FDA warns CVS, Walgreens about marketing of unapproved eye products

The U.S. Food and Drug Administration this week warned CVS Health Corp.
CVS,
+2.79%
,
Walgreens Boots Alliance Inc.
WBA,
+2.26%

and several smaller consumer products companies about marketing unapproved eye products. “The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the FDA said in a release Tuesday. In a letter to Walgreens dated Monday, the agency said several eye-drop products offered on the company’s website, including drops for allergies and pink eye, are unapproved new drugs whose delivery through interstate commerce may violate federal law. The FDA’s letter to CVS contained similar warnings about “CVS Health Pink Eye Relief Drops” offered through the CVS website. Both letters also raised concerns about the manufacturing practices of contract manufacturers producing the products. The FDA asked the companies to notify the agency of steps taken to correct the violations within 15 working days. CVS said in a statement that on receipt of the FDA letter it stopped the sale of the CVS Health brand pink-eye relief drops at stores and online, and customers who purchased the product can return it for a full refund. “We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers,” CVS said. Walgreens did not immediately respond to requests for comment. CVS shares gained 0.7% Tuesday, while Walgreens stock was up 0.6%.

Source link

Canopy Growth’s stock falls back from recent gains

Canopy Growth Corp.’s stock
CGC,
-13.91%

fell about 14% on Tuesday after it more than doubled in the two previous days. The stock had briefly moved higher earlier in the day before dropping down into the red, as most cannabis stock cooled off after recent gains. The AdvisorShares Pure US Cannabis ETF
MSOS,
-5.86%

fell 5%, Curaleaf Holdings Inc.
CURLF,
-3.44%

dropped 1.3%, Trulieve Cannabis Corp.
TCNNF,
-4.17%

fell 3.5% and Green Thumb Industries Inc.
GTBIF,
-6.73%

fell 5.9%. The AXS Cannabis ETF
THCX,
-2.81%

dropped 2.8%, and Tilray Brands Inc.
TLRY,
-8.46%

dropped 10%. Optimism around a potential re-scheduling of cannabis rose last week after the U.S. Department of Health and Human Services recommended a Schedule III classification for cannabis under federal law. However, on Tuesday, 14 Republican members of Congress wrote a letter to the Drug Enforcement Administration (DEA) recommending against re-scheduling and keeping marijuana’s Schedule I status, which is the most restrictive category under the U.S. Controlled Substances Act (CSA), as initially reported by Marijuana Moment.

Source link

Gaetz threatens to oust McCarthy from House speaker post

Republican Rep. Matt Gaetz of Florida on Tuesday fired a salvo in an intraparty fight over spending that could lead to a partial government shutdown, saying he would launch a process for removing House Speaker Kevin McCarthy from his post if McCarthy doesn’t meet his demands. In a speech on the House floor, Gaetz called on McCarthy to steer clear of a short-term spending bill that would prevent a shutdown and instead rely on individual spending bills, and he urged the California Republican to hold votes on balanced budgets and term limits. The Florida Republican also demanded impeachment for President Joe Biden and subpoenas for Biden’s family. “Do these things or face a motion to vacate the chair, and let me alert the country — a motion to vacate might not pass at first, but it might before the 15th vote,” Gaetz added, referring to how McCarthy was elected speaker in January in the 15th round of voting.

Source link

3 Biotech Blockbusters to Turn $5,000 Into $50,000

Investing in biotech stock can provide investors with immense rewards but also substantial risks. The key is finding the right balance.

With diligent research, it’s possible to identify promising companies that appear undervalued relative to their blockbuster prospects. Their innovative therapies could be game-changers, and clinical trial successes could lead to surges in share price. However, inherent risks in biotech investing cannot be overlooked. That’s because the outcomes for these stocks rely entirely on unpredictable clinical data and regulatory decisions. This is not data that the public has full access to, meaning investing in biotech is usually a hit-or-miss game.

