KarXT

PureTech Launches Seaport Therapeutics with $100 Million Oversubscribed Series A and Announces Management Transitions

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Depression, Eli Lilly, Major depressive disorder, Patient, Bristol Myers Squibb, PureTech Health, PRTC, Therapy, Creativity, Disorder, General counsel, CNS, Life, DSM-IV codes, Pleasure, Pharmacokinetics, Interim, Third Rock Ventures, U.S. FDA, Schizophrenia, KarXT, Teva Pharmaceuticals, ARCH Venture Partners, Merck, Anxiety, Merck & Co., Research and development, FDA, Lymphatic system, Hepatotoxicity, Sirna Therapeutics, Generalized anxiety disorder, Growth, Neuropsychiatry, Partner, Multimedia, Eli Lilly and Company, Probability, Liver, Medicine, Pharmaceutical industry

Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.

Key Points: 
  • Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.
  • Under its license agreement with Karuna, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals.
  • Eric Elenko, Ph.D., a PureTech co-founder and current Chief Innovation Officer, has been promoted to the role of President of PureTech.
  • Daphne Zohar, the Chief Executive Officer of Seaport, is the founder and former CEO of PureTech Health where she also co-founded Karuna Therapeutics.

Seaport Therapeutics Launches with $100 Million Oversubscribed Series A Financing Round to Advance Novel Neuropsychiatric Medicines

Retrieved on: 
Tuesday, April 9, 2024
Mental Health, Health, Neurology, General Health, Pharmaceutical, Biotechnology, Generalized anxiety disorder, Depression, Eli Lilly, U.S. FDA, Schizophrenia, KarXT, Major depressive disorder, ARCH Venture Partners, Patient, CNS, Anxiety, Bristol Myers Squibb, PureTech Health, DSM-IV codes, Pleasure, Neuropsychiatry, Research and development, Therapy, Pharmacokinetics, Partner, Disorder, Third Rock Ventures, Probability, FDA, Lymphatic system, Hepatotoxicity, Liver, Medicine, Pharmaceutical industry

Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.

Key Points: 
  • Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.
  • The round was co-led by ARCH Venture Partners and Sofinnova Investments along with Third Rock Ventures and Seaport founder PureTech Health.
  • Seaport is advancing a clinical-stage pipeline of novel neuropsychiatric medicines powered by its proprietary Glyph™ Technology Platform, which leverages the lymphatic system to create new medicines building on clinically validated mechanisms.
  • I am eager to support Seaport as an investor and board member as the team continues to advance its clinical-stage pipeline of novel therapeutics.”

Bristol Myers Squibb Completes Acquisition of Karuna Therapeutics, Strengthening Neuroscience Portfolio

Retrieved on: 
Monday, March 18, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, BMY, Psychosis, Bristol Myers Squibb, Citigroup, Growth, Schizophrenia, Goldman Sachs, KarXT, EPS, Patient, Simpson Thacher & Bartlett, Acquisition, BMS, LLP, Therapy, GAAP, Covington & Burling, Bipolar I disorder, PDUFA, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that it has successfully completed its acquisition of Karuna Therapeutics, Inc. (“Karuna”).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that it has successfully completed its acquisition of Karuna Therapeutics, Inc. (“Karuna”).
  • With the acquisition's completion, Karuna shares have ceased trading on the Nasdaq Global Select Market and Karuna is now a wholly owned subsidiary of Bristol Myers Squibb (“BMS”).
  • “We are excited to expand our neuroscience portfolio as we welcome Karuna to Bristol Myers Squibb,” said Chris Boerner, Ph.D., Chief Executive Officer, Bristol Myers Squibb.
  • Bristol Myers Squibb expects to offset the operational expenses of the transaction through continued disciplined resource allocation, cost efficiencies and portfolio prioritization.

