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Anebulo (ANEB) Gains on Positive FDA Response for ANEB-001
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Anebulo Pharmaceuticals (ANEB - Free Report) was up almost 10.4% on Monday, after receiving a positive FDA response following a Type B meeting held in July related to its lead candidate ANEB-001. The FDA’s positive feedback marks a step forward for Anebulo that will enable it to move forward with the design and execution of phase III study for ANEB-001.
ANEB-001 is currently being evaluated in a phase II proof-of-concept for treating patients suffering from acute cannabinoid intoxication (ACI). This candidate is a small molecule cannabinoid receptor antagonist that has the potential to alleviate symptoms of ACI.
During the meeting, the FDA suggested that the single well-controlled study of ANEB-001 in ACI patients who arrive at the emergency room, along with a larger study involving THC challenges in enrolled patients, could potentially support the new drug application for ANEB-001.
This promising feedback from the FDA marks a crucial step forward for Anebulo, enabling it to move forward with the design and execution of phase III study for ANEB-001.
ACI episodes are a growing concern in the United States, especially in states where cannabis have been legalized for medical and recreational use. These episodes often result from consuming large amounts of THC, the primary psychoactive component in cannabis. If ANEB-001 is approved, it could be the first FDA-approved treatment to reverse the effects of THC.
Anebulo's shares have rallied 27.5% year to date against the industry's 13.1% decline.
Image Source: Zacks Investment Research
The company also completed dosing patients in an open-label part C portion of the phase II study, which is evaluating the safety and efficiency of ANEB-001at higher challenge doses of THC. The part A and part B of the study were completed earlier in March.
Data from part A of the study showed positive protective effects of a single oral dose of 50 or 100 mg ANEB-001 when co-administered with an oral challenge dose of 10.5 mg THC.
Part B of the study showed that a single low oral dose of ANEB-001 (10 mg), when administered an hour after a THC challenge, effectively and significantly reversed key psychotropic effects induced by THC doses as high as 30 mg.
Furthermore, Anebulo is conducting an observational pharmacokinetic (PK) study in patients reporting to the emergency department with ACI. Data from both the part C extension and the observational PK study will help the company better understand THC exposures related to ACI.
In the past 90 days, the Zacks Consensus Estimate for Emergent Biosolutions has widened from a loss of $1.32 per share to a loss of $1.35 for 2023. The bottom-line estimate has gone down from $2.06 to $1.06 for 2024 during the same time frame. Shares of the company have lost 59.7% year to date.
EBS’ earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 577.88%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 4.3% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 66 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 64 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 54.7% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Anebulo (ANEB) Gains on Positive FDA Response for ANEB-001
Anebulo Pharmaceuticals (ANEB - Free Report) was up almost 10.4% on Monday, after receiving a positive FDA response following a Type B meeting held in July related to its lead candidate ANEB-001. The FDA’s positive feedback marks a step forward for Anebulo that will enable it to move forward with the design and execution of phase III study for ANEB-001.
ANEB-001 is currently being evaluated in a phase II proof-of-concept for treating patients suffering from acute cannabinoid intoxication (ACI). This candidate is a small molecule cannabinoid receptor antagonist that has the potential to alleviate symptoms of ACI.
During the meeting, the FDA suggested that the single well-controlled study of ANEB-001 in ACI patients who arrive at the emergency room, along with a larger study involving THC challenges in enrolled patients, could potentially support the new drug application for ANEB-001.
This promising feedback from the FDA marks a crucial step forward for Anebulo, enabling it to move forward with the design and execution of phase III study for ANEB-001.
ACI episodes are a growing concern in the United States, especially in states where cannabis have been legalized for medical and recreational use. These episodes often result from consuming large amounts of THC, the primary psychoactive component in cannabis. If ANEB-001 is approved, it could be the first FDA-approved treatment to reverse the effects of THC.
Anebulo's shares have rallied 27.5% year to date against the industry's 13.1% decline.
Image Source: Zacks Investment Research
The company also completed dosing patients in an open-label part C portion of the phase II study, which is evaluating the safety and efficiency of ANEB-001at higher challenge doses of THC. The part A and part B of the study were completed earlier in March.
Data from part A of the study showed positive protective effects of a single oral dose of 50 or 100 mg ANEB-001 when co-administered with an oral challenge dose of 10.5 mg THC.
Part B of the study showed that a single low oral dose of ANEB-001 (10 mg), when administered an hour after a THC challenge, effectively and significantly reversed key psychotropic effects induced by THC doses as high as 30 mg.
Furthermore, Anebulo is conducting an observational pharmacokinetic (PK) study in patients reporting to the emergency department with ACI. Data from both the part C extension and the observational PK study will help the company better understand THC exposures related to ACI.
Anebulo Pharmaceuticals, Inc. Price and Consensus
Anebulo Pharmaceuticals, Inc. price-consensus-chart | Anebulo Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Anebulo currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are Emergent Biosolutions (EBS - Free Report) , Annovis Bio (ANVS - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Emergent Biosolutions has widened from a loss of $1.32 per share to a loss of $1.35 for 2023. The bottom-line estimate has gone down from $2.06 to $1.06 for 2024 during the same time frame. Shares of the company have lost 59.7% year to date.
EBS’ earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 577.88%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 4.3% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 66 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 64 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 54.7% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.