Breaking Uranium Stock News: Pegasus Resources (TSXV: $PEGA.V) (OTC PINK: $SLTFF) Announces Private Placement for up to C$1,500,000; @pegasusresinc

Breaking Uranium Stock News: Pegasus Resources (TSXV: $PEGA.V) (OTC PINK: $SLTFF) Announces Private Placement for up to C$1,500,000; @pegasusresinc

 

NOT FOR DISTRIBUTION TO UNITED STATES NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

 

VANCOUVER, BC / July 22, 2024 / (Investorideas.com Newswire) Pegasus Resources Inc. (TSX-V:PEGA) (OTCPK:SLTFF) (Frankfurt:0QS0) (the "Company" or "Pegasus") is pleased to announce its intention to complete a non-brokered private placement for gross proceeds of up to C$1,500,000 (the "Offering").

 

The Offering will consist of up to 9,375,000 units of the Company (each, a "Unit", and collectively the "Units") at a price of C$0.16 per Unit (the "Offering Price"). Each Unit consists of one Common Share (each, a "Common Share", and collectively the "Common Shares") and one-half of one Common Share purchase warrant (each whole warrant, a "Warrant" and collectively the "Warrants"). Each Warrant entitles the holder thereof to acquire one Common Share at a price of C$0.20 per Common Share for a period of 2 years from the closing date of the Offering.

 

The Company will apply to list the Common Shares (including the Common Shares underlying the Warrants and the broker warrants (as described below)) on the TSXV upon closing of the Offering.

 

The net proceeds of the Offering will be used for exploration of the Energy Sands Uranium Project and the Jupiter Uranium Project, both in Utah, USA, and for general and working capital purposes.

 

This news is paid advertisement/ news disseminated on behalf of/issued on behalf of Pegasus Resources Inc.

 

Read this news, featuring PEGA in full at https://www.investorideas.com/news/2024/07221PEGA-Private-Placement.asp

 

The Units will be offered and sold by private placement in Canada to "accredited investors" within the meaning of National Instrument 45-106 - Prospectus Exemptions and other exempt purchasers in each province of Canada and may be sold outside of Canada on a basis which does not require the qualification or registration of any of the Common Shares or the Warrants comprising the Units in the subscriber's jurisdiction. The Company may also concurrently offer and sell Units outside of Canada on a non-brokered, unregistered private placement basis to a limited number of "accredited investors" (as defined in Regulation D under the United States Securities Act of 1933, as amended (the "U.S. Securities Act")) with whom the Company has substantive pre-existing relationships, in reliance on exemptions from the registration requirements of the U.S. Securities Act and applicable state securities laws or in other jurisdictions where permitted by law.

 

The common shares, share purchase warrants and shares underlying the share purchase warrants from the Offering will be subject to a four-month-and-one-day statutory hold period from the date of issuance. Closing of the Offering remains subject to the receipt of all regulatory approvals, including the approval of the TSX Venture Exchange ("TSXV"). The Company may pay finder's fees as permitted by TSXV and applicable securities laws.

 

Closing of the Offering is expected to occur on or about August 21, 2024 (the "Closing Date").

 

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities described in this news release. Such securities have not been, and will not be, registered under the U.S. Securities Act, or any state securities laws, and, accordingly, may not be offered or sold within the United States, or to or for the account or benefit of persons in the United States or "U.S. Persons", as such term is defined in Regulation S promulgated under the U.S. Securities Act, unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to an exemption from such registration requirements.

 

About Pegasus Resources Inc.

Pegasus Resources Inc. is a diversified Junior Canadian Mineral Exploration Company with a focus on uranium, gold, and base metal properties in North America. The Company is also actively pursuing the right opportunity in other resources to enhance shareholder value. For additional information, please visit the Company at www.pegasusresourcesinc.com.

 

On Behalf of the Board of Directors:

 

Christian Timmins

President, CEO and Director

Pegasus Resources Inc.

