Axsome Therapeutics

Altimmune Secures $100 Million Credit Facility to Advance Pemvidutide Development for MASH and Alcohol-Related Disorders

9 days ago

• Altimmune has secured a $100 million credit facility from Hercules Capital, with $15 million funded immediately and additional tranches available upon meeting clinical and financial milestones. • The financing will support ongoing development of pemvidutide, a GLP-1/glucagon dual receptor agonist currently in Phase 2b trials for MASH, with top-line data expected in Q2 2025. • Altimmune plans to initiate Phase 2 trials for pemvidutide in Alcohol Use Disorder and Alcohol Liver Disease in the second and third quarters of 2025, expanding the drug's potential therapeutic applications.

Axsome Therapeutics Secures $570 Million Credit Facility from Blackstone to Strengthen CNS Portfolio

10 days ago

• Axsome Therapeutics has entered into a $570 million credit facility with Blackstone, expanding their available credit by over $200 million while significantly reducing capital costs. • The new facility includes a $500 million term loan and $70 million revolving credit facility, with Axsome drawing $120 million initially to retire its previous Hercules Capital loan. • The strategic partnership aims to accelerate Axsome's path to profitability while supporting its mission to develop innovative treatments for CNS disorders that affect over 150 million Americans.

Newron Pharmaceuticals Advances Pivotal Phase III Program for Treatment-Resistant Schizophrenia

2 months ago

• Newron Pharmaceuticals has received regulatory approval for its ENIGMA-TRS Phase III program evaluating Evenamide as an add-on therapy for treatment-resistant schizophrenia, with patient recruitment beginning immediately. • The pivotal program consists of two studies designed to meet requirements for marketing authorization in major markets including the USA and Europe, with results expected by late 2026. • Evenamide, a first-in-class glutamate modulator, has shown promising results in earlier trials with 70% of TRS patients experiencing clinically significant benefits and 25% achieving remission during one-year treatment.

Hypersomnia Pipeline Shows Promise with 10+ Emerging Therapies in Development

2 months ago

• DelveInsight's latest report reveals 8+ companies developing 10+ therapies for hypersomnia, with Avadel's Lumryz, Zevra's KP1077, and Alkermes' ALKS 2680 among the key candidates advancing through clinical trials. • Recent clinical milestones include Axsome's AXS-12 meeting its Phase III primary endpoint with 72-82% reduction in cataplexy attacks, and Takeda's TAK-861 showing promise as the first treatment targeting the underlying pathophysiology of narcolepsy type 1. • The hypersomnia market is driven by increased awareness, unmet medical needs, and advances in neuroscience, though challenges remain including lack of biomarkers, high trial costs, and regulatory hurdles.

Axsome Therapeutics Reports Strong Growth with 88% Revenue Increase in 2024, Advances CNS Pipeline

3 months ago

• Axsome Therapeutics achieved remarkable financial performance in 2024, with total net product revenue reaching $385.7 million, representing an 88% year-over-year growth driven by strong Auvelity and Sunosi sales. • The company secured FDA approval for Symbravo for acute migraine treatment in adults and successfully completed Phase 3 trials for AXS-05 in Alzheimer's disease agitation, with NDA submission planned for late 2025. • Multiple late-stage clinical programs are advancing, including trials for solriamfetol in ADHD and depression, with key data readouts expected in Q1 2025.

FDA Approves Axsome's Symbravo (Meloxicam and Rizatriptan) for Acute Migraine Treatment

4 months ago

• The FDA has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults, offering a novel multi-mechanistic approach. • Clinical trials demonstrated that Symbravo can rapidly eliminate migraine pain and allow patients to return to normal functioning with a single dose. • Studies showed a statistically significant percentage of patients achieved pain freedom and were free from their most bothersome symptom within two hours of dosing versus placebo. • Axsome Therapeutics anticipates Symbravo will be commercially available in the U.S. in approximately four months, providing a new option for migraine sufferers.

FDA Approves Axsome's Auvelity for Major Depressive Disorder Treatment

4 months ago

The FDA has approved Axsome Therapeutics' Auvelity, a novel oral NMDA receptor antagonist, for treating major depressive disorder in adults. This marks the first new mechanism of action for an oral depression treatment in nearly 60 years, offering rapid efficacy starting within a week. Auvelity's approval highlights the ongoing need for faster-acting antidepressants to address the risk of self-harm in severely affected patients.

Corcept Therapeutics Submits New Drug Application for Relacorilant to Treat Cushing's Syndrome

5 months ago

• Corcept Therapeutics has submitted a New Drug Application to the FDA for relacorilant, a selective cortisol modulator designed to treat patients with endogenous hypercortisolism (Cushing's syndrome). • The application is supported by positive results from multiple clinical trials, including the pivotal GRACE trial, Phase 3 GRADIENT study, and long-term extension studies, demonstrating improvements in various symptoms with an acceptable safety profile. • Relacorilant showed no instances of serious adverse events common in current treatments, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation, positioning it as a potential new standard of care.

Axsome's AXS-05 Shows Promise in Alzheimer's Agitation Trials, NDA Submission Planned for 2025

5 months ago

• Axsome Therapeutics' AXS-05 demonstrated a statistically significant delay in agitation relapse in Alzheimer's patients in the ACCORD-2 Phase 3 trial. • The ADVANCE-2 trial did not meet its primary endpoint, but results numerically favored AXS-05, with a good safety profile across trials. • Axsome plans to submit an NDA to the FDA in the second half of 2025, supported by data from four Phase 3 trials. • AXS-05 has Breakthrough Therapy designation, potentially expediting its review for Alzheimer's disease agitation, a condition with limited options.

AXS-12 Demonstrates Long-Term Efficacy and Safety in Narcolepsy Phase 3 Trial

6 months ago

• Axsome Therapeutics' AXS-12 (reboxetine) significantly reduced cataplexy attacks compared to placebo in the Phase 3 ENCORE trial, meeting its primary endpoint. • Long-term treatment with AXS-12 showed sustained improvements in cataplexy, excessive daytime sleepiness, and cognition in patients with narcolepsy. • The ENCORE trial's results support AXS-12 as a potential novel treatment option for narcolepsy, with a favorable long-term safety and tolerability profile. • Axsome Therapeutics plans to submit a New Drug Application (NDA) to the FDA for AXS-12 based on the positive Phase 3 results.

FDA Accepts Satsuma and SNBL's NDA Resubmission for STS101 Migraine Treatment

7 months ago

• The FDA has accepted for review Satsuma Pharmaceuticals and SNBL's resubmitted NDA for STS101, a dihydroergotamine nasal powder, for acute migraine treatment. • The PDUFA date is set for April 30, 2025, offering hope for the nearly 40 million Americans suffering from migraine, especially women in their 20s to 40s. • STS101 is designed for quick self-administration, leveraging a proprietary nasal delivery device for rapid DHE absorption and sustained plasma concentrations. • The resubmission addresses FDA's previous concerns related to formulation, with no additional clinical trials requested, marking a significant step toward potential approval.