Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
$SLNO NEWS$ VIDEO )))
Yup..so predictable!
Went to $18 then dropped to $10 then exploded to $20. This is by far the best casino ever!
20.80= $$$$$$$$$ WOAAAAAAAAAH
17.90 WHAT I BOUGHT @ $13 THINKING THAT WAS CRAZY HIGH
VERY, THIS STUFF IS CONTROLLED BY ARTIFICIAL INTELLIGENCE ALGORITHMS (AIA)
Thanks just when I took my daughter for our morning walk before school (BUT SHES WORTH IT)
https://ih.advfn.com/stock-market/NASDAQ/soleno-therapeutics-SLNO/stock-news/92125525/form-8-k-current-report
On September 26, 2023, Soleno Therapeutics, Inc. (the “Company”) issued a press release (the “Press Release”) announcing the top-line results of the Randomized Withdrawal Study of the Company’s once-daily DCCR (Diazoxide Choline) Extended Release tablets for the treatment of Prader-Willi Syndrome (PWS). A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference
Soleno Therapeutics Announces Positive Statistically Significant Top-line Results from Randomized Withdrawal Period of Study C602 of DCCR for Prader-Willi Syndrome
Study Met Primary Endpoint; Highly Statistically Significant Difference in Change from Baseline in HQ-CT Total Score for DCCR Compared to Placebo (p=0.0022)
Soleno Intends to Submit a New Drug Application for DCCR in PWS Mid-Year 2024
Company to Host Conference Call and Webcast Today at 9:00 AM ET
REDWOOD CITY, Calif., Sept. 26, 2023 (GLOBE NEWSWIRE) -- September 26, 2023 – Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced positive top-line results from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS).
“We are delighted with the highly statistically significant results from the randomized withdrawal phase of Study C602,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno. “These results will support our planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) mid-year of next year. We would like to thank the patients, families, investigators, study site personnel and the advocacy community involved in this study, as well as the entire Soleno team for their support of the DCCR development program. We remain committed to the goal of delivering DCCR, if approved, as an effective and safe therapy to individuals with PWS as expeditiously as possible.”
The FDA previously acknowledged that data from this study have the potential to support an NDA submission for DCCR, which has Orphan Drug designation for the treatment of PWS in the U.S. and E.U. and Fast Track designation from the FDA.
C602 Randomized Withdrawal Period Design:
The multi-center, randomized, double-blind, placebo-controlled randomized withdrawal period enrolled 77 patients previously enrolled in Study C602 who had been on open-label treatment with DCCR for between two and four years. Participants were randomized 1:1 to receive either DCCR (n=38) or placebo (n=39) for a period of four months. The primary endpoint was the change from baseline in hyperphagia-related behaviors as assessed by the hyperphagia questionnaire for clinical trials (HQ-CT), a caregiver-completed nine item validated questionnaire for assessing hyperphagia in PWS. Secondary endpoints included investigator assessments of participants’ overall severity of illness and change in condition, as measured by Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) ratings, respectively.
Key Top-line Results:
Hyperphagia-related behaviors markedly worsened in the placebo group compared to DCCR, represented by a highly statistically significant, clinically meaningful difference in mean change from baseline in the HQ-CT total score of 5.0 at week 16 (p=0.0022).
Secondary endpoints of CGI-S and CGI-I both showed strong trends towards worsening in the placebo group compared to DCCR over the course of the randomized withdrawal period (p=0.08 and 0.09), respectively.
DCCR continued to be generally well-tolerated in the randomized withdrawal period with no new or unexpected safety signals, including no serious adverse events or discontinuations due to adverse events occurring in any participants in the DCCR group.
