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FDA Shares Information on Redundancy Risk Management Plans for Critical Food Manufacturers

This new requirement was established following a months-long infant formula shortage sparked by insanitary conditions at one of the nation’s largest infant formula facilities. 




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Designer Vern Yip Shares Thoughts on Redesigning His N.Y. Home

What happens when a designer redesigns his own home? Floor Trends was invited to the New York City apartment of nationally known interior design Vern Yip to find out.




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Ceramicist Shares His Joy With New Collection At The Currier

The Currier Museum of Art 's latest exhibition features the work of Philadelphia-based potter Roberto Lugo. Lugo finds inspiration for his work in his upbringing and his cultural heritage. His new collection, Te traigo mi le lo lai -- I bring you my joy , will be on display at the Currier Museum through September. Lugo will also be in Manchester this summer for a residency with the museum, where he'll be teaching pottery classes. Below are some excerpts from Robert Lugo's conversation with NHPR's Rick Ganley. On Lugo’s inspiration: “ I've always found that it's important for me as a person to not forget where I'm from. I'm from Philadelphia in a really impoverished neighborhood, mostly made up of Black and Latinx people. And so I identify and associate that as a culture and as almost its own society. And so in the tradition that people have represented their cultures in pottery, I do that.” On his new exhibition, Te traigo mi le lo lai -- I bring you my joy : “ One of the reasons why I




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Generosity Path director shares remarkable stories of how Jesus-like giving is transforming people's lives

Bonar Tanudjaja, Southeast Asia and East Asia regional director of Generosity Path, shares the core principles of biblical generosity and how the Journey of Generosity has transformed individuals, churches and communities across Asia through sharing stories of people who are radically generous.




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COGIC bishop anoints Kamala Harris with prayer, declares ‘I believe we have the victory’

Despite being rebuked by Pastor Donnie Swaggart for endorsing Vice President Kamala Harris to become the next president of the United States, Bishop John Drew Sheard, presiding bishop and chief apostle of the Church of God in Christ, defiantly anointed her with prayer before his congregation Sunday after declaring, “I believe we have the victory.”




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Ohio State Football Prepares For Season Kickoff Against Bowling Green

Ohio State Football beings its 2016 campaign Saturday at noon in Ohio Stadium. The Buckeyes take on Bowling Green in what should be an easy win for Ohio State. Thomas Bradley and Steve Brown break down the matchup, the season and the team with Eric Seger from ElevenWarriors.com .




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Ohio State Prepares For Big Mathcup With Oklahoma

Ohio State is getting ready for its big matchup against Top 25 Oklahoma. A win on the road for the Buckeyes could equal big plans for the 2016 season.




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Ukraine prepares for its new Trump era

The processes that have been taken in Ukraine lately seem very curious. The Parliament of Ukraine, the Rada, is calling on Donald Trump to help end the war in order to hold parliamentary elections. In a nutshell, Ukrainian MPs beg him to intervene in Ukraine's internal affairs. "We will work with the Administration, with the elected Congress, the Senate… I don't think that the composition of the Parliament will change 100% there. Unfortunately, we at the Verkhovna Rada cannot change like that. But we would very much like, starting with Donald Trump, the elected president, and ending with Congress, the Senate, for them to do their utmost to enable us to be re-elected. This is our request, as deputies, to them…" Vice Speaker Kornienko said.




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RFID company prepares to scale IoT offering via global partnerships

Omni-ID, the developer of passive industrial radio frequency identification (RFID) tags, used by major global organisations for monitoring the location and identity of assets, has appointed Amir Mobayen as Chief Revenue Officer.




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Incheon’s Ganghwa County Declares ‘Danger Zone,’ Bans Anti-Pyongyang Leafleting

[Inter-Korea] :
Incheon’s Ganghwa County, near the inter-Korean border, has designated itself a “danger zone” effective Friday and issued an administrative order banning the dissemination of anti-Pyongyang propaganda leaflets north of the border. According to county officials on Thursday, the decision stems from ...

[more...]




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N. Korea Declares Success after Hwasong-19 ICBM Test

[Inter-Korea] :
North Korea said Friday that the missile it launched the previous day was the new Hwasong-19 intercontinental ballistic missile(ICBM) and declared the test a success. The North’s state-run Korean Central News Agency(KCNA) said the Missile Administration conducted the test under the guidance of North ...

