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This is the great US-Market, its normal ?
05/10/2023 7:22:39 EDTI 1 x 4.888
05/10/2023 7:22:23 EDTI 1 x 4.892
05/10/2023 7:22:20 EDTI 2 x 4.891
05/10/2023 7:21:52 EDTI 3 x 4.912
05/10/2023 7:21:47 EDTI 5 x 4.925
05/10/2023 7:19:29 EDTI 1 x 5.091
05/10/2023 7:19:17 EDTI 2 x 5.10
Look, Wallstreet is selling !!!
04/17/2023 12:49:30 EDT 14.336214
04/17/2023 12:49:12 EDT 14.38100
04/17/2023 12:49:02 EDTI 14.3320
04/17/2023 12:48:53 EDTI 14.381
04/17/2023 12:48:42 EDTI 14.4123
04/17/2023 12:47:14 EDTI 14.3320
04/17/2023 12:47:06 EDTI 14.3810
04/17/2023 12:47:06 EDTI 14.391
04/17/2023 12:47:06 EDTI 14.3810
04/17/2023 12:47:06 EDTI 14.3810
04/17/2023 12:47:06 EDTI 14.38
It's unbelievable, we are in the middle of a real earthquake.
If, yes, if all the control organizations would work. This neoliberal agenda of deregulation could be the beginning of the end with our example.
Sorrento with JJ are laying the groundwork to stop these brute capitalist machinations of Wall Street.
What we need is media publicity to expose everything. It would be so, so important and good for this financial center.
In the reddit forum someone wrote about fish food for piranhas.
Guys, we were the fish food for years. I find it very symphatic to be a piranha.
These are the cute little fish with the horny teeth
hehe ...
www.reddit.com
and search for r/srne and
r/BANDOFBROTHERSOFSRNE
Here you will find a lot of good dd ...
So far 6 Srne - 1 Scylex
Sales not for May ...
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. This mRNA vaccine incorporates a mutation in the furin cleavage site that prevents the S1 subunit cleavage from the spike protein from anchoring on the muscle cell membrane. This modification was introduced to prevent the leakage of S1 subunit from the expressed spike protein (S protein) into the blood circulation, which is known in part to potentially cause undesirable side effects in vital organ tissues following administration of the current FDA-approved mRNA vaccines. The mRNA is encapsulated in a Sorrento proprietary lipid nanoparticle formulation (LNP) to protect mRNAs from degradation and enable potent translation of the S protein in host cells after intramuscular (IM) delivery, thus inducing an adaptive immune response.
The preclinical work that supported this investigational new drug application has been published online in Molecular Therapy Nucleic Acids, a Cell Press partner journal. The paper (https://www.cell.com/molecular-therapy-family/nucleic-acids/fulltext/S2162-2531(22)00287-6), titled “Chimeric mRNA-based COVID-19 vaccine induces protective immunity against Omicron and Delta variants,” will appear in print in the December 2022 issue of the journal.
Sorrento plans to pursue more advanced mRNA vaccine strategies in the future with the Sofusa MuVaxx lymphatic delivery system. This proprietary microneedle system delivers vaccines intradermally and, in animal models with an mRNA vaccine candidate, demonstrated improved humoral immunity and superior cellular immunity with 1/10th of the IM dose. This preclinical work has been accepted for publication by the Journal of Molecular Cell Biology (JMCB) (https://academic.oup.com/jmcb/advance-article/doi/10.1093/jmcb/mjac041/6634240), “Delivering an mRNA vaccine using a lymphatic drug delivery device improves humoral and cellular immunity against SARS-CoV-2.” In these preclinical studies using MuVaxx, immune responses were elicited and maintained at a 10-fold dose reduction compared to traditional IM administration as measured by anti-spike antibodies, cytokine-producing CD8 T cells, neutralizing antibodies. Remarkably, a 4-fold elevated T cell response was also observed in MuVaxx administered vaccination compared to that of IM administered vaccination. This microneedle system delivers the vaccine into at the epidermal/dermal boundary and is virtually pain free. These next generation advances may provide important alternative to the vaccines in the U.S. and enable improved access globally in countries like Mexico, Brazil, and China where mRNA-based vaccines are not readily available.