700 - 838 West Hastings Street

Vancouver, BC V6C 0A6

PH: 1-403-597-3410

 

X: https://twitter.com/MrChris_Timmins

X: https://twitter.com/pegasusresinc

E: info@pegasusresourcesinc.com

 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.

 

Disclaimer for Forward-Looking Information

This news release contains certain information that may be deemed "forward-looking information" with respect to the Company within the meaning of applicable securities laws. Such forward-looking information involves known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking information. Forward-looking information includes statements that are not historical facts and are generally, but not always, identified by the words "expects," "plans," "anticipates," "believes," "intends," "estimates," "projects," "potential" and similar expressions, or that events or conditions "will," "would," "may," "could" or "should" occur. Forward-looking information contained in this press release may include, without limitation, statements regarding creation of value for Company shareholders, results of operations the size, timing and completion of the Offering, the use of proceeds from the Offering and the listing of the Common Shares (including the Common Shares underlying the Warrants and the broker warrants) on the TSXV upon closing of the Offering.

 

Although the Company believes the forward-looking information contained in this news release is reasonable based on information available on the date hereof, by its nature, forward-looking information involves assumptions and known and unknown risks, uncertainties and other factors which may cause our actual results, level of activity, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information.

 

Examples of such assumptions, risks and uncertainties include, without limitation, assumptions, risks and uncertainties associated with general economic conditions; the COVID-19 pandemic; adverse industry events; the receipt of required regulatory approvals and the timing of such approvals; that the Company maintains good relationships with the communities in which it operates or proposes to operate, future legislative and regulatory developments in the mining sector; the Company's ability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favorable terms; mining industry and markets in Canada and generally; the ability of the Company to implement its business strategies; competition; the risk that any of the assumptions prove not to be valid or reliable, which could result in delays, or cessation in planned work, risks associated with the interpretation of data, the geology, grade and continuity of mineral deposits, the possibility that results will not be consistent with the Company's expectations, as well as other assumptions risks and uncertainties applicable to mineral exploration and development activities and to the Company, including as set forth in the Company's public disclosure documents filed on the SEDAR+ website at www.sedarplus.ca.

 

The forward-looking information contained in this press release represents the expectations of Pegasus as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While Pegasus may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws.

 

SOURCE: Pegasus Resources, Inc.

 

Pegasus Resources Inc. (TSX-V:PEGA) (OTCPK:SLTFF) (Frankfurt:0QS0) is a featured mining stock on Investorideas.com

 

More info on PEGA at Investorideas.com Visit: https://www.investorideas.com/CO/PEGA/

 

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New Stocks to watch in the Biotech and Cleantech Sectors; (TSXV: $YNV.V) (OTCQB: $YNVYF) (NASDAQ: $SLS) (NASDAQ: $SYRS) (NYSE: $LICY) (NASDAQ: $RDUS) (NASDAQ: $STLD) (NYSE: $LZM)

New Stocks to watch in the Biotech and Cleantech Sectors; (TSXV:  $YNV.V) (OTCQB: $YNVYF) (NASDAQ: $SLS) (NASDAQ: $SYRS) (NYSE: $LICY) (NASDAQ: $RDUS) (NASDAQ: $STLD) (NYSE: $LZM)

 

 

 

 

July 19, 2024 – (Investorideas.com Newswire) Investorideas.com, a global news source and expert investing resource, announces today’s roundup of stocks to watch in the Biotech, Cleantech Sectors.

 

The newest biotech companies are involved in blood disorder treatments, cancer treatments and medical at home test e-papers.

 

The latest cleantech companies provide recycling services for batteries and metals.

 

Read this in full at https://www.investorideas.com/news/2024/main/07191Stocks.asp

 

Investor Ideas is always researching and searching for new stocks to add to our growing list of free stock directories. The directories are not meant as recommendations but as a research tool to discover opportunities and trading ideas in a particular sector.

