Search Results

Braintale to Showcase Data on Exploratory Sub-study of Minoryx’s Pivotal ADVANCE Phase 2/3 Study at 33 rd ENRS Conference

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

Braintale, a medtech that is deciphering white matter, spin off from the Assistance Publique-Hôpitaux de Paris, showcases, with Minoryx, a biotechnology company developing a treatment for X-linked Adrenoleukodystrophy, the results of the multicentric ADVANCE sub study with Braintale biomarker platform on the occasion of the American Academy of Neurology.

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales

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.

Minoryx Therapeutics opens Belgian subsidiary that will lead important development activities