CytomX Therapeutics, Inc. (CTMX Quick QuoteCTMX - Free Report) , Freeline Therapeutics Holdings plc and Puma Biotechnology, Inc. (PBYI Quick QuotePBYI - Free Report) , 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 CytomX Therapeutics’ 2024 loss per share have narrowed from 22 cents to 6 cents. In the past year, shares of CTMX have plunged 40.9%.

CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter earnings surprise of 45.44%, on average.

In the past 60 days, estimates for Freeline Therapeutics’ 2024 loss per share have narrowed from 35 cents to 15 cents. In the past year, shares of FRLN have declined 17.5%.

Earnings of Freeline Therapeutics beat estimates in each of the last three quarters. FRLN delivered a four-quarter average earnings surprise of 67.17%.

In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have lost 5.4%.

Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.