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N. Korean Leader's Sister Declares to Continue Bolstering Nuclear Capabilities

[Inter-Korea] :
Kim Yo-jong, the powerful sister of North Korean leader Kim Jong-un, declared that the regime will continue to bolster its nuclear capabilities in protest of criticisms from the international community. In a statement carried by the North's Korean Central News Agency(KCNA) on Saturday, Kim ...

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Neil deGrasse Tyson shares his top 3 StarTalk guests

L-R Access Hollywood film critic Scott Mantz moderates a talk by Neil deGrasse Tyson at the Aero Theatre in Santa Monica, June 9, 2017. Courtesy of the American Cinematheque; Credit: Robert Enger

Chris Greenspon | Off-Ramp®

Neil deGrasse Tyson came onto the science-themed, late night talk show circuit with some clout. The "Cosmos" host, author, educator, and Hayden Planetarium director's first guest when StarTalk "jumped species" from podcast to television was Whoopi Goldberg. 

On Friday June 9, 2017, Tyson opened up a screening of "Star Trek II: The Wrath of Khan" at the American Cinematheque's Aero Theatre in Santa Monica with a talk on his career as an astrophysicist-turned-broadcaster. Access Hollywood's film critic, Scott Mantz, moderated the event and asked Tyson for his three favorite StarTalk guests.

1. Nichelle Nichols

While StarTalk was still just a podcast, Nichols appeared on StarTalk twice. Tyson learned that Star Trek had been a holdover gig for Nichols while paying her dues to land dancing parts on Broadway. Tyson didn't think being Lieutenant Uhura was anything to sneeze at. "She is actually in the chain of command to be captain of the ship," remarked Tyson.

Early on into the series, Nichols decided it was time to go back to New York and find her dream job, Tyson said. However, before leaving she attended a party where she bumped into Dr. Martin Luther King Jr. 

"And he says, 'Oh, my children! We line up at night, and you make us all proud.' And she said, 'Oh, thank you, but I'm going back to New York,' and he said, 'You can't do that. There are no other black people on television. Much less, what there are, they're not in any kind of role of responsibility, and integrity, and dignity.' And he convinced her to stay with the series." - Neil deGrasse Tyson

Tyson teared up, searched for tissues, and said he opened up a bottle of wine at eleven in the morning during the taping with Nichols. "And then, I think it was only one and a half glasses of wine," Tyson said, before he asked Nichols about her and William Shatner's interracial kiss on Star Trek, one of the first interracial kisses on television. Tyson said Nichols told him that the producers of the show wanted to film a version of the scene without the kiss, but that she and Shatner purposefully kept messing up the non-kiss until they ran out of filming time so that the editors of the show wouldn't have any such scene to work with.

Nichols then asked Tyson if he wanted to see what a "racial kiss" was, and then she kissed him.

Tyson also recognized Nichols for her role in recruiting women and people of color for NASA space missions from engineering schools across the United States. Tyson said Nichols was able to find these recruits by looking where NASA had not been looking.

"You were only looking at the U.S. Naval Academy and not Tuskegee Institute where they have a huge engineering group. So she laid out this recipe, and that first astronaut class: it had black people, it had Asians, it had women. And they were at the top of their class when they came out of college and graduate school, so she shaped the modern view of NASA."

2. Biz Stone

"The name doesn't even sound real," said Tyson, referring to the co-founder of Twitter. Tyson counts Stone among the great entrepreneurs who never finished college: Bill Gates, Michael Dell, Mark Zuckerberg.

"Until he described how he envisioned Twitter, I had not fully appreciated what it was," said Tyson. Stone asked Tyson if he had ever seen birds suddenly take flight and flock together after behaving independently, and then, just as swiftly as they started, return to their posts and be "individuals again."

"Twitter is a flocking mechanism for humans," Tyson said. "I live near Ground Zero in New York City," Tyson recalled what could be described as a Twitter moment from 2011. "I'm watching TV, all of a sudden I heard noises in the street. Crowds were developing. I said, 'What's going on?'" While Tyson was sitting in his home, it had been announced that Osama Bin Laden had been killed.

Tyson got on the internet and read the news. "I missed all that, but all these people got the tweet, and everyone gathered back at Ground Zero." That realization of the nature of social media made Biz Stone Tyson's number two guest.

