Company

Product

Description

Indication

Status

Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co. Ltd., of Tokyo

[Fam-] trastuzumab deruxtecan (DS-8201)

HER2-targeting antibody-drug conjugate

HER2-positive metastatic breast cancer

FDA accepted the BLA and granted priority review; PDUFA date set for second quarter of 2020

Foamix Pharmaceuticals Ltd., of Rehovot, Israel

FMX-103 (minocycline, 1.5% topical foam)

Tetracycline antibiotic

Rosacea

FDA accepted for review NDA for treatment of moderate to severe papulopustular rosacea in adults, setting June 2, 2020, PDUFA date

Genentech, of South San Francisco, a member of the Roche Group

Xofluza (baloxavir marboxil)

Antiviral designed to inhibit cap-dependent endonuclease protein

Acute, uncomplicated influenza

FDA approved a supplemental NDA for use in people 12 and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications

Kiadis Pharma NV, of Amsterdam, the Netherlands

ATIR-101

T-cell-based therapeutic

Hematopoietic stem cell transplant in blood cancers

Expects EMA's Committee for Medicinal Products for Human Use to issue negative opinion and recommend against conditional marketing authorization at November meeting; EMA feedback indicates phase II and historical T-cell deplete control data do not provide adequate support for MAA due to the evolution of standard of care with post-transplant cyclophosphamide; phase III study currently enrolling, with interim readout expected in 2021

Minoryx Therapeutics SL, of Barcelona

Leriglitazone (MIN-102)

PPAR gamma agonist

Friedreich's ataxia

FDA granted orphan drug designation

Neuren Pharmaceuticals Ltd., of Melbourne, Australia

NNZ-2591

Analogue of cyclic glycine proline

Angelman syndrome; Phelan-McDermid syndrome; Pitt Hopkins syndrome

FDA granted orphan designation for all 3 indications


Notes

For more information about individual companies and/or products, see Cortellis.

No Comments