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Jazz Pharmaceuticals announced that eight abstracts presenting data from across its sleep portfolio were featured at the 37th annual Psych Congress in Boston October 29 through November 2. The data [...]

Avadel Pharmaceuticals (AVDL) announced that yesterday, the U.S. District Court for the District of Columbia ruled in favor of the Food and Drug Administration, FDA, in a suit brought by [...]

Avadel Pharmaceuticals and nference announced the publication of real-world data that identified the demographic characteristics and the top 20 most prevalent comorbidities of people living with narcolepsy. The paper, titled [...]

H.C. Wainwright analyst Douglas Tsao is becoming increasingly positive on Alkermes' orexin portfolio after the company hosted an analyst meeting to review its orexin strategy following 'very strong' early Phase [...]

Morgan Stanley upgraded Centessa to Overweight from Equal Weight with a price target of $26, up from $11. The firm had been 'cautiously optimistic heading' into the Phase 1 readout [...]

Guggenheim raised the firm's price target on Centessa to $24 from $20 and keeps a Buy rating on the shares. ORX750 'checks off all the boxes' and its healthy volunteer [...]

Mizuho notes that Centessa (CNTA) released data from their Phase 1 Single Ascending Dose, or SAD, trial of ORX750 in acutely sleep-deprived, healthy volunteers for 1 and 2.5 mg and [...]

UBS analyst Ashwani Verma last night initiated coverage of Harmony Biosciences with a Buy rating and $56 price target. The firm says continued growth 'is feasible' for Wakix while Harmony [...]

Alkermes announced initiation of the Vibrance-2 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with narcolepsy type 2. ALKS [...]

'Momentum is building across Centessa's orexin agonist program. During the second quarter, we initiated a Phase 1 clinical study with ORX750, a potential best-in-class OX2R agonist being developed for sleep-wake [...]

Eisai announce that screening for Study E2086-A001-101 to assess the efficacy, safety and tolerability of E2086, a novel selective orexin-2 receptor, is now registered on ClinicalTrials.gov as NCT06462404. Study sites [...]

Rodman & Renshaw initiated coverage of Avadel Pharmaceuticals with a Buy rating and $27 price target. The company last year gained approval for a once-nightly sodium oxybate, Lumryz, for the [...]

Jefferies analyst Akash Tewari believes orexin 2 receptors will shift the narcolepsy treatment paradigm. The updated ALKS 2680 narcolepsy type 1 data presented by Alkermes looks consistent with the last [...]

Takeda will present results from its Phase 2b trial of TAK-861 in narcolepsy type 1 as late-breaking data presentations at SLEEP 2024, the 38th annual meeting of the American Academy [...]

Alkermes announced new data from the full narcolepsy type 1 cohort of a phase 1b, proof-of-concept study evaluating ALKS 2680, the company's novel, investigational, oral orexin 2 receptor agonist in [...]

Cantor Fitzgerald raised the firm's price target on Alkermes to $48 from $43 and keeps an Overweight rating on the shares ahead of the SLEEP 2024 conference in Houston in [...]

Reports Q1 revenue $27.178M, consensus $25.9M. 'We are pleased to report another strong quarter of launch performance from LUMRYZ as we continue to serve the narcolepsy patient community. The continued [...]

Reports Q1 revenue $75M, consensus $73.29M. 'The first quarter was marked by strong financial performance for our on-market products which are delivering important and differentiated treatment options for patients living [...]

Reports Q1 revenue $350.4M, consensus $360.26M. 'The first quarter of 2024 marks our first full quarter as a profitable, pure-play neuroscience company. During the quarter, we continued to advance our [...]

Reports Q1 revenue $154.615M, consensus $154.8M. 'We believe Harmony is well-positioned to become the leading patient-focused CNS biotechnology company delivering innovative treatments to patients living with unmet medical needs. We [...]

Alkermes announced initiation of the Vibrance-1 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in patients with narcolepsy type 1. ALKS [...]

Centessa Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has cleared the Investigational New Drug application, IND, to initiate a Phase 1 first-in-human, clinical trial of ORX750 for [...]

Mizuho analyst Uy Ear says Alkermes' ALKS 2680 'could be best-in-class' following this morning's data release from the Phase 1b trial in the narcolepsy type 2 cohort. The orexin 2 [...]

Stifel says the efficacy of Alkermes' ALKS2680 in narcolepsy type 2 and idiopathic hypersomnia, albeit in a small, single day study, look promising and better than expected, showing a very [...]

