隶属于 vivo capital llc
相关临床试验
7
3 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1999
进行中（未招募）
1
14.3%
已完成
3
42.9%
Enrolling By Invitation
1
14.3%
尚未招募
1
14.3%
撤回
1
14.3%
暂无批准数据
- Novartis's pelacarsen and Novo Nordisk's ziltivekimab both failed to separate from placebo in late-stage cardiovascular outcome trials despite strong genetic support for their targets. - Cardiologist Ethan Weiss said the field can no longer claim that genetics is undefeated in predicting which drugs will work in outcome studies. - Novartis shares fell 14% in a single session and Amgen dropped 9.8% as investors repriced roughly 35,000 patients still enrolled in Lp(a) outcome trials. - Weiss attributed the Lp(a) failure largely to background therapy, arguing the risk signal diminishes in patients already on statins and other powerful medicines.
- Neurocrine Biosciences announced a $2.9 billion acquisition of Soleno Therapeutics for $53.00 per share, representing a 34% premium to Soleno's closing price. - The deal adds VYKAT XR (diazoxide choline), the first and only FDA-approved treatment for hyperphagia in Prader-Willi syndrome, to Neurocrine's portfolio. - VYKAT XR generated $190 million in 2025 revenue following its successful launch and is supported by intellectual property extending into the mid-2040s. - The acquisition expands Neurocrine's rare disease portfolio to three first-in-class medicines, including INGREZZA and CRENESSITY, positioning the company for sustained growth.
- Neurocrine Biosciences has agreed to acquire Soleno Therapeutics, a biopharmaceutical company developing novel therapeutics for rare diseases, in a $2.9 billion transaction. - The acquisition represents Neurocrine's strategic expansion into the rare disease therapeutic space, building on its existing portfolio of specialized treatments. - Soleno focuses on developing and commercializing innovative therapies specifically targeting rare disease populations with significant unmet medical needs. - This marks another major acquisition for Neurocrine following its 2023 purchase of Diurnal, demonstrating continued consolidation in the rare disease sector.
- Soleno Therapeutics faces a securities class action lawsuit alleging systematic problems in Phase 3 clinical trials for DCCR (VYKAT XR), their FDA-approved treatment for hyperphagia in Prader-Willi syndrome patients. - The lawsuit claims the pivotal randomized withdrawal study enrolled only 77 participants with enrollment skewed toward a single site, while the original 13-week Phase 3 trial failed to meet its primary endpoint. - Investigators allegedly identified placebo bias from unblinding caused by visible side effects and expressed sharp criticism of trial conduct, with many indicating no plans to prescribe the drug. - The complaint alleges defendants concealed safety concerns including fluid retention, potential pulmonary edema cases, and linear increases in prediabetes and diabetes markers over three years of treatment.
- Soleno Therapeutics is targeting approximately 10% of the total addressable market, equating to about 1,000 start forms over 9-12 months for its PWS treatment VYKAT XR. - The company has achieved better-than-expected reimbursement coverage through almost 48 Medicaid programs and Medicare, with over 600 prescribers now using the therapy. - Start forms typically convert to active patients within 30-45 days with single-digit cancellation rates, while overall discontinuation remains around 15-20%. - European regulatory review continues with Day 180 questions expected by end of February for a potential patient population of approximately 9,500 in EU4 plus UK markets.
- Soleno Therapeutics announced publication of pivotal randomized withdrawal study results for VYKAT XR in the Journal of Clinical Endocrinology and Metabolism, demonstrating significant worsening of hyperphagia when treatment was withdrawn compared to continued administration. - The 16-week study involving 77 participants showed statistically significant increases in hyperphagia scores with placebo versus VYKAT XR (P=0.0022), along with greater weight gain in the placebo cohort. - VYKAT XR represents the first and only FDA-approved treatment for hyperphagia in Prader-Willi syndrome, addressing a critical unmet medical need for this rare genetic disorder affecting one in 15,000 live births. - The comprehensive Phase 3 clinical program included 127 participants with over 400 patient years of drug exposure, supporting the drug's March 2025 FDA approval for adults and children 4 years and older.
- Rhythm Pharmaceuticals experienced a late-2025 stock decline after the FDA extended its review of setmelanotide for acquired hypothalamic obesity by three months to March 20, 2026. - The company's Phase 3 TRANSCEND trial demonstrated impressive results with setmelanotide achieving a -19.8% placebo-adjusted BMI reduction, and combination therapy with GLP-1 drugs showed BMI reductions up to -27.1%. - Despite regulatory delays, Rhythm maintains leadership in rare genetic obesity with 54% revenue growth and strong analyst support, while advancing oral candidate Bivamelagon through Phase 2 trials. - The FDA delay has intensified short interest to 30% of float and created opportunities for competitors like Soleno Therapeutics, which received approval for Vykat XR in Prader-Willi Syndrome.
- Soleno Therapeutics completed a $200 million public offering at $85 per share to fund commercialization of VYKAT XR, the first FDA-approved therapy for hyperphagia in Prader-Willi syndrome patients. - The company received FDA approval for VYKAT XR on March 26, 2025, marking a significant milestone for treating this rare genetic disorder. - Proceeds will also support regulatory and market development activities in the European Union and further research and development efforts. - The offering included 2,352,941 shares with underwriters holding a 30-day option to purchase an additional 352,941 shares at the same price.
• Vivo Capital has closed the third cycle of its Opportunity Fund with over $740 million in commitments, focusing on preclinical and clinical-stage life sciences companies developing novel therapies. • The fund has previously backed companies that achieved significant milestones, including FDA approvals for treatments targeting COPD, myelodysplastic syndrome, narcolepsy, and Prader-Willi Syndrome. • Several Vivo-backed companies have been acquired by pharmaceutical giants in billion-dollar deals, including RayzeBio (Bristol-Myers Squibb, $4.1B), Chinook Therapeutics (Novartis, $3.2B), and Sierra Oncology (GSK, $1.9B).
- The FDA has approved Soleno Therapeutics' Vykat XR (diazoxide) as the first treatment specifically targeting hyperphagia in Prader-Willi syndrome, a rare genetic disorder affecting 10,000-20,000 Americans. - The approval follows an unconventional regulatory pathway after the drug initially failed its primary endpoint in Phase 3 trials, with Soleno successfully arguing that COVID-19 disruptions skewed results while demonstrating efficacy in secondary measures. - Vykat XR is approved for patients aged four and older, addressing the most debilitating symptom of Prader-Willi syndrome that can lead to extreme obesity, poor metabolic health, and potentially life-threatening complications.
