SAN DIEGO, Aug. 06, 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
Phase 3 CATT1 trial evaluating cadisegliatin for the treatment of type 1 diabetes (T1D) expected to complete enrollment in third quarter of 2026 Cadisegliatin Phase 2a hybrid closed-loop trial (Hybrid CATT1) in T1D to initiate before year end 2026 Strong balance sheet expected to fund operations
Mid-cycle meeting completed for ulixacaltamide HCl; FDA identified no major safety or efficacy concerns to date and does not plan to request an advisory committee meeting; PDUFA date of January 29, 2027 Mid-cycle meeting completed for relutrigine; FDA identified no major safety or efficacy concerns
TransCon ® CNP and TransCon hGH combination therapy Week 78 data from the Phase 2 COACH Trial showed durable, unprecedented increase in healthy, proportional growth TransCon CNP monotherapy Week 104 data from the pivotal ApproaCH Trial demonstrated durable improvements in height, body
August 6, 2026 – 7:45 AM ET Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology innovation company today announced that Avena Merger Sub Inc. (“ Purchaser ”), a wholly-owned subsidiary of argenx BV (“ argenx ”), has commenced a tender offer to purchase all of the
– DSMB recommends advancement of PGN-EDODM1 into the highest dose cohort in the FREEDOM2-DM1 study, as well as FREEDOM-OLE dose escalation from 5 mg/kg to 10 mg/kg – – 10 mg/kg FREEDOM2-DM1 cohort fully enrolled, with 7 of 8 participants having completed dosing; data expected in November – –
Enrollment complete in Phase 3 SONATA-HCM study; top-line data expected Q1 2027 NDA resubmission activities for ZYNQUISTA ® in type 1 diabetes nearing completion Phase 1 clinical development of LX9851 ongoing by Novo Nordisk Conference call and webcast at 8:30 am ET THE WOODLANDS, Texas, Aug.
The Company expects feedback from the FDA this quarter regarding the COMPANION-002 Phase 2/3 data for tovecimig (DLL4 x VEGF-A bispecific antibody) in patients with biliary tract cancer (BTC), prior to a potential BLA filing later this year. Tovecimig data from this study has also been selected for
– DSMB also recommended dose escalation in FREEDOM-OLE from 5 mg/kg to 10 mg/kg – BOSTON --(BUSINESS WIRE)--Aug. 6, 2026-- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of
RGX-202 BLA submission for Duchenne muscular dystrophy on track for Q3 2026 initiation, with potential accelerated approval in 2H 2027 Long-term surabgene lomparvovec (sura-vec, ABBV-RGX-314) data highlight durable safety and efficacy profile ahead of key catalyst Topline data from pivotal
Generated second quarter 2026 XDEMVY ® net product sales of $173.9 million, an increase of more than 69% year-over-year Increased full-year 2026 XDEMVY net product sales guidance to $685-705 million Pending acquisition of Alkeus Pharmaceuticals to expand Tarsus’ retina pipeline with a Phase 3
IRVINE, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (Nasdaq: TARS) (“Tarsus”) today announced that it has entered into a securities purchase agreement with certain qualified institutional buyers and accredited investors for a private investment in public equity (“PIPE”)
Conference Call and Webcast Today at 8:30 a.m. ET Received U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (AMD); on track to initiate Phase 3 this quarter Granted Regenerative Medicine
Adds a potential blockbuster opportunity with gildeuretinol (ALK-001), a differentiated Phase 3 oral investigational medicine designed to target the underlying biology of Stargardt disease, one of the largest inherited retinal diseases with no FDA-approved therapy 400+ individuals treated to date,
U.S. Amtagvi Revenue Reaches ~$91M and Total Revenue Increased 66% Year-over-Year Gross Margin Increased to 56% Fast Track Designation (FTD) Granted by the FDA for Lifileucel in Soft Tissue Sarcomas SAN CARLOS, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc.