Still, many drug companies are currently targeting massive addressable markets and are trading at meager valuations. These stocks can provide astronomical returns, turning $5,000 invested today into $50,000 or more. While such gains are far from guaranteed, these companies’ prospects are worth considering for those seeking unlimited upside.

Abeona Therapeutics (ABEO)

Abeona Therapeutics (NASDAQ:ABEO) develops cutting-edge genetic medicines for rare diseases. The company’s lead candidate, EB-101, delivered impressive clinical data in patients with recessive dystrophic epidermolysis bullosa (RDEB). This is devastating skin disorder which is currently without treatments.

EB-101 has shown the ability to heal chronic wounds in this population. With a Biologics License Application submitted, a regulatory decision is expected by mid-2023. If approved, EB-101 would become the first gene therapy for RDEB, a potential game-changer for these patients.

Beyond EB-101, Abeona has additional gene therapy assets, including treatments for genetic eye disorders and neurometabolic diseases. However, with the stock trading around $4 per share, I believe the market underappreciates the company’s promising pipeline. An FDA approval for EB-101 could propel a re-rating of the stock to properly reflect the potential of its platform.

For investors able to stomach clinical-stage risks, Abeona offers a robust upside. I expect significant share price appreciation if the company’s programs continue advancing successfully toward commercialization. A price target of $38 by Cantor Fitzgerald points to whopping potential upside over the next year of 833%.

Vaxart (VXRT)

For investors comfortable with clinical-stage biotech volatility, Vaxart (NASDAQ:VXRT) offers massive upside potential at today’s prices. Vaxart is pioneering oral tablet vaccines, an innovative approach to delivering vaccines with potential benefits over injectables. These include easier administration and storage.

Its lead Norovirus candidate recently demonstrated strong immune responses. Phase 2 results should provide more clarity later this year, as the company approaches the latter stages of its trials. Notably, Vaxart’s COVID-19 oral vaccine also displayed strong results and is currently in Phase 2 trials. However, there isn’t likely going to be a sizeable market for this, especially as recent outbreaks have been mild and people have learned to live with this virus.

Still, Vaxart’s platform shows promise in other large markets like norovirus, flu, and HPV. Positive Phase 2 data recently reported for its norovirus tablet vaccine adds even more credibility. Additionally, with over $67 million in cash, Vaxart is funded well to advance these programs through H2 2024.

Despite this progress, the company trades at a modest $117 million valuation. The market has yet to appreciate Vaxart’s disruptive platform and sizable market opportunities. Positive late-stage data could drive rapid gains in the stock as the company’s prospects are re-valued. Currently, the consensus price targets on VXRT stock implies 563% one-year upside potential.

CRISPR Therapeutics (CRSP)

CRISPR Therapeutics (NASDAQ:CRSP) is pioneering precision gene editing therapies using Nobel Prize-winning CRISPR/Cas9 technology. Its lead candidate, exagamglogene autotemcel (exa-cel), achieved promising results for patients suffering with sickle cell disease and beta-thalassemia by functionally correcting the causative gene mutations. With a regulatory decision possible this year, exa-cel could become the first approved CRISPR therapy, validating this breakthrough platform.

Beyond these initial diseases, CRISPR has numerous preclinical gene editing therapies under development areas such as oncology, diabetes, and other indications. The possibilities for precise genetic medicine enabled by CRISPR are incredible. Indeed, this company appears positioned as a leader in the field.

Despite the enormous prospects of its platform, CRISPR trades at a $4 billion valuation. While clinical risks exist, I view this as an attractive entry point for such an innovative biotech. Investors’ upside from today’s prices could be substantial, as the company’s prospective therapies advance toward commercialization. But of course, CRISPR is still an emerging technology, and it will take a lot of patience before substantial gains can materialize.

On Penny Stocks and Low-Volume Stocks: With only the rarest exceptions, InvestorPlace does not publish commentary about companies that have a market cap of less than $100 million or trade less than 100,000 shares each day. That’s because these “penny stocks” are frequently the playground for scam artists and market manipulators. If we ever do publish commentary on a low-volume stock that may be affected by our commentary, we demand that InvestorPlace.com’s writers disclose this fact and warn readers of the risks.

