Phase

Edison issues initiation on Cereno Scientific (CRNO B): Differentiated approach in CVD with potential

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星期三, 三月 13, 2024

Cereno Scientific is a clinical-stage biotech, developing treatments for cardiovascular diseases (CVDs) using novel approaches.

Key Points: 
  • Cereno Scientific is a clinical-stage biotech, developing treatments for cardiovascular diseases (CVDs) using novel approaches.
  • Lead asset CS1, a delayed immediate release formulation of valproic acid, is an HDAC inhibitor, aiming to deliver disease-modifying results in pulmonary arterial hypertension (PAH).
  • Preclinical candidates include CS014, for thrombosis prevention without increased risk of bleeding (seen with current antithrombotics), and CS585 for CVD (specific indication not yet determined).
  • As with all Edison publications, Edison controls the editorial and timings of publications and we wish to make it clear that Cereno Scientific had no involvement in the aforementioned issue.

EQS-News: Heidelberg Pharma Announces Royalty Financing Agreement with HealthCare Royalty for up to USD 115 million

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星期三, 三月 13, 2024

Ladenburg, Germany, 4 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed a royalty financing agreement.

Key Points: 
  • Ladenburg, Germany, 4 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed a royalty financing agreement.
  • Key terms of the agreement between Heidelberg Pharma and HCRx:
    Following the receipt by HCRx of a maximum cumulative amount, royalty payments will revert to Heidelberg Pharma and HCRx will receive a low single digit royalty tail percentage thereafter
    Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted to partner with HealthCare Royalty.
  • This agreement will provide us with a non-dilutive financing based on expected royalty payments from the worldwide sales of ZircaixTM.
  • Heidelberg Pharma will hold a conference call on 25 March 2024 with the publication of the Annual Report.

BetRoyale Raises $500,000 in First Days of Presale! Could Crowns Be the Next Gamblefi Sensation?

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星期一, 三月 11, 2024

This significant milestone marks the initial step in the launch of BetRoyale's native token , $BCRN (Crowns), and the development of its comprehensive Web3 ecosystem.

Key Points: 
  • This significant milestone marks the initial step in the launch of BetRoyale's native token , $BCRN (Crowns), and the development of its comprehensive Web3 ecosystem.
  • The sudden hype surrounding the project has been marked by all 3 stages selling out rapidly, reaching half a million in just a few days.
  • With the online gambling industry projected to expand, especially into the Web3 sector in the coming years, BetRoyale holds significant promise for growth.
  • Revenue Sharing with Stakers (50%): The remaining tokens are distributed as rewards to loyal stakers, incentivizing long-term participation and commitment.

ACELYRIN, INC. Announces Positive Top-line Results from Its Global Phase 2b/3 Clinical Trial of Izokibep in Psoriatic Arthritis

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星期一, 三月 11, 2024

LOS ANGELES, March 11, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance. Results from the 160 mg weekly (QW) and every other week (Q2W) arms showed improved magnitude of responses on higher hurdle endpoints such as ACR70, PASI100, and Minimal Disease Activity relative to the Phase 2 80 mg Q2W dose. This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.

Key Points: 
  • (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance.
  • This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.
  • Izokibep was well-tolerated with a favorable safety profile consistent with previous experience and the IL-17A class, without evidence of the safety liabilities observed with targeting IL-17A&F.
  • This reinforces our enthusiasm for developing izokibep as an important potential new medicine for patients.”

Arch Biopartners Announces Dosing of First Patient in Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

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星期四, 三月 7, 2024

TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Arch Biopartners team is currently working with hospital sites in Canada to prepare for their participation in this Phase II trial.
  • The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.

BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

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星期一, 三月 4, 2024

Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress.

Key Points: 
  • Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress.
  • Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (8.3% vs. 13.2%, respectively).
  • CardiAMP cell therapy was also associated with trends toward reduced ventricular tachyarrhythmias, enhanced heart function as measured by left ventricular ejection fraction, and improved NTproBNP.
  • “These positive results for CardiAMP cell therapy are very encouraging, especially for patients with elevated NTproBNP, who encompass the majority of heart failure patients that we see in our daily practice,” said trial co-principal investigator Dr. Raval.

NMD Pharma announces poster and oral presentations on skeletal muscle targeted ClC-1 therapy at two leading neuromuscular disease conferences

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星期五, 三月 1, 2024

ClC-1 is a chloride ion channel specifically expressed in skeletal muscle cells that normally dampens muscle fiber excitability and is involved in regulating muscle fiber excitability during exercise.

Key Points: 
  • ClC-1 is a chloride ion channel specifically expressed in skeletal muscle cells that normally dampens muscle fiber excitability and is involved in regulating muscle fiber excitability during exercise.
  • ClC-1 inhibition could be a possible mechanism to improve muscle fiber activation to address muscle weakness and fatigue in neuromuscular diseases.
  • Details of NMD Pharma’s poster presentations are below:
    The 4th Scientific International Congress on SMA is taking place in Ghent, Belgium, from 14-16 March.
  • : NMD Pharma be presenting one poster and one oral presentation at the congress.

Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC

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星期四, 二月 29, 2024

SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today provided a clinical update on the first release of data from its second-line RAS-mutated metastatic colorectal cancer (mCRC) ONSEMBLE trial. Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment. The 23 enrolled patients continued treatment per protocol. The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.

Key Points: 
  • Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment.
  • The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.
  • “The randomized data from the ONSEMBLE trial further validates the opportunity for onvansertib in the first-line RAS-mutated mCRC setting.
  • We look forward to sharing the topline results of our first-line CRDF-004 trial in mid-2024.”
    In August 2023, Cardiff Oncology discontinued enrollment in the second-line ONSEMBLE trial to focus on its new lead program in first-line RAS-mutated mCRC.

Itronics Updates Investors - Announces Plan to Activate Auric Gold & Minerals, Inc.

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星期四, 二月 29, 2024

Itronics believes its subsidiaries, each based on their own unique Intellectual Property (IP) can generate interest from crowdfunding investors.

Key Points: 
  • Itronics believes its subsidiaries, each based on their own unique Intellectual Property (IP) can generate interest from crowdfunding investors.
  • This timing is very opportunistic for Itronics due to forecasted increases in silver and gold prices for 2024 and future years.
  • Plan to Activate and Fund Auric Gold & Minerals, Inc.
    Itronics owns a majority interest in Auric Gold & Minerals, Inc. (“Auric”) through its wholly owned Technical Services subsidiary Whitney & Whitney, Inc.  Auric controls a large mineral land package consisting of 148 lode mining claims (almost 3,000 acres) called the Auric Fulstone Project in the Yerington Mining District near Yerington, Nevada.
  • Itronics believes that the steps being taken will produce a significant increase in value to its shareholders through its Auric ownership.

uniQure Announces 2023 Financial Results and Highlights Recent Company Progress

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星期三, 二月 28, 2024

LEXINGTON, Mass. and AMSTERDAM, Feb. 28, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the fourth quarter and full year 2023 and highlighted recent progress across its business.

Key Points: 
  • and AMSTERDAM, Feb. 28, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the fourth quarter and full year 2023 and highlighted recent progress across its business.
  • “We are pleased with the progress made across the company in 2023 and are now laser-focused on execution across multiple clinical programs,” stated Matt Kapusta, chief executive officer of uniQure .
  • By the end of 2024, the Company expects to have greater clarity regarding a potential approval pathway for AMT-130.
  • AMT-191 for the treatment of Fabry disease – In November 2023, the Company announced the clearance of an IND for the Phase I/IIa clinical study of AMT-191.