Articles from Phathom Pharmaceuticals
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FLORHAM PARK, N.J., Jan. 29, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today that members of the management team will participate in a fireside chat at the Guggenheim Securities SMID Cap Biotech Conference on Thursday, February 6, 2025, at 10:00 am ET.
By Phathom Pharmaceuticals · Via GlobeNewswire · January 29, 2025
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FLORHAM PARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today it has submitted a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA). The petition formally requests correction of the Orange Book listings for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets to accurately reflect the full 10-year NCE exclusivity period until May 3, 2032.
By Phathom Pharmaceuticals · Via GlobeNewswire · December 11, 2024
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FLORHAM PARK, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today reported financial results for the third quarter of 2024, and provided recent business updates.
By Phathom Pharmaceuticals · Via GlobeNewswire · November 7, 2024
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FLORHAM PARK, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today that members of its management team are scheduled to participate in the following investor conferences in November and December:
By Phathom Pharmaceuticals · Via GlobeNewswire · November 4, 2024
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FLORHAM PARK, N.J., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it will host a live webcast at 8:30 am ET on Thursday, November 7, 2024, to report its third quarter 2024 financial results and provide a business update.
By Phathom Pharmaceuticals · Via GlobeNewswire · October 28, 2024
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FLORHAM PARK, N.J., Oct. 27, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced that the company will present data from multiple investigational studies for its first-in-class treatment VOQUEZNA® (vonoprazan) tablets at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting, being held October 25-30 in Philadelphia, PA. VOQUEZNA is approved for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD), for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn, and in combination with antibiotics for the eradication of Helicobacter pylori (H. pylori) infection.1 VOQUEZNA is the first and only U.S. Food and Drug Administration (FDA)-approved potassium-competitive acid blocker (PCAB).2
By Phathom Pharmaceuticals · Via GlobeNewswire · October 27, 2024
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FLORHAM PARK, N.J., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today that members of its management team are scheduled to participate in the following investor conferences in September:
By Phathom Pharmaceuticals · Via GlobeNewswire · August 29, 2024
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FLORHAM PARK, N.J., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the pricing of its underwritten offering of 8,695,652 shares of its common stock and pre-funded warrants to purchase 2,608,922 shares of common stock. The shares of common stock are being sold at a price of $11.50 per share and the pre-funded warrants are being sold at a price of $11.499 per pre-funded warrant, which represents the per share price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The gross proceeds to Phathom from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $130 million. The offering is expected to close on or about August 20, 2024, subject to satisfaction of customary closing conditions.
By Phathom Pharmaceuticals · Via GlobeNewswire · August 19, 2024
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FLORHAM PARK, N.J., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today reported financial results for the second quarter of 2024, and provided recent business updates.
By Phathom Pharmaceuticals · Via GlobeNewswire · August 8, 2024
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FLORHAM PARK, N.J., July 30, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announces that effective immediately, CVS Caremark has added VOQUEZNA® (vonoprazan) tablets to its commercial formularies. VOQUEZNA is approved for the relief of heartburn associated with Non-Erosive GERD and for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn. VOQUEZNA is the first and only FDA-approved potassium-competitive acid blocker (PCAB) available in the United States. Over 116 million commercially covered lives are now estimated to have access to VOQUEZNA.
By Phathom Pharmaceuticals · Via GlobeNewswire · July 30, 2024
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FLORHAM PARK, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it will host a live webcast at 8:30 am ET on Thursday, August 8, 2024, to report its second quarter 2024 financial results and provide an update on business progress.
By Phathom Pharmaceuticals · Via GlobeNewswire · July 29, 2024
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A Media Snippet accompanying this announcement is available by clicking on this link.
By Phathom Pharmaceuticals · Via GlobeNewswire · July 18, 2024
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FLORHAM PARK, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today that members of its management team are scheduled to participate in the following investor conferences in June:
By Phathom Pharmaceuticals · Via GlobeNewswire · May 28, 2024
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FLORHAM PARK, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced that the company will present data from multiple studies for its first-in-class treatment VOQUEZNA® (vonoprazan) including an oral presentation at Digestive Disease Week® (DDW) 2024, being held May 18-21 in Washington, D.C.
By Phathom Pharmaceuticals · Via GlobeNewswire · May 15, 2024
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FLORHAM PARK, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today reported financial results for the first quarter of 2024, and provided recent business highlights.
