17 August 2026 Enhertu demonstrated statistically significant and clinically meaningful improvement in progression-free survival as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial AstraZeneca and Daiichi Sankyo's Enhertu is the first and only HER2-directed medicine to improve...
17 August 2026 Update on eVOLVE-Lung02 Phase III trial of volrustomig plus chemotherapy in metastatic non-small cell lung cancer AstraZeneca is discontinuing the eVOLVE-Lung02 Phase III trial evaluating volrustomig in combination with chemotherapy as a 1st-line therapy compared to pembrolizumab and chemotherapy in patients with metastatic non-small cell...
17 August 2026 Tagrisso plus Orpathys demonstrated statistically significant and clinically meaningful improvements in progression-free and overall survival in MET-driven EGFR-mutated lung cancer after progression on Tagrisso First global Phase III trial to show significant progression-free and overall survival benefits in this setting SAFFRON trial results...
Study met primary endpoint of mean Total Improvement Score (TIS) at Week 52 in the combined study population of IMNM and DM patients (p=0.0011) Patient improvements observed early and sustained throughout study; consistent treatment effect across IMNM and DM First Phase 3 study to show
WATERTOWN, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases, today announced that the Company granted non-statutory stock options to new
CAMBRIDGE, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a biopharmaceutical company leveraging a novel Oligonucleotide Promoted Editing of RNA (OPERA ®) platform to develop a new class of genetic medicines for rare and highly prevalent diseases, today announced
EMERYVILLE, Calif., Aug. 14, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to
ZUG, Switzerland, Aug. 14, 2026 (GLOBE NEWSWIRE) -- The attached notifications relate to the vesting and settlement of RSUs previously granted to directors of the Company. Attachments Notification of managers' transaction - Anthony Rosenberg - 13 August 2026 RSU vest Notification of managers'
MIRAMAR, Fla., Aug. 14, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer and senescence-associated dysplasia,
Exploratory analyses of patients with very severe social anxiety disorder demonstrated nominally statistically significant improvement in recently reported clinical studies FDA engagement planned during the current quarter regarding potential future Phase 3 path forward for fasedienol in social
Clene expects to submit a New Drug Application for CNM-Au8® in ALS under the accelerated approval pathway in early fourth quarter of 2026 Clene announces survival and functional benefit in CNM-Au8-treated patients whose NfL declined or stabilized SALT LAKE CITY, Aug.
– Receives FDA Conditional Approval of QYLEKI™ as the Proposed Brand Name for QRX003 for Netherton Syndrome – Reports Positive Clinical Update from Ongoing Pediatric Compassionate Use Program in Netherton Syndrome – Receives U.S. Notice of Allowance for a Patent Covering a Combination Treatment for
Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial completed Rezatapopt NDA submission for platinum-resistant/refractory ovarian cancer planned in first quarter of 2027 Cash, cash
COPENHAGEN, Denmark, August 14, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will provide a business update and report its second quarter 2026 financial results on Thursday August 20, 2026,
TUDRIQEV™ in combination with nivolumab receives FDA accelerated approval and will launch within 60 days Michelle DiNapoli appointed as Chief Commercial Officer Recently completed financing extends cash runway to support commercial launch and confirmatory trial WOBURN, Mass., Aug.
BEDFORD, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced U.S.
- Appointed Michael Halstead, former President of Intra-Cellular Therapies, as Chief Executive Officer to lead Helus Pharma through late-stage development and commercialization - - Completed enrollment in the Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder (“MDD”); topline
- Appointed Michael Halstead, former President of Intra-Cellular Therapies, as Chief Executive Officer to lead Helus Pharma through late-stage development and commercialization - - Completed enrollment in the Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder (“MDD”); topline
Favorable pre-clinical data reported for NMRA-215 with plan to submit IND in fourth quarter of 2026 and initiate Phase 1 study by end of 2026 Progressing NMRA-511 in Alzheimer’s disease (AD) agitation and NMRA-898 in schizophrenia with clinical data expected in fourth quarter of 2026 and second
First patient dosed in an outpatient setting, discharged the same day; multiple patients in the process of screening at several activated sites Trial advances FT819 toward a potential accelerated regulatory pathway supported by RMAT designation and participation in the FDA CMC Development and
NEW YORK & LYON, France, August 14, 2026 Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, the companies’ 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin...
