Lennox–Gastaut syndrome

ProMIS Neurosciences appoints accomplished biopharmaceutical leader, Dr. Gail M. Farfel, as Chief Executive Officer

Retrieved on: 
Tuesday, September 13, 2022

The past 18 months have been transformative for ProMIS, stated Eugene Williams, ProMIS Chairman and Co-Founder.

Key Points: 
  • The past 18 months have been transformative for ProMIS, stated Eugene Williams, ProMIS Chairman and Co-Founder.
  • We have also continued to expand our strong management team, having added to the team earlier this year Dr. Larry Altstiel as Chief Medical Officer and, in late 2021, Gavin Malenfant as Chief Operating Officer.
  • Gail has a distinguished track record of accomplishments in both large pharma and biotech, and she has invaluable expertise in neurologic disease drug development.
  • I am honored and excited to take on the role of CEO at ProMIS, remarked Gail Farfel.

Ovid Therapeutics to Present at the H.C. Wainwright 24th Annual Global Investment Conference

Retrieved on: 
Wednesday, September 7, 2022

Ovid Therapeutics Inc. is a New York-based biopharmaceutical company striving to conquer seizures and brain disorders with courageous science.

Key Points: 
  • Ovid Therapeutics Inc. is a New York-based biopharmaceutical company striving to conquer seizures and brain disorders with courageous science.
  • Ovids pipeline of small molecule and genetic medicines candidates seek to meaningfully improve the lives of people and families affected by epilepsies.
  • Ovid is developing OV329, a GABA aminotransferase inhibitor, for treatment-resistant seizures, and OV350, a direct activator of the KCC2 transporter, for potential treatment of epilepsies.
  • In addition, Ovid maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally.

Aquestive Therapeutics to Participate in Two Investor Conferences in September

Retrieved on: 
Wednesday, August 31, 2022

Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company advancing medicines to solve patients problems with current standards of care and provide transformative products to improve their lives.

Key Points: 
  • Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company advancing medicines to solve patients problems with current standards of care and provide transformative products to improve their lives.
  • We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies.
  • Certain statements in this press release include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
  • PharmFilm, Sympazan and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc.

Aquestive Therapeutics Receives FDA Tentative Approval for Libervant™ (diazepam) Buccal Film

Retrieved on: 
Wednesday, August 31, 2022

"Tentative approval" means the FDA has concluded that Libervant has met all required quality, safety, and efficacy standards for approval but, due to an existing FDA regulatory grant of orphan drug market exclusivity for Valtoco, a diazepam nasal spray product, Libervant is not yet eligible for marketing in the United States.

Key Points: 
  • "Tentative approval" means the FDA has concluded that Libervant has met all required quality, safety, and efficacy standards for approval but, due to an existing FDA regulatory grant of orphan drug market exclusivity for Valtoco, a diazepam nasal spray product, Libervant is not yet eligible for marketing in the United States.
  • This FDA action further validates our ability to gain FDA approval of our pipeline programs.
  • Aquestive provided the data along with a cross-study comparison to a similar study performed with Libervant, to FDA during the review process.
  • PharmFilm, Sympazan and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.

Ovid Therapeutics Reports Second Quarter 2022 Financial Results and Corporate Highlights

Retrieved on: 
Tuesday, August 9, 2022

Ovid presented preclinical data that will support the IND submission for OV329 in the second half 2022.

Key Points: 
  • Ovid presented preclinical data that will support the IND submission for OV329 in the second half 2022.
  • Ovid plans to submit an IND and initiate a Phase 1 trial in the second half 2022.
  • General and administrative expenses were $8.3 million for the quarter ended June30, 2022, compared to $6.6 million for the same period in 2021.
  • Ovid Therapeutics Inc. is a New York-based biopharmaceutical company striving to conquer seizures and brain disorders with courageous science.

Longboard Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2022 Financial Results

Retrieved on: 
Thursday, August 4, 2022

LP659, an oral, selective, centrally acting S1P receptor modulator targeting multiple neurological diseases, is currently in IND-enabling studies with IND application submission to the FDA expected in the fourth quarter of 2022.

Key Points: 
  • LP659, an oral, selective, centrally acting S1P receptor modulator targeting multiple neurological diseases, is currently in IND-enabling studies with IND application submission to the FDA expected in the fourth quarter of 2022.
  • Second Quarter 2022 Financial Results:
    At June 30, 2022, Longboards cash, cash equivalents and short-term investments were approximately $87.4 million.
  • Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases.
  • Longboard disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Aquestive Therapeutics to Participate in Wedbush PacGrow Healthcare Conference

Retrieved on: 
Tuesday, July 26, 2022

WARREN, N.J., July 26, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today that the management team will participate in the Wedbush PacGrow Healthcare Conference that will be held August 9 - 10.

Key Points: 
  • WARREN, N.J., July 26, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today that the management team will participate in the Wedbush PacGrow Healthcare Conference that will be held August 9 - 10.
  • The Aquestive team is scheduled to hold a fireside chat on August 9th at 10:55 am ET and will host investor meetings at the conference through August 10th.
  • Aquestive Therapeutics, Inc.(NASDAQ: AQST) is a pharmaceutical company advancing medicines to solve patients problems with current standards of care and provide transformative products to improve their lives.
  • PharmFilm, Sympazan and the Aquestive logo are registered trademarks ofAquestive Therapeutics, Inc.

Aquestive Therapeutics to Report Second Quarter 2022 Financial Results and Recent Business Highlights on August 2 and Host Conference Call on August 3 at 8:00 a.m. ET

Retrieved on: 
Wednesday, July 20, 2022

In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin.

Key Points: 
  • In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin.
  • A live webcast of the call will be available on Aquestives website at: Second Quarter 2022 Results .
  • The live webcast will be available on the Investors section of the Companys website at https://investors.aquestive.com/events-and-presentations .
  • PharmFilm, Sympazan and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc.

Aquestive Therapeutics Reports Positive Results from Final Two Arms of EPIPHAST Trial Supporting Performance and Real-World Functionality of AQST-109 Epinephrine Oral Film

Retrieved on: 
Monday, July 11, 2022

The data also showed that swallowing the film whole immediately with water unexpectedly resulted in significant absorption of epinephrine.

Key Points: 
  • The data also showed that swallowing the film whole immediately with water unexpectedly resulted in significant absorption of epinephrine.
  • It is very promising that AQST-109 continues to perform well in challenging and less than ideal circumstances, further validating performance and real-world functionality.
  • EPIPHAST was a randomized, open-label, three-part adaptive design, crossover study in healthy adult subjects comparing the pharmacokinetics and pharmacodynamics of epinephrine delivered via Aquestives AQST-109 oral film compared to intramuscular injection of epinephrine.
  • PharmFilm, Sympazan and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.

Aquestive Therapeutics Reports Positive Initial Topline Data from Part 3 of EPIPHAST Trial Evaluating AQST-109 Epinephrine Oral Film

Retrieved on: 
Wednesday, June 15, 2022

We are anxious to share this data with the FDA following the completion of the upcoming head-to-head study with EpiPen.

Key Points: 
  • We are anxious to share this data with the FDA following the completion of the upcoming head-to-head study with EpiPen.
  • EPIPHAST is a randomized, open-label, three-part adaptive design, crossover study in healthy adult subjects comparing the pharmacokinetics and pharmacodynamics of epinephrine delivered via Aquestives AQST-109 oral film compared to intramuscular injection of epinephrine.
  • Aquestive plans to conduct a repeat dosing comparative study of AQST-109 and 0.3 mg EpiPen during the third quarter 2022.
  • PharmFilm, Sympazan and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.