 

New Stocks Added to the Biotech Directories:

Ynvisible Interactive Inc. (TSXV: YNV) (OTCQB: YNVYF) (FSE: 1XNA) is disrupting the low-cost and ultra-low-power display industry thanks to the latest advantages in sustainable electronics and roll-to-roll printing production. Ynvisible's printed e-paper displays are ideal for low-power and cost-sensitive applications, such as digital signage, smart monitoring labels, authenticity and security, and retail labels and signage. Ynvisible has the experience, know-how, and intellectual property in electrochromic materials, inks, and systems and offers a mix of services, materials, and technology to brand owners developing smart objects and IoT products. Biotech - Ynvisible to Deliver First E-paper Displays for Medical At-Home Tests

 

SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ other lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases.

 

Syros Pharmaceuticals (NASDAQ:SYRS) is committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies. Driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches, Syros is developing tamibarotene, an oral selective RARα agonist in frontline patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression.

 

New Stocks Added to the Cleantech Directories:

Li-Cycle Holdings Corp. (NYSE: LICY) is a leading global lithium-ion battery resource recovery company. Established in 2016, and with major customers and partners around the world, Li-Cycle’s mission is to recover critical battery-grade materials to create a domestic closed-loop battery supply chain for a clean energy future. The Company leverages its innovative, sustainable and patent-protected Spoke & Hub Technologies™ to recycle all different types of lithium-ion batteries. At our Spokes, or pre-processing facilities, we recycle battery manufacturing scrap and end-of-life batteries to produce black mass, a powder-like substance which contains a number of valuable metals, including lithium, nickel and cobalt. At our future Hubs, or post-processing facilities, we plan to process black mass to produce critical battery-grade materials, including lithium carbonate, for the lithium-ion battery supply chain.

 

Radius Recycling, Inc. (NASDAQ: RDUS) (formerly Schnitzer Steel Industries, Inc.) is one of the largest manufacturers and exporters of recycled metal products in North America with operating facilities located in 25 states, Puerto Rico, and Western Canada. Radius has seven deep water export facilities located on both the East and West Coasts and in Hawaii and Puerto Rico. The Company’s integrated operating platform also includes 50 stores which sell serviceable used auto parts from salvaged vehicles and receive over 4 million annual retail visits. The Company’s steel manufacturing operations produce finished steel products, including rebar, wire rod, and other specialty products. The Company began operations in 1906 in Portland, Oregon.

 

Steel Dynamics, Inc. (NASDAQ:STLD) is one of the largest domestic steel producers and metals recyclers in North America, based on estimated annual steelmaking and metals recycling capability, with facilities located throughout the United States, and in Mexico. Steel Dynamics produces steel products, including hot roll, cold roll, and coated sheet steel, structural steel beams and shapes, rail, engineered special-bar-quality steel, cold finished steel, merchant bar products, specialty steel sections, and steel joists and deck. In addition, the company produces liquid pig iron and processes and sells ferrous and nonferrous scrap.

 

Lifezone Metals (NYSE: LZM) mission is to provide cleaner and more responsible metals production and recycling. Using a scalable platform underpinned by our Hydromet Technology, we offer the potential for lower energy, lower emission and lower cost metals production compared to traditional smelting. Our Kabanga Nickel Project in Tanzania is believed to be one of the world's largest and highest-grade undeveloped nickel sulfide deposits. By pairing with our Hydromet Technology, we are working to unlock a new source of LME-grade nickel, copper and cobalt for the global battery metals markets, to empower Tanzania to achieve full in-country value creation and become the next premier source of Class 1 nickel. A Definitive Feasibility Study for the project is due for completion in Q3 2024. Through our US-based, platinum, palladium and rhodium recycling partnership, we are working to demonstrate that our Hydromet Technology can process and recover platinum group metals from responsibly sourced spent automotive catalytic converters in a cleaner and more efficient way than conventional smelting and refining methods.

