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Arcutis Enjoys Seborrheic Dermatitis Win But Experts Itching For Psoriasis Approval

 
• By Ayisha Sharma

The firm is planning a US NDA filing after its roflumilast formulation succeeded in a pivotal seborrheic dermatitis study but analysts are keener on a ‘make or break’ approval in psoriasis.  

Roflumilast Has An Oral, Cream And Foam Formulation • Source: Shutterstock

Arcutis Biotherapeutics, Inc.’ roflumilast foam product has passed an advanced seborrheic dermatitis study prompting filing plans but experts are more invested in a potentially “transformational” psoriasis approval expected in July.

The Westlake Village, CA-headquartered biotech unveiled topline data from the Phase III STRATUM study of 457 seborrheic dermatitis patients on...

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Atai Gives Up On Recognify’s Schizophrenia Drug After Phase IIb Miss

 
• By Joseph Haas

Set to merge with Beckley Psytech, Atai will focus on psychedelic candidates for treatment-resistant depression while Recognify will analyze Phase IIb data for possible next steps.

Celcuity Preps For Potentially Huge Market After Phase III Gedatolisib Win

 
• By Alaric DeArment

The biotech announced positive results in the PIK3CA wild-type population in second-line HR+/HER2- breast cancer for its PAM inhibitor.

Roche Unveils Alzheimer’s Phase III Plan And Preclinical Study

 
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The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.

Bayer’s Elinzanetant Is Latest Drug Hit By FDA Review Delays

 
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Comes Days After PDUFA Pushback For GSK's Blenrep.

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Pipeline Watch: Twelve Approvals And Six Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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• By Jessica Merrill

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