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Good Stocks To Buy Right Now? 4 Vaccine Stocks To Check Out

Could these vaccine stocks be prime additions to your portfolio today?
The post Good Stocks To Buy Right Now? 4 Vaccine Stocks To Check Out appeared first on Stock Market News, Quotes, Charts and Financial Information | StockMarket.com.

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Top Vaccine Stocks To Pay Close Attention To Now

Vaccine stocks have been making waves in the stock market over the past two years. As the world adapts to the new normal, vaccine stocks have seen some correction this year. However, the new Omicron variant has reminded us again that the threat is not over. The number of cases around the world is rising again and this has brought the limelight back to the pharmaceutical companies that are responsible for developing coronavirus vaccines. Fortunately, a new study from Denmark has found that boosters of mRNA origin significantly increase protection against the Omicron variant. Moderna and BioNTech (NASDAQ: BNTX) are among the companies developing mRNA vaccines. 

Besides that, there is also new phase 3 data from Gilead Sciences (NASDAQ: GILD) that claims Veklury (remdesivir) is effective at reducing the risk of COVID-19 hospitalization. The data published in the New England Journal of Medicine found that there was an 87% risk reduction of COVID-19 related hospitalization or all-cause death by day 28 compared to placebo. In light of this, Gilead said that it has submitted the data to the FDA for authorization of early-stage treatment. Considering these advancements, vaccine stocks appear to be interesting prospects right now. So, here is a list of some of the top vaccine stocks in the stock market today. 

Best Vaccine Stocks To Buy [Or Sell] Right Now

Pfizer

First, we have the research-based global biopharmaceutical company, Pfizer. In detail, the company engages in the discovery, development, sales, and distribution of pharmaceutical products. With the increasing concern of the Omicron variant, PFE stock appears to be gaining attention lately. In fact, the stock has risen over 15% just within the past month. 

biotech stocks to buy (PFE stock)

Yesterday, the company announced that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in patients who are 12 years of age and older. The oral drug can be used for patients who tested positive, and patients who are at high risk for progression to severe COVID-19. Yet again, this development is a testament to the company’s ability to rise to the occasion whenever the world needs it most. 

This new therapy significantly reduces hospitalizations and death. Furthermore, it can be taken at home and this would change the way we could treat the viral infection in the future. Thus, it would hopefully help reduce the burden on health care centers and hospital systems. Well, the company claims that it is now ready to begin delivery in the U.S. immediately into the hands of appropriate patients as quickly as possible. Given the current circumstances, would you be buying PFE stock now?

[Read More] 4 Artificial Intelligence Stocks To Watch Right Now

Moderna

Following that, we have one of the pioneers in the coronavirus vaccine scene, Moderna. The company focuses on creating transformative medicines based on messenger ribonucleic acid (mRNA). In fact, it has created modalities including prophylactic vaccines, systemic secreted and cell surface therapeutics, and cancer vaccines, to list a few.

biotech stocks (MRNA stock)

On Monday, the biotech company announced a preliminary neutralizing antibody data against the Omicron variant. The company’s booster candidates at 50 µg increase neutralizing antibody levels against the variant by approximately 37-fold. Meanwhile, if a 100 µg dose is used, it will increase antibody levels by approximately 83-fold compared to pre-boost levels. The data would surely give a sense of reassurance to the general public as the variant has become more prevalent in many regions around the world. 

On top of that, Moderna also announced an agreement with the Australian Government last week. Under the agreement, both parties will collaborate to build a state-of-the-art mRNA vaccine manufacturing facility in Victoria, Australia. This would build the foundation to support Australia with direct access to rapid pandemic response capabilities while providing access to Moderna’s vaccines in development for respiratory viruses. Overall, there have been plenty of exciting developments coming out from the company. With that in mind, would you consider MRNA stock a top vaccine stock to buy?

[Read More] Best Lithium Battery Stocks To Buy Now? 4 To Know

AstraZeneca

Another top vaccine company that should not be overlooked is AstraZeneca. The company primarily focuses on three main therapy areas, Oncology, Cardiovascular & Metabolic Disease, and Respiratory. It is also selectively active in the areas of autoimmunity, neuroscience, and infection. Similar to other vaccine companies, AstraZeneca plays a vital role in providing coronavirus vaccines around the globe. 

top biotech stocks to watch (azn stock)

Earlier this month, AstraZeneca and Samsung Biologics announced that they will continue their strategic biopharmaceutical manufacturing collaboration. Samsung will manufacture AstraZeneca’s COVID-19 long-acting antibody combination, AZD7442, and will start to manufacture a cancer immunotherapy product next year. So, the AZD7442 can potentially complement national vaccination programs by supporting those who are at increased risk of inadequate response to a COVID-19 vaccine. This includes patients who are immunocompromised, oncology patients, and many more. 

