Noah AI Industry News

Delivers real-time biopharma news and signals — powered by AI, curated for professionals.

Harmony Biosciences' Fragile X Trial Falters, Casting Doubt on ZYN002's Future

Harmony Biosciences' Fragile X Trial Falters, Casting Doubt on ZYN002's Future

Harmony Biosciences' ambitious foray into Fragile X syndrome treatment has hit a significant roadblock, as the company announced the failure of its pivotal trial for ZYN002, a synthetic cannabidiol. The study's primary endpoint was not met, dealing a blow to the $60 million acquisition of Zynerba Pharmaceuticals in 2023.

NoahAI News9/25/2025
Privia Health Expands Value-Based Care Footprint with $100M Acquisition of Evolent Care Partners

Privia Health Expands Value-Based Care Footprint with $100M Acquisition of Evolent Care Partners

Privia Health, a leading physician enablement company, has announced the acquisition of Evolent Health's accountable care organization (ACO) business, Evolent Care Partners, in a deal valued at up to $113 million. This strategic move aims to bolster Privia's presence in the value-based care landscape and increase its participation in Medicare's largest value-based program.

NoahAI News9/25/2025
FDA Setbacks for Biogen and Scholar Rock in SMA Treatment Development

FDA Setbacks for Biogen and Scholar Rock in SMA Treatment Development

In a series of unexpected developments, both Biogen and Scholar Rock have encountered regulatory hurdles in their pursuit of new treatments for spinal muscular atrophy (SMA). The U.S. Food and Drug Administration (FDA) has issued complete response letters (CRLs) to both companies, citing manufacturing-related concerns.

NoahAI News9/25/2025
Pharmaceutical Industry Embraces Multispecific Antibodies as Next-Generation Therapeutics

Pharmaceutical Industry Embraces Multispecific Antibodies as Next-Generation Therapeutics

The pharmaceutical industry is witnessing a surge in the development and investment of multispecific antibodies (msAbs), signaling a shift towards more complex and potentially more effective therapeutic approaches. This "more is better" strategy is gaining traction in both oncology and autoimmune disease treatment, with several candidates showing promise in clinical trials.

NoahAI News9/25/2025
Thyme Care Secures $97M Series D Funding, Achieves Unicorn Status in Cancer Care Navigation

Thyme Care Secures $97M Series D Funding, Achieves Unicorn Status in Cancer Care Navigation

Thyme Care, a value-based cancer care navigation company, has raised $97 million in a Series D funding round, propelling its valuation to over $1 billion. The investment, backed by major strategic players across the healthcare spectrum, marks a significant milestone for the company and underscores the growing importance of innovative approaches to cancer care management.

NoahAI News9/25/2025
Cyclerion Therapeutics Pivots to Neuropsychiatry with MIT-Licensed Technology

Cyclerion Therapeutics Pivots to Neuropsychiatry with MIT-Licensed Technology

Cyclerion Therapeutics, a Cambridge, Massachusetts-based biotech company, has announced a major strategic shift, repositioning itself as a neuropsychiatric-focused enterprise. This latest pivot marks a significant departure from the company's previous ventures and introduces a novel approach to treating neuropsychiatric disorders.

NoahAI News9/25/2025
Merck Expands AI-Driven Vaccine Portfolio with $592M Evaxion Deal

Merck Expands AI-Driven Vaccine Portfolio with $592M Evaxion Deal

Merck & Co. has exercised its option to license a novel vaccine candidate from Danish biotech Evaxion, marking a significant expansion of its AI-driven vaccine development efforts. The deal, worth up to $592 million in potential milestone payments, centers on EVX-B3, a preclinical asset designed to address an undisclosed but serious global medical issue.

NoahAI News9/25/2025
Acadia's Prader-Willi Syndrome Drug Fails Phase 3 Trial, Leaving Soleno as Sole Market Player

Acadia's Prader-Willi Syndrome Drug Fails Phase 3 Trial, Leaving Soleno as Sole Market Player

Acadia Pharmaceuticals has announced the discontinuation of its intranasal carbetocin program for the treatment of hyperphagia in patients with Prader-Willi Syndrome (PWS) following disappointing phase 3 trial results. This development leaves Soleno Therapeutics as the only company with an approved treatment for the condition, solidifying its market position.

NoahAI News9/25/2025
Wave of Layoffs Sweeps Across Pharma and Biotech

Wave of Layoffs Sweeps Across Pharma and Biotech

The pharmaceutical and biotech sectors have seen a surge in workforce reductions as companies aim to streamline operations and extend cash runways. Notable recent announcements include:Seres Therapeutics is cutting 25% of its workforce, affecting approximately 26 employees. The move is expected to extend the company's cash runway into the second quarter of 2026 and support the advancement of its lead program, SER-155, for preventing bacterial bloodstream infections in stem cell transplant patients.

NoahAI News9/24/2025
FDA Rejects Scholar Rock's Spinal Muscular Atrophy Drug Due to Manufacturing Site Issues

FDA Rejects Scholar Rock's Spinal Muscular Atrophy Drug Due to Manufacturing Site Issues

In a setback for patients with spinal muscular atrophy (SMA), the U.S. Food and Drug Administration (FDA) has declined to approve Scholar Rock's investigational myostatin blocker apitegromab. The rejection, announced on Tuesday, stems from problems at a third-party manufacturing facility rather than concerns about the drug's efficacy or safety.

NoahAI News9/24/2025
Capital Rx Secures $400M Funding, Rebrands as Judi Health to Expand Beyond PBM Services

Capital Rx Secures $400M Funding, Rebrands as Judi Health to Expand Beyond PBM Services

Pharmacy benefit manager Capital Rx has announced a significant expansion of its business operations, backed by a substantial $400 million funding round. The company, known for its transparent approach to pharmacy benefits management, is rebranding as Judi Health to reflect its growing portfolio of health benefits technology services.

NoahAI News9/24/2025
FDA Takes Bold Steps: Reviving Old Drug for Autism and Issuing Acetaminophen Warning

FDA Takes Bold Steps: Reviving Old Drug for Autism and Issuing Acetaminophen Warning

The U.S. Food and Drug Administration (FDA) has made two significant announcements that could have far-reaching implications for the pharmaceutical industry and public health. The agency is seeking to bring back a decades-old drug as a potential treatment for autism symptoms while also initiating a label update for acetaminophen products due to potential risks during pregnancy.

NoahAI News9/24/2025
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