MONTREAL, March 17, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltda. has received approval from ANVISA, the Brazilian health regulatory agency, for an additional indication for MINJUVI® (tafasitamab). The approval follows a supplemental regulatory filing and review by ANVISA under Project Orbis for MINJUVI®, in combination with rituximab and lenalidomide for th ...

Summary of BrightSpring Health Services FY Conference Call Company Overview - **Company**: BrightSpring Health Services (NasdaqGS: BTSG) - **Date of Conference**: March 02, 2026 Key Industry Insights - **Growth Expectations**: BrightSpring anticipates broad-based growth across its pharmacy and provider services segments in 2026, driven by high-quality services and operational efficiencies [4][3] - **EBITDA Guidance**: The company provided an EBITDA guidance of $760 million to $790 million, with core growth expected to be between 18% and 23% when excluding contributions from Amedisys LLC [6][4] Core Business Segments Pharmacy Services - **Volume Growth**: Strong volume growth is expected, particularly in specialty and infusion pharmacy, with larger script growth opportunities anticipated [6][4] - **Generics Contribution**: The company is set to launch several new generics, including Pomalyst and lenalidomide, which are expected to contribute positively to growth [8][7] - **Headwinds**: The company faces headwinds from the Inflation Reduction Act (IRA), estimating an unmitigated impact of $35 million to $40 million, but has mitigated approximately $15 million of this impact through negotiations with Pharmacy Benefit Managers (PBMs) [11][10] Provider Services - **Home Health Reimbursement**: The final home health reimbursement rates for 2026 were better than expected, with CMS recognizing the importance of home health services in reducing costs and improving outcomes [35][34] - **Acquisition of Amedisys Assets**: The integration of Amedisys assets is expected to enhance margins and growth opportunities, particularly in states where BrightSpring previously had limited presence [39][38] Strategic Focus - **Operational Efficiency**: The company is focused on improving operational efficiencies and processes to drive margin expansion [4][3] - **M&A Strategy**: BrightSpring is evaluating M&A opportunities, particularly in home infusion, and plans to maintain a robust pipeline of potential acquisitions [45][44] - **Debt Management**: The company aims to reduce leverage to below 2 times by the end of 2026, with proceeds from divestitures being used to pay down debt [42][41] Future Outlook - **Long-term Growth**: BrightSpring is optimistic about achieving mid-teens growth in the long term, supported by investments made in previous years that are expected to yield results in 2027 and 2028 [60][59] - **Volume Growth Opportunities**: The company is focused on maximizing volume growth across its business lines, leveraging high-quality services and strategic growth channels [62][61] Additional Considerations - **Regulatory Environment**: The company is actively engaging with regulators to address the impacts of the IRA on the pharmacy industry, advocating for enhanced support from PBMs [13][12] - **Market Positioning**: BrightSpring is positioning itself to gain market share amidst industry pressures, leveraging its scale and operational capabilities [14][13] This summary encapsulates the key points discussed during the conference call, highlighting BrightSpring Health Services' growth strategies, financial outlook, and industry challenges.

Core Insights - Dr. Reddy's Laboratories Limited (RDY) reported Q3 fiscal 2026 earnings of 16 cents per American Depositary Share (ADS), matching the Zacks Consensus Estimate, but down from 19 cents per ADS in the same quarter last year [1][5] - Revenues increased by 4.4% year over year to $971 million, but fell short of the Zacks Consensus Estimate of $978 million, primarily due to lower growth in global generics revenues [1][5] Revenue Breakdown - Global Generics revenues reached INR 79.1 billion, reflecting a 7% year-over-year increase, driven by growth in key markets and favorable foreign exchange movements, although North America Generics saw a decline [2][5] - Pharmaceutical Services & Active Ingredients (PSAI) revenues totaled INR 8 billion, down 2% year over year due to lower volume uptake in the active pharmaceutical ingredient (API) business [6] - Revenues in the Others segment were INR 0.1 billion, a significant decline of 92% year over year [6] North America Performance - North America segment revenues decreased by 12% due to lower sales of lenalidomide and increased price erosion in key products [3][5] - As of December 31, 2025, there were 73 generic filings pending FDA approval, including 71 abbreviated new drug applications (ANDAs) and two new drug applications, with 43 of the ANDAs being Para IVs [3] Margin and Expenses - Gross margin fell by 505 basis points year over year to 53.6%, attributed to lower lenalidomide sales, price erosion, adverse product mix in PSAI, and one-time provisions related to new Labor Codes in India [7][5] - Research and development (R&D) expenses were $68 million, down 8% year over year, primarily due to reduced spending in biosimilars [8] - Selling, general and administrative expenses rose to $300 million, a 12% increase year over year, driven by investments in branded franchises and adverse foreign exchange movements [9] Strategic Developments - Dr. Reddy's gained approval for AVT03, a proposed biosimilar to Amgen's Prolia and Xgeva, in the EU and the UK, and launched the product in Germany in December 2025 [12] - The company signed a strategic collaboration with Immutep to develop and commercialize the investigational immuno-oncology therapy eftilagimod alfa (efti) outside major markets, involving a $20 million upfront payment and potential milestone payments of up to $349.5 million [17][18]

