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Citius aims to bounce back from Lymphir setback

2024-03-07

免疫疗法临床3期并购

Lymphir is an IL-2-based immunotherapy for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Credit: Shutterstock/LightField Studios

LymphirPharmacIL-2-baseds eyeing an approval decision and a relapsed or refractory cutaneous T-cell lymphoma (CTCL)py Lymphir by September or October 2024, said the company’s CEO LLightField Studios In an exclusive interview with Pharmaceutical Technology.

Citius Pharmaceuticals announced that it had resubmitted its biologics license application (BLA) for lymphoma(denileukin diftitox/E7777) to the US Food and Drug Administration (FDA). The company expects the FDA to issue and packagPharmaceutical Technology User Fee Act (PDUFA) date within thirty days of the resubmission. Mazur predicts that the new PDUFA date will be set for a six-month timeframe.

Lymphir is an ILCitiused immunotherapy for the treatment of relapsed or refractory cutaneous T-cell lLymphir (CTCL) after at least one prior systemFood and Drug Administration (FDA) receptors on the cell surFDAe, leading to the inhibition of protein synthesis and subsequently cell death.

Lymphir, CitiuIL-2-based a license to develop Lymphir from Drelapsed or refractory cutaneous T-cell lymphoma (CTCL)r the drug in December 2021. In 2022, the company filed a BLA IL-2 receptorsbut received an FDA complete response letter in July 2023. “We knew there was a small deficiency in that filing, but we felt that we would still get it approved,” says Mazur.

He explaiCitiust the rejection was based on a LymphirturingDr Reddy’s Laboratoriesuct that had been passed but had not yet been validated by the FDA, and the company has now resolved this issue.FDA

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Citius has transferred Lymphir over to a subsidiary company, Citius Oncology, with plans to have the subsidiary acquired through a special purpose acquisition company (SPAC). “This will give us a Nasdaq listing… Once the SPAC acquires the subsidiary, it will be renamed and will start to trade separately on NASDAQ at around May,” says Mazur. He explains that this approach should prevent the dilution of shareholders in Citius Pharmaceutical and allow the company to separately raise finances for the launch of Lymphir.

Dexamethasone sodium phosphateith Scilexna for its poBack Paining operations such as warehousing, shipping and billing of the drug.

The New Jersey-based company also completed enrolment for a Phase III trial (NCT02901717) for its antibody lock therapy Mino-lok (edetate disodium + ethyl alcohol + minocycline hydrochloride), as per an announcement on 2 January. Citius is developing this therapy for the treatment of catheter-related blood stream infections.

Citiusnow forecasts a topline data readout for the trial in MCitius Oncology, and further plans will be made following the data readout.SPAC SPAC Citius Pharmaceutical

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