Boca Raton, Florida, June 30, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company, today announced that it has closed its registered direct offering, announced on June 27, 2025, (the "Offering") for the purchase and sale of 3,000,000 shares of its common stock at a purchase price of $6.30 per share, priced at-the-market under Nasdaq rules. The gross proceeds from the Offering are approximately $19 million, before deducting placement a ...

Core Insights - Addex Therapeutics has made a strategic investment of CHF 2 million in Stalicla, a company focused on precision medicine for neurodevelopmental and neuropsychiatric disorders [1][2] - The investment aims to support Stalicla's portfolio of autism-focused drug candidates and its series C financing, while also enhancing Addex's commitment to advancing innovative treatments for CNS disorders [2][3] Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company developing novel small molecule allosteric modulators for neurological disorders, with a lead drug candidate, dipraglurant, under evaluation for brain injury recovery [4] - Stalicla has raised over $50 million in equity and more than $30 million in non-dilutive funding, focusing on transforming treatments for neurodevelopmental disorders [3][4] Investment Details - The investment will enable Stalicla to advance its lead autism candidate STP1 and a second asset into Phase 2 trials, targeting specific subpopulations within autism spectrum disorder (ASD) [2][3] - Stalicla is also progressing its STP7 program (mavoglurant) for cocaine use disorders, which is the most advanced treatment candidate in development for this indication [2][3] Leadership Changes - As part of the investment, Addex CEO Tim Dyer has been appointed to Stalicla's Board of Directors and nominated as Chairman, indicating a deeper collaboration between the two companies [1][2]

Core Viewpoint - RetinalGenix Technologies Inc. has partnered with LabCorp to launch a cost-effective DNA/RNA/GPS Pharmaco-Genetic Mapping™ platform aimed at improving early detection of ocular and systemic diseases while reducing reliance on expensive diagnostic procedures [1][6]. Group 1: Collaboration and Methodology - The collaboration allows patients to visit LabCorp locations for genetic testing and high-resolution retinal imaging, utilizing proprietary algorithms to correlate genetic and retinal biomarkers [2][3]. - The methodology aims to establish a new standard for early detection of various health conditions, enhancing accessibility and affordability of healthcare services [5][6]. Group 2: Technological Innovations - RetinalGenix is introducing high-resolution retinal imaging as an additional service, which is expected to improve diagnostic accuracy and facilitate mass screening by general practitioners and standard eye clinics [4][7]. - The integration of genetic screening and advanced imaging technologies is designed to prevent blindness and detect early physiological changes indicative of future diseases [7]. Group 3: Market Impact and Future Prospects - The company is working with regulators to establish CPT codes, which could lower healthcare costs and streamline patient assessment processes [6]. - As the database of disease-associated biomarkers expands, the value of the DNA/RNA/GPS platform for diagnosing diseases is anticipated to grow, promising improved patient outcomes and more accessible care [3][4].

Core Insights - Tempus AI (TEM) is experiencing significant growth in its Data and Services segment, with a 43.2% year-over-year revenue increase to $61.9 million in Q1 2025, driven by a 58% growth in its Insights data licensing business [1][7] - The company has secured major contracts, including a $200 million licensing agreement with AstraZeneca (AZN) and Pathos, which has increased AZN's total remaining contract value to over $1 billion [2][7] - Tempus has expanded collaborations with key pharmaceutical companies, including Illumina and Boehringer Ingelheim, enhancing its position in biomarker development and oncology applications [3][7] Financial Performance - Gross profit for Tempus outpaced revenue growth, increasing by 65.2% with only a modest 3% rise in the cost of revenues [1] - Year-to-date, Tempus AI shares have surged 102.5%, significantly outperforming the industry average growth of 18% [6] Competitive Landscape - Competitors like ICON (ICLR) and IQVIA (IQV) are also experiencing growth, but Tempus AI's performance in securing contracts and expanding its service offerings positions it favorably in the market [4][5] - Tempus currently trades at a forward 12-month Price-to-Sales (P/S) ratio of 8.47X, compared to the industry average of 5.83X, indicating a premium valuation [8]

Core Viewpoint - Excelitas has appointed Lynn Swann to its Board of Directors, highlighting the company's commitment to attracting high-integrity leaders with diverse perspectives to support growth and innovation [1][2][3]. Company Overview - Excelitas is a leading provider of advanced technologies serving global market leaders in life sciences, advanced industrial, next-generation semiconductor, and avionics sectors [1][3]. - The company is headquartered in Pittsburgh, PA, and focuses on the design, development, and manufacture of advanced technologies, including sensing, detection, imaging, optics, and specialty illumination [3]. Leadership Experience - Lynn Swann brings extensive business acumen and leadership experience, having served on the boards of several notable companies, including Apollo Global Management, Xylem Inc., and Caesars Entertainment [2]. - His appointment is expected to provide valuable insights as Excelitas expands its global footprint and pursues its corporate purpose of enriching life and driving innovation [3]. Strategic Focus - Excelitas is positioned at the forefront of addressing significant megatrends such as precision medicine, industrial automation, artificial intelligence, and connected devices (IoT) [3].

