First patients dosed in aleniglipron (oral small molecule GLP-1 receptor agonist) Phase 3 ACCOMPLISH program for chronic weight management Data from Phase 1 SAD clinical trial of ACCG-2671 (oral small molecule dual amylin and calcitonin receptor agonist) and initiation of MAD clinical trial on
Selected z ovegalisib plus atirmociclib as go-forward triplet regimen for 1L breast cancer; Phase 3 1L trial in endocrine - sensitive patients expected to initiate in early 2027, subject to regulatory feedback Presented initial positive clinical data from Phase 1/2 ReInspire trial in vascular
Company pivot to neuro-ophthalmology continues with Privosegtor positioned as lead late-stage asset through the registrational PIONEER program with expansion potential in acute multiple sclerosis (MS) relapses following positive FDA pre-IND feedback Enrollment progressing as planned in the
August 25, 2026 U.S. PDUFA target action date for zanidatamab has potential to unlock a $250 million U.S. approval milestone and up to $190 million in potential additional global regulatory milestones Acquisition of Theravance Biopharma, Inc. expected to close in 2H 2026, adding durable
– Company reports record demand for YCANTH® as dispensed applicator units grew to 19,626 in Q2 2026, up 28.3% over the previous quarter and 46.1% year-over-year – – Topline data from global Phase 3 program studying common warts currently expected in mid-2027 – – The Company’s cash runway could
Reported topline data from 400-person sentinel cohort of the Phase 2b COVID-19 trial; Topline data from 400-person sentinel safety cohort and approximately 5,000 participants in main cohort anticipated in first half of 2027 Cash, cash equivalents, and investments of $64.0 million as of June 30,
Strategic milestone advancements for lead clinical candidate PH-762 Initiation of commercial scale API, long term non-clinical toxicology, completion of Phase 1b pharmacology, and new IP announcementsKing of Prussia, Pennsylvania--(Newsfile Corp. - August 6, 2026) - Phio Pharmaceuticals Corp. (NASDAQ:...
All Active Patients Successfully Reached Highest Planned Dose Levels of 48 mg and 64 mg in Ongoing Phase 1 Part 3 Study of DA-1726 16-Week Topline Data Expected in the Fourth Quarter of 2026 CAMBRIDGE, Mass., Aug. 6, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology
Raising 2026 Revenue and Net Income Guidance Based on Increased Demand for NERLYNX LOS ANGELES --(BUSINESS WIRE)--Aug. 6, 2026-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the second quarter ended June 30, 2026.
Advancing the Alector Brain Carrier (ABC) blood-brain barrier platform across antibodies, enzymes, and siRNA, with AL137 advancing as Alector’s lead ABC -enabled anti-amyloid beta (Aβ) antibody program for Alzheimer’s disease (AD). Continued progress across AL064/AL164 ( ABC -enabled Tau siRNA for
Advanced next-generation gamma delta (γδ) T cell engager (TCE) platform demonstrating a novel mechanism for γδ T cell expansion, deep target cell depletion, and favorable cytokine profile; Initial in vivo data expected in the second half of 2026 Presented updated data at ASCO 2026 demonstrating
NDA submission for azetukalner on track for Q3 2026 following pre-NDA meeting with FDA Phase 3 X-TOLE3 study in FOS and X-ACKT study in PGTCS continue to enroll Three Phase 3 studies of azetukalner in neuropsychiatry continue to advance, with topline data from X-NOVA2 study in MDD expected H1 2027
NAARDEN, The Netherlands and MIAMI, Aug. 06, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”)
— Facility will support YCANTH® commercialization, global Phase 3 program for YCANTH® in common warts and general corporate operations — — Facility provides potential for no scheduled interest or principal payments until maturity in December 2030 — — Facility provided by an entity controlled by
AVMAPKI® FAKZYNJA® CO-PACK net product revenue of $25.1 million First patients dosed in all three TARGET-D Phase 2 registration-directed clinical trials evaluating VS-7375 across 2L PDAC, 2L/3L NSCLC, and 2L+ CRC Updated clinical data for VS-7375 across pancreatic, lung, and colorectal cancers
- VY7523 clinical data and VY1706 clinical entry, both in Alzheimer’s, expected Q4 2026 - - Ended Q2 2026 with cash position of $149 million, runway into 2028 - LEXINGTON, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to
Enrollment completed in TX45 APEX Phase 2 clinical trial in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”) with topline results anticipated in early Q1 2027 TX45 APEX Phase 2 clinical trial Independent Data Monitoring Committee
Announced Proposed Merger with Avere Therapeutics Preserving Capital in Support of Merger Closing; Continuing Clinical Transition and Legacy Asset Activities BELTSVILLE, Md., Aug. 06, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to
Strong first full quarter of AVLAYAH™ (tividenofusp alfa-eknm) launch generated $3.6 million in net product revenue Advanced TransportVehicle™ portfolio with two Alzheimer’s disease programs now in clinical development $195 million in gross proceeds received in July 2026 from sale of a Priority
Enrollment in soquelitinib registrational Phase 3 relapsed/refractory peripheral T-cell lymphoma (PTCL) and Phase 2 atopic dermatitis trials on track Soquelitinib’s potential in atopic dermatitis and broader immunology and inflammation indications supported by Phase 1 clinical, immunologic and
Barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2) ongoing, topline data expected in Sept/ Oct 2026; BLA submission planned for 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling; Phase 2 topline data
COPENHAGEN, Denmark, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it plans to report second quarter 2026 financial results and provide a business update on Thursday, August 13, 2026, before the open of the U.S. financial markets.
