Core Viewpoint - Nuvalent, Inc. is set to discuss pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in a conference call on June 24, 2025, focusing on its application in advanced ROS1-positive non-small cell lung cancer patients [1] Group 1: Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company dedicated to developing targeted therapies for cancer, specifically aimed at overcoming limitations of existing treatments for kinase targets [5] - The company is advancing a robust pipeline that includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, along with multiple discovery-stage research programs [5] Group 2: Zidesamtinib and Clinical Trials - Zidesamtinib is designed to be a brain-penetrant ROS1-selective inhibitor, addressing resistance seen with current ROS1 inhibitors and targeting tumors with treatment-emergent ROS1 mutations [3] - The ARROS-1 trial is a first-in-human Phase 1/2 clinical trial evaluating zidesamtinib in patients with advanced ROS1-positive non-small cell lung cancer and other solid tumors, focusing on safety, tolerability, and preliminary anti-tumor activity [4] - Zidesamtinib has received breakthrough therapy designation for ROS1-positive metastatic non-small cell lung cancer patients previously treated with two or more ROS1 tyrosine kinase inhibitors, as well as orphan drug designation for ROS1-positive NSCLC [3]

Phase 1 clinical study of TERN-601 demonstrated differentiated profile in 28-day study; topline data were presented in September 2024 Phase 2 FALCON clinical trial of TERN-601 completed enrollment; 12-week data expected in 4Q 2025 FOSTER CITY, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and ...

Core Viewpoint - Candel Therapeutics has appointed Charles Schoch as the permanent Chief Financial Officer after his successful tenure as interim CFO, demonstrating strong financial leadership and guiding the company through significant operational and financial milestones [1][2]. Company Leadership - Charles Schoch has been with Candel since November 2021, serving in various financial roles, including VP of Finance and Corporate Controller, before becoming interim CFO in January 2024 [2][3]. - Under Schoch's leadership, the company raised approximately $86 million following positive phase 3 clinical trial results for CAN-2409 in localized prostate cancer [2]. Financial Management - Schoch has established strong investment banking relationships and has effectively managed capital during a complex market environment, supporting Candel's strategic priorities [2][4]. - The finance function under Schoch oversees financial close processes, internal controls, SEC reporting, financial planning, procurement, payroll, and treasury operations [2]. Clinical Development - Candel is focused on developing multimodal biological immunotherapies, with CAN-2409 as the lead product candidate from its adenovirus platform [5]. - The company has completed successful phase 2a clinical trials for CAN-2409 in non-small cell lung cancer and pancreatic ductal adenocarcinoma, and a pivotal phase 3 trial in localized prostate cancer [6][7]. Regulatory Designations - CAN-2409 has received Fast Track Designation from the FDA for multiple cancer treatments and has also been granted Regenerative Medicine Advanced Therapy Designation for localized prostate cancer [6][7]. - The company is preparing for a Biologics License Application submission for CAN-2409 in localized prostate cancer [2]. Future Outlook - Schoch expressed optimism about Candel's financial foundation and disciplined capital allocation, focusing on sustainable growth and advancing the clinical pipeline [4].

Company has applied for new Commissioner's National Priority Vouchers (CNPV) for NRX-100. Continues to anticipate decisions on drug approval by year-end 2025 Application under CNPV program is accretive to already-filed Abbreviated New Drug Application (ANDA) for preservative-free ketamine, with proprietary formulation under priority review request Company has received and complied with FDA information request for updated drug ingredient and label information on NRX-100 Company has previously filed full Che ...

A Strategic Move to Accelerate Market Reach for Innovative Pharmaceutical Patents on June 23, 2025 NEW YORK, June 23, 2025 (GLOBE NEWSWIRE) -- Dr Ashleys Limited, a Hong Kong based global pharmaceutical company (“Dr Ashleys”), and Impact BioMedical Inc. (“Impact BioMedical”) (NYSE American: IBO), a Texas based biopharmaceuticals developer listed on the New York Stock Exchange American (“Impact BioMedical”, together with Dr Ashleys, the “Parties”), are pleased to announce the execution of a merger and share ...

Core Insights - Palvella Therapeutics has successfully completed the SELVA Phase 3 trial for QTORIN™ rapamycin, which targets microcystic lymphatic malformations, a serious genetic disease with no FDA-approved therapies [2][3] - The trial enrolled 51 subjects, exceeding the initial target of 40 by over 25%, indicating strong demand and interest in this treatment [2][3] - Top-line data from the SELVA trial is expected in the first quarter of 2026, with a New Drug Application submission planned for the second half of 2026 [5] Company Overview - Palvella Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for rare genetic skin diseases without FDA-approved treatments [7] - The company is developing a pipeline of product candidates based on its QTORIN™ platform, with QTORIN™ rapamycin as the lead candidate currently in clinical trials [7] - The company has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA for QTORIN™ rapamycin, which may qualify for seven years of orphan drug market exclusivity if approved [4] Clinical Trial Details - The SELVA trial is a 24-week, single-arm, baseline-controlled study evaluating QTORIN™ rapamycin in individuals aged three years and older with microcystic lymphatic malformations [3] - Following an 8-week baseline period, eligible participants may continue treatment in an open-label extension study, which is also open to new subjects aged three to five years [3] Disease Background - Microcystic lymphatic malformations are characterized by malformed lymphatic vessels that lead to persistent lymph fluid leakage and bleeding, often resulting in serious infections [6] - The disease affects an estimated 30,000 diagnosed patients in the United States, with symptoms worsening over time and no current FDA-approved treatments available [6]

