Streetwise Reports' Article Archives — August 2026 back to current month (38)
REGENXBIO Faces Clinical Hold on RGX-121 but Duchenne BLA Advances (08/31/2026)
REGENXBIO's RGX-121 gene therapy faces an FDA clinical hold after spinal MRI findings, while the Duchenne muscular dystrophy program remains on track for its Q3 2026 BLA submission, along with wet AMD pivotal data expected in Q4.
REGENXBIO Faces FDA Clinical Hold on Hunter Syndrome Gene Therapy (08/28/2026)
REGENXBIO Inc. (RGNX:NASDAQ) faces an FDA clinical hold on RGX-121 after spinal MRI findings in five patients, while its Duchenne and wet AMD programs remain on track.
Is This Biopharmaceutical Co. Developing ALS Drug a Buy? (08/25/2026)
Read to find out what analysts think of Houston-based Coya Therapeutics Inc. (COYA:NASDAQ), which is a clinical-stage biopharmaceutical company developing therapies for neurodegenerative, autoimmune, and metabolic diseases.
Ultragenyx Delivers First Gene Therapy FDA Approval for GSDIa (08/25/2026)
Ultragenyx earns FDA approval for GENGLYCOS, its first gene therapy for GSDIa in patients aged 8 and older. Phase 3 data showed reduced cornstarch needs, with analyst price targets rising and a September UX111 decision ahead.
Coya Therapeutics Advances Phase 2 ALSTARS ALS Trial Toward 2026 Enrollment Finish (08/25/2026)
Coya Therapeutics moves COYA 302 through Phase 2 ALSTARS for ALS with enrollment completion expected in 2026 and topline data in Q1 2027. Learn key catalysts, pipeline details, and analyst targets.
FDA Approves GENGLYCOS, Ultragenyx's First Gene Therapy (08/21/2026)
The FDA granted accelerated approval to GENGLYCOS, Ultragenyx Pharmaceutical Inc.'s first gene therapy, for adults and pediatric patients eight years and older with GSDIa, based on Phase 3 data showing a reduction in daily cornstarch intake.
Rocket Doctor AI Secures California Network Deal Reaching 60M Consumers (08/20/2026)
Rocket Doctor AI enters a major provider network agreement in California covering 60 million consumers across multiple lines including workers compensation and Medicare. Learn the key details and next steps for investors.
Rocket Doctor AI Signs Strategic Network Agreement to Expand California Reimbursement Access (08/20/2026)
New multi-channel partnership opens contracted entry points into workers' compensation, auto medical, and Medicare networks, further extending Rocket Doctor AI Inc.'s (AIDR:CSE; AIRDF:OTC; 939:FRA) U.S. partnering strategy.
DMD Biotech Delivers Early Muscle Data as SAT-3247 Advances (08/19/2026)
Satellos Bioscience reports positive six-month DMD trial data and FDA Fast Track status. Learn about its cash position, upcoming pediatric results, and analyst price targets.
Sarepta Therapeutics Delivers Q2 Operating Profit as CEO Transition Advances Pipeline (08/19/2026)
Sarepta Therapeutics reports Q2 2026 results with $328.7M product revenue and new CEO Michael Severino leading pipeline progress in rare diseases. Read the latest on SRPT financials and catalysts.
Cleantech Firm Raises 86% of Capital Without Selling Stock (08/18/2026)
Cleantech innovator BioLargo Inc. (BLGO:OTCQX) files its financial results for the three and six months ended June 30. Find out how the company funded its five businesses while raising 86% of its capital without selling BioLargo stock.
Cleantech Developer Advances Five Platforms With 26% Revenue Growth (08/18/2026)
BioLargo reports 26% revenue growth excluding exited line, 54% gross margins and subsidiary-led funding model across medical, water and energy businesses.
Sarepta Posts US$328.7M Results (08/17/2026)
Sarepta Therapeutics Inc. (SRPT:NASDAQ) reported US$328.7 million in Q2 2026 product revenue, with data readouts expected in DMD and FSHD this year.
Satellos TRAILHEAD Data Suggests Muscle Regeneration as Company Cash Reaches US$61.8M (08/17/2026)
Satellos Bioscience Inc. (MSCL:TSX; MSLE:NASDAQ) has reported six-month TRAILHEAD data showing reduced muscle fat fraction and increased effort among the four adult DMD participants included in the interim analysis.
Clinical AI Use Surges as Revenue Climbs and Doctors Embrace New Tools (08/14/2026)
Doximity Inc. (DOCS:NYSE) reported 7% revenue growth as workflow active prescribers increased more than 30% year over year and AI Search queries climbed more than 25% quarter over quarter.
Doximity AI Tools Fuel Physician Engagement Growth Amid Healthcare Digital Shift (08/14/2026)
Doximity reports fiscal Q1 revenue of $156.6 million with strong workflow growth. See how its AI suite and 85% physician reach position the company in expanding digital health markets.
Virtual Care Network Expands to Include 100,000 More New Yorkers, Reaching 24 Million Nationwide (08/13/2026)
Rocket Doctor AI Inc. (AIDR:CSE; AIRDF:OTC; 939:FRA) recently added 100,000 eligible members in New York to its network. This expansion brings the total number of individuals with potential in-network access to the company's virtual care services to approximately 10 million in New York and 24 million across the United States.
AI Cancer Drug Developer Advances Pipeline as Funding Expands (08/13/2026)
Rakovina Therapeutics Inc. (RKV:TSX.V) is advancing in vivo testing and AI-driven lead optimization across its cancer drug pipeline as it expands relationships with AI companies and pursues additional non-dilutive funding.
