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Citius (CTXR) Posts Top-Line Data From Pivotal Lymphoma Study

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Citius Pharmaceuticals, Inc. (CTXR - Free Report) announced top-line data from the pivotal phase III study evaluating its novel IL-2R immunotherapy, I/ONTAK (E7777), for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (“CTCL”).

The data showed the anti-tumor activity of I/ONTAK in treating persistent or recurrent CTCL.

I/ONTAK (denileukin diftitox) is a purified and more bioactive formulation of the previously marketed cancer drug, Ontak. The above-mentioned top-line data was similar to the prior formulation and no new safety signal was identified.

Based on this encouraging data, the company plans to file a biologics license application to the FDA in the second half of 2022 for I/ONTAK to treat persistent or recurrent CTCL. Currently, there is no single standard of care for this disease.

Despite the encouraging news, shares of Citius were down 7.1% on Wednesday. The stock has rallied 11% so far this year against the industry’s decline of 13.8%.

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In December 2021, the company completed the pivotal phase III study for I/ONTAK for the treatment of persistent or recurrent CTCL.

The FDA has granted orphan drug designation to I/ONTAK for the treatment of CTCL and peripheral T-cell lymphoma (“PTCL”). I/ONTAK is already approved in Japan for the treatment of CTCL and PTCL.

We remind investors that, in 2008, Ontak was granted full approval for CTCL in the United States until it was voluntarily withdrawn from the market in 2014 due to manufacturing issues.

Citius is developing another product candidate, Mino-Lok, an antibiotic lock solution, which is in late-stage studies for the treatment of patients with catheter-related bloodstream infections. The company is currently enrolling patients in a pivotal phase III superiority study evaluating Mino-Lok for the given indication.

The FDA has granted Fast Track designation to Mino-Lok to treat catheter-related bloodstream infections.

Citius currently has no approved product in its portfolio. Therefore, the successful development of I/ONTAK, Mino-Lokand other pipeline candidates remains in key focus for the company.

Zacks Rank & Stocks to Consider

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

Better-ranked stocks in the same sector include Corbus Pharmaceuticals Holdings, Inc. (CRBP - Free Report) , Gemini Therapeutics, Inc. (GMTX - Free Report) and Minerva Neurosciences, Inc. (NERV - Free Report) , 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.

Corbus Pharmaceuticals’ loss per share estimates have narrowed 2.8% for 2022 and 24.3% for 2023 over the past 60 days.

Earnings of CRBP have surpassed The Zacks Consensus Estimate in three of the trailing four quarters and missed the same on the other occasion.

Gemini Therapeutics’ loss per share estimates have narrowed 65.3% for 2022 and 71.2% for 2023 over the past 60 days.

Earnings of GMTX have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.

Minerva Neurosciences’ loss per share estimates have narrowed 20.4% for 2022 and 19.7% for 2023 over the past 60 days.

Earnings of NERV have surpassed estimates in one of the trailing four quarters, met the same once and missed the same on the other two occasions.