H.C. Wainwright raised the firm's price target on Axsome Therapeutics to $190 from $180 and keeps a Buy rating on the shares. The company said its late-stage candidate AXS-12 achieved [...]

Citi analyst David Hoang raised the firm's price target on Axsome Therapeutics to $127 from $125 and keeps a Buy rating on the shares. The company reported positive Phase 3 [...]

NLS Pharmaceutics announced an exclusive worldwide license agreement with Aexon Labs. This license grants NLS the opportunity to acquire global development and commercialization rights to Aexon's Dual Orexin Receptor Agonists [...]

Baird initiated coverage of Alkermes with an Outperform rating and $37 price target. The company's 2024 guidance and its over $800M in cash as of the end of 2023 'provides [...]

A recent study conducted by Takeda Development Center Americas Inc. focused on the epidemiology, patient characteristics, and treatment patterns of individuals with narcolepsy in Sweden. The research found that the prevalence of narcolepsy was lower than previously reported, with a higher proportion of females affected than males. The study also highlighted the common use of stimulants as a treatment for narcolepsy, with many patients switching medications due to lack of efficacy or side effects. This non-interventional study utilized Swedish register data from 2010 to 2020 and included both prevalent and incident narcolepsy patients. [Extracted from the article]

A recent study conducted by Avadel Pharmaceuticals in Chesterfield, Missouri, focused on the impact of extended-release, once-nightly sodium oxybate (ON-SXB) on weight loss in individuals with narcolepsy. The research found that participants who received ON-SXB experienced a decrease in weight and body mass index, with 17.8% of them achieving a weight loss of 5% or more. The study concluded that ON-SXB could be a preferred treatment for overweight or obese individuals with narcolepsy, offering a tailored approach to managing excessive daytime sleepiness and cataplexy. [Extracted from the article]

A recent study conducted by Avadel Pharmaceuticals in Chesterfield, Missouri, focused on the efficacy of once-nightly sodium oxybate (ON-SXB) in improving daytime symptoms in individuals with narcolepsy, with or without concomitant alerting agent use. The study found that regardless of alerting agent use, treatment with ON-SXB resulted in significant improvements in mean sleep latency, Clinical Global Impression-Improvement rating, number of weekly cataplexy episodes, and Epworth Sleepiness Scale score compared to a placebo. The research concluded that ON-SXB effectively improved both daytime and nighttime narcolepsy symptoms. [Extracted from the article]

A study conducted by investigators from Jazz Pharmaceuticals PLC in Palo Alto, California, examined the risk of new-onset hypertension in patients with narcolepsy initiating sodium oxybate. The retrospective cohort study found that patients in the sodium oxybate cohort had a higher risk of new-onset hypertension compared to the control cohort. The research concluded that sodium oxybate use was associated with new-onset hypertension in normotensive patients with narcolepsy. The study was published in Mayo Clinic Proceedings and received financial support from Jazz Pharmaceuticals. [Extracted from the article]

Centessa Pharmaceuticals announced a robust set of new preclinical data from in vivo and in vitro studies of its investigational, novel orexin receptor 2 agonist, ORX750, that support its potential [...]

Mizuho analyst Uy Ear views the selloff yesterday in shares of Alkermes after the company resented first-time narcolepsy type 1 in human for its orexin 2 receptor agonist, ALKS 2680, [...]

Jazz Pharmaceuticals announced new data that examine the comorbid risk of cardiovascular disease in patients with narcolepsy and idiopathic hypersomnia as well as the effect of sodium intake on cardiovascular [...]

Alkermes announced preliminary results, including initial proof-of-concept data, from a phase 1 study evaluating ALKS 2680, the company's novel, investigational orexin 2 receptor agonist in development for the treatment of [...]

Avadel Pharmaceuticals announced new and encore data supporting the clinical profile for LUMRYZ for extended-release oral suspension and patient preference for a once-nightly oxybate in 15 poster presentations and two [...]

Piper Sandler lowered the firm's price target on Harmony Biosciences to $42 from $72 and keeps an Overweight rating on the shares. The firm notes that while it had asserted [...]

Amneal Pharmaceuticals announced the launch of its authorized generic for Xyrem oral solution CIII in the United States. Sodium Oxybate oral solution, 0.5 g/mL is a central nervous system depressant [...]

NLS Pharmaceutics announced that the U.S. Food and Drug Administration has reviewed the full protocol for the NLS-1031 study, part of the Phase 3 program for Mazindol ER, called AMAZE. [...]

Avadel Pharmaceuticals announced that LUMRYZ is now commercially available. LUMRYZ is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or [...]