Australia’s world ranking for biotechnology innovation jumped from seventh to fourth on Scientific American’s latest ‘Worldview’ scorecard. The publication’s scorecard provides a balanced assessment of biotechnology innovation around the world and indicated that Australia’s biotech market is undergoing a resurgence.

Donald Trump announced that biotech investor Vivek Ramaswamy, who ended his Presidential bid in January 2024, will work closely with Mr Musk on this initiative.

A spokesperson said the company's move was "part of our efforts to align resources with our long-term strategic goals."

In simplest words, Biotechnology is based on biology. It is all around us and is already a big part of our lives. It is used in developing breakthrough products and technologies that help improving the health of the planet, using...

(EMAILWIRE.COM, November 09, 2024 ) The global Al in Biotechnology Market is projected to reach USD 7.75 billion by 2029 from USD 3.23 billion in 2024, at a high CAGR of 19.1% during the forecast period. Increasing cross-industry collaborations and partnerships that foster innovation and resource...

A new "LinkOut" feature introduced by the National Center for Biotechnology Information (NCBI) NCBI’s allows the easy linking to content on PubMed and GenBank.  Dryad has already introduced the feature benefitting from easy and fast linking of associated content to the two resources.

PubMed and GenBank, from the National Center for Biotechnology Information (NCBI), are hugely popular resources for searching and retrieving article abstracts and nucleotide sequence data, respectively.  PubMed indexes the vast majority of the biomedical literature, and deposition of nucleotide sequences in GenBank or one of the other INSDC databases is a near universal requirement for publication in a scientific journal. LinkOut allows the data from an article to be distributed among repositories without compromising its discoverability.

Dryad, intends to expand on this feature in a couple of ways. First, it is planned to make Dryad content searchable via the PubMed and GenBank identifiers, which because of their wide use will provide a convenient gateway for other biomedical databases to link out to Dryad.  Second, open web standards will be used to expose relationships between content in Dryad and other repositories, not just NCBI.

Original source: Dryad news and views

DolCas Biotech, LLC has attained two Health Canada natural product licenses, one for its concentrated turmeric extract, Curcugen®, and the other for Ginfort®, a powerful ginger extract in powdered format.

“Bergacyn is not simply a blend of two powdered herbs,” says Vincenzo Mollace, Ph.D., a professor at the University of Catanzaro and a top researcher in the area of nutraceuticals. “The synergism activated by the patented, in-process combination reduces the clinically substantiated, individual dose requirements of Bergamot and Cynara — at 1,300 mg and 500 mg, respectively — to only 300 mg in Bergacyn. 

A synergistic five-ingredient botanical formula demonstrated significant benefits in the support of men’s healthy sexual performance in recently published clinical research. These findings demonstrate the effectiveness of Fortiquin™ (OLNP-05) in supporting healthy sexual male performance, an issue that affects 20% to 30% of men globally. 

Pharmactive Biotech Products, S.L.U., launches Liboost®, a novel botanical extract of Damiana (Turnera diffusa), as the first formulation to help enhance sexual function in both men and women. Its sexual performance boosting capabilities have been confirmed in a consumer study conducted by the company yielding impressive results. 

Source: Ed Arce 10/09/2024

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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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, )

Source: Andrew Fein 10/23/2024

H.C. Wainwright & Co. analysts Andrew S. Fein, Matthew Caufield, Dr. Andres Y. Maldonado, and Dr. Ananda Ghosh, in a research report published on October 23, 2024, maintained a Buy rating on DBV Technologies SA (DBVT:NASDAQ) while raising their price target to US$7.00 from US$5.00. The report follows DBV's announcement of regulatory clarity regarding the path forward for its Viaskin Peanut patch.

The analysts highlighted the significance of the FDA agreement, stating, "DBV Technologies has reached an agreement with the FDA regarding the regulatory pathway for the Viaskin Peanut patch in toddlers aged one to three, under the Accelerated Approval pathway."

Regarding the company's development timeline, the analysts noted, "The Biologics License Application (BLA) submission for Viaskin Peanut in this age group is expected to be supported by positive efficacy and safety data from DBV's completed EPITOPE Phase 3 study, as well as additional safety data from the upcoming six-month COMFORT Toddlers supplemental safety study, which is expected to begin in 2Q25."

