The global biopharmaceutical landscape is rapidly evolving, driven by innovations targeting complex diseases like organ fibrosis and liver conditions. As companies push the boundaries of medical science, new therapies are emerging that promise to transform patient care and redefine market leadership in these critical areas.

On Tuesday, HC Wainwright initiated coverage on Gyre Therapeutics Inc. GYRE, a commercial-stage biopharmaceutical company focused on drugs for organ fibrosis.

Its flagship product, ETUARY (pirfenidone capsule), was the first approved treatment for idiopathic pulmonary fibrosis (IPF) in China in 2011, with sales of $105 million in 2024.

Gyre Therapeutics reported second-quarter sales of $26.78 million, missing the consensus of $30.8 million.

For the full year 2025, the company expects to generate revenues of $118 million to $128 million, representing growth of 11.3% to 20.8% over 2024 revenue, primarily driven by the anticipated commercial launches of Etorel and Contiva and sales of ETUARY.

Gyre’s lead asset under development is hydronidone (also known as F351), which is a structural analog of the anti-fibrotic drug pirfenidone.

Analyst Matthew Keller writes that Hydronidone is a potent inhibitor of fibrosis that targets key molecules in the transforming growth factor beta (TGF-β) pathway, particularly in the liver.

Also Read: European Advisory Panel Backs Conditional Approval For Madrigal’s Fatty Liver Disease Drug

In May, Hydronidone met the primary endpoint in a pivotal Phase 3 trial evaluating its efficacy and safety for liver fibrosis in patients with chronic hepatitis B (CHB) in China.

The trial showed a statistically significant proportion of patients receiving Hydronidone achieving a ≥1-stage regression in liver fibrosis compared to placebo (P=0.0002). These results are consistent with the efficacy and safety outcomes observed in Gyre’s prior Phase 2 trial.

The therapy is anticipated to enter clinical Phase 2 assessment for MASH and liver fibrosis in the U.S. in the second half of 2025.

Gyre intends to seek accelerated approval for hydronidone in CHB fibrosis, with a submission of a new drug application to the Chinese regulatory authority expected in the third quarter of 2025.

In addition to hydronidone, the company boasts a portfolio of clinical and commercial-stage therapies for fibrosis and other related inflammatory indications.

In June, Gyre dosed the first volunteer in a Phase 1 trial evaluating F230, a novel endothelin A (ETA) receptor antagonist, for pulmonary arterial hypertension (PAH).

Despite these upsides, HC Wainwright writes that “Gyre’s story is still flying under the radar with investors, its portfolio of established therapeutics is compelling, and the stock represents significant upside for investors that warrants additional attention.”

HC Wainwright initiated with a Buy rating and a price forecast of $18.

In May, the company raised approximately $23 million via a public offering of 2.56 million shares of its common stock at $9.00 per share.

In March 2024, Madrigal Pharmaceuticals Inc.'s MDGL Rezdiffra (resmetirom) became the first FDA-approved treatment for MASH, liver scarring due to fatty liver disease.

Madrigal anticipates strong revenue growth for Rezdiffra, potentially reaching nearly $5 billion in annual sales by 2031.

“Although mechanistically differentiated products, we believe REZDIFFRA’s success is a window into hydronidone’s future,” the analyst wrote in an investor note.

Keller forecasts hydronidone could also be a blockbuster drug with estimated annual sales in the U.S. of approximately $6 billion by 2033.

Most recently, the FDA approved an additional indication for Novo Nordisk A/S' NVO Wegovy (semaglutide 2.4 mg) for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in combination with a reduced-calorie diet and increased physical activity.

GYRE Price Action: Gyre Therapeutics shares were down 6.04% at $7.70 at the time of publication on Tuesday, according to Benzinga Pro data.

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