ROCKVILLE, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a global biotechnology company that identifies differentiated innovation and applies disciplined development, financing, and partnering strategies to create value, today announced
Executed a development collaboration with Senlang Biotechnology to advance certain in vivo CAR-T product candidates, including TPST-4003, a CD7-targeted next-generation in vivo CAR-T, with first patient dosing anticipated in the fourth quarter of 2026 and initial clinical data expected in the first
-- Topline data from Phase 3 OnPrime/GOG-3076 ovarian cancer registrational trial of Olvi-Vec expected in 2H26 -- -- Olvi-Vec systemic development programs continue to advance, with additional dose-escalation updates anticipated in 2026 -- -- Recently published Phase 1b/2 VIRO-15 translational
AKTX-101 advancing through IND-enabling development activities toward planned initiation of Phase 1 clinical trial in mid-2027 Compelling ASCO 2026 preclinical data further differentiates PH1 mechanism in KRAS-mutated pancreatic cancer models Strategic research collaboration with Whitehawk
SAN FRANCISCO, Aug. 13, 2026 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today reported financial results for the second quarter ended June 30, 2026. Cash and investments in marketable securities
REVTORPYK™ (gedatolisib) approved by the U.S. FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or metastatic breast cancer on July 14, 2026; on track for commercial launch late third quarter 2026 NCCN® Clinical Practice Guidelines recommended REVTORPYK in combination with
-- ANTLER phase 1 data presented at EHA 2026 reinforce vispa-cel safety, efficacy, and durability are on par with approved autologous CAR-T cell therapies and that vispa-cel has the potential to overcome access barriers for patients with 2L LBCL -- -- CaMMouflage dose escalation phase 1 data
Completed enrollment for 4D-150 4FRONT-2 wet AMD Phase 3; topline data expected in H2 2027 4D-150 4FRONT-1 Phase 3 topline data expected in Q2 2027 Presented positive 2-year data from 4D-150 PRISM Phase 2b at ASRS, highlighting long-term continuous treatment effect and ongoing favorable safety
BEDFORD, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular” or the “Company”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it has granted inducement awards to Ms.
Achieved Q2 2026 PEMGARDA ® (pemivibart) net product revenue of $14.3 million, representing 21% growth versus Q2 2025 net product revenue of $11.8 million Completed rapid enrollment in VYD2311 DECLARATION clinical trial expansion cohort and LIBERTY clinical trial, driven by strong subject demand
Announced sale of manufacturing operations ( July 2026) for $122.5 million and transition to fully outsourced model with leaner, approximately 140-person workforce focused on novel therapeutics pipeline Data presentations at ESMO planned for MGC026 (B7-H3 ADC) and lorigerlimab (PD-1 × CTLA-4)
Record revenue, with Q2 2026 product sales of $37.6 million, representing 99% growth over Q2 2025 Q2 2026 fully diluted GAAP EPS of $0.35, non-GAAP fully diluted EPS of $0.43; EBITDA of $14.1 million, Adjusted EBITDA of $16.2 million Raising full year revenue guidance, with 2026 revenue now
Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody drug conjugate (ADC) targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC), continues enrolling with interim analysis on track for 4Q 2026 Phase 3 protocol of roxadustat for the treatment of anemia in
$26.2 million in U.S. neffy ® net product revenue in Q2 2026; total U.S. epinephrine market share for Type 1 allergies of 5% and 8% share within field-targeted accounts Commercial investment realigned toward targeted provider engagement, significantly reducing total operating expenses for 2H 2026
Final Data from Phase 2 Expansion Study of NUC-7738 Remains on Track for 2026 Advancing Additional Indications and Combination Strategies for NUC-7738 Cash Runway Expected to Extend into 2029 EDINBURGH, United Kingdom, Aug. 13, 2026 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) (“NuCana” or the
– ONWARD3: 54% of patients reached complete skin clearance (PASI 100) at 48 weeks, positioning envudeucitinib to set a new standard in PsO – – Alumis remains on track to submit its New Drug Application to FDA for envudeucitinib in moderate-to-severe plaque psoriasis (PsO) in Q4 2026 – – Potentially
Announced positive blinded six-month interim safety and biomarker results from PRECISE-AD, the Company's Phase 1b trial of PMN310 in patients with early Alzheimer's disease (AD), including zero cases of amyloid-related imaging abnormalities-edema (ARIA-E) across all participants and genotypes, including APOE4 homozygotes....
PALO ALTO, Calif., Aug. 13, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the second quarter ended June 30, 2026. "Kodiak continues to execute broadly across our late-stage clinical portfolio as we approach three Phase 3
KELOWNA, BC / ACCESS Newswire / August 13, 2026 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the “ Company ” or “ Lexaria “), a global innovator in drug delivery platforms, announces that it has entered into a Material Transfer Agreement (“ MTA “) with Pegbio Co., Ltd (“ PegBio “) to investigate Lexaria’s DehydraTECH technology with a proprietary PegBio...
WOBURN, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the quarter ended...