Regenxbio (NASDAQ:RGNX) Bolsa

Regenxbio

Regenxbio Inc is a biotechnology company. Its main activity is the development and commercialization of recombinant adeno associated virus gene therapy to correct an underlying genetic defect. The diseases that the Regenxbio platform targets are metabolic (homozygous familial hypercholesterolemia), neurodegenerative conditions (mucopolysaccharidosis), and retinal diseases (wet age-related macular degeneration, X-linked retinitis pigmentosa). The company derives the majority of its revenue from the United States.

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Semtech sorprendió al mercado con ingresos y ganancias superiores a lo esperado. Inversores reaccionan ante este sólido desempeño trimestral.

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Las acciones de KB Home suben 9,1% tras superar expectativas de ganancias. Descubre los mayores ganadores y perdedores del mercado hoy.

Las acciones de KB Home se disparan un 9%; 20 acciones que se mueven en el premercado de EE.UU.

Regenxbio Inc

Earnings

Earnings Misses

BSRR

Sierra Q1 EPS $0.65 Misses $0.66 Estimate, Sales $36.75M Miss $37.51M Estimate

ZJK Industrial (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZJK#NASDAQ">ZJK</a>) reported quarterly earnings of $0.06 per share. This is a 53.85 percent decrease over earnings of $0.13 per share from the same period last year. The company reported $37.81 million in sales this quarter. This is a 30.15 percent increase over sales of $29.05 million the same period last year.

ZJK Industrial FY EPS $0.06 Down From $0.13 YoY, Sales $37.81M Up From $29.05M YoY

Newegg Commerce (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NEGG#NASDAQ">NEGG</a>) reported $1.24 million in sales this quarter. This is a 99.92 percent decrease over sales of $1.50 billion the same period last year.

NEGG

Newegg Commerce FY24 Sales $1.24M Down From $1.50B YoY

Macro Economic Events

Global

Economics

Bessent Says India Could Be One Of First Trade Deals We Sign

<ul>
<li>Findings in a younger, commercially insured population build on Medicare-based CAMELOT results, expanding the generalizability of Zio LTCM's clinical impact across patient groups.</li>
<li>Latest data showed Zio LTCM was associated with higher diagnostic yield and lower likelihood of repeat testing and cardiovascular events compared to all other LTCM products.</li>
</ul>
SAN FRANCISCO, April 28, 2025 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=Ikwp3f39jnu34tuHM0kHVjLa90aVBTaCBY2hja6eWJExuBXp8_Y6rAsaxWHfbSueKtdCrmddSVqac7FC2MVt8bz0OAy0xibL25f77FW-JPA=">iRhythm Technologies, Inc</a>. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IRTC#NASDAQ">IRTC</a>) announced results from a large real-world retrospective analysis presented at the Heart Rhythm Society's annual meeting, HRS2025, held April 24–27 in San Diego, CA, The Assessment of Variation in AmbuLatory Cardiac MONitoring: Real-World Evidence of Commercially Insured Beneficiaries (AVALON) study—drawing on claims data from a cohort of 428,707 commercially insured patients—represents the largest real-world comparative evaluation of ambulatory cardiac monitoring (ACM) among this population to date, and reinforces the clinical superiority of the Zio&#xAE; long-term continuous monitoring (LTCM) service.

IRTC

iRhythm Presents AVALON Study Results at HRS2025, Showcasing Largest Real-World ACM Analysis

TDH Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PETZ#NASDAQ">PETZ</a>) reported quarterly earnings of $0.26 per share. This is a 111.35 percent increase over losses of $(2.29) per share from the same period last year. The company reported $563.73 thousand in sales this quarter. This is a 74.66K percent increase over sales of $754.00 the same period last year.

