HOUSTON, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 16,216,216 shares of common stock of the Company originally issued in June 2025 at an exe ...

Core Insights - Teva Pharmaceuticals has received FDA approval for a generic version of Saxenda (liraglutide injection), marking the first-ever generic GLP-1 product specifically indicated for weight loss in the U.S. market [1][2][7] - The launch of this generic is part of Teva's strategy to expand its complex generics portfolio and is the fifth first-to-market entry for the company in 2025 [2][7] - Saxenda generated annual sales of $165 million as of June 2025, indicating a significant market opportunity for Teva's generic version [2] Company Strategy - The approval and launch of the generic Saxenda align with Teva's "Pivot to Growth" strategy, emphasizing the company's commitment to complex generic medicines [7] - Teva aims to address the increasing demand for weight loss therapies in the U.S. market through this new product [7] Product Information - Liraglutide injection is indicated for adults with obesity or overweight who have weight-related medical problems, as well as for pediatric patients aged 12-17 years with obesity [3][7][8] - The product should be used in conjunction with a reduced-calorie diet and increased physical activity to achieve weight loss and maintain weight reduction [3][7] Market Context - The introduction of the generic Saxenda is expected to enhance competition in the GLP-1 therapy market, which has seen rising demand for weight loss solutions [7] - Teva's entry into this segment may influence pricing and accessibility for patients seeking weight management options [7]

CHAPEL HILL, N.C., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today announced that the Company will participate in a fireside chat at the Cantor Global Healthcare Conference 2025, which is taking place from September 3-5, 2025, in New York, NY. Details of presentation: Format: Fireside chat Participants: Chris Giordano ...

Core Viewpoint - SciSparc Ltd. has announced the approval of a strategic merger with AutoMax Motors Ltd., aiming to enhance shareholder value by diversifying into the automotive sector, particularly focusing on the electric vehicle market in Israel [2][3]. Group 1: Merger Details - The merger will involve SciSparc acquiring 100% of AutoMax's share capital through a reverse merger, with AutoMax continuing as a wholly-owned subsidiary [2]. - Following the merger, SciSparc shareholders are expected to hold approximately 50.01% of the combined company's share capital [2]. - The merger is part of a definitive agreement entered into on April 11, 2024, and marks a significant step in expanding SciSparc's operations [2][3]. Group 2: Financial Support and Strategy - SciSparc has previously supported AutoMax's growth with financial assistance, including a $4.25 million bridge loan in 2024 and an additional $2 million loan in February 2025 [3]. - The merger aligns with SciSparc's long-term strategy to diversify its portfolio and capitalize on the expanding electric vehicle market in Israel [3]. Group 3: Closing Conditions - The closing of the merger is subject to customary closing conditions, including shareholder approvals from both companies and Israeli court approval [4]. - Special meetings for AutoMax's shareholders to vote on the merger approval are scheduled for August 28, 2025 [4]. Group 4: Company Overview - SciSparc Ltd. is a specialty clinical-stage pharmaceutical company focused on developing therapies for central nervous system disorders, with ongoing drug development programs based on cannabinoid pharmaceuticals [5]. - The company also has a controlling interest in a subsidiary that sells hemp seed oil-based products on the Amazon.com Marketplace [5].

Core Insights - Sai Life Sciences Limited has completed Phase II of its new Production Block (PB-11) at its API manufacturing facility in Bidar, India, enhancing its production capabilities [1][2]. Expansion Details - Phase I of PB-11, inaugurated in December 2024, had a capacity of 110 KL, and with the addition of Phase II (~91 KL), the total capacity of PB-11 now stands at approximately 200 KL, making it the largest reactor volume block at the Bidar site [2]. - The total installed reactor capacity at the Bidar facility has increased to around 700 KL following this expansion [2][7]. Strategic Importance - The CEO of Sai Life Sciences emphasized that this expansion is not just about increasing capacity but also about providing clients with the confidence to scale operations, ensuring reliable delivery, and adapting to the complexity of their programs [3]. - The PB-11 block is designed for large-scale commercial products, reinforcing the company's commitment to high-quality API and intermediate manufacturing for regulated markets such as the US, EU, and Japan [3]. Regulatory Compliance - The Bidar facility has been inspected and approved by major global regulatory agencies, including the USFDA, PMDA (Japan), and CDSCO (India), demonstrating the company's commitment to quality and compliance [3]. - Over the past three years, Sai Life Sciences has successfully undergone more than 75 customer audits, reflecting its dedication to safety and quality standards [3]. Company Overview - Sai Life Sciences is a leading integrated CRDMO, collaborating with over 300 global pharma and biotech companies to accelerate the development of new chemical entities (NCE) [4]. - The company has a workforce of over 3,400 employees across its facilities in India, the UK, and the USA [4].

