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Candel Therapeutics reports immune activation data for prostate cancer drug
Company News

Candel Therapeutics reports immune activation data for prostate cancer drug

INVESTING.COM

Candel Therapeutics, Inc. (Nasdaq: CADL) announced clinical and biomarker data from its phase 3 PrTK03 and phase 2 PrTK05 trials evaluating aglatimagene besadenovec in patients with intermediate-risk localized prostate cancer, according to a company press release.

In the PrTK03 phase 3 trial, 635 patients with intermediate-risk disease treated with aglatimagene plus external beam radiation therapy (EBRT) showed a 41% reduction in the risk of prostate cancer recurrence or prostate cancer-specific death compared with placebo plus EBRT, with a hazard ratio of 0.59 (95% CI 0.41–0.84; p=0.0034), based on follow-up through March 15, 2026, with a median of 58.0 months.

Exploratory analyses from the same trial showed a 52% improvement in time to biochemical failure (HR 0.48), a 90% improvement in time to metastasis (HR 0.10), and a 49% reduction in time to salvage anticancer therapy (HR 0.51).

Biopsy data from 277 evaluable intermediate-risk patients, collected 22–26 months after treatment,

Rafael Holdings stock tumbles 25% as drug trial misses goal
Company News

Rafael Holdings stock tumbles 25% as drug trial misses goal

STREETINSIDER.COM

Investing.com -- Rafael Holdings Inc Class B (NYSE: RFL) shares fell 25% in premarket trading Wednesday after the company's Phase 3 trial of Trappsol Cyclo for Niemann-Pick Disease Type C failed to meet its primary endpoint.

The TransportNPC study, which enrolled 94 patients, showed Trappsol Cyclo did not achieve statistical significance on the primary endpoint of change in the 4-domain NPC Clinical Severity Scale at Week 96. The drug demonstrated a directionally favorable treatment effect versus placebo, slowing disease progression by 64%, but the result missed statistical significance with a p-value of 0.19.

However, a prespecified analysis in patients receiving background miglustat and/or leucine therapy, representing approximately 83% of the study population, showed a statistically significant effect. In this subgroup of 78 patients, Trappsol Cyclo slowed disease progression by 71% compared with placebo at Week 96, with a p-value of 0.046.

The drug demonstrated a well-tolerated

Sagimet stock surges on positive acne trial data
Company News

Sagimet stock surges on positive acne trial data

STREETINSIDER.COM

Investing.com -- Sagimet Biosciences Inc Series A (NASDAQ: SGMT) shares rose over 12% in premarket trading Wednesday following positive 52-week results from its license partner Ascletis' Phase 3 open-label extension trial of denifanstat for moderate to severe acne.

The trial showed denifanstat achieved a 57% treatment success rate, with a 72% reduction in total lesions and 77% reduction in inflammatory lesions after 52 weeks of treatment. The drug was generally well-tolerated, with no adverse event-related permanent discontinuations.

In the Phase 3 open-label extension trial, 240 patients with moderate to severe acne received denifanstat for up to 52 weeks, including 124 patients who previously received placebo in the initial 12-week trial. Treatment success was defined as at least a 2-point reduction in Investigator's Global Assessment score with a score of 0 or 1.

The results were presented at the European Academy of Dermatology and Venereology Congress in Vienna by Ascletis BioSc

Yiren Digital Q2 2026 slides: AI gains amid transformation losses
Company News

Yiren Digital Q2 2026 slides: AI gains amid transformation losses

INVESTING.COM

Yiren Digital (NYSE:YRD) presented its September 2026 investor update on September 30, outlining an ambitious transformation from a traditional fintech lender to an AI-native, multi-industry operating platform. The presentation comes as the company navigates significant regulatory headwinds in China’s online lending sector while posting a second-quarter net loss of RMB 449.6 million—a sharp reversal from the RMB 357.5 million profit recorded a year earlier.

Despite the financial pressure, with shares trading near their 52-week low at $0.94 in premarket activity, the company’s presentation emphasized measurable operational improvements driven by artificial intelligence deployment and a deliberate pivot toward asset-light business models. The investor deck highlighted both the pain of transition and the potential of its AI-first strategy across credit, insurance, and new verticals.

The company’s core strategic shift centers on moving away from capital-intensive, balance-sheet lending t

Theriva Biologics’ VCN-01 trial results published in Nature Medicine
Company News

Theriva Biologics’ VCN-01 trial results published in Nature Medicine

INVESTING.COM

Theriva Biologics (NYSE American: TOVX) announced that results from its VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) in metastatic pancreatic cancer patients were published in Nature Medicine, according to a company statement.

