First Wave BioPharma

First Wave Biopharma, Inc. is a clinical stage biopharmaceutical company, which engages in the research and development of non-systemic therapies for the treatment of gastrointestinal diseases. The firm is involved in a therapeutic development pipeline populated with multiple clinical stage programs built around its proprietary technologies, such as Niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. Its programs include FW-UP, FW-UC, FW-CD, FW-COV, FW-ICI-AC, MS1819, COVID-19 GI infections, and FW-EPI. The company was founded on January 30, 2014 and is headquartered in Boca Raton, FL.

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Entero Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the research and development of non-systemic therapies for the treatment of gastrointestinal diseases. The firm is involved in a therapeutic development pipeline populated with multiple clinical stage programs built around its proprietary technologies, such as Niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. Its programs include FW-UP, FW-UC, FW-CD, FW-COV, FW-ICI-AC, MS1819, COVID-19 GI infections, and FW-EPI. The company was founded on January 30, 2014 and is headquartered in Boca Raton, FL.

Committee members include globally renowned experts in gastrointestinal diseases, including ulcerative colitis and Crohn's disease Committee members include globally renowned experts in gastrointestinal diseases, including ulcerative colitis and Crohn's disease

First Wave BioPharma Forms Clinical Steering Committee Focused on Advancing Inflammatory Bowel Disease (IBD) Product Portfolio

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BOCA RATON, Fla., March 28, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced the continued enhancement of the intellectual property (IP) portfolio governing niclosamide as a treatment for COVID-19-related GI infections. The Company has filed U.S. Patent and Patent Cooperation Treaty (PCT) applications entitled “Treatment of Long Haulers Syndrome with Niclosamide” (U.S. Application No. 17/703,626 and PCT Application No. PCT/US22/21736).

First Wave BioPharma Files U.S. and PCT Patent Applications for Niclosamide in Long-Haul COVID-19

BOCA RATON, Fla., March 22, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that James Sapirstein, Chairman and Chief Executive Officer, will deliver a virtual presentation at Maxim's 2022 Virtual Growth Conference being held March 28 – 30, 2022.

First Wave BioPharma to Participate in Maxim's 2022 Virtual Growth Conference

Poster presentation to feature research involving niclosamide as a potential treatment for mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis Poster presentation to feature research involving niclosamide as a potential treatment for mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis

First Wave BioPharma Announces Poster Presentation at the 2022 Digestive Disease Week (DDW) Conference

BOCA RATON, Fla., March 02, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ: FWBI) (the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal diseases, announced today the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules of 6,498,195 shares of its common stock (or common stock equivalents in lieu thereof) and five-year warrants to purchase up to an aggregate of 6,498,195 shares of common stock at an exercise price of $1.26 per share, at an effective purchase price of $1.385 per share and accompanying warrant.

First Wave BioPharma, Inc. Announces Closing of $9 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

BOCA RATON, Fla., Feb. 28, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. (NASDAQ: FWBI) (the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal diseases, announced today that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of an aggregate of 6,498,195 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 6,498,195 shares of common stock at an effective purchase price of $1.385 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants have an exercise price of $1.26 per share, are exercisable immediately, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about March 2, 2022, subject to the satisfaction of customary closing conditions.

First Wave BioPharma, Inc. Announces $9 Million Registered Direct Offering Priced At-The-Market Under NASDAQ Rules

BOCA RATON, Fla., Feb. 07, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman, President and CEO of First Wave BioPharma, will deliver a virtual presentation at the 2022 BIO CEO & Investor Conference. The event is taking place February 14-17, 2022, at the New York Marriott Marquis as a hybrid conference that allows virtual and in-person participation.

First Wave BioPharma to Participate in the 2022 BIO CEO & Investor Conference

First Wave BioPharma Inc (NASDAQ: FWBI) has filed two new provisional patent applications on adrulipase with the U.S. Patent and Trademark Office (USPTO).  The first application is directed to new lipase dosage forms, treatment methods, and manufacturing.

First Wave BioPharma Files Two Provisional US Patent Applications For Adrulipase

BOCA RATON, Fla., Jan. 13, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today provided an update on its adrulipase (FW-EPI) clinical program and advances involving adrulipase. Adrulipase is a recombinant lipase enzyme derived from the Yarrowia lipolytica yeast that First Wave BioPharma is developing for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis.

First Wave BioPharma Provides Update on Adrulipase (FW-EPI) Clinical Program

BOCA RATON, Fla., Jan. 07, 2022 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has further adjourned its Annual Meeting of Stockholders (the “Annual Meeting”) in order to provide stockholders additional time within which to vote on all proposals, including Proposal 2 to approve an amendment to the Company's certificate of incorporation to increase the Company's authorized shares of common stock from 25,000,000 to 50,000,000.