Read More: Penny Stocks — How to Profit Without Getting Scammed

On the date of publication, Omor Ibne Ehsan did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.

Omor Ibne Ehsan is a writer at InvestorPlace. He is a self-taught investor with a focus on growth and cyclical stocks that have strong fundamentals, value, and long-term potential. He also has an interest in high-risk, high-reward investments such as cryptocurrencies and penny stocks. You can follow him on LinkedIn.

Source link

3 Growth Stocks to Sell in September Before They Crash & Burn

Growth stocks to sell - 3 Growth Stocks to Sell in September Before They Crash & Burn

Source: shutterstock.com/mentalmind

When looking at growth stocks it is uncommon to be looking for growth stocks to sell. Companies that experience impressive revenue growth tend to excite investors based on the potential for significant returns that continue. This generally makes growth stocks a vital addition to a solid portfolio. They allow for the possibility of a substantial increase in their underlying stock price due to more and more investors looking to be a part of a company’s growth.

On the other hand, growth stocks also have their downfall, particularly the ones mentioned below. In that, a company may be experiencing impressive revenue growth from their products or services selling very well, but still need to be more profitable overall. These growth stocks to sell have seen consistent revenue growth but continue to see expanding net losses. That digs them deeper into unprofitability and gives investors hesitation towards investing in these companies for the long term.

Lucid Group (LCID)

Lucid Group (NASDAQ:LCID) is an automotive production company. They build luxury electric vehicles, batteries and powertrains. The company produces three Lucid Air models, the Grand Touring, Pure and Touring. And their Lucid Gravity model, a luxury electric SUV, is expected to roll out in 2024.

Since early September of 2022, Lucid Group’s share price has fallen by 59%. Partially due to interest rate increases and a challenging market at this time for luxury vehicles. On August 7, they released their second quarter earnings for 2023. Revenue increased by 55% compared to the second quarter of 2022. They reported a significant net loss increase that more than tripled from $220 million in Q2 2022 to $764 million in Q2 2023. The company has seen impressive revenue growth but with their net losses continuing to compound leaves investors unsure of their future.

They only delivered 1,404 vehicles for Q2 2023.

Affirm Holdings (AFRM)

Affirm Holdings (NASDAQ:AFRM) is a finance company specializing in payment processing. They offer a mobile app that allows customers in North America and internationally to make purchases through their platform, select payment installments that go up to 12 months and offer interest-free and interest-applied payment plans.

Affirm Holdings started trading publicly back in January of 2021. And over the last year, they saw a 5% drop in their overall share price. Back on August 25, the company released its earnings results for the fourth quarter of the fiscal year 2023. It stated an increase in overall revenue for the full year 2023 grew by 18% compared to the full year 2022. Within the same time period the company also announced their net loss expanded from $707 million to $985 million an increase of 39%. Similar to Lucid, AFRM has strong revenue growth, but they are struggling to become profitable.

Plug Power (PLUG)

Plug Power (NASDAQ:PLUG) provide hydrogen fuel cells for logistics application, electric vehicles and the power market. They offer products such as GenDrive, which are hydrogen fuel cell systems made for material handling equipment and GenSure, which uses fuel cells for grid support applications.

Over the past year, the company has seen its share price fall by approximately 68%. On August 9, they released their second quarter results for 2023. Plug Power stated an increase in total revenue of 72%, and their net loss has expanded by 36% to $236 million.

Like other companies on this list, Plug Power has seen significant growth in overall revenue recently but still is not profitable, and their margin keeps getting thinner each quarter.

As of this writing, Noah Bolton did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to  InvestorPlace.com Publishing Guidelines.

Noah has about a year of freelance writing experience. He’s worked with Investopedia dealing with
topics such as the stock market and financial news.