SAN DIEGO, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) is pleased to announce the results of a Phase II NK/T-cell lymphoma study of IMC-001, a PD-L1 monoclonal antibody licensed to ImmuneOncia Therapeutics, LLC (“ImmuneOncia”) (Seongnam, South Korea). ImmuneOncia is a biotechnology company specializing in immuno-oncology drug development, jointly established by Yuhan Corporation of Korea and Sorrento. In addition to IMC-001, ImmuneOncia has a wide range of new products in the pipeline, such as IMC-002, a CD47 antibody, and IMC-201, a bispecific antibody.
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. The clinical data demonstrated that in patients with heavily treated NK/T-cell lymphoma, 6 of 10 evaluable patients (60%) not only achieved an objective response, but all 6 patients with an objective response also achieved a complete remission with IMC-001. Additionally, 4 of these 6 patients stayed on treatment for over a year, which provides encouraging indication of long-term IMC-001 treatment safety and durable efficacy.
NK/T-cell lymphoma is a rare cancer that is most prevalent in Asian countries, including China and Korea, and is typically treated with a regimen of radiation and chemotherapy. NK/T-cell lymphoma has a high recurrence rate of 75% within two years. 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. To date, no single immuno-oncology drug has obtained approval in this indication.
Professor Won Seog Kim of Samsung Medical Center, the presenter and Principal Investigator of the IMC-001 study, commented, “The complete remission and response rate of 60% of IMC-001 significantly outperformed currently available drugs for the treatment, and very rare adverse events of grade 3 or higher also limit concerns over the side effects, making it a leader among PD-L1 drugs. We expect these results to satisfy the criteria for approval.”
Heung Tae Kim, Chief Executive Officer of ImmuneOncia said, “This achievement sets a new standard for the second-line treatment of NK/T-cell lymphoma, which has high unmet needs. ImmuneOncia is preparing additional clinical trials to expand its indications in solid cancer.”
Henry Ji, Ph.D., Chief Executive Officer of Sorrento commented, “We expect to leverage these data to create momentum to secure additional partnership and co-development opportunities for IMC-001 in regions with a high incidence of NK/T-cell lymphoma, such as China, as well as in other indications.”
IMC-001 is a PD-L1 antibody, a fully human immune checkpoint inhibitor, that serves as the basis of the current immuno-oncology market. This antibody activates the anticancer functions of T cells by strongly inhibiting the binding between PD-1 expressed on T cells and PD-L1 expressed on the surface of cancer cells. Moreover, it can mediate ADCC (antibody-dependent cellular cytotoxicity) against tumor cells, as it maintains the Fc effector function using human IgG1.
New 8k
On December 2, 2022, the arbitrator in the NantCell/NANTibody Arbitration issued an award granting contractual damages and pre-award interest in the amounts of $156,829,562 to NantCell and $16,681,521 to NANTibody, exclusive of post-award, prejudgment interest, which will accrue at 9% per annum (the “Award”). The Company believes the Award was wrongly decided and is evaluating next steps, including, among other things, potential grounds to vacate, modify, or correct the Bullish
The Award is limited to the NantCell/NANTibody
Arbitration and does not resolve the additional, previously disclosed legal proceedings brought by Sorrento against Patrick Soon-Shiong
and entities controlled by him, which remain pending.
Specifically, as previously disclosed, in April
2019, the Company filed an arbitration demand against NantPharma, LLC (“NantPharma”) and its Chief Executive Officer Patrick
Soon-Shiong, seeking several hundred million dollars in damages for alleged breaches of the Stock Sale and Purchase Agreement,
dated May 14, 2015, entered into between NantPharma and the Company, arising out of NantPharma’s purchase of the drug Cynviloq™
from the Company in May 2015. Sorrento’s claims against NantPharma remain
pending before the American Arbitration Association, and have been submitted to the arbitrator for a decision, which is currently expected
later this year.
ATLANTA and SAN DIEGO, Nov. 13, 2022 (GLOBE NEWSWIRE) -- Sofusa®, a wholly-owned division of Sorrento Therapeutics (Nasdaq: SRNE, “Sorrento”), today announced that it will host a virtual Key Opinion Leader (KOL) panel discussion titled “Empowering the Lymphatics: Unleashing the Potential of Biologics that Target the Immune System” to be held on Thursday, November 17, 2022 at 11:30 AM EST.
