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Pharmaceutical

Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b

Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b

Share:   Company to initiate Phase 2b clinical trial in lead asset, LP-10 in 2H 2024 Pittsburgh, PA, May 21, 2024 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company, announced today the receipt of U.S. Food & Drug Administration (“FDA”) Type-C meeting guidance regarding the LP-10 (liposomal tacrolimus) clinical program. Lipella expects to initiate a Phase 2b clinical trial evaluating LP-10 as a treatment for hemorrhagic...

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PRISM MarketView – Weekly Market Report – April 26, 2024 

PRISM MarketView – Weekly Market Report – April 26, 2024 

PRISM Market Pulse: Equities Rally Amid Mixed Big Tech Earnings; Economic Shifts and Sector-Specific Highlights New York, N.Y., April 26, 2024 - PRISM MarketView - Equities were higher through the morning into midday trading as the S&P 500 and Nasdaq are set to snap their three- and four-week losing streaks. Big tech was the topic of Street-talk this week as some of the Magnificent Seven reported earnings. The reports produced mixed and opposite reactions by the Street as Tesla (TSLA)...

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PRISM MarketView – Biotech Breakfast 

PRISM MarketView – Biotech Breakfast 

Roche’s Alecensa Gets FDA Green Light; ImmunityBio Gains as PDUFA Date Approaches for Bladder Cancer Drug; Key Drug Trial Failures in 2024 New York, N.Y., April 22, 2024 - PRISM MarketView - Healthcare equities finished mostly higher after a very quiet trading session on Friday. The S&P 500 Healthcare Index closed up +0.32% versus the S&P 500 Index which lost (0.88%) and the XBI settled down (0.78%). A lack of momentum today left Roche stock up by just +0.95% following the FDA greenlit...

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PRISM MarketView – Weekly Market Report 

PRISM MarketView – Weekly Market Report 

PRISM Market Pulse: Market Tumbles Amid Fed's Rate Stance; Mixed Corporate Earnings Highlight Sector Struggles New York, N.Y., April 19, 2024 - PRISM MarketView - Equities were down in the morning and into midday as the major indices remain on track to notch their third straight week of declines. Fedspeak continues to support the “higher-for-longer” narrative with no urgency to cut rates which has created further sharp outflows and investor skepticism. The Street has taken investors’ pulses in...

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PRISM MarketView – Bio Investor Alert

PRISM MarketView – Bio Investor Alert

New York, N.Y., April 18, 2024 - PRISM MarketView - More than 83,000 new cases of bladder cancer are diagnosed in the US each year, and the illness is responsible for around 17,000 deaths annually. Urothelial carcinoma accounts for 90% of bladder cancers in the US and western Europe, and surgery, followed by chemotherapy or radiation is the current standard of care. There are 24 drugs approved by the FDA for bladder cancer, but due to invasive and life-changing surgical procedures, researchers...

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Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b

Lipella Pharmaceuticals Expands its Advisory Board to Include Oncology Expertise

The new oncology committee will include: Jason Hafron, MD, DDS, PhD, MPH; and Pradeep Tyagi, PhD, MBA Pittsburgh, PA, April 17, 2024 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company, today announced the expansion of its Scientific Advisory Board to include oncology expertise. The new committee members are: Jason Hafron, MD, DDS, PhD, MPH, the Chief Medical Officer at Michigan Institute of Urology, and Professor of Urology at the...

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PRISM MarketView – Biotech Breakfast

PRISM MarketView – Biotech Breakfast

Mobile-Health Network Solutions (MNDR) IPOs; Q32 Bio Surges; EMA Concludes GLP-1 Drugs Not Associated with Suicidal Thoughts New York, N.Y., April 15, 2024 - PRISM MarketView - Healthcare equities finished lower on Friday, in line with broad declines across the market. The S&P 500 Healthcare Index closed down (1.52%) versus the S&P 500 Index which lost (1.46%) and the XBI settled down (3.43%). The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee concluded...

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Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b

Lipella Pharmaceuticals to Publish Abstract Detailing Compelling Preclinical Support for New Product Candidate at ASCO 2024

Pittsburgh, PA, April 05, 2024 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces that its abstract has been accepted for the 2024 American Society of Clinical Oncology (ASCO) meeting on May 31 through June 4 in Chicago, Illinois. Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel...