PETZ

TDH Hldgs FY EPS $0.26 Up From $(2.29) YoY, Sales $563.73K Up From $754.00 YoY

&nbsp;80% of EVX-01 vaccine targets triggered a tumor-specific immune response, a substantially higher frequency than what has been reported for other similar vaccine candidatesThe data underscores the precision of
&nbsp;
<ul>
<li>80% of EVX-01 vaccine targets triggered a tumor-specific immune response, a substantially higher frequency than what has been reported for other similar vaccine candidates</li>
<li>The data underscores the precision of Evaxion's AI-Immunology&#x2122; platform in selecting therapeutically relevant vaccine targets</li>
<li>New findings show EVX-01 inducing a robust and durable immune response, further enhanced by booster immunizations
<ul>
<li>The ongoing phase 2 trial with EVX-01 remains on track for two-year data readout in the second half of 2025</li>
</ul>
</li>
</ul>

Biotech

General

EVAX

Evaxion Biotech Announces Data Underscoring Ability Of Cancer Vaccine EVX-01

Market-Moving Exclusives

Exclusives

ARTL

EXCLUSIVE: Artelo Biosciences Tells Benzinga 'ART26.12 Phase 1 in healthy volunteers completes enrollment with clinical data announcement expected this quarter'

EXCLUSIVE: Artelo Biosciences Tells Benzinga Co. Announces Publication Of New Peer-Reviewing Research Demonstrating ART26.12's Effectiveness In Treating Psoriasis

U.S. Treasury Secretary Bessent Says All Aspects Of Government Are In Contact With China; Up To China To De-escalate On Tariffs

Artelo Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARTL#NASDAQ">ARTL</a>) on Monday announced new research published in the peer-reviewed&nbsp;Journal of Investigative Dermatology describing the positive effects of ART26.12 in both in vitro <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">and </a><a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">in vivo</a><a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener"> psoriasis models</a>.
The research shows results comparable to immunomodulatory drugs with known serious adverse events.
The research highlights ART26.12, Artelo&#8217;s orally active, small-molecule inhibitor of Fatty Acid Binding Protein 5 (FABP5), and its potential ability to treat psoriasis.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/01/42854815/why-is-hoth-therapeutics-stock-trading-over-100-higher-on-tuesday" rel="noreferrer noopener">Why Is Hoth Therapeutics Stock Flying Higher On Tuesday?</a>
George Warren, PhD, Lead Author and Principal Scientist at Artelo, said, &#8220;We are excited to share the results on this novel target in psoriasis. Our findings demonstrate that ART26.12 has effects comparable to powerful immunomodulators, while its unique pharmacology leads to a significantly distinct expression of proteins and lipids in the skin.&#8221;
Dr. Warren added, &#8220;Pre-clinical IND-enabling studies with ART26.12, supported by a literature review of greater than 300 studies examining FABP inhibition, imply a low toxicological risk for ART26.12, which, if borne out in clinical studies, suggest FABP5 inhibition with an orally delivered small molecule may be an attractive, less costly, and safer approach for treating this debilitating chronic disease.&#8221;
A Phase 1 Single Ascending Dose study in healthy volunteers with ART26.12 has completed enrollment, and data announcements are expected in the second quarter of 2025.
The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN).
In addition to ART26.12 in CIPN, Artelo&#8217;s extensive library of small molecule inhibitors of FABPs has shown therapeutic promise for certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders.
In January, Artelo Biosciences completed a safety review of the first cohort of eight healthy volunteers in the company&#8217;s <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/42943914/exclusive-artelo-biosciences-concludes-first-cohort-of-healthy-volunteers-of-fabp-inhibitor-program" rel="noreferrer noopener">Phase 1 study of ART26.12</a>.&nbsp;
In December, Artelo Biosciences announced the presentation of preliminary data on ART27.13, a benzimidazole derivative being studied for&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/g42390296/artelo-biosciences-announces-presentation-of-phase-1-data-with-art27-13-in-cancer-related-anorexia" rel="noreferrer noopener">cancer-related anorexia</a>.
Artelo is evaluating ART27.13 in the Phase 1/2 trial in cancer-related anorexia, which is currently enrolling Phase 2 of the study.
In Phase 1, ART27.13 was orally administered at 150 to 650 microgram doses.
The investigational drug was well tolerated, with only mild to moderate adverse events observed in a minority of participants.
At one month of treatment, two-thirds of participants showed evidence that the drug was impacting their weight loss, with either stabilization or reversal of weight loss associated with their cancer.
Phase&nbsp;2 is accruing participants at a 650 microgram dosage with planned escalation at 4-week intervals up to a dose of 1300 micrograms per day. Initial data from the Phase 2 CAReS trial is anticipated by the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44074980/artelo-biosciences-provides-business-update-and-reports-fiscal-2024-year-end-financial-results" rel="noreferrer noopener">end of Q2 2025</a>.
Price Action: ARTL stock closed at $1.04 on Friday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/25/04/45021274/merck-stays-confident-on-ma-despite-market-uncertainty-analyst" target="_blank" rel="noreferrer noopener">Merck Stays Confident On M&amp;A Despite Market Uncertainty: Analyst</a></li>
</ul>

