KIRKLAND, QC, Nov. 20, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that it has successfully completed negotiations with the pan‑Canadian Pharmaceutical Alliance (pCPA) for WINREVAIR® (sotatercept). The pCPA negotiates on behalf of the provinces, territories, and federal drug programs serving as a critical step in bringing WINREVAIR® closer to public reimbursement. WINREVAIR® is...Read more
SAN DIEGO, Nov. 20, 2025 /PRNewswire/ -- Aspen Neuroscience, Inc., a clinical-stage biotechnology company pioneering autologous regenerative therapies, today announced the closing of a $115 million Series C financing round. This significant investment will fuel the continued clinical development of Aspen's lead program, ANPD001, for moderate to advanced Parkinson's disease. The Series C round was co-led by OrbiMed, ARCH Venture...Read more
Following Priority Review, the U.S. FDA granted HYRNUO® (sevabertinib) approval for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. WHIPPANY, N.J. / Nov 20, 2025 / Business Wire / Bayer announced today...Read more
New lecanemab findings highlight the safety and potential benefits of subcutaneous administration for initiation dosing, the potential for additional long-term clinical benefits with continued treatment, and real-world experience Biogen is committed to deepening scientific understanding of Alzheimer’s disease, including therapeutic delivery and disease progression CAMBRIDGE, Mass., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Biogen Inc....Read more
MISSISSAUGA, Ontario, Nov. 20, 2025 (GLOBE NEWSWIRE) -- BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the three months (Q3) and nine months (YTD) ended September 30, 2025. Key highlights include: (CAD) Q3 2025 % Change vs.Q3 2024 YTD 2025 % Change vs.YTD 2024 Trailing Twelve Months (TTM) Sept 30, 2025 % Change vs.TTM Sept 30, 2024 Canadian Pharma...Read more
Investigational DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority to BIC/FTC/TAF in a Phase 3 clinical trial in treatment-naïve adults with HIV-1 infection RAHWAY, N.J. / Nov 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from the pivotal double-blind Phase 3 trial of the investigational, once-daily, oral, two-drug,...Read more
This marks the approval of the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered by a health care provider in as little as one minute RAHWAY, N.J. / Nov 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved a new subcutaneous (SC), or under the skin, route of administration and a new...Read more
Global Confirmatory Phase 3 DeLLphi-304 Trial Showed IMDELLTRA Reduced Risk of Death by 40% Compared to Chemotherapy Underscores IMDELLTRA as a Recognized Standard of Care Treatment for Patients With Extensive Stage Small Cell Lung Cancer That Has Progressed THOUSAND OAKS, Calif., Nov. 19, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to...Read more
PARSIPPANY, N.J. / Nov 19, 2025 / Business Wire / Zoetis Inc. (NYSE:ZTS) will host an Innovation Webcast at 8:30 a.m. ET on Tuesday, December 2, 2025, featuring Kristin Peck, Chief Executive Officer; Wetteny Joseph, Executive Vice President and Chief Financial Officer; Rob Polzer, Ph.D., Executive Vice President and President of Research and Development; and Kevin Esch, D.V.M, M.P.H., Ph.D., Dipl. ACVP (anatomic), Senior Vice President of...Read more
First cohort features 7 real-world challenges across R&D, manufacturing and supply chain, commercial and medical affairs Teva's first-ever global innovation platform aims to accelerate patient impact and drive business transformation, as part of its Pivot to Growth Strategy Rise will enable startups and tech players worldwide to validate their solutions in real-world settings, scaling impact across Teva's global ecosystem...Read more
MELBOURNE, Australia and INDIANAPOLIS, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces results from the ZIRCON-X study which finds that almost half of all patients imaged with TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab) PET/CT2 would have undergone a change in clinical management, when compared with baseline standard of care (SOC) imaging. The data will be presented at the...Read more
WINNIPEG, MB / ACCESS Newswire / November 19, 2025 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today reported its results from operations for the quarter ended September 30, 2025. Quarter Ended September 30, 2025 Highlights: Recorded total net...Read more
ProPhase Labs in discussions for strategic initiative to realize significant underlying value in the Company. Voting for Current Proxy Critically Important. Crown Medical Achieves Final Hurdle. Appointed Special Counsel to Launch Litigation Against Insurance Companies. First Settlement Completed. Reiterates $50 MILLION Net A/R Goal Next-Phase Commercialization of BE-Smart™ Underway Following Landmark Study Published in the Official...Read more
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapyIn the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2 with approximately 3 out of 4...Read more
At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy These unprecedented results support its potential as a new standard-of-care endocrine therapy in the early-stage setting Data to be presented at an upcoming medical meeting and shared with health authorities around the world lidERA is the second positive Phase III readout for...Read more
WINREVAIR demonstrated a statistically significant and clinically meaningful reduction in the primary endpoint of pulmonary vascular resistance (PVR) compared to placebo, improving the ability of blood to transition through the lungs to the heart These data support proof-of-concept to inform Phase 3 development for WINREVAIR in this population RAHWAY, N.J. / Nov 18, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the...Read more
Arrivals of the twice-yearly PrEP option in Eswatini and Zambia mark an important milestone in the goal of ending the HIV epidemic in sub-Saharan Africa FOSTER CITY, Calif. & MBABANE, Eswatini / Nov 18, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced the delivery of first shipments of lenacapavir – Gilead’s twice-yearly injectable HIV-1 capsid inhibitor – for the prevention of HIV as pre-exposure...Read more
WIXOM, Mich. / Nov 18, 2025 / Business Wire / Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that the Company appointed Joe Dawson to its board of directors. Additionally, Andrea Heslin Smiley has resigned from the Company's board of directors to pursue other...Read more
UNIONDALE, NY, Nov. 18, 2025 (GLOBE NEWSWIRE) -- ProPhase Labs Inc. (NASDAQ: PRPH) (the “Company” or “ProPhase”), a next generation biotech, genomics and consumer products company, announced today that they will be presenting third quarter 2025 financial results on a virtual conference call hosted by Renmark Financial on November 19, 2025, at 2:00 pm EST. A press release detailing these results will be issued prior to the virtual...Read more
First-line treatment with TREMFYA® shows significant