Últimas noticias sobre BioCardia (NASDAQ:BCDA) Bolsa

BioCardia

BioCardia Inc is a clinical-stage company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. Its two cell therapy platforms derived from the bone marrow. CardiAMP autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Its immunomodulatory allogeneic mesenchymal stem cell (MSC) therapy platform is being an "off the shelf" cell therapy for two clinical indications: the treatment of ischemic HFrEF (CardiALLO), which is actively enrolling, and acute respiratory distress syndrome (ARDS).

BioCardia Inc

News

GRMN

Garmin Says G3000 PRIME Integrated Flight Deck Selected By Pilatus For Its New PC-12 PRO Aircraft

MDIA

Spectral AI Reports Results Of Performance Of Its DeepView System In Connection With Completion Of Its Burn Validation Study

HC Wainwright &amp; Co. analyst Andrew Fein reiterates Zentalis Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZNTL#NASDAQ">ZNTL</a>) with a Buy and maintains $10 price target.

Price Target

Reiteration

Analyst Ratings

ZNTL

HC Wainwright & Co. Reiterates Buy on Zentalis Pharma, Maintains $10 Price Target

PBGENE-HBV is the first-ever investigational in vivo gene editing therapy cleared to enter clinical trials for the treatment of chronic hepatitis B in the United States (U.S.) –
- IND clearance represents a significant regulatory milestone for PBGENE-HBV –
- Company to expand its Phase 1 ELIMINATE-B study to the U.S., joining world-class clinical sites in Moldova, Hong Kong, and New Zealand where strong clinical execution is currently underway –

DTIL

Precision BioSciences Achieves Regulatory Milestone As FDA Clears IND For First-in-Class PBGENE-HBV Gene Editing Therapy For Chronic Hepatitis B

Founder and Chairman of the Board, Michael Heffernan, and Board Member, Gwen A. Melincoff, will retire from Collegium's Board at the Annual General Meeting (AGM) on May 15, 2025, and Gino Santini, the Board's Lead Independent Director, will become Chairman.&nbsp;

Management

COLL

Collegium Names Gino Santini As Chairman; Michael Heffernan And Gwen Melincoff To Retire From Board

HROW

Harrow Unveils VEVYE Access For All Initiative

Orphan Drug Designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenström Macroglobulinemia
First-in-class Bruton's tyrosine kinase (BTK) degrader NX-5948 assigned nonproprietary name "bexobrutideg" in newly named degrader class of drugs

Biotech

Health Care

General

NRIX

The FDA Has Granted Orphan Drug Designation To Nurix Therapeutics' Bexobrutideg (NX-5948) For The Treatment Of Waldenström Macroglobulinemia

D. Boral Capital analyst Jason Kolbert initiates coverage on Plus Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSTV#NASDAQ">PSTV</a>) with a Buy rating and announces Price Target of $9.

Initiation

PSTV

D. Boral Capital Initiates Coverage On Plus Therapeutics with Buy Rating, Announces Price Target of $9

Patients in this cohort are receiving [212Pb]VMT01 at 1.5 mCi in combination with nivolumab, a PD-1 blocking antibody developed and marketed by Bristol Myers Squibb as Opdivo&#xAE;. Patients in earlier cohorts received [212Pb]VMT01 as monotherapy. Initial results from the earlier cohorts were previously presented at the <a href="https://www.globenewswire.com/Tracker?data=lbnqdoEdOBXDI0tazCF7O6Gm7aX960Z1DPz2hC7XVYWhydPL2gB28iRuKsyv7ZVPFqojoIIM72ZkxXaHKLxmJt6PtL3nFc73iqhtgo0Yz-LnEZm3oXkwl2rnwMjMCskTVi4Poh6LA4DWRL6fyrFyOWegGsn_SutWUndN7X518RZuVXN46SyFeCQbKYM-LL2KR7mx-p2m7KH6VzfFKZWpEg==">21st International Congress of the Society for Melanoma Research</a> (SMR) in October 2024.

CATX

Perspective, Therapeutics Has Dosed The First Patient In A New Cohort Of A Phase 1/2a Trial Evaluating The Safety Of [212Pb]VMT01, A Targeted Alpha-particle Therapy, In Patients With Histologically Confirmed Melanoma And Positive Melanocortin 1 Receptor Imaging Scan

TVTX

Travere Submits sNDA To FDA For Seeking Priority Review For Traditional Approval Of FILSPARI For Focal Segmental Glomerulosclerosis Treatment

Guidance

SAIC

Science Applications Intl Revised FY26 Revenue Outlook To $7.60B-$7.75B From $7.55B-$7.75B (Vs. Cons. $7.644B), Adj. EPS To $9.10 - $9.30 From $8.90 - $9.10 (vs. Cons. Of $9.07)

