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Streetwise Biotech / Pharmaceuticals Articles



FDA Rejects Melanoma Drug Again as Analysts Slash Targets and Approval Path Comes Under Fire
Source: Streetwise Reports  (5/8/26)
Replimune Group Inc. (REPL:NASDAQ) received a second FDA rejection for RP1 in advanced melanoma, prompting analyst downgrades, price target cuts, and renewed debate over approval standards for cancer therapies. More >


Biotech Innovator Niagen Uncovers Breakthrough NAD+ Booster, Reports Strong Q1 Results
Source: Streetwise Reports  (5/8/26)
Niagen Bioscience Inc. (NAGE:NASDAQ) reports a 3% increase in total net sales to US$31.5 million for the first quarter. Read why analysts recommend this stock in a rapidly expanding market. More >


Sublingual Drug Reformulator Expands into Caffine Market and Gets Capital Injection
Source: Stewart Thomson  (5/8/26)
Technical Analyst Stewart Thomson reviews Aspire Biopharma Holdings, Inc. (ASBP:NASDAQ) in light of its recent news. More >


Oncology Company Given Neutral Rating as Q1/26 Beat Sets Up Catalyst
Source: Dr. David Nierengarten  (5/7/26)
Wedbush Securities reiterated a Neutral rating on Novocure Ltd. (NVCR:NASDAQ) after the company posted a Q1/26 revenue beat of US$174.1 million, raised FY26 guidance to US$690710 million, and reported encouraging early Optune Pax launch metrics. More >


Three AI-Driven Cancer Programs Advance Toward Key 2026 Milestones
Source: Streetwise Reports  (5/6/26)
Rakovina Therapeutics Inc. (RKV:TSX.V) reported 2025 financial results and outlined progress across its kt-5000, kt-3283, and kt-2000 programs, alongside financing, leadership updates, and ongoing AI partnerships. More >


MA Biotech Downgraded to Neutral After Second FDA CRL for RP1 Melanoma BLA
Source: Dr. Robert Driscoll  (5/6/26)
Wedbush Securities downgraded Replimune Group Inc. (NASDAQ:REPL) to NEUTRAL after the FDA issued a second complete response letter for RP1 in PD-1 refractory melanoma. More >


Oncology Co. Tests Advanced Cancer Treatments, Reports Q1 2026 Financial Results
Source: Streetwise Reports  (5/6/26)
Novocure Ltd. (NVCR:NASDAQ) posted 12% revenue growth, strong international patient gains, FDA momentum, and promising pancreatic cancer trial results in 2026.


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Biotech Downgraded to Neutral After Second FDA CRL for Reproxalap in Dry Eye Disease
Source: Matthew Caufield  (5/5/26)
H.C. Wainwright & Co. downgraded Aldeyra Therapeutics Inc. (ALDX:NASDAQ) to Neutral and slashed its price target after the company received a second FDA Complete Response Letter for its Reproxalap NDA in dry eye disease. More >


Biotech Co. Faces Mounting ELEVIDYS Efficacy Risk as Roche Phase 3 Study Threatens US Franchise
Source: Mitchell Kapoor  (5/4/26)
H.C. Wainwright analysts argue that Roche's new placebo-controlled Phase 3 study of ELEVIDYS, while aimed at reopening the European market, creates significant downside risk for Sarepta Therapeutics Inc.'s (SRPT:NASDAQ) core U.S. ambulatory business by potentially generating another failed NSAA readout. More >


Wedbush Sees Denifanstat as Front-Line Acne Therapy with 249% Upside Potential
Source: Dr. Yun Zhong  (5/1/26)
Wedbush Securities analyst Dr. Yun Zhong reiterated a price target on Sagimet Biosciences (SGMT:NASDAQ), implying roughly 249% upside. More >


California Biopharma Co. Uncovers Massive Oncology Breakthrough
Source: Streetwise Reports  (4/28/26)
Nurix Therapeutics Inc. (NRIX:NASDAQ) new cancer pipeline data highlights powerful targeted protein degradation advances, with analysts projecting 92% upside potential. More >


Biopharma Advances High-Impact, First-of-Its-Kind Neuroreparative Drug
Source: Streetwise Reports  (4/28/26)
NervGen Pharma Corp. (NGEN:TSX.V; NGENF:OTCQX) drug produced sustained neurologic and functional gains in chronic tetraplegia, positioning it for pivotal Phase 3 development. More >