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PRISM MarketView Features Auto Parts 4 Less in the Automotive E-Commerce Marketplace

PRISM MarketView Features Auto Parts 4 Less in the Automotive E-Commerce Marketplace

New York, N.Y., April 05, 2024 - PRISM MarketView announces the release of an informative interview with Auto Parts 4 Less CEO Christopher Davenport, explaining the company’s strategic business model and focus on expanding its automotive eCommerce marketplace. Christopher Davenport - CEO of Auto Parts 4 Less Auto Parts 4 Less is an innovator focused on developing a world-class eCommerce marketplace for automotive parts that utilizes integrated technologies to optimize the listing, selling, and...

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Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b

Lipella Pharmaceuticals Announces FDA Type C Meeting for LP-10 for Hemorrhagic Cystitis

Pittsburgh, PA, April 03, 2024 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Type C meeting request to discuss the company’s proposed Phase-2b clinical trial design for the evaluation of LP-10, an intravesical liposomal formulation of tacrolimus, as a potential treatment for...

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PRISM MarketView – Biotech Breakfast

PRISM MARKETVIEW PREVIEWS ANTICIPATED FDA DRUG APPROVALS FOR 2024

New York, N.Y., March 25, 2024 - PRISM MarketView - Drug development is an arduous, costly and time-consuming process for the teams involved behind the scenes, and the patients anxiously awaiting breakthroughs in different disease areas. It takes 12 years on average for a company to take a drug from discovery to commercialization, and every hard-won FDA approval is a cause for celebration for researchers, companies and the end-users whose lives may be changed by these treatments. The past few...

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PRISM MarketView Spotlights Companies Leading the Charge in Liver Disease Treatment Following Landmark FDA Approval

PRISM MarketView Spotlights Companies Leading the Charge in Liver Disease Treatment Following Landmark FDA Approval

New York, N.Y., March 18, 2024 - PRISM MarketView, a leading provider of unbiased market insight and company news, today highlights the FDA’s landmark approval of Rezdiffra™ and the companies leading the charge in developing new, safe, and effective treatments for liver disease. The landmark decision has shone a light on metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic fatty liver disease, a leading cause of liver-related mortality that affects between...

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PRISM MarketView Spotlights Lipella Pharmaceuticals as it Seizes Opportunities in Rare Disease

PRISM MarketView Spotlights Lipella Pharmaceuticals as it Seizes Opportunities in Rare Disease

New York, N.Y., March 07, 2024 - PRISM MarketView announces the release of an insightful interview with Lipella Pharmaceuticals’ CEO, Dr. Jonathan Kaufman, discussing the company's recent regulatory accomplishments and how investors stand to benefit. Lipella Pharmaceuticals was recently granted Orphan Drug Designation by the FDA for LP-410, its drug candidate for oral Graft-versus-Host Disease (GvHD) and previously received Orphan Drug Designation for LP-10 in 2023. With these nods from the...

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Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b

Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline

Clinical testing of LP-410 expected to commence in Q2 2024 Pittsburgh, PA, March 05, 2024 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for clinical testing of LP-410 in the treatment of oral Graft-Versus-Host Disease (GVHD). Lipella’s...

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PRISM MarketView Highlights Work of Emerging Companies on Rare Disease Day

PRISM MarketView Highlights Work of Emerging Companies on Rare Disease Day

New York, N.Y., February 29, 2024 - PRISM MarketView, a leading provider of unbiased market insight and company news, recognizes the remarkable contributions of companies developing treatments for the 10,000 rare diseases affecting more than 30 million Americans. All areas of medicine, and all organs and body systems, are impacted by rare diseases, including rare neurological and neuromuscular diseases, metabolic, skin and bone diseases, and chromosomal disorders. Approximately 95% of rare...

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Lipella Pharmaceuticals to Present at PropThink Digital Investor Conference

Lipella Pharmaceuticals to Present at PropThink Digital Investor Conference

Chief Medical Officer Dr. Michael Chancellor will discuss hemorrhagic cystitis and the company’s lead candidate, LP-10 Pittsburgh, PA, February 20, 2023 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company") a pioneering, clinical-stage pharmaceutical company, announced today that Chief Medical Officer Dr. Michael Chancellor will present at the PropThink Digital Investor Conference’s key opinion leader (KOL) discussion on Friday, February 23, 2024, at 2 PM ET....

