MannKind Announces Expansion of United Therapeutics Collaboration for Second Inhaled Therapy
Globenewswire· 2025-08-27 12:05
Core Insights - MannKind Corporation has announced that United Therapeutics Corporation has exercised its option to develop a second dry powder inhalation therapy under their 2018 collaboration agreement [1][2] Group 1: Collaboration and Agreement Details - The original agreement led to the FDA approval of Tyvaso DPI in May 2022 and included an option for United Therapeutics to expand the license to additional active ingredients [2] - Under the expanded agreement, MannKind will formulate a second investigational molecule using its proprietary Technosphere platform, while United Therapeutics will handle preclinical and clinical development [2] - MannKind will receive an upfront payment of $5 million, with potential development milestone payments of up to $35 million and 10% royalties on net sales of any resulting product [3] Group 2: Development Activities - Formulation and development activities for the new investigational molecule will commence immediately [4] Group 3: Company Overview - MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products and devices to address serious unmet medical needs, particularly in endocrine and orphan lung diseases [5] - The company aims to utilize its formulation capabilities and device engineering to alleviate the burden of diseases such as diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension [6]
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Expanded Access Policy for NRX-100 (preservative-free ketamine)
Globenewswire· 2025-08-27 12:03
Core Viewpoint - NRx Pharmaceuticals has announced an expanded access policy for NRX-100, a preservative-free ketamine, following its Fast Track designation by the FDA for treating suicidal ideation in patients with depression, including bipolar depression [1][6]. Group 1: Expanded Access Policy - NRX-100 is now available for expanded access to eligible patients, addressing an unmet need in treating suicidal depression [2][6]. - Physicians can request NRX-100 for patients who are not responsive to or cannot tolerate approved treatment options [3][7]. - The company emphasizes the urgent need for NRX-100 for patients with suicidal depression [3]. Group 2: FDA Designation and Clinical Development - The FDA granted Fast Track designation for NRX-100 based on preliminary data indicating its potential to meet an unmet medical need [2][6]. - NRX Pharmaceuticals is also developing NRX-101, which has received Breakthrough Therapy Designation for treating suicidal bipolar depression [5]. Group 3: Patient Statistics and Clinical Trials - Approximately 13 million adults in the U.S. seriously consider suicide each year, with a suicide occurring every 11 minutes [6]. - NRX has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application for NRX-100, based on results from well-controlled clinical trials [8].
Belite Bio to Participate in Three Upcoming Investor Conferences
Globenewswire· 2025-08-27 12:00
Company Overview - Belite Bio, Inc is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including Stargardt disease type 1 and Geographic Atrophy in advanced dry age-related macular degeneration [2] - The lead candidate, Tinlarebant, is an oral therapy aimed at reducing toxin accumulation in the eye, currently undergoing Phase 3 and Phase 2/3 studies [2] Upcoming Events - The executive management team will participate in three investor conferences: - Cantor Global Healthcare Conference on September 5, 2025, at 8:00 am ET - Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, at 5:35 pm ET - H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 8:00 am ET [3] - Webcasts of the presentations will be available on the investor relations section of the Belite Bio website, with replays archived for 90 days [1]
Enphase Energy Ships IQ Battery 10C with U.S. Domestic Content, Delivering Enhanced TPO Project Value
Globenewswire· 2025-08-27 12:00
Core Insights - Enphase Energy has announced the initial shipments of the IQ Battery 10C, which is designed to meet the growing demand in the third-party ownership (TPO) market and includes domestically sourced components to qualify for federal tax credits [1][2]. Group 1: Product Launch and Features - The IQ Battery 10C meets the current 45% U.S.-sourced materials threshold for tax credits, with future thresholds of 50% in 2026 and 55% in 2027 anticipated [2]. - The battery has been added to approved vendor lists for several major TPO providers, allowing companies to capture significant tax credit value [2][3]. - The new battery system is part of Enphase's 4th-generation battery launch, which includes the IQ Meter Collar and IQ Combiner 6C, enhancing its functionality as a whole-home backup solution [4][5]. Group 2: Market Impact and Industry Trends - The shift towards third-party owned financing in the energy sector emphasizes the importance of reliable batteries that qualify for domestic content [4]. - The introduction of the IQ Battery 10C aligns with the industry's trend towards leases and power purchase agreements (PPAs), helping installers and developers maximize tax credit opportunities [5]. - Enphase's commitment to building high-performance, incentive-eligible energy systems in the U.S. strengthens its domestic supply chain and competitive position in the market [5]. Group 3: Company Background - Enphase Energy is a leading global energy technology company based in Fremont, CA, specializing in microinverter-based solar and battery systems [7]. - The company has shipped approximately 83.1 million microinverters and deployed over 4.9 million Enphase-based systems in more than 160 countries [7].
