Clobazam

Longboard Pharmaceuticals Announces Positive Topline Data from the PACIFIC Study, a Phase 1b/2a Clinical Trial, for Bexicaserin (LP352) in Participants with Developmental and Epileptic Encephalopathies (DEEs)

Retrieved on: 
Tuesday, January 2, 2024

Of the 52 participants enrolled in the study, 43 participants were randomized to bexicaserin (DS=4, LGS=24, DEE Other=15) and 9 to placebo (DS=0, LGS=5, DEE Other=4).

Key Points: 
  • Of the 52 participants enrolled in the study, 43 participants were randomized to bexicaserin (DS=4, LGS=24, DEE Other=15) and 9 to placebo (DS=0, LGS=5, DEE Other=4).
  • The median number of countable motor seizures per 28-day period at baseline was 38.8 in the bexicaserin group compared to 20.8 in the placebo group.
  • Most participants (85.7%) in the bexicaserin treated group (n=35) that started the maintenance period tolerated the highest dose (12 mg).
  • 100% of the participants who completed the PACIFIC Study elected to enroll in the ongoing 52-week open-label extension study.

 Virpax Pharmaceuticals Announces Leadership Transition

Retrieved on: 
Friday, November 17, 2023

Prior to Virpax, Mr. Bruce served as Vice President of sales for Danone Specialized Nutrition North America, Danone’s medical nutrition division.

Key Points: 
  • Prior to Virpax, Mr. Bruce served as Vice President of sales for Danone Specialized Nutrition North America, Danone’s medical nutrition division.
  • He has a BA from Lincoln University and a Master’s degree in Leadership from Georgetown University’s McDonough School of Business.
  • Aside from Virpax Pharmaceuticals, he also serves on the board of Advent Therapeutics Inc. and is a member of the Board of Trustees of Meharry Medical College.
  • I am proud of what we have accomplished together and confident that Virpax under Gerald and Eric’s leadership will remain on track to begin first-in-human trials in the coming year,” commented Mr. Mack.

Assertio Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 8, 2023

LAKE FOREST, Ill., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company that acquires, commercializes and develops safe and effective therapies that make a difference in the lives of patients, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Indocin net products sales in the third quarter were $17.9 million, a $4.0 million decrease from the prior year quarter reflecting competition from a generic entrant and a compounder.
  • Gross margin2 in the third quarter was 80%, decreased from 88% in the prior year third quarter.
  • Patel has been with Assertio since 2019, holding financial and accounting positions with increasing leadership responsibility during his tenure.
  • I am excited to work with both of them in these new roles for the continued transformation of our business.”
    Assertio’s management will host a conference call to discuss its third quarter 2023 financial results today:

Aquestive Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023

“We continue to successfully execute on our 2023 key initiatives as demonstrated by our third quarter 2023 results,” said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • “We continue to successfully execute on our 2023 key initiatives as demonstrated by our third quarter 2023 results,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • The Company is on track to commence its initial Phase 3 pivotal PK study for Anaphylm in the fourth quarter 2023.
  • Total reported revenues were $13.0 million in the third quarter 2023, compared to $11.5 million in the third quarter 2022.
  • Aquestive is updating its full-year 2023 financial guidance based on third quarter 2023 results and updated outlook for the remainder of 2023.

Pharmanovia Acquires Global Central Nervous System (CNS) Portfolio From Sanofi

Retrieved on: 
Monday, September 18, 2023

PRESS RELEASE – FOR TRADE, BUSINESS AND MEDICAL MEDIA ONLY

Key Points: 
  • PRESS RELEASE – FOR TRADE, BUSINESS AND MEDICAL MEDIA ONLY
    This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20230918003077/en/
    Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has today announced the expansion of its neurology portfolio with the acquisition of 11 central nervous system (CNS) brands from global healthcare company, Sanofi.
  • The brands span four therapy areas of ongoing unmet need associated with CNS disorders - psycholeptic, anxiolytic, anti-epileptic and anti-psychotic.
  • For local indications it is advised to check the local approved label.

Aquestive Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 7, 2023

“Our strong second quarter 2023 results continue to drive the Company forward,” said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • “Our strong second quarter 2023 results continue to drive the Company forward,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • The Company manufactured approximately 48 million doses in the second quarter 2023, compared to 47 million in the second quarter 2022.
  • Total reported revenues were $13.2 million in the second quarter 2023, compared to $13.3 million in the second quarter 2022.
  • Aquestive is updating its full-year 2023 financial guidance based on second quarter 2023 results and updated outlook for the remainder of 2023.

Assertio Reports Second Quarter 2023 Financial Results, Closes Spectrum Acquisition

Retrieved on: 
Thursday, August 3, 2023

LAKE FOREST, Ill., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today reported financial results for the second quarter ended June 30, 2023 and provided updates related to the acquisition of Spectrum Pharmaceuticals, Inc. (“Spectrum”), which closed effective July 31, 2023.

Key Points: 
  • Gross margin3 in the second quarter was 88.1%, increased from 87.2% in the year-ago quarter, reflecting shifts in sales mix.
  • SG&A expense was $16.8 million in the second quarter of 2023, compared with $10.5 million in the second quarter 2022.
  • The 2023 second quarter included the effect of $3.4 million in transaction related costs, while the prior year second quarter included the benefit of a $2.0 million insurance settlement.
  • Assertio’s management will host a conference call to discuss its second quarter 2023 financial results today:

Assertio Reports First Quarter 2023 Financial Results, Raises Full Year 2023 Outlook

Retrieved on: 
Tuesday, May 9, 2023

LAKE FOREST, Ill., May 09, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today reported financial results for the first quarter ended March 31, 2023.

Key Points: 
  • Indocin sales increased 42%, primarily due to the transition of volumes to more profitable commercial channels implemented in October 2022.
  • Sympazan prescriptions achieved a new record in the quarter, following its prior record in the third quarter 2022.
  • GAAP net loss of $3.5 million, compared to GAAP net income of $9.1 million in the prior year quarter.
  • At March 31, 2023, cash and cash equivalents was $68.6 million and outstanding principal amount of convertible debt was $40 million.

Aquestive Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 2, 2023

“Our first quarter 2023 results continue to drive the Company towards important upcoming inflection points,” said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • “Our first quarter 2023 results continue to drive the Company towards important upcoming inflection points,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • Total reported revenues were $11.1 million in the first quarter 2023, compared to $12.3 million in the first quarter 2022.
  • Non-GAAP Adjusted EBITDA loss was $3.9 million in the first quarter 2023, compared to an adjusted EBITDA loss of $8.1 million in the first quarter of 2022.
  • Aquestive is updating its full-year 2023 financial guidance based on first quarter results and updated outlook for the remainder of 2023.

Assertio Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Wednesday, March 8, 2023

LAKE FOREST, Ill., March 08, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today reported financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • Fourth quarter results included the following as compared to the prior year quarter:
    Net product sales increased 55% to $49.9 million.
  • “Assertio’s successful achievement of its strategic priorities in 2022 delivered financial results that exceeded our outlook quarter after quarter, culminating in an especially strong fourth quarter as we shifted Indocin demand in favor of higher margin commercial purchases,” said Dan Peisert, Chief Executive Officer.
  • For the quarter ended December 31, 2022, the Company generated $26.7 million in cash flow from operations, its seventh consecutive quarter of positive cash flows.
  • As previously announced, Assertio’s management will host a conference call to discuss its fourth quarter and full year 2022 financial results today: