RedHill Biopharma Ltd, (NASDAQ: $RDHL) headquartered in Israel, is a specialized biopharmaceutical company primarily concentrating on gastrointestinal and infectious diseases. RedHill markets gastrointestinal drugs like Talicia, designed for treating Helicobacter pylori (H. pylori) infection, and Aemcolo, intended for addressing travelers’ diarrhea.
The company’s ongoing clinical late-stage development programs encompass RHB-204 for pulmonary nontuberculous mycobacteria (NTM) disease; opaganib (ABC294640), an SPHK2 inhibitor using a host-directed approach to target various indications; RHB-107 (upamostat), an oral serine protease inhibitor with potential for pandemic preparedness, currently in late-stage development for treating non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; RHB-104 for Crohn’s disease; and RHB-102 tailored for addressing nausea and vomiting induced by chemotherapy and radiotherapy.
$RDHL Price Soars
RedHill Biopharma’s stock saw a significant surge, more than doubling, following the approval by federal regulators granting the company five years of market exclusivity for its bacterial infection medication, Talicia.
The stock, which closed at 32 cents on Friday, opened at 70 cents, marking a remarkable increase. Despite this positive development, the shares are still down approximately 87% since the beginning of the year.
In a notable spike, RedHill Biopharma experienced an increase of over 216.9572%, reaching a price of $1 on Monday, November 27.
RedHill Biopharma Announces FDA Grant of 5-Year U.S. Market Exclusivity for Talicia with IP Protection Running to 2034
RedHill Biopharma Ltd. (RDHL), a specialty biopharmaceutical company, has disclosed that the U.S. FDA (U.S. Food and Drug Administration) granted five years of market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, following the FDA Exclusivity Board’s recommendation.
This exclusivity period is in addition to the three years granted for Talicia’s approval under Section 505(b)(2). Talicia’s protection extends through its broad intellectual property suite until 2034.
Patricia Anderson, Senior Vice President of Regulatory Affairs at RedHill, stated, “Talicia is the sole FDA-approved rifabutin-based therapy for eradicating H. pylori. Its optimized components and formulation aim to provide patients with the necessary medications for successful H. pylori eradication.
This market exclusivity, coupled with other intellectual property, reinforces protection until 2034.” She emphasized Talicia’s advantages, including favorable efficacy, tolerability, and resistance profile, as the only all-in-one formulation available, potentially surpassing clarithromycin-based regimens for most patients.
In a recent development, the FDA approved a supplemental new drug application (sNDA) for Talicia, permitting a more flexible three-times-daily (TID) dosing regimen, taken at least 4 hours apart with food, for H. pylori eradication.
This change allows patients to adopt a convenient “breakfast, lunch, and dinner” dosing routine, potentially enhancing patient adherence and optimizing the likelihood of successful H. pylori eradication.
What is the price prediction for RedHill Biopharma?
Seven analysts providing 12-month projections for Redhill Biopharma Ltd-sp Adr (RDHL) have set a target share price of $40. This average forecast indicates a significant 12,761.74% increase from the current price of $0.31.
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