Bionomics (BNOX) Up on Positive Updates on PTSD & SAD Candidate
Bionomics Limited BNOX surged more than 15% on Aug 23, as it announced last patient visit in the mid-stage study of BNC210 for post-traumatic stress disorder (PTSD) and its plans for the end of phase II meeting with the FDA for BNC210 for social anxiety disorder (SAD).
The phase IIb ATTUNE study is evaluating its lead candidate, BNC210 as a monotherapy PTSD. Data from the study is expected by September 2023. The primary endpoint of the study is to evaluate change in symptom severity score measured by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) compared to placebo.
In addition to the development of PTSD treatment, Bionomics is also developing BNC210 for treating SAD.
The company completed evaluating BNC210 in a phase II PREVAIL study for SAD. The data from the study showed that both 225-mg and 675-mg doses of BNC210resulted in a decline in anxiety across multiple phases of the public speaking challenge. Patients who received BNC210 experienced significantly less anxiety during the public speaking task (combined resting, anticipation and performance phases) compared to placebo.
BNOX plans to meet the FDA in mid-September to discuss the clinical requirements for advancing BNC210 into phase III development, based on data of PREVAIL study. The company is confident that the results from the phaseIIPREVAIL study will support this progression.
The development of phase III study and its data will potentially support the submission of a new drug application for BNC210 for the treatment of SAD.
Bionomics’ shares have lost 70.1% year to date compared with the industry's 13.0% decline.
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We note that the FDA granted a Fast Track designation to BNC210 for treatment of patients with PTSD and SAD. The designation provides the company with additional market exclusivity and expedited regulatory paths.
SAD is one of the most common mental disorders in the United States that represents with significant and persistent fear of social and performance-related situations. An estimated 31 million Americans suffer from SAD at some point in their lives. PTSD is a psychological condition that can manifest in individuals who have encountered or observed a traumatic incident, a sequence of events, or a particular set of circumstances.
The successful development and commercialization of the candidate will boost Bionomics’ prospects.
Bionomics Limited Unsponsored ADR Price and Consensus
Bionomics Limited Unsponsored ADR price-consensus-chart | Bionomics Limited Unsponsored ADR Quote
Zacks Rank & Stocks to Consider
Bionomics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are ANI Pharmaceuticals ANIP, Annovis Bio ANVS and Corcept Therapeutics CORT, 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 forANI Pharmaceuticals has gone up from $3.31 per share to $3.73 for 2023. The bottom-line estimate has gone up from $4.32 to $4.35 for 2024 during the same time frame. Shares of the company have rallied 58.6% year to date.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise 91.56%.
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 3.2% 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 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 56.6% 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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