Today's top gainers included uniQure, which rallied after the FDA softened its stance on the company's investigational gene therapy; Elicio Therapeutics, following encouraging treatment responses from its cancer vaccine in pancreatic cancer trial; Lunai, after its CEO issued a letter to shareholders outlining the developments in the company; and Polyrizon, which announced the publication of a U.S. patent application for its nasal drug delivery technology, among others.
Read on…
QURE Surges on Positive FDA Surprise
uniQure N.V. (QURE), a gene therapy company, has been informed by the FDA that the 3-year analysis from the Phase I/II study would be acceptable as the primary basis of a Biologics License Application for the accelerated approval of AMT-130 in Huntington's disease.
Previously, the regulatory agency had strongly recommended that the company conduct a prospective, randomized, double-blind, sham-surgery-controlled study and that the data from the Phase I/II study would not be sufficient as the primary evidence of effectiveness required for a marketing application.
Now that the FDA has softened its stance, the company intends to submit the BLA for AMT-130 in Huntington's disease in the third quarter of 2026.
QURE closed Wednesday's trading at $48.16, up 78.44%.
ELTX Reports Encouraging Treatment Responses
Elicio Therapeutics Inc. (ELTX) reported on Tuesday that three patients with advanced pancreatic cancer in a phase 2 study, dubbed AMPLIFY-7P, responded extremely well after treatment with its experimental vaccine ELI-002 7P, followed by an immune checkpoint drug - Bristol Myers Squibb's Opdivo (nivolumab).
According to the company, the three patients who received ELI-002 7P during Elicio's recently completed Phase 2 AMPLIFY-7P study initially experienced disease progression after treatment and subsequently achieved confirmed complete radiographic and complete metabolic responses after receiving nivolumab-based therapy. These responses were accompanied by normalization of the tumor biomarker CA19-9 levels.
The findings suggest that ELI-002 7P-induced mutant KRAS("mKRAS")-specific T cells may enhance the effectiveness of checkpoint inhibition, leading to deep antitumor responses in a tumor type previously considered refractory to immunotherapy. The post-study observations support evaluation of ELI-002 7P in combination with checkpoint inhibition in metastatic pancreatic cancer, the company noted.
Elico plans to initiate a Phase 1 study evaluating ELI-002 7P in combination with standard gemcitabine/nab-paclitaxel chemotherapy and an anti-PD-1 inhibitor in treatment-naïve metastatic mKRAS pancreatic cancer, subject to funding availability.
ELTX closed Wednesday's trading at $4.71, up 70.65%.
LNAI CEO Outlines Key Developments
Shares of Lunai Bioworks (LNAI) jumped more than 40% on Wednesday, after the CEO highlighted a series of developments that have substantially strengthened the company's position and created multiple pathways for shareholder value creation.
Notable achievements include Lunai's first revenue-generating U.S. government defence contract secured this April and the formation of the Pathfinder Consortium, a national alliance of institutions including Harvard University, Brigham and Women's Hospital (led by Dr. Calum MacRae), the University of Utah, Purdue University, and the University of Colorado.
The company is also advancing a precision neurology pipeline through its Augusta AI platform in Epilepsy, Parkinsons, and Alzheimer's.
Looking ahead to the second half of 2026, the company believes that its Augusta platform, which combines AI, large toxicity databases, and animal testing, fits well with the priorities outlined in the 2027 Defense Authorization Bill released this month.
The CEO also disclosed that the company initiated legal action last month against alleged naked short sellers, citing evidence of significant trading irregularities.
With NASDAQ compliance restored, management believes Lunai is well positioned to capitalize on the convergence of AI, biotechnology, and national security while remaining focused on creating long-term value for shareholders.
LNAI closed Wednesday's trading at $4.00, up 40.06%.
CLPT Rallies on AMT-130 Spillover Effect
ClearPoint Neuro Inc. (CLPT) jumped more than 26% on Wednesday, following the encouraging regulatory news related to uniQure's investigational gene therapy AMT-130 in Huntington's disease.
The AMT-130 gene therapy is administered to trial participants using the ClearPoint Neuro Navigation System and SmartFlow MRI-safe neuro ventricular cannulae under MRI guidance.
CLPT closed Wednesday's trading at $16.81, up 26.01%.
What's the buzz at INDP?
Indaptus Therapeutics Inc. (INDP), a clinical-stage biotechnology company, has been on a roll since the beginning of this month on no specific news.
Last month, while reporting first quarter results, the company announced that it is evaluating its Decoy platform, including its preclinical data and underlying scientific rationale, to assess its potential relevance to its ongoing therapeutic, immunological, and translational research programs. As part of this review, the company is also reassessing its development priorities, operational initiatives, and resource allocation.
As of March 31, 2026, the company had approximately $1.5 million in cash and disclosed that it will need to raise additional capital to support its business objectives.
INDP closed Wednesday's trading at $4.50, up 20.97%.
PLRZ Soars on Patent News
Shares of Polyrizon Ltd. (PLRZ) were up over 15% on Wednesday, following the publication of a U.S. patent application for its nasal drug delivery technology.
This development-stage biotech company specialises in the development of innovative intranasal hydrogels.
The patent application covers Polyrizon's proprietary Trap & Target (T&T) mucoadhesive polymer technology platform for nasal drug delivery. The platform supports the delivery of a broad range of therapeutic compounds, including anti-inflammatory drugs, vaccines, biologics, and additional pharmaceutical actives, and is designed to help medicines stay longer in the nasal passage and improve how well they are absorbed.
PLRZ closed Wednesday's trading at $13.23, up 15.55%.
FTH On Watch
Sensei Biotherapeutics Inc., which changed its corporate name to Faeth Therapeutics, Inc. and ticker symbol to "FTH" on June 16, 2026, was up over 14% on Wednesday.
The company's lead drug candidate is PIKTOR, which is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer, with topline data anticipated in the second half of 2026.
A Phase 1b/2 trial of PIKTOR in HR+/HER2- advanced breast cancer is also ongoing, in which the first patient was dosed in April 2026, and interim data is anticipated in 2027.
FTH closed Wednesday's trading at $16.65, up 14.59%.
Did you know?
With annual revenue of $94.2 billion in 2025, Johnson & Johnson (JNJ) is the world's largest pharmaceutical company by revenue. It is followed by Roche at $77 billion (61.5 billion CHF) and Eli Lilly at $65.2 billion.
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Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.