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Menlo’s Setback Not Expected To Affect Results In Lead Pruritus Indication

 
• By Joseph Haas

With Foamix merger closing soon, Menlo’s serlopitant failed a Phase II trial in chronic pruritus of unknown origin, but the firm said a Phase III program in prurigo nodularis shouldn’t be affected. Its share in the new company is contingent on the PN data.

Winding curvy rural road with light trail from headlights leading through British countryside.
Disappointing data in one indication has Menlo looking ahead to Phase III PN readouts

Menlo Therapeutics Inc.'s oral serlopitant failed a Phase II trial in chronic pruritus of unknown origin on 26 February, but more important data readouts for the neurokinin receptor 1 (NK1) antagonist are coming in a few weeks. The dermatology firm’s equity in the pending merger with Foamix Pharmaceuticals Ltd.is based on the outcome of a pair of Phase III studies of serlopitant in pruritus (itch) associated with prurigo nodularis (PN).

Meno reported that in a 233-patient study testing serlopitant versus placebo in chronic pruritis of unknown origin (CPUO), an unmet...

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Genentech Gets Columvi Complete Response Following ODAC’s No

 
• By Joseph Haas

Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

BMS’s Reblozyl Misses Primary Endpoint In Myelofibrosis Anemia

 
• By Alaric DeArment

The drugmaker announced topline results from the Phase III INDEPENDENCE trial, which did meet key secondary endpoints.

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By Vibha Ravi

As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?

Actuate Is Looking For A Buyer To Advance Pancreatic Cancer Candidate

 
• By Jessica Merrill

After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.

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Actuate Is Looking For A Buyer To Advance Pancreatic Cancer Candidate

 
• By Jessica Merrill

After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.

In Brief: Kezar Plots Lupus Revival For Zetomipzomib As FDA Lifts Hold On Hepatitis Trial

 
• By Manas Mishra

The go-ahead to resume a trial for its only drug candidate, zetomipzomib, in hepatitis could give Kezar a glimmer of hope of reviving another halted study in lupus nephritis.

AstraZeneca’s Amyloidosis Drug Fails In Phase III But Subgroup Hopes Persist

 
• By Andrew McConaghie

Anselamimab was expected to complement Alexion's portfolio of amyloid therapies, but regulators will have to be convinced of its benefits to a patient subgroup in the CARES trial.