Postherpetic neuralgia

Lexicon Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 2, 2023
Heart failure, NDA, Postherpetic neuralgia, Congress, PHN, Risk, Neuropathic pain, PDUFA, American College, Lexicon Pharmaceuticals, FDA, SGLT, DPN, Pharmaceutical industry, Cardiology

THE WOODLANDS, Texas, May 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended March 31, 2023 and provided an update on key corporate milestones.

Key Points: 
  • NDA for Sotagliflozin on Track for May 27th, 2023 PDUFA date
    THE WOODLANDS, Texas, May 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended March 31, 2023 and provided an update on key corporate milestones.
  • For the first quarters of 2023 and 2022, net loss included non-cash, stock-based compensation expense of $3.4 million and $2.8 million, respectively.
  • Cash and Investments: As of March 31, 2023, Lexicon had $105.9 million in cash and investments, as compared to $138.4 million as of December 31, 2022.
  • Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update.

Lexicon To Present Results From LX9211 Phase 2 Trial In Postherpetic Neuralgia At The 2023 American Academy Of Neurology (AAN) Annual Meeting And The British Pain Society (BPS) 56th Annual Scientific Meeting 2023

Retrieved on: 
Friday, April 21, 2023
Food, Fast Track, Suma, National University of Computer and Emerging Sciences, Doctor of Philosophy, Postherpetic neuralgia, BPS, The Woodlands, Texas, MD, Boston Convention and Exhibition Center, Neuropathic pain, Convention center, Poster, Lexicon Pharmaceuticals, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Treatment, Lexicon, BST, Pharmaceutical industry

THE WOODLANDS Texas, April 21, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc .

Key Points: 
  • THE WOODLANDS Texas, April 21, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc .
  • (Nasdaq: LXRX), today announced that results from RELIEF-PHN-1, a Phase 2 double-blind, placebo-controlled trial of its investigational drug LX9211 for the treatment of postherpetic neuralgia, will be presented during the Emerging Science session at the AAN Annual Meeting, April 22-27, in Boston, MA:
    RELIEF-PHN-1: A Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial of LX9211 in the Treatment of Postherpetic Neuralgia Pain - an oral presentation and poster (004), Monday April 24, 11:33-11:39 a.m.
  • LX9211 achieved significant and consistent benefits in the treatment of diabetic peripheral neuropathic pain in the RELIEF-DPN-1 study, from which full results were presented in November 2022.
  • LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for development in diabetic peripheral neuropathic pain.

Lexicon Pharmaceuticals Reports Fourth Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 2, 2023
PHN, American Heart Association, FDA, UACR, SGLT1, NDA, Albuminuria, Poster, Society, Treatment, Science, DPN, Heart failure, Patient, Pharmacokinetics, Efficacy, PDUFA, Congress, Therapy, SGLT, Neuropathic pain, Mortality, American College, Postherpetic neuralgia, Pharmaceutical industry, Cardiology, Safety

THE WOODLANDS, Texas, March 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and full-year ended December 31, 2022 and provided an update on key corporate milestones.

Key Points: 
  • THE WOODLANDS, Texas, March 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and full-year ended December 31, 2022 and provided an update on key corporate milestones.
  • Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2022 compared to the fourth quarter and full year of 2021.
  • For the fourth quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $3.3 million and $2.2 million, respectively.
  • Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update.

Acasti Pharma Reports Third Quarter 2023 Operational Results

Retrieved on: 
Tuesday, February 14, 2023
Bank statement, Subarachnoid hemorrhage, Toxicity, Caregiver, Brain, Dizziness, Nimodipine, NDA, AUC, Bupivacaine, Trial of the century, OS, Human, Blood, Postherpetic neuralgia, PK, Cmax, TSX, Hypoesthesia, Aes, Investment, SAH, Safety, Literature, Acquisition, Tmax, Anesthesiology, Patient, PHN, Telephone, AE, Skin, Food, Skull, Research, Government, Aneurysm, Risk, IM, SubArachnoid Space, Betamethasone, Plasma, Tongue, FDA, Nausea, A-T, Food and Drug Administration Amendments Act of 2007, Calendar, Bleeding, Type, Ataxia–telangiectasia, ACST, Pharmacokinetics, Rupture, Headache, Pharmaceutical industry, Vaccine, Cryptocurrency

LAVAL, Québec, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced financial and operational results for the third quarter ended December 31, 2022

Key Points: 
  • These positive results allow us to advance both programs to the next stage of clinical development in 2023.
  • We expect 2023 to be very exciting for Acasti with two of our drug candidates ready to enter Phase 3.
  • Topline results from this study were reported on December 23, 2022, and the results met all primary outcome measures.
  • Acasti will host a conference call on Tuesday, February 14, 2023, at 1:00 PM Eastern Time to discuss the Company’s corporate progress and other developments, as well as financial results for its quarter ended December 31, 2022.