Broad label to address high unmet need in advanced melanoma Replimune will host conference call on August 6, 2026 at 4:30 p.m. ET. WOBURN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel
First patients treated with agenT-797 were alive and afebrile at endpoint Day 28 with improved oxygenation, infection control and removal from ventilator and vasopressor support Analysis of blood and lung fluid showed signals of infection control and biological changes associated with immune
August 6, 2026 Copenhagen, Denmark; Interim Report for the Six Months Ended June 30, 2026 Highlights Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant
SAN FRANCISCO, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio, Inc. (Nasdaq: KYNB) will announce second quarter 2026 financial results on Thursday, August 13 after market close. Kyntra Bio will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further
Collaboration supports development of a next-generation AWS-native platform designed to accelerate commercialization, scalability and enterprise adoption SARASOTA, FLA., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company”), a manag...
MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that it will release its financial results for
MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that it will release its financial results for
Repeat dose of fasedienol demonstrated favorable safety and tolerability similar to single dose Efficacy signals were observed across primary and secondary endpoints in repeat dose and single dose Prespecified analysis of patients with very severe social anxiety disorder demonstrated nominally
NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and immune disorders, today announced that it will report financial results for the
PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC anticipated in the near-term BLA completion for HR BCG-unresponsive NMIBC expected fourth quarter 2026 Phase 3 BOND-003 Cohort C Study Results published in The Lancet Oncology,
PLYMOUTH MEETING, Pa., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the Piper Sandler Virtual CNS Symposium on Thursday, August 13, 2026, at 1:30 p.m. ET.
One-year data demonstrated sustained benefit of once-weekly canvuparatide as a potential PTH replacement therapy in chronic hypoparathyroidism; Phase 3 pivotal trial now recruiting Initial Phase 1 data for MBX 4291, a GLP-1/GIP co-agonist prodrug for obesity, support potential for once-monthly
Proposed combination with Clywedog Therapeutics Inc. (“Clywedog”) progressing towards closing Completed enrollment of 42 planned subjects in the Phase 1 AVALON trial evaluating VTP-1000 in patients with celiac disease; topline data from multiple ascending dose ("MAD") expected in the fourth quarter
– On track for mid-2027 topline data readout from 80 patients in the Phase 2 ASPEN-09-Breast clinical trial evaluating evorpacept in combination with trastuzumab and chemotherapy in HER2-positive metastatic breast cancer – – Presented encouraging Phase 1b/2 breast cancer data at ESMO Breast Cancer
Early Outcomes Reinforce the Consistency and Reproducibility of Tanruprubart Treatment Effect Previously Demonstrated in Phase 3 and Real-World Evidence Studies Potential to Become the First Approved Targeted Therapy to Treat GBS Worldwide, Addressing the Significant Unmet Need and Over $20
— A single locally administered intra-articular injection of PCRX-201 into the knee was well tolerated in patients with moderate-to-severe knee osteoarthritis — — Exploratory clinical outcome measures showed improvements out to two years in pain, stiffness, and function across all doses and groups
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