Massachusetts Biotech's Flagship Gene Therapy Posts Fifth Straight Quarterly Decline as Muscular Dystrophy Data Loom (08/13/2026)
The company's flagship gene therapy posted a fifth consecutive sequential decline in 2Q26, with DM1 and FSHD data updates seen as the next potential value inflection points.
Virtual Care AI Provider Expands Potential Access to 100k+ New York Covered Lives (08/13/2026)
Rocket Doctor AI expanded potential in-network access to more than 100,000 additional eligible covered lives in New York through a new payer agreement, while continuing to expand its physician network and healthcare AI capabilities in the United States.
DarioHealth Reports Q2 Revenue, with 62% Gross Margin as AI Platform Expands (08/12/2026)
DarioHealth Corp. (DRIO:NASDAQ) reported US$5.2 million in Q2 revenue, a 62% gross margin and US$13.1 million in contracted and late-stage ARR.
Cancer Detection Firm Nears FDA Breakthrough Blood-Test Review (08/12/2026)
GRAIL Inc. (GRAL:NASDAQ) announces that an FDA committee will meet in September to evaluate the Premarket Approval (PMA) application for the Galleri multi-cancer early detection (MCED) blood test. Read why one financial expert thinks it will gain approval.
GRAIL Galleri Test Heads to FDA Panel for Multi-Cancer Screening Review (08/12/2026)
GRAIL Inc. prepares for its Sept. 23 FDA advisory committee meeting on the Galleri MCED test PMA, backed by large clinical studies and growing commercial revenue in the expanding multi-cancer early detection market.
AI Chronic Care Platform Adds Fifth Fortune 50 Client, Lifts Margin to 62% (08/12/2026)
DarioHealth reported Q2 revenue of $5.2 million with gross margin rising to 62 percent and contracted ARR reaching $13.1 million after signing a fifth Fortune 50 client and expanding provider-backed care.
AI Health Platform Expands Into Women's Health and Sleep With New Revenue Expected in Q4 (08/06/2026)
DarioHealth Corp. (DRIO:NASDAQ) launched Dario Women and Dario Sleep, expanding its provider-backed cardiometabolic platform with programs expected to begin contributing recurring revenue in the fourth quarter.
Digital Health Provider Launches Women's Health and Sleep Solutions (08/06/2026)
DarioHealth expands its cardiometabolic platform with Dario Women and Dario Sleep programs. Revenue contribution expected late 2026 amid rising demand for multi-condition digital care solutions.
Sarepta Therapeutics Navigates FDA Hold on Elevidys in Expanding DMD Market (08/05/2026)
Sarepta Therapeutics contends with an FDA clinical hold on Elevidys following safety signals, while the Duchenne muscular dystrophy market projects strong growth through 2030.
Myelofibrosis Combo Advances as Karyopharm Preps August sNDA (08/05/2026)
Karyopharm Therapeutics plans an sNDA filing for selinexor plus ruxolitinib in myelofibrosis. SVR35 endpoint and Phase 3 SENTRY data support the accelerated approval path.
Migraine Biotech Doses First Patient in Phase 2b EVO756 Trial (08/05/2026)
Evommune begins Phase 2b testing of oral MRGPRX2 antagonist EVO756 for migraine prevention. The placebo-controlled study targets 330 patients with doses up to 100 mg and reports data in 2027.
This AI Healthcare Platform Is Taking Its New York Expansion Through 2029 (08/04/2026)
Rocket Doctor AI Inc. (AIDR:CSE; AIRDF:OTC; 939:FRA) extended its EngageWell partnership after an initial virtual-care pilot connected more than 400 underserved New Yorkers with physician-led care.
Cleantech Company Delivers PFAS Removal Breakthrough in New Jersey (08/04/2026)
BioLargo Inc. (BLGO:OTCQX) announces the processing of more than 2 million gallons of PFAS-contaminated water using its patented Aqueous Electrostatic Concentrator (AEC) technology. Find out why one technical analyst likes BLGO's business model.
PFAS Treatment System Processes 2 Million Gallons at New Jersey Site (08/04/2026)
BioLargo's AEC technology has treated over 2 million gallons of PFAS-contaminated water in New Jersey while meeting regulatory standards. Learn how the system reduces waste and costs compared with traditional methods.
NY Telehealth Extension Advances Rocket Doctor AI Platform (08/04/2026)
Rocket Doctor AI extends its New York telehealth engagement through 2029, combining grants and Medicaid to serve underserved patients while scaling its AI platform amid strong digital health market growth.
New GLP-1 Platform Combines Doctor Prescriptions, AI Coaching and Chronic Care (08/03/2026)
DarioHealth Corp. (NASDAQ: DRIO) introduced its Integrated GLP-1 Program, bringing licensed provider evaluations, FDA-approved GLP-1 prescribing where clinically appropriate and ongoing care into one experience.
Digital Health Firm Launches Integrated GLP-1 Program (08/03/2026)
DarioHealth integrates its digital platform with licensed providers to offer end-to-end GLP-1 support. See how the new program targets employers and health plans in a growing market.
Sarepta Grants New CEO 2.2M Stock Options Amid "Sell" Rating (08/03/2026)
Sarepta Therapeutics Inc. (SRPT:NASDAQ) granted CEO Michael Severino options for 2,224,342 shares and 756,104 RSUs as an inducement award tied to his hiring.
Karyopharm Pursues Myelofibrosis FDA Milestone (08/03/2026)
Karyopharm Therapeutics Inc. (KPTI:NASDAQ) prepares an FDA filing for selinexor plus ruxolitinib after Phase 3 results, targeting the first approved combination therapy for myelofibrosis.
Evommune Doses First Patient in Migraine Trial (08/03/2026)
Evommune Inc. (EVMN:NYSE) dosed its first patient in a Phase 2b trial of EVO756, an oral migraine prevention drug targeting the MRGPRX2 receptor.
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