Not to mention, there has also been new preclinical data pertaining to the company’s EVUSHELD, a long-acting antibody combination for the prevention of COVID-19. It appears that EVUSHELD retained its neutralizing activity against the new Omicron variant. Considering all these, would you be keeping an eye on AZN stock?

[Read More] 4 Semiconductor Stocks To Watch Right Now

Novavax

Novavax is a clinical-stage vaccine company. For those unaware, it specializes in recombinant nanoparticle vaccines and adjuvants. By leveraging its recombinant nanoparticle vaccine technology, it produces vaccine candidates to respond to both known and newly emerging diseases. NVAX stock has climbed more than 60% thus far this year.

best biotech stocks (NVAX stock)

It appears that early data suggest that the company’s coronavirus vaccine is effective in generating an immune response against the Omicron variant. Novavax’s two-dose vaccine was authorized for use this week by European Union regulators and the World Health Organization (WHO). The world would surely welcome this new development as the U.S. drugmaker can now contribute to combating the new variant. 

Furthermore, Novavax also claims that an additional booster dose would increase people’s immune response to Omicron. An ongoing Phase 2 study for the company’s coronavirus vaccine shows that a third dose at six months from the second dose would increase anti-spike antibody levels against Omicron by 73.5 fold. Given the positive progress, would you add NVAX stock to your portfolio?


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The post Good Stocks To Buy Right Now? 4 Vaccine Stocks To Check Out appeared first on Stock Market News, Quotes, Charts and Financial Information | StockMarket.com.

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CytoDyn Inc (OTCMKTS: CYDY) On the Comeback Trail (HIV Leronlimab Update)

CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold…

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CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold on the Company’s HIV program and a full clinical hold on its COVID-19 program in the United States. CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share and MIcrocapdaily covered the stock regularly back in those exciting times. Since than CYDY has been downward bound, first suffering from the Citron short attack and more recently the March 30 drop after the FDA hold. Further, CytoDyn elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission. CYDY saw further declines after the Company’s CEO and registered public accounting firm, Warren Averett LLC, both resigned. 

On May 23 CYDY reached a non-cash settlement with its former Chief Medical Officer, Dr. Richard Pestell. The Company will release to Dr. Pestell 8.3 million shares of CYDY held in escrow, transfer to Dr. Pestell the assets acquired from ProstaGene LLC and subsequently written-off by the Company and issue a warrant at an exercise price of $0.37 per share to Dr. Pestell for seven million shares of the Company’s common stock. Dr. Pestell and the Company are also exploring ways in which Dr. Pestell can reengage with the Company to help realize Leronlimab’s full potential in oncology. This is an important step forward for CytoDyn as any potential suitor would want the current management to clear the deck of lawsuits before initiating a buyout or partnership. Also, an all-stock settlement shows a lot of faith in the Company from Dr. Pestell who make come back. At this point Cytodyn must find a sponsor or partner to get Leronmilab back on track for HIV. 

The underlying science of Leronmilab has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, and HIV.  Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab. 

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CytoDyn Inc (OTCMKTS: CYDY) is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions. 

In January Cytodyn reported positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.  

The pre-clinical and clinical development of PRO 140 was led by Progenics Pharmaceuticals, Inc. through 2011. The Company acquired the asset from Progenics in October 2012. In February 2018, CYDY announced it had met the primary endpoint in its Phase 3 trial for leronlimab as a combination therapy with HAART for highly treatment-experienced HIV patients and first submitted the non-clinical portion of the Company’s Biologics License Application (“BLA”) to the FDA in March 2019.  

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CYDY

Cytodyns current business strategy is to resubmit its BLA to the FDA as soon as possible, to finalize with the FDA our submitted protocol for a pivotal Phase 3 clinical trial with leronlimab as a monotherapy for HIV patients, to seek emergency use authorization and approval for leronlimab as a potential therapeutic benefit for COVID-19 patients with mild-to-moderate, severe-to-critical, and long-haulers indications in the U.S., Brazil, and other countries, to advance the Company’s clinical trials with leronlimab for various forms of cancer, including, among others, the Phase 2 clinical trial for metastatic triple-negative breast cancer and Phase 2 basket trial for 22 solid tumor cancers, to complete the Phase 2 trial for liver fibrosis associated with nonalcoholic steatohepatitis (“NASH”), and to explore other cancer and immunologic indications for leronlimab.  

