Orthostatic hypotension

D.A. Davidson Acts as Financial Advisor to Head Rush Technologies, a Pike Street Capital Portfolio Company, on Its Sale to TZP Group

Retrieved on: 
Monday, January 22, 2024
Consulting, Professional Services, Finance, Multimedia, CO, Food, Sale, M&A, Safety, TZP, Orthostatic hypotension, Growth, Risk management

Davidson & Co. announced today that it served as the exclusive financial advisor to Head Rush Technologies (“Head Rush”) and its Private Equity Sponsor, Pike Street Capital, in the sale of Head Rush to TZP Group.

Key Points: 
  • Davidson & Co. announced today that it served as the exclusive financial advisor to Head Rush Technologies (“Head Rush”) and its Private Equity Sponsor, Pike Street Capital, in the sale of Head Rush to TZP Group.
  • Head Rush products leverage a patented magnetic braking system which provides for increased safety, lower cost of ownership, and enhanced user experience compared to competing braking systems.
  • Davidson & Co. announced today that it served as the exclusive financial advisor to Head Rush Technologies (“Head Rush”) and its Private Equity Sponsor, Pike Street Capital, in the sale of Head Rush to TZP Group.
  • Davidson team throughout the process, as they proved themselves essential in helping us find a knowledgeable and experienced partner in TZP,” said Head Rush CEO, Lea Ann Zuellig.

Theravance Biopharma to Present New Ampreloxetine Data at the 34th International Symposium on The Autonomic Nervous System

Retrieved on: 
Thursday, November 16, 2023
SEQUOIA, American Autonomic Society, Autonomic nervous system, OHQ, Orthostatic hypotension, AAS, Patient, University School, Research, Week, Noh, Neurology, Dysautonomia, Pharmaceutical industry, Medical imaging

DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that a new, anchor-based analysis of ampreloxetine data in neurogenic orthostatic hypotension (nOH) will be presented at the 34th International Symposium on The Autonomic Nervous System, a meeting of the American Autonomic Society (AAS), taking place November 15-18, 2023, in Rio Grande, Puerto Rico.

Key Points: 
  • DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that a new, anchor-based analysis of ampreloxetine data in neurogenic orthostatic hypotension (nOH) will be presented at the 34th International Symposium on The Autonomic Nervous System, a meeting of the American Autonomic Society (AAS), taking place November 15-18, 2023, in Rio Grande, Puerto Rico.
  • Anchor-based analyses help establish thresholds used to interpret the clinical meaningfulness of changes in patient-reported outcomes measures such as the Orthostatic Hypotension Questionnaire (OHQ).
  • This anchor-based analysis model will aid in the interpretation of clinically meaningful changes to the OHSA composite score observed in CYPRESS.
  • Further, establishment of an anchor-based, clinically meaningful change in the OHSA composite primary endpoint will be important for clinicians, regulators, and payors.

RVL Pharmaceuticals plc to Discuss Second Quarter 2023 Financial Results and Provide Commercial Update

Retrieved on: 
Wednesday, August 2, 2023
Blood pressure, Glaucoma, Blepharoplasty, Ptosis, Orthostatic hypotension, Hypotension, Conference call, Focal neurologic signs, Stroke, Cardiovascular disease, Eye, Orbit, Myasthenia gravis, Beta blocker, Hypertension, Telecanthus, Ophthalmoparesis, Metabolism, Patient, Xanthine oxidase inhibitor, Risk, Eye injury, Glycosidic bond, System, Aneurysm, Headache, Conference, Horner's syndrome, Phosphorus, Pharmaceutical industry

UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.

Key Points: 
  • UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.
  • Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses.
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

BioXcel Therapeutics Announces Promising Topline Results from Part 1 of Pivotal SERENITY III Trial of BXCL501 for At-Home Use in Acute Treatment of Agitation in Bipolar Disorders or Schizophrenia

Retrieved on: 
Thursday, May 25, 2023
Yale School of Medicine, Bradycardia, Orthostatic hypotension, Dexmedetomidine, Somnolence, Schizophrenia, Xerostomia, Hypotension, Safety, Tolerability, Yale school, BS 5839 Part 1, II, Șaeș, Alignment, Incidence, PEC, Dizziness, Patient, Translational research, Psychiatry, Artificial intelligence, FDA, Therapy, Agitation, Bipolar disorder, Caregiver, DSM-IV codes, Vaccine, Pharmaceutical industry, Part

BXCL501 would represent the first-ever FDA approved therapy for at-home use in this indication, if approved.