The report emphasized the strength of DBV's regulatory position, stating, "The FDA has stated that DBV has already satisfied two of the three criteria: the product treats a serious condition, and the product candidate provides a meaningful advantage over available therapies."

The analysts also highlighted progress in Europe, noting, "The EMA confirmed that the successfully completed EPITOPE Phase 3 efficacy and safety trial in the one to three-year-old population, along with positive results from the VITESSE study in the four to seven-year-old population, and a new safety study using the modified circular patch in one to three-year-olds, could support an MAA for the one to seven-year-old indication with the modified patch."

The analysts' valuation methodology for DBV Technologies is based on a composite approach. They explained, "Our US$7 price target is based on an equally weighted composite of: (a) US$5.10/share, as a 20x multiple of taxed and diluted FY34 GAAP EPS of US$5.13 discounted back to FY24 at 35%; and (b) an NPV of US$8.52/share with a 13% discount rate and 1% growth rate."

The report included commercial projections, with the analysts stating, "We continue to model initial approval in 2027, with projected initial sales of US$17.5M, growing to US$1,182.8M by 2034."

The analysts also outlined several risk factors, including potential clinical study failures, regulatory approval challenges, and market size uncertainties.

In conclusion, H.C. Wainwright & Co.'s increased price target to US$7 reflects growing confidence in DBV Technologies' regulatory pathway for the Viaskin Peanut patch. The share price at the time of the report of US$0.70 represents a potential return of approximately 900% to the analysts' target price, highlighting the significant upside potential if the company successfully navigates the regulatory process and commercializes its product.

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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.

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Disclosures for H.C. Wainwright & Co. DBV Technologies S.A., October 23, 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, Andrew S. Fein, Matthew Caufield, Andres Y. Maldonado, PhD and Ananda Ghosh, PhD , 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 DBV Technologies S.A. (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 DBV Technologies S.A.

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 received compensation from DBV Technologies S.A. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from DBV Technologies S.A. 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 DBV Technologies S.A. 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: DBVT:NASDAQ, )

Source: Dr. Robert Driscoll 10/28/2024

Wedbush analysts Dr. Robert Driscoll, Dr. Ritika Das, and Sam Ravina, in a research report published on October 28, 2024, maintained their Outperform rating on Monte Rosa Therapeutics Inc. (GLUE:NASDAQ) while raising their price target to US$15.00 from US$11.00. The report follows Monte Rosa's announcement of a collaborative agreement with Novartis for the development of MRT-6160, its VAV1-degrader program.

The analysts highlighted the significant financial terms of the agreement, stating, "GLUE will receive an upfront payment of US$150M as well as total milestone payments of up to US$2.1B that will include US$1.5B in potential development and regulatory milestones that begin upon Ph 2 studies."

Regarding the partnership structure, the analysts noted, "Upon start of Ph 3 studies, 30% US P&L would be shared with Ph 3 development co-fund and ex-US tiered royalties. Importantly, NVS will cover the complete costs of Ph 2 studies and will obtain worldwide rights to develop, commercialize and manufacture MRT-6160 as well as other VAV MGDs."

The analysts viewed this collaboration positively, stating, "We view this favorable collaboration agreement as an additional robust validation of GLUE's QuEEN MGD platform (noting Novartis' significant efforts in the degrader space), as well as an acknowledgment of the significant potential opportunities around targeting VAV1 with a first in class degrader."

They also emphasized the strategic benefits, noting, "Furthermore, we note the likely accelerated timelines for the MRT-6160 development program overall, and significant extension of GLUE's operational cash runway, which we expect to allow advancement of its deep pipeline."

The report highlighted the ongoing Phase 1 SAD/MAD healthy subject study for MRT-6160 in autoimmune diseases, with initial data expected in 1Q:25.

Wedbush's valuation methodology is based on sales multiples. The analysts explained, "Our PT is derived from applying a 6x multiple to estimated US sales and a 15x multiple to EU royalties of MRT-2359 in 2031, discounted by 30% annually."

The analysts also outlined several risk factors, including potential clinical and regulatory failure of MRT-2359, challenges in achieving sales estimates, and possible commercial competition from current and future therapies.

In conclusion, Wedbush's increased price target to US$15 reflects growing confidence in Monte Rosa Therapeutics following the Novartis collaboration agreement. The share price at the time of the report of US$8.05 represents a potential return of approximately 86% to the analysts' target price, highlighting the significant upside potential as the company advances its development programs with its new partner.