Bristol Myers Squibb Completes Acquisition of PureTech's Founded Entity Karuna Therapeutics for $14 Billion

Retrieved on: 
Monday, March 18, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, BMY, Psychosis, Bristol Myers Squibb, Citigroup, Growth, Schizophrenia, KarXT, Goldman Sachs, EPS, Patient, Neuroscience, Simpson Thacher & Bartlett, Acquisition, BMS, LLP, PRTC, Therapy, GAAP, Covington & Burling, Psychiatry, Bipolar I disorder, PDUFA, Pharmaceutical industry

The full text of the announcement from Bristol Myers Squibb is as follows:

Key Points: 
  • The full text of the announcement from Bristol Myers Squibb is as follows:
    Bristol Myers Squibb Completes Acquisition of Karuna Therapeutics, Strengthening Neuroscience
    PRINCETON, N.J.-- Bristol Myers Squibb (NYSE: BMY) today announced that it has successfully completed its acquisition of Karuna Therapeutics, Inc. (“Karuna”).
  • With the acquisition's completion, Karuna shares have ceased trading on the Nasdaq Global Select Market and Karuna is now a wholly owned subsidiary of Bristol Myers Squibb (“BMS”).
  • “We are excited to expand our neuroscience portfolio as we welcome Karuna to Bristol Myers Squibb,” said Chris Boerner, Ph.D., Chief Executive Officer, Bristol Myers Squibb.
  • Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

Royalty Pharma Reports Q4 and Full Year 2023 Results

Retrieved on: 
Thursday, February 15, 2024
MorphoSys, Pfizer, European Commission, Recurrence, Docetaxel, Roche, Cystic fibrosis, Share repurchase, FDA, Food, Schizophrenia, Growth, Sacituzumab govitecan, PTC, Vertex, Astellas Pharma, Risdiplam, Metastasis, Projection, KarXT, Bristol Myers Squibb, PTC Therapeutics, Endocrine gland, Lung cancer, Civil service commission, JAK, Therapy, Tourette syndrome, Webcast, Patient, Cytokinetics, Eastern Time Zone, Novartis, Ruxolitinib, NDA, Pharmaceutical industry

In October 2023, Royalty Pharma drew $350 million under its existing unsecured revolving credit facility, which was repaid during the fourth quarter of 2023.

Key Points: 
  • In October 2023, Royalty Pharma drew $350 million under its existing unsecured revolving credit facility, which was repaid during the fourth quarter of 2023.
  • Royalty Pharma began repurchasing its Class A ordinary shares in April 2023 under a $1.0 billion multi-year share repurchase program.
  • During the fourth quarter of 2023, Royalty Pharma announced new transactions of up to $1.6 billion.
  • Royalty Pharma will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2023 results today at 8:00 a.m., Eastern Time.

Anavex Life Sciences Reports Publication of ANAVEX®3-71 in Clinical Journal Confirming Pharmacokinetic Dose Proportionality of ANAVEX®3-71 in Humans

Retrieved on: 
Wednesday, January 24, 2024
KarXT, Food, DSM-IV codes, Drug development, SIGMAR1, Rett syndrome, Disease, KRTX, Alzheimer's disease, Central nervous system, Frontotemporal dementia, Doctor of Philosophy, Therapy, Deficit spending, Treatment, Pharmacology, Trial of the century, CNS, Pharmaceutical industry

The results from this PK evaluation demonstrated that ANAVEX®3-71, at single ascending doses of 5 to 200 mg, is linear, dose proportional, and time invariant.

Key Points: 
  • The results from this PK evaluation demonstrated that ANAVEX®3-71, at single ascending doses of 5 to 200 mg, is linear, dose proportional, and time invariant.
  • Food had no effect on the PK of ANAVEX®3-71.
  • This data also expands the safety objectives met in this first-in-human study of ANAVEX®3-71, further supporting its drug development program.
  • Phase 2 clinical trial in Schizophrenia with ANAVEX®3-71.”
    The paper can be accessed online at: https://pubmed.ncbi.nlm.nih.gov/38073274/ .