Key Points: 
  • BXCL501 would represent the first-ever FDA approved therapy for at-home use in this indication, if approved.
  • SERENITY III is a two-part, double-blinded, placebo-controlled pivotal study designed to evaluate BXCL501 in acutely agitated adult patients with bipolar disorders or schizophrenia for at-home use.
  • Although the primary efficacy endpoint was not statistically significant at 2 hours (p=0.077), BXCL501 separated from placebo at 4 hours (p=0.049).
  • These data provide a clear path for initiating SERENITY III Part 2, to pursue approval in the at-home setting.

BioXcel Therapeutics Announces Positive Top-Line Data from Repeat Dosing of BXCL501 in Phase 1b Multiple Ascending Dose Trial in Healthy Volunteers for Major Depressive Disorder (MDD) Program

Retrieved on: 
Tuesday, May 16, 2023
Volunteering, Index, Depression, Orthostatic hypotension, Dexmedetomidine, Half-life, Somnolence, Schizophrenia, Hypotension, Anxiety, Safety, Tolerability, Bipolar II disorder, Pharmacokinetics, DSM-IV codes, Disorder, Selective serotonin reuptake inhibitor, Dizziness, MDD, Patient, BID, Artificial intelligence, MTD, MAD, Intermittent explosive disorder, Serotonin–norepinephrine reuptake inhibitor, POC, Therapy, Headache, III, Agitation, Pharmaceutical industry, Vaccine, Neuroscience, HAVEN

NEW HAVEN, Conn., May 16, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced positive top-line data from its Phase 1b multiple ascending dose (MAD) trial of BXCL501 (dexmedetomidine) sublingual film. BXCL501 is the Company’s proprietary, orally dissolving film under investigation for the treatment of agitation associated with neuropsychiatric disorders and as a potential adjunctive treatment in Major Depressive Disorder (MDD).

Key Points: 
  • The trial was designed to evaluate the safety and tolerability of repeat dosing of BXCL501 in healthy volunteers as a single agent and in combination with antidepressant duloxetine.
  • “This positive outcome supports the potential market expansion opportunity for our lead asset, BXCL501, into chronic neuropsychiatric disorders,” said Vimal Mehta, CEO of BioXcel Therapeutics.
  • We believe these new data present a transformative opportunity beyond acute treatment for the BXCL501 program, including treatment for MDD.
  • The study’s primary objectives were to assess the safety, tolerability, and pharmacokinetics of BXCL501 in healthy volunteers in multiple ascending doses.

Theravance Biopharma, Inc. Announces Orphan Drug Designation Granted to Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy

Retrieved on: 
Tuesday, May 9, 2023
Blood pressure, Orphan Drug Act of 1983, US Foods, Noh, Prevalence, Marketing, ODD, Quality of life, Multiple system atrophy, Head, Movement, Orthostatic hypotension, Muscle weakness, ODA, Orphan drug, Dizziness, Patient, MSA, Norepinephrine, Dysautonomia, Orphan, Heart rate, FDA, Food, Caregiver, Fatigue, Pharmaceutical industry

DUBLIN, May 9, 2023 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) status to ampreloxetine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA).

Key Points: 
  • DUBLIN, May 9, 2023 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) status to ampreloxetine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA).
  • MSA is a rare neurodegenerative disorder in which patients suffer autonomic dysfunction affecting movement, balance, heart rate and blood pressure.
  • "We are very pleased to have received Orphan Drug status for ampreloxetine in the treatment of nOH in patients with MSA," said Rick E Winningham, Chief Executive Officer.
  • "Ampreloxetine has the potential to improve MSA patients' and their caregivers' quality of life significantly.

