Tuesday, June 3, 2025
Kiora, Senju Pharmaceutical Partner on Treatment of Retinal Diseases in Asia
Kiora Pharmaceuticals (NASDAQ: KPRX) has granted Senju Pharmaceutical an exclusive option for the development and commercialization of KIO-301, a molecular photoswitch therapy for retinal diseases, in key Asian markets including Japan and China. The deal has a potential value of $110 million plus royalties, starting with an immediate $1.25 million option fee. If exercised, Kiora will receive an additional mid-single digit million upfront payment plus development, regulatory, and commercial milestones. This agreement complements Kiora's existing partnership with Théa Open Innovation for markets outside Asia, bringing the total potential value of strategic partnerships to over $400 million plus royalties. KIO-301 is currently in the ABACUS-2 Phase 2 clinical trial, targeting 36 patients with ultra-low vision or no light perception due to retinitis pigmentosa. The therapy aims to restore visual function by targeting surviving retinal ganglion cells.
Atyr management to meet with Piper Sandler
Meeting to be held in New York on June 4 hosted by Piper Sandler.
https://www.tipranks.com/news/the-fly/atyr-pharma-management-to-meet-with-piper-sandler-thefly
Hims & Hers Erases Most Of Its Acquisition-Tied Sprint
Hims stock shot higher and then erased most of it steep gains Tuesday after the telehealth platform announced the pending acquisition of ZAVA, a European digital health platform.
The move will expand Hims & Hers Health's (HIMS) presence in the U.K. and officially launch the company into Germany, France and Ireland, Hims said in a news release.
"This acquisition is expected to accelerate Hims & Hers' vision to deliver the same seamless, personalized care experience it has successfully built in the U.S. to millions more people globally," the company said.
In morning trades, Hims stock rose a fraction to 56.85, pulling back from a steeper 19% gain in earlier action.
Hims Stock Rides Weight-Loss Drugs
Hims has rocketed to stardom amid the fervor over weight-loss drugs. Today, the company partners with Novo Nordisk (NVO) to offer obesity treatment Wegovy in combination with a Hims & Hers membership. It also sells Eli Lilly's (LLY) Zepbound on its website.
Chief Executive Andrew Dudum expects the acquisition of ZAVA to "fundamentally transform access to care for millions across Europe."
"Whether in rural towns, vibrant cities, or remote communities across Europe, people battling widespread, often silent chronic conditions like obesity, depression, and more will have access to the personalized, high-quality care they deserve," he said in a written statement.
ZAVA currently has 1.3 million active customers. Last year, its in-house medical team completed almost 2.3 million consultations across the UK, Germany, France and Ireland.
Hims & Hers expects the deal to close in the second half of 2025. The company didn't disclose the deal's terms, but said it will be funded entirely through cash from the balance sheet.
https://www.investors.com/news/technology/hims-stock-zava-acquisition/
Amylyx Pharmaceuticals Receives U.S. FDA Fast Track Designation for AMX0114 for ALS
AMX0114 is an Amylyx-developed antisense oligonucleotide designed to target calpain-2, a key contributor to the axonal degeneration pathway in ALS
- Phase 1 LUMINA trial of AMX0114 underway; early cohort data expected in 2025
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for the treatment of people living with amyotrophic lateral sclerosis (ALS).
“Obtaining FDA Fast Track designation for AMX0114 is an important step forward in our mission to develop potential treatments for people living with ALS, a relentlessly progressive and fatal disease with limited therapeutic options,” said Camille L. Bedrosian, MD, Chief Medical Officer at Amylyx. “This designation from the FDA recognizes both the seriousness of this devastating disorder and the encouraging preclinical evidence supporting AMX0114’s potential to target calpain-2, which has been found to be an important contributor to axonal degeneration, a critical driver in ALS progression. We are committed to advancing AMX0114 as quickly and efficiently as possible, and we continue to anticipate early cohort data from the Phase 1 LUMINA clinical trial later this year. We look forward to continued interaction with the FDA as we work to expeditiously advance the development of AMX0114, with the ultimate goal of addressing the urgent, unmet needs of the ALS community.”
FDA Grants Breakthrough Device Designation to Guardant Health’s Shield Multi-Cancer Detection
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.
https://finance.yahoo.com/news/fda-grants-breakthrough-device-designation-120500589.html
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