CAMBRIDGE, Mass.--(BUSINESS ... disease (AD), including both APOE4 and non-APOE4 gene carriers. The agency issued the "May Proceed" notification on August 10, 2026, activating the company's Investigational New Drug (IND) application. PHENOGENE-1A is an inhaled formulation of cromolyn, a compound with decades of clinical use, that incorporates PhenoNet’s proprietary targeted delivery technology. This approach is designed to achieve therapeutic concentrations ... CAMBRIDGE, Mass.--(BUSINESS WIRE)--Today, PhenoNet, Inc. announced that the U.S. Food and Drug Administration (FDA) has notified the company that it may proceed with a Phase 3 clinical trial of its lead candidate, PHENOGENE-1A, in patients with early Alzheimer's disease (AD), including both APOE4 and non-APOE4 gene carriers. The agency issued the "May Proceed" notification on August 10, 2026, activating the company's Investigational New Drug (IND) application. PHENOGENE-1A is an inhaled formulation of cromolyn, a compound with decades of clinical use, that incorporates PhenoNet’s proprietary Gupta has extensive experience in neurodegenerative disease trials and will serve as a Principal Medical Monitor in the trial. "I am truly excited to serve as Principal Investigator of this Phase III study, as it holds the potential to advance a promising new therapy and contribute meaningfully to the treatment landscape for AD," said Dr. "Addressing the triggers of AD progression in diagnosed genotypes with a multifunctional therapeutic approach offers a new strategy to modify the disease course that could potentially benefit a large AD population," said Dr. David R. Elmaleh, PhenoNet, Inc. Founder and Chairman. "Very early intervention in non-APOE4 patients at the earliest clinical signs of cognitive and functional decline may help prevent or delay disease progression. "AD-modifying therapies that work alongside the underlying genotype pathophysiology of the disease can add significant value to existing treatment options," added Dr. Atul Gupta, Chief Medical Officer of PhenoNet, Inc. "If successful, our multifunctional therapy has the potential to slow decline over the long term."

Original title: “PhenoNet Cleared by FDA to Begin Phase 3 Trial of Inhaled PHENOGENE-1A in Early Alzheimer's Disease - BioSpace”

The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Simparica TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs and puppies.

Original title: “FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies”

Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February.

Original title: “Taiho and Cullinan’s zipalertinib clears Phase 3, teeing up first-line competition”

KUP101 enters clinic for advanced solid tumours

Original title: “Kupando doses first patient in phase 1 trial”

SMC acceptance offers new option for patients

Original title: “First-in-class house dust mite allergy treatment now available in Scotland”

Reports of seven deaths in patients who had taken Neurocrine Biosciences’ Vykat and the official termination of Aardvark Therapeutics’ Phase 3 trial after cardiac complications marked a tough day for the Prader-Willi syndrome community.

Original title: “Deaths reported after treatment with Neurocrine’s approved Prader-Willi drug”

Results from a late-stage study focused on generalized anxiety disorder were a “clean win” to analysts, who believe Definium has a drug with multibillion-dollar sales potential.

Original title: “Psychedelics developer Definium scores more positive data for LSD pill”

It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression.

Original title: “Definium’s LSD asset beats analyst expectations in Phase 3 anxiety readout”

After two rejections, Replimune has made it across the regulatory finish line with its twice-rejected therapy for advanced melanoma. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk, reported second quarter earnings, and psychedelics made headlines once again.

Original title: “Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight”

Delayed‑release mercaptamine approved for routine use

Original title: “NHS backs new treatment option for cystinosis”