3. Kareem Abdul-Jabbar

Jabbar's appearance on StarTalk is from the upcoming season, so Tyson did not want to reveal the topics of the episode, but he could not resist including Jabbar because of his numerous qualifications.

  • He has written a novel about Sherlock Holmes' older brother, Mycroft Holmes (which Jabbar talked with Off-Ramp about in 2015)
  • He had a column in Time Magazine
  • His high scores on Celebrity Jeopardy
  • He's the highest scorer ever for the NBA, with 38,387 career points (Kobe Bryan is third with 33,643 points)
  • He played in the All-Star Game 19 times out of his 20 NBA seasons
  • He has six NBA Championship rings
  • And he was in "Airplane!" and Bruce Lee's "Game of Death"

Tyson gives us one giveaway though, from Jabbar's interview. The one film role that Jabbar is disappointed about never being cast in was Chewbacca in "Star Wars."

Neil deGrasse Tyson's new book is Astrophysics for People in a Hurry. Thanks to him and the American Cinematheque for allowing us to excerpt their presentation on Off-Ramp.

 

This content is from Southern California Public Radio. View the original story at SCPR.org.




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We Just Got Our Clearest Picture Yet Of How Biden Won In 2020

Incoming President Biden and Vice President Harris stand with their respective spouses Jill Biden and Doug Emhoff after delivering remarks in Wilmington, Del., on Nov. 7, the day the Democrats were declared the winners in the 2020 election.; Credit: Jim Watson/AFP via Getty Images

Danielle Kurtzleben | NPR

We know that President Biden won the 2020 election (regardless of what former President Donald Trump and his allies say). We just haven't had a great picture of how Biden won.

That is until Wednesday, when we got the clearest data yet on how different groups voted, and crucially, how those votes shifted from 2016. The Pew Research Center just released its validated voters' report, considered a more accurate measure of the electorate than exit polls, which have the potential for significant inaccuracies.

The new Pew data shows that shifts among suburban voters, white men and independents helped Biden win in November, even while white women and Hispanics swung toward Trump from 2016 to 2020.

To compile the data, Pew matches up survey respondents with state voter records. Those voter files do not say how a person voted, but they do allow researchers to be sure that a person voted, period. That helps with accuracy, eliminating the possibility of survey respondents overreporting their voting activity. In addition, the Pew study uses large samples of Americans — more than 11,000 people in 2020.

It's a numbers-packed report, but there are some big takeaways about what happened in 2020 (and what it might tell us about 2022 and beyond):

Suburban voters (especially white suburban voters) swung toward Biden

Suburban voters appear to have been a major factor helping Biden win. While Pew found Trump winning the suburbs by 2 points in 2016, Biden won them by 11 points in 2020, a 13-point overall swing. Considering that the suburbs accounted for just over half of all voters, it was a big demographic win for Biden.

That said, Trump gained in both rural and urban areas. He won 65% of rural voters, a 6-point jump from 2016. And while cities were still majority-Democratic, his support there jumped by 9 points, to 33%.

Men (especially white men) swung toward Biden

In 2020, men were nearly evenly split, with 48% choosing Biden to Trump's 50%. That gap shrank considerably from 2016, when Trump won men by 11 points. In addition, this group that swung away from Trump grew as a share of the electorate from 2016 — signaling that in a year with high turnout, men's turnout grew more.

White men were a big part of the swing toward Biden. In 2016, Trump won white men by 30 points. In 2020, he won them again, but by a substantially slimmer 17 points.

In addition, Biden made significant gains among married men and college-educated men. All of these groups overlap, but they help paint a more detailed portrait of the type of men who might have shifted or newly participated in 2020.

However, we can't know from this data what exactly was behind these shifts among men — for example, exactly what share of men might have sat on the sidelines in 2016, as opposed to 2020.

Women (especially white women) swung toward Trump

The idea that a majority of white women voted for Trump quickly became one of the 2016 election's most-cited statistics, as many Hillary Clinton supporters — particularly women — were outraged to see other women support Trump.

While that statistic was repeated over and over, Pew's data ultimately said this wasn't true — they found that in 2016, white women were split 47% to 45%, slightly in Trump's favor but not a majority.

This year, however, it appears that Trump did win a majority of white women. Pew found that 53% of white women chose Trump this year, up by 6 points from 2016.

