These new ways to treat mental illness should be celebrated. Making the most of them, however, will involve dispelling the poor reputation that hormones have gained over the years https://t.co/WJdMeU0LkJ ...

"These new ways to treat mental illness should be celebrated. Making the most of them, however, will involve dispelling the poor reputation that hormones have gained over the years https://t.co/7CRDOu76R1 Illustration: Nathalie Lees https://t.co/1yBwRG0OyS ...

Mental Health & Hormones - The exact number of treatment-resistant mental health conditions caused by hormonal factors is difficult to determine [1] - The evidence suggests that hormones should be taken more seriously in both sexes regarding mental health [1]

Key Takeaways RARE and MREO fell after delaying new data from the phase III UX143 Orbit study to year-end. The Orbit study continues as planned, with final data expected by the end of 2025. Interim safety review found UX143 acceptable, allowing studies to proceed without changes.Ultragenyx Pharmaceutical (RARE) and partner, Mereo BioPharma (MREO) , have reported an update on the progress of the mid-to-late-stage Orbit study, which is evaluating UX143 (setrusumab) for the treatment of osteogenesis imperfec ...

NEW YORK, July 10, 2025 (GLOBE NEWSWIRE) -- via InvestorWire — Calidi Biotherapeutics Inc. (NYSE American: CLDI) today announces its placement in an editorial published by NetworkNewsWire ("NNW"), one of 70+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. To view the full publication, “Breaking Through: Systemic Genetic Medicines f ...

PURCHASE, N.Y., July 10, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. The objective of this meeting was to review results from the Phase 2 study of zervimesine (CT1812) and to discuss plans for a Phase 3 program that would support a new drug application (NDA) for zervimesine ...

– Data from an analysis designed to evaluate the potential effects of the Phase 3 zorevunersen dosing regimen showed improvements in cognition and behavior at Week 68 – – These findings support the inclusion of key secondary endpoints assessing cognition and behavior in the Phase 3 EMPEROR study and contrast with outcomes observed in natural history data – CAMBRIDGE, Mass. and BEDFORD, Mass., July 10, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechn ...

Core Viewpoint - Pharvaris is advancing its late-stage development of deucrictibant, an oral bradykinin B2 receptor antagonist, targeting unmet needs in bradykinin-mediated diseases, with topline data from the RAPIDe-3 Phase 3 study expected in Q4 2025 and a potential NDA submission in H1 2026 [1][2][4] Group 1: Study and Data - The RAPIDe-3 study has achieved target enrollment, and the topline data announcement is now anticipated in the fourth quarter of 2025 [2] - The study evaluates deucrictibant immediate-release capsules (20 mg) for on-demand treatment of angioedema attacks in approximately 120 participants aged 12 and older, including those with C1 inhibitor deficiency [2][3] - Primary endpoints include time to onset of symptom relief and other measures of symptom resolution and safety [2][3] Group 2: Drug Development - Deucrictibant is being developed in two formulations: an extended-release tablet for prophylactic treatment and an immediate-release capsule for rapid treatment [3][4] - The drug has received orphan drug designation from the FDA and the European Commission for treating bradykinin-mediated angioedema [3] Group 3: Company Overview - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability through oral therapies for bradykinin-mediated angioedema [4] - The company is conducting multiple pivotal Phase 3 studies, including CHAPTER-3 for prevention and RAPIDe-3 for on-demand treatment of HAE attacks [4]

Our ancestors first grew scalp hair to cool our growing brains. Now, researchers discuss how it happened, with implications for hair-loss treatments. https://t.co/QaWDX5P7G5 ...

Core Insights - The RESILIENT trial data demonstrates that TNX-102 SL significantly reduces fibromyalgia pain compared to placebo, confirming previous findings from the RELIEF trial [1][2] - If approved, TNX-102 SL will be the first new drug for fibromyalgia in over 15 years, with a PDUFA target date set for August 15, 2025 [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company focused on developing therapies for pain management and central nervous system disorders [8] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on two statistically significant Phase 3 studies [2][8] Study Details - The RESILIENT study was a randomized, double-blind, placebo-controlled trial involving 457 adults with fibromyalgia across 33 sites in the U.S. [2][7] - Participants received TNX-102 SL in two dosage phases: 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, with a primary endpoint of pain reduction assessed over fourteen weeks [2][7] Efficacy Results - TNX-102 SL achieved a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale, compared to a 1.2-point reduction for placebo, indicating high statistical significance [2][7] - Statistically significant improvements were also noted across all six prespecified key secondary endpoints, including various patient-reported outcomes [2][3] Safety Profile - TNX-102 SL was generally well tolerated, with the most common adverse events being mild and transient, such as oral tingling/numbness and a bitter aftertaste [3] - No serious drug-related adverse events or deaths were reported, highlighting a favorable risk-benefit profile [3] Fibromyalgia Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., predominantly women, and is characterized by chronic pain, fatigue, and sleep disturbances [4] - Current treatment options are often met with dissatisfaction from both physicians and patients, indicating a significant unmet need in the market [4] Product Information - TNX-102 SL is a patented sublingual formulation of cyclobenzaprine hydrochloride designed for rapid absorption and reduced side effects [5][6] - The drug is also being explored for other indications, including acute stress reaction, Long COVID, and alcohol use disorder [5][8]