Source link

Berkshire Hathaway on track to close with market cap above $800 billion for the first time ever

With shares on track for another record-high finish on Tuesday, Warren Buffett’s Berkshire Hathaway Inc.
BRK.A,
+0.79%

BRKB,
+0.88%

was on pace to close with a market value of more than $800 billion for the first time on record. Berkshire’s Class A shares were up 0.8% on Tuesday and trading at $559,271 apiece. At its current price, the conglomerate would close with a market cap of $804.6 billion. The company, whose businesses include Geico and BNSF Railway, reported a profit last month for its second quarter. Berkshire’s Class A shares are up 19.2% so far this year. By comparison, the S&P 500 Index is up 16.9% over that period.

Source link

Oracle stock dives toward worst day in 2 decades after disappointing earnings report

Shares of Oracle Corp.
ORCL,
-11.43%

have accelerated to the downside after the opening bell, and is not on course to suffer their worst one-day performance in 21 years. The stock was down as much as 11.5% in premarket trading, after the software and cloud services company reported late Monday fiscal first-quarter revenue that missed expectations and provided a downbeat second-quarter outlook. But the stock fell even further after the open, with the stock last down 13.4% in morning trading, which would be the biggest one-day drop since it fell 14.5% on March 4, 2002. The stock, which closed at a record $126.71, has still rallied 34.3% year to date, while the S&P 500
SPX,
-0.35%

has gained 16.6%.

Source link

U.S. stocks open lower as tech shares retreat after Oracle earnings; investors await Apple event, inflation data

U.S. stock indexes opened lower on Tuesday after starting the week on a strong footing, with disappointing guidance from Oracle weighing on technology stocks. The Nasdaq Composite
COMP,
-0.69%

was off 0.4%, while the S&P 500
SPX,
-0.43%

was dropping 0.3% and the Dow Jones Industrial Average
DJIA,
-0.15%

was falling 0.2%. Oracle Corp.
ORCL,
-12.45%

shares slumped 11.5% at the open after the cloud database company posted earnings and guidance that fell short of Wall Street expectations. Investors were awaiting Apple’s marketing event later in the session with the company set to unveil its highly anticipated iPhone 15 series at 1 p.m. Eastern. On Wednesday, investors will receive August Consumer Price Index data, which is expected to show the headline inflation accelerated to 0.6% last month from July’s 0.2% gain, while the core measure that strips out volatile food and fuel costs is forecast to rise a mild 0.2% from a month earlier, according to a survey of economists by The Wall Street Journal.

Source link

Canopy Growth’s stock stays hot after big gains, but some cannabis stocks cool

Canopy Growth Corp.’s stock
CGC,
-5.92%

moved up by 10% Tuesday after it more than doubled in the two previous days. The stock had fallen as much as 18% in morning trades, before moving into positive territory. The AdvisorShares Pure US Cannabis ETF
MSOS,
-4.38%

fell 2%, Curaleaf Holdings Inc.
CURLF,
-5.15%

rose 0.6%, Trulieve Cannabis Corp.
TCNNF,
-6.18%

fell 4% and Green Thumb Industries Inc.
GTBIF,
-7.37%

fell 4%. The AXS Cannabis ETF
THCX,
+0.01%

rose 2.6%, and Tilray Brands Inc.
TLRY,
-8.61%

dropped 3.6%.

Source link

WestRock stock rallies on $11B merger deal with Smurfit Kappa

WestRock Co.’s stock
WRK,
+6.03%

was up 8.2% as a leading gainer in premarket trading Tuesday as the packaging company confirmed plans to merge with Smurfit Kappa Group
SK3,
-9.21%

to form Smurfit WestRock. WestRock shareholders will receive $43.51 a share for each share through a combination of $5 per share in cash and one new share of Smurfit WestRock. The deal values WestRock at about $11 billion. Smurfit Kappa shareholders will own 50.4% of the combined company, while WestRock stockholders are expected to own about 49.6% of Smurfit WestRock. The companies had confirmed merger talks last week.

Source link