 

About Investorideas.com - Big Investing Ideas

Investorideas.com is the go-to platform for big investing ideas. From breaking stock news to top-rated investing podcasts, we cover it all. Our original branded content includes podcasts such as Exploring Mining, Cleantech, Crypto Corner, Cannabis News, and the AI Eye. We also create free investor stock directories for various sectors, including gaming, biotech, tech and sports. Public companies within the sectors we cover can use our news publishing and content creation services to help tell their story to interested investors. Paid content is always disclosed.

 

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Breaking Mining Stock News: New Destiny Mining (TSXV: $NED.V) 2024 Drilling Program Underway Treasure Mountain Silver Property, Hope BC; @NEDminingcorp

Breaking Mining Stock News: New Destiny Mining (TSXV: $NED.V) 2024 Drilling Program Underway Treasure Mountain Silver Property, Hope BC; @NEDminingcorp

 

VANCOUVER, British Columbia - July 18, 2024 (Investorideas.com Newswire) New Destiny Mining Corp. (TSXV: NED), (the “Company” or “NED”) announces it has completed mobilizing crews and equipment and has started its 2024 drilling program at the Treasure Mountain project, near Princeton, BC. 

 

The Treasure Mountain property is situated 38 km west of the Copper Mountain mine at Princeton in southern BC.  and covers 10,819 hectares. Targets on the property include critical minerals in porphyry copper-moly deposits, and gold-quartz vein and polymetallic silver-rich vein deposits.

 

Paid news dissemination on behalf of New Destiny Mining.

 

Read this news, featuring NED in full at https://www.investorideas.com/news/2024/07181NED-2024-Drilling-Program.asp

 

 

Temporary exploration camp.

 

The 2024 drilling program has now started after a temporary exploration camp was constructed and crews and equipment were mobilized to site.

 

The drill program has started at the first target.  The Railroad copper-silver mineralized zone was explored historically in several adits dating from at least 1937.  In 2019, an average grade of 0.64% copper and 116.0 ppm silver was channel sampled over a 4.2 metre width in a trench.  The drilling this year will drill test this zone down dip.  The occurrence is interpreted to be genetically related to a concealed porphyry intrusion. 

 

Photo of drill on site at Treasure Mountain North Property.

 

The next target planned is the Jim Kelly gold-quartz vein, which is exposed in a historic adit on the bank of Jim Kelly Creek.  A 2018 grab sample returned a result of 11.3 grams per tonne gold. The vein will be explored for extensions by drilling, and trenching may be done depending on the thickness of overburden.

 

Map showing Treasure Mountain property and targets for 2024.

 

Readers are cautioned that historical records referred to in this News Release have been examined but not verified by a Qualified Person. Further work is required to verify that historical records referred to in this News Release are accurate.

 

Dr. Mathew Ball, P.Geo., a Qualified Person as defined by NI 43-101 and consultant to the Company, approved the technical information contained in this News Release. 

 

ON BEHALF OF THE BOARD OF DIRECTORS

 

 

“Al Beaton”

Director

604-488-3900

 