On May 23 CYDY announced it has reached a non-cash settlement with its former Chief Medical Officer, Dr. Richard Pestell, concerning an ongoing legal dispute related to his former employment with the Company. 

Under the terms of the agreement, the parties will release each other of all claims, and the Company will release to Dr. Pestell 8.3 million shares of the Company’s common stock held in escrow, transfer to Dr. Pestell the assets acquired from ProstaGene LLC and subsequently written-off by the Company and issue a warrant at an exercise price of $0.37 per share to Dr. Pestell for seven million shares of the Company’s common stock. Dr. Pestell and the Company are also exploring ways in which Dr. Pestell can reengage with the Company to help realize leronlimab’s full potential in oncology. CytoDyn regrets Dr. Pestell’s departure from the Company and the subsequent public statements made by its former CEO about Dr. Pestell. 

Dr. Pestell has published more than 600 works, is the most frequently cited scientist in the field of cell-cycle control and was appointed an Officer of the Order of Australia in the 2019 Queen’s Birthday Honours for distinguished service to medicine and medical education. He has served on editorial boards of six journals, was the Director of two NCI-designated Cancer Centers and has founded several biotechnology companies. He serves as an advisor and reviewer for a number of domestic and international research centers, including NCI cancer centers. 

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Currently trading at a $226 million market valuation CYDY is an SEC filer and is fully reporting OTCQB. The Company has close to $100 million in assets and about that in debt. At current price levels CYDY is worth a close look; CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share. While there are plenty of ricks not to mention the CEO and accounting firm resigning CYDY is moving northbound now and looks to be coming back. The underlying science has not changed; Leronlimab has demonstrated significant potential to attack a number of diseases including cancer and HIV.  Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.

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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.

The post CytoDyn Inc (OTCMKTS: CYDY) On the Comeback Trail (HIV Leronlimab Update) first appeared on Micro Cap Daily.

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Pfizer Moves To Dismiss Lawsuit From COVID-19 Vaccine Trial, Citing ‘Prototype’ Agreement

Pfizer Moves To Dismiss Lawsuit From COVID-19 Vaccine Trial, Citing ‘Prototype’ Agreement

Authored by Zachary Stieber via The Epoch Times…

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Pfizer Moves To Dismiss Lawsuit From COVID-19 Vaccine Trial, Citing 'Prototype' Agreement

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

Pfizer has asked a U.S. court to throw out a lawsuit from a whistleblower who revealed problems at sites that tested Pfizer’s COVID-19 vaccine.

Albert Bourla, chief executive officer of Pfizer pharmaceutical company, at the New York Stock Exchange in New York on Jan. 17, 2019. (Drew Angerer/Getty Images)

Brook Jackson, the whistleblower, alleged in a suit that was unsealed in February that Pfizer and associated parties violated clinical trial regulations and federal laws, including the False Claims Act.

In its motion to dismiss, Pfizer says the regulations don’t apply to its vaccine contract with the U.S. Department of Defense because the agreement was executed under the department’s Other Transaction Authority (OTA), which gives contract holders the ability to skirt many rules and laws that typically apply to contracts.

That means that Jackson’s claim that Pfizer must still comply with the Federal Acquisition Regulations “is simply wrong,” Pfizer said.

Warner Mendenhall, a lawyer who is working on Jackson’s case, said in a recent interview that Pfizer has “clearly not followed federal procurement laws.”

“And now they’re saying, ‘of course we didn’t follow federal procurement laws, we didn’t have to—this was just for a prototype,'” he added.

Mendenhall, who declined an interview request, said lawyers for Jackson are working on figuring out legal ways to counter Pfizer’s argument.

“We may lose on this issue because their contract imposes … none of the normal checks and balances on quality control and consumer protection that we fought for decades in this country,” he said.

The contract in question was outlined in a base agreement and a statement of work for the agreement, which was signed in the summer of 2020.

The government agreed to pay up to $1.9 billion for 100 million doses of the COVID-19 vaccine pending U.S. regulatory clearance. That included the manufacturing of the vaccine on top of researching and developing it.

The contract was granted under the “prototype” provision, which falls under the OTA. The rules for prototypes state that just one of four conditions must be satisfied. The condition that was satisfied in the Pfizer contract was the involvement of a “nontraditional defense contractor.”

Federal law defines nontraditional defense contractors as “an entity that is not currently performing and has not performed” a contract or subcontract for the Department of Defense for at least one year preceding the solicitation of the OTA agreement. Pfizer has dozens of contracts with the military.

