Ironwood Shares Tank on Regulatory Update for Apraglutide

Shares of Ironwood Pharmaceuticals IRWD plunged 31.5% yesterday after it announced regulatory updates on the next-generation GLP-2 analog, apraglutide, which is being developed for treating short bowel syndrome (“SBS”) with intestinal failure (“IF”).

Following the recent discussion with the FDA, management noted that a confirmatory phase III study will be required to seek approval of apraglutide for patients with SBS-IF and dependent on parenteral support.

Simultaneously, IRWD is looking to explore alternatives aimed at maximizing shareholder value.

IRWD's Price Performance

Year to date, shares of Ironwood have plunged 85.4% compared with the industry’s decline of 9.8%.

IRWD's Recent Development Activities for Apraglutide

The phase III STARS study evaluated apraglutide for reducing parenteral support dependency in adult patients with SBS-IF. The open-label extension study, STARS Extend, also evaluated apraglutide for the given indication.

Ironwood initiated the rolling new drug application (“NDA”) submission to the FDA for apraglutide to treat SBS patients who are dependent on parenteral support in January 2025.

The NDA filing was expected to be completed in the third quarter of 2025.

While gearing up for the NDA filing for apraglutide, pharmacokinetic analysis showed that the exposure and dose delivered in the STARS study were lower than planned due to dose preparation and administration.

However, following the latest discussion with the FDA, a confirmatory phase III study will now be required for apraglutide approval. This, in turn, is likely to extend the timeline for the NDA filing completion and also potentially delay the approval for apraglutide.

Management continues to believe that data from the STARS study will be essential for the NDA submission for apraglutide in SBS-IF.

Ironwood acquired the rights to develop and commercialize apraglutide following the acquisition of VectivBio in June 2023.

IRWD's Zacks Rank & Stock to Consider

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

Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. JAZZ, Krystal Biotech, Inc. KRYS and ADMA Biologics, Inc. ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Jazz Pharmaceuticals’ earnings per share have increased from $22.11 to $23.33 for 2025. During the same time, earnings per share estimates for 2026 have increased from $23.23 to $23.35. Year to date, shares of JAZZ have lost 17.4%.

JAZZ’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.20%.

In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.40 to $7.00 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $10.84. Year to date, shares of KRYS have gained 7.8%.

KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.

In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA rallied 21.9%.

ADMA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research