Core Viewpoint - Replimune Group, Inc. is engaging with the FDA to discuss the complete response letter for its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment, emphasizing the urgent need for access to this therapy in the melanoma community [1][3]. Company Overview - Replimune Group, Inc. is a clinical-stage biotechnology company founded in 2015, focused on developing novel oncolytic immunotherapies to transform cancer treatment [5]. - The company's lead product candidate, RP1, is based on a proprietary strain of herpes simplex virus engineered to enhance tumor killing potency and activate systemic anti-tumor immune responses [4][5]. FDA Interaction - A Type A meeting with the FDA has been scheduled to address the complete response letter concerning the BLA for RP1, with the company submitting a briefing book that responds to the FDA's concerns [1][2]. - The briefing book includes prior agreements on patient population, PD-1 resistance criteria, and additional data analysis from the BLA [2]. Community Support - The melanoma community, including physicians and patient advocacy groups, has highlighted the urgent need for RP1 due to limited effective treatment options available [3].

SALT LAKE CITY, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the H.C. Wainwright 27th Annual Global Investment Conference and host 1x1 investor meetings. Dat ...

Core Points - Reeflex Solutions Inc. held its Annual General and Special Meeting of Shareholders on August 29, 2025, with 30,783,820 common shares voted, representing approximately 66.3% of the outstanding shares [2][5] - All matters proposed in the Management Information Circular dated July 18, 2025, were approved by shareholders, including the election of directors and the appointment of auditors [2][5] - The election results for the directors showed overwhelming support, with all nominees receiving over 99.9% of votes in favor [2][5] Company Overview - Reeflex Solutions Inc. is a public company that provides advanced engineering and manufacturing solutions across various industries [3] - The company operates through its subsidiary, Coil Solutions Inc., which specializes in coil tubing injectors and downhole tools for the oil and gas sector [3] - The manufacturing division, Ranglar Manufacturing, focuses on custom-designed mobile equipment for a wide range of industrial applications [3]

Core Insights - GDEV Inc. has increased its ownership in Royal Ark to 57% through a conversion option, enhancing their strategic partnership established in 2022 [1] - The partnership has led to the successful launch of Idle Zombie Miner, which achieved over 17 million installs and generated approximately $23 million in revenue in the first half of 2025 [2] - Royal Ark remains independently managed by its founder, Leonid Sirotin, while GDEV provides strategic oversight and resource allocation [3] Company Overview - GDEV is a gaming and entertainment holding company with a diverse portfolio, including subsidiaries like Nexters and Royal Ark, and has achieved over 550 million installs and $2.7 billion in bookings globally [5] - Royal Ark, founded by Leonid Sirotin, focuses on creating mobile games and operates independently, emphasizing player care and attention to detail [6]

MALVERN, Pa., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced its CEO, Maria Maccecchini, Ph.D., will present at the H.C. Wainwright 27th Annual Global Investment Conference happening September 8-10, 2025 in Lotte New York Palace Hotel, New York City. Presentation details D ...

ATHENS, Greece, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Advent Technologies Holdings, Inc. (NASDAQ: ADN), an innovation-driven leader in the fuel cell and hydrogen technology space, announce today that its wholly owned Greek subsidiary, Advanced Energy Technologies S.A. has submitted five (5) required deliverables to the European Climate, Infrastructure and Environment Executive Agency (CINEA) -since April 1st 2025 when the RHyno Project officially commenced- and is preparing to submit the first Progress Report ...

TEL AVIV, Israel, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Nasus Pharma Ltd. (NYSE: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products to treat emergency medical conditions, today announced that company management will present at the H.C. Wainwright 27th Annual Global Investment Conference. Location: VirtualDate: September 5, 2025Time: 07:00-07:30 a.m. ETType: Company presentation Presenter: Dan Teleman, Chief Executive Off ...

CALGARY, Alberta, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Reconnaissance Energy Africa Ltd. (the “Company” or “ReconAfrica”) (TSXV: RECO) (OTCQX: RECAF) (Frankfurt: 0XD) (NSX: REC) is pleased to provide a drilling update on the Kavango West 1X exploration well that spud on July 31, 2025. Brian Reinsborough, President and CEO of the Company commented: "Our operations team members in Namibia are doing an excellent job on the drilling the Kavango West well, both efficiently and safely. Drilling remains on schedule, ...

MCDONALD, Tenn., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Amaero Ltd (ASX:3DA, OTC:AMROF) (“Amaero” or the “Company”), a leading U.S. domestic producer of high-value C103, refractory alloy, and titanium powders for additive and advanced manufacturing of components utilized by the defense, space, and aviation industries, is pleased to announce that it has entered into a five-year exclusive supplier and development agreement with Titomic Limited (ASX:TTT) (“Titomic”) for refractory and titanium alloy spherical powd ...

Results will underscore rapid adoption of Rezolve’s Ai platform and the Company’s positioning to capture share in the $30 trillion global retail market.NEW YORK, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Rezolve Ai (NASDAQ: RZLV), the company reinventing retail through real-time AI-driven consumer engagement, today announced it will release its financial results for the first half of 2025 before market open on Wednesday, October 1, 2025. Management will host a live conference call at 8:30am Eastern Time to review ...