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Lipella Pharmaceuticals Marks Successful First Year with Strategic Progress and Key Milestones Accomplished

Lipella Pharmaceuticals Marks Successful First Year with Strategic Progress and Key Milestones Accomplished

-Lipella Granted Two Orphan Drug Designations by FDA- Pittsburgh, PA, December 20, 2023 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company") a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity. Based in Pittsburgh, PA, the Company has made substantial strides over the past year, achieving critical milestones and advancing its pipeline with three clinical indications and two orphan drug designations...

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PRISM AdTech & Media Company Spotlight: Creative Realities (CREX) Illuminates the Future of Experiential Design

PRISM AdTech & Media Company Spotlight: Creative Realities (CREX) Illuminates the Future of Experiential Design

NEW YORK, NY, December 14, 2023 - In the fast-paced landscape of experiential design and technology, Creative Realities Inc. ($CREX) seamlessly integrates the physical and digital realms in creating immersive experiences that captivate audiences across various industries. From transforming retail spaces into dynamic environments to utilizing cutting-edge technologies in interactive displays, CREX is reshaping the way we interact with the world....

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FDA Grants PMA Supplement Approval for ReShape Lifesciences Lap Band; Shares Surge 100%

FDA Grants PMA Supplement Approval for ReShape Lifesciences Lap Band; Shares Surge 100%

NEW YORK, NY, December 13, 2023 - ReShape Lifesciences (Nasdaq: RSLS) has been granted FDA approval of a PMA supplement for the company’s next generation, enhanced Lap-Band® 2.0 FLEX. The company’s share price surged 100% in trading on Wednesday morning. https://prismmarketview.com/companies/reshape-lifesciences-inc/ Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences, said, “PMA supplement approval for our next generation Lap-Band® 2.0 FLEX is a...

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PRISM MarketView Biotech in Motion Spotlight: Quoin Receives FDA Clearance for Netherton Syndrome Clinical Optimization Plan

PRISM MarketView Biotech in Motion Spotlight: Quoin Receives FDA Clearance for Netherton Syndrome Clinical Optimization Plan

NEW YORK, NY, December 13, 2023 - Quoin Pharmaceuticals (Nasdaq: QNRX) has received U.S. Food and Drug Administration (FDA) clearance to implement several protocol amendments to its two ongoing clinical trials for QRX003, which is a potential treatment for Netherton Syndrome, a rare genetic skin disease for which there is no cure and no approved treatments. These protocol amendments are being implemented with a view to generating an even more robust data set and potentially more...

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Hand-Spun Success: Why Did Shake Shack’s Shares Jump Today?

Hand-Spun Success: Why Did Shake Shack’s Shares Jump Today?

NEW YORK, NY, December 11, 2023 - Shares in the casual dining chain, Shake Shack ($SHAK) jumped nearly 10% today after the company provided a financial outlook for 2024 and announced the departure of its long-time CEO, Randy Garutti. Mr. Garutti will continue to lead Shake Shack as CEO and as an executive Board member until early 2024. The company stated it would retain Mr. Garutti as an advisor through the end of 2024 to ensure a seamless transition....

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MyMD Tackles Rheumatoid Arthritis with Launch of Phase 2 Trial in Early 2024

MyMD Tackles Rheumatoid Arthritis with Launch of Phase 2 Trial in Early 2024

NEW YORK, NY, December 11, 2023 - The FDA has cleared an Investigational New Drug Application (IND) for MyMD Pharmaceuticals (Nasdaq: MYMD) to initiate a  Phase 2 clinical trial of oral MYMD-1® as a treatment for rheumatoid arthritis (RA). The company plans to launch the trial in the first quarter of 2024. Chris Chapman, M.D., president, director, and chief medical officer of MyMD Pharmaceuticals, said, “With the FDA’s recent clearance of our IND in RA, we are moving forward with plans to...