- First clinical biopsy evidence of direct cccDNA elimination from ongoing Phase 1 ELIMINATE-B trial; PBGENE-HBV treatment led to a 1-log reduction in cccDNA with
KRRO-121, a potential first-in-class transformational treatment for hyperammonemia, remains on track to commence first-in-human clinical trial in second half of 2026 Received Orphan Drug Designation from the European Medicines Agency (EMA) for KRRO-121 for patients with urea cycle disorders (UCDs)
Commercial preparations for brepocitinib in dermatomyositis (DM) are progressing well and on track for launch by the end of September 2026; topline data from Phase 3 study in non-infectious uveitis (NIU) expected in the second half of calendar year 2026 First patients enrolled in the Phase 3 study
CS is a highly morbid, chronic, and disfiguring condition with no approved therapies Brepocitinib is the first investigational therapy to generate a positive result in a placebo-controlled CS study (Phase 2 BEACON) and has received FDA Breakthrough Therapy Designation for CS Global Phase 3 study
Completed enrollment and dosing for GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease (CVD) risk; readout anticipated in H2 2026 Company expects to initiate multiple MRT-8102 Phase 2 studies, including in patients with elevated atherosclerotic risk and cardiometabolic
CLYM116 Phase 1 data in healthy volunteers to be presented at R&D Spotlight Event on September 3, 2026 Anticipate CLYM116 Phase 2 trial in IgA nephropathy to initiate dosing in Q3 2026 Budoprutug clinical programs continue to advance, with data expected from pMN, ITP, and SLE studies in Q4 2026
CLN-978 (CD19 TCE) multi-dose regimen data in RA in Q3 2026 and SLE in Q4 2026; Phase 2 expansion studies to begin early 2027 Velinotamig (BCMA TCE) multi-dose regimen data in SLE in Q4 2026; Phase 1/2 basket study in autoimmune cytopenias to begin early 2027 CLN-049 (FLT3 TCE) potentially
PreciSION CF Phase 2a proof-of-concept trial evaluating NBD1 stabilizer SION-719 as an add-on to standard of care is on track for topline data summer of 2026 Phase 1 trial evaluating NBD1 stabilizer SION-451 in proprietary dual combinations with SION-2222 and with SION-109 also is on track for
BOSTON, Aug. 06, 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
Worldwide revenue of $388.2 million in the second quarter of 2026 GAAP fully diluted earnings per share of $1.11, compared to $1.12 in the second quarter of 2025 Adjusted fully diluted earnings per share of $1.55, compared to $1.57 in the second quarter of 2025 Announced on August 3, 2026 that it
First pivotal cohort enrolled 300 subjects, with topline clinical data from 24-week primary endpoint on track for December 2026 release Completion of enrollment in the second pivotal cohort evaluating 600 subjects across the PEAK and PINNACLE studies is expected in 4Q 2026, with topline clinical
Infinitum founder and Groq board director brings frontier AI and technology-investing expertise to Biohaven as the company advances AI-enabled approaches to drug development NEW HAVEN, Conn., Aug. 6, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global biopharmaceutical company, today
Last participant completed final study visit in the 16-week double-blind period of the pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia; topline data on track and anticipated in late August or early September 2026 Cash runway expected to fund operations into 2028
Delivers Total Revenues of $3.8 Billion, Representing 5% Reported Growth Compared to Second Quarter 2025 and a U.S. GAAP Net Loss of $119 Million Total Revenues Were Up 3.5% Operationally Compared to Second Quarter 2025 Adjusted EBITDA was $1.2 Billion, Up 8% Operationally Compared to Second
- Full Top Line Results from Phase 1a SAD/MAD Trial of ATI-052 Validate Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Timelines Reaffirmed for Upcoming Top Line Results from Phase 1b Proof-of-Concept (POC) Trials of ATI-052 and Phase 2 Trial of Bosakitug
People with AAE-C1INH experience frequent misdiagnoses, emergency medical events, and wide-ranging impact on physical, emotional, and social well-being Study results informed the design and endpoint selection of the ongoing Phase 3 CREAATE study ZUG, Switzerland, Aug.
EMA also accepts application for the same population for ENFLONSIA based on results from the Phase 3 SMART trial If approved, children under two years of age at increased risk for severe RSV disease will be eligible to receive an additional dose of ENFLONSIA for their second RSV season RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE:...
The Company advanced multiple global oncology and immunology programs toward key clinical and regulatory milestones, with significant pipeline catalysts expected in the second half of 2026 Global Phase 1 data for zocilurtatug pelitecan (zoci) in combination with a PD-L1 inhibitor in first-line SCLC
IRVINE, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced that it will host a live webcast at 5:00 a.m. PT / 8:00 a.m. ET on Thursday, August 6, 2026 to report its second quarter 2026 financial results and provide a corporate update.
LOS ANGELES --(BUSINESS WIRE)--Aug. 5, 2026-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on August 3, 2026, the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering 35,375 shares of Puma