Health Care

EXCLUSIVE: Artelo Biosciences' New Peer-Reviewed Research Shows Effectiveness Of Psoriasis Candidate In Animal Models

Silicom (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SILC#NASDAQ">SILC</a>) sees Q2 sales of $14.500 million-$15.500 million vs $14.94 million analyst estimate.

Guidance

SILC

Silicom Sees Q2 Sales $14.500M-$15.500M vs $14.94M Est

– Identified and prospectively replicated an EEG-based biomarker for placebo response in MDD –
– New data strengthen the mechanistic link between ALTO-300 and the EEG biomarker being used for patient selection; biomarker signature induced by activating 5-HT2C or depleting dopamine directly –
– Preclinical ALTO-101 rescue study underscores the therapeutic potential of this novel PDE4 inhibitor, and validates EEG theta response as a robust translational biomarker for CIAS –
Alto Neuroscience, Inc. ("Alto") (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ANRO#NYSE">ANRO</a>) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced multiple presentations at the Society of Biological Psychiatry (SOBP) Annual Meeting, in Toronto, Canada, held April 24-26, 2025.
"The biological and clinical insights we presented at SOBP support our precision psychiatry pipeline and mark important advancements for the field," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. "To address the longstanding challenge of high placebo response in neuropsychiatric clinical development, we have successfully identified and prospectively replicated an EEG biomarker that captures placebo response patterns in patients with major depressive disorder. We believe this biomarker has the potential to reduce noise and improve the detection of true therapeutic effect."
Dr. Etkin continued, "We enhanced our understanding of the mechanistic link between ALTO-300 and the machine-learning derived, EEG biomarker used to identify patients who are more likely to respond to treatment. We showed that increasing 5-HT2C activity or directly depleting dopamine—both the opposite mechanistic effect of ALTO-300—resulted in greater EEG irregularity, consistent with a biomarker positive profile. Additionally, in a preclinical rescue study we demonstrated that ALTO-101 increased theta response, demonstrating its robustness as a translational biomarker for cognitive impairment associated with schizophrenia and potential pro-cognitive drug effect. We look forward to leveraging these findings to drive meaningful innovation in psychiatry and enhance clinical outcomes for patients."

ANRO

Alto Neuroscience Announces Multiple Presentations Made At The Society of Biological Psychiatry Annual Meeting, In Toronto, Canada, Held April 24-26, 2025

PANW

Palo Alto Networks Announces Intent To Acquire Protect AI, Terms Not Disclosed

Offerings

MSTR

MicroStrategy Sold 4.02M Shares For $1.40B From April 21-27; Acquired 15,355 BTC For $1.42B During April 21-27

Bessent Says Negotiations With Asian Trading Partners Going Very Well

Calidi Biotherapeutics Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CLDI#NYSE">CLDI</a>) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced the selection of IL15 superagonist (Il15-IL15Ra) as the first payload to be delivered into tumors using its systemic antitumor virotherapy platform, RTNova. New preclinical data were presented at the American Association for Cancer Research (AACR) Annual Meeting on April 27, 2025, in Chicago, IL.