By Phathom Pharmaceuticals · Via GlobeNewswire · May 9, 2024
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FLORHAM PARK, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it will host a live webcast at 8:30 am ET on Thursday, May 9, 2024, to report its first quarter 2024 financial results and provide an update on business progress.
By Phathom Pharmaceuticals · Via GlobeNewswire · April 29, 2024
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FLORHAM PARK, N.J., April 03, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of the management team will participate in a fireside chat at the 23rd Annual Needham Virtual Healthcare Conference on Wednesday, April 10, 2024, at 9:30 a.m. ET.
By Phathom Pharmaceuticals · Via GlobeNewswire · April 3, 2024
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National TV and digital media campaign aims to motivate millions of people suffering from Erosive GERD to learn more about VOQUEZNA® (vonoprazan), the first and only FDA-approved potassium-competitive acid blocker (PCAB)
By Phathom Pharmaceuticals · Via GlobeNewswire · March 26, 2024
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FLORHAM PARK, N.J., March 07, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent business highlights.
By Phathom Pharmaceuticals · Via GlobeNewswire · March 7, 2024
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FLORHAM PARK, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it will host a live webcast at 8:30 am ET on Thursday, March 7, 2024, to report its fourth quarter and full year 2023 financial results and provide recent business progress.
By Phathom Pharmaceuticals · Via GlobeNewswire · February 29, 2024
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FLORHAM PARK, N.J., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced the placement of VOQUEZNA® (vonoprazan) tablets for the treatment of adults with Erosive Esophagitis, commonly referred to as Erosive GERD (gastroesophageal reflux disease), and relief of heartburn associated with Erosive Esophagitis on the Express Scripts national formularies, effective immediately. VOQUEZNA is the first and only FDA-approved potassium-competitive acid blocker (PCAB) and the first new class of Erosive GERD treatment to become available in the United States in over 30 years. Commercial access for VOQUEZNA tablets is now estimated at 60 million covered lives in the United States.
By Phathom Pharmaceuticals · Via GlobeNewswire · February 13, 2024
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FLORHAM PARK, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of the management team will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Wednesday, February 7, 2024, at 1:30 p.m. ET.
By Phathom Pharmaceuticals · Via GlobeNewswire · January 31, 2024
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FLORHAM PARK, N.J., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced an amendment to its term loan facility from Hercules Capital, Inc. (NYSEHTGC), a leader in customized debt financing for companies in life sciences and technology-related markets. Sagard Healthcare is also participating in the term loan facility.
By Phathom Pharmaceuticals · Via GlobeNewswire · December 14, 2023
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FLORHAM PARK, N.J., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the FDA has accepted for review the company’s NDA for VOQUEZNA (vonoprazan) as a daily treatment of heartburn associated with Non-Erosive gastroesophageal reflux disease (GERD) in adults. The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.
By Phathom Pharmaceuticals · Via GlobeNewswire · December 6, 2023
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FLORHAM PARK, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the U.S. commercial availability of VOQUEZNA® (vonoprazan). VOQUEZNA is now available for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD (gastroesophageal reflux disease), and the relief of heartburn associated with Erosive GERD.1 As the first and only approved potassium-competitive acid blocker (PCAB) in the U.S., this milestone brings the power of a new class of acid suppression treatment to a disease with high unmet need.
By Phathom Pharmaceuticals · Via GlobeNewswire · November 28, 2023
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FLORHAM PARK, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the third quarter of 2023 and provided updates on recent regulatory and business progress.
By Phathom Pharmaceuticals · Via GlobeNewswire · November 9, 2023
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FLORHAM PARK, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today the U.S. Food and Drug Administration (FDA) has approved VOQUEZNA® (vonoprazan) tablets 10 mg and 20 mg, a novel potassium-competitive acid blocker (PCAB), as a new treatment for adults for the healing of all grades of Erosive Esophagitis, also known as Erosive GERD (gastroesophageal reflux disease), maintenance of healing of all grades of Erosive GERD, and relief of heartburn associated with Erosive GERD.2
By Phathom Pharmaceuticals · Via GlobeNewswire · November 1, 2023
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FLORHAM PARK, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) for the reformulation of vonoprazan tablets for both VOQUEZNA TRIPLE PAK (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA DUAL PAK (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori (H. pylori) infection in adults. VOQUEZNA treatment regimens contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years.