Soleno entered into a Securities Purchase Agreement with Nantahala Capital Management, LLC, Abingworth LLP and Vivo Capital, LLC in December 2022, which may result in gross proceeds to Soleno of up to $60 million (the Securities Purchase Agreement). To date, pursuant to the Securities Purchase Agreement, Soleno has received $10 million in exchange for Tranche A and Tranche B warrants to purchase common stock. Under the terms of the Securities Purchase Agreement, the investors are required to exercise Tranche A warrants to purchase 8,598,870 shares of common stock at $1.75 for a total of approximately $15 million within 30 days of the announcement of positive top-line data from the randomized withdrawal period of Study C602.
Conference Call and Webcast Details
Soleno will host a conference call and webcast to discuss these results today, September 26, 2023 at 9:00 AM ET. Details can be found below:
Title: Randomized Withdrawal Period of Study C602 Top-line Results
Date: Tuesday, September 26, 2023
Time: 9:00 AM ET
Conference Call Details: Toll-free: 1-877-423-9813
International: 1-201-689-8573
Conference ID: 13741535
Call me™ Feature (avoid waiting for operator): Click Here
Webcast: Webcast Link – Click here
A replay of the call will be available following the call on the Investors section of the Soleno website.
About PWS
The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger, food pre-occupation, extreme drive to food seek and consume food that severely diminish the quality of life for patients with PWS and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant morbidities (e.g., obesity, diabetes, cardiovascular disease) and mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior). In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia and 92.9% rated body composition as either the most important or a very important symptom to be relieved by a new medicine. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder.
About DCCR (Diazoxide Choline) Extended-Release Tablets
DCCR is a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and adults, but has not been approved for use in PWS. Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide, diazoxide choline and DCCR in patients with PWS. The DCCR development program is supported by data from five completed Phase 1 clinical studies in healthy volunteers and three completed Phase 2 clinical studies, one of which was in patients with PWS. In the PWS Phase 3 clinical development program, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and E.U., and Fast Track Designation in the U.S.
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of PWS, recently completed its Phase 3 development program to support a planned NDA submission. For more information, please visit www.soleno.life.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the potential receipt of gross proceeds from the warrant financing under the Securities Purchase Agreement, management’s assessment of the top-line data results from the randomized withdrawal period, and the timing and pathway of the regulatory process and clinical development path for seeking approval of DCCR for the treatment of PWS. In some cases, you c
RMB. P3 results any day now ...certainly by the Sept 30th
One prediction on outcome ...$10 if positive trial , 10c on failure !!!!
Oppy out with a price target of $8-$14
Kiwi
Vivo now reported owning 51% of Co
Perceptive Advisors owns 25% of Co
Trial fully enrolled May 3 ...to run 16 weeks ...so late August into Sept for Top line data
Kiwi
Perceptive Advisors Llc ownership in US8342033094 / SOLENO THERAPEUTICS INC
2023-05-18 - Perceptive Advisors Llc has filed an SC 13D form with the Securities and Exchange Commission (SEC) disclosing ownership of 1,864,455 shares of SOLENO THERAPEUTICS INC (US:US8342033094). This represents 22.8 percent ownership of the company.
------------------------------
Kiwi
RMB They almost have this fully enrolled ( UK was slow in approving the trial ). Once fully enrolled they get a $10m cash infusion .
Trial ( once fully enrolled ) only lasts 4 mths .
High risk but potentially high reward. ......an opinion , NOT a recommendation :--)
Kiwi
SLNO....................https://stockcharts.com/h-sc/ui?s=SLNO&p=W&b=5&g=0&id=p86431144783
RMB. I'll let U know ( actually price action will show it ) ...when they have this final trial fully enrolled
https://investors.soleno.life/news-releases/news-release-details/soleno-therapeutics-announces-initiation-randomized-withdrawal
So they have to persuade 80 patients currently in their long term study to drop out and enroll in this trial .
This may be hard to do.... as those in this ongoing long term study are probably staying on the drug as they have seen benefits ( note photos in Co presentations ) .
So at some pt they may have to say they are discontinuing providing the drug to all ...until the trial is fully enrolled.