<ul>
<li>Once-daily, steroid-free topical treatment designed to rapidly reduce itch and proactively support long term disease control</li>
<li>Rapid and significant improvements in disease clearance with ZORYVE cream with children and adults reaching validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) Success at week 4, with significant improvements seen as early as week 1</li>
<li>Demonstrated efficacy and tolerability in treating facial involvement in AD, which affected 42% of trial participants</li>
<li>Shown to deliver sustained improvement in disease control for up to 56 weeks of treatment</li>
</ul>

ARQT

The Health Canada Has Approved Arcutis' Approved Zoryve (Roflumilast Cream 0.15%), For The Treatment Of Mild To Moderate Atopic Dermatitis In Adults And Children Ages 6 Years And Older

BECN

QXO In Discussions To Acquire Beacon Roofing Supply For $124.35 Per Share In All-Cash Deal Worth ~$11B

D. Boral Capital analyst Jesse Sobelson maintains FiscalNote Holdings (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NOTE#NYSE">NOTE</a>) with a Buy and maintains $3.75 price target.

NOTE

D. Boral Capital Maintains Buy on FiscalNote Holdings, Maintains $3.75 Price Target

Contracts

PRSO

Peraso Receives $3.6M Purchase Order For Its mmWave Devices From A Provider Of Wireless Networking Systems

<ul>
<li>On track for year end 2025 BLA submission for accelerated approval of 5 mg/kg every six weeks of del-zota in DMD44</li>
<li>Consistent favorable safety and tolerability across del-zota dose cohorts&nbsp;</li>
<li>Plan to present functional data in fourth quarter of 2025</li>
</ul>

Avidity Biosciences Announced Del-Zota Topline Data From The Phase 1/2 Explore44 Trial For Duchenne Muscular Dystrophy Amenable To Exon 44 Skipping, Demonstrating Consistent, Statistically Significant Improvements In Dystrophin, Exon Skipping And Creatine Kinase As Well As Favorable Safety And Tolerability

Following the close of the transaction, the Company expects its outstanding share count to be reduced by approximately 12% and the transaction is expected to close on or around March 18, 2025.
Concurrent with the announced stock transaction, the Company also announced that Jonathan Seiffer will step down from the Board of Directors, effective immediately.
 &nbsp;

Buybacks

ASLE

AerSale To Repurchase Approximately 6.428M Shares Of Stock From Its Long-term Private Equity Sponsor Leonard Green & Partners At Negotiated Price Of $7.00 Per Share

FBMS

RNST

Renasant And The First Receive Full Regulatory Approval, Advancing Merger To Build A Customer-Focused, $26B Southeastern Bank

D. Boral Capital analyst Jesse Sobelson maintains Veritone (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERI#NASDAQ">VERI</a>) with a Buy and maintains $4.5 price target.

VERI

D. Boral Capital Maintains Buy on Veritone, Maintains $4.5 Price Target

Coda Octopus Group (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CODA#NASDAQ">CODA</a>) reported quarterly earnings of $0.08 per share which missed the analyst consensus estimate of $0.09 by 11.11 percent. This is a 33.33 percent increase over earnings of $0.06 per share from the same period last year. The company reported quarterly sales of $5.21 million which beat the analyst consensus estimate of $5.10 million by 2.16 percent. This is a 16.79 percent increase over sales of $4.46 million the same period last year.

Earnings

Earnings Beats

Earnings Misses

CODA

Coda Octopus Group Q1 EPS $0.08 Misses $0.09 Estimate, Sales $5.21M Beat $5.10M Estimate

Markets

Press Releases

BioCardia Regains Full Compliance with Nasdaq Listing Requirements

BioCardia Completes Phase III Randomized Double-Blind Controlled Trial of Autologous Cell Therapy for Ischemic Heart Failure

BioCardia to Host Q3 2024 Corporate Update and Financial Results Conference Call on November 13, 2024

BioCardia Reports Third Quarter 2024 Business Highlights and Financial Results

BioCardia Announces Positive Consultation with Japan PMDA on CardiAMP Cell Therapy for Ischemic Heart Failure

BioCardia Announces Commercial Availability of Morph® DNA™ Steerable Introducer Product Family

BioCardia Announces Late Breaking Clinical Trial Presentation on CardiAMP Heart Failure Trial at the American College of Cardiology 2025 Scientific Sessions

BioCardia Reports Completion of Low Dose Cohort Enrollment for CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells to Treat Ischemic Heart Failure of Reduced Ejection Fraction (HFrEF)

BioCardia Announces Primary Outcome Measures Data Freeze in CardiAMP Heart Failure Trial for Presentation at the American College of Cardiology 2025 Scientific Sessions

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