Core Insights - Knight Therapeutics Inc. has relaunched ORGOVYX (relugolix) in Canada, marking a significant step in its oncology portfolio [1][4] - ORGOVYX is the first oral GnRH receptor antagonist approved in Canada for advanced prostate cancer treatment, with a market valued at over $200 million and a five-year CAGR of 8% [3][5] Company Overview - Knight Therapeutics Inc. is a specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products in Canada and Latin America [7] - The company has entered into exclusive license and supply agreements with Sumitomo Pharma America Inc. for multiple products, including ORGOVYX [2] Product Details - ORGOVYX (relugolix) is designed to provide a convenient oral alternative for rapidly suppressing testosterone production in prostate cancer patients [4] - Sales of ORGOVYX in Canada were approximately $1.2 million in 2024 [5] Market Context - Prostate cancer is the most prevalent malignancy among Canadian men, with an estimated 24,700 diagnoses and approximately 4,700 deaths in 2023 [6] - The treatment landscape for prostate cancer includes both GnRH agonists and antagonists, with ORGOVYX positioned to compete effectively in this market [3]

Core Insights - Knight Therapeutics Inc. has been ranked No. 384 on the 2025 Report on Business magazine's list of Canada's Top Growing Companies, achieving a three-year revenue growth of 53% [1][2] Company Performance - The recognition marks the fifth consecutive year that Knight has been named one of Canada's Top Growing Companies, reflecting the company's commitment to innovation and strategic vision [2] - Knight has expanded its product pipeline and existing sales through acquisitions from Paladin Pharma and Sumitomo Canada, as well as strengthened partnerships with Helsinn and Incyte [2] Industry Recognition - The ranking is part of an editorial initiative launched in 2019 to celebrate innovative businesses in Canada, with 400 companies making the list this year [2][3] - The annual ranking aims to highlight the ingenuity of Canadian entrepreneurs and corporate leaders, inspiring future generations [3] Company Overview - Knight Therapeutics Inc. is a specialty pharmaceutical company based in Montreal, focused on acquiring and commercializing pharmaceutical products for Canada and Latin America [5] - The company's shares are traded on the TSX under the symbol GUD [5]

Core Viewpoint - Knight Therapeutics Inc. has announced the acceptance of its Notice of Intention to Make a Normal Course Issuer Bid (NCIB) to repurchase up to 3,000,000 common shares, representing approximately 3% of its outstanding shares, over the next 12 months [1][3] Group 1: NCIB Details - The NCIB allows the company to purchase shares from August 22, 2025, to August 21, 2026, with a maximum daily purchase limit of 15,823 shares [1] - The company previously obtained approval to buy up to 5,312,846 shares and has already repurchased 2,019,906 shares at a weighted average price of $5.48 in the past twelve months [1] Group 2: Automatic Share Purchase Plan - Knight has entered into an automatic share purchase plan with a broker to facilitate share repurchases under the NCIB, allowing purchases during regulatory restrictions or blackout periods [2] - The plan has been pre-cleared by the TSX and will be effective from August 22, 2025 [2] Group 3: Company Perspective - The company believes that the market price of its common shares may not reflect its inherent value, making the share repurchase an appropriate use of funds [3] Group 4: Company Overview - Knight Therapeutics Inc. is a specialty pharmaceutical company based in Montreal, focused on acquiring and commercializing pharmaceutical products for Canada and Latin America [4] - The company's shares are traded on the TSX under the symbol GUD [4]