The event will feature a deep dive and discussion of the clinical study design and clinical data demonstrating improved therapeutic outcomes and lymphatic functioning in rheumatoid arthritis (RA) patients receiving the Sofusa Lymphatic Drug Delivery System (Sofusa) treatment. Patients who were enrolled in this study had inadequate response to the standard dose of an approved TNF inhibitor subcutaneous (SC) treatment, and 10 of 10 patients achieved a significant improvement in disease activity and lymphatic function following initiation of Sofusa lymphatic treatment, with dose levels at half of the prior SC dose or less. This data was accepted and presented today at the American College of Rheumatology (ACR) Convergence 2022 meeting in Philadelphia.
Chris Jeffers, Ph.D., J.D., Chief Executive Officer of Mayflower BioVentures and Hibiscus BioTechnology, will moderate this panel discussion following the ACR conference. Speakers for the event include:
Roel Querubin, M.D., Board Certified Rheumatologist, Atlanta Research Center for Rheumatology and Marrieta Rheumatology AssociatesVibeke Strand, M.D. Adjunct Clinical Professor, Division of Immunology and Rheumatology, Stanford University School of MedicineMike Royal, M.D., Chief Medical Officer, SorrentoBrian Cooley, Senior Vice President, Head of Sofusa Lymphatic Drug DevelopmentRussell Ross, Ph.D., Chief Technical Officer, Sofusa Lymphatic Drug Development
To register for the live event, please visit the Online Experiences website. Detailed biographies for all the speakers can be accessed here.
Following the live webcast, an archived replay will be available on the Company’s website at Events Calendar - Sorrento Therapeutics.
About Sorrento’s Sofusa Business Unit
The Sofusa Business Unit is a wholly owned division of Sorrento based in Atlanta, Georgia and is focused on lymphatic drug development with pre-clinical, analytical, clinical development, and device manufacturing capabilities. The Sofusa platform is a novel microneedle technology that delivers both small and large molecule drugs through the skin and into the initial lymphatic capillaries resulting in significantly higher drug concentrations in lymph nodes over sustained periods of time compared to traditional injections or infusions. Drug targets for many diseases of the immune system (e.g., autoimmune diseases and cancer) reside in the lymphatic system and lymph nodes. In multiple pre-clinical models, Sofusa’s proprietary nanotopography-draped microneedle system has consistently demonstrated the ability to improve therapeutic responses by delivering over 40-fold increases in drug concentration to targeted lymph nodes when compared to traditional subcutaneous injections or intravenous infusions. The Sofusa Business Unit is currently conducting human proof of concept studies in autoimmune disease and in cancer.
PALO ALTO, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that shares of its common stock will trade on the Nasdaq Capital Market on Friday, November 11, 2022 under the ticker symbol “SCLX”. Scilex’s trading debut comes after the completion of its business combination with Vickers Vantage Corp. I, a special purpose acquisition company (the “Business Combination”). The combined company now operates as Scilex Holding Company.
Scilex Holding Company is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life.
Henry Ji, Ph.D., Executive Chairman of Scilex and Chairman and Chief Executive Officer of Sorrento, and Jaisim Shah, President and Chief Executive Officer of Scilex, will lead the ceremony alongside other members of Scilex’s executive team, and Scilex and Sorrento board members. “This is an extremely exciting moment for the Scilex team. Ringing the opening bell at Nasdaq is indicative of our team’s hard work and celebration of our continued growth”, said Henry Ji, Ph.D. “I am confident and excited for Scilex’s future growth and journey ahead.”
Scilex Holding Company will ring the Nasdaq opening bell at 9:30 a.m. ET on Friday, November 11, 2022. Watch the ceremony live on Nasdaq’s livestream.
About Scilex Holding Company
Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics, Inc., is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Results from the Phase III Pivotal Trial C.L.E.A.R Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain. Scilex launched its first commercial product in October 2018, in-licensed a commercial product in June 2022, and is developing its late-stage pipeline, which includes a pivotal Phase 3 candidate and one Phase 2 and one Phase 1 candidate. Its commercial product, ZTlido® (lidocaine topical system) 1.8%, or ZTlido®, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain. Scilex in-licensed the exclusive right to commercialize Gloperba® (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex is planning to commercialize Gloperba® in 2023 and is well-positioned to market and distribute the product. Scilex’s three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status; SP-103 (lidocaine topical system) 5.4%, a Phase 2, triple-strength formulation of ZTlido®, for the treatment of low back pain, with FDA Fast Track status; and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia in multiple Phase 1 programs expected to be initiated this year. For further information regarding the SP-102 Phase 3 efficacy trial, see NCT identifier NCT03372161 – Corticosteroid Lumbar Epidural Analgesia for Radiculopathy – Full Text View – ClinicalTrials.gov.