Core Viewpoint - The U.S. FDA has approved a label expansion for Telix Pharmaceuticals' Illuccix® to include patient selection for radioligand therapy (RLT) in the pre-taxane setting, which is expected to significantly increase its clinical utilization [1][2]. Group 1: FDA Approval and Market Impact - The label expansion for Illuccix® is its third indication, allowing for the selection of patients indicated for PSMA-directed therapy [2]. - Following the FDA's approval of Pluvicto® for use in metastatic castration-resistant prostate cancer (mCRPC) patients, the clinical utilization of Illuccix® is projected to increase by at least 20,000 scans annually [2]. Group 2: Clinical Significance - The expansion of the indication allows clinicians to make more informed and personalized decisions earlier in the disease course, potentially providing access to life-prolonging targeted radionuclide therapy for more prostate cancer patients [3]. - PSMA-PET imaging has become a standard of care in the detection and management of prostate cancer, enhancing the diagnostic accuracy of Illuccix® [3]. Group 3: Product Information - Illuccix® is used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer [4]. - The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, with the most commonly reported adverse reactions being nausea, diarrhea, and dizziness, occurring at a rate of less than 1% [7][8].

Core Insights - Skye Bioscience, Inc. is focused on developing nimacimab, an anti-obesity drug that targets peripheral CB1 receptors, aiming to address unmet needs in obesity treatment [1][2][3] - The company has launched a video series titled "Anatomy of Progress" to provide updates on nimacimab's development and its advantages over traditional treatments [1][2] Group 1: Product Development - Nimacimab is a peripherally-restricted CB1 antibody that aims to provide weight loss benefits without the neuropsychiatric side effects associated with small molecule CB1 inhibitors [4][3] - The video series discusses the mechanistic advantages of nimacimab, emphasizing its potential to revolutionize obesity treatment by addressing biological resistance to traditional therapies [3][4] Group 2: Clinical Insights - Skye's management participated in a panel discussing the clinical and preclinical experiences with nimacimab, highlighting its peripheral blockade of the CB1 pathway [5] - Presentations at the American Diabetes Association's 85th Scientific Sessions included data on nimacimab's effectiveness in promoting weight loss and reducing obesity-induced inflammation [6][8] Group 3: Market Positioning - The company is positioning nimacimab as a differentiated therapeutic option in the obesity market, particularly as a non-GLP1 alternative, based on feedback from obesity physicians [7] - The market opportunity for nimacimab is framed by its unique target product profile, which is expected to complement existing incretin-based therapies [7][9] Group 4: Research Findings - Preclinical studies demonstrated that nimacimab promotes metabolic homeostasis and improves hormonal regulation in diet-induced obesity models [8] - New biomarker data presented indicates significant reductions in obesity-related inflammation and liver steatosis, supporting nimacimab's potential as a standalone and combination therapy [6][8]

Core Viewpoint - PTC Therapeutics has received marketing authorization from the European Commission for Sephience™ (sepiapterin) to treat phenylketonuria (PKU) in patients of all ages and disease severities, marking a significant advancement in treatment options for this rare metabolic disorder [1][2][3] Group 1: Product Information - Sephience™ (sepiapterin) is indicated for the treatment of hyperphenylalaninaemia (HPA) in both adult and pediatric patients with PKU, acting as a natural precursor of the enzymatic co-factor BH4, which is essential for the enzyme phenylalanine hydroxylase (PAH) [4] - The product functions as a dual pharmacological chaperone, improving the activity of defective PAH enzymes and effectively reducing blood phenylalanine (Phe) levels [4] - The European launch of Sephience will begin in Germany in the first half of July 2025, with ongoing review for approval in other countries including Japan and Brazil [3] Group 2: Clinical Evidence - The European approval is based on statistically significant results from the Phase 3 APHENITY trial, demonstrating a durable treatment effect and allowing participants to liberalize their diet in the long-term extension study [2] Group 3: Company Overview - PTC Therapeutics is a global biopharmaceutical company focused on developing and commercializing medicines for rare disorders, leveraging scientific expertise and a global commercial infrastructure to maximize value for patients [6] - The company aims to provide access to best-in-class treatments for patients with unmet medical needs, supported by a robust and diversified pipeline of transformative medicines [6]

Ad hoc announcement pursuant to Art. 53 LR Idorsia to receive USD 50 million (an additional USD 30 million) approval milestone payment in return for a reduction in Simcere potential sales milestones and tiered royalty payments. Allschwil, Switzerland – June 23, 2025Idorsia Ltd. (SIX: IDIA) today announced that Simcere Pharmaceuticals Group Ltd (2096.HK, “Simcere”) has received approval for QUVIVIQ® (daridorexant) from the Chinese National Medical Products Administration for the treatment of adult patients w ...