60 Degrees Pharmaceuticals(SXTP)

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Sixty Degrees Pharmaceuticals to Ensure Continuity of Tafenoquine Supply in U.S. by Importing Limited Quantity of KODATEF®
Globenewswire· 2025-02-11 17:59
Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has received FDA approval to import KODATEF (tafenoquine) from Australia as a precautionary measure to ensure the availability of ARAKODA (tafenoquine) in the U.S. market [1][3] Group 1: Product Information - ARAKODA is an antimalarial drug approved for malaria prophylaxis in patients aged 18 and older in the U.S., while KODATEF is its equivalent in Australia [2][5] - Both ARAKODA and KODATEF share identical dosing regimens, mechanisms of action, safety and efficacy profiles [2][5] - Tafenoquine has a long terminal half-life of approximately 16 days, allowing for less frequent dosing [5] Group 2: Market Demand and Supply Strategy - Demand for ARAKODA has been increasing in the U.S. due to heightened awareness and usage [3] - The company plans to import a five-month supply of KODATEF while also increasing the manufacturing output of ARAKODA in the long term [3] Group 3: Company Background - 60 Degrees Pharmaceuticals, Inc. was founded in 2010 and focuses on developing medicines for infectious diseases [16] - The company achieved FDA approval for ARAKODA in 2018, with both ARAKODA and KODATEF launched commercially in 2019 [5][16]
60 Degrees Pharma Announces Closing of $1.075 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2025-02-06 19:07
Raised approximately $2.118 million in gross proceeds since the beginning of 2025WASHINGTON, Feb. 06, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of an aggregate of 1,503,500 shares of its common stock at a purchase price of ...
60 Degrees Pharma Announces $1.075 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2025-02-05 14:22
WASHINGTON, Feb. 05, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,503,500 shares of its common stock at a purchase price of $0.715 per share in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, th ...
60 Degrees Pharma Announces Closing of $1.043 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2025-01-30 19:20
Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has successfully closed a registered direct offering, raising approximately $1.043 million through the sale of 1,021,549 shares of common stock at a price of $1.021 per share, along with a concurrent private placement of short-term warrants [1][2]. Group 1: Offering Details - The registered direct offering involved the sale of 1,021,549 shares of common stock at a price of $1.021 per share [1]. - In addition to the common stock offering, the company issued unregistered short-term warrants to purchase up to 2,043,098 shares of common stock at an exercise price of $0.771 per share [1]. - The gross proceeds from the offering were approximately $1.043 million, before deducting fees and expenses [2]. Group 2: Use of Proceeds - The company intends to use the net proceeds from the offering for working capital and other general corporate purposes [2]. Group 3: Regulatory Compliance - The shares of common stock were offered under a "shelf" registration statement filed with the SEC, which became effective on July 18, 2024 [3]. - The short-term warrants were issued in a private placement and have not been registered under the Securities Act, limiting their sale in the U.S. [4]. Group 4: Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for infectious diseases and achieved FDA approval for its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018 [6]. - The company collaborates with prominent research organizations in the U.S., Australia, and Singapore, and has received support from the U.S. Department of Defense and private investors [6].
60 Degrees Pharma Announces $1.043 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2025-01-29 13:00
Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has announced a registered direct offering of 1,021,549 shares of common stock at a price of $1.021 per share, along with a concurrent private placement of short-term warrants to purchase up to 2,043,098 shares at an exercise price of $0.771 per share [1][2]. Group 1: Offering Details - The total gross proceeds from the offering are expected to be approximately $1.043 million before deducting fees and expenses [2]. - The closing of the offering is anticipated to occur on or about January 30, 2025, pending customary closing conditions [1]. - The shares are being offered under a "shelf" registration statement that became effective on July 18, 2024 [3]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for working capital and other general corporate purposes [2]. Group 3: Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for infectious diseases and received FDA approval for its lead product, ARAKODA® (tafenoquine), in 2018 [6]. - The company collaborates with research organizations in the U.S., Australia, and Singapore and has received support from the U.S. Department of Defense and private investors [6].