Scilex Holding Company is headquartered in Palo Alto, California, with operations in both Palo Alto and San Diego, California. For further information please visit www.scilexholding.com.
PALO ALTO and NEW YORK, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX and SCLXW), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and Vickers Vantage Corp. I, a special purpose acquisition company, today announced the closing of their previously announced business combination (the "Business Combination").
The Business Combination was approved by Vickers’s shareholders at its Extraordinary General Meeting held on November 9, 2022 (the “Meeting), along with all other proposals presented at the Meeting including a proposal to redomesticate Vickers prior to the Business Combination from the Cayman Islands to Delaware. The combined company will operate as “Scilex Holding Company” on November 11, 2022, its shares of common stock and warrants are expected to begin trading on the Nasdaq Capital Market under the ticker symbols “SCLX” and “SCLXW,” respectively.
“Scilex is entering an exciting phase as the resources of the public capital markets will be available to enhance our business growth and enable us to continue to fulfill our mission to address patient pain management needs”, said Henry Ji, Ph.D., Executive Chairman of Scilex and Chairman and Chief Executive Officer of Sorrento. “With Scilex on its way to becoming a publicly-traded entity, our unique model continues to demonstrate the multiple ways in which we are generating value at Sorrento, including equity stakes in public and private entities, royalties and milestone payments due to us from certain proprietary products, pharma collaborations worldwide to advance core programs, and most importantly, our rapidly progressing and advanced wholly-owned pipeline which we see as our major value driver going forward. We appreciate our partnership with the team at Vickers as we prepare for this next chapter.”
“Our Scilex team and I are proud to continue our leadership in the creation of prescription non-opioid therapeutics addressing acute and chronic pain," said Jaisim Shah, President and Chief Executive Officer of Scilex. "As a public company, we aim to accelerate our mission to increase access to prescription non-opioid therapeutics by further commercializing our two FDA-authorized non-opioid pain management products, expanding public and private payer adoption, and advancing our pipeline of innovative opioid sparing products. We are grateful to all of our investors for supporting us through our successful transition."
Paul Hastings LLP served as legal counsel to Scilex. Loeb & Loeb, LLP served as legal counsel to VCKA
10 Q is out ...
Agree, we have many more questions than answers ...
SCILEX HOLDING COMPANY ("SCILEX"), A SORRENTO COMPANY (NEARLY 100% OR OVER 99.9% MAJORITY-OWNED SUBSIDIARY OF SORRENTO THERAPEUTICS, INC.) (NASDAQ: SRNE, "SORRENTO"), AND VICKERS VANTAGE CORP. I ANNOUNCE EFFECTIVENESS OF REGISTRATION STATEMENT ON FORM S-4, DATE OF VICKERS VANTAGE EXTRAORDINARY GENERAL MEETING TO APPROVE PROPOSED BUSINESS COMBINATION
My glass is half full, your glass is half empty ...
Here we go ...
SORRENTO SUCCESSFULLY COMPLETES PHASE 1 STUDY AND IS PROCEEDING TO IMPLEMENT GLOBAL REGISTRATIONAL TRIALS WITH STI-1558, AN ORAL MPRO INHIBITOR AS A STANDALONE ORAL TREATMENT AND PREVENTION OF COVID-19 WITHOUT THE NEED FOR A RITONAVIR BOOSTER
Phase 1 Study (with 58 healthy volunteers) of STI-1558 was completed in Australia with 300 mg, 600 mg, 1,200 mg and 2,000 mg doses in the single ascending dose (SAD) portion of the study and 300 mg, 600 mg and 800 mg BID (twice a day) daily for 7.5 days in the multiple ascending dose (MAD) portion of the study.The pharmacokinetics (PK) were dose proportional in the SAD study. In the MAD study, the 600 mg BID dose cohort achieved trough concentrations (C trough ) significantly above the EC 90 value for viral inhibition by STI-1558 and no accumulation was seen in the subjects, supporting a 600 mg twice daily dose for 5 days as the recommended dose for standalone treatment without ritonavir as booster.There were no serious adverse events (SAEs) or severe treatment emergent adverse events (TEAEs) and the maximum tolerated dose (MTD) was not reached in either the SAD (up to 2000 mg) or the MAD (up to 800 mg BID daily for 7.5 days) portions of the study.Global registrational Phase 2/3 trials of STI-1558 as a standalone treatment of COVID-19 are proceeding and are expected to be implemented rapidly in the US, Mexico, China, Australia and other regions.