Summary of Acadia Pharmaceuticals (ACAD) R&D Day - June 25, 2025 Company Overview - Acadia Pharmaceuticals focuses on advancing care for patients with underserved neurological and rare diseases, guided by a mission to address high unmet needs in these areas [4][5][11] - The company has two profitable brands, NUPLAZID and Debut, which are expected to generate over $1 billion in combined revenue for the first time in 2025 [5][11] Financial Performance - NUPLAZID is projected to achieve net sales between GBP $650 million and GBP $690 million in 2025, reflecting a 7% to 13% year-over-year growth [6] - Debut is expected to generate net sales between $380 million and $405 million, indicating a 916% growth [7] - The total peak sales potential for NUPLAZID and Debut combined could reach between $1.5 billion and $2 billion [12] Pipeline and Future Growth - Acadia has a robust pipeline with nine disclosed programs, eight of which are expected to be in clinical stages by the end of the year [17] - The company anticipates five study readouts from Phase II or Phase III trials between now and the end of 2027 [17] - The pipeline includes later-stage assets like ACP101 for Prader-Willi syndrome and ACP204 for Alzheimer's disease psychosis, with top-line data expected in 2025 and 2026, respectively [8][17] Key Pipeline Assets 1. **ACP204**: A novel 5-HT2A inverse agonist targeting Alzheimer's and Lewy body dementia psychosis, with a significant unmet need as there are currently no approved therapies for these conditions [24][60] - Approximately 3 million people are affected by psychosis related to these diseases [27] - ACP204 is designed to avoid QT prolongation, allowing for higher dosing and potentially greater efficacy [30][60] 2. **ACP211**: An oral agent with potential ketamine-like efficacy for major depressive disorder (MDD) and treatment-resistant depression (TRD), aiming to minimize sedation and dissociation [62][81] - MDD affects approximately 21 million adults in the U.S., with only 9 million receiving treatment [67] - The drug is designed to provide rapid antidepressant effects without the severe side effects associated with current treatments [81] Strategic Focus - Acadia's growth strategy is anchored in precision medicine, data innovation, globalization, and patient empowerment [4] - The company aims to expand into adjacent rare disease categories, leveraging its scientific approach and internal capabilities [11] Market Opportunity - The potential market for the pipeline assets is significant, with an estimated combined peak sales potential of up to $12 billion if all five pipeline assets succeed [12][13] - Acadia believes that the current market undervalues its clinical programs, and it is committed to delivering data and executing its strategy to unlock this potential [13] Conclusion - Acadia Pharmaceuticals is positioned for transformational growth through its innovative pipeline and strong commercial brands, addressing critical needs in neurological and rare diseases while aiming to enhance patient care and outcomes [2][4][11]

Financial Performance and Expectations - Acadia Pharmaceuticals expects to generate over $1 Billion in total U S revenues in 2025[12] - The company estimates a risk-adjusted peak sales potential of $25 Billion from its pipeline molecules[17] - The full potential peak sales for pipeline molecules is estimated at $12 Billion, assuming successful approval and commercialization[17] - Potential peak sales of current products are projected to be in the range of $15-$2 Billion[19] Pipeline Development and Strategy - Acadia Pharmaceuticals is focused on advancing care for underserved neurological and rare diseases[11] - The company has a late-stage pipeline with ACP-101 (P3-PWS) data expected in early Q4 2025 and ACP-204 (P2-ADP) data expected in mid-2026[12] - Acadia has 2 approved medicines and 9 disclosed and multiple undisclosed programs[30] - The company anticipates 7 Phase 2 or Phase 3 study starts in 2025 and 2026, and 5 Phase 2 or Phase 3 study readouts between 2025 and 2027[30] Key Programs and Indications - ACP-204 is being developed for Alzheimer's Disease Psychosis (ADP) and Lewy Body Dementia with Psychosis (LBDP), targeting approximately 3 million patients with psychosis across PDP, LBDP, and ADP in the US[45] - ACP-211 is in development for Major Depressive Disorder (MDD), a condition affecting approximately 21 million adults in the US[93, 125] - ACP-711 is being investigated for Essential Tremor (ET), which affects an estimated 7 million people or 22% of the US population[136, 171] - DAYBUE, approved for Rett syndrome, has seen >50% of patients remain on treatment at 12 months and 65% on treatment for 12+ months[271]