Lubica Parilakova
ir@NewDestinyMining.com

Forward Looking Information

This news release includes certain statements that constitute "forward-looking information" within the meaning of applicable securities law, including without limitation, the Company’s information and statements regarding or inferring the future business, operations, financial performance, prospects, and other plans, intentions, expectations, estimates, and beliefs of the Company. Such statements include statements regarding the completion of the proposed transactions. Forward-looking statements address future events and conditions and are necessarily based upon a number of estimates and assumptions. These statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as "expects" or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "estimates" or "intends", or stating that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved), and variations of such words, and similar expressions are not statements of historical fact and may be forward-looking statements. Forward-looking statement are necessarily based upon several factors that, if untrue, could cause the actual results, performances or achievements of the Company to be materially different from future results, performances or achievements express or implied by such statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of gold and other metals, anticipated costs and the ability to achieve goals, and the Company will be able to obtain required licenses and permits. While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks including that resource exploration and development is a speculative business; that environmental laws and regulations may become more onerous; that the Company may not be able to raise additional funds when necessary; fluctuating prices of metals; the possibility that future exploration, development or mining results will not be consistent with the Company’s expectations; operating hazards and risks; and competition. There can be no assurance that economic resources will be discovered or developed. Accordingly, actual results may differ materially from those currently anticipated in such statements. Factors that could cause actual results to differ materially from those in forward looking statements include continued availability of capital and financing and general economic, market or business conditions, the loss of key directors, employees, advisors or consultants, equipment failures, litigation, competition, fees charged by service providers and failure of counterparties to perform their contractual obligations. Investors are cautioned that forward-looking statements are not guarantees of future performance or events and, accordingly are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty of such statements. The forward-looking statements included in this news release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities legislation.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this releas

Disclaimer/Disclosure: New Destiny Mining Corp. (NED.V) is a paid featured mining stock on Investor Ideas. More info:Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Contact management and IR of each company directly regarding specific questions. More disclaimer and disclosure info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp

 

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Biotech/Pharma Stocks to Watch Citius Pharmaceuticals (Nasdaq: $CTXR), Soligenix (Nasdaq: $SNGX), Takeda (NYSE: $TAK), Pfizer (NASDAQ: $PFE)

 

Biotech/Pharma Stocks to Watch Citius Pharmaceuticals (Nasdaq: $CTXR), Soligenix (Nasdaq: $SNGX), Takeda (NYSE: $TAK), Pfizer (NASDAQ: $PFE)

 

The Race for Solutions for Cutaneous T-Cell Lymphoma (CTCL)

 

July 18, 2024 - Investorideas.com, a go-to investing platform releases the second of a two-part series looking at biotech/biopharma stocks, featuring Citius Pharmaceuticals, Inc. (Nasdaq:CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates.

 

Looking specifically at the opportunity for Cutaneous T-Cell Lymphoma (CTCL) treatments, the  market was approximately USD 399 Million in 2021 says Delveinsight. “CTCL has an active pipeline as many pharmaceutical companies are working toward developing an effective and affordable therapy. The disease has a tendency to show resistance to medications creating a need for a more efficacious and effective drug.”

 

The US Cutaneous T-cell Lymphoma Market is projected to reach $1.38 Billion by 2030 reports Insights10.

 

Citius Pharmaceuticals (Nasdaq:CTXR) is approaching the FDA target date of August 13^th for its LYMPHIR product candidate to address this unmet need.

 

Citius announced earlier this year that the US Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has assigned a PDUFA goal date of August 13, 2024.

 

Paid news dissemination for Citius Pharmaceuticals.

 

Read this article featuring CTXR in full at https://www.investorideas.com/news/2024/biotech/07181Cutaneous-T-Cell-Lymphoma.asp

 

"The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL.  No concerns relating to safety or efficacy were noted in the letter, and we remain confident in the robustness of the clinical data package included with the initial BLA submission," stated Leonard Mazur, Chairman and CEO of Citius.

 

"We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative. We are grateful for the FDA's vital support for rare disease drug development as we work to expand treatment options for patients with cutaneous T-cell lymphoma. We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL," added Mazur.

 

More from the news: The BLA is supported by a pivotal Phase 3 study (NCT01871727). The resubmission follows dialog with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023. Citius believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter. There were no safety or efficacy issues cited and no additional trials required.

 

EF Hutton just initiated coverage of Citius Pharmaceuticals (Nasdaq:CTXR) with a Buy recommendation with a price target of $6.00. Analyst Jason Kolbert sees the stock as low risk – high reward based on their two late stage therapeutics, Mino-Lok and LYMPHIR.

 

Talking about LYMPHIR he said, “Since CTCL treatments are non-curative and often have a limited duration of response and/or discontinued early, patients are put on multiple alternative therapies.