By Phathom Pharmaceuticals · Via GlobeNewswire · October 30, 2023
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FLORHAM PARK, N.J., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of its management team are scheduled to participate in the following investor conferences in November:
By Phathom Pharmaceuticals · Via GlobeNewswire · October 25, 2023
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FLORHAM PARK, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the submission of an NDA to the FDA for vonoprazan as a daily treatment for Non-Erosive gastroesophageal reflux disease (GERD) in adults. The regulatory submission is supported by the positive data from the PHALCON-NERD-301 study, a Phase 3 study evaluating the efficacy and safety of vonoprazan for the daily treatment of adults with Non-Erosive GERD (NERD). Vonoprazan is an investigational first-in-class potassium-competitive acid blocker (PCAB) from a novel class of medicines that block acid secretion in the stomach.
By Phathom Pharmaceuticals · Via GlobeNewswire · September 26, 2023
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FLORHAM PARK, N.J., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of its management team will participate in the following upcoming investor conferences:
By Phathom Pharmaceuticals · Via GlobeNewswire · September 5, 2023
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FLORHAM PARK, N.J., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced it has submitted to the FDA six-month stability data from its long-term and accelerated stability program for its reformulated vonoprazan tablets. The additional stability was required for the FDA to complete its NDA review for vonoprazan, a novel first-in-class potassium-competitive acid blocker (PCAB), for the treatment of Erosive GERD (gastroesophageal reflux disease), also referred to as erosive esophagitis.
By Phathom Pharmaceuticals · Via GlobeNewswire · August 21, 2023
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FLORHAM PARK, N.J., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the second quarter of 2023 and provided updates on recent regulatory and business progress.
By Phathom Pharmaceuticals · Via GlobeNewswire · August 10, 2023
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FLORHAM PARK, N.J., June 12, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged that its New Drug Application (NDA) resubmission for vonoprazan, a novel first-in-class potassium-competitive acid blocker (PCAB), for the treatment of Erosive GERD (gastroesophageal reflux disease) constitutes a complete response to the February 2023 complete response letter (CRL). The FDA has classified this as a Class 2 resubmission and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023.
By Phathom Pharmaceuticals · Via GlobeNewswire · June 12, 2023
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FLORHAM PARK, N.J., June 09, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the closing of the sale of an additional 1,668,750 shares of common stock at a public offering price of $11.75 per share pursuant to the exercise in full of the underwriters’ option to purchase additional shares in connection with Phathom’s recently completed public offering. After giving effect to the sale of these additional shares, the total gross proceeds to Phathom from the offering were approximately $150.3 million, before deducting the underwriting discounts and commissions and other offering expenses.
By Phathom Pharmaceuticals · Via GlobeNewswire · June 9, 2023
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FLORHAM PARK, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of its management team will participate in the following upcoming investor conferences:
By Phathom Pharmaceuticals · Via GlobeNewswire · June 1, 2023
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FLORHAM PARK, N.J., May 23, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the pricing of its underwritten public offering of 11,125,000 shares of its common stock at a price to the public of $11.75 per share. The gross proceeds to Phathom from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $130.7 million. In addition, Phathom has granted the underwriters a 30-day option to purchase up to an additional 1,668,750 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about May 26, 2023, subject to satisfaction of customary closing conditions.
By Phathom Pharmaceuticals · Via GlobeNewswire · May 23, 2023
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FLORHAM PARK, N.J., May 23, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. In addition, Phathom intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of the shares of its common stock offered in the public offering. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
By Phathom Pharmaceuticals · Via GlobeNewswire · May 23, 2023
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FLORHAM PARK, N.J., May 23, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it has resubmitted its New Drug Application (NDA) for vonoprazan, a novel first-in-class potassium-competitive acid blocker (PCAB), for the treatment of Erosive GERD (gastroesophageal reflux disease), also referred to as erosive esophagitis, to the U.S. Food and Drug Administration (FDA).
By Phathom Pharmaceuticals · Via GlobeNewswire · May 23, 2023
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FLORHAM PARK, N.J., May 10, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the first quarter of 2023 and provided updates on recent regulatory progress.
By Phathom Pharmaceuticals · Via GlobeNewswire · May 10, 2023
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FLORHAM PARK, N.J., May 09, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced new data from two post-hoc analyses presented in poster presentations at Digestive Disease Week® (DDW) 2023, held May 6-9 in person in Chicago, IL and virtually.