Other notes
29% of Aussies are obese vs 36% in the US
6% of Aussies have diabetes vs 11% in the US
Am moving back into SWAV as demand for their product is still strong. China will open up once this Covid wave pass's there ( They have an approved Chinese partner ) and valuation is now a lot better.
ETNB currently one of my largest biotechs ..data in Q1
Good luck
Kiwi
Thanks for your DD.
Thx for the analysis RMB
My quick take
Their pivotal trial failed to meet its primary endpoint because the most recent data shows DCCR tablets are most effective in those with severe hyperphagia ( insatiable hunger ) ...so if U enroll to many with low to moderate hyperphagia it would obviously be harder to get the stat sig results U need .
Think of the R-IT trial being run with mostly primary prevention instead of the 70% secondary prevention patients actually used.
So this final short trial ...80 patients over 4 mths I'm sure they will try and recruit the most severe patients ....and may only get approval for this subset
The patent issue. Diazoxide is an oral suspension that apparently tasted horrible . DCCR are extended release tablets and apparently far more effective. In the Prader Willi population those with severe hyperphagia are often institutionalized ( group homes ) ....and care givers will want the best drug available to help control the often aggressive behaviors associated with this condition. Also the drug they can get these ( mostly kids / teenagers ) to take daily for at least a yr .
So Amarins Vascepa brand vs generic is not the best comparison .
Agree its very speculative ...but the FDA is under pressure from PW families to approve something for this condition ( currently theres no FDA approved drugs for PW ) ...and the severe hyperphagia indication with DCCR looks to be the best near term hope .
Short trial ...80 patients for 4 mths once fully enrolled.
Once fully enrolled the Co get $10m from the investors with additional payments on trial success etc
Kiwi
Kiwi, saw your mention of SLNO on the Aurinia board. I have never met anyone with PWS but it sounds like a very distressing situation to have a child afflicted with the condition.
See the stock jumped upon news of funding about 10 days ago, but over the years this stock is way down. It is said they have good patent protection but diazoxide is available as a generic and you know my history with that type of situation in another stock.
Sounds like a plan....
$SLNO 1.29 another fill on watch for bottom $2.42 HIGH today
$SLNO 1.35 fills on this big ah DIP
$SLNO trying to rebreak HOD 2.42
$SLNO: Now 2.40
BOOOooooooommmmmmmmmmmmmmmmmm
Yeehawwwwwwww go babyyyyyy
GO $SLNO
$SLNO: Added 10k here at 1.50 today
Goooooooooooooooooo $SLNO
$SLNO moon incoming. Bear trap $SLNOW
Soleno Therapeutics Presents Long Term Data for DCCR Showing Metabolic and Body Composition Improvements in Patients with PWS
Soleno Therapeutics to Participate in the BIO CEO & Investor Conference
Source: GlobeNewswire Inc.
Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Anish Bhatnagar, M.D., Chief Executive Officer, will present a corporate overview at the BIO CEO & Investor Conference on Tuesday, February 15, 2022 at 2:15 PM Eastern Time.
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase 3 clinical development program. For more information, please visit www.soleno.life.
8k issuance for 25 million shares. How convenient to provide short cover at near yearly low. An obviously clear indicator of inept or corrupt management. Glad I got out. Morons..
* * $SLNO Video Chart 06-02-2021 * *
Link to Video - click here to watch the technical chart video
* * $SLNO Video Chart 12-24-2019 * *
Link to Video - click here to watch the technical chart video
$SLNO: Dude did you bungle up........... $2.70 now
ANyways...... never too late.
GO $SLNO
* * $SLNO Video Chart 12-23-2019 * *
Link to Video - click here to watch the technical chart video
Completely unloaded between 1.55 and 1.70 nice green on a bloody day. GLTA
Followers
|
32
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
302
|
Created
|
02/19/15
|
Type
|
Free
|
Moderators |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |