MENLO PARK, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced the appointment of Chris Martin to its Board of Directors. Additionally, Cameron Turtle, DPhil, resigned from the Board effective December 11, 2025. “As we rapidly advance our co-lead programs through development, I’m ...

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced it has received official notification from the U.S. Food and Drug Administration (FDA) that the clinical hold on the MyPEAK-1™ Phase 1b/2a clinical trial of TN-201 has been removed. All concerns raised by the FDA related ...

Telo Genomics Presents Genomic Profiles of Peripheral Blood Minimal Residual Disease Cells at the 67th American Society of Hematology MeetingDecember 11, 2025 4:00 PM EST | Source: Telo Genomics Corp.Toronto, Ontario--(Newsfile Corp. - December 11, 2025) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo") a leader in the development of diagnostic and prognostic tests for human disease through the analysis of telomeres, today announced that the company highlighted its ap ...

Company Overview - Evommune is developing next-generation therapies for chronic inflammation, which contributes to 3 out of 5 deaths worldwide[8] - The annual direct cost of chronic inflammation is at least $90 billion[9] - Evommune completed a $173 million IPO in November 2025 and has approximately $235 million in cash and investments as of September 30, 2025[115, 116] Clinical Programs - Evommune has two Phase 2 programs: EVO756 (oral MRGPRX2 antagonist) and EVO301 (long-acting IL-18 fusion protein)[15, 117] - EVO756 is being developed for chronic spontaneous urticaria (CSU) and atopic dermatitis (AD)[20, 117] - EVO301 is being developed for atopic dermatitis and ulcerative colitis[20, 117] - Three Phase 2 data readouts are expected in 2026: EVO756 in CSU (H1 2026), EVO756 in AD (H2 2026), and EVO301 in AD (H1 2026)[20, 117] EVO756 Clinical Data - In a Phase 2 trial in chronic inducible urticaria (CIndU), both 300 mg QD and 50 mg BID doses of EVO756 demonstrated robust clinical activity, with 30% of patients achieving a complete response after just 4 weeks[47, 49] - In the CIndU trial, at week 4, patients on 300 mg QD (N=10) saw a 14 point reduction and 50 mg BID patients (N=17) saw a 15 point reduction in Mean FricTest Score (0-4)[52] EVO756 Phase 2b Trials - A Phase 2b dose-ranging trial in CSU (N = 160) is underway, with topline data expected in H1 2026[72] - A Phase 2b dose-ranging trial in AD (N = 120) is underway, with topline data expected in H2 2026[80]

Bioxytran Conference Call Summary Company Overview - **Company Name**: Bioxytran (OTCPK:BIXT) - **Industry**: Clinical stage biotechnology - **Core Technologies**: Three platform technologies utilizing AI for drug development - Broad-spectrum oral antiviral drug achieving 100% viral reduction in seven days - Carbohydrate drug neutralizing COVID-19, influenza, and RSV - Oxygenation molecule for stroke treatment, supported by an FDA-approved device for local tissue oxygenation [3][4][7] Key Points and Arguments - **Clinical Trials**: - Recently completed dose escalation trial with positive indications from the CRO, expecting top-line data readout before year-end [8][9] - Future phase three trial design optimized for the Indian market, focusing on upper respiratory tract infections including influenza, RSV, and COVID-19 [10] - **Research Report**: - A comprehensive 29-page research report available on the company website, targeting institutional investors, highlighting the potential of the drug to address pandemics and common colds, as well as stroke treatment [11][12] - **Stroke Drug**: - The stroke drug acts as an oxygen carrier, significantly smaller than blood cells, providing oxygen to the brain during critical moments before standard treatment [13][14] - Market potential estimated to exceed the existing tPA market, valued at $6 billion-$7 billion annually, with additional cost savings in rehabilitation and caregiver expenses [15] - **Partnerships**: - Actively seeking partnerships, particularly in cancer immunotherapy, to enhance the efficacy of existing treatments using their galectin blocker [16][17] - Collaboration with the University of Georgia for bird flu research, pending formal announcement and funding confirmation [18][19] Additional Important Information - **Market Disruption**: The company aims to disrupt traditional treatment methods by addressing root causes of diseases rather than just symptoms [7] - **Cancer Metastasis Platform**: Mentioned as a significant aspect of their technology portfolio, although not highlighted in the recent research report [11][12] - **Investor Communication**: Emphasis on setting realistic expectations for investors regarding ongoing research and development efforts [19] This summary encapsulates the critical insights from the Bioxytran conference call, focusing on the company's innovative technologies, clinical trial progress, market potential, and strategic partnerships.

PresentationLadies and gentlemen, thank you for standing by. Welcome to Rhythm Pharmaceuticals Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would like now to turn the conference over to Dave Connolly, Head of Investor Relations. Please go ahead.David ConnollyHead of Investor Relations & Corporate Communications Thank you, Michelle. Good morning, everyone, and welcome. This morning, we issued a press release announcing that the preliminary data from ...

Core Insights - Celcuity Inc. announced updated results from the Phase 3 VIKTORIA-1 trial for gedatolisib, a multi-target PI3K/AKT/mTOR inhibitor, in patients with advanced breast cancer [1] Efficacy Results - For patients with time to progression on prior therapy >18 months, median progression-free survival (PFS) was 12.4 months for the gedatolisib triplet and 10.0 months for the gedatolisib doublet, compared to 1.9 months for fulvestrant [2][6] - In patients from the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months for the gedatolisib triplet and 7.1 months for the gedatolisib doublet, versus 1.9 months for fulvestrant [2][6] Safety Analysis - Stomatitis was effectively managed, with median time to improvement for Grade 2 or 3 stomatitis being 12 and 14 days for the triplet, and 8 and 9 days for the doublet [3][6] - Gedatolisib did not cause clinically relevant hyperglycemia, and glucose levels remained stable over time [3][6] Patient-Reported Outcomes - Both gedatolisib regimens delayed time to definitive deterioration in well-being measures compared to fulvestrant, with median time to deterioration being 23.7 months for the triplet and not reached for the doublet, versus 4.0 months for fulvestrant [4][6] Company Perspective - The Chief Medical Officer of Celcuity expressed excitement over the results, highlighting nearly two years of delay in definitive deterioration of well-being for patients and the differentiated safety profile of gedatolisib regimens [5][6] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors, with gedatolisib as its lead candidate [6][7] - The company is conducting multiple clinical trials, including VIKTORIA-2 for first-line treatment in HR+/HER2- advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [7]

PresentationGood afternoon, ladies and gentlemen, and welcome to the continued improvement in PFS with iSCIB1+ in advanced melanoma Phase II update, ESMO IO. [Operator Instructions] I would like to remind all participants that this call is being recorded.Phillip L'HuillierCEO & Director Thank you. Good afternoon. Good morning, everyone. Thank you for joining us today. Today, I'm excited to share with you an update on the SCOPE data. And we're calling this presentation redefining the standard of care of adva ...

Elicio Therapeutics (ELTX) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the ...

CHICAGO, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Ateganosine (THIO, 6-thio-2'-deoxyguanosine), a first-in-class telomere-targeting therapy under development by MAIA Biotechnology (NYSE American: MAIA), appears to be gaining increasing attention in the oncology community as emerging clinical results continue to surpass expectations in advanced non-small cell lung cancer (NSCLC). With the therapy’s Phase 2 trial ongoing and a pivotal Phase 3 program initiated this week, ateganosine is being closely watched as one o ...