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Northstrive Biosciences Co-Founder Featured on Bear Bull Traders Following Announcement of Positive FDA Response Supporting Submission of IND for EL-22 Phase 2 Clinical Trial
Globenewswire· 2025-04-28 12:00
The full interview featuring Deniel Mero can be viewed here. NEWPORT BEACH, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Northstrive Biosciences Inc. ("Northstrive"), a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB) (the "Company," "PMGC," "we," or "our"), is proud to announce that Co-Founder Deniel Mero was recently featured in an exclusive interview hosted by Bear Bull Traders, a leading global online stock trading community for professional and aspiring traders. During the interview, Mr. Mero discussed No ...
Northstrive Biosciences Announces Positive FDA Response Supporting A Submission of IND for a Phase 2 Clinical Trial for EL-22 in Combination with GLP-1 Receptor Agonist for Obesity Treatment
Newsfilter· 2025-04-24 12:00
Core Viewpoint - Northstrive Biosciences Inc. has received preliminary feedback from the FDA regarding its pre-IND meeting, indicating support for the IND submission to initiate a Phase 2 clinical study for EL-22 in combination with GLP-1 receptor agonists [1][2][6] Group 1: FDA Feedback and Clinical Development - The FDA agreed that Northstrive's pharmacology studies support the activity of EL-22 [2] - The FDA indicated that Northstrive's nonclinical studies are adequate to support the safety and activity of EL-22 in overweight and obese populations [2] - Data from Northstrive's Phase 1 study and completed nonclinical studies are sufficient to allow the initiation of the proposed Phase 2 clinical trial [2] Group 2: EL-22 Overview - EL-22 is a novel, patent-pending engineered probiotic designed to express myostatin on its surface, targeting the myostatin pathway to support muscle health [3] - Preclinical studies have shown significant physiological and functional improvements in mdx mice, a model for Duchenne muscular dystrophy [3][4] - EL-22 has completed a Phase 1 clinical trial in South Korea, demonstrating it to be generally well-tolerated and safe in healthy volunteers [3] Group 3: Company Strategy and Future Plans - Northstrive aims to file the Investigational New Drug application in 2025 and subsequently initiate a Phase 2 clinical trial for obesity treatment [2] - The company is in discussions with cGMP manufacturing partners to prepare for the production of EL-22 [2] - The development of EL-22 addresses the need for preserving muscle in patients undergoing GLP-1 therapies for weight loss [4]
Is Viking Therapeutics Stock (VKTX) Nearing A Bottom?
See It Market· 2025-04-22 03:39
Group 1 - Viking Therapeutics is set to focus on key pipeline updates during its first-quarter earnings call, particularly on three clinical candidates: VK2735 for obesity, VK2809 for non-alcoholic steatohepatitis (NASH), and VK0214 for X-linked adrenoleukodystrophy (X-ALD) [1] - VK2735 is highlighted as a significant interest due to the growing trend in obesity treatments and the transformative effects of weight loss in the consumer health space [2] - The company has shown a classic reversal bottom in its stock price, indicating potential positive momentum, and is currently outperforming benchmarks on the Leadership indicator [3] Group 2 - The weekly chart analysis indicates that VKTX is in a distribution phase rather than a bear phase, with the 200-week moving average serving as a strong support area for the stock price [4] - The stock price is currently trading at levels similar to the end of 2023, with a notable peak at $100, suggesting potential for recovery [5] - A weekly close above $24.50 is seen as a positive indicator, with the potential for rewards exceeding risks by 4-5 times [5]
Novo Nordisk defends disappointing next-gen obesity drug: 'It will be an important product'
CNBC· 2025-03-28 13:37
Core Viewpoint - Novo Nordisk defends the disappointing trial results of its obesity drug candidate CagriSema, asserting its potential as an important weight loss treatment despite underwhelming performance in clinical trials [1][2]. Company Summary - CEO Lars Fruergaard Jørgensen acknowledged the negative impact on share price following two late-stage trials that showed lower-than-expected weight reduction results, yet expressed confidence in CagriSema's weight loss profile [2][5]. - CagriSema, a combination of cagrilintide and semaglutide, demonstrated a weight loss of 15.7% over 68 weeks in patients with type 2 diabetes, compared to 3.1% with placebo, which fell short of the high-teens percentage previously forecast [3][4]. - A prior trial indicated a 22.7% weight loss in obese patients without type 2 diabetes, also below the expected 25% [4][7]. - The company's stock has declined over 50% from its 2024 highs due to investor disappointment regarding the drug's performance compared to existing treatments like Wegovy and Eli Lilly's Zepbound [5]. Industry Summary - Shareholders have called for clearer trial designs and targets to mitigate drastic share price fluctuations, with the CEO acknowledging the need for better communication regarding trial designs [6]. - The weight-loss industry is experiencing skepticism regarding the differentiation of obesity drugs, as noted by BofA Global Research, which has become more cautious following CagriSema's results [8]. - Analysts emphasize the necessity for a diverse range of treatments to address obesity and related health risks, highlighting the significant market opportunity for various products catering to different patient needs [9].
Palatin Technologies(PTN) - 2025 Q2 - Earnings Call Transcript
2025-02-13 17:00
Palatin (PTN) Q2 2025 Earnings Call February 13, 2025 11:00 AM ET Company Participants Carl Spana - Co-Founder, President, CEO & DirectorStephen Wills - Executive Vice President, Chief Financial Officer and Chief Operating OfficerJoe Pantginis - Managing Director Operator Greetings. Welcome to Palatin's Second Quarter Fiscal Year twenty twenty five Operating Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal As a reminder, ...