First Wave BioPharma Announces Further Adjournment of Annual Meeting

No Drug-Related SAEs Reported; Topline Data Expected 1H 2022

First Wave BioPharma Completes Enrollment for Part 2 of RESERVOIR Phase 2 Trial Evaluating FW-COV in COVID-19-Related GI Infections

CEO James Sapirstein to Moderate Panel Discussion during Longwood Healthcare Leaders Conference and Host Virtual Presentation at H.C. Wainwright BioConnect 2022 CEO James Sapirstein to Moderate Panel Discussion during Longwood Healthcare Leaders Conference and Host Virtual Presentation at H.C. Wainwright BioConnect 2022

First Wave BioPharma to Participate in Two Investor Conferences in January 2022

BOCA RATON, Fla., Dec. 17, 2021 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has adjourned its 2021 Annual Meeting of Stockholders (the “Annual Meeting”) in order to provide stockholders additional time within which to vote on all proposals, including Proposal 2 to approve an amendment to the Company's certificate of incorporation to increase the Company's authorized shares of common stock from 25,000,000 to 50,000,000.

First Wave BioPharma Announces Adjournment of Annual Meeting

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Appointment of world-renowned gastroenterologist and researcher reflects expanded clinical development of niclosamide in the treatment of inflammatory bowel diseases (IBDs) Appointment of world-renowned gastroenterologist and researcher reflects expanded clinical development of niclosamide in the treatment of inflammatory bowel diseases (IBDs)

First Wave BioPharma Names Brian Feagan, M.D., to Scientific Advisory Board

Industry leaders to discuss the trends fueling the future of Florida's life sciences industry Industry leaders to discuss the trends fueling the future of Florida's life sciences industry

First Wave BioPharma's CEO and President, James Sapirstein, to Participate in CEO Panel Discussion at 2021 BioFlorida Conference

The independent data monitoring committee (DMC) has recommended First Wave BioPharma Inc (NASDAQ: FWBI) to continue enrollment in Part 2 of the RESERVOIR Phase 2 trial evaluating FW-COV for COVID-19-related gastrointestinal (GI) infections.  FW-COV is a proprietary, oral tablet formulation of micronized niclosamide developed to remove SARS-CoV-2 from the GI tract.

First Wave BioPharma Stock Jumps On Niclosamide's Favorable Safety Profile In COVID-19 Related GI Infections

Shares of First Wave BioPharma Inc. FWBI, -2.58% rocketed 46.6% on very heavy volume in premarket trading Tuesday, after the biopharmaceutical company said an independent data monitoring committee (DMC) recommended continued enrollment in a Phase 2 trial of its treatment (FW-COV) for COVID-19-related gastrointestinal (GI) infections. Trading volume spiked to 12.0 million shares ahead of the open, enough to make the stock the most actively traded in the premarket, and compared with the full-day average of about 1.4 million shares.

First Wave BioPharma stock rockets after upbeat news on treatment for COVID-19-related GI infections

The stock price of First Wave BioPharma Inc (NASDAQ: FWBI) increased by over 50% pre-market today. This is why it happened.

First Wave BioPharma (FWBI) Stock: Why The Price Surged Today

Review of Data from Initial 25 Patients Completed with Favorable Recommendation Review of Data from Initial 25 Patients Completed with Favorable Recommendation

First Wave BioPharma Announces Independent Data Monitoring Committee Provides Positive Interim Safety Assessment for Part 2 COVID-19 RESERVOIR Clinical Trial of Niclosamide for the Treatment of Gastrointestinal Infections

First Wave BioPharma Inc (NASDAQ: FWBI) has agreed with the former shareholders of First Wave Bio Inc to amend the payment structure of the initial merger consideration and extend payments into 2023. Related Link:   AzurRx BioPharma To Acquire First Wave Bio For $229M.

First Wave Restructures Merger Consideration Payment Terms

Committee members include globally renowned experts in medical oncology, immune checkpoint inhibitor therapeutics, gastrointestinal (GI) diseases and cancer immunotherapy-related GI complications Committee members include globally renowned experts in medical oncology, immune checkpoint inhibitor therapeutics, gastrointestinal (GI) diseases and cancer immunotherapy-related GI complications

First Wave BioPharma Forms Steering Committee for Phase 2a PASSPORT Clinical Trial to Evaluate FW-ICI-AC in Cancer Patients with Immune Checkpoint Inhibitor-Associated Colitis

$229 million acquisition using only $22 million up-front. Low-risk, blockbuster potential GI assets acquired.

First Wave BioPharma Set For New Growth Trajectory With GI Pipeline Expansion De-Risking The Investment

BOCA RATON, Fla., Oct. 19, 2021 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that the U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug (IND) application and provided a “Study May Proceed” letter for the Company's Phase 2a PASSPORT trial investigating FW-ICI-AC as a treatment for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors (ICIs). FW-ICI-AC is a proprietary oral immediate-release tablet formulation of niclosamide, a prescription small molecule with anti-inflammatory and anti-viral properties.

First Wave BioPharma Announces FDA Clearance of IND Application for Phase 2a PASSPORT Trial of FW-ICI-AC as Treatment for Immune Checkpoint Inhibitor-Associated Colitis

News for First Wave BioPharma Stock (FWBI)