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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, Monte Rosa Therapeutics Inc., October 28, 2024

Analyst Certification We, Robert Driscoll, Ritika Das and Sam Ravina, 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.

The Distribution of Ratings is required by FINRA rules; however, WS' stock ratings of Outperform, Neutral, and Underperform most closely conform to Buy, Hold, and Sell, respectively. Please note, however, the definitions are not the same as WS' stock ratings are on a relative basis. The analysts responsible for preparing research reports do not receive compensation based on specific investment banking activity. The analysts receive compensation that is based upon various factors including WS' total revenues, a portion of which are generated by WS' investment banking activities. Company Specific Disclosures This information is subject to change at any time. 2. WS managed a public offering of securities for Monte Rosa Therapeutics within the last 12 months. 4. WS has received compensation for investment banking services from Monte Rosa Therapeutics within the last 12 months. 5. WS provided Monte Rosa Therapeutics with investment banking services within the last 12 months.

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: GLUE:NASDAQ, )

Source: Dr. David Nierengarten 10/29/2024

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.

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( Companies Mentioned: KNSA:NASDAQ, )

Source: Dr. Douglas Loe 10/31/2024

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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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.

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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.

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

Source: Streetwise Reports 11/08/2024

Vertex Pharmaceuticals Inc. (VRTX:NASDAQ) has reported a robust financial performance for the third quarter of 2024. The report has demonstrated the company's continued revenue growth and the strengthening of its innovative pipeline. For Q3 2024, Vertex's product revenue reached US$2.77 billion, a 12% increase from the previous year. This was primarily driven by strong demand for its TRIKAFTA®/KAFTRIO® therapies. Based on this momentum, Vertex raised its full-year product revenue guidance to a range of US$10.8 billion to US$10.9 billion, citing a solid trajectory in its cystic fibrosis (CF) portfolio and expected future launches.

In Q3, the company made notable advancements in its pipeline. Three programs have begun moving into Phase 3 clinical development: suzetrigine in diabetic peripheral neuropathy (DPN), povetacicept in IgA nephropathy (IgAN), and VX-880 in type 1 diabetes (T1D). Vertex is also preparing for the launch of two potential treatments in early 2025, with PDUFA dates set for January 2 for the vanzacaftor triple therapy for CF and January 30 for suzetrigine, the latter being a pain medication in a new therapeutic class aimed at reducing reliance on opioids.

GAAP and Non-GAAP net income both reached US$1.0 billion, largely driven by increased product revenue, which offset rising R&D and SG&A expense. This was s due to investments in global commercialization and late-stage clinical development. For Q3, Vertex's combined R&D and SG&A expenses were US$1.2 billion and US$1.1 billion, respectively, an increase from last year attributed to new global program advancements and upcoming launch support.

Vertex's cash position remained strong, with US$11.2 billion in cash, cash equivalents, and marketable securities as of September 30. The decline from US$13.7 billion at the end of 2023 primarily reflects the acquisition of Alpine Immune Sciences and share repurchases under the company's buyback program.

A Look At Biotechnology and Pharma

The U.S. Pharmaceuticals Report for 2024 by Nova One Advisor detailed the size and growth trajectory of the U.S. pharmaceutical market. Valued at US$602.19 billion in 2023, the sector is projected to exceed US$1 trillion by 2033. The report pointed to a "high healthcare expenditure provided by government bodies" as a primary growth driver, further bolstered by the aging population's demand for advanced treatments.

In an October 24 article, The Investing News Network reported on a dynamic landscape within the biotechnology sector. The report highlighted advancements in AI-powered drug discovery. Despite a cautious investment climate, interest remained strong in AI's potential to reshape healthcare, with venture capital investment reaching US$6.59 billion. At the HealthTech Ignite conference, Susie Roberts from Relay Therapeutics expressed confidence, noting, "We will definitely see AI design drugs in the next 10 years."

On November 4, Yahoo! Finance shared insights from MIT professors Andrew Lo and Dennis Whyte. They emphasized that biotechnology's rapid advancement over the past five decades offers valuable lessons for future innovation. In their research paper, Lo and Whyte proposed initiatives to accelerate biotechnology's growth, underscoring the importance of "reducing risk and uncertainty" to foster a robust investment ecosystem that supports groundbreaking discoveries.

