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Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, announced today that the first patient has been enrolled in its Phase 1b study combining temozolomide and eflornithine in patients newly diagnosed with glioblastoma.

Orbus Therapeutics Inc. announced an exclusive license agreement with Michigan State University (MSU) and Helen DeVos Children’s Hospital (HDVCH), part of Corewell Health ® (formerly Spectrum Health), that grants Orbus exclusive rights to intellectual property related to the method of use of eflornithine in the treatment of a novel pediatric condition known as Bachmann-Bupp Syndrome (BABS).

We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system

Orbus Therapeutics Inc. announced that it has been granted patent No. 3432872 entitled “Compositions and Methods for Use of Eflornithine and Derivatives and Analogs thereof to Treat Cancers, Including Gliomas,” by the European Patent Office.

Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, today announced that patient enrollment of its Phase 3 STELLAR clinical study of eflornithine in patients with recurrent anaplastic astrocytoma is complete.

The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.

Following disappointing results for an antibiotic candidate whose development program is now being suspended, Spero Therapeutics is looking to extend its cash runway while it focuses on other assets in its pipeline.