Company Overview - Eli Lilly and Company is a leading global pharmaceutical firm with a market capitalization of $605.19 billion as of August 12, 2025, focusing on research-driven innovation and strategic alliances to maintain a competitive position [5] - The company offers a broad portfolio of pharmaceuticals for various therapeutic areas, including diabetes, oncology, immunology, and neuroscience, with key products such as Humalog, Trulicity, Verzenio, and Taltz [8] - Eli Lilly generates revenue primarily through the development, manufacturing, and global sale of branded prescription drugs, targeting patients with chronic and acute medical conditions across more than 120 countries [8] Financial Performance - As of the quarter ended June 30, 2025, Eli Lilly's revenue (TTM) was $53.26 billion, with a net income (TTM) of $13.80 billion [3] - The company's dividend yield stands at 0.79%, with a forward P/E ratio of 32.15 and an EV/EBITDA of 35.32 [2][3] - Eli Lilly's one-year total return was -23.1%, underperforming the S&P 500 by 38.3 percentage points [2] Market Position and Competition - Eli Lilly's weight loss drug, Zepbound, claims to provide 47% greater relative weight loss compared to Novo Nordisk's Wegovy, positioning it favorably in the competitive weight-loss drug market [9] - The race to launch oral versions of weight loss drugs is intensifying, with Novo Nordisk's oral Wegovy under FDA review and Eli Lilly planning to submit its oral weight loss drug, orforglipron, for approval by the end of 2025 [10][11] - In clinical trials, Novo Nordisk's oral Wegovy achieved a mean weight loss of 15.1%, while orforglipron reached 12.4% at its highest dosage, indicating potential challenges for Eli Lilly in maintaining its competitive edge [11]

GSK won UK approval for its oral antibiotic treatment for uncomplicated urinary tract infections, which the medicines regulator said affect around half of women in the country https://t.co/Ibi6ZjYynp ...

Core Insights - Idorsia Ltd has introduced TRYVIO™ (aprocitentan), the first hypertension therapy targeting the endothelin pathway, addressing the need for novel treatments in difficult-to-control hypertension [1][2][3] - TRYVIO is the only endothelin receptor antagonist included in the ACC/AHA clinical practice guidelines, highlighting its significance in hypertension management [2][9] Company Overview - Idorsia aims to challenge medical paradigms by discovering, developing, and commercializing transformative medicines, positioning itself as a leading biopharmaceutical company [19][21] - The company is headquartered in Allschwil, Switzerland, and is listed on the SIX Swiss Exchange under the ticker symbol IDIA [21] Product Details - TRYVIO is a once-daily, orally active dual endothelin receptor antagonist approved in the US for systemic hypertension treatment in combination with other antihypertensives since October 2024 [11] - The drug targets a significant patient population, with approximately 26 million patients in the US potentially eligible for treatment under TRYVIO's indication [3][4] Market Opportunity - The hypertension market presents a substantial opportunity, particularly for patients with difficult-to-control hypertension, which is defined as elevated blood pressure despite the use of multiple antihypertensive drug classes [5][6] - Nearly half of US adults, around 120 million people, have hypertension, with 40 million currently treated with antihypertensive drugs [3] Clinical Insights - Patients with difficult-to-control hypertension face higher risks of cardiovascular events and premature mortality, emphasizing the need for effective treatment options [5] - Idorsia will present scientific findings at the AHA Hypertension Scientific Sessions, showcasing the efficacy of aprocitentan in achieving rapid blood pressure control and reducing urinary albumin-to-creatinine ratio (UACR) [7] Recognition - TRYVIO has been nominated for the 2025 Prix Galien USA Awards in the "Best Pharmaceutical Product" category, reflecting its innovative approach in the pharmaceutical landscape [8]