CLDI

Calidi Biotherapeutics Says IL15 superagonist Chosen As First Payload To Be Delivered Into Tumors Using Systemic Antitumor Virotherapy Platform, RTNova

THAR

Tharimmune Says FDA Confirmed No Additional Trials Appear To Be Necessary Prior To A 505(b)(2) New Drug Application Submission

Mainz Biomed N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MYNZ#NASDAQ">MYNZ</a>) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first quarter of 2025, and provided an outlook on its path to FDA premarket approval.&nbsp;&nbsp;
During the first quarter of 2025:
<ul>
<li>Path to FDA premarket approval: The Company enrolled the first patient into its feasibility study eAArly DETECT 2, which evaluates the Mainz Biomed's next-generation colorectal cancer (CRC) test, integrating a portfolio of proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test. The study is expected to include a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to prevention. The inclusion of the first patient keeps the Company on schedule to report top-line results by the end of 2025.</li>
<li>Mainz Biomed signed a license and option agreement with Liquid Biosciences to access novel mRNA biomarkers for early detection of pancreatic cancer via blood test. Independent validation of the algorithm-biomarker combination showed 95% sensitivity and 98% specificity.</li>
<li>The Company entered into a strategic partnership with labor team w ag, a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert&#xAE;, a DNA-based CRC screening test to the Swiss market for the very first time, marking Mainz Biomed's initial footprint in Switzerland. In Switzerland, thousands of new cases are diagnosed annually, underscoring the urgent need for early detection and prevention. The introduction of a DNA-based CRC screening test offers a transformative opportunity to increase participation rates and ensure early detection, aligning with national efforts to reduce CRC-related mortality and improve population health outcomes.</li>
<li>Mainz Biomed announced that GANZIMMUN Diagnostics has officially launched the enhanced ColoAlert CRC screening test. Since January 2025, patients across Germany can access this new version of the Company's screening test. The announcement was made in conjunction with Colorectal Cancer Awareness Month in March.</li>
<li>On January 23, 2025, the Company received formal notice from Nasdaq confirming that it had regained compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rule 5550(b)(1). Mainz Biomed had previously received confirmation that it had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). Mainz Biomed is now in full compliance with all Nasdaq continued listing requirements. &nbsp;</li>
</ul>
"I'm extremely pleased with the progress achieved during the first quarter of 2025 as we execute our strategy driven by our excellent clinical results in three studies published during 2024," commented Guido Baechler, Chief Executive Officer of Mainz Biomed. "Our eAArly DETECT 2 study, scheduled to report results by the end of 2025, is essential to move rapidly to the beginning of enrollment for our pivotal U.S. FDA study ReconAAsense shortly thereafter."

MYNZ

Mainz Biomed Provides First Quarter 2025 Corporate Update Including Path To FDA Approval For Its eAArly DETECT 2

Jones Trading analyst Debanjana Chatterjee initiates coverage on Tvardi Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TVRD#NASDAQ">TVRD</a>) with a Buy rating and announces Price Target of $39.

Price Target

Initiation

Analyst Ratings

TVRD

Jones Trading Initiates Coverage On Tvardi Therapeutics with Buy Rating, Announces Price Target of $39

Press Releases

Apollo Global Management and Workday Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600

AbbVie and REGENXBIO Announce Updates on the ABBV-RGX-314 Clinical Program

REGENXBIO and Nippon Shinyaku Announce Exclusive Partnership to Develop and Commercialize RGX-121 and RGX-111 for MPS Diseases

REGENXBIO Announces Presentations of RGX-121 at the 21st Annual WORLDSymposium 2025

REGENXBIO to Participate in Upcoming Investor Conferences

REGENXBIO to Host Conference Call on March 13 to Discuss Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Highlights

REGENXBIO Announces Closing of Strategic Partnership with Nippon Shinyaku for MPS Diseases

REGENXBIO Announces Presentations at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference

REGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates

REGENXBIO REPORTS POSITIVE BIOMARKER DATA FROM AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY

Comments

Regenxbio

Noticias

SOCIO/CONTRIBUIDOR

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