RAMSEY, N.J. and BOCA RATON, Fla., Oct. 29, 2025 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced that it will report third quarter 2025 financial results on November 5, 2025, after the U.S. financial markets close. ADMA’s management team will host a live conference call and audio webcast on that date at 4:30 p.m. ET to disc ...

BOSTON, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced its participation as a presenting company at BIO-Europe 2025. The event, Europe’s premier life sciences partnering conference, will take place November 3–5, 2025, at the Vienna Exhibition and Congress C ...

― Announced encouraging results in July 2025 from the 12 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD) ― ― Enrollment complete in the 20 mg dose cohort (n=12) of the PIONEER trial; on track to provide data from the 20 mg dose cohort by year-end ― ― Ended Q3 2025 with $200.6 million in cash, cash equivalents, and marketable securities; cash runway into 2028 ― CAMBRIDGE, Mass., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a c ...

Core Insights - Kyverna Therapeutics announced positive interim data from the Phase 2 portion of the KYSA-6 clinical trial for KYV-101 in generalized myasthenia gravis (gMG), achieving 100% clinically meaningful responses in primary endpoints [1][2][5] - The results indicate that KYV-101 can provide rapid and durable symptom improvement with a single dose, potentially leading to drug-free, disease-free remission [2][5][10] Efficacy - 100% of patients (6 out of 6) achieved clinically meaningful reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores, with mean reductions of -8.0 points and -7.7 points at 24 weeks, respectively [6][12] - Deep responses were observed as early as two weeks post-treatment, indicating rapid efficacy [6][12] Safety - KYV-101 was well-tolerated, with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported [12] - One patient experienced a serious adverse event of Grade 4 neutropenia, which improved with standard supportive care [12] Clinical Trial Design - The Phase 2 portion of the KYSA-6 trial is a single-arm, open-label, multicenter study focusing on the efficacy and safety of KYV-101 in gMG [3][8] - The trial was amended to a registrational Phase 2/3 study following discussions with the FDA [8] Future Plans - The company plans to initiate enrollment for the Phase 3 portion of the trial by the end of the year and will share updated data from the Phase 2 portion next year [5][12] - Kyverna aims to establish a first-in-class neuroimmunology franchise and expand growth opportunities across multiple autoimmune indications [2][13]

Core Viewpoint - Relief Therapeutics announced positive results from a pivotal bioequivalence clinical study for RLF-OD032, demonstrating it is bioequivalent to KUVAN® Powder, supporting a planned NDA submission in early 2026 [1] Company Summary - Relief Therapeutics is a biopharmaceutical company focused on innovative treatment options for specialty, unmet, and rare diseases [1] - The study evaluated RLF-OD032, a highly concentrated liquid formulation of sapropterin dihydrochloride, aimed at treating phenylketonuria (PKU) [1] Study Results - The pivotal study achieved its primary pharmacokinetic endpoints, confirming the bioequivalence of RLF-OD032 to KUVAN® Powder as defined by the U.S. Food and Drug Administration [1]

Core Points - Addex Therapeutics has issued 34,300,000 new registered shares at a nominal value of CHF 0.01, fully subscribed by its wholly-owned subsidiary, Addex Pharma S.A, to enhance future financing flexibility [1] - The total issued share capital has increased to CHF 2,186,544.96, with a total of 218,654,496 shares issued, while the number of outstanding shares remains unchanged [1] Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule allosteric modulators for neurological disorders [2] - The lead drug candidate, dipraglurant, is being evaluated for brain injury recovery, including post-stroke and traumatic brain injury recovery [2] - Addex has partnered with Indivior for a GABAB PAM drug candidate aimed at substance use disorders, which has completed IND enabling studies [2] - The company is also advancing an independent GABAB PAM program for chronic cough and holds a 20% equity interest in Neurosterix LLC, which is developing allosteric modulator programs for various neurological conditions [2] - Additionally, Addex has invested in Stalicla, a private Swiss company focused on precision medicine for neurodevelopmental and neuropsychiatric disorders [2] Stock Information - Addex shares are listed on the SIX Swiss Exchange and NASDAQ under the ticker symbol "ADXN" [3]

PresentationGood day, and thank you for standing by. Welcome to the Arcutis Biotherapeutics 2025 Third Quarter Financial Results and Investor Day Presentation. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Brian Schoelkopf, Head of Investor Relations. Please go ahead.Brian Schoelkopf Thank you. Good morning, everyone, and thank you for joining us today to review our third quarter 2025 financial r ...