The trial enrolled 112 patients across 14 sites in the U.S. and Spain. Patients in the VCN-01 treatment arm received intravenous VCN-01 seven days prior to the first and fourth cycles of standard-of-care gemcitabine/nab-paclitaxel chemotherapy. The control arm received chemotherapy alone.

Patients treated with VCN-01 combined with chemotherapy showed improved overall survival, progression-free survival, and duration of response compared to those receiving chemotherapy alone, according to the publication. Greater improvements were observed in patients who received two doses of VCN-01 administered three months apart.

"The Kaplan-Meier survival analysis and the timing of responses in VCN-01 treated patients suggest an immune mediated mecha

Synopsys signs $1B+ multi-year custom silicon IP agreement with AWS
Company News

Synopsys signs $1B+ multi-year custom silicon IP agreement with AWS

STREETINSIDER.COM

Investing.com -- Synopsys Inc (NASDAQ: SNPS) stock rose 1.5% in Wednesday premarket trade after the chip design software maker announced a multi-year deal with Amazon Web Services worth more than $1 billion to license its silicon intellectual property. The agreement establishes Amazon.com Inc (NASDAQ: AMZN) as the lead customer for Synopsys' expanded offering of application-optimized IP blueprints.

Synopsys produces electronic design automation software used by major chipmakers to lay out billions of transistors on silicon, alongside a growing IP licensing business that generated $1.75 billion in revenue during its most recent fiscal year. While Synopsys historically focused on licensing standard chip components, the new arrangement expands its reach into more complex, custom designs suited for specific cloud workloads.

For AWS, the partnership supports its ongoing push to design in-house processors, including its Graviton central processing units and Trainium artificial intelligence

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Peoples Bancorp (PEBO) will acquire Capital Bancorp (CBNK) in an all-stock transaction valued at approximately $728.1 million. Capital shareholders will receive 1.11 shares of PEBO for each CBNK share, valuing CBNK at $43.75 per share based on PEBO's 20-day VWAP 🔗. The deal is expected to be immediately accretive to Peoples' 2027 earnings and create a combined entity with $14 billion in assets. PEBO shares fell 6%, while CBNK surged 11% on the news 🔗.

Peoples Bancorp falls, Capital Bancorp rises amid all-stock deal

Peoples Bancorp falls, Capital Bancorp rises amid all-stock deal

STREETINSIDER.COMSep 30, 2:56 PM UTC
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The biotech sector is experiencing notable volatility following a wave of clinical trial results:

  • Candel Therapeutics (CADL): Shares likely to react positively after Phase 3 data showed a 41% reduction in prostate cancer recurrence risk for its drug aglatimagene. BLA submission planned for Q4 2026 🔗.
  • Rafael Holdings (RFL): Stock tumbled 25% as its Phase 3 trial for Niemann-Pick Disease Type C missed its primary endpoint, despite showing a statistically significant effect in a prespecified subgroup 🔗.
  • Sagimet Biosciences (SGMT): Stock surged over 12% on positive 52-week Phase 3 data for its acne drug denifanstat, showing a 57% treatment success rate. The company also announced a $115M stock offering 🔗.
  • Theriva Biologics (TOVX): Results from its Phase 2b pancreatic cancer trial, showing improved overall survival with VCN-01, were published in Nature Medicine 🔗.
  • Merck (MRK): Positive Phase 2b data for tulisokibart in hidradenitis suppurativa, meeting primary and key secondary endpoints. These findings will inform Phase 3 development 🔗.
  • Eli Lilly (LLY): Ebglyss met primary and secondary endpoints in a Phase 3b trial for hand and foot atopic dermatitis, showing 53% clear/almost clear skin vs. 27% for placebo 🔗.
  • Sarepta Therapeutics (SRPT): Presented new functional outcome data for its gene therapy Elevidys in older Duchenne muscular dystrophy patients, showing improved North Star Ambulatory Assessment scores 🔗.

These diverse outcomes highlight the high-stakes nature of clinical development, driving significant stock movements across the industry.

