Ironwood Pharmaceuticals, Inc. IRWD announced that it has initiated the rolling new drug application (“NDA”) submission for the next-generation GLP-2 analog, apraglutide, for treating short bowel syndrome (“SBS”) patients who are dependent on parenteral support.

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

The company also announced a corporate restructuring and a strategic reorganization. IRWD has decided to reduce its current workforce by almost 50% to achieve long-term growth.

Shares of Ironwood were down 11.6% yesterday following the announcement.

The stock has plunged 73.8% in the past year compared with the industry’s decline of 5.8%.

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More on IRWD's Rolling NDA for Apraglutide

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

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

Data from the open-label extension study showed that treatment with apraglutide led to a further increase in patients achieving enteral autonomy, the goal of SBS patients who are dependent on parenteral support.

The extension study data showed that with longer exposure to apraglutide, a greater number of patients gradually reduced parenteral support.

Along with data from the STARS study, IRWD plans to include data from the long-term extension study in its NDA submission for apraglutide.

IRWD's Latest Strategic Reorganization

As part of the restructuring, the company is looking to reduce its existing workforce by almost 50%, primarily the field force.

The company also decided to close the phase II exploratory study, STARGAZE, which evaluated apraglutide for treating Graft-versus-Host Disease. This might have hurt investors' sentiments and resulted in the stock to decline yesterday.

Ironwood anticipated restructuring charges of around $20-$25 million to be incurred primarily in the first half of 2025.

Also, owing to the strategic reorganization, the company expects to make annual operating expense savings of approximately $55-$60 million.

IRWD has promoted Greg Martini to the position of senior vice president and chief financial officer. Martini previously served as vice president, Strategic Finance and Investor Relations for the company.

IRWD's 2025 Financial Guidance

Ironwood expects total revenues in the range of $260-$290 million for 2025. The Zacks Consensus Estimate for the metric is pegged at $329.7 million. This can also be a catalyst for the stock price decline yesterday.

U.S. sales of Linzess (linaclotide) are expected in the range of $800-$850 million.

The company expects to deliver adjusted EBITDA of more than $85 million in 2024.

Ironwood’s sole marketed drug Linzess, which is marketed in collaboration with AbbVie ABBV, is approved for treating irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation. Linzess is also approved as a once-daily treatment for functional constipation in pediatric patients, aged between six years to 17 years.

IRWD and ABBV equally share Linzess’ brand collaboration profits and losses in the United States.

Linzess is marketed by AbbVie for IBS-C in certain countries in Europe under the brand name Constella.

IRWD's Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the drug/biotech sector are Rigel Pharmaceuticals, Inc. RIGL and BioMarin Pharmaceutical Inc. BMRN, 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 Rigel Pharmaceuticals’ earnings per share have increased from 92 cents to $1.05 for 2025. In the past year, shares of RIGL have rallied 92.3%.

RIGL’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 1,754.28%.

In the past 60 days, estimates for BioMarin’s earnings per share have moved up from $3.94 to $4.02 for 2025. In the past year, shares of BMRN have plunged 28%.

BMRN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 28.70%.

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