Acasti to Host Conference Call on Tuesday, January 10, 2023 to Discuss Results from Recent Phase 1 PK Studies for GTX-101 and GTX-102 That Met All Outcome Measures

Retrieved on: 
Thursday, January 5, 2023
Bupivacaine, Calendar, Betamethasone, Pain, Pharmacokinetics, Telephone, Ataxia–telangiectasia, PK, Neuropathic pain, TSX, ACST, Trial of the century, Nerve Damage, A-T, Safety, FDA, Human, Pharmaceutical industry, Internet service provider, Postherpetic neuralgia

ET to review the recently reported preliminary topline results from two separate Phase 1 pharmacokinetic (PK) studies for GTX-101 and GTX-102.

Key Points: 
  • ET to review the recently reported preliminary topline results from two separate Phase 1 pharmacokinetic (PK) studies for GTX-101 and GTX-102.
  • Both studies successfully met all target outcome measures.
  • The conference call will be available via telephone by dialing toll free 844-836-8745 for U.S. callers or +1 412-317-6797 for international callers.
  • On December 28, 2022, Acasti announced that the preliminary topline results of the pharmacokinetic (PK) bridging study for GTX-102 met all primary outcome measures.

Acasti Pharma Announces Preliminary Topline Results Met All Primary Outcome Measures in the Single Dose Pharmacokinetic Study for GTX-101, the Company’s Drug Candidate for the Treatment of Postherpetic Neuralgia (PHN)

Retrieved on: 
Thursday, December 22, 2022
Standard of care, Bupivacaine, Calendar, Betamethasone, Pain, Blood, Pharmacokinetics, Gabapentin, Lidocaine, PHN, Ataxia–telangiectasia, PK, Neuropathic pain, Hydrogen chloride, TSX, Tmax, ACST, Skin, NDA, Toxicity, Risk, Trial of the century, Irritation, Nerve Damage, Patient, Plasma, Type, A-T, AUC, Safety, Physician, FDA, Headache, Human, Hypoesthesia, Postherpetic neuralgia, Cmax, Pharmaceutical industry, Risk management, Generic drug

The final clinical study report is anticipated to be received by the Company in the first half of 2023.

Key Points: 
  • The final clinical study report is anticipated to be received by the Company in the first half of 2023.
  • The potential benefits of GTX-101 could include faster onset of action and a longer duration of pain relief as compared to the lidocaine patch.
  • The study enrolled 48 healthy adult subjects (24 males/24 females, mean age = 36 years), in 12 subjects per cohort.
  • Following GTX-101 topical application: headache (3%) and numbness (3%) at the sprayed area, and
    In conclusion, this Single Dose PK study was conducted successfully, and it achieved all its primary outcome measures.

Lexicon Announces Topline Results From Phase 2 Proof-of-Concept Study of LX9211 in Postherpetic Neuralgia

Retrieved on: 
Wednesday, December 21, 2022
Death, Dizziness, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Neuropathic pain, Diabetic neuropathy, Week, Patient, Postherpetic neuralgia, Fast Track, Pharmaceutical industry

THE WOODLANDS, Texas, Dec. 21, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced topline results of RELIEF-PHN-1, its Phase 2 proof-of-concept study of LX9211 in postherpetic neuralgia. LX9211 achieved a reduction in average daily pain score (ADPS) of 2.42 from baseline at week 6 compared to a reduction of 1.62 in the placebo arm, with a placebo adjusted difference of 0.80 (p=0.12). Although these results did not reach statistical significance on the primary endpoint of the study, overall study results demonstrated clear evidence of effect. Separation of LX9211 from placebo on ADPS was seen at week 1 and maintained consistently thereafter, with an average placebo adjusted reduction over the 6 Week dosing period of 0.80 (p=0.03).

Key Points: 
  • Although these results did not reach statistical significance on the primary endpoint of the study, overall study results demonstrated clear evidence of effect.
  • “The RELIEF-PHN-1 study results are broadly consistent with the results achieved in our positive Phase 2 study of LX9211 in painful diabetic neuropathy (RELIEF-DPN-1) which enrolled over 300 patients.
  • LX9211 achieved significant and consistent benefits in the treatment of painful diabetic neuropathy in the RELIEF-DPN-1 study, from which full results were presented in November 2022.
  • LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for development in diabetic peripheral neuropathic pain.