Opus Genetics Inherited Retinal Disease Programs Featured at Medical and Industry Conferences in September
Globenewswire· 2025-08-27 12:00
Company Overview - Opus Genetics, Inc. is a clinical-stage biopharmaceutical company focused on developing gene therapies for inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders [3] - The company's pipeline includes AAV-based gene therapies targeting conditions such as Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa [3] - Lead gene therapy candidates include OPGx-LCA5, currently in a Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1 for BEST1-related retinal degeneration [3] - Additionally, the company is advancing Phentolamine Ophthalmic Solution 0.75%, which is approved for one indication and is being studied in two Phase 3 programs for presbyopia and low light vision disturbances [3] Upcoming Presentations - Opus Genetics will present its IRD gene therapy programs at several scientific conferences in September 2025 [1] - Presentation at the Ophthalmology Futures Forum will focus on "Gene & Cell Therapies for Rare & Common Retinal Diseases: Hype Vs Progress" on September 3, 2025 [2] - At the RD 2025 International Symposium, the company will share one-year results from a Phase I/II study of OPGx-LCA5 for inherited retinal degeneration due to biallelic mutations in the LCA5 gene [2] - The LSX World Congress will feature a presentation titled "The Equation for Maturation: Biotech Requirements to Achieve Scale" [2] Key Personnel - Sally Tucker, Ph.D., Senior Vice President Clinical Development, will present at the Ophthalmology Futures Forum and participate in a panel discussion in Paris, France on September 3, 2025 [4] - Ash Jayagopal, Ph.D., Chief Scientific & Development Officer, will present in Prague, Czech Republic on September 15, 2025 [4] - Ben Yerxa, Ph.D., President, will also participate in a panel discussion in Boston, MA on September 17, 2025 [4]
Soleno Therapeutics to Participate in Upcoming September Conferences
Globenewswire· 2025-08-27 12:00
Group 1 - Soleno Therapeutics, Inc. will participate in several investor conferences in September 2025, including the Cantor Global Healthcare Conference and Wells Fargo Healthcare Conference [1] - The presentation format for all listed conferences will be a fireside chat, allowing for an interactive discussion [1] - Replays of the Cantor and Wells Fargo events will be available on the company's website for investors [1] Group 2 - Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases [2] - The company's first commercial product, VYKAT™ XR, is an oral treatment for hyperphagia in individuals with Prader-Willi syndrome, available for adults and children aged 4 and older [2] - For further information, the company provides resources on its website [2]
Nautilus Biotechnology to Participate in Upcoming September Investor Conferences
Globenewswire· 2025-08-27 12:00
Core Insights - Nautilus Biotechnology, Inc. is participating in multiple investor conferences to enhance visibility and engagement with investors [1][4] Company Overview - Nautilus Biotechnology is a development stage life sciences company headquartered in Seattle, Washington, with R&D operations in San Carlos, California [3] - The company focuses on creating a platform technology for quantifying and analyzing the complexity of the proteome, aiming to democratize access to proteomics and advance human health and medicine [3] Upcoming Events - Management will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8 at 10:50 a.m. Pacific Time [4] - A presentation is scheduled for the Q3 Investor Summit Group Virtual Conference on September 16 at 10:00 a.m. Pacific Time, followed by 1x1 meetings on September 17 [4]
Blade Air Mobility Sets Timing for Name Change to Strata Critical Medical and Commencement of Trading Under the New Ticker Symbol “SRTA”
Globenewswire· 2025-08-27 12:00
Company Overview - Blade Air Mobility, Inc. is changing its legal name to Strata Critical Medical, Inc. to focus on mission-critical logistics and medical services for hospitals and healthcare providers [1][2] - The company is one of the largest transporters of human organs for transplant in the United States and provides air transportation and logistics services primarily in the Northeast United States, Southern Europe, and Western Canada [3] Stock Information - The name change will take effect on August 28, 2025, and the company's common stock will begin trading under the symbol "SRTA" on August 29, 2025 [2] - The CUSIP numbers for the company's common stock and warrants will remain unchanged, and no action is required from securityholders [2] Business Model - Blade operates an asset-light model with exclusive passenger terminal infrastructure and proprietary technologies, facilitating a transition to Electric Vertical Aircraft (EVA or eVTOL) for lower-cost, quiet, and emission-free air mobility [3]
RTX Chairman and CEO to present at the Morgan Stanley 13th Annual Laguna Conference
Prnewswire· 2025-08-27 12:00
ARLINGTON, Va., Aug. 27, 2025 /PRNewswire/ -- RTX (NYSE: RTX) Chairman and CEO Chris Calio will speak at the Morgan Stanley 13th Annual Laguna Conference on Wednesday, Sept. 10 at 11:30 a.m. Eastern Time. The presentation will be broadcast live at www.rtx.com and will be archived on the website afterward. Media Contact C: 202.384.2474 Investor Contact C: 781.522.5123 SOURCE RTX About RTX RTX is the world's largest aerospace and defense company. With more than 185,000 global employees, we push the limits of ...
Harmonic Unwraps the Game Plan for Next-Gen Broadband Delivery at SCTE TechExpo25
Prnewswire· 2025-08-27 12:00
Core Insights - Harmonic is set to showcase innovative broadband solutions at SCTE TechExpo25, focusing on enabling fiber-grade multi-gigabit connectivity and enhancing subscriber experiences [1][2] Group 1: Innovations in Broadband Technology - The company is introducing Unified DOCSIS 4.0, which supports both Full Duplex (FDX) and Frequency Division Duplex (FDD) technologies, allowing for ultra-high-capacity throughput and significant cost savings for operators [3] - Harmonic's cOS broadband platform, along with devices like Pearl R-OLT and Jetty remote switch, facilitates a transition from GPON to XGS-PON and up to 100G PON, addressing the demand for high-speed fiber service delivery [4] - The new AI Assistant capability in cOS Central enables smarter, self-healing networks, improving network reliability and subscriber satisfaction while reducing operating costs [5] Group 2: Enhancing User Experience - Harmonic's cOS platform features L4S capabilities that provide ultra-low-lag experiences, crucial for latency-sensitive applications such as online gaming and video conferencing [6] - The SeaStar™ optical node allows for rapid deployment of fiber-grade connectivity in lower-density MDUs, reducing capital expenses and enabling revenue expansion for operators [7] Group 3: Industry Engagement and Expertise - Harmonic will share insights on broadband trends and strategies at SCTE TechExpo25, highlighting its cOS platform's role in powering next-gen broadband services for over 35 million CPE devices globally [8] - Key executives from Harmonic will participate in various sessions at the expo, discussing topics such as next-gen networks, AI in broadband operations, and the future of FTTx [12]