Loading...
Market
How will Soleno's stock react within a week of FDA's decision on DCCR?
2
Resolution / Starting Odds
Significant Increase (>20%) • 25%
Moderate Increase (10-20%) • 25%
No Significant Change • 25%
Decrease • 25%
Stock market data from reputable financial sources like Bloomberg or Yahoo Finance
Story
Soleno's Prader-Willi Drug Gets FDA Priority Review, No AdCom; Stock Up 12% to 52-Week High
Oct 8, 2024, 06:14 PM
Soleno Therapeutics announced a regulatory update for its DCCR (diazoxide choline) Extended-Release Tablets, aimed at treating Prader-Willi Syndrome. The FDA has decided not to convene an advisory committee (AdCom) for the drug, which is seen as a positive indicator for its potential approval. This decision has led to a significant increase in Soleno's stock price, with shares rising 12% to a new 52-week high, and 7.9% in pre-market trading. The drug has also received Priority Review status from the FDA, further boosting investor confidence. Analysts suggest that the lack of an AdCom reduces potential uncertainties and highlights the FDA's recognition of the unmet medical need for treating Prader-Willi Syndrome. Additionally, Soleno benefits from low cash burn, which could support further stock gains.
View original story
Similar markets
Increase by 5% or more • 25%
Increase by less than 5% • 25%
Decrease • 25%
No significant change • 25%
Stock increases by more than 10% • 25%
Stock increases by 5-10% • 25%
Stock changes by less than 5% • 25%
Stock decreases • 25%
Increase >10% • 25%
Increase <=10% • 25%
Decrease <=10% • 25%
Decrease >10% • 25%
Approval recommended • 25%
Approval not recommended • 25%
No consensus • 25%
Meeting postponed • 25%
Approved • 25%
Approved with conditions • 25%
Rejected • 25%
Review extended • 25%
Below $10 • 25%
$10 - $15 • 25%
$15 - $20 • 25%
Above $20 • 25%
Approval • 25%
Conditional Approval • 25%
Rejection • 25%
Request for More Data • 25%
Launches new product • 25%
Announces partnership • 25%
Pursues merger/acquisition • 25%
No major move • 25%
Top-selling PWS treatment • 25%
Moderate market success • 25%
Limited market impact • 25%
Withdrawn from market • 25%
Stock price increases by over 20% • 25%
Stock price increases by 10-20% • 25%
Stock price changes by less than 10% • 25%
Stock price decreases • 25%