This support contributed to an overall shift in women's numbers — while Clinton won women of all races by 15 points in 2016, Biden won them by 11 points in 2020. Combined with men's shifts described above, it shrank 2016's historic gender gap.

Notably, the swing in white women's margin (5 points altogether) was significantly smaller than white men's swing toward Biden (13 points altogether).

Hispanic voters swung toward Trump

Trump won 38% of Hispanic voters in 2020, according to Pew, up from 28% in 2016.

That 38% would put Trump near George W. Bush's 40% from 2004 — a recent high-water mark for Republicans with Hispanic voters. That share fell off substantially after 2004, leading some Republican pollsters and strategists to wonder how the party could regain that ground. Trump in 2016 intensified those fears, with his nativist rhetoric and hard-line immigration policies.

There are some important nuances to these Hispanic numbers. Perhaps most notably, there is a sizable education gap. Biden won college-educated Hispanic voters by 39 points, but the Democrat won those with some college education or less by 14 points.

That gap mirrors the education gap regularly seen in the broader voting population.

Unfortunately, Pew's sample sizes from 2016 weren't big enough to break down Hispanic voters by gender that year, so it's impossible to see if this group's gender gap widened.

Nonwhite voters leaned heavily toward Biden

Unlike white and Hispanic voters, Black voters didn't shift significantly from 2016. They remained Democratic stalwarts, with 92% choosing Biden — barely changed from four years earlier.

Nearly three-quarters of Asian voters also voted for Biden, along with 6 in 10 Hispanic voters and 56% of voters who chose "other" as their race. (Those groups' sample sizes also weren't big enough in 2016 to draw a comparison over time.)

2018 trends stuck around ... but diminished

In many of these cases where there were substantial shifts in how different groups voted, they weren't surprising, given how voters in the last midterms voted. For example, white men voted more for Democrats in 2018 than they did in 2016, as did suburban voters.

What it means for 2022

The data signals that Democrats' strength with Hispanic voters has eroded, but that the party succeeded in making further inroads in the suburbs, including among suburban whites.

It suggests that these groups, already major focuses for both parties, will continue to be so in 2022, with Republicans trying to cement their gains among Hispanics (and regain suburban voters), while Democrats do Hispanic outreach and try to hold onto the suburbs.

However, it's hard to project much into the future about what voters will do based on the past two elections because of their unique turnout numbers.

"It's hard to interpret here, because 2018 was such a high turnout midterm election, and then our last data point, 2014, was a historically low turnout midterm election," said Ruth Igielnik, senior researcher at Pew Research Center.

Copyright 2021 NPR. To see more, visit https://www.npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.




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H.C. Wainwright & Co. Shares Buy Rating on Biotech Co.

Source: Ed Arce 10/09/2024

H.C. Wainwright & Co. analysts gave Unicycive Therapeutics Inc. (UNCY:NASDAQ) a Buy rating after the company announced the successful completion of the Phase 1 study for UNI-494 in healthy volunteers.

H.C. Wainwright & Co. analysts Ed Arce and Thomas Yip, in a research report published on October 9, 2024, maintained a Buy rating on Unicycive Therapeutics Inc. (UNCY:NASDAQ) with a price target of US$2.50. The report follows Unicycive's announcement of the successful completion of the Phase 1 study for UNI-494 in healthy volunteers.

Arce and Yip highlighted the significance of the study results, stating, "UNI-494 showed rapid metabolism, enabling the expected release of nicorandil and its linker." They added, "Importantly, PK results collected in the study showed fast absorption of UNI-494, with rapid metabolism leading to the expected release of nicorandil and its linker."

The analysts noted the safety profile of UNI-494, commenting, "UNI-494 was generally safe and well-tolerated; headache was the most common adverse event (AE), and all AEs were mild with no serious adverse events (SAEs) or AEs leading to withdrawal in Part 1."

Regarding Unicycive's strategic plans, the analysts stated, "Management plans to request a meeting with the FDA by year-end 2024 to review these Phase 1 results and discuss the design of a potential Phase 2 study in patients with acute kidney injury (AKI)."

The report also highlighted the pending milestone for Unicycive's other product candidate, Oxylanthanum Carbonate (OLC), noting, "We await the FDA's formal acceptance of the NDA for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis (we expect by November 2) with a PDUFA date assignment to further narrow OLC's potential approval timing."

