Daily Top News – June 23, 2020

June 23, 2020

PL8177 / Palatin Technologies
Palatin Technologies to Develop PL8177 as a Potential Treatment for COVID-19 and Associated Lung Complications (PRNewswire) – Jun 23, 2020 – “Palatin Technologies, Inc….announced it is developing PL8177 as a treatment for patients with COVID-19….Palatin submitted a preliminary proposal to the Biomedical Advanced Research and Development Authority…and submitted a pre-Investigational New Drug (pre-IND) package….Company is planning to submit an IND in the third quarter of calendar year 2020 and planning a Phase 2 clinical trial initiation in the fourth quarter of calendar year 2020. Required preclinical and Phase 1 safety studies are complete and support the safe use of PL8177 in a Phase 2 clinical study….PL8177 will be delivered as a sterile subcutaneous injection.”


stannous protoporphyrin (RBT-9) / Renibus Therap
Renibus Therapeutics Receives FDA Fast Track Designation for RBT-9 Treatment in COVID-19 (GlobeNewswire) – Jun 23, 2020 – “Renibus Therapeutics, Inc….announced today that it has been granted Fast Track designation by the FDA for RBT-9 treatment in COVID-19….RBT-9 has demonstrated antiviral activity in several enveloped viruses and inhibits a key mediator of viral replication in coronaviruses, including SARS-CoV-2 – the virus that causes COVID-19.”


Imbruvica (ibrutinib) / AbbVie, J&J
IMBRUVICA (ibrutinib) Seeks to Expand U.S. Label with Long-Term Data in Waldenström’s Macroglobulinemia (WM) (PRNewswire) – Jun 23, 2020 – “AbbVie…announced that the U.S. Food and Drug Administration (FDA) will review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia (WM), a rare and incurable type of non-Hodgkin’s lymphoma (NHL). The application seeks to update the IMBRUVICA U.S. Prescribing Information based on analysis of more than five years of data from the Phase 3 iNNOVATE clinical trial.”


xanomeline/trospium (KarXT) / PureTech
Karuna Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for KarXT for the Treatment of Acute Psychosis in Patients with Schizophrenia (Businesswire) – Jun 23, 2020 – “The Company and FDA aligned on key elements of the Phase 3 program to support a New Drug Application (NDA) filing…The Company plans to initiate two five-week inpatient trials evaluating the efficacy and safety of KarXT for the treatment of acute psychosis in adults with schizophrenia….The first Phase 3 trial is expected to commence by the end of 2020….Details of the second efficacy trial will be finalized by the end of 2020, with initiation expected in the first half of 2021….The Company currently plans to also conduct a separate 52-week open-label trial evaluating the long-term safety of KarXT in adults with schizophrenia who have not been enrolled in the inpatient trials. This trial is expected to begin the first half of 2021….Additional details regarding the development plan, including anticipated completion timelines, will be shared in the second half of 2020.”


seviprotimut-L (POL-103A) / Polynoma
Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L (PRNewswire) – Jun 23, 2020 – “Polynoma LLC…announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L, its melanoma cancer vaccine for the adjuvant treatment of stage IIB/IIC melanoma patients post-resection to improve recurrence-free survival.”

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