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X @Bloomberg
Bloomberg· 2025-07-14 12:45
LEO Pharma agreed to acquire the global rights for skin disease drug Spevigo from Boehringer, as the Danish dermatology specialist strengthens its portfolio ahead of a planned IPO in 2026 https://t.co/hCCBv5pCxI ...
OGN FRAUD CLASS ACTION: Organon & Co. Investors may have been Affected by Fraud – Contact BFA Law by July 22 Legal Deadline (NYSE:OGN)
GlobeNewswire News Room· 2025-07-14 12:33
NEW YORK, July 14, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Organon & Co. (NYSE: OGN) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Organon you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/organon-co-class-action. Investors have until July 22, 2025, to ask the Court to be appointed to lea ...
Journey Medical Corporation Announces Expanded Payer Coverage for Emrosi™
Globenewswire· 2025-07-14 12:30
Payer coverage for Emrosi™ now available for 65% of commercial lives, up from 29% in May 2025 Expanding payer coverage supports the adoption of Emrosi as prescription demand continues to increase SCOTTSDALE, Ariz., July 14, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company primarily focused on selling and marketing FDA-approved prescription pharmaceutical products for the treatment of dermatolog ...
This stock rockets 260% after $900 million mega crypto deal
Finbold· 2025-07-14 12:18
Shares of Sonnet BioTherapeutics (NASDAQ: SONN) soared in pre-market trading on Monday after the company announced a $888 million business combination to pivot into the cryptocurrency sector.Sonnet’s stock, which closed at $5.17 on Friday, traded as high as $18.68 in pre-market hours, marking a 265% jump. Year-to-date, SONN shares have already gained more than 220%. By press time, the stock was down slightly, trading about 2% lower on the day.SONN one-day stock price chart. Source: Google FinanceThe momentu ...
Red Light Holland's FDA-Compliant, DEA-Registered Partner Irvine Labs Receives First Global Shipment of Psilocybin from Company's Netherlands Facility via USA Controlled Substances Permit
Newsfile· 2025-07-14 11:45
Core Viewpoint - Red Light Holland has successfully shipped its naturally occurring psilocybin from its Netherlands facility to Irvine Labs in California, marking a significant milestone in their partnership and advancing their goal of developing microdosing capsules for global distribution [2][4][5]. Group 1: Shipment and Partnership - The shipment of psilocybin was made possible through the approval of a United States Controlled Substances import permit and the securing of a DEA quota [2][3]. - This first global shipment represents a groundbreaking milestone in the collaboration between Red Light Holland and Irvine Labs, with potency testing and shelf life extension protocols currently underway [3][5]. Group 2: Product Development and Research - The partnership aims to develop a commercialized and standardized psilocybin product that can be legally sold in emerging markets and utilized in government-funded pilot programs and clinical trials in the United States [5]. - Red Light Holland is focused on overcoming challenges in product development and manufacturing by implementing proprietary preservation technology to maintain the integrity of natural compounds while extending product shelf life [6]. Group 3: Future Plans and Capacity - Irvine Labs has the capacity for larger shipments under its existing 2025 DEA quota, allowing for the scaling of research and development efforts following the initial shipment [7]. - The companies plan to conduct comprehensive potency testing and shelf life extension testing of the delivered psilocybin materials, with future larger shipments already being planned [11].
Ascentage Pharma Announces Proposed Top-Up Placement
Globenewswire· 2025-07-14 09:23
Core Viewpoint - Ascentage Pharma Group International Inc. is conducting an offshore placement of ordinary shares to raise funds for commercialization, clinical development, and operational strengthening [1][2]. Group 1: Offshore Placement Details - The Dajun Yang Dynasty Trust, affiliated with the CEO, will offer ordinary shares in an offshore transaction to non-U.S. persons under Regulation S of the Securities Act [1]. - The Vendor will subscribe for new ordinary shares equal to the number of Placement Shares offered, at the same price per share [1]. - The transaction is subject to customary closing conditions and will occur after the Offshore Placement [1]. Group 2: Use of Proceeds - The net proceeds from the Offshore Placement will be utilized for commercialization efforts, expanding patient access, global clinical development of core pipeline candidates, and enhancing infrastructure and working capital [2]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is approved in China for treating specific types of chronic myeloid leukemia (CML) and is undergoing a global Phase III trial [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global Phase III trials [7]. Group 4: Partnerships and Collaborations - Ascentage Pharma has established a portfolio of global intellectual property rights and partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as research institutions like Dana-Farber Cancer Institute and Mayo Clinic [8].