H.C. Wainwright & Co.'s valuation methodology for Unicycive is based on a risk-adjusted Net Present Value (rNPV) model. The analysts explained, "We employ a rNPV valuation model to estimate the value of UNCY shares and arrive at our US$2.50 PT based on: (1) about US$2.30 per share for royalties on net sales of OLC in the U.S. and EU (85% PoS, US$149.1M global peak revenue in 2034); and (2) about US$0.25 per share for royalties on net sales of UNI-494 in the U.S. and EU for AKI (20% PoS; US$195M global peak revenue in 2036)."

They added, "In our valuation model, we employ a 14.5% discount rate, which we believe adequately reflects the overall risks of the Unicycive development pipeline. We conservatively assume zero terminal value after the end of the market exclusivity period that runs through 2037."

The analysts also outlined several risk factors, including regulatory, commercialization, market, intellectual property, and funding risks.

In conclusion, H.C. Wainwright & Co.'s maintenance of a Buy rating and US$2.50 price target reflects a positive outlook on Unicycive Therapeutics' potential in developing UNI-494 for AKI and OLC for hyperphosphatemia. The share price at the time of the report of US$0.36 represents a potential return of approximately 594% to the analysts' target price, highlighting the upside potential if the company's clinical development and regulatory plans prove successful.

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Important Disclosures:

  1. This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
  2. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for H.C. Wainwright & Co., Unicycive Therapeutics Inc., October 9, 2024

Important Disclaimers This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to unsubscribe@hcwresearch.com and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet.

H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Ed Arce and Thomas Yip , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Unicycive Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Unicycive Therapeutics, Inc..

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The Firm or its affiliates did not receive compensation from Unicycive Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Unicycive Therapeutics, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

( Companies Mentioned: UNCY:NASDAQ, )




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NY Biopharma Shares Promising Clinical Data

Source: Dr. Ram Selvaraju 10/18/2024

Anavex Life Sciences Corp. (AVXL:NASDAQ) recently released encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing Phase 2 clinical study of ANAVEX3-71 for schizophrenia treatment, according to an H.C. Wainright & Co. research note.

H.C. Wainwright & Co. analyst Dr. Ram Selvaraju, in a research report published on October 18, 2024, reiterated a Buy rating on Anavex Life Sciences Corp. (AVXL:NASDAQ) with a price target of US$40.00. The report follows Anavex's announcement of encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing Phase 2 clinical study of ANAVEX3-71 for schizophrenia treatment.

Selvaraju highlighted the significance of these results, stating, "Preliminary results demonstrated a dose-dependent effect of ANAVEX3-71 on two key EEG biomarkers in patients with schizophrenia. Treatment with ANAVEX3-71 vs. placebo resulted in improvements in 40 Hz Auditory Steady-State Response (ASSR) Inter Trial Coherence (ITC) and Resting State Alpha Power."

The analyst viewed these developments positively, noting, "These results provide evidence of CNS target engagement and potential therapeutic effects of ANAVEX3-71 in schizophrenia. The observed changes reversed known EEG and ERP biomarker abnormalities associated with schizophrenia."

Regarding Anavex's lead candidate, blarcamesine, Selvaraju stated, "Anavex remains committed to completing the Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) under the Centralized Procedure petitioning for approval of blarcamesine for treatment of Alzheimer's disease (AD) in 4Q24."

The report also highlighted Anavex's progress with other clinical programs, including a pivotal Phase 2b/3 trial in Parkinson's disease and potential trials in Rett syndrome and Fragile X Syndrome.

Selvaraju's valuation methodology for Anavex Life Sciences is based on a discounted cash flow (DCF) approach. He explained, "We utilize a discounted cash flow (DCF)-driven methodology, which ascribes a total value of roughly US$3.25B to blarcamesine alone without ascribing value to any other pipeline assets. We employ a 50% probability of approval in Rett syndrome; 60% in Parkinson's disease dementia (PDD); and 50% in AD."

The analyst added, "Further, we apply a 12% discount rate and 1% terminal growth rate. We derive a total firm value of ~US$3.4B, which yields a 12-month price objective of US$40 per share, assuming 84.8M shares outstanding as of end-F2Q25."

Selvaraju also outlined several risk factors, including potential negative clinical data, regulatory approval challenges, and commercialization difficulties.

