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The Latest Biotechnology / Pharmaceuticals Articles from Streetwise Reports

REGENXBIO Faces Clinical Hold on RGX-121 but Duchenne BLA Advances

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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.
Tags: Biotechnology / Pharmaceuticals

REGENXBIO Faces FDA Clinical Hold on Hunter Syndrome Gene Therapy

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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.
Tags: Biotechnology / Pharmaceuticals

Is This Biopharmaceutical Co. Developing ALS Drug a Buy?

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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.
Tags: Biotechnology / Pharmaceuticals

Coya Therapeutics Advances Phase 2 ALSTARS ALS Trial Toward 2026 Enrollment Finish

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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.
Tags: Biotechnology / Pharmaceuticals

Ultragenyx Delivers First Gene Therapy FDA Approval for GSDIa

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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.
Tags: Biotechnology / Pharmaceuticals

FDA Approves GENGLYCOS, Ultragenyx's First Gene Therapy

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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.
Tags: Biotechnology / Pharmaceuticals

DMD Biotech Delivers Early Muscle Data as SAT-3247 Advances

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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.
Tags: Biotechnology / Pharmaceuticals

Sarepta Therapeutics Delivers Q2 Operating Profit as CEO Transition Advances Pipeline

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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.
Tags: Biotechnology / Pharmaceuticals

Satellos TRAILHEAD Data Suggests Muscle Regeneration as Company Cash Reaches US$61.8M

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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.
Tags: Biotechnology / Pharmaceuticals

Sarepta Posts US$328.7M Results

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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.
Tags: Biotechnology / Pharmaceuticals

Massachusetts Biotech's Flagship Gene Therapy Posts Fifth Straight Quarterly Decline as Muscular Dystrophy Data Loom

Research Report
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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.
Tags: Biotechnology / Pharmaceuticals

Virtual Care Network Expands to Include 100,000 More New Yorkers, Reaching 24 Million Nationwide

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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.
Tags: Biotechnology / PharmaceuticalsHealthcare Services

Virtual Care AI Provider Expands Potential Access to 100k+ New York Covered Lives

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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.
Tags: Biotechnology / PharmaceuticalsHealthcare ServicesArtificial Intelligence

Sarepta Therapeutics Navigates FDA Hold on Elevidys in Expanding DMD Market

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Sarepta Therapeutics contends with an FDA clinical hold on Elevidys following safety signals, while the Duchenne muscular dystrophy market projects strong growth through 2030.
Tags: Biotechnology / Pharmaceuticals

Myelofibrosis Combo Advances as Karyopharm Preps August sNDA

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Karyopharm Therapeutics plans an sNDA filing for selinexor plus ruxolitinib in myelofibrosis. SVR35 endpoint and Phase 3 SENTRY data support the accelerated approval path.
Tags: Biotechnology / Pharmaceuticals

Migraine Biotech Doses First Patient in Phase 2b EVO756 Trial

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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.
Tags: Biotechnology / Pharmaceuticals

New GLP-1 Platform Combines Doctor Prescriptions, AI Coaching and Chronic Care

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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.
Tags: Biotechnology / PharmaceuticalsHealthcare Services

Digital Health Firm Launches Integrated GLP-1 Program

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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.
Tags: Biotechnology / PharmaceuticalsHealthcare Services

Sarepta Grants New CEO 2.2M Stock Options Amid "Sell" Rating

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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.
Tags: Biotechnology / Pharmaceuticals

Karyopharm Pursues Myelofibrosis FDA Milestone

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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.
Tags: Biotechnology / Pharmaceuticals

Evommune Doses First Patient in Migraine Trial

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Evommune Inc. (EVMN:NYSE) dosed its first patient in a Phase 2b trial of EVO756, an oral migraine prevention drug targeting the MRGPRX2 receptor.
Tags: Biotechnology / Pharmaceuticals

Biotech Produces Ebola Proteins in Just 15 Days as African Outbreak Intensifies

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Dyadic International Inc. (NASDAQ: DYAI) has rapidly developed and produced recombinant protein antigens targeting Bundibugyo ebolavirus, progressing from receipt of the plasmids to purified proteins in approximately 15 days. As the Ebola outbreak in Africa continues, this achievement highlights the speed and potential of Dyadics C1 protein-production platform. Read why one technical analyst believes DYAIs' stock could be positioned for a bullish move.
Tags: Biotechnology / Pharmaceuticals

Dyadic C1 Platform Delivers Ebola Antigens in 15 Days

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Dyadic International produced two Bundibugyo ebolavirus antigens in about 15 days using its C1 platform and delivered them for preclinical testing amid an active outbreak in Africa.
Tags: Biotechnology / Pharmaceuticals

Wet AMD Drug Secures First FDA-Approved Bevacizumab Status

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Outlook Therapeutics gains FDA approval for LYTENAVA, the first ophthalmic bevacizumab for wet AMD. The approval opens access to an $8.5 billion U.S. market with 12 years of exclusivity expected.
Tags: Biotechnology / Pharmaceuticals

Blood in the Streets: Why I'm Buying Gold Miners, a Peru Tailings Giant, and Two Biotech 10-Baggers This Summer

Contributed Opinion
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Newsletter writer Chen Lin shares his view on the current state of the market and shares some stocks on his list.
Tags: GoldBiotechnology / PharmaceuticalsTechnologyCopperSilver

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