Core Insights - The combination of evorpacept, rituximab, and lenalidomide achieved a complete response (CR) rate of 92% in patients with untreated indolent non-Hodgkin lymphoma (iNHL), significantly higher than the historical CR rate of approximately 50% for rituximab alone [1][2] - The treatment regimen was well-tolerated and demonstrated impressive anti-tumor activity in the frontline setting, with a one-year progression-free survival (PFS) rate of 91% and a one-year overall survival (OS) rate of 100% [2] Study Details - The Phase 2 investigator-sponsored trial enrolled 24 patients, including 14 with follicular lymphoma and 10 with marginal zone lymphoma, and met the primary objective of achieving a CR rate above 80% [2] - The trial was led by Dr. Paolo Strati from The University of Texas MD Anderson Cancer Center, and the results were presented at the American Society of Hematology (ASH) Annual Meeting 2025 [3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as its lead candidate [4] - The company is also advancing a second pipeline candidate, ALX2004, which is an EGFR-targeted antibody-drug conjugate currently in Phase 1 trials [5]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE® FL-1 study, demonstrating that the combination of EPKINLY® (epcoritamab) with rituximab and lenalidomide significantly reduces the risk of disease progression or death by 79% compared to standard care [2][3] - The overall response rate (ORR) for patients treated with EPKINLY + R2 was 95%, compared to 79% for those receiving R2 alone, indicating a substantial improvement in treatment efficacy [2][3] - The U.S. FDA has approved the EPKINLY + R2 combination for patients with relapsed or refractory follicular lymphoma after one or more lines of systemic therapy, marking a significant advancement in treatment options [4][5] Study Results - The EPCORE FL-1 study included patients with relapsed or refractory follicular lymphoma, showing that 83% of patients achieved a complete response (CR) with EPKINLY + R2, compared to 50% with R2 alone [3][5] - The duration of response (DOR) at 12 months was 89% for EPKINLY + R2 versus 49% for R2, highlighting the long-term benefits of the new treatment [3][5] - The safety profile of EPKINLY + R2 was consistent with known safety profiles, with 90.1% of patients experiencing Grade 3 or 4 treatment-emergent adverse events (TEAEs) [3][4] Industry Context - Follicular lymphoma is a common form of non-Hodgkin lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new diagnoses in the U.S. annually [7] - Current standard treatments are often ineffective over time, leading to relapses and shorter remission periods, which underscores the need for innovative therapies like EPKINLY [7] - Epcoritamab, developed using Genmab's DuoBody technology, is designed to target both T cells and B cells, enhancing the immune response against cancer cells [8][9] Future Developments - Genmab and AbbVie are continuing to explore the use of epcoritamab in various hematologic malignancies, with multiple ongoing Phase 3 trials assessing its efficacy as a monotherapy and in combination with other treatments [9] - The companies aim to expand regulatory approvals for epcoritamab in additional indications, including relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [8][9] - Genmab's vision is to transform cancer treatment through innovative antibody medicines, with a focus on improving patient outcomes [10]

Core Insights - EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is the first and only bispecific antibody combination therapy approved for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy [1] - In the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 showed significantly superior progression-free survival and overall response rates compared to the standard of care R2, with approximately 75% of patients achieving a complete response [1] - This approval marks the third indication for EPKINLY and the first-ever FDA approval for a bispecific combination therapy in lymphoma [1] Company Insights - AbbVie (NYSE: ABBV) announced the FDA approval of EPKINLY® (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory follicular lymphoma [1]

Core Insights - Genmab A/S announced FDA approval for EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma, based on the Phase 3 EPCORE FL-1 study results [2][7][9] Group 1: Study Results - EPKINLY + R reduced the risk of disease progression or death by 79% compared to standard treatment R, with a hazard ratio of 0.21 [3] - The median progression-free survival (PFS) was not reached for EPKINLY + R, while it was 11.2 months for R [3] - Among patients treated with EPKINLY + R, 89% responded to treatment and 74% achieved a complete response, compared to 74% overall response rate and 43% complete response rate for R [3] Group 2: Safety Profile - The safety profile of EPKINLY + R was consistent with known safety profiles of the individual components, with common adverse reactions including rash, upper respiratory infections, and fatigue [4] - Cytokine release syndrome (CRS) occurred in 24% of patients, primarily low grade, with a single event of immune effector cell-associated neurotoxicity syndrome (ICANS) reported [4][21] Group 3: Industry Impact - The approval of EPKINLY + R represents a significant advancement for patients with follicular lymphoma, providing a chemotherapy-free treatment option that can be administered in outpatient settings [5][6] - Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma affecting approximately 15,000 new patients annually in the U.S., with current therapies considered incurable [5][26] Group 4: Future Prospects - EPKINLY + R is the first bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line setting, marking the third indication for EPKINLY [7] - Genmab and AbbVie are continuing to evaluate epcoritamab in various hematologic malignancies, with multiple ongoing Phase 3 trials [29][28]

