#fda
Latest news and interesting information about fda.
Cogent Stock Price Target Raised to $55
Cogent Biosciences PEAK trial: combination therapy shows 45.6% response rate, 16.5 months PFS, FDA accepts NDA. H.C. Wainwright raises price target to $55.
Immunome presents phase 3 trial results for desmoid tumor drug
Immunome announces phase 3 results for varegacestat in desmoid tumors: 84% reduction in progression risk, 56% objective response rate.
FDA OKs Inhaled Insulin for Kids
FDA approved MannKind's inhaled insulin Afrezza for children aged 6+ with diabetes. Needle-free option offers new hope for young patients.
QT Imaging Revenue Surges 133% in Q1 2026
QT Imaging Holdings Q1 2026 revenue surged 133% to $6.5M, but net loss and earnings miss led to an 11.59% stock drop.
Compass Pathways Elects Kathleen Tregoning to Board
Compass Pathways elects Kathleen Tregoning to its board. The company advances COMP360 psilocybin therapy for depression with Phase 3 success.
FDA advisors to weigh COVID vaccines for 2026-2027
FDA advisors meet to discuss COVID vaccines for 2026-2027, targeting XFG variant amid data limitations.
Outlook Therapeutics director buys $176K in stock
Outlook Therapeutics director Kurt J. Hilzinger bought 400,000 shares worth $176,520. The stock is up 46.6% in the past week.
FP-001 42 mg Clinical Trial Completed
Foresee Pharmaceuticals completes Phase 3 trial for FP-001 42 mg for precocious puberty. FDA submission planned for 2026. CAMCEVI 21mg approved in Europe.
JPMorgan Initiates Larimar at Overweight
JPMorgan starts Larimar Therapeutics at Overweight with $9 target. Stock at $3.47. Key developments on nomlabofusp.
Big Tobacco Wins After US FDA Shake-Up
FDA loosens vape regulations after tobacco lobbying, potentially flooding the market with new products. Big Tobacco emerges victorious.
Poolbeg Pharma Gets FDA Feedback on POLB 001
Poolbeg Pharma receives FDA feedback on POLB 001 for cancer immunotherapy-induced Cytokine Release Syndrome.
Hansa Biopharma trial results at ATC in June
Hansa Biopharma's Phase 3 ConfIdeS trial results for kidney transplantation will be presented at ATC 2026. 12-month data including eGFR and safety.
Benitec Biopharma gene therapy stock shows clinical promise
Benitec Biopharma gene therapy stock shows clinical promise. BB-301 achieves 100% response rate in OPMD. Analysis on Bond.az.
Kura Oncology SWOT Analysis: Launch Test
Kura Oncology SWOT analysis: FDA approval, early sales results, and future prospects for this biotech stock.
BioCryst: Growth from Pediatric Expansion
BioCryst Pharmaceuticals' pediatric expansion and Orladeyo revenue potential analysis. 2026 profitability target.
Ionis Stock Gains on FDA Approval
Ionis Pharmaceuticals stock gains momentum following FDA approval of REDEMPLO. Financials, pipeline, and growth prospects analyzed.
Guardant Health director sells $735k in shares
Guardant Health director Ian T. Clark sold $735k worth of shares on May 20, 2026. The company received early FDA approval for G360 Liquid CDx test and reported Q1 2026 results.
Gilead wins FDA approval for first hepatitis delta treatment
Gilead Sciences gets FDA approval for Hepcludex, the first treatment for chronic hepatitis delta virus. Shares rose over 2%.
Trodelvy Gets EU Backing for Breast Cancer
Gilead's Trodelvy receives EU backing for triple-negative breast cancer. ASCENT-03 study shows 38% risk reduction.
NervGen Prices $60M Offering at $2.50/Share
NervGen Pharma prices $60M public offering of 24 million shares at $2.50 each. Proceeds to fund NVG-291 clinical trials and corporate needs.
Bernstein Starts Revolution Med at Market Perform
Bernstein initiates Revolution Medicines coverage with Market Perform rating and $151 target. Stock trades at $153.73.
Bernstein Initiates Neurocrine with Outperform Rating
Bernstein initiates Neurocrine Biosciences with an outperform rating and $221 price target. Highlights Crenessity's potential and stock upside.
FDA panel to review Moderna flu vaccine
FDA panel to review Moderna's mRNA-based flu vaccine in June. Decision expected by August 5.
Belite Bio Stock Rises on NDA Progress
Belite Bio stock rises as H.C. Wainwright reiterates Buy rating and NDA progresses. Tinlarebant potential FDA approval expected in Q1 2027.
Immix Biopharma reports 95% complete response rate in trial
Immix Biopharma's NEXICART-2 trial achieves 95% complete response rate in AL Amyloidosis patients. Promising results for CAR-T therapy NXC-201.
Novo, Lilly weight-loss pills lure patients from compounded drugs
Lower prices for Novo Nordisk and Eli Lilly weight-loss pills are driving patients from compounded drugs to branded Wegovy and Foundayo, according to doctors.
Syndax stock gains momentum on strong launch
Syndax Pharmaceuticals stock gains momentum with strong Revuforj launch. Learn about financial performance, pipeline, and market outlook.
Foundation Fighting Blindness sells $7.4M Opus Genetics stock
Foundation Fighting Blindness fund sells $7.4M in Opus Genetics stock. The sale of 1.7M shares at $4.35 each. Opus Genetics stock down 11.7% for the week.
Jupiter Stock Surges on MDMA Therapy Deal
Jupiter Neurosciences stock surges 75.9% on MDMA therapy licensing deal. ALA-002 is a next-generation formulation.
Piper Sandler Reiterates Boston Scientific Buy Rating
Piper Sandler reiterated an Overweight rating on Boston Scientific. Agent DCB drives growth; stock undervalued per Bond.az.
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