Psych | Jotup

Cingulate Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update

Retrieved on:

Monday, April 1, 2024

Research, ADHD, Psych, NDA, Sale, Cingulata, Attention deficit hyperactivity disorder, Insurance, IND, Market, Adolescence, Safety, Clutch (eggs), Poster, WFIA, FDA, Security (finance)

KANSAS CITY, Kan., April 01, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the twelve months ended December 31, 2023, and provided a clinical and business update. Highlights include capital raised from multiple sources and the addition of three independent board members.

Key Points:

“Our lead asset CTx-1301 continues to impress clinical investigators and key opinion leaders as we share our Phase 3 results.
These tailwinds put Cingulate in a position to obtain non-dilutive capital and expand our pipeline of assets.
Looking ahead, Cingulate has several financial instruments in place to raise additional capital while fighting to preserve shareholder’s equity.
“Overall, I am very pleased with the progress made by our team in 2023 and into 2024.

Cingulate Inc. Reports Third Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on:

Monday, November 13, 2023

WFIA, Safety, Exercise, Psych, Patient, ADHD, Series, Cingulata, Dietary supplement, Security (finance), Adult, AISRS

KANSAS CITY, Kan., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) (Cingulate or the Company), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the quarter ended September 30, 2023, as well as a clinical and business update.

Key Points:

If results from this study are successful, pivotal Phase 3 clinical trials in all patient segments for CTx-1302 are expected to begin in 2025.
Cash Position: As of September 30, 2023, Cingulate had $2.0 million in cash and cash equivalents.
Cingulate expects its cash and cash equivalents will enable the Company to fund its research and development and operating expenditures through mid-November 2023.
Net loss was $16.6 million for the nine months ended September 30, 2023, compared to $13.0 million for the same period in 2022.

Supernus Announces Third Quarter 2023 Financial Results

Retrieved on:

Wednesday, November 8, 2023

Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022

Key Points:

Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022
Qelbree® net product sales of $37.1 million in the third quarter of 2023, a 103% increase compared to the third quarter of 2022 and a 20% increase compared to the second quarter of 2023
GOCOVRI® net product sales of $32.9 million in the third quarter of 2023, an 18% increase compared to the third quarter of 2022 and a 14% increase compared to the second quarter of 2023
Operating earnings (GAAP) of $8.1 million in the third quarter of 2023, compared to an operating loss (GAAP) of ($1.5) million in the third quarter of 2022
Adjusted operating earnings (non-GAAP) of $37.3 million in the third quarter of 2023, an increase of 47% compared to the third quarter of 2022
SPN-830 (apomorphine infusion device) NDA resubmission accepted for review by FDA; PDUFA date of April 5, 2024
ROCKVILLE, Md., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the third quarter of 2023, and associated Company developments.
“Our third-quarter performance underscores the strength of our growth products, with combined Qelbree and GOCOVRI net product sales increasing 52% in the third quarter of 2023 compared to the same period last year,” said Jack Khattar, President and CEO of Supernus.
Qelbree continues to expand its base of prescribers, with approximately 24,189 prescribers in the third quarter of 2023, up from 21,291 prescribers in the second quarter of 2023.
A reconciliation of the full year 2023 financial guidance for Operating Loss (GAAP) to Adjusted Operating Earnings (non-GAAP) is included under the heading “Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments.”
The Company hosted a successful Research & Development (R&D) Day in October 2023 highlighting clinical and R&D progress and its emerging pipeline of novel CNS product candidates.

FHU Hosts "One More Light" Event to Highlight Suicide Prevention

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Tuesday, October 3, 2023

Psych, Student, Life, Education, Suicide, Hope, Leighann Lord, Multimedia, Social work, Grief, FHU, Behavioural sciences, University counseling center, Freed–Hardeman University, One More Light, Nursing, Management

HENDERSON, Tenn., Oct. 3, 2023 /PRNewswire-PRWeb/ -- During a month recognized for promoting suicide prevention awareness, Freed-Hardeman University students, along with members of the Henderson/Chester County community, gathered to "shine light" on an issue that has impacted many.

Key Points:

On Sept. 18, the FHU Department of Behavioral Sciences and the University Counseling Center banded together to bring attention to suicide prevention and mental wellness by organizing an event entitled "One More Light," marking the second time the FHU community has come together for this purpose.
Junior social work major Makenna Minor, one of the student organizers of the event, said, "Students seem to want to talk about it.
This free event included brief messages by organizers, a song by the FHU Chorale, personal reflections, prayers and honest conversations about a difficult topic.
"[The event] opened my eyes a lot to those who struggle with [suicide] or have been indirectly affected by it," FHU senior psychology major LeighAnn Dugger said.

Cingulate Announces Detailed Trial Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD

Retrieved on:

Monday, September 11, 2023

KANSAS CITY, Kan., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced full results from the Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of attention deficit/hyperactivity disorder (ADHD), presented on September 8th at the 36th Annual Psych Congress, in Nashville, TN. A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.

