Jean-François Zygel

Harmony Biosciences Reports Strong Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, October 31, 2023
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ET

Key Points: 
  • ET
    PLYMOUTH MEETING, Pa., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today reported financial results and business updates for the quarter ended September 30, 2023.
  • The average number of patients on WAKIX increased by approximately 350 sequentially to approximately 5,800 for the quarter ended September 30, 2023.
  • Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.
  • ET
    We are hosting our third quarter 2023 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern Time.

Zynerba Pharmaceuticals Stockholders Reminded to Tender Shares Before 5:00 PM New York City Time, on Tuesday October 10, 2023

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Friday, September 29, 2023
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The Offer was initially scheduled to expire at 5:00 p.m. New York City time on September 26, 2023.

Key Points: 
  • The Offer was initially scheduled to expire at 5:00 p.m. New York City time on September 26, 2023.
  • On September 27, 2023, Harmony announced an extension of the Offer until 5:00 p.m., New York City time, on Tuesday, October 10, 2023, to allow for additional shares to be tendered by stockholders.
  • I am reaching out to remind you to tender your shares prior to the expiration of the Offer on October 10, 2023.
  • The Zynerba Board unanimously recommends that Zynerba stockholders tender their shares pursuant to the Offer.

Zynerba Pharmaceuticals Reports First Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Monday, May 15, 2023
Purchasing, Methylation, Anxiety, Shareholder, Perception, Annual Meetings of the International Monetary Fund and the World Bank Group, NDA, Canaccord Genuity, Depression, FXS, INSPIRE, Fragile X syndrome, General Instruction of the Roman Missal, Patient, Behavior, Form S-3, Annual general meeting, Form, Asset purchase agreement, MAA, Research, FDA, Press release, Regulation of tobacco by the U.S. Food and Drug Administration, LPC, Conference, Food, Safety, Pharmaceutical industry, Auction, Birth control, Cryptocurrency, Security (finance), Jean-François Zygel

DEVON, Pa., May 15, 2023 (GLOBE NEWSWIRE) --  Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today reported financial results for the first quarter ended March 31, 2023, and provided an overview of recent operational highlights and a pipeline update.

Key Points: 
  • “The first quarter of 2023 was a period of continued focus and execution on our two lead programs with Zygel,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba.
  • Research and development expenses were $7.1 million for the first quarter of 2023, including stock-based compensation of $0.4 million.
  • General and administrative expenses were $3.4 million in the first quarter of 2023, including stock-based compensation expense of $0.4 million.
  • Net loss for the first quarter of 2023 was $10.1 million, with basic and diluted loss per share of $(0.21).

Zynerba Pharmaceuticals Presents Data on Zygel™ at the 55th Gatlinburg Conference

Retrieved on: 
Wednesday, April 12, 2023
Clinician Administered PTSD Scale, Methylation, Anxiety, DiGeorge syndrome, Safety, Adolescence, Maharashtra University of Health Sciences, Depression, FXS, INSPIRE, Fragile X syndrome, Behavior, FMR1, Syndrome, Patient, Conference, Birth control, Cannabidiol, Jean-François Zygel

DEVON, Pa., April 12, 2023 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, is presenting two posters at the 55th Gatlinburg Conference, being held April 10-13, 2023, in Kansas City, Mo. Copies of the posters are available on the Zynerba corporate website at www.zynerba.com/publications.

Key Points: 
  • Zygel achieved statistically significant and clinically meaningful improvements from baseline in multiple efficacy assessments and was generally well-tolerated through 38 weeks of treatment in INSPIRE, a Phase 2 trial with Zygel in children and adolescents with 22q
    DEVON, Pa., April 12, 2023 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals , Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, is presenting two posters at the 55th Gatlinburg Conference, being held April 10-13, 2023, in Kansas City, Mo.
  • Copies of the posters are available on the Zynerba corporate website at www.zynerba.com/publications .
  • Patients with complete methylation, who match the primary efficacy population in the ongoing confirmatory trial, RECONNECT, achieved and maintained clinically meaningful changes in Social Avoidance over 24 months, further supporting this design enhancement for RECONNECT.
  • These results are consistent with the previously reported 14-week treatment data suggesting a positive risk-benefit profile for Zygel in improving anxiety-related and other behavioral symptoms in children and adolescents with 22q when added to standard of care.

Zynerba Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights

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Tuesday, March 28, 2023
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DEVON, Pa., March 28, 2023 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided an overview of recent operational highlights and a pipeline update.

Key Points: 
  • Published data in the Journal of Neurodevelopmental Disorders describing the role of the endocannabinoid system and cannabidiol therapy in FXS.
  • Research and development expenses were $5.5 million for the fourth quarter of 2022, including stock-based compensation of $0.5 million.
  • General and administrative expenses were $3.2 million in the fourth quarter of 2022, including stock-based compensation expense of $0.5 million.
  • Net loss for the fourth quarter of 2022 was $8.0 million, with basic and diluted loss per share of $(0.18).