60 Degrees Pharma Announces IRB Approval of Phase II Study to Evaluate Tafenoquine for Chronic Babesiosis
GlobeNewswire News Room· 2025-01-28 13:01
Investigational Review Board (IRB) approval has been granted for the open-label study to evaluate tafenoquine for treatment of patients with a presumptive diagnosis of chronic babesiosis in outpatient settings.Enrollment expected to commence Q3 2025. WASHINGTON, Jan. 28, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today the approval of an Investigational Review ...
60 Degrees Pharmaceuticals Enrolls First Patient in Tafenoquine Expanded Access Clinical Study for Persistent (B. microti) Babesiosis
Newsfilter· 2025-01-08 13:02
Clinical Study and Market Potential - The first patient has been enrolled in NCT06478641, an expanded access clinical study to confirm the activity of tafenoquine in treating persistent babesiosis in high-risk patients who have failed standard care [1] - Tafenoquine exhibited an 80% cure rate in five high-risk patients with persistent, relapsing babesiosis who had failed prior standard-of-care treatments [2] - The total cumulative accessible market for ARAKODA (tafenoquine) for babesiosis may exceed 400,000 patients through the end of U.S. patent protection in December 2035 [4][8] Tafenoquine and ARAKODA Overview - Tafenoquine is approved for malaria prophylaxis in the U.S. under the product name ARAKODA and in Australia as KODATEF [6] - ARAKODA is indicated for malaria prophylaxis in patients aged 18 years and older, with a long terminal half-life of approximately 16 days, offering potential advantages in less-frequent dosing [6][7] - Tafenoquine was discovered by Walter Reed Army Institute of Research and commercially launched in 2019 [6] Safety and Adverse Reactions - ARAKODA should not be administered to patients with G6PD deficiency, during pregnancy or lactation, or with a history of psychotic disorders [9][10][11][17] - Common adverse reactions include headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams, and anxiety [13] - Serious hypersensitivity reactions, delayed adverse reactions, and psychiatric effects have been observed with ARAKODA use [12] Company Background - 60 Degrees Pharmaceuticals, founded in 2010, specializes in developing and marketing new medicines for infectious diseases [16] - The company achieved FDA approval of ARAKODA for malaria prevention in 2018 and collaborates with research organizations in the U.S., Australia, and Singapore [16] - The company is headquartered in Washington D.C., with a majority-owned subsidiary in Australia [18]
Sixty Degrees Pharmaceuticals and Tufts Medical Center Announce Patent License Agreement to Advance Development of Tafenoquine for Babesiosis Treatment and Prevention
Globenewswire· 2024-12-23 13:57
WASHINGTON, Dec. 23, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), pharmaceutical company, and Tufts Medical Center (“Tufts MC”), a leading academic medical center, today announced the signing of a Patent License Agreement to jointly advance the development and commercialization of tafenoquine for the treatment and prevention of babesiosis. Tafenoquine is not currently approved by the U.S. Food and Drug Administration (“FDA”) for the treatme ...
60 Degrees Pharmaceuticals Expands Tafenoquine Clinical Trial for Babesiosis to Brigham and Women's Hospital
GlobeNewswire News Room· 2024-12-11 13:56
The trial (NCT06207370) evaluates tafenoquine combined with standard treatment for babesiosis, addressing a critical unmet medical need.The clinical site is led by Brigham and Women’s Hospital researchers Ann Woolley, M.D., and David Leaf, M.D.The double-blind, placebo-controlled trial will examine outcomes for hospitalized patients with severe babesiosis, a tick-borne illness often found as a co-infection of Lyme disease. WASHINGTON, Dec. 11, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDA ...
60 Degrees Pharmaceuticals Inc. (SXTP) Reports Q3 Loss, Misses Revenue Estimates
ZACKS· 2024-11-14 21:26
60 Degrees Pharmaceuticals Inc. (SXTP) came out with a quarterly loss of $0.93 per share versus the Zacks Consensus Estimate of a loss of $0.60. This compares to loss of $3.60 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -55%. A quarter ago, it was expected that this company would post a loss of $3.96 per share when it actually produced a loss of $4.23, delivering a surprise of -6.82%.Over the last four quarters, the compan ...