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The Latest Breaking News from FDA

4 High-Yield Tobacco Stocks to Add to Your Dividend Portfolio

Stringent FDA regulations imposed on nicotine consumption have hindered the tobacco industry’s growth over the past few years. However, manufacturers have produced various alternatives, like e-cigarettes, vapes, and similar smoking substitutes, which could help the industry grow. So, we think high dividend-yielding tobacco stocks Philip Morris (PM), British American (BTI),…

StockNews.com

ACHV: 2021 Results: ORCA-3 Underway, ORCA-V1 Soon to Start

By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT

Benzinga

FDA Lifts Clinical Hold on Immunome's COVID-19 Candidate IND

The FDA has lifted the clinical hold on Immunome Inc's (NASDAQ:IMNM) Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01) to treat COVID-19. Immunome previously announced that the FDA had placed its IND application on clinical hold due to a request for further information related to the preparation and administration of IMM-BCP-01 at clinical sites. …

Benzinga

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Surgical Robot Maker Memic Terminates SPAC Merger

Memic Innovative Surgery Ltd has pulled out of a reverse merger deal with MedTech Acquisition Corporation (NASDAQ:MTAC), a special purpose acquisition company (SPAC) focused on medical technology. Last August, Memic announced its merger with MedTech Acquisition Corporation to take the surgical robot public. As of this week, however, the deal is off. Memic is a developer of…

Benzinga

Orphazyme Calls For Court-Mediated Restructuring, Lays Off 50% Workforce

Orphazyme A/S's (NASDAQ:ORPH) board of directors has called for a court-mediated restructuring, prompting the second round of layoffs in less than a year. The in-court restructuring will determine whether any operations can continue if the Company can raise any capital or if it is prudent to sell all or some parts of…

Benzinga

LPCN: 2021 Results

By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT

Benzinga

Up More Than 175% in 2022, is Kaival Brands Innovations Group Still a Buy?

Shares of Kaival Brands Innovations Group (KAVL) have gained more than 175% in price so far this year, driven primarily by the company’s success in winning a judicial stay of a marketing denial order issued by the U.S. Food and Drug Administration last year. However, considering the company’s lean profit…

StockNews.com

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HeartBeam, Triple Ring To Co-Develop Telehealth Solution Device For Heart Attack Monitoring

HeartBeam Inc (NASDAQ:BEAT) has signed a professional services agreement with Triple Ring Technologies Inc to assist in the design and development of its Telehealth complete solution 3D vector Electrocardiogram (ECG) collection device for remote heart attack or myocardial infarction (MI) monitoring. The joint partnership is a five-phase expedited device development project scheduled to be completed…

Benzinga

Tiziana Life Shares Rise On Encouraging Data From Intranasal Foralumab In Multiple Sclerosis Patient

Tiziana Life Sciences Ltd (NASDAQ:TLSA) has reported clinical data in a patient with Secondary Progressive Multiple Sclerosis (SPMS) following six months of treatment with intranasally administered foralumab. In addition to being well-tolerated, both biological and clinical improvements were seen in the patient using Tiziana's immunotherapy technology, which overcame the challenge of delivering foralumab…

Benzinga

The FDA-approved, Kiwi-owned, PCR test technology the Health Ministry wouldn’t even look at

Newsroom is an independent, New Zealand-based news and current affairs site.

Newsroom.co.nz

Medical Device Maker Merit Medical Mulls Sale: Reuters

Merit Medical Systems Inc (NASDAQ:MMSI) is exploring options that include an outright sale to a private equity firm, Reuters reported citing people familiar with the matter. The U.S. medical device manufacturer has an enterprise value of approximately $3.9 billion. The sources said that Merit Medical is working with an investment bank and…

Benzinga

FDA Backs Immutep's Eftilagimod Registrational Trial In Metastatic Breast Cancer

Immutep Limited (NASDAQ: IMMP) has

Benzinga

Intellia's CRISPR-Engineered Cell Therapy Receives FDA Orphan Drug Tag For Bone Marrow Cancer