SAN DIEGO, Oct. 17, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced the completion of a Phase 1 study of its oral main viral protease (M pro ) inhibitor, the STI-1558 in 58 healthy volunteers.
The Phase 1 safety and PK study in healthy volunteers was conducted in Australia. The study (MPR-COV-101AU) is entitled: “A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of STI-1558 in Healthy Volunteers.” In the SAD portion of the study, 4 dose-escalation cohorts (single oral dose of 300 mg, 600 mg, 1200 mg, and 2000 mg STI-1558 or placebo) were conducted with 8 subjects in each cohort, randomized 3:1 (active:placebo, except for an additional cohort at the Cohort 2 dose for the PK of fasted and fed dosing with 10 subjects randomized 4:1). In the MAD portion of the study, 3 dose-escalation cohorts with daily doses of 300 mg BID, 600 mg BID or 800 mg BID for consecutive 7.5 days (total 15 doses) were conducted with 8 subjects in each dose cohort randomized 3:1 (active:placebo).
The preliminary blinded safety and PK data from the SAD and MAD portions of the study are available. Overall, there were no changes in vital signs, physical examinations, ECGs or safety clinical labs resulting from study participation. The preliminary summary of treatment-emergent adverse events (TEAEs) showed that there were no serious AEs (SAEs) or severe TEAEs and the maximum tolerated dose was not reached in either the SAD or MAD portions of the study. No dose limiting toxicities were noted and there were no premature terminations from the study post-treatment.
The linear and semi-log plots for doses from 300 mg to 2000 mg (Cohorts 1-4) are proportional in the SAD portion. In the 600 mg BID dose cohort of the MAD portion, the trough concentration (C trough ) was significantly above the EC 90 value of predicted value for viral inhibition and no accumulation was seen, supporting a 600 mg twice-daily dose as a recommended dose for standalone treatment without ritonavir booster. In preclinical study, STI-1558 has shown sufficient lung tissue penetration and dual inhibition of M pro for viral replication and cathepsin L for viral entry to host cells, indicating a potential robust antiviral activity in COVID-19 patients.
A phase 1 trial in participants infected with SARS-CoV-2 has been initiated in China (MPR-COV-101CN), and a total 56 participants will be enrolled to assess the safety, tolerability, and efficacy in 3 MAD dose cohorts (300 mg BID, 600 mg BID and 800 mg BID daily for 7.5 days). Eight participants infected with SARS-CoV-2 in the first MAD dose cohort of 300 mg BID have been dosed.
A large Phase 2 registrational study is planned in Mexico that could support an Emergency Use Authorization (EUA) in Mexico with potential for distribution throughout Latin America. Registrational Phase 2/3 trials in US, China and other major regions have also been planned.
“The successful completion of the Phase 1 in Australia allows us to move STI-1558 forward quickly with registrational Phase 2/3 studies in the US, Mexico, and China,” stated Henry Ji, Ph.D., Chairman, President and CEO of Sorrento. “These results confirm the pharmacokinetics for this antiviral treatment are appropriate for a standalone treatment for COVID patients.”
New Video - it is called COVI MARK AFF
Today not to find ?
8K is out ...
Item 1.02. Termination of a Material Definitive Agreement
On September 28, 2022, Scilex Pharmaceuticals Inc. (“Scilex Pharma”), an indirect subsidiary of the Company, repurchased (the “Repurchase”) all of the outstanding Senior Secured Notes due 2026 that were issued by Scilex Pharma on September 7, 2018 (the “Notes”). As of immediately prior to the Repurchase, the aggregate principal amount of the Notes was approximately $67.7 million, and Scilex Pharma repurchased the Notes for an aggregate cash payment of approximately $39.7 million as the holders of the Notes forgave and discharged an aggregate of $28.0 million of principal amount of the Notes in connection with the Repurchase.
