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FibroGen (FGEN) DMD Drug Pamrevlumab Gets FDA's Fast Track Tag

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FibroGen, Inc. FGEN announced that the FDA has granted a Fast Track designation to its anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy (“DMD”) – a rare neuromuscular disease.

Notably, the FDA provides a Fast Track designation to help the development and faster review of drugs which treat serious and unmet medical conditions.

Shares of FibroGen were up 7.1% following the announcement of the news on Monday. However, the stock has plunged 46.3% so far this year compared with the industry’s decline of 10.6%.

price chart for FGEN
price chart for FGEN


Per the company, the Fast Track status was based on review of the phase II data from a single-arm study in non-ambulatory patients with DMD. The FDA notified that pamrevlumab has the potential to address an unmet medical need in DMD. In March 2021, the company initiated the phase III LELANTOS-2 study on pamrevlumab for treating patients with ambulatory DMD.

Meanwhile, pamrevlumab is also being investigated in several late-stage studies targeting other indications. Enrollment is currently underway in the phase III LAPIS study which is evaluating pamrevlumab for treating patients with locally advanced unresectable pancreatic cancer.

This apart, the phase III ZEPHYRUS study is evaluating pamrevlumab in patients with idiopathic pulmonary fibrosis. Last December, the company started a second phase III ZEPHYRUS-2 study on pamrevlumab for the given indication.

If successfully developed and upon potential approval, pamrevlumab can lend a big boost and drive growth for the company in the days ahead.

Zacks Rank & Stocks to Consider

FibroGen currently carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the same sector include Zoetis Inc. ZTS, Infinity Pharmaceuticals, Inc. INFI and Catalent, Inc. CTLT, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Zoetis earnings estimates have been revised 5.2% upward for 2021 and 4.2% upward for 2022 over the past 60 days.

Infinity’s loss per share estimates have narrowed 9.8% for 2021 and 12.3% for 2022 over the past 60 days. The stock has rallied 41.5% year to date

Catalent’s earnings estimates have been revised 2.9% upward for 2021 and 4.1% upward for 2022 over the past 60 days. The stock has gained 5.1% year to date.

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Infinity Pharmaceuticals, Inc. (INFI) : Free Stock Analysis Report

FibroGen, Inc (FGEN) : Free Stock Analysis Report

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