OMass Therapeutics Presents Positive Preclinical Data For its Best-in-class MC2 Program at ENDO 2025
GlobeNewswire News Room· 2025-07-14 07:00
PRESS RELEASE OMass Therapeutics Presents Positive Preclinical Data For its Best-in-class MC2 Program at ENDO 2025 OMS1620 is advancing through IND-enabling studies for diseases associated with ACTH excess, including congenital adrenal hyperplasiaDesigned to resist competition from endogenous ACTH by maximizing receptor residency timeOMS1620 demonstrates best-in-class efficacy in acute and chronic preclinical models of ACTH excess Oxford, United Kingdom – 14th July 2025 – OMass Therapeutics (‘OMass’ or ‘the ...
X @Bloomberg
Bloomberg· 2025-07-14 04:02
The UK has options if AstraZeneca moves its listing, writes @hughes_chris (via @opinion) https://t.co/PJ8EvEXCla ...
Amylyx Pharmaceuticals (AMLX) Update / Briefing Transcript
2025-07-14 02:00
Summary of Amylyx Pharmaceuticals (AMLX) Update / Briefing July 13, 2025 Company Overview - **Company**: Amylyx Pharmaceuticals (AMLX) - **Focus**: Development of Avexatide, a potential GLP-1 receptor antagonist for treating post-bariatric hypoglycemia (PBH) with Breakthrough Therapy Designation from the FDA Industry Context - **Condition**: Post-bariatric hypoglycemia (PBH) is a serious metabolic condition that occurs in patients after bariatric surgery, characterized by severe hypoglycemic episodes - **Prevalence**: Approximately 400,000 individuals in the U.S. experience clinically important hypoglycemia after bariatric surgery, with around 166,000 requiring medical management [42][43] Key Points and Arguments 1. **Patient Experience**: A patient shared her struggles with PBH, highlighting the debilitating nature of the condition, which severely limits daily activities and quality of life [8][9][15][16] 2. **Medical Need**: There is a significant unmet medical need for effective treatments for PBH, as current dietary modifications and off-label medications often fail to provide relief [39][40] 3. **Mechanism of PBH**: PBH is caused by an exaggerated GLP-1 response post-surgery, leading to hyperinsulinism and subsequent hypoglycemia. This condition can develop 2-3 years after surgery, but may occur anytime from 2 to 20 years post-operation [19][41] 4. **Current Treatments**: Existing treatments are limited and often ineffective, with no FDA-approved medications specifically for PBH. Dietary modifications and off-label medications have high failure rates and significant side effects [22][39] 5. **Avexatide's Mechanism**: Avexatide targets the GLP-1 receptor to normalize insulin secretion and stabilize glucose levels, addressing the underlying pathophysiology of PBH [49][50] 6. **Clinical Trials**: The Phase II and Phase IIb studies showed that Avexatide significantly reduced the frequency of Level II and Level III hypoglycemic events by over 50% [57][72] 7. **FDA Breakthrough Therapy Designation**: Avexatide is the only drug in development for PBH to receive this designation, indicating its potential to address a serious condition with high unmet medical need [57] 8. **LUCIDITY Phase III Trial**: The ongoing Phase III trial will evaluate the efficacy of Avexatide at a dose of 90 mg once daily, focusing on reducing hypoglycemic events [78][81] Additional Important Content - **Patient Education**: There is a critical need for increased awareness and education about PBH among healthcare providers and patients, as many patients are misdiagnosed or experience delays in receiving appropriate care [38][41] - **Quality of Life Impact**: The unpredictable nature of hypoglycemic events leads to social isolation and significant emotional distress for patients, emphasizing the need for effective treatment options [66][68] - **Future Outlook**: The company is actively recruiting for the LUCIDITY trial, with data expected in the first half of 2026, aiming to bring a much-needed therapy to market for PBH patients [85][86]