The Notes were governed by that certain indenture, dated September 7, 2018 (as amended, the “Indenture”), by and among Scilex Pharma, the Company, as parent guarantor, and U.S. Bank Trust Company, National Association (as successor in interest to U.S. Bank National Association), as trustee and collateral agent (the “Trustee”) and were secured by assets of Scilex Pharma related to ZTlido™ (lidocaine topical system 1.8%), including the property and assets of Scilex Pharma necessary for, or otherwise relevant to, the manufacture and sale of ZTlido™ (lidocaine topical system 1.8%), on a worldwide basis (exclusive of Japan). Pursuant to the Indenture, the Company had agreed to irrevocably and unconditionally guarantee, on a senior unsecured basis, the punctual performance and payment when due of all obligations of Scilex Pharma under the Indenture (the “Guarantee”). The security interests and liens granted in connection with the Indenture and Notes, as well as the Notes, the Indenture and the Guarantee, were terminated in connection with the Repurchase and the discharge of indebtedness thereunder.
Item 2.04. Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement.
The information set forth in Item 1.02 is hereby incorporated by reference in its entirety into this Item 2.04.
Our doctor bought 88,888 shares. A strong buy signal
Scilex Holding Company (“Scilex”), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, today announced that FDA has granted fast track designation for its investigational drug and device product candidate, SP-103. Scilex is a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”).
Scilex is developing SP-103 to be a non-opioid triple-strength, non-aqueous lidocaine topical system for the treatment of acute LBP. If approved, SP-103 could become the first FDA-approved lidocaine topical product for the treatment of acute LBP. Acute LBP can range in intensity from a dull, constant ache to a sudden, sharp sensation that leaves the person incapacitated. According to the CDC in 2020, LBP was the most common type of pain reported by patients, with 25% of U.S. adults reporting LBP in the prior 3 months1. LBP is estimated to have a total potential global market opportunity of approximately $10.0 billion by 2026.2
“We are pleased that the FDA has granted Fast Track Designation for SP-103,” said Dr. Dmitri Lissin, Chief Medical Officer of Scilex. “The FDA's decision to place SP-103 in a category that may enable expedited development and review is an important milestone for Scilex.”
There are currently no approved pharmaceutical treatments specifically indicated for the treatment of acute LBP. The market Scilex intends to address with SP-103, if approved, includes etiologies that are currently treated with non-procedural or non-surgical interventions, and where available treatments provide inadequate pain relief or result in unacceptable adverse effects. These treatments may include NSAIDs, antidepressants and opioids, as well as off-label use of lidocaine patches.
“We are very pleased that the FDA has granted Fast Track designation for the non-opioid SP-103 program, the next generation triple strength formulation of ZTlido®,” said Jaisim Shah, President and Chief Executive Officer of Scilex. There are currently very limited approved treatment options for acute low back pain, a serious condition the prevalence of which continues to rise, leaving this affected group with very limited safe and effective treatment options to date. Receiving this designation underscores the potential of the ZTlido® platform and the need for a new therapy like SP-103 that may improve outcomes for those with this serious debilitating condition.”