Zynerba Pharmaceuticals Announces Publication in the Journal of Neurodevelopmental Disorders Describing the Role of the Endocannabinoid System and Cannabidiol Therapy in Fragile X Syndrome

Retrieved on: 
Wednesday, January 11, 2023
CONNECT, Neurodevelopmental disorder, Cannabidiol, Methylation, FMR1, Patient, Fragile X syndrome, Journal, FMRP, ECS, Irritability, Endocannabinoid system, Binary relation, Journal of Neurodevelopmental Disorders, FXS, Medical device, Pharmaceutical industry, Jean-François Zygel

DEVON, Pa., Jan. 11, 2023 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today announces the publication of a paper entitled, “Role of the Endocannabinoid System in Fragile X Syndrome: Potential Mechanisms for Benefit From Cannabidiol Treatment,” in the Journal of Neurodevelopmental Disorders. The review of evidence suggests a central role for the endocannabinoid system (ECS) in neuronal development and cognitive function and in the pathogenesis of Fragile X syndrome (FXS), and the potential role of cannabidiol as a treatment for FXS. The article can be accessed online at the Journal of Neurodevelopmental Disorders at https://rdcu.be/c25fu.

Key Points: 
  • The review of evidence suggests a central role for the endocannabinoid system (ECS) in neuronal development and cognitive function and in the pathogenesis of Fragile X syndrome (FXS), and the potential role of cannabidiol as a treatment for FXS.
  • The article can be accessed online at the Journal of Neurodevelopmental Disorders at https://rdcu.be/c25fu .
  • “This publication describes the potential of Zygel as a treatment for Fragile X syndrome based on the central role the endocannabinoid system plays in neuronal development and function,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba.
  • Cannabidiol may help restore the function of the ECS in FXS according to a review of data to date.

Zynerba Pharmaceuticals Announces Positive Long-Term Data from Phase 2 INSPIRE Trial in 22q11.2 Deletion Syndrome at the Annual Meeting of the American College of Neuropsychopharmacology

Retrieved on: 
Monday, December 5, 2022
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DEVON, Pa., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, presented positive long-term 38-week data from the Phase 2 INSPIRE trial with Zygel in children and adolescents with 22q11.2 deletion syndrome (22q). The data were presented in a poster at the 61st Annual Meeting of the American College of Neuropsychopharmacology, being held December 4-7, 2022 in Phoenix, Arizona. A copy of the poster is available on the Zynerba corporate website at www.zynerba.com/publications.

Key Points: 
  • The data were presented in a poster at the 61st Annual Meeting of the American College of Neuropsychopharmacology, being held December 4-7, 2022 in Phoenix, Arizona.
  • A copy of the poster is available on the Zynerba corporate website at www.zynerba.com/publications .
  • Patients with a ≥35% improvement in the ABC-C irritability subscale were allowed to continue treatment for an additional 24 weeks.
  • Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release.

Zynerba Pharmaceuticals Announces Poster Presentation at the Annual Meeting of the American College of Neuropsychopharmacology

Retrieved on: 
Tuesday, November 29, 2022
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Recent studies suggest that cannabidiol may modulate the endocannabinoid system and improve certain behavioral symptoms associated with neuropsychiatric conditions.

Key Points: 
  • Recent studies suggest that cannabidiol may modulate the endocannabinoid system and improve certain behavioral symptoms associated with neuropsychiatric conditions.
  • Additionally, Zygel has been designated a Fast Track development program for treatment of behavioral symptoms of FXS.
  • Zynerba Pharmaceuticals is the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders.
  • Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release.

Zynerba Pharmaceuticals Announces European Commission Has Granted Orphan Drug Designation for Zygel™ in 22q11.2 Deletion Syndrome

Retrieved on: 
Tuesday, November 15, 2022
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Orphan drug designation is another important step forward in advancing Zygel as a potential new treatment option for patients with 22q.

Key Points: 
  • Orphan drug designation is another important step forward in advancing Zygel as a potential new treatment option for patients with 22q.
  • Zygel was previously granted orphan drug designation by the EC for the treatment of Fragile X syndrome (FXS) and by U.S. Food and Drug Administration (FDA) for the treatment of FXS and 22q.
  • Additionally, the FDA has granted Fast Track designation for Zygel for the treatment of behavioral symptoms associated with FXS.
  • The Company has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the FDA and the European Commission in the treatment of FXS and the treatment of 22q.

Zynerba Pharmaceuticals Reports Third Quarter 2022 Financial Results and Operational Highlights

Retrieved on: 
Monday, November 14, 2022
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DEVON, Pa., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today reported financial results for the third quarter ended September 30, 2022, and provided an overview of recent operational highlights and a pipeline update.

Key Points: 
  • $55.9 million in cash and cash equivalents at September 30, 2022; Cash runway into first quarter 2024
    DEVON, Pa., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals , Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today reported financial results for the third quarter ended September 30, 2022, and provided an overview of recent operational highlights and a pipeline update.
  • The Company currently plans to initiate a Phase 3 program in children and adolescents with 22q following topline results from RECONNECT.
  • Research and development expenses were $5.0 million for the third quarter of 2022, including stock-based compensation of $0.5 million.
  • General and administrative expenses were $3.5 million in the third quarter of 2022, including stock-based compensation expense of $0.6 million.