Candel Therapeutics reports immune activation data for prostate cancer drug

Candel Therapeutics reports immune activation data for prostate cancer drug

INVESTING.COMSep 30, 12:37 PM UTC
Rafael Holdings stock tumbles 25% as drug trial misses goal

Rafael Holdings stock tumbles 25% as drug trial misses goal

STREETINSIDER.COMSep 30, 1:21 PM UTC
Sagimet stock surges on positive acne trial data

Sagimet stock surges on positive acne trial data

STREETINSIDER.COMSep 30, 1:21 PM UTC
Theriva Biologics’ VCN-01 trial results published in Nature Medicine

Theriva Biologics’ VCN-01 trial results published in Nature Medicine

INVESTING.COMSep 30, 12:08 PM UTC
Merck’s tulisokibart meets goals in skin disease Phase 2b trial

Merck’s tulisokibart meets goals in skin disease Phase 2b trial

INVESTING.COMSep 30, 12:22 PM UTC
Lilly’s Ebglyss shows efficacy in hand, foot dermatitis trial

Lilly’s Ebglyss shows efficacy in hand, foot dermatitis trial

INVESTING.COMSep 30, 12:12 PM UTC
Sarepta presents Elevidys data in older Duchenne patients

Sarepta presents Elevidys data in older Duchenne patients

INVESTING.COMSep 30, 12:36 PM UTC
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The biotech sector is experiencing significant volatility driven by recent clinical trial data. Candel Therapeutics (CADL) surged on positive Phase 3 data for its prostate cancer drug, showing a 41% reduction in recurrence risk and plans for a Q4 2026 BLA submission 🔗. Similarly, Sagimet Biosciences (SGMT) rose over 12% after positive 52-week results for its acne drug, denifanstat, with a 57% treatment success rate 🔗. Theriva Biologics (TOVX) also announced improved overall survival in pancreatic cancer patients from its VCN-01 trial, published in Nature Medicine 🔗.

Conversely, Rafael Holdings (RFL) shares tumbled 25% as its Phase 3 trial for Niemann-Pick Disease Type C failed to meet its primary endpoint, despite a statistically significant effect in a subgroup 🔗. Merck (MRK) and Eli Lilly (LLY) also reported positive Phase 2b/3b data for their respective drugs in skin diseases, with Merck's tulisokibart meeting primary endpoints in hidradenitis suppurativa 🔗 and Lilly's Ebglyss showing efficacy in hand/foot atopic dermatitis 🔗.

Candel Therapeutics reports immune activation data for prostate cancer drug

Candel Therapeutics reports immune activation data for prostate cancer drug

INVESTING.COMSep 30, 12:37 PM UTC
Sagimet stock surges on positive acne trial data

Sagimet stock surges on positive acne trial data

STREETINSIDER.COMSep 30, 1:21 PM UTC
Theriva Biologics’ VCN-01 trial results published in Nature Medicine

Theriva Biologics’ VCN-01 trial results published in Nature Medicine

INVESTING.COMSep 30, 12:08 PM UTC
Rafael Holdings stock tumbles 25% as drug trial misses goal

Rafael Holdings stock tumbles 25% as drug trial misses goal

STREETINSIDER.COMSep 30, 1:21 PM UTC
Merck’s tulisokibart meets goals in skin disease Phase 2b trial

Merck’s tulisokibart meets goals in skin disease Phase 2b trial

INVESTING.COMSep 30, 12:22 PM UTC
Lilly’s Ebglyss shows efficacy in hand, foot dermatitis trial

Lilly’s Ebglyss shows efficacy in hand, foot dermatitis trial

INVESTING.COMSep 30, 12:12 PM UTC
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Meta Platforms' (META) new AI agent, Muse, is pressuring online travel agency (OTA) stocks, according to Truist analysts 🔗. Muse's ability to book travel, combined with Meta's consumer reach and data resources, poses significant downside risks to OTAs.

Truist highlights Expedia Group (EXPE) as particularly vulnerable, given Muse's North American launch and Expedia's two-thirds U.S.-based B2C operations. Booking Holdings (BKNG) has lower U.S. exposure. The extent of impact on bookings, commission rates, and competitive positioning remains uncertain, but investor sentiment is likely to be affected 🔗.

Meta's Muse AI agent pressures online travel stocks, Truist comments

Meta's Muse AI agent pressures online travel stocks, Truist comments

STREETINSIDER.COMSep 30, 9:36 AM UTC
0

Hedge funds now hold a record 7% ($2 trillion) of the $30 trillion US Treasury market, nearly tripling their holdings in five years 🔗. This surge, while helping fund government debt, raises concerns among experts about potential systemic risk due to hedge funds' aggressive leverage 🔗.

Key points:

  • Hedge funds' share of marketable Treasury debt reached 7% by end of 2025, continuing to grow in H1 2026 🔗.
  • Experts warn that forced deleveraging in extreme situations could lead to broader liquidity and financial stability events 🔗.
  • This comes as 10-year and 30-year Treasury yields hit multi-year highs 🔗.
Hedge funds hold a record share of the $30 trillion Treasury market. What could go wrong?