The safe and effective treatment of acute LBP represents high unmet needs and creates a large market opportunity. LBP is one of the costliest musculoskeletal conditions in industrialized countries. Experts have estimated that approximately 80% of Americans will experience LBP during their lifetime. The annual prevalence of LBP is 15% to 45% with a point prevalence of approximately 30% in the United States. Sixty percent of those who suffer from acute LBP recover in six weeks and up to 80-90% recover within 12 weeks. However, the recovery of the remaining patients with LBP is less certain. LBP accounts for 19% of all workers’ compensation claims in the United States.3 Americans spent at least $135 billion in 2016 on treating low back and neck pain, which was the highest expenditure among 154 conditions studied by the Department of the Institute for Health Metrics and Evaluation at the University of Washington.4
Scilex’s triple-strength SP-103 is an investigational, non-aqueous lidocaine topical system undergoing clinical development in acute LBP conditions. SP-103 builds on the learnings from Scilex’s FDA-approved product, ZTlido® (topical lidocaine system) 1.8%, because both products share the same adhesive drug delivery formulation and manufacturing technology. Scilex believes that, if approved, SP-103 could become the first FDA-approved lidocaine topical product for acute LBP indications. All current uses of topical lidocaine products for acute LBP are off-label. SP-103 has three times the drug load of ZTlido® (108 mg versus 36 mg) in the same adhesive system to potentially deliver a three-fold level of the drug within a targeted area, but retaining the convenience of a single topical system. Additionally, SP-103 is designed to deliver a localized dose of lidocaine that is three times greater than any lidocaine topical product that Scilex is aware of either on the market or in development. Scilex believes that, if approved, SP-103 may be able to address the limitations of prescription lidocaine patches in treating acute LBP by delivering a higher dose of lidocaine to the application site. As part of the lifecycle management, Scilex will also target localized musculoskeletal pain, acute and chronic pain conditions, and post-operation pain management, to focus on developing and commercializing non-opioid therapies for patients with acute and chronic pain. Scilex expects to complete its current Phase 2 trial of SP-103, randomized, double-blind, placebo controlled, parallel group, multicenter study to evaluate the safety and efficacy in subjects with acute lower back pain (LBP) in 10 U.S. sites, in Q1-2023. The outcome should enable planning of subsequent Phase 3 trial(s). ClinicalTrials.gov link: Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain - Full Text View - ClinicalTrials.gov
Under Section 561A(f)(2) of the United States Federal Food, Drug, and Cosmetic Act, Scilex is required to make our expanded access policy for SP-103 (lidocaine topical system) 5.4% publicly available by September 10, 2022 (within 15 days of the signature date of the FDA Fast Track letter).
Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) (“Vickers”), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, have entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the “Combined Company”) will be renamed Scilex Holding Company, and its common stock and warrants to purchase common stock are expected to be listed on Nasdaq under the ticker symbol “SCLX” and “SCLXW”, respectively. The boards of directors of each of Vickers, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur in the third quarter or early fourth quarter of 2022, is subject to the approval of Vickers’s and Scilex’s shareholders and the satisfaction or waiver of certain other customary closing conditions.
SRNE Short Interest
SETTLEMENT DATE SHORT INTEREST AVG. DAILY SHARE VOLUME DAYS TO COVER
08/15/2022 55,133,826 8,341,782 6.609358
07/29/2022 60,200,790 9,179,004 6.558532
07/15/2022 56,972,598 10,579,070 5.385407
06/30/2022 60,074,801 16,552,675 3.629311
06/15/2022 51,964,976 9,209,917 5.642285
Premarket Volume 470.000 in 14 min.
Look at the so called Market, they are working every second to hold this down ...
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced positive results from a pivotal study of Abivertinib on 209 response evaluable, heavily pretreated NSCLC patients by an IRC assessment with matured long-term follow up data.
Abivertinib is a pyrrolopyrimidine-based, third-generation EGFR inhibitor, which is structurally distinct from osimertinib. Abivertinib selectively inhibits EGFR-activating and resistant mutation with nearly 300-fold greater potency as compared with wild-type EGFR. Previously, a positive interim result assessed by investigators was published in the peer-reviewed Clinical Cancer Research journal with interim data (https://clincancerres.aacrjournals.org/content/early/2021/11/04/1078-0432.CCR-21-2595). In these IRC-assessed preliminary topline results with more matured long-term follow up data (previously 16.8 months, now 38.8 months), Abivertinib showed significant treatment benefits in 209 response evaluable, heavily treated NSCLC patients with ORR of 56.5%, and notably a significant CR rate was seen with Abivertinib (5.3%) in comparison with that of osimertinib (Tagrisso) (0.5%)*, while the ORR rate is comparable between the two drugs. This combined data, the ORR of 56.5%, the CR rate of 5.3%, and median OS of 28.2 months (versus Tagrisso’s median OS of 26.8 months)**, is potentially superior to that of the approved third generation EGFR inhibitor (osimertinib). Abivertinib demonstrated significantly efficacious effects in overcoming the resistant mutation in NSCLC. Based on these results, Sorrento is closing the study and preparing the pre-NDA materials and NDA package. Sorrento will request a pre-NDA meeting with the FDA and other regulatory agencies around the world with potential NDA filings pending agreements with the regulatory agencies in different countries.
“We are very encouraged by the significant positive results of Abivertinib assessed by the IRC with long-term follow up data and look forward to meeting with the FDA and other regulatory authorities for the possibility of bringing Abivertinib to the U.S. and global markets,” said Dr. Henry Ji, Chairman and CEO of Sorrento. Abivertinib is one of the multiple clinical and pre-clinical stage assets obtained by Sorrento in the previously completed acquisition of ACEA Therapeutics, Inc. in June of 2021.