Sorrento Therapeutics has Received FDA Clearance to Initiate Clinical Trials with a Next Generation mRNA (STI-1557) Vaccine Against Omicron SARS-CoV-2 Virus

Retrieved on: 
Tuesday, December 6, 2022
Phase, Vaccination, Annual report, Degenerative disease, Nucleic acid, SAN, Security (finance), Cell Press, Antibody, Autoimmune disease, FDA, LNP, Omicron, PHN, Safety, US, CD8, Cancer, RNA transfection, JMCB, Delta, Pain, Trial of the century, Vaccine, Risk, Sciatica, Osteoarthritis, TRPV1, Time-invariant system, Mutation, Severe acute respiratory syndrome coronavirus 2, Therapy, RTX, Injection, Postherpetic neuralgia, Furin, Patient, Cell, IM, Pharmaceutical industry, Generic drug, Journal, COVID-19

SAN DIEGO, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") has received clearance from the US FDA to initiate clinical trials with STI-1557, its next generation mRNA vaccine against SARS-CoV-2 Omicron variants.

Key Points: 
  • SAN DIEGO, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") has received clearance from the US FDA to initiate clinical trials with STI-1557, its next generation mRNA vaccine against SARS-CoV-2 Omicron variants.
  • Sorrento plans to pursue more advanced mRNA vaccine strategies in the future with the Sofusa MuVaxx lymphatic delivery system.
  • Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19.
  • ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.
    All other trademarks are the property of their respective owners.

Sorrento Announces Positive Phase II Results of PD-L1 Checkpoint Inhibitor IMC-001 Presented at Asian Congress of the European Society for Medical Oncology (ESMO)

Retrieved on: 
Monday, December 5, 2022
Samsung Medical Center, Phase, ESMO, Extranodal NK/T-cell lymphoma, nasal type, Annual report, SAN, Incidence, Immunoglobulin G, Partnership, Security (finance), Antibody, Autoimmune disease, FDA, PHN, Safety, Cancer, Congress, PD-1, Pain, Trial of the century, RTX, Risk, ADCC, Recurrence, Vaccine, European Society for Medical Oncology, Principal, Sciatica, CD47, Osteoarthritis, Toxicity, Oncology, Radiation, TRPV1, FC, Therapy, Postherpetic neuralgia, Patient, PD-L1, Pharmaceutical industry, Generic drug, COVID-19

ImmuneOncia is a biotechnology company specializing in immuno-oncology drug development, jointly established by Yuhan Corporation of Korea and Sorrento .

Key Points: 
  • ImmuneOncia is a biotechnology company specializing in immuno-oncology drug development, jointly established by Yuhan Corporation of Korea and Sorrento .
  • The Phase II NK/T-cell lymphoma study was selected for an oral presentation at the Asian Congress of the European Society for Medical Oncology (ESMO Asia 2022) in Singapore on December 4th, 2022.
  • Due to the absence of standard-of-care treatment for relapsed/refractory cases, NK/T lymphoma represents a high unmet medical need and significant market opportunity.
  • RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients.

Sorrento Releases Positive Topline Results from the Phase I Study Completed in Australia and Preliminary Results from a Phase Ib Study in China with STI-1558, an Oral M(pro) Inhibitor as a Standalone Treatment for COVID-19 without the Need for Ritonavir B

Retrieved on: 
Tuesday, November 29, 2022
SAN, Wireless ambulatory ECG, CYP3A4, Bilirubin, Therapy, Osteoarthritis, Security (finance), BID, Sciatica, Severe acute respiratory syndrome coronavirus 2, NMPA, Cathepsin L, Pharmacokinetics, TRPV1, PK, User experience, Pain, Patient, Risk, Trial of the century, University of Novi Sad Faculty of Technical Sciences, FDA, Autoimmune disease, SAD, RNA, Phase, Mpro, Toxicity, Postherpetic neuralgia, Annual report, Death, AES, Liver, AUC, Headache, Antibody, RTX, Viral load, Vital signs, PHN, AE, PCR, Cancer, Ritonavir, Vaccine, Generic drug, Copper, Pharmaceutical industry, COVID-19, Safety, Tolerability

There were no severe or serious AEs, no premature discontinuation of STI-1558 due to an AE, and no deaths.

Key Points: 
  • There were no severe or serious AEs, no premature discontinuation of STI-1558 due to an AE, and no deaths.
  • Even the lowest dose produced trough levels significantly above the EC90 value for viral inhibition of STI-1558.
  • A similar Phase I/Ib SAD/MAD study has been fully enrolled in China in both healthy subjects and patients infected with SARS-CoV-2.
  • The liver enzyme elevations occurred late ( 5 days) in study treatment and resolved without the need for any treatment.