Hedge funds hold a record share of the $30 trillion Treasury market. What could go wrong?

CNBC.COMSep 30, 12:19 AM UTC
0

S&P Global Ratings has upgraded Wells Fargo (WFC) long-term issuer credit rating to 'A-' from 'BBB+'. The upgrade reflects significant progress in governance, risk culture, and operational oversight following the termination of its Federal Reserve asset cap. The bank's balance sheet growth has outpaced the sector, with resilient credit performance and strong capital cushions. S&P maintains a stable outlook, expecting continued return improvements while managing risk. 🔗

S&P upgrades Wells Fargo to A- following risk management overhauls

S&P upgrades Wells Fargo to A- following risk management overhauls

STREETINSIDER.COMSep 29, 9:17 PM UTC
1

Cruise operators are sailing higher today after Carnival (CCL) reported better-than-expected Q3 earnings and issued an optimistic outlook. CCL shares jumped 12%, leading gains among rivals Royal Caribbean (RCL) and Norwegian Cruise Line Holdings (NCLH).

Key Highlights:

  • CCL adjusted EPS of $1.43 vs. $1.35 est. on $8.44B revenue vs. $8.35B est. 🔗
  • Net yields projected up 3.8% in FY2026, above 3.2% consensus 🔗
  • Booked occupancy and pricing for 2027 at record levels 🔗

This performance reinforces the sector's recovery trajectory despite macroeconomic headwinds. 🔗

Cruise Stocks Jump After Carnival Posts Strong Results and Rosy Outlook

Cruise Stocks Jump After Carnival Posts Strong Results and Rosy Outlook

INVESTOPEDIA.COMSep 29, 4:10 PM UTC
1

Iovance Biotherapeutics (NASDAQ: IOVA) shares jumped over 14% in premarket trading after the company significantly raised its full-year 2026 revenue outlook to $410M-$420M. This updated forecast, driven by strong adoption of its Amtagvi therapy, exceeds the prior guidance midpoint by $55M and clears consensus analyst estimates of $402.8M 🔗.

Key points:

  • Guidance Increase: Midpoint of new guidance ($415M) is 3.0% above consensus.
  • Commercial Momentum: Strong domestic adoption of Amtagvi and sustained Proleukin sales cited.
  • Expansion: On track to expand authorized treatment centers to 110 by year-end 2026.
  • Profitability: Operational efficiencies accelerating timeline toward profitability.
Iovance shares jump in premarket as raised outlook clears consensus views

Iovance shares jump in premarket as raised outlook clears consensus views

STREETINSIDER.COMSep 29, 1:11 PM UTC
1

AI lab Anthropic plans to spend at least $518 billion over the next decade on AI infrastructure, with the majority in non-cancelable deals. This massive commitment signals significant future revenue for key tech partners:

  • Alphabet (GOOGL): $111.1 billion
  • Amazon (AMZN): $110 billion
  • Microsoft (MSFT): $31.4 billion
  • Broadcom (AVGO): $161.2 billion in equipment lease obligations

The company highlights compute power as the key constraint for AI development, with future demand likely to exceed supply. This underscores the ongoing AI infrastructure buildout and its direct financial impact on major cloud and chip providers. 🔗

Anthropic’s $518 billion AI buildout hinges largely on deals that cannot be canceled, filing shows

Anthropic’s $518 billion AI buildout hinges largely on deals that cannot be canceled, filing shows

INVESTING.COMSep 29, 10:15 AM UTC
1

The CME Group's FedWatch Tool indicates a significant increase in the probability of further Federal Reserve rate hikes. There's now a 45.9% chance of 50 basis points in hikes and a 25.1% possibility of 75 basis points in hikes by the January 27, 2027 FOMC meeting. This suggests a strong market expectation for aggressive tightening to combat persistent inflation, with President Trump's tariff policies cited as a contributing factor 🔗. This development could signal continued pressure on equities and bonds as borrowing costs rise.

The Odds of the Fed Ramping Up Its Rate-Hiking Cycle Are Skyrocketing, and 4 Variables -- 2 Directly Tied to President Donald Trump -- Are to Blame

The Odds of the Fed Ramping Up Its Rate-Hiking Cycle Are Skyrocketing, and 4 Variables -- 2 Directly Tied to President Donald Trump -- Are to Blame

FOOL.COMSep 29, 8:06 AM UTC
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