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. reported a decline in net product revenues for Q2 2025 but achieved increased profitability due to a shift in distribution strategy and cash-pay patients utilizing KODATEF® [2][6] Financial Highlights - Q2 2025 net product revenues decreased by 19% year-over-year, from $125 thousand in Q2 2024 to $101 thousand in Q2 2025, attributed to a 17% decrease in ARAKODA pharmacy deliveries [7] - Gross profit for Q2 2025 was approximately $51 thousand, up from $35 thousand in Q2 2024, primarily due to lower overall cost of sales and sales of KODATEF 16-count boxes [7] - Operating expenses were approximately $1.86 million in Q2 2025, significantly lower than $4.22 million in Q2 2024, due to the absence of one-off, non-cash R&D costs [7] - Net loss attributable to common shareholders in Q2 2025 was approximately $1.84 million, or ($1.25) per share, compared to a net loss of approximately $4.29 million, or ($21.12) per share in Q2 2024, representing a $2.45 million decrease in loss [7] - The company had $1.97 million in cash on hand as of June 30, 2025, and expects to remain financially viable through March 31, 2026, assuming no additional capital is raised [7] Business Highlights - The company specializes in developing and marketing new medicines for infectious diseases, with FDA approval for its lead product, ARAKODA® (tafenoquine), for malaria prevention achieved in 2018 [5] - A new 8-count bottle format of ARAKODA was introduced to reduce costs for short-term travelers to malaria-endemic regions [7] - The total addressable U.S. market for ARAKODA for human babesiosis may approach $1.1 billion over the remaining 10-year patent life, with annual incidence of babesiosis estimated between 25,000 and 380,000 cases [7] - The company is conducting a hospitalized babesiosis study and aims to complete interim analysis before the end of the 2025 tick season [3][7]

Core Insights - Knight Therapeutics Inc. reported record-high quarterly revenues of $107,358, an increase of 12% compared to the same period last year, driven by key promoted products and acquisitions [7][16][10] - The company has increased its financial guidance for 2025, now expecting revenues between $410 million to $420 million, up from a previous estimate of $390 million to $405 million [48] Financial Results - Revenues for Q2-25 were $107,358, up $11,785 or 12% year-over-year, with adjusted revenues at $108,541, reflecting a 15% increase [7][72] - Gross margin decreased to 42% of revenues from 50% in Q2-24, primarily due to hyperinflation accounting impacts in Argentina [7][23] - Operating loss was $3,669 compared to an operating income of $4,494 in the same period last year, while net loss increased to $12,622 from $1,942 [7][27] - Cash inflow from operations was $20,252, a significant improvement from cash outflows of $1,086 in the prior year [7] Corporate Developments - The company entered into a revolving credit facility of US$50,000 with National Bank of Canada, with $60,000 withdrawn to fund part of the Paladin acquisition [7][46] - Knight completed the acquisition of Paladin Pharma Inc. for $106,885, including $22,341 for inventory, and may pay additional contingent payments based on sales milestones [7][43] - The company also entered into exclusive license and supply agreements with Sumitomo for several products, including Myfembree and Orgovyx, with an upfront payment of $25,400 [7][44] Product Updates - Knight submitted Crexont for regulatory approval in Canada and Mexico, and Minjuvi for approval in Brazil for follicular lymphoma [36][38] - The company obtained regulatory approval for Pemazyre in Argentina and Rembre in Chile [35][7] Market Performance - The innovative product portfolio delivered organic growth of 15% on a constant currency basis during the first half of 2025 [10] - The therapeutic area revenues showed varied performance, with oncology/hematology down 4%, infectious diseases up 17%, and other specialty up 32% year-over-year [17][20][21]

Core Viewpoint - Knight Therapeutics Inc. is advancing its neurology portfolio by submitting a marketing authorization application for CREXONT in Mexico, addressing the high unmet medical need in Parkinson's disease treatment [1][3]. Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring, in-licensing, and commercializing pharmaceutical products for Canada and Latin America [9]. - The company operates through its Latin American subsidiaries, including United Medical, Biotoscana Farma, and Laboratorio LKM [9]. Product Information - CREXONT is a novel oral formulation of carbidopa/levodopa (CD/LD) designed for the treatment of Parkinson's disease, featuring both immediate-release granules and extended-release beads [2][4]. - The product was developed in collaboration with Amneal Pharmaceuticals, which holds exclusive rights for regulatory approval and commercialization in Canada and Latin America [2]. Clinical Study - CREXONT was evaluated in the RISE-PD clinical study, a 20-week phase 3 trial involving 630 patients, which successfully met its primary and secondary endpoints [5][6]. - The study demonstrated that CREXONT significantly improved daily "Good On" time by 0.53 hours with fewer doses compared to immediate-release CD/LD, with an average dosing frequency of three times per day versus five times per day for IR CD/LD [6]. Market Context - Parkinson's disease is the fastest-growing neurological disorder globally, with approximately 1 million diagnosed patients in the U.S. and an estimated 500,000 affected individuals in Mexico aged 45 to 60 [7][8]. - The average age of diagnosis for Parkinson's disease is 60, and the number of patients is expected to grow significantly as life expectancy increases [8].