Key Points:

A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.
The Phase 3 CTx-1301-022 study ( NCT05631626 ) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting.
“Along with a restricted duration of efficacy, another limitation of current stimulant-based treatments for ADHD is the phenomena of crash and rebound they produce.
Additionally, CTx-1301 demonstrated a reduction in Adult ADHD Investigator Symptom Rating Scale (AISRS) scores (-16.3).

Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms

Retrieved on:

Sunday, September 10, 2023

Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant.

Key Points:

Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant.
“These data demonstrate Qelbree’s ability to enhance efficacy when co-administered with stimulants, including significant improvement during evening hours when the effects of stimulants often wear off following their morning dose.
Patients ADHD symptoms improved from 37.9 (6.34) to 19.7 (12.16) on the Adult ADHD Investigator Symptom Rating Scale (AISRS), representing average symptom reduction of -18.2 (11.54).
Patients executive function improved from 70.4 (10.94) to 58.3 (16.19) on the BRIEF-A Global Executive Composite scale, representing improvement in executive function of -12.9 (13.48).

Zevra Therapeutics Presents Full Data Set on the Cardiovascular Safety and Pharmacokinetics of SDX, the sole API in KP1077, in Healthy Volunteers at Psych Congress 2023

Retrieved on:

Sunday, September 10, 2023

In addition, both doses of SDX were generally better tolerated compared to Ritalin and fewer subjects experienced cardiovascular adverse events after SDX compared to Ritalin.

Key Points:

In addition, both doses of SDX were generally better tolerated compared to Ritalin and fewer subjects experienced cardiovascular adverse events after SDX compared to Ritalin.
Lastly, vital signs after a single oral dose of 200 mg SDX (the highest dose tested) were comparable to Ritalin IR 80 mg and Ritalin LA 80 mg.
The results demonstrate a robust safety profile for SDX, positioning it as a promising option for treating sleep disorders characterized by excessive daytime sleepiness.
Details of Zevra’s poster presentation are as follows:
Sr. Vice President of Clinical Development, Zevra Therapeutics

Integrating Drug-Drug Interactions and Lifestyle Factors with Drug-Gene Interactions Provided by Castle Biosciences’ IDgenetix® Test Significantly Impacted the Number of Drug Recommendations for Patients with Moderate to Severe Depression

Retrieved on:

Sunday, September 10, 2023

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced data from a study showing the addition of drug-drug interactions and lifestyle factors to drug-gene interactions provided by its IDgenetix® test significantly impacted the number of drug recommendations and contributed to improved remission rates for patients with moderate to severe depression.

Key Points:

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced data from a study showing the addition of drug-drug interactions and lifestyle factors to drug-gene interactions provided by its IDgenetix® test significantly impacted the number of drug recommendations and contributed to improved remission rates for patients with moderate to severe depression.
The non-genetic information (drug-drug interactions and lifestyle factors) accounted for 43% of all drug recommendations in study participants, while single-gene testing for CYP2D6 and CYP2C19 contributed to only 22%.
At 12 weeks, patients whose medication management was guided by IDgenetix had a remission rate of 41%, compared to only 27% of patients whose medication management was not guided by the test (p=0.03, risk ratio=1.49 [1.05-2.12]).
The poster can be viewed here and will also be published on HMP Global’s Psychiatry & Behavioral Health Learning Network in approximately 30-60 days.

Jazz Pharmaceuticals Showcases Impact of Sleep Medicine Portfolio at Psych Congress 2023

Retrieved on:

Monday, September 11, 2023

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023. One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy. Oxybate is the active ingredient in Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution.

Key Points:

Review of multiple clinical trials provided a comprehensive analysis showing that oxybate improves sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy, independent of once- or twice-nightly dosing
DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023.
One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy.
The review found that oxybate improved measures of sleep architecture and disrupted nighttime sleep in narcolepsy patients, independent of dosing regimen or prior oxybate experience.
"Idiopathic hypersomnia has a profound impact on those who live with this debilitating sleep disorder," said Kelvin Tan, MBBCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals.

Jazz Pharmaceuticals Showcases Impact of Sleep Medicine Portfolio at Psych Congress 2023

Retrieved on:

Monday, September 11, 2023

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023. One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy. Oxybate is the active ingredient in Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution.

Key Points:

Review of multiple clinical trials provided a comprehensive analysis showing that oxybate improves sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy, independent of once- or twice-nightly dosing
DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023.
One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy.
The review found that oxybate improved measures of sleep architecture and disrupted nighttime sleep in narcolepsy patients, independent of dosing regimen or prior oxybate experience.
"Idiopathic hypersomnia has a profound impact on those who live with this debilitating sleep disorder," said Kelvin Tan, MBBCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals.