MENLO PARK, Calif., Aug. 24, 2026 (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) and hidradenitis
SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it
Proprietary DehydraTECH 3.0 amycretin tablet formulation more than doubled absolute bioavailability compared to a leading industry study Proprietary DehydraTECH 3.0 retatrutide tablet formulation increased drug absorption by as much as an astonishing 4,552% compared to the DehydraTECH 2.0 retatrutide tablet evaluated Findings support Lexaria’s expanding...
Ionis partner GSK announces Hibsago (bepirovirsen) approved in Japan as first and only functional cure for chronic hepatitis B August 24, 2026 – Ionis partner GSK today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Hibsago (bepirovirsen) as a functional cure for
LX9851 is a first-in-class, oral non-incretin candidate being developed by Novo Nordisk for the treatment of obesity and associated metabolic disorders Lexicon is eligible to receive up to $1 billion in total upfront and milestone payments from the collaboration, plus royalties on net sales THE
LEQEMBI IQLIK is the first-of-its-kind anti-amyloid treatment worldwide offering at-home dosing for initiation and maintenance (approved in the U.S.) TOKYO and CAMBRIDGE, Mass., Aug. 24, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that once weekly
- Former Deputy Director of the FDA’s Office of Neuroscience - Dr. Lee has previously advised AEON through Clintrex Research LLC (Clintrex), an affiliate of BlueRidge Life Sciences, on the regulatory strategy for ABP-450 ALISO VIEJO, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc.
FDA Found Spruce's Chemistry, Manufacturing and Controls (CMC) Comparability Strategies Reasonable to Support the BLA Following Technology Transfer to Leading Global Biologics Manufacturer Spruce and FDA Aligned on the Overall Content and Format of the Planned BLA, Including Structure of the
– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 – – Supplemental BLA will be supported by results from three Phase 3 studies of ATEV, including results from V012 dialysis access study in women – – The V012 dialysis
Designation follows encouraging Phase 1 activity across multiple tumor types including 2L+ KRAS G12X pancreatic cancer Three potentially registration-enabling trials planned across pancreatic and lung cancers Additional Phase 1 monotherapy and combination data expected in H1 2027 SAN DIEGO, Aug.
- Detailed results from the Phase 3 SHASTA-3 and SHASTA-4 Studies of Plozasiran in Patients with Severe Hypertriglyceridemia will be presented as a HOT LINE Late-Breaking Science Session on August 30, 2026 - - Arrowhead will host a webcast to review ESC data and Q&A on August 31, 2026 - PASADENA,
Scinai Reports First Half 2026 Corporate Highlights and Results with Spotlight on Growing CDMO Momentum Investor webinar scheduled for August 26, 2026 at 11:00 a.m. EDT JERUSALEM, August 24, 2026 /PRNewswire/ – Scinai Immunotherapeutics Ltd. (Nasdaq:...
ROCKVILLE, Md., Aug. 24, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today provided an update on its investigational gene therapy, RGX-121 (clemidsogene lanparvovec), for the treatment of Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome. The U.S.
Topline 26-week primary endpoint data from COVALENT-211 in insulin deficient type 2 diabetes (“T2D”) patients who are not achieving glycemic targets despite antihyperglycemic medications anticipated in the first quarter of 2027 COVALENT-212 Phase II enrollment T2D patients who are not achieving
BOSTON and SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Rapport Therapeutics, Inc. (Nasdaq: RAPP) (“Rapport” or the “Company”), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological or psychiatric
Study will evaluate PSA and RECIST response, duration of response, radiographic progression-free survival (rPFS), and safety Updated data from the initial Phase 1/2 study of MRT-2359 plus enzalutamide in patients with advanced CRPC expected by end of year BOSTON, Aug.
BOSTON, Aug. 24, 2026 (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
Dr. Trenor brings more than two decades of clinical, translational and drug development leadership experience advancing innovative therapies across rare diseases, hematology and oncology MENLO PARK, Calif. --(BUSINESS WIRE)--Aug. 24, 2026-- AN2 Therapeutics, Inc.
-First patient dosed with PBGENE-DMD, the first clinical gene-editing program for DMD – -First patient dosed at Arkansas Children’s Hospital, a PPMD Certified Duchenne Care Center and designated MDA Care Center– DURHAM, N.C. --(BUSINESS WIRE)--Aug. 24, 2026-- Precision BioSciences, Inc.
The PIONEER program marks a key step toward potential first-in-class neuroprotection for optic neuritis and other neurological diseases, supported by positive Acuity Phase 2 data, FDA Breakthrough Therapy and EMA PRIME designations, and recent positive feedback from the FDA Neurology Division.
If approved, Jemperli could eliminate the need for chemotherapy, radiation, and surgery for some patients.
First global approval for Hibsago
HENDERSON, Nev. --(BUSINESS WIRE)--Aug. 21, 2026-- Zura Bio Limited (Nasdaq: ZURA) (“Zura” or the “Company”), a clinical-stage biotechnology company developing novel and differentiated medicines to meaningfully improve the lives of patients with serious and debilitating autoimmune and inflammatory
SAN CARLOS, Calif., Aug. 21, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today
SAN DIEGO, Aug. 21, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio ® ” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that
BRANFORD, Conn., Aug. 21, 2026 /PRNewswire/ -- Azitra, Inc. (" Azitra " or the "Company") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and high value cosmetic proteins and peptides, today announced that it has
New facility in Hillsboro, Oregon for the assembly of injectable medicines and delivery devices will further advance end-to-end U.S. drug manufacturing capabilities. Approximately $750 million investment will double the size of the existing facility and is expected to create an additional 250 specialised manufacturing jobs....
Pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome remains ongoing, with top-line results on track for anticipated readout in late November 2026 Sol-Gel has initiated a proof-of-concept study in High-frequency BCC (HF-BCC) Sol-Gel initiated a study evaluating topical
SAN DIEGO and SUZHOU, China, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (Nasdaq: ADAG) a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced that senior management will participate in three upcoming
COPENHAGEN, Denmark, August 20, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, provides business update and announces second quarter 2026 financial results.
BURLINGTON, Mass., Aug. 20, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced that it will host a virtual
Collaboration grants UroGen a research license and exclusive options to license and develop up to three oncology products utilizing IntraGel's proprietary SRGel platform Agreement also includes an exclusive option to acquire worldwide rights to TumoCure, an investigational therapy for advanced head
Executing NovaBridge’s strategy to identify differentiated science, develop it efficiently and create long-term value for patients and shareholders Appointed Srishti Gupta, MD, MPP, as Chief Executive Officer, to strengthen strategic oversight, governance, and capital allocation across the Company
CARLSBAD, Calif. --(BUSINESS WIRE)--Aug. 20, 2026-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that new data in the management of severe hypertriglyceridemia (sHTG) will be presented at the European Society of Cardiology (ESC) Congress 2026, taking place August 28 – 31 in Munich.
AC Immune Announces Positive Preliminary Phase 1 Data for NLRP3 Inhibitor ACI-19764 ACI-19764 is an orally available inhibitor of the NLRP3 inflammasome Preliminary data showed ACI-19764 was safe and well tolerated across single and multiple ascending dose cohorts with confirmed CSF penetration
Pumitamig plus B7H3-targeting elfetabart drozuntecan delivers the first data in lung cancer for any PD-(L)1xVEGF bispecific immunomodulator combined with an antibody-drug conjugate, underscoring BioNTech’s leadership in novel-novel combination treatment strategies Updated overall survival data for
CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 19, 2026-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the pricing of an upsized underwritten public offering of 14,090,000 shares of its common stock at a public offering price of $35.50 per share.
MELBOURNE, Australia and INDIANAPOLIS, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces its financial results for the period ended June 30, 2026. H1 2026 key results Group performance 1: Double-digit revenue growth and gross margin
Revenue for the first half of 2026 increased 29% year-over-year to US$44.5 million (RMB302.2 million), primarily attributable to increased product sales. Expanded executive leadership with appointments of Dr. Faical Miyara as Chief Business Officer and Mr.