 

“LYMPHIR’s differentiated MOA reinforces rationale for inclusion among the current core therapeutic options in the US market.”

 

Kolbert also notes, “We assume a price of $200,000 per treatment, consistent with competing therapies in the CTCL space.”

 

Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, on July 9^th announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage CTCL. To date six patients have been enrolled and treated with HyBryte™ over a time period ranging up to 44 weeks. Patients have responded positively to HyBryte™ therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving "Treatment Success", as predefined in the study's protocol as ≥50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. Of the three Treatment Successes, two were achieved within the first 12 weeks of treatment and the third within 18 weeks. Of the remaining three patients, two have only recently started HyBryte™ therapy and have not yet reached their first efficacy evaluation visit (i.e., at Week 6) and the other had a substantial improvement documented at the Week 18 visit, but has not yet achieved the success threshold. In addition, HyBryte™ appears to be safe and well tolerated in all patients, with no treatment-related adverse events reported to date.

 

Continued: "In the Phase 3 FLASH study, HyBryte™ was shown to be efficacious with a promising safety profile. With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments. In our U.S. Food and Drug Administration (FDA)-funded study, initial results evaluating the expanded use of HyBryte™ in a 'real world' treatment setting are promising, further supporting and extending results from the previous positive Phase 2 and 3 clinical trials," noted Dr. Kim, Principal Investigator of the IIS. "We look forward to continuing to work with the FDA to complete this study and to participating in the upcoming confirmatory Phase 3 placebo-controlled study."

 

In June, Takeda (NYSE: TAK) and Pfizer (NASDAQ: PFE) announced Four-Year results from positive Phase 3 HD21 Trial of Additional ADCETRIS® (brentuximab vedotin) Combination in Frontline Hodgkin Lymphoma.

 

The four-year analysis presented by the GHSG showed superior progression-free survival (PFS) and improved tolerability for patients compared to a current standard of care regimen used in Europe in this setting.

 

“In our ongoing effort to improve outcomes for patients with lymphoma, we’ve partnered with the GHSG on the HD21 study to deepen our understanding of how ADCETRIS could further benefit patients in need of new options,” said Awny Farajallah, Chief Medical Officer, Global Oncology at Takeda.

 

The HD21 study is a Phase 3, randomized, multi-country, prospective, open-label study, sponsored by the GHSG and supported by Takeda, designed to evaluate ADCETRIS in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (BrECADD) in comparison to a standard of care treatment – escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone (eBEACOPP) – in patients with newly diagnosed Stage IIb/III/IV classical Hodgkin lymphoma. At a preplanned three-year analysis, the study met its co-primary endpoints, with the ADCETRIS combination regimen demonstrating significantly.

 

More from the news: ADCETRIS received conditional marketing authorization from the European Commission in October 2012, and the specific obligations of the conditional marketing authorization were fulfilled in May 2022. The approved indications in the European Union are: (1) for the treatment of adult patients with previously untreated CD30-positive Stage III & IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD), (2) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (3) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (4) for the treatment of adult patients with relapsed or refractory sALCL, (5) for the treatment of adult patients with previously untreated sALCL in combination with CHP and (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

 

ADCETRIS has received marketing authorization by regulatory authorities in more than 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL.

 

Continued: ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies.

 

Pfizer and Takeda fund joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

 

Citius Pharmaceuticals, Inc. (Nasdaq:CTXR) says on its website, “There is no single standard-of-care for the treatment of CTCL, with only a few FDA-approved targeted therapies for patients with advanced CTCL. Existing targeted therapies are often poorly tolerated or have limited efficacy and may be discontinued due to toxicity, adverse events, or the development of resistance to treatment. As such, we expect LYMPHIRTM, with its unique non-cross-resistant mechanism-of-action and ONTAK’s prior well documented safety and efficacy profile, to be an important option for patients and their physicians in the management of this disease.”

 

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