Summary of Telix Pharmaceuticals (TLX) Update / Briefing August 27, 2025 Company Overview - **Company**: Telix Pharmaceuticals - **Product**: TLX250 CDx, provisionally designated as ZERKAICS - **Context**: Discussion regarding the FDA Biologics License application and the recent complete response letter (CRL) received from the FDA Key Points FDA Response and Issues - **CRL Received**: Telix received a complete response letter from the FDA regarding TLX250 CDx, which was unexpected and not positive news [2][4] - **Key Issues Identified**: 1. **Chemistry Manufacturing Controls (CMC)**: Issues related to the complexity of the manufacturing package [3][4] 2. **Comparability Demonstration**: Inadequacies in demonstrating comparability between the drug product used in the successful Zircon Phase III trial and the commercial manufacturing process [3][4] 3. **Supply Chain Complexity**: Reliance on multiple third-party suppliers, with two suppliers receiving Form 483 observations during inspections [3][4] Remediation Plans - **Next Steps**: Telix plans to request a Type A meeting with the FDA to address the issues raised in the CRL [4][5] - **Timeline for Remediation**: Preparation of the briefing document for the meeting is expected to take a few weeks, with a potential timeline for resubmission not exceeding a year [5][17] - **Breakthrough Therapy Designation**: The product has a breakthrough therapy designation, which may expedite the review process [18][35] Product Novelty and Market Impact - **First-in-Class Product**: TLX250 CDx is a novel biologic-based PET agent, marking a first in this category [5][6] - **Commercialization Delay**: The delay in commercialization does not impact the financial guidance for FY 2025, as revenue from unapproved products is not included [6][66] Comparability Data and Clinical Trials - **Existing Data**: Telix has additional comparability data that was not included in the original BLA submission, which may address FDA concerns [29][58] - **Clinical Comparability**: The company has conducted additional studies to prepare for potential questions from regulators, indicating readiness to provide further data if required [29][58] Supply Chain and Manufacturing - **Third-Party Suppliers**: The two suppliers with deficiencies are independent, and the issues do not relate to critical components of the product [27][49] - **Alternative Suppliers**: Telix has already qualified alternative suppliers for one of the components, indicating a proactive approach to supply chain management [46][47] Financial and R&D Implications - **R&D Spending**: The company does not foresee a material impact on R&D spending due to the CRL, as they are financially positioned to continue their current projects [66][73] - **Market Launches**: Telix is actively preparing for market launches in Europe and other regions, indicating ongoing business activities despite the setback [66][67] Regulatory Environment - **Increased Scrutiny**: The regulatory environment has become more stringent, with the FDA applying higher standards to novel products, which may contribute to the challenges faced by Telix [39][41] Conclusion - **Commitment to Product Development**: Telix remains committed to addressing the FDA's concerns and bringing TLX250 CDx to market, viewing the current challenges as learning opportunities for future product developments [76]

Summary of Jazz Pharmaceuticals (JAZZ) Update / Briefing on Modesto Company and Industry Overview - **Company**: Jazz Pharmaceuticals - **Product**: Modesto (formerly known as dorbapril) - **Industry**: Oncology, specifically focused on rare brain tumors Key Points and Arguments 1. **FDA Approval**: Modesto received accelerated approval from the FDA on August 6, 2025, for treating adult and pediatric patients with diffuse midline glioma harboring an H3K27M mutation with progressive disease following prior therapy [5][41] 2. **Market Need**: This is the first and only FDA-approved treatment for this ultra-rare and aggressive brain tumor, primarily affecting children and young adults, with an estimated annual incidence of approximately 2,000 patients in the U.S. [10][49] 3. **Launch Readiness**: Following the acquisition of Chimerix, Jazz Pharmaceuticals has prepared for a rapid launch, with Modesto available to patients as of August 15, 2025 [5][6] 4. **Mechanism of Action**: Modesto is a first-in-class small molecule that reverses the loss of H3K27 trimethylation, a hallmark of H3K27M mutant diffuse midline glioma, leading to decreased tumor cell proliferation and death [13][14] 5. **Clinical Data**: In clinical studies, the overall response rate for Modesto was 22%, with a median duration of response of 10.3 months. Approximately 73% of responders maintained their response for at least six months [40][28] 6. **Safety Profile**: Modesto has been well tolerated, with only 2.1% of patients discontinuing due to adverse reactions. Serious adverse reactions occurred in 33% of patients, but no treatment-related deaths were reported [44][36] 7. **Commercial Strategy**: The launch strategy includes targeting academic centers of excellence, with a dedicated neuro-oncology sales team and disease education campaigns to raise awareness about the H3K27M mutation and the importance of testing [50][52] 8. **Pricing**: The wholesale acquisition cost for Modesto is set at $32,000 per bottle, reflecting the value and innovation it brings to patients [54] 9. **Future Trials**: The ongoing Phase III ACTION trial aims to confirm the benefits of Modesto in newly diagnosed patients, with expectations for broader international submissions based on supportive trial results [46][47] Additional Important Information - **Patient Support Services**: Jazz Pharmaceuticals has established robust access and patient support services to help patients navigate reimbursement and ensure access to Modesto [53] - **Long-term Outlook**: The patent for Modesto extends to 2037, with potential for patent term extension, indicating a long-term product lifecycle [58] - **Epidemiology Insights**: The disease was codified in the WHO classification in 2016, and the company is working to increase biopsy rates and improve diagnostic accuracy for H3K27M mutations [100][83] - **Potential for Expansion**: There is ongoing research into the broader applicability of Modesto beyond its current indication, exploring similar biological mechanisms in other tumor types [104][106]