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Friday, December 2, 2022

Vanda anxiety treatment get positive response in first test

 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported results in a Phase II clinical study of VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist, in the treatment of acute performance anxiety in social situations, such as public speaking.

In clinical study VP-VQW-765-2201 (Study 2201), 230 volunteers with prior history of performance anxiety were randomized to receive a single dose of VQW-765 or placebo and were challenged with the standardized Trier Social Stress Test (TSST). The TSST creates an acute stress by requiring participants to make an interview-style presentation in front of a panel who provides no feedback or encouragement. Participants who received VQW-765 showed numerically lower stress levels compared to those who received placebo.

In Study 2201, the stress level was assessed by the Subjective Units of Distress Scale (SUDS), a self-rating scale of level of nervousness or distress ranging from 0 to 100 at multiple timepoints during the duration of the TSST. In particular, female participants (approximately 70% of the total participants) reported a larger magnitude and statistically significant response to VQW-765. A higher stress reaction in females (as well as higher prevalence of performance anxiety) as compared to male participants is consistent with prior reports in this particular test of acute performance anxiety.1 A significant relationship was also seen between exposure to VQW-765 (amount of drug measured in blood) and the clinical response.

This is the first time that an alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist has shown efficacy in a clinical study of performance anxiety. The observed significant relationship between exposure and clinical outcome further supports the hypothesis that VQW-765 could be effective in treating performance anxiety and creates a valuable roadmap to future confirmatory studies. Clinical data gathered indicates an adverse event profile similar to placebo and there were no observed negative cognitive effects reported by any participant in Study 2201. If the results of the current study are confirmed, VQW-765 could be the first drug in the class of nicotinic receptor agonists approved to treat performance anxiety.

https://finance.yahoo.com/news/vanda-pharmaceuticals-reports-results-phase-120000624.html

Incyte, CMS in Dermatology Collaboration in Greater China, Southeast Asia

 Incyte (NASDAQ:INCY) and CMS Aesthetics, a dermatology medical aesthetic company and subsidiary of CMS (HKEX: 00867), today announced that the companies have entered into a Collaboration and License Agreement for the development and commercialization of ruxolitinib cream, a novel cream formulation of Incyte’s selective JAK inhibitor ruxolitinib, for the treatment of autoimmune and inflammatory dermatologic diseases in Greater China and certain countries in Southeast Asia.

Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development, regulatory and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.

CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture ruxolitinib cream, and potentially other future topical formulations of ruxolitinib, in autoimmune and inflammatory dermatologic diseases, including vitiligo and atopic dermatitis, for patients in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.

https://finance.yahoo.com/news/incyte-cms-announce-collaboration-license-133000684.html

'10 Pump and Dump Stocks Hedge Funds Like'

 In this article, we discuss the 10 pump and dump stocks hedge funds like. If you want to read about some more pump and dump stocks, go directly to 5 Pump and Dump Stocks Hedge Funds Like.

The influx of retail investors on the stock market in recent months and the rise of social media speculation around meme stocks has given strong momentum to pump and dump schemes. This is a phenomenon not limited to just the United States but spread across the world. On August 11, the Singapore police warned traders of “a resurgence in pump and dump schemes” after seven people lost more than $1 million through investments in a publicly-traded equity. In the US, legendary investors like Mario Gabelli have raised similar warnings. 

To understand pump and dump schemes, a small introduction to penny stocks is also important. Penny stocks are more popular than ever, enticing investors with low entry costs and the possibility of large financial gains. Stories of shares increasing in value by more than 4,000% in a matter of months add to their allure, and new trading technology makes it easier than ever to enter the market. However, while penny stocks can be profitable, they also carry a high level of risk, which must be balanced with value investments. 

Penny stocks are a form of investable asset. With such investments, a potential investor must exercise caution. Due to their extreme volatility and limited liquidity, the stocks are inherently speculative. These securities are commonly utilized in illegal activities. For instance, they are the targets of pump-and-dump schemes, in which stock promoters manipulate their prices. Since many penny stocks are traded over the counter, the stocks have little liquidity. The ideal moment to sell the shares might not always be available to the investor. 

To illustrate the risk pump and dumps may carry, consider that on August 30, the US Department of Justice issued an arrest warrant for Frederick Sharp, the key accused in a pump and dump scheme and accused of $1 billion worth of illegal sales of stock in penny stock firms. Investors should be cautious of these schemes. For those who want to take advantage of the rise in interest around meme stocks, some shrewd investing techniques can also help turn a tidy profit. For example, following smart money is almost always a good choice. 

However, these hedge funds, which managed close to $5.1 trillion in assets in 2022, are also pouring into pump and dump stocks to make some easy money. Some of these stocks are discussed in detail below. The advent of tech-enabled stock trading has transformed the stock market and made these schemes more mainstream. 

It is important to clarify that stocks rise and fall over time based on their profitability and the expectations that investors may have over their future profitability. To be worth ten times its current price, a stock must demonstrate the significant future potential to the market. However, penny stocks, often the subject of pump and dump schemes, rarely exhibit this level of potential. They may spike from time to time, but they will not experience the kind of sustained increase that can make you wealthy. 

Our Methodology

We scanned Insider Monkey's database of 920 hedge funds' holdings and picked 10 small stocks which have a high 52-week volatility and strong popularity among these funds. It's important to clarify that calling these companies "pump and dump stocks" does not mean these firms don't have any solid fundamentals or long-term growth catalysts. We call them pump and dump purely due to their volatility and high risk.

10. Panbela Therapeutics, Inc. (NASDAQ:PBLA)

Number of Hedge Fund Holders: 1    

 

52-Week Price Range ($): 0.10 - 2.40

Panbela Therapeutics, Inc. (NASDAQ:PBLA) is a clinical-stage biopharmaceutical company that focuses on developing disruptive therapeutics for the treatment of patients with cancer. On September 30, Panbela Therapeutics announced a public offering of 20 million shares of its common stock and warrants to purchase up to 30.2 million shares of its common stock at a purchase price of $0.30 per share. 

At the end of the third quarter of 2022, 1 hedge fund in the database of Insider Monkey held stakes worth $588,000 in Panbela Therapeutics, Inc. (NASDAQ:PBLA), compared to 1 in the preceding quarter worth $7,000.

9. Kintara Therapeutics, Inc. (NASDAQ:KTRA)

Number of Hedge Fund Holders: 3    

 

52-Week Price Range ($): 3.50 - 42.00

Kintara Therapeutics, Inc. (NASDAQ:KTRA) is a clinical-stage drug development company that focuses on developing and commercializing anti-cancer therapies to treat cancer patients. On August 3, Kintara Therapeutics unveiled that it has signed a direct equity purchase agreement for up to $20 million investment with a Chicago-based institutional investor - Lincoln Park Capital Fund. In this deal, Kintara will have the right, but not the obligation, to sell to LPC up to $20 million of its shares over the period of the three-year agreement. 

At the end of the third quarter of 2022, 3 hedge funds in the database of Insider Monkey held stakes worth $96,000 in Kintara Therapeutics, Inc. (NASDAQ:KTRA), compared to 3 in the previous quarter worth $248,000.

Among the hedge funds being tracked by Insider Monkey, Connecticut-based investment firm Nantahala Capital Management is a leading shareholder in Kintara Therapeutics, Inc. (NASDAQ:KTRA) with 594,813 shares worth more than $64,000. 

8. Baudax Bio, Inc. (NASDAQ:BXRX)

Number of Hedge Fund Holders: 3  

 

52-Week Price Range ($): 0.12 - 13.65

Baudax Bio, Inc. (NASDAQ:BXRX) is a pharmaceutical company that develops and commercializes products for hospitals and other acute care settings. On August 11, Baudax Bio posted earnings for the second quarter of 2022, reporting losses per share of $1.05, beating market estimates by $0.22. The revenue over the period was $0.3 million, up 50.0% compared to the revenue over the same period last year.

