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FDA Approvals News 17 July 2025 - 19 October 2025

Intuitive Surgical Stock Primed for Rally on FDA Approvals and Congressional Buying

Intuitive Surgical Stock Primed for Rally on FDA Approvals and Congressional Buying

Stock Performance & Analyst Consensus Intuitive’s stock has been volatile in 2025. It gained ground last week on optimism (e.g. up ~2.7% on Oct. 17) and now sits around $446 Investing Marketbeat. Over the past year, the price swung between about $425 and $616 Investing. At ~$446, ISRG trades at a high single-digit P/E (~60x) compared to the medtech sector,…
19 October 2025
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Artiva Biotherapeutics (ARTV) Stock Skyrockets on FDA Fast Track News – What’s Next for Investors?

Artiva Biotherapeutics (ARTV) Stock Skyrockets on FDA Fast Track News – What’s Next for Investors?

In summary, Artiva Biotherapeutics stock has erupted in October 2025 on the back of a major FDA Fast Track win and renewed optimism around its NK-cell therapy for RA. The latest developments – from surging share price and volume to analyst projections of multi-fold upside – underscore the high stakes and high hopes riding on AlloNK’s success. For biotech investors…
17 October 2025
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Femasys (FEMY) Stock Soars 46% on Fertility Tech and FDA Milestones

Femasys (FEMY) Stock Soars 46% on Fertility Tech and FDA Milestones

Femasys’ stock surge on Oct. 16 mirrors growing investor interest in its reproductive healthcare pipeline. The company’s FemaSeed™ technology is designed to boost pregnancy rates by delivering sperm directly into the fallopian tube, and published trials report more than double the pregnancy rate of traditional intrauterine insemination Globenewswire Stocktitan. Femasys is positioning FemaSeed as a first-line, lower-cost infertility option ahead of IVF. Meanwhile, FemBloc…
16 October 2025
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Scienture (SCNX) Stock Skyrockets on New FDA-Approved Blood Pressure Drug Launch

Scienture (SCNX) Stock Skyrockets on New FDA-Approved Blood Pressure Drug Launch

SCNX Stock Climbs on Arbli Launch Pills and a daily pill organizer: Arbli’s liquid formulation helps patients (especially children/elderly) who can’t swallow tablets. Scienture’s stock jumped sharply on Oct. 16 after the company formally launched Arbli™ in the U.S. market. In a GlobeNewswire press release that morning, Scienture announced that Arbli™ is now shipping through major pharmaceutical wholesalers nationwide Globenewswire.…
16 October 2025
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Spruce Biosciences Skyrockets on FDA Breakthrough – Will SPRB’s Rally Last or Fade?

Spruce Biosciences Skyrockets on FDA Breakthrough – Will SPRB’s Rally Last or Fade?

Stock Performance & Recent Price Action Spruce Biosciences’ stock has been on a wild ride in early October 2025. Heading into this period, SPRB was a little-known micro-cap biotech trading in the high single digits (post-reverse-split). At the close on Oct 3, 2025, shares stood at $8.82 (market cap ~$4.8M) Stocktitan after a period of relatively low activity. That calm…
6 October 2025
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Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

Stock Performance and Trends Sarepta’s stock is recovering some ground after steep losses. As of Oct 2, 2025, SRPT closed at $19.57, up about 6.8%for the day Investing. This followed a general uptrend in recent weeks: SRPT is up roughly 16% over the last month Marketbeat (though still down >80% from early 2025 levels). Trading volume has been moderate (0.6 million on Oct 2 vs.…
2 October 2025
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Breakthrough Trials, FDA Greenlights & Global Health Alerts: Biotech & Health News (Aug 10–11, 2025)

Breakthrough Trials, FDA Greenlights & Global Health Alerts: Biotech & Health News (Aug 10–11, 2025)

Novartis announced that two Phase III trials, NEPTUNUS-1 and NEPTUNUS-2, met their primary endpoints in Sjögren’s disease, marking the first global Phase III evidence of significant disease activity reduction with ianalumab and its dual B-cell depletion and BAFF signaling blockade. IO Biotech will disclose topline results from its Phase III melanoma trial of Cylembio (IO102-IO103) in combination with Merck’s Keytruda…
11 August 2025
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Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

Drug Approvals & Regulatory Developments (In Europe, regulators also made news: the EMA’s committee recommended approving darolutamide (Bayer’s Nubeqa) with hormone therapy for metastatic prostate cancer based on positive Phase 3 data Onclive.) Clinical Trials & Research Breakthroughs Public Health & Policy Industry & Business Updates Sources: Key information and quotes in this report were drawn from Reuters news wires…
9 August 2025
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AI Pathology Breakthrough: Roche’s Lung Cancer Diagnostic Makes FDA History

AI Pathology Breakthrough: Roche’s Lung Cancer Diagnostic Makes FDA History

In April 2025, Roche’s Ventana TROP2 (EPR20043) RxDx test became the first AI-powered diagnostic to receive FDA Breakthrough Device Designation. The device pairs an immunohistochemistry stain for TROP2 with a digital pathology AI algorithm that runs in Roche’s Navify system to analyze NSCLC biopsy slides. The AI calculates a Normalized Membrane Ratio (NMR), the ratio of surface TROP2 to internal…
17 July 2025
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Stock Market Today

  • Nutanix appears undervalued after price slump, DCF suggests
    January 17, 2026, 3:39 PM EST. Nutanix Inc. NTNX closed at $45.74, after a 7-day decline of 14.5% and a year-to-date drop of 9.6%. Seven days aside, three- and five-year returns run 70.7% and 36.5%, but the stock is down 29.8% over the last 12 months. The shares carry a valuation score of 3 out of 6, signaling mixed sentiment about cloud-infrastructure software and subscription models. A two-stage Free Cash Flow to Equity (FCF; cash available to equity holders) model yields an intrinsic value of about $74.61 per share, suggesting ~38.7% undervaluation versus the current price. The model is anchored by a trailing twelve-month FCF of about $773.8 million and projects roughly $1.55 billion in 2035, underscoring the sector's sensitivity to subscription dynamics.
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