Brisbane Biotech Showcases Degrader Pipeline Advantages at AACR
Source: Robert Burns  (4/27/26)
Nurix Therapeutics (NASDAQ: NRIX) recently showcased AACR presentations that highlighted the mechanistic superiority of the company's protein degrader platform and preclinical data across key pipeline assets, NX-1607, NRX-4972. More >


AI-Designed Cancer Drug Shows In Vivo Results, Brain Penetration
Source: Streetwise Reports  (4/24/26)
Rakovina Therapeutics Inc. (RKV:TSX.V) reported new preclinical data across two oncology programs at the AACR Annual Meeting, including ATR-mTOR inhibitor efficacy and kt-3283 formulation progress. More >


Asceniv Growth, Margin Expansion, and Pipeline Optionality Drive Price Target
Source: Gary Nachman  (4/23/26)
Canaccord Genuity initiates coverage of ADMA Biologics Inc. (ADMA:NASDAQ), citing Asceniv's differentiated hyperimmune IVIG profile, accelerating margins from yield enhancement, and an underappreciated pipeline. More >


Company Wins Back Promising Eye Disease Drug and Eyes Two Product Launches by 2028
Source: Mitchell Kapoor  (4/20/26)
MeiraGTx Holdings plc. (MGTX:NASDAQ) reported three-year durability data for AAV-hAQP1 in radiation-induced xerostomia, the reacquisition of filing-ready XLRP asset bota-vec from Johnson & Johnson, and a US$100M, according to an H.C. Wainwright research note. More >


Genetic Medicines Co. Reveals Transformative 'Only-of-Its-Kind' AAV Therapy Milestone
Source: Streetwise Reports  (4/20/26)
MeiraGTx Holdings Plc (MGTX:NASDAQ) reports 3-year gene therapy results, secures US$100M funding, and advances late-stage pipeline, signaling major commercial potential. More >


Massachusetts Biotech Co. Faces Major Melanoma Drug Setback
Source: Streetwise Reports  (4/14/26)
Replimune Group Inc.'s (REPL:NASDAQ) RP1 melanoma therapy hits FDA rejection, raising uncertainty around approval timelines and future market potential. More >


Biotech Firm Advances Voice-Based Intoxication Tech Aiming to Revolutionize Medical Diagnostics
Source: Streetwise Reports  (4/13/26)
MindBio Therapeutics Corp.'s (MBIO:CSE; MBQIF:OTCQB; WF6:Frankfurt) AI voice model analyzes 140+ biomarkers, targeting non-invasive impairment screening. More >


MA Biotech Co. Downgraded to Sell After Second FDA CRL for RP-1 Melanoma BLA
Source: Robert Burns  (4/13/26)
H.C. Wainwright downgraded Replimune Group (REPL:NASDAQ) to Sell after the FDA issued a second Complete Response Letter for the RP-1 plus Opdivo BLA in anti-PD1 failed melanoma. More >


What Do Analysts Think About the Biopharma Set on Transforming Psychiatry
Source: Streetwise Reports  (4/9/26)
Alto Neuroscience Inc. (ANRO:NYSE) is a clinical-stage biopharmaceutical company focused on transforming psychiatry through novel drug candidates. More >


Canadian Biotech Co. Appoints Elite Regulatory Expert for Chile Expansion
Source: Streetwise Reports  (4/8/26)
MindBio Therapeutics Corp. (MBIO:CSE; MBQIF:OTCQB; WF6:Frankfurt) appoints Chilean policy leader Felipe Leyton for the mining rollout of its AI impairment detection tech. More >


San Francisco Pharma Co.'s HORIZON Phase 2 Data Validates APOL1 Path to Pivotal Trial
Source: Dr. Ananda Ghosh  (4/7/26)
H.C. Wainwright reiterated its rating and price target on Maze Therapeutics (MAZE:NASDAQ), following KOL calls that validated the HORIZON Phase 2 dataset as biologically coherent, confirmed the diabetic cohort signal as drug-attributable proof of concept, and outlined a clear path to pivotal trials. More >


California Biotech Co. Advances Depression Drug Breakthrough
Source: Streetwise Reports  (4/7/26)
Alto Neuroscience Inc. (ANRO:NYSE) pivots after mixed trial results, targeting treatment-resistant depression with analyst support and major market growth potential. More >


Philly Biotech Co. Develops High-Potential Autoimmune Therapy Breakthrough
Source: Streetwise Reports  (4/2/26)
Cabaletta Bio Inc. (CABA:NASDAQ) pushes rese-cel CAR T program forward with strong clinical momentum, production scalability, and analyst-backed upside potential. More >


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