At the end of the third quarter of 2022, 3 hedge funds in the database of Insider Monkey held stakes worth $173,000 in Baudax Bio, Inc. (NASDAQ:BXRX), compared to 4 in the previous quarter worth $703,000.

Among the hedge funds being tracked by Insider Monkey, New Jersey-based investment firm Sabby Capital is a leading shareholder in Baudax Bio, Inc. (NASDAQ:BXRX) with 439,220 shares worth more than $108,000. 

7. NeuBase Therapeutics, Inc. (NASDAQ:NBSE)

Number of Hedge Fund Holders: 8   

 

52-Week Price Range ($): 0.18 - 3.19

NeuBase Therapeutics, Inc. (NASDAQ:NBSE) is a pre-clinical-stage biopharmaceutical company that focuses on the development of therapies to treat rare genetic diseases and cancers caused by mutant genes. On October 21, NeuBase Therapeutics announced a research agreement with a group of top ten global healthcare companies. Healthcare will evaluate NeuBase’s PATrOL technology for three monogenic genetic diseases. The companies will collaborate on the evaluation of the drug candidates for three undisclosed indications.

Among the hedge funds being tracked by Insider Monkey, New York-based investment firm Greenlight Capital is a leading shareholder in NeuBase Therapeutics, Inc. (NASDAQ:NBSE) with 2.7 million shares worth more than $1 million. 

At the end of the third quarter of 2022, 8 hedge funds in the database of Insider Monkey held stakes worth $2.2 million in NeuBase Therapeutics, Inc. (NASDAQ:NBSE), compared to 6 in the previous quarter worth $6.7 million.

In its Q4 2020 investor letter, Greenlight Capital Fund, an asset management firm, highlighted a few stocks and NeuBase Therapeutics, Inc. (NASDAQ:NBSE) was one of them. Here is what the fund said:

“One already-public investment that we have never discussed is NeuBase Therapeutics, Inc. (NASDAQ:NBSE), which we invested in a couple years ago at an average price of $3.96. The combination of the frothy environment for companies with large addressable markets and NBSE’s own pre-clinical progress leaves us surprised that NBSE hasn’t yet joined the “story stock” party. NBSE is a “platform” company with a technology called PATrOL, which develops highly targeted therapies that increase, decrease or change the protein function of genes. By addressing all of the causal mechanisms underlying rare and common diseases – including cancer – PATrOL consolidates the capabilities of highly-valued gene silencing, gene editing and gene replacement companies in a single unified platform. NBSE’s emerging therapies also feature the best precision in engaging misbehaving genes of any technology, which is critical to eliminating “off-target” engagement with healthy genes elsewhere in the genome and to ensuring well-tolerated medicines. The company’s laboratory successes over the last couple years suggest that PATrOL could be a breakthrough technology that addresses many types of diseases. Like DNMR, the addressable market is immense. While there is a long path from here to products on the market, NBSE’s current market capitalization of less than $200 million prices in little chance of success. We think the risk-reward is asymmetrical. NBSE ended the year at $6.99.”

6. Workhorse Group Inc. (NASDAQ:WKHS)

Number of Hedge Fund Holders: 12 

 

52-Week Price Range ($): 2.07 - 5.85

Workhorse Group Inc. (NASDAQ:WKHS) is a technology company that engages in the design, manufacture, and sale of zero-emission commercial vehicles in the United States. On September 13, Workhorse Group announced that it has won the patent for a land vehicle system which was filed on December 9, 2021. On September 7, Linamar Corporation revealed that it has secured a new eAxle system contract with Workhorse Group for commercial vehicle delivery trucks.

Among the hedge funds being tracked by Insider Monkey, New York-based firm DE. Shaw is a leading shareholder in Workhorse Group Inc. (NASDAQ:WKHS) with 911,603 shares worth more than $2.6 million. 

At the end of the third quarter of 2022, 12 hedge funds in the database of Insider Monkey held stakes worth $5.1 million in Workhorse Group Inc. (NASDAQ:WKHS), compared to 10 in the previous quarter worth $4.3 million. 

Click to continue reading and see 5 Pump and Dump Stocks Hedge Funds Like.

https://finance.yahoo.com/news/10-pump-dump-stocks-hedge-144707244.html

Theratechnologies pauses Phase 1

 Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that it has decided to pause the enrollment of patients in its Phase 1 clinical trial of TH1902, the Company’s lead investigational peptide drug conjugate (PDC) for the treatment of sortilin-expressing cancers. The Company plans to submit an amendment to its protocol to the U.S. Food and Drug Administration (FDA) for approval.

Theratechnologies voluntarily made the decision to pause enrollment and revisit the study design after consulting with its investigators. Efficacy results observed thus far were not convincing enough to pursue enrolling patients and did not outweigh the adverse events seen in some patients. As previously reported, these adverse events consist mainly of neuropathy and eye toxicity.

https://finance.yahoo.com/news/theratechnologies-announces-ongoing-th1902-study-233000257.html

Vaxxinity: Positive Topline Pivotal Phase 3 COVID-19 Booster

 Vaxxinity’s next-generation COVID-19 booster candidate UB-612 achieves primary and key secondary immunogenicity endpoints in a pivotal head-to-head heterologous booster trial against three authorized vaccine platforms: mRNA (Pfizer-BioNTech’s BNT162b2), adenovirus vector (AstraZeneca’s ChAdOx1-S), and inactivated virus (Sinopharm’s BIBP)

UB-612 elicits superior neutralizing antibody titers and seroconversion rates against both Wuhan and Omicron BA.5 variants compared to adenovirus vector (ChAdOx1-S) and inactivated (BIBP) vaccines

UB-612 continues to be generally safe and well tolerated

Vaxxinity expects to submit the final sections of its marketing application to the MHRA and the TGA in 1H 2023 for conditional/provisional approval in the UK and Australia

https://finance.yahoo.com/news/vaxxinity-announces-positive-topline-pivotal-130000593.html

US economy adds 263,000 jobs in November, better than expected as hiring remains solid

 U.S. job growth rose faster than expected in November as the labor market remained resilient in the face of higher interest rates, scorching-hot inflation and mounting recession fears.

Employers added 263,000 jobs in November, the Labor Department said in its monthly payroll report released Friday, topping the 200,000 jobs forecast by Refinitiv economists. It marks a slight deceleration from the upwardly revised job gain of 284,000 recorded in October.

The unemployment rate, meanwhile, held steady at 3.7%.

https://www.foxbusiness.com/economy/us-economy-adds-jobs-november-better-expected-hiring-remains-solid

El Paso facing pressure to declare migrant emergency as predicted surge looms

 Migrant crisis flashpoint city El Paso has run out of money and is so overwhelmed it released 1,000 people to fend for themselves on the city’s streets in November — but the mayor is refusing to give in to pressure and declare a state of emergency.

The Texas city is has become ground zero for the immigration crisis with over 53,000 migrants entering the US in October alone, making it the busiest border crossing in the nation.

The number of people flooding in is set to skyrocket in three weeks when Title 42 — a pandemic-era restriction which allows authorities to refuse entry to many migrants based on medical fears — expires on Dec 21.

Estimates are as high as 18,000 people crossing into the US from Mexico across the whole southern border per day.

In El Paso, over 5,000 people are currently being processed and let into the country each week, after which they are put into temporary shelters. Once those are full, the city has no option but to release migrants into the city with nowhere to stay, as city officials confirmed they did with over 1,000 people in November.