RVL Pharmaceuticals plc to Discuss First Quarter 2023 Financial Results and Provide Commercial Update

Retrieved on: 
Thursday, May 4, 2023
Blood pressure, Glaucoma, Blepharoplasty, Ptosis, Orthostatic hypotension, Hypotension, Focal neurologic signs, Stroke, Cardiovascular disease, Eye, Orbit, Myasthenia gravis, Beta blocker, Hypertension, Telecanthus, Ophthalmoparesis, Metabolism, Patient, Xanthine oxidase inhibitor, Risk, Eye injury, Glycosidic bond, System, Aneurysm, Headache, Horner's syndrome, Phosphorus, Pharmaceutical industry

Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses.

Key Points: 
  • Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses.
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

RVL Pharmaceuticals plc to Discuss Fourth Quarter and Full Year 2022 Financial Results and Provide Commercial Update

Retrieved on: 
Wednesday, March 15, 2023
Ophthalmoparesis, Conference, Myasthenia gravis, Hypotension, Glaucoma, Eye, International, Patient, Blood pressure, Horner's syndrome, Risk, URL, Telecanthus, Focal neurologic signs, Aneurysm, Hypertension, Metabolism, Beta blocker, Orthostatic hypotension, Ptosis, Eye injury, Glycosidic bond, Blepharoplasty, Cardiovascular disease, ID, Conference call, Headache, System, Orbit, Stroke, Xanthine oxidase inhibitor, Phosphorus, Pharmaceutical industry

UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.

Key Points: 
  • UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Multiple System Atrophy

Retrieved on: 
Wednesday, March 8, 2023
Parkinson's disease, Therapy, IND, Brain, Biomarker, Animal, Atrophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MRI, Mouse, Quality of life, Patient, Multiple system atrophy, Pharmacokinetics, Food, Neuron, Pathology, FDA, Orthostatic hypotension, Safety, Skin, Pharmaceutical industry, Medical imaging, Parkinsonism

BOSTON and ATLANTA, March 8, 2023 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the U.S. Food and Drug Administration ("FDA" or "Agency") has lifted the full Clinical Hold on IkT-148009, the Company's c-Abl inhibitor, in Multiple System Atrophy (MSA) allowing the Company to proceed with its plans for a future Phase 2 clinical trial in MSA.

Key Points: 
  • "We are grateful for the expeditious review by the FDA of our response to the Clinical Hold on IkT-148009 in MSA," stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics.
  • One of two ongoing model studies has shown a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009.
  • With the clinical hold lifted and the IND now open, we look forward to completing these studies prior to initiation of the Phase 2a trial in this patient population.
  • Clinical effect on the progression of atrophy will be monitored in the trial using MRI.

Theravance Biopharma, Inc. Announces Strategic Actions and Reports Fourth Quarter / Full Year 2022 Financial Results and Business Update

Retrieved on: 
Monday, February 27, 2023
Janus, Orthostatic hypotension, Chronic obstructive pulmonary disease, Blood pressure, JAK, Telephone, Atrophy, Norepinephrine, SG, American Autonomic Society, GSK, Internet, MBA, Research, Noh, Owens & Minor, Executive, Maintenance, J.P. Morgan & Co., Partnership, Webcast, FDA, Patient, R, MSA, Janssen, Growth, Research and development, Wesleyan University, COPD, Bank statement, CIBC, CIBC World Markets, Columbia University, Hypertension, Asthma, Sale, BA, Merrill (company), Multiple system atrophy, Medication, Administration, Pharmaceutical industry, Cryptocurrency, Beauty salon, Holding company, Fine chemical, Management, Viatris

Revenue: Total revenue for the fourth quarter of 2022 was $14.6 million, almost entirely comprised of $14.6 million in Viatris collaboration revenue.

Key Points: 
  • Revenue: Total revenue for the fourth quarter of 2022 was $14.6 million, almost entirely comprised of $14.6 million in Viatris collaboration revenue.
  • In the fourth quarter of 2022, Theravance Biopharma recognized its first revenue associated with non-US YUPELRI royalties.
  • Cash burn in fourth quarter of 2022 was $7 million excluding a $118 million tax payment and $34 million of share repurchases.
  • A replay of the webcast will be available on Theravance Biopharma's website for 30 days through March 29, 2023.