Core Insights - ANI Pharmaceuticals is a profitable and rapidly growing biopharmaceutical company focused on rare diseases and underserved patients [1] - The company's growth strategy involves reinvesting profits from its rare disease, generic, and branded drug sales [1] Company Overview - ANI Pharmaceuticals operates in the biopharmaceutical sector, emphasizing the treatment of rare diseases [1] - The company has established a profitable business model that supports its growth trajectory [1] Growth Strategy - The growth of ANI Pharmaceuticals has been accelerated by reinvesting profits into various segments, including rare diseases, generics, and branded drugs [1]

Core Insights - GENFIT is participating in the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025, showcasing its commitment to addressing rare and life-threatening liver diseases [1][10] Pipeline Developments - GENFIT will present new data on its lead program G1090N, a reformulation of nitazoxanide, focusing on its efficacy in treating Acute on-Chronic Liver Failure (ACLF) [2] - The company will also present data on SRT-015, an ASK1 inhibitor that reduces systemic inflammation and promotes immune defense mechanisms in ACLF models [3] - Additional presentations will cover CLM-022, an NLRP3 inflammasome inhibitor, and the effects of VS-01 on systemic inflammation and liver injury, although VS-01 has been discontinued in ACLF [3] Real-World Evidence and Biomarkers - An oral presentation will highlight real-world evidence characterizing patients admitted for acute decompensation, emphasizing management differences [4] - Posters will present new data on biomarkers for cirrhosis, including the effectiveness of single circulating biomarkers sVCAM-1 and TSP2 in detecting fibrosis progression [7] Collaborations and Additional Data - Ipsen will present data on Iqirvo® (elafibranor) in Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC), supporting its efficacy and safety profile [11] - The data presented will underscore Iqirvo®'s potential in addressing disease progression and symptom burden in rare cholestatic liver diseases [8] Company Overview - GENFIT is dedicated to improving the lives of patients with rare liver diseases and has a strong focus on ACLF and related conditions [10][12] - The company has a rich history in liver disease research and has achieved accelerated approval for Iqirvo® in multiple jurisdictions [13][14]

Core Insights - Cytokinetics' stock surged after strong phase 3 trial results for its lead cardio drug Aficamten, which improves exercise capacity in patients with obstructive hypertrophic cardiomyopathy [1] - The company is awaiting FDA approval for Aficamten, which could disrupt the market currently dominated by Bristol Myers Squibb [1][4] - Cytokinetics has seen a 69% increase in shares over the past three months and a 31% increase year-to-date, indicating strong investor interest [2] Company Background - Cytokinetics has a history of developing heart disease-related drugs, including Mavacamten, which was acquired by Bristol Myers Squibb in 2020 [3] - The acquisition provided Cytokinetics with capital to fund further clinical trials [3] Competitive Landscape - The new drug Aficamten is positioned to compete directly with Bristol Myers Squibb's offerings in the same therapeutic area [4] - Cytokinetics' CEO highlighted the company's transition from developing drugs to competing in the market, emphasizing the potential benefits for patients [5] Financial Strategy - The company has utilized specialized biotech financing, royalty financing, and partnerships to secure investments for drug development [5] - Significant investments have been made in research and development to advance a portfolio of potential medicines targeting heart disease [6] Market Opportunity - Heart disease is a leading cause of hospitalization in the U.S., particularly among the aging population, presenting a substantial market opportunity for Cytokinetics [6] - The company aims to build a sustainable business model starting with Aficamten as its first potential medicine [7]