Pyxis Oncology Reports 46% ORR for MICVO Monotherapy in R/M HNSCC
- Monotherapy Efficacy: In the 2L+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), MICVO demonstrated a confirmed overall response rate (ORR) of 46%, establishing a solid foundation for further clinical development.
- Combination Therapy Potential: When used in combination with KEYTRUDA®, MICVO achieved a 71% ORR and a 100% disease control rate (DCR) in 1L/2L+ R/M HNSCC patients, indicating promising synergistic effects in treatment.
- Good Tolerability: Among 18 patients treated at a dose of 5.4 mg/kg, 89% experienced adverse reactions, yet no Grade 4 or higher serious adverse events were observed, suggesting favorable safety and tolerability profiles for MICVO.
- Future Development Plans: The company plans to present updated clinical data for the monotherapy in mid-2026 and updated data for the combination with KEYTRUDA® in the second half of 2026, further advancing MICVO's clinical application.
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- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in GOBLET Cohort 4, significantly surpassing the historical benchmark of 10%, indicating substantial clinical value in third-line anal cancer patients with no FDA-approved treatment options.
- Duration of Response: The median duration of response reached approximately 17 months, far exceeding the standard treatment's 9.5 months, showcasing pelareorep's durable efficacy in heavily pretreated patients and addressing a critical unmet medical need.
- FDA Interaction Plan: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss its registration-directed clinical study plan for second-line and later SCAC, with the potential for accelerated approval if data meets expectations.
- Strategic Investment and Expansion: The company is enhancing its expertise in gastrointestinal oncology through the expansion of its Scientific Advisory Board, further validating its Phase 3 study design for first-line metastatic pancreatic cancer, demonstrating its strategic positioning in the oncology immunotherapy landscape.
- Clinical Trial Progress: ALX Oncology Holdings Inc. announced positive data from its Phase 2 trial of evorpacept for indolent B-cell non-Hodgkin lymphoma, leading to a 10.17% stock increase to $1.30, with detailed results set to be presented at the ASH Annual Meeting on December 7, 2025, potentially boosting investor confidence.
- Sales Performance Surge: Globus Medical, Inc. reported preliminary unaudited Q4 2025 sales of approximately $823.2 million, a 25.2% year-over-year increase, with full-year sales expected to reach $2.936 billion, reflecting strong performance and growth potential in the medical device market.
- Future Outlook: Globus Medical set its 2026 revenue guidance between $3.18 billion and $3.22 billion, with projected non-GAAP earnings per share ranging from $4.30 to $4.40, indicating confidence in future performance that may attract more investor interest.
- Industry Developments: Acrivon Therapeutics, Inc. plans to release clinical data updates for ACR-368 and ACR-2316 on January 8, 2026, resulting in a 6.44% stock increase to $3.14, reflecting market optimism regarding its R&D progress, which could influence future financing and partnership opportunities.
Preliminary Data Release: Pyxis Oncology announced preliminary results from Phase 1 studies of micvotabart pelidotin (MICVO) for recurrent/metastatic head and neck squamous cell carcinoma, showing a 46% overall response rate in monotherapy and 71% in combination with Keytruda, with high disease control rates.
Future Plans: The company plans to present updated data from both studies in mid and late 2026 and is evaluating the path forward for pivotal studies of MICVO as both a monotherapy and in combination with pembrolizumab.
Financial Update: Pyxis completed a sale of rights for $11 million to support MICVO development, but concerns over cash reserves and data interpretability led to a significant drop in share price, with analysts expressing caution regarding the trial's small sample size and tolerability issues.
Market Reaction: Following the data release, Pyxis shares fell approximately 49%, reflecting investor concerns about the limited interpretability of the results and the company's financial outlook, despite a slight recovery in premarket trading.

Analyst Upgrades: Truist Securities raised price targets for NXP Semiconductors and Tesla, maintaining a Buy and Hold rating respectively, while Wells Fargo upgraded Generac Holdings from Equal-Weight to Overweight.
Analyst Downgrades: Barclays downgraded Agco Corp from Equal-Weight to Underweight, cutting its price target significantly, while JP Morgan downgraded Lockheed Martin from Overweight to Neutral despite raising its price target.
Other Price Target Changes: Bernstein increased Caterpillar's price target while maintaining a Market Perform rating, and Piper Sandler raised Assurant's target with an Overweight rating.
Nike's Price Target Cut: Telsey Advisory Group reduced Nike's price target from $75 to $72, keeping a Market Perform rating as the stock closed lower.
U.S. Stock Market Performance: U.S. stocks saw gains, with the Nasdaq Composite rising over 200 points, while the Dow and S&P 500 also experienced increases. Consumer discretionary shares rose by 2%, but energy stocks fell by 0.5%.
Inflation and Economic Indicators: U.S. inflation cooled to 2.7% in November, below expectations, boosting investor confidence in the Federal Reserve's easing cycle. Initial jobless claims decreased to 224,000, and the Philadelphia Fed Manufacturing Index fell significantly.
Notable Stock Movements: Athira Pharma's shares surged 84% after a development agreement, while Trump Media & Technology Group and FuelCell Energy also saw significant gains. Conversely, Insmed Inc and Pyxis Oncology experienced sharp declines in their stock prices.
Global Market Trends: European shares rose, with the eurozone's STOXX 600 gaining 0.56%, while Asian markets closed mixed, with Japan's Nikkei falling and China's Shanghai Composite rising slightly.
U.S. Stock Market Performance: U.S. stocks rose significantly, with the Dow Jones gaining approximately 400 points, while the NASDAQ and S&P 500 also saw notable increases.
Accenture's Strong Earnings: Accenture reported better-than-expected first-quarter results for 2026, with earnings of $3.94 per share and sales of $18.7 billion, surpassing analyst estimates.
Equities Movement: Athira Pharma's shares surged 88% following an acquisition announcement, while Mega Fortune Co Ltd and Pyxis Oncology saw significant declines of 59% and 54%, respectively.
Economic Indicators: The Philadelphia Fed Manufacturing Index fell sharply, initial jobless claims decreased, and the annual inflation rate dropped to 2.7%, the lowest since July.