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PRISM Analysis: Stocks Making the Biggest Moves in Thursday Trading

PRISM Analysis: Stocks Making the Biggest Moves in Thursday Trading

NEW YORK, NY, December 07, 2023 - US equities are settling mostly higher in Thursday midday trading, with big tech broadly higher as Google ($GOOG) rallies after the company’s launch of Project Gemini, an AI model trained to behave in human-like ways. Airlines, including JetBlue ($JBLU), credit cards and chemicals are performing well. https://prismmarketview.com/prism-analysis-stocks-making-the-biggest-moves-in-thursday-trading/ Notable gainers for the day include Verint Systems ($VRNT) which...

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PRISM Analysis: Stocks Making the Biggest Moves in Thursday Trading

PRISM Next Gen Tech Company Spotlight: The Glimpse Group’s Journey into the Future

NEW YORK, NY, December 07, 2023 - In the ever-evolving landscape of technological innovation, the Glimpse Group, Inc. (VRAR) emerges as a beacon of creativity and ingenuity, weaving a future where virtual and augmented realities seamlessly blend with our daily lives. Glimpse, combines reality with the extraordinary, allowing for the future to become a tangible reality. https://prismmarketview.com/companies/the-glimpse-group/ Company Snapshot: A Glimpse into Glimpse Group At the heart of...

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PRISM Analysis: Stocks Making the Biggest Moves in Thursday Trading

PRISM MarketView Biotech Index Top Mover Spotlight: Kamada (KMDA)

NEW YORK, NY, December 07, 2023 - PRISM MarketView, a leading provider of unbiased market insight and company news, highlights Kamada Ltd. (Nasdaq: KMDA), a commercial-stage global biopharmaceutical company with a portfolio of products for rare and serious conditions and a leader in the specialty plasma-derived field, today announced it has inked its largest commercial agreement to date, set to take effect in January 2024. https://prismmarketview.com/companies/kamada-ltd/...

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PRISM Analysis: Stocks Making the Biggest Moves in Thursday Trading

PRISM MARKETVIEW HIGHLIGHTS ALTIMMUNE’S POSITIVE TOPLINE RESULTS IN OBESITY DRUG TRIAL

NEW YORK, NY, December 05, 2023 - PRISM MarketView, a leading provider of unbiased market insight and company news, highlights Altimmune, Inc. (Nasdaq: ALT) which has reported positive topline results from its 48-week MOMENTUM Phase 2 obesity trial of pemvidutide. https://prismmarketview.com/companies/altimmune-inc/ The company’s study enrolled 391 subjects with obesity and at least one comorbidity. Over 50% of subjects achieved at least 15% weight loss and over 30% of subjects achieved at...

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Timber Pharmaceuticals Announces Commencement of NYSE American Delisting Proceedings: Common Stock Expected to Begin Trading on the OTC Market

Timber Pharmaceuticals Announces Commencement of NYSE American Delisting Proceedings: Common Stock Expected to Begin Trading on the OTC Market

WARREN, N.J., Nov. 29, 2023 -- Timber Pharmaceuticals, Inc. ("Timber" or the "Company") (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that the staff of NYSE Regulation (the “NYSE Regulation”) has determined to immediately suspend trading in the Company’s common stock from NYSE American, LLC (the “NYSE American”). As previously disclosed, the NYSE...

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Timber Pharmaceuticals Announces Commencement of NYSE American Delisting Proceedings: Common Stock Expected to Begin Trading on the OTC Market

Lipella Pharmaceuticals Granted FDA Orphan Designation for Oral Graft-versus-Host Disease Drug

“GvHD affects approximately 30,000 Americans and oral GvHD causes significant oral pain and discomfort, making it difficult for patients to eat, drink and speak. Oral GvHD is a great unmet need in cancer survivors.” Dr. Michael Chancellor, Chief Medical Officer at Lipella Pharmaceuticals Pittsburgh, PA, November 10, 2023 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our, “us” or the “Company”), has received Orphan Drug Designation for its LP-310 drug candidate for oral...

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Lipella Pharmaceuticals to Present at the Fall Foliage MicroCap Rodeo Conference

Lipella Pharmaceuticals to Present at the Fall Foliage MicroCap Rodeo Conference

Pittsburgh, PA, October 23, 2023 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our, “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, will present at the 2023 virtual Fall Foliage MicroCap Rodeo Conference to be held from October 24th - 27th. Dr. Jonathan Kaufman, CEO of Lipella, said: “2023 continues to be a year of significant milestone achievements for Lipella. Early in the year, we were delighted to report...

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