Intellia Therapeutics Inc's (NASDAQ: NTLA) CRISPR-powered T cell therapy has

Benzinga

Truist Sees 350% Upside On This Cancer-Focused Biopharma Stock - Read Why

Truist has initiated coverage on Verastem Oncology Inc (NASDAQ:VSTM) with a Buy rating and $6.00 price target, equivalent to approximately 350% upside. Analyst Srikripa Devarakonda notes that trading at about 2-times cash, the stock is "undervalued" given its programs in two cancers. Devarakonda adds that the Verastem base case is supported by a…

Benzinga

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Benzinga

Amryt Pharma's Q4 FY21 Sales, FY22 Guidance Shy Of Street Consensus

Amryt Pharma Plc's (NASDAQ:AMYT) Q4 FY21 sales increased 29% Y/Y to $54.8 million, missing the consensus of $56.81 million. The growth was driven by metreleptin revenues that increased 44% to $31.9 million. Cash of $113 million at December 31, 2021 (2020: $118.8M) The Company reported a wider operating loss of $(50.5) million…

Benzinga

Renalytix Launches National Physician Access To KidneyIntelX Platform

Renalytix plc (NASDAQ:RNLX) has launched its new provider access portal, myIntelX, to provide nationwide online access for physicians to order KidneyIntelX bioprognostic testing. KidneyIntelX enables early-stage diabetic kidney disease (DKD) progression risk assessment by combining diverse data inputs, including blood-based biomarkers and personalized health data. It employs a proprietary algorithm to generate a…

Benzinga

Wednesdays With Wedbush: 3 Smid-Cap Biotech Stock Picks

Since the coronavirus pandemic began in early 2020, the FDA's plate has been full with reviews of COVID-19 vaccines and treatments. That has put the approval of many other drugs and therapies on the back burner.

Reason

Enforcing Abortion Bans Is Much Harder Than Passing Them

The experience in Texas shows that workarounds pose daunting obstacles to such laws.

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Benzinga

Former Moderna Vice President Joins Psychedelics Company In Phase 3 Trials For Ecstasy

Michael Mullette, a former Moderna (NASDAQ:MNRA) vice president is taking a senior leadership position in the MAPS Public Benefit Corporation, a biotech company in the psychedelics sector. The MAPS PCB is a for-profit company wholly owned by the Multidisciplinary Association for Psychedelic Studies, a nonprofit founded in 1986 to advance patient…

Benzinga

This Microcap Pharma Stock Almost Doubled Today - Read Why

UnitedHealthcare has added Kala Pharmaceuticals Inc's (NASDAQ:KALA) Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% as a covered brand on its commercial formularies effective March 2022. Eysuvis now has coverage for approximately 118 million lives or 70% of all commercial lives. Kala also announced that Cigna Medicare had added Eysuvis as a preferred brand effective…

Reason

Congress Seems Poised To Let the FDA Ban E-Cigarettes Containing Synthetic Nicotine

A spending bill provision would redefine "tobacco products" to include products that have nothing to do with tobacco.

Benzinga

Read Why Valneva's Stock Gained 7% Today

Valneva SE (NASDAQ:VALN) completed the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. Valneva posted topline results from the phase 3 trial in August last year. The primary endpoint result is mainly unchanged from that data drop. The removal of two subjects from the analysis increased the proportion of participants with protective…

Benzinga

Why Owlet Shares Are Trading Lower Today

Owlet Inc (NYSE:OWLT) reported FY21 sales of 75.8 million, just 0.6% higher than the $75.4 million reported a year ago. The Company noted that through the first three quarters of 2021, revenues were $78.4 million, up 44% Y/Y, but early in Q4 FY21, Owlet received an FDA Warning Letter, resulting in halting sales…

Benzinga

The Daily Biotech Pulse: Moderna Outlines Steps For mRNA Tech Advancement, Voyager-Novartis Strike Licensing Deal, Valneva Reports Positive Chikungunya Shot Readout

Here's a roundup of top developments in the biotech space over the last 24 hours:

Reason

Can the FDA's New Commissioner Save the Agency From Itself?

Robert Califf must demand transparency and accountability from the bureaucrats.

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