*https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000MedR.pdf
** https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208065s025lbl.pdf
PALO ALTO, Calif., Aug. 17, 2022 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex”), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, today announced the signing of a Product Distribution Agreement (“Agreement”) for certain designated territories with CH Trading Group LLC (“CH Trading”), an international import, export and trading company focused on the Middle East and North Africa (MENA) Region and other markets, to distribute Scilex’s lead non-opioid commercial pain management product, ZTlido ® . Scilex is a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”).
“Our Agreement with CH Trading is another significant step in our continuing efforts to expand our global presence with our portfolio of innovative non-opioid pain management products, to address unmet medical needs. We are extremely pleased to collaborate with CH Trading, whose deep expertise and relationships will help us build a solid foundation in key MENA Region and other markets,” said Henry Ji, Ph.D., Executive Chairman of Scilex and Chairman and Chief Executive Officer of Sorrento.
“We are pleased to work with CH Trading to help support us through the processes of obtaining global Halal certification as well as regulatory approval in the overseas designated territories, so that we may continue to fulfill our mission to address patient pain management needs with ZTlido ® ,” said Jaisim Shah, Chief Executive Officer of Scilex.
BLACKROCK just added aprox 12 milions shares !!
CITI Group just added 1,341,465 share...!!!
... delayed to 19. August ...
10 Q is out ...
After one hour 4.5 mill volume ...
not bad
SAN DIEGO, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced the completion of the SAD portion of the Phase 1 study of its oral main viral protease (Mpro) inhibitor, the STI-1558.
The Phase 1 safety and PK study in healthy volunteers was conducted in Australia. The MPR-COV-101AU study is entitled: “A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of STI-1558 in Healthy Volunteers”. In the SAD portion of the study, 4 dose-escalation cohorts (single oral dose of 300, 600, 1200, and 2000 mg STI-1558 or placebo) with 8 subjects in each cohort randomized 3:1 (except for Cohort 2 for the fasted and fed dosing with 10 subjects randomized 4:1).
Only the preliminary blinded safety and PK data from the SAD portion of the study is available. Overall, there were no changes in vital signs, physical examinations, ECGs or safety clinical labs resulting from study participation. The preliminary overall summary of treatment-emergent adverse events (TEAEs), showed that there were no serious AEs (SAEs) or severe TEAEs and the maximum tolerated dose was not reached. No dose limiting toxicity was noted and there were no premature terminations from the study post treatment and no deaths during the study.
The linear and semi-log plots for doses from 300 mg to 1,200 mg (Cohorts 1-3) are proportional and support a twice daily dose of 600 mg to maintain drug levels in plasma above EC90 of the predicted value for viral inhibition. In rats, STI-1558 has showed sufficient lung tissue penetration with 5.8-fold higher drug level in lungs than in plasma, indicating a potential robust antiviral activity in COVID-19 patients.
A high fat meal reduced Cmax and AUC, therefore it is appropriate to take the STI-1558 capsules on an empty stomach twice daily.
The multiple ascending dose (MAD) study is starting in Australia. A large Phase 2 study is planned in Mexico that could support an Emergency Use Authorization (EUA) in Mexico. Phase 2/3 trials in US and other major regions have also been planned once the MAD part is successfully completed.
07/15/2022 56,972,598 10,579,0705.385407
06/30/2022 60,074,801 16,552,6753.629311
06/15/2022 51,964,976 9,209,9175.642285
05/31/2022 54,079,548 7,557,9367.15
News just hit the wire. Thanks ididathing99 from StockTwits. Scilex merger will go through. HF’s trying to snooker retail before the news sinks in. I consider this good news.
https://www.nasdaq.com/market-activity/stocks/vcka/sec-filings
Shorties are working ...
06/30/2022 60,074,801 16,552,6753.629311
06/15/2022 51,964,976 9,209,9175.642285
05/31/2022 54,079,548 7,557,9367.155333
05/13/2022 52,974,930 10,514,6515.038201
04/29/2022 54,656,185 9,306,7455.87275
04/14/2022 53,577,390 8,161,4986.564651
03/31/2022 52,391,572 12,321,3724.25208903
A lot of great videos ...