That means the government certified “an absurd fiction” to use an OTA to grant the contract, Kathryn Ardizzone, counsel with Knowledge Ecology International, told The Epoch Times in an email.

The Department of Defense and other government agencies have increased the use of the OTA over time. Thirty-four such agreements were hammed out in fiscal year 2016; by fiscal year 2018, that number was 173, according to the Government Accountability Office (pdf).

Because the agreements shield contract holders from some regulations and laws, “the increasing use of OTAs, which includes in contexts where it’s inappropriate to do so, is undermining the rule of law and jeopardizing the public’s interests,” Ardizzone said. The Pfizer contract is an example of an inappropriate context, because the contract “was not about producing a prototype,” she asserted.

As far as Pfizer’s argument, about the Federal Acquisition Regulations (FAR) not applying to the agreement, it’s not clear that is the case.

The base agreement only mentions the regulations pertaining to the handling of classified information. The statement of work does not mention any.

“I’m not sure what it means when an OTA is silent on a regulation that appears in the FAR,” Ardizzone said. “That would be up for the judge to decide, and it might side with Pfizer since the prevailing view is that FAR regulations do not necessarily apply for an OTA.”

Pfizer, in its motion to dismiss, noted that the government did not join Jackson’s suit—it was filed on the government’s behalf—nor have regulators rescinded clearance of its vaccine, which was authorized by the Food and Drug Administration (FDA) in late 2020, after Jackson revealed issues at sites managed by Ventavia Research Group, a Pfizer subcontractor.

“The agreement makes no mention of the FDA regulations and FAR provisions cited in relator’s complaint,” Pfizer said. “The agreement instead conditions payment, more simply, on Pfizer’s delivery of an FDA authorized or approved product. Pfizer’s vaccine has satisfied that condition since December 2020, as the complaint acknowledges, and the vaccine continues to satisfy that condition today. The Court should reject Relator’s express certification claim for this reason alone.”

Tyler Durden Mon, 05/23/2022 - 21:00

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CDC Now Recommends COVID Testing For All Domestic Air Travel, Including The Vaccinated

CDC Now Recommends COVID Testing For All Domestic Air Travel, Including The Vaccinated

Authored by Jack Phillips via The Epoch Times,

The…

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CDC Now Recommends COVID Testing For All Domestic Air Travel, Including The Vaccinated

Authored by Jack Phillips via The Epoch Times,

The Centers for Disease Control and Prevention (CDC) is recommending that all domestic travelers undergo COVID-19 testing before and after they travel - regardless of vaccination status.

In an update on the agency’s website, anyone traveling within the United States may want to consider “getting tested as close to the time of departure as possible,” and no more than three days before a flight. It previously only recommended testing for people who have not received COVID-19 vaccines or up-to-date booster shots.

The CDC update is also recommending that people take a test before or after a trip if they went to crowded spaces “while not wearing a well-fitting mask or respirator.”

In April, a Florida federal judge struck down the CDC mandate that required people to wear masks inside airports or on airplanes. Justice Department officials have signaled they will challenge the rule, implemented after President Joe Biden took office in early 2021, in court.

A spokesperson for the agency told AFAR Magazine on May 19 that “COVID-19 vaccines are effective at preventing severe disease and death,” but added, “since vaccines are not 100 percent effective at preventing infection, some people who are up to date can still get COVID-19.”

“People who are up to date with their COVID-19 vaccines may feel well and not have symptoms but still can be infected and spread the virus to others,” the spokesperson said.

In January of this year, the CDC also implemented a change to its international travel rule, requiring plane passengers aged 2 and older to show a negative COVID-19 test from no more than a day before boarding a flight or proof of recovery from COVID-19 within the previous 90 days. Foreign nationals have to show proof of COVID-19 vaccination as well.

Neither the CDC nor the White House has given any public indication of when the mandatory testing rule for international travelers will be relaxed. Travel groups have pushed for that rule to be removed for months now.

In a letter to the White House, a group representing more than 250 organizations called for an end to the rule, saying it’s only caused “slow economic recovery of the business and international travel sectors.”

After the federal judge’s order was handed down last month, the CDC issued a new recommendation that people inside airports and airplanes wear masks, despite nearly all major airliners having scrapped enforcement.

And during a news briefing last week, CDC Director Rochelle Walensky, who has been criticized for her agency’s messaging during the COVID-19 pandemic, said that people living in counties that the agency deems to have high COVID-19 transmission should wear masks in indoor settings.

Tyler Durden Mon, 05/23/2022 - 17:40

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