Axsome Therapeutics: Sunosi met the primary endpoint in the SHARP study » 06:3510/0310/03/22
Axsome Therapeutics announced that Sunosi met the primary endpoint in the SHARP study and significantly improved cognitive function, measured using the Digit Symbol Substitution Test subtest of the Repeatable Battery for the Assessment of Neuropsychological Status, as compared to placebo in cognitively impaired patients with excessive daytime sleepiness associated with obstructive sleep apnea. Superiority of Sunosi as compared to placebo was further demonstrated using patient-reported measures of cognitive function. In the study, Sunosi replicated previous findings by significantly reducing EDS symptoms as compared to placebo. On the study's primary endpoint, Sunosi demonstrated statistically significant improvement in cognitive function compared to placebo as assessed by the change from baseline on the DSST RBANS, with an effect size of 0.36. The DSST RBANS is an objective neuropsychological test that assesses executive function, processing speed and attention. Statistically significant improvement in cognitive function with Sunosi treatment was also demonstrated using the British Columbia Cognitive Complaints Inventory overall score compared to placebo, with an effect size of 0.43. The BC-CCI is a patient-reported test that assesses domains of memory, concentration, trouble expressing thoughts, word finding, and problem solving. Sunosi significantly improved EDS symptoms compared to placebo, as measured by the Epworth Sleepiness Scale. The improvement on the ESS with Sunosi treatment was approximately twice that observed with placebo, with an effect size of 0.50. The most commonly reported adverse events with Sunosi treatment (incidence greater than or equal to3%) were nausea (6.9%) and anxiety (3.4%). The study completion rate was 96.7% for patients randomized to each treatment sequence.
Axsome Therapeutics price target lowered to $90 from $92 at Jefferies » 09:1809/3009/30/22
Jefferies analyst Chris…
Jefferies analyst Chris Howerton lowered the firm's price target on Axsome Therapeutics to $90 from $92 and keeps a Buy rating on the shares after the company said following a Type A Meeting with the FDA that it will now resubmit its NDA for AXS-07 for the acute treatment of migraine in Q3 of 2023. The six month review from guidance leads him to push back a migraine launch to the second half of 2024 from the second half of 2023 previously and this delay reduces his target , but Howerton contends that this opportunity for '07 is "dwarfed by the ongoing MDD launch."
Axsome to resubmit AXS-07 NDA based on FDA Type A meeting » 07:2909/2909/29/22
Axsome Therapeutics, announced that, following a Type A meeting with the U.S. Food and Drug Administration, it intends to resubmit its New Drug Application for AXS-07 for the acute treatment of migraine in the third quarter of 2023. The purpose of the Type A meeting was to obtain the FDA's feedback and agreement on the Company's plan to address the issues raised in the previously received Complete Response Letter to support a resubmission of the AXS-07 NDA. The issues principally related to chemistry, manufacturing, and controls considerations. Based on the FDA feedback, the Company will include new CMC information, including stability data on newly manufactured commercial scale batches of AXS-07, in its resubmission package. The resubmission package may also include additional clinical pharmacology information. The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review. No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA.
Which Alzheimer's stock may be next to jump after Biogen's 'clean’ win? » 10:5609/2809/28/22
CERE, BTAI, AXSM, ATHA, ALEC, A, ABOS, MOR, LLY, PRTA, ESALY, BIIB
Eisai (ESALY) and Biogen…
Mizuho says Biogen data will serve as catalyst for these stocks » 07:1209/2809/28/22
ALEC, BIIB, ATHA, AXSM, BTAI, CERE
Mizuho analyst Graig…
Mizuho analyst Graig Suvannavejh believes Biogen's (BIIB) positive Phase 3 data for lecanemab will serve as an overall catalyst for companies working in the Alzheimer's space. The Phase 3 data for lecanemab "appear to be quite robust" and are likely to support an FDA approval, Suvannavejh tells investors in a research note. That said, given the effect size of 0.45, clinical meaningfulness "could be called into question," says the analyst. He views the Phase 3 data as a "significant positive" for companies not only working on Alzheimer's, but also the neurodegenerative disease space, "where there remains a very high unmet medical need." The companies that could stand to most directly benefit from a stock perspective include Alector (ALEC), Athira Pharma (ATHA), Axsome Therapeutics (AXSM), BioXcel Therapeutics (BTAI) and Cerevel Therapeutics (CERE).
|Over a week ago|
Axsome Therapeutics call volume above normal and directionally bullish » 11:4509/0909/09/22
Bullish option flow…
Bullish option flow detected in Axsome Therapeutics with 3,686 calls trading, 1.3x expected, and implied vol increasing almost 5 points to 78.21%. Oct-22 80 calls and Sep-22 62.5 calls are the most active options, with total volume in those strikes near 2,800 contracts. The Put/Call Ratio is 0.07. Earnings are expected on November 7th.
Axsome Therapeutics begins Phase 3 trial of AXS-05 in Alzheimer's Agitation » 07:0409/0809/08/22
Axsome Therapeutics has…
Axsome Therapeutics has enrolled the first patient in the ADVANCE-2 trial of AXS-05, an investigational treatment for Alzheimer's disease - AD - agitation. ADVANCE-2 - Addressing Dementia via Agitation-Centered Evaluation-2 - is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, trial to assess the efficacy and safety of AXS-05 for the treatment of agitation associated with AD. The primary efficacy measure is the Cohen-Mansfield Agitation Inventory. AXS-05 has been granted FDA Breakthrough Therapy designation for the treatment of Alzheimer's disease agitation.
Axsome Therapeutics announces publication of post-hoc analysis of Sunosi » 07:1809/0709/07/22
Axsome Therapeutics announced the publication of a post-hoc analysis comparing the effects of Sunosion excessive daytime sleepiness in patients with and without a history of depression. Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adult patients with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea. This secondary analysis included data from two 12-week, randomized, double-blind, placebo-controlled trials in adult patients with EDS associated with narcolepsy or OSA. The analysis showed that treatment with Sunosi improved EDS symptoms both in patients with and without a clinical history of depression, compared to placebo. The results also confirmed earlier findings of a high prevalence of a history of depression in participants with narcolepsy or OSA, and suggest that increased awareness of this association may have clinical significance. Common treatment-emergent adverse events were also similar in those with and without a history of depression.
Axsome Therapeutics assumed with a Buy at Mizuho » 06:4109/0709/07/22
Mizuho analyst Graig…
Mizuho analyst Graig Suvannavejh assumed coverage of Axsome Therapeutics with a Buy rating and price target of $76, up from $49. The company is developing a portfolio of assets targeting disorders of the central nervous system, addressing large markets with unmet medical need, Suvannavejh tells investors in a research note. He sees "modest novelty" in Axsome's candidates, while noting the markets they address feature meaningful branded and generic competition.
|Over a month ago|
Axsome enrolls 1st patient in EMERGE trial of AXS-07 for migraine treatment » 07:0609/0109/01/22
Axsome Therapeutics, announced that it has enrolled the first patient in the EMERGE trial of AXS-07 for the acute treatment of migraine. EMERGE is a Phase 3, open-label, multicenter trial to assess the efficacy and safety of AXS-07 in the acute treatment of migraine in patients with a prior inadequate response to an oral Calcitonin Gene-Related Peptide, CGRP, inhibitor. Approximately 100 patients experiencing migraine attacks will be treated with AXS-07 for up to eight weeks, following an inadequate response to prior treatment with an oral CGRP inhibitor. The two co-primary endpoints will be pain relief and absence of the most bothersome symptom two hours after dosing. The study is being conducted to further elucidate the clinical profile of AXS-07 and is not a regulatory requirement.