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]

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].

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]

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].

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]

REDWOOD CITY, Calif., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it will participate in the following investor conferences in September: Cantor Global Healthcare ConferencePresentation Date: Wednesday, September 3, 2025 at 1:00 PM ETPresentation Format: Fireside ChatWebcast: Here Wells Fargo Healthcare ConferencePresentation Date: Thursday, September ...

SEATTLE, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Nautilus Biotechnology, Inc. (NASDAQ: NAUT; or “Nautilus”), a company pioneering a single-molecule protein analysis platform, today announced the company will be participating in the following investor conferences. Morgan Stanley 23rd Annual Global Healthcare Conference in New York, NYManagement is scheduled to participate in a fireside chat on Monday, September 8h at 10:50 a.m. Pacific Time / 1:50 p.m. Eastern Time. Q3 Investor Summit Group Virtual ConferenceManag ...

WAYNE, Pa., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the Company will participate in two upcoming healthcare conferences in September. On Wednesday September 3, 2025, at 1:00 PM EDT, Aclaris’ Chief Executive Officer Dr. Neal Walker and other members of Aclaris’ senior leadership team will participate in a fireside chat during the ...

NEW YORK, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Blade Air Mobility, Inc. (Nasdaq: BLDE, “Blade” or the “Company”), today confirmed that the previously announced change of its legal name to Strata Critical Medical, Inc is expected to occur this week. The change is intended to reflect the Company’s plan to focus on providing mission critical logistics and medical services to hospitals and healthcare providers throughout the country following the closing of the previously announced agreement to sell Blade’s Passen ...

Harmonic's DOCSIS and Fiber Innovations Enable Low-Latency Multi-Gigabit Connectivity and Unlock New Revenue for Broadband Service Providers SAN JOSE, Calif., Aug. 27, 2025 /PRNewswire/ -- Harmonic (NASDAQ: HLIT) today announced that the company will once again bring game-changing innovations to SCTE TechExpo25, empowering operators to deliver fiber-grade multi-gigabit broadband connectivity and outstanding subscriber experiences. Harmonic's industry-leading cOS™ virtualized broadband platform and extensive ...