Royalty Pharma Highlights Accomplishments and Provides Business Update at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Conference, Economics, Bladder cancer, Growth, Heart, Bank statement, Nadofaragene firadenovec, Schizophrenia, Investment, Webcast, Cardiovascular disease, KarXT, Fine chemical

This represents underlying growth of 11% year-over-year prior to Biohaven-related payments and reflects the strong performance of Royalty Pharma’s diversified royalty portfolio.

Key Points: 
  • This represents underlying growth of 11% year-over-year prior to Biohaven-related payments and reflects the strong performance of Royalty Pharma’s diversified royalty portfolio.
  • Royalty Pharma also expects Net cash provided by operating activities to be approximately $2,980 million to $2,990 million for full year 2023.
  • Royalty Pharma’s management will host a conference call to discuss Royalty Pharma’s fourth quarter and full year 2023 results in February 2024.
  • Royalty Pharma will present at the 42nd Annual J.P. Morgan Healthcare Conference at 12:00 p.m.

Karuna Therapeutics Announces The Lancet Publication of Data from Phase 3 EMERGENT-2 Trial Evaluating KarXT in Schizophrenia

Retrieved on: 
Thursday, December 14, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, KRTX, Schizophrenia, Psychosis, Psychiatry, PANSS, Research, Manuscript, Patient, Safety, Therapy, Pharmaceutical industry, Lancet, KarXT

The manuscript shares KarXT data showcasing a clinically meaningful and statistically significant reduction in positive and negative symptoms of schizophrenia among adult patients experiencing acute psychosis, alongside a distinct tolerability profile.

Key Points: 
  • The manuscript shares KarXT data showcasing a clinically meaningful and statistically significant reduction in positive and negative symptoms of schizophrenia among adult patients experiencing acute psychosis, alongside a distinct tolerability profile.
  • Participants were randomized 1:1 to receive a twice-daily, flexible dose of KarXT or placebo.
  • KarXT was generally well tolerated, with overall discontinuation rates similar to placebo (KarXT 25% vs. placebo 21%).
  • Discontinuation rates due to treatment-emergent adverse events (TEAEs) were also similar between KarXT and placebo (7% vs. 6%, respectively).

PureTech Founded Entity Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia

Retrieved on: 
Wednesday, November 29, 2023
FDA, Pharmaceutical, Health, Mental Health, NDA, Neuropsychiatry, DSM-IV codes, KRTX, Safety, Employment, Food, Therapy, PureTech Health, Risk, PANSS, LSE, Nature, PRTC, Weight gain, New Drug Application, Master of Education, Housing, PDUFA, Psychiatry, Somnolence, Life, Pharmaceutical industry, Schizophrenia, KarXT

The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

Key Points: 
  • The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.
  • The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia.
  • PureTech is a founder of Karuna and co-inventor of the KarXT program.
  • If approved, KarXT will be the third therapeutic candidate to be taken from inception at PureTech to FDA regulatory approval.

Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia

Retrieved on: 
Wednesday, November 29, 2023
Mental Health, Health, FDA, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, NDA, Neuropsychiatry, DSM-IV codes, KRTX, Safety, Employment, Food, Therapy, Risk, PANSS, Nature, Weight gain, New Drug Application, Master of Education, Housing, Psychiatry, PDUFA, Somnolence, Life, Pharmaceutical industry, Schizophrenia, KarXT

The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

Key Points: 
  • The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.
  • “We are pleased the NDA for KarXT has been accepted, and we look forward to working with the FDA during the review process,” said Bill Meury, president and chief executive officer of Karuna Therapeutics.
  • “Diagnosis marks the beginning of an often long and tiresome search for effective and tolerable treatment options.
  • Notably, KarXT was not associated with common side effects of currently available antipsychotics, including weight gain, somnolence, and movement disorders.