In conclusion, H.C. Wainwright & Co.'s maintenance of a Buy rating and US$40 price target reflects a positive outlook on Anavex Life Sciences' clinical progress and potential in developing treatments for neurological disorders. The share price at the time of the report of US$5.51 represents a potential return of approximately 626% to the analyst's target price, highlighting the significant upside potential if the company's clinical development plans prove successful.

Important Disclosures:

  1. This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
  2. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for H.C. Wainwright & Co., Anavex Life Sciences Corp., October 18, 2024.

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to unsubscribe@hcwresearch.com and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Anavex Life Sciences Corp. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Anavex Life Sciences Corp.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr. Selvaraju's position with Relief when reading this research report. The firm or its affiliates received compensation from Anavex Life Sciences Corp. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Anavex Life Sciences Corp. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Anavex Life Sciences Corp. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

( Companies Mentioned: AVXL:NASDAQ, )




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Mass. Biotech Shares Strong Q3 Results

Source: Dr. David Nierengarten 10/29/2024

Kiniksa Pharmaceuticals Ltd. (KNSA:NASDAQ) recently reported strong Q3 2024 earnings, which led to its Outperform rating, according to a Wedbush research note.

Wedbush analysts Dr. David Nierengarten, Dennis Pak, and Dr. Martin Fan, in a research report published on October 29, 2024, maintained their Outperform rating on Kiniksa Pharmaceuticals Ltd. (KNSA:NASDAQ) with a price target of US$34.00. The report follows Kiniksa's Q3 2024 earnings announcement, which showed continued strong growth for Arcalyst.

The analysts highlighted the company's strong quarterly performance, stating, "Net product revenues of US$112.2MM (+73% y/y) slightly edged out our US$112.0MM estimate. Management's updated FY revenue guidance to US$410-US$420MM (previously US$405-US$415MM) implies Q4 revenue of US$115.5-US$125.5MM (3%-12% q/q growth)."

Regarding market penetration, the analysts noted, "More than 11% of patients in KNSA's target RP population of 14,000 patients that suffer from two or more recurrences are now actively on Arcalyst therapy, compared to 9% penetration at YE23." They added, "Notably, ~45% of all new prescriptions were written by repeat prescribers, which accounted for ~25% (640) of total prescriber base."

The analysts emphasized the growing duration of therapy, stating, "Importantly, average total duration of Arcalyst therapy in RP continues to grow, increasing to ~27 months as of 3Q24 from ~23 months as of 1Q24."

Regarding the company's pipeline, the report highlighted progress with abiprubart, noting, "Abiprubart's subcutaneous formulation and potential for once-monthly dosing should provide a greater dosing convenience relative to other agents and support uptake in a crowded but large market (300,000+ patients in the U.S.A.) assuming comparable efficacy."

The analysts addressed the stock's recent performance, stating, "We think today's share action reflects overoptimistic expectations investors may have had following the outsized Q2 sequential growth over a seasonally weak Q1. Net-net, we believe Arcalyst fundamentals remain strong and view current trading levels as an attractive entry point."

Wedbush's valuation methodology is based on a sum-of-parts approach. The analysts explained, "Our PT is derived from a sum-of-parts valuation for each of the company's clinical programs: an 8x multiple to KNSA's share of estimated US sales of Arcalyst in RP in 2027 and CAPS in 2025 (discounted back by 15%), and an 8x multiple to abiprubart's estimated sales in Sjogren's disease in 2029/30 (discounted back by 35%)."

In conclusion, Wedbush's maintenance of its Outperform rating and US$34 price target reflects confidence in Kiniksa's commercial execution with Arcalyst and pipeline potential. The share price at the time of the report of US$23.76 represents a potential return of approximately 43% to the analysts' target price, suggesting a significant upside as the company continues to expand its market penetration and advance its pipeline.

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Important Disclosures:

  1. This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
  2. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for Wedbush, Kiniksa Pharmaceuticals, October 29, 2024

Analyst Certification We, David Nierengarten, Dennis Pak and Martin Fan, certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report.

Company Specific Disclosures This information is subject to change at any time. 1. WS makes a market in the securities of Kiniksa Pharmaceuticals.