Asylum-seeking migrants from Venezuela cross the Rio Bravo river to turn themselves in to U.S. Border Patrol agents to request asylum in El Paso, Texas, U.S., near a Venezuelan migrant camp, as seen from Ciudad Juarez, Mexico November 17, 2022.
Asylum-seeking migrants from Venezuela cross the Rio Bravo river to turn themselves in to US Border Patrol agents to request asylum in El Paso, Texas near a Venezuelan migrant camp on Nov. 17, 2022.
REUTERS
Border Patrol agents process immigrants arriving in El Paso, Texas in a makeshift, outdoor processing center near downtown.
Border Patrol agents process immigrants arriving in El Paso, Texas in a makeshift, outdoor processing center near downtown.
REUTERS

El Paso has shut down its welcome center for migrants and program to bus people to other cities after using $9.5 million of its own money, saying it will not spend another dime until the federal government reimburses them.

But aware of the oncoming influx, Council members have been joined by other officials calling for the Democrat-run city to declare an emergency — which would open it up to additional funding and resources from the state and federal government.

“A declaration of a state of emergency would place us in a better position so that we don’t have to absorb as much of the costs as the influx continues,” El Paso City Manager Tommy Gonzalez — a non-partisan, non-elected city leader — wrote in a recommendation to Mayor Oscar Leeser.

El Paso City Manager Tommy Gonzalez urged elected officials to declare a state of emergency as the city is expected to be flooded with immigrants when Title 42 ends on Dec. 21.
El Paso City Manager Tommy Gonzalez urged elected officials to declare a state of emergency as the city is expected to be flooded with immigrants when Title 42 ends on Dec. 21.
elpasotexas.gov

Mayor Oscar Leeser did not respond to The Post’s questions about whether he would declare a border emergency. In the past, he has resisted issuing a declaration — even admitting the White House had asked him not to because it would make President Biden look bad.

“If we don’t declare [an emergency] or if the mayor doesn’t declare, I don’t see anyway around it, unless the federal government comes in and opens up their own shelter at Fort Bliss or something,” City Council Member Claudia Rodriguez told The Post.

Without intervention from the city or federal governments, Rodriquez predicts migrants will end up sleeping on the streets again in tents, like they did in September when one Congressman described El Paso looking like a third-world country.

The County of El Paso is currently operating a processing center to help migrants who enter the country and have money and a destination make travel plans within the US.

In September, immigrants overwhelmed city resources and ended up sleeping on the streets of downtown El Paso-- something local leaders have called the worst case scenario in the past.
In September, immigrants overwhelmed city resources and ended up sleeping on the streets of downtown El Paso — something local leaders have called the worst case scenario in the past.
KFOX-TV

“That amount looks like it might increase, so we’re looking at options to possibly expand that operation,” El Paso County Commissioner David Stout told The Post on Thursday.

The county neither feeds or shelters migrants — but Stout added they may soon have to step in and take over those duties.

On a national level President Biden has not announced any plan or remedy for when Title 42, which has been used to expel as many as 40% of immigrants who try and cross the border ends.

Mayor Oscar Leeser has resisted previous calls to declare a state of emergency over the border crisis.
Mayor Oscar Leeser has resisted previous calls to declare a state of emergency over the border crisis.
City of El Paso

Four democratic senators — Mark Kelly ​and Kyrsten Sinema of Arizona, Maggie Hassan of New Hampshire and Jon Tester of Montana — have even warned of their concerns as to what will happen after Dec. 21.

In a letter made public earlier this week they wrote: “We have expressed concern with Department of Homeland Security’s preparations for the end of Title 42, especially as the situation has deteriorated at times. Record annual encounters have led to untenable situations.

“In Arizona, shelters have been forced well beyond capacity … This is not safe, and creates a dangerous situation for migrants and communities.”

Migrants line up for a bus in El Paso
Local taxpayers have spent $9.5 million to feed, shelter and bus immigrants out of El Paso, while Biden officials have yet to fulfill their promise to reimburse El Pasoans.
REUTERS

Rodriguez agreed, and called the lack of a plan to deal with the coming wave of migrants a “recipe for disaster.”

“We need to proactive, we need to be prepared for Dec. 21 because it’s coming, it’s already here,” said Rodriguez.

https://nypost.com/2022/12/01/pressure-on-el-paso-to-declare-migrant-emergency-mounts/