Core Insights - iBio, Inc. is set to announce a third target in its collaboration with AstralBio, focusing on advancements in obesity and cardiometabolic disease treatments [1][2] - The company aims to pioneer next-generation antibody medicines that are targeted, longer-lasting, and potentially better tolerated, with a strategic overview of its obesity treatment strategy [2][4] Company Overview - iBio is a biotech company utilizing AI and advanced computational biology to develop biopharmaceuticals for various diseases, including cardiometabolic diseases, obesity, and cancer [4] - The company combines proprietary 3D modeling with innovative drug discovery platforms to create a pipeline of breakthrough antibody treatments addressing significant unmet medical needs [4] Upcoming Events - A conference call is scheduled for June 24, 2025, at 8:30 a.m. ET to discuss the latest advancements and the new target in the AstralBio collaboration [1][3]

Fadra (Fadraciclib) Development - Cyclacel is developing fadraciclib, a next-generation CDK2/9 inhibitor, with a precision medicine strategy in Phase 2 trials[3] - Phase 2 cohorts are enrolling patients with solid tumors with CDKN2A/CDKN2B abnormalities and T-cell lymphoma, with readouts expected in 2H 2024 and 2H 2024-1H 2025, respectively[3] - In a Phase 1 dose escalation study, 11 patients had CDKN2A/B abnormalities[12] - One endometrial cancer patient with CDKN2A, CDKN2B, and MTAP loss achieved a complete response (CR) with fadraciclib at 213mg QD[13] - In an oral Phase 1 dose escalation study (065-101), out of 32 patients, 2 achieved partial responses (PR), 21 had stable disease (SD), and 9 had progressive disease (PD)[17, 18] - In an expansion cohort of 12 patients, 7 (58.3%) experienced at least one related treatment-emergent adverse event (TEAE) of any grade, with most being Grade 1 or 2[34] - In the expansion cohorts, the overall response rate (ORR) was 8%, with a disease control rate (DCR) of 67%[35] Plogosertib (CYC140) Development - Plogosertib (CYC140) is a next-generation PLK1 inhibitor with a novel mechanism of action targeting ARID1A and TP53 mutated cancers[42, 44] - Preclinical data shows anti-cancer activity in 5 out of 13 solid tumors[43] - A Phase 1/2 clinical study (140-101) is ongoing in solid tumors and lymphoma, with dose escalation up to Dose Level 5 showing good tolerability and no dose-limiting toxicities observed to date[55, 57] - In vitro studies of 16 CRC PDX models showed that 5 models had an EC50 < 30 nM to plogosertib[65, 67] Financial Status - As of June 30, 2024, Cyclacel had $6.0 million in cash equivalents[82]

Core Insights - Incyte (INCY) shares increased by 5.1% following a global partnership with QIAGEN N.V. to develop a diagnostic panel for myeloproliferative neoplasms (MPNs), which account for approximately 40% of hematological malignancies [1][4] Partnership Details - The collaboration focuses on INCA033989, Incyte's investigational monoclonal antibody targeting mutant calreticulin (mutCALR), currently in early-stage development for myelofibrosis (MF) and essential thrombocythemia (ET) [2] - QIAGEN will create a multimodal panel using next-generation sequencing (NGS) technology to identify key gene alterations in MPNs, initially concentrating on mutCALR, the second most common driver of MPNs [2][5] - The panel will be validated on the Illumina NextSeq 550Dx platform for whole blood samples, with QIAGEN assisting in regulatory submissions and market access in the U.S., EU, and certain Asia-Pacific regions [3][6] Benefits of the Collaboration - The partnership enhances Incyte's precision medicine efforts by facilitating the identification of genetic mutations like CALR, which is crucial for treatment decisions in rare blood cancers [5] - It allows for widespread CALR testing, improving patient selection for Incyte's therapies and increasing the likelihood of better treatment outcomes [6] - The collaboration strengthens Incyte's position in personalized medicine and accelerates regulatory and market access for its mutCALR-targeted treatment [6][7] Clinical Data and Future Prospects - Incyte reported positive data from two Phase I studies of INCA033989, showing rapid and lasting platelet normalization in ET patients, with 86% achieving a complete/partial hematologic response at doses above 400 mg [11][12] - The candidate demonstrated selective targeting of mutCALR cells while sparing healthy cells, indicating potential for disease modification [12] - Incyte plans to advance INCA033989 into late-stage development for MPN indications in 2026 after discussions with regulatory authorities [13]