Wedbush disclosure price charts are updated within the first fifteen days of each new calendar quarter per FINRA regulations. Price charts for companies initiated upon in the current quarter, and rating and target price changes occurring in the current quarter, will not be displayed until the following quarter. Additional information on recommended securities is available on request. Disclosure information regarding historical ratings and price targets is available: Research Disclosures *WS changed its rating system from (Strong Buy/ Buy/ Hold/ Sell) to (Outperform/ Neutral/ Underperform) on July 14, 2009. Applicable disclosure information is also available upon request by contacting the Research Department at (212) 833-1375, by email to leslie.lippai@wedbush.com. You may also submit a written request to the following: Wedbush Securities, Attn: Research Department, 142 W 57th Street, New York, NY 10019.

OTHER DISCLOSURES The information herein is based on sources that we consider reliable, but its accuracy is not guaranteed. The information contained herein is not a representation by this corporation, nor is any recommendation made herein based on any privileged information. This information is not intended to be nor should it be relied upon as a complete record or analysis: neither is it an offer nor a solicitation of an offer to sell or buy any security mentioned herein. This firm, Wedbush Securities, its officers, employees, and members of their families, or any one or more of them, and its discretionary and advisory accounts, may have a position in any security discussed herein or in related securities and may make, from time to time, purchases or sales thereof in the open market or otherwise. The information and expressions of opinion contained herein are subject to change without further notice. The herein mentioned securities may be sold to or bought from customers on a principal basis by this firm. Additional information with respect to the information contained herein may be obtained upon request. Wedbush Securities does and seeks to do business with companies covered in its research reports. Thus, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. Please see pages 3–7 of this report for analyst certification and important disclosure information. Retail Investors The information provided is for general informational purposes only and should not be considered an individual recommendation or personalized investment advice. The companies/investments mentioned may not be suitable for everyone. Each investor needs to review their own respective situation(s) before making any investment decisions. All expressions of opinion are subject to change without notice due to shifting market(s), economic or political conditions. Investment involves risks including the risk of principal. Past performance is no guarantee of future results and the opinions presented cannot be viewed as an indicator of future performance.

( Companies Mentioned: KNSA:NASDAQ, )




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Biotech Shares Positive Phase I Data for Alzheimer's Treatment

Source: Dr. Douglas Loe 10/31/2024

Leede Financial Inc.'s target price on ProMIS Neurosciences Inc. (PMN:TSX; PMN:NCM) reflects a potential return of 822%.

Leede Financial analysts Dr. Douglas Loe and Siew Ching Yeo, in a research report published on October 30, 2024, maintained their Speculative Buy rating on ProMIS Neurosciences Inc. (PMN:TSX; PMN:NCM) with a price target of US$9.50. The report follows ProMIS's presentation of interim Phase I data for PMN310, its Alzheimer's disease (AD) candidate, at the Clinical Trials on Alzheimer's Disease (CTAD) conference.

The analysts highlighted the positive safety and pharmacokinetic (PK) data, stating, "We were encouraged (though not overly surprised) to see that the mAb was well-tolerated at all five test doses ranging from 2.5mg/kg-to-40mg/kg." They added, "PK analysis of all of these patient cohorts in this single-ascending dose (SAD) trial suggests that once-monthly dosing may be sufficient to sustain mAb levels both in plasma and in cerebrospinal fluid over time."

Regarding dosing efficacy, the analysts noted, "Importantly, ProMIS indicated in the Jul/24 update that even at 2.5mg/kg dosing, PMN310 levels in CSF were over 100x higher than predicted to be necessary to bind to all beta-amyloid oligomers that could accumulate in CSF in diseased patients."

The analysts emphasized the significance of recent industry developments, particularly AbbVie's acquisition of Aliada Therapeutics, stating, "AbbVie's tangible interest in Phase I-stage AD assets shows us that ProMIS could itself be attractive to future suitors if/when it can document direct impact on cognitive impairment in diseased patients."

The report highlighted ProMIS's financial position following its recent equity offering, noting that the company raised US$30.3M with multiple layers of warrant coverage tied to development milestones.

Leede Financial's valuation methodology combines multiple approaches. The analysts explained, "We are maintaining our Speculative Buy rating and one-year PT of US$9.50 on PMN, with our valuation still based on NPV (30% discount rate) and multiples of our F2029 EBITDA/fd EPS forecasts."