Core Insights - Viatris Inc. (VTRS) reported third-quarter 2025 adjusted earnings per share (EPS) of 67 cents, exceeding the Zacks Consensus Estimate of 63 cents, but down from 75 cents in the same quarter last year [1][7] - Total revenues for the quarter were $3.76 billion, a 2% decline year over year on an operational basis, yet surpassing the Zacks Consensus Estimate of $3.6 billion [1][7] Revenue Breakdown - Total sales reached $3.7 billion, down 2% year over year, with a 1% decline on a divestiture-adjusted operational basis [3] - Sales from Developed Markets were $2.25 billion, down 5% on a divestiture-adjusted operational basis, but slightly above the Zacks Consensus Estimate of $2.20 billion [3] - Emerging Markets generated $570.4 million in sales, reflecting a 7% increase on a divestiture-adjusted operational basis, beating the Zacks Consensus Estimate of $550 million [4] - Sales from Japan, Australia, and New Zealand (JANZ) totaled $306.3 million, down 9% on a divestiture-adjusted operational basis, yet exceeding the Zacks Consensus Estimate of $303 million [4] - Greater China sales amounted to $615.2 million, up 9% on a divestiture-adjusted operational basis, surpassing the Zacks Consensus Estimate of $579 million [4] Product Category Performance - Revenues from Brands increased by 3% to $2.4 billion, with a 1% rise on a divestiture-adjusted operational basis, driven by strong performance in Greater China and Emerging Markets [5] - Key branded products included Lipitor with sales of $396.1 million, Norvasc at $179.7 million, and EpiPen at $157.2 million, while Lyrica sales decreased to $126.5 million [8] Generics Performance - Generics revenue was $1.31 billion, down 5%, with a 6% decline on an operational change basis, primarily due to the impact from the Indore facility [9][10] - The decline in generics was offset by growth in complex products in North America and strong performance in key European markets [9] Financial Guidance and Shareholder Returns - Viatris raised its 2025 revenue guidance to a range of $13.9-$14.3 billion, up from the previous guidance of $13.5-$14 billion, and adjusted EPS guidance to $2.25-$2.35 from $2.16-$2.30 [12] - The company has returned over $920 million to shareholders year to date, including more than $500 million in share repurchases, and is on track to return over $1 billion in 2025 [11] Strategic Developments - Viatris acquired Aculys Pharma, gaining exclusive rights in Japan for pitolisant and plans to file two new drug applications in Japan [13] - The acquisition also includes rights for Spydia Nasal Spray, approved in Japan for treating status epilepticus [14]

Core Insights - Genmab A/S has released results from the Phase 3 EPCORE FL-1 trial, showing that subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) significantly improves outcomes for adult patients with relapsed or refractory follicular lymphoma [1][2] Study Results - The trial met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating a 79% reduction in the risk of disease progression or death [2] - Results will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will support global regulatory submissions [3] Regulatory Developments - The U.S. FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2, based on significant ORR and PFS improvements from interim analysis [4] - The FDA has set a target action date of November 30, 2025, for the sBLA [5] Market Performance - Genmab reported revenue of $1.64 billion for the first half of 2025, up from $1.38 billion year-over-year, with second-quarter sales of $925 million exceeding consensus estimates [6] - The 19% revenue increase was driven by higher royalties from collaborations and increased sales of Epkinly [7] - The company raised its fiscal year 2025 sales guidance to between $3.5 billion and $3.7 billion, surpassing consensus expectations [7]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE FL-1 trial for subcutaneous epcoritamab in combination with rituximab and lenalidomide, showing significant improvements in overall response rate (ORR) and progression-free survival (PFS) for patients with relapsed or refractory follicular lymphoma [2][6][4] - The U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for epcoritamab plus rituximab, with a target action date of November 30, 2025, which could make it the first bispecific antibody combination available in the U.S. for second-line treatment of this condition [3][6] - Epcoritamab is designed to target CD3 on T cells and CD20 on B cells, facilitating T-cell-mediated killing of malignant B cells, and has received regulatory approval in various lymphoma indications [8][9] Trial Results - The EPCORE FL-1 trial met its dual primary endpoints, achieving an ORR of 95.7% (p-value < 0.0001) and a PFS hazard ratio of 0.21 (p-value < 0.0001), indicating a 79% reduction in the risk of disease progression or death [2][6][4] - The safety profile of epcoritamab in combination with rituximab was consistent with known safety profiles, with no new safety signals observed [4][6] Industry Context - Follicular lymphoma (FL) is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new cases annually in the U.S. [5] - Current treatment options for R/R FL often lead to declining response rates and shorter remission periods, with over 25% of patients potentially transforming to aggressive large-cell lymphoma [5][4] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform cancer treatment by 2030 [11][12] - The company is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, while pursuing additional international regulatory approvals [9][10]