MONTREAL, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has expanded its existing relationship and amended its agreement with Incyte Biosciences International Sàrl, the Swiss-based affiliate of Incyte (NASDAQ:INCY), for the exclusive rights to distribute retifanlimab (sold as ZYNYZ® in the United States and Europe) and axatilimab (sold as NIKTIMVO™ in the United States) in Latin America. Und ...

MONTREAL, Aug. 01, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a pan-American (ex-USA) specialty pharmaceutical company, will release its second quarter 2025 financial results on Thursday, August 7, 2025 prior to market opening. Following the release, Knight will hold a conference call and audio webcast. Knight cordially invites all interested parties to participate in this call. Date: Thursday, August 7, 2025Time: 8:30 a.m. ETTelephone: Toll Free: 1-888-699-1199 or Internationa ...

Core Viewpoint - Knight Therapeutics Inc. announced a supplemental application to ANVISA for MINJUVI® (tafasitamab) in combination with rituximab and lenalidomide for treating adult patients with previously treated follicular lymphoma in Brazil, highlighting the company's commitment to innovation in cancer treatment [1][4]. Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products in Canada and Latin America, with shares trading on TSX under the symbol GUD [11]. Product Information - MINJUVI® (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, designed to mediate B-cell lysis through various immune mechanisms [7]. - The product is already approved in the U.S. in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma [8]. Regulatory Developments - The supplemental application for MINJUVI® was selected for review under Project Orbis, indicating a streamlined regulatory process for innovative therapies [1]. - The submission is based on results from the pivotal Phase 3 inMIND trial, which showed significant improvements in progression-free survival for patients treated with tafasitamab compared to placebo [6]. Market Context - Follicular lymphoma is the most common indolent form of non-Hodgkin lymphoma, with an expected incidence of 5.57 per 100,000 in the general Brazilian population, and it constitutes 20% to 25% of adult NHL cases [5]. - There are limited treatment options available for relapsed or refractory follicular lymphoma, underscoring the need for new therapeutic options [5].

Core Insights - Knight Therapeutics Inc. has announced that its New Drug Submission (NDS) for CREXONT has been accepted for review by Health Canada [1] - CREXONT is a novel oral formulation of carbidopa/levodopa (CD/LD) designed for the treatment of Parkinson's disease, with a market potential exceeding $50 million in Canada and $120 million in Brazil [2][3] - The RISE-PD clinical study demonstrated that CREXONT significantly improves "Good On" time with fewer doses compared to immediate-release CD/LD [7] Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products for Canada and Latin America [11] - The company has entered into an agreement with Amneal Pharmaceuticals for exclusive rights to seek regulatory approval and commercialize CREXONT in Canada and Latin America [3] Product Details - CREXONT combines immediate-release granules and extended-release beads, allowing for rapid onset and prolonged drug release [4][5] - The product was studied in a 20-week phase 3 clinical trial involving 630 patients, which met its primary and secondary endpoints [6] Market Context - Parkinson's disease is the fastest-growing neurological disorder globally, with over 100,000 diagnosed patients in Canada and an estimated 6,600 new cases annually [9][10] - The controlled release segment of the Parkinson's treatment market in Canada was valued at $15 million for the twelve-month period ending September 2024 [2]