FDA approval for DRM04 in hyperhidrosis is expected at the end of June, but Phase III data for DRM01 in acne was the main event for investors. CEO Tom Wiggans said Dermira will try to understand what went wrong, while staying focused on DRM04 commercialization and lebrikizumab in Phase IIb.
Dermira Inc. Chairman and CEO Tom Wiggans did not pull any punches when talking about negative Phase III results for acne candidate olumacostat glaseratil (DRM01) March 5, instead being very upfront that the CLAREOS-1 and CLAREOS-2 studies failed and did not merit continued development of the drug.
Wiggans told Scrip that while Dermira was "stunned" by the results – the most anticipated milestone for the company's investors...
Nemluvio is a first-in-class IL-31 inhibitor that the US FDA approved for prurigo nodularis.
New pivotal data on Regeneron and Sanofi’s antibody in chronic urticaria are underwhelming, though probably sufficient for approval. A green light may beckon in bullous pemphigoid, too.
The Danish firm’s dermatology products have made significant strides in the past six months, leading to an upwards revision of its sales forecast for full-year 2024.
TMB-001, a topical formulation of isotretinoin, missed its primary endpoint in the ASCEND study and will not be filed for approval. Leo is turning its attention to hand eczema and dealmaking.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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