Catalysts Driving Vertex Pharma

According to Vertex's November 2024 investor presentation, the company sees multiple growth catalysts over the next few years. Vertex aims to meet its goal of achieving "five launches in five years," focusing on expanding the treatable patient base in CF with vanzacaftor triple, addressing critical needs in sickle cell disease (SCD) and beta thalassemia (TDT) with CASGEVY, and launching suzetrigine for acute pain management.

Additionally, Vertex expects its expansive R&D pipeline to support long-term growth. This includes pivotal clinical trials for VX-880 in T1D, povetacicept in IgAN, and NaV1.8 pain inhibitors like suzetrigine, indicating a commitment to treating a range of chronic and life-threatening conditions with limited therapeutic options.

By driving advancements in CF therapies, diversifying its portfolio with novel pain treatments, and pursuing accelerated approvals for renal and blood-related disorders, Vertex is strategically positioning itself to sustain growth and achieve several near-term milestones.

What Are Experts Saying About Vertex?

In a November 5, 2024, H.C. Wainwright & Co. update, the analysts highlighted promising data from Vertex's recent Phase 2 trial for suzetrigine, which showed encouraging reductions in pain intensity. [OWNERSHIP_CHART-4085]

The analysts noted that suzetrigine's peripheral nervous system-specific mechanism could potentially address "a significant, unmet medical need worldwide" in non-opioid pain management. They set a price target of US$600.00, projecting Vertex's continued growth from its strong cystic fibrosis franchise and pipeline expansion.

From the November 7 Kingswood Capital Partners report, analysts noted Vertex Pharmaceuticals' "sustained execution" in advancing product development programs and achieving robust operating margins, enabling "continued, significant investments" in both its pipeline and commercial capabilities. The firm maintained a "Buy" rating with a 12-month target price of US$550.00, attributing this outlook to Vertex's deep cash resources and historical successes in clinical trials.

Ownership and Share Structure

According to Refinitiv, 95.44% of Vertex Pharmaceuticals is held by Institutions. The top among them are Capital World Investors at 10.37%, The Vanguard Group at 8.88%, BlackRock Institutional Trust with 5.49%, State Street Global Advisors (US) with 4.55%, and Fidelity Management and Research with 4.11%. Strategic Investors hold .12%. The rest is retail.

The company's market cap is US$129,395.59 million with 257.07 million free float shares. The 52 week range is US$341.90–$510.64.

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Important Disclosures:

1) James Guttman wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.

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.

For additional disclosures, please click here.

( Companies Mentioned: VRTX:NASDAQ, )

Recent strides in biotechnology offer the promise of new and innovative applications -- from edible vaccines to protein-based electronics components.

Good morning. Welcome to the release of the report Preparing for Future Products of Biotechnology, from the National Academies of Sciences, Engineering, and Medicine.

A profusion of biotechnology products is expected over the next five to 10 years, and the number and diversity of new products has the potential to overwhelm the U.S. regulatory system, says a new report from the National Academies of Sciences, Engineering, and Medicine.

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Dr. Prasanna Thwar Krishnan is a pioneer in genomics and molecular diagnostics

Brian Anthony Choy has been honored for achievements in the biotechnology industry

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Katherine Hester, MD, PhD, RAC, is noted for her success in clinical research and regulatory submissions

William Keun Chan Park, PhD, serves as the chief scientific officer at Theromics Inc.

Abe Germansderfer is a seasoned expert and leader in biotechnology manufacturing, quality, process development, statistics, regulatory affairs and regulatory submissions

Ralph Almeleh is a celebrated surgeon and distinguished entrepreneur

Tuhin Bhowmick, PhD, is devoted to biotechnology innovation as the co-founder of Pandorum Technologies Pvt. Ltd.

Jonathan Colon, PhD, celebrated for nearly 15 years of building skills in nanotechnology and biotechnology

Providing robust cybersecurity solutions to protect sensitive data, ensure compliance, and mitigate cyber threats across various industries.

At ASHG, Illumina to Share Updates to Sequencing, Proteomics, and Single-Cell Technologies  Genetic Engineering & Biotechnology News

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ProMach brand Pharmaworks will debut their capability to handle new 100-percent recyclable, mono-material packaging films on their blister machines.

The innovative biotech company plans to hire 60 people over the next five years.

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