By Phathom Pharmaceuticals · Via GlobeNewswire · May 9, 2023
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FLORHAM PARK, N.J., April 12, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of its management team will participate in the following upcoming investor conferences:
By Phathom Pharmaceuticals · Via GlobeNewswire · April 12, 2023
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FLORHAM PARK, N.J., April 04, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today provided a regulatory update following its recent meeting with the FDA regarding the complete response letters (CRLs) for Phathom’s erosive esophagitis NDA and H. pylori post approval supplement (PAS) to VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® NDAs. Both CRLs were solely related to specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan (NVP).
By Phathom Pharmaceuticals · Via GlobeNewswire · April 4, 2023
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FLORHAM PARK, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.
By Phathom Pharmaceuticals · Via GlobeNewswire · February 28, 2023
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FLORHAM PARK, N.J., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced regulatory updates for its approved products, VOQUEZNA™ TRIPLE PAK™ and VOQUEZNA DUAL PAK™, approved in the U.S. for the treatment of H. pylori infection, and its pending New Drug Application (NDA) for vonoprazan for the treatment of erosive esophagitis. Phathom has received complete response letters from the U.S. Food and Drug Administration (FDA) relating to its erosive esophagitis NDA and H. pylori post approval supplement, both of which address specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan (NVP), that was detected in the initial commercial launch materials of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. These letters formalize FDA’s request, announced by the Company last month, that Phathom provide additional stability data to demonstrate that levels of the impurity previously found in vonoprazan drug product will remain at or below the daily acceptable intake throughout the proposed shelf life of the product. No additional deficiencies were cited by the FDA in either letter.
By Phathom Pharmaceuticals · Via GlobeNewswire · February 9, 2023
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FLORHAM PARK, N.J., Jan. 08, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, announced today positive topline results from PHALCON-NERD-301, a Phase 3 study evaluating the efficacy and safety of vonoprazan for the daily treatment of adults in symptomatic non-erosive gastroesophageal reflux disease (sGERD or NERD). Vonoprazan is an investigational first-in-class potassium-competitive acid blocker (PCAB) from a novel class of medicines that block acid secretion in the stomach. Full results from the study are expected later this year.
By Phathom Pharmaceuticals · Via GlobeNewswire · January 8, 2023
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FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that no action will be taken on the Company’s new drug application (NDA) for vonoprazan, a novel potassium-competitive acid blocker (PCAB), under review as a treatment for erosive esophagitis, on or prior to the current Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023.
By Phathom Pharmaceuticals · Via GlobeNewswire · January 3, 2023
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FLORHAM PARK, N.J., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the third quarter of 2022 and provided recent business updates.
By Phathom Pharmaceuticals · Via GlobeNewswire · November 8, 2022
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FLORHAM PARK, N.J., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, announced today that members of its management team will participate in upcoming investor conferences:
By Phathom Pharmaceuticals · Via GlobeNewswire · November 3, 2022
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FLORHAM PARK, N.J., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced that up to an additional $40 million in non-dilutive capital has been secured from an additional investor under the terms of Phathom’s revenue interest financing agreement announced on May 4, 2022.
By Phathom Pharmaceuticals · Via GlobeNewswire · November 1, 2022
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FLORHAM PARK, N.J., Oct. 24, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced it has completed enrollment in its PHALCON-NERD Daily Dosing Phase 3 trial of vonoprazan in non-erosive gastroesophageal reflux disease (NERD). Vonoprazan is an investigational first-in-class potassium-competitive acid blocker (PCAB) from a novel class of medicines that block acid secretion in the stomach. The Company expects to share topline data from the primary endpoint in the first quarter of 2023 and full results from the study in late 2023.
By Phathom Pharmaceuticals · Via GlobeNewswire · October 24, 2022
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FLORHAM PARK, N.J., Oct. 23, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, announced today that detailed results from an investigational Phase 2 study evaluating the efficacy of vonoprazan in non-erosive gastroesophageal reflux disease (NERD) and other data will be presented at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting, being held October 21-26 in Charlotte, NC.
By Phathom Pharmaceuticals · Via GlobeNewswire · October 23, 2022
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FLORHAM PARK, N.J., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, announced today the company will present new data and research at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting, being held October 21-26 in Charlotte, NC.
By Phathom Pharmaceuticals · Via GlobeNewswire · October 18, 2022