They added, "By direct comparison to Aliada's US$1.4B value, PMN shares would notionally be valued on a fully-diluted basis at US$17.65/shr."

In conclusion, Leede Financial's maintenance of their Speculative Buy rating and US$9.50 price target reflects confidence in ProMIS's development of PMN310 and its potential in the Alzheimer's disease market. The share price at the time of the report of US$1.03 represents a potential return of approximately 822% to the analysts' target price, highlighting the significant upside potential if the company's clinical development plans prove successful.

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Important Disclosures:

  1. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of ProMIS Neurosciences Inc.
  2. This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
  3. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for Leede Financial Inc., ProMIS Neurosciences Inc., October 30, 2024

Important Information and Legal Disclaimers Leede Financial Inc. (Leede) is a member of the Canadian Investment Regulatory Organization (CIRO) and a member of the Canadian Investor Protection Fund (CIPF). This document is not an offer to buy or sell or a solicitation of an offer to buy or sell any security or instrument or to participate in any particular investing strategy. Data from various sources were used in the preparation of these documents; the information is believed but in no way warranted to be reliable, accurate and appropriate. All information is as of the date of publication and is subject to change without notice. Any opinions or recommendations expressed herein do not necessarily reflect those of Leede. Leede cannot accept any trading instructions via e-mail as the timely receipt of e-mail messages, or their integrity over the Internet, cannot be guaranteed. Dividend yields change as stock prices change, and companies may change or cancel dividend payments in the future. All securities involve varying amounts of risk, and their values will fluctuate, and the fluctuation of foreign currency exchange rates will also impact your investment returns if measured in Canadian Dollars. Past performance does not guarantee future returns, investments may increase or decrease in value, and you may lose money. Leede employees may buy and sell shares of the companies that are recommended for their own accounts and for the accounts of other clients. Disclosure codes are used in accordance with Policy 3600 of CIRO.

Description of Disclosure Codes 1. Leede and its affiliates collectively beneficially own 1% or more of any class of equity securities of the company as of the end of the preceding month or the month prior to the preceding month if the report was issued prior to the 10th. 2. The analyst or any associate of the analyst responsible for the report or public comment hold shares or is short any of the company's securities directly or through derivatives. 3. Leede or a director or officer of Leede or any analyst provided services to the company for remuneration other than normal investment advisory or trade execution services within the preceding 12 months. 4. Leede provided investment banking services for the company during the 12 months preceding the publication of the research report. 5. Leede expects to receive or intends to seek compensation for investment banking services in the next three months. 6. The analyst preparing the report received compensation based upon Leede investment banking revenues for this issuer within the preceding 12 months. 7. The director, officer, employee, or research analyst is an officer, director or employee of the company, or serves in an advisory capacity to the company. 8. Leede acts as a market maker of the company. 9. The analyst has conducted a site visit and has viewed a major facility or operation of the issuer. 10. The company has paid for all, or a material portion, of the travel costs associated with the site visit by the analyst.

Dissemination All final research reports are disseminated to existing and potential institutional clients of Leede Financial Inc. (Leede) in electronic form to intended recipients thorough e-mail and third-party aggregators. Research reports are posted to the Leede website and are accessible to customers who are entitled to the firm’s research. Reproduction of this report in whole or in part without permission is prohibited.

Research Analyst Certification The Research Analyst(s) who prepare this report certify that their respective report accurately reflects his/her personal opinion and that no part of his/her compensation was, is, or will be directly or indirectly related to the specific recommendations or views as to the securities or companies. Leede Financial Inc. (Leede) compensates its research analysts from a variety of sources and research analysts may or may not receive compensation based upon Leede investment banking revenue.

Canadian Disclosures This research has been approved by Leede Financial Inc. (Leede), which accepts sole responsibility for this research and its dissemination in Canada. Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). Canadian clients wishing to effect transactions in any designated investment discussed should do so through a Leede Registered Representative.

U.S. Disclosures This research report was prepared by Leede Financial Inc. (Leede). Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). This report does not constitute an offer to sell or the solicitation of an offer to buy any of the securities discussed herein. Leede is not registered as a broker-dealer in the United States and is not subject to U.S. rules regarding the preparation of research reports and the independence of research analysts. Any resulting transactions should be effected through a U.S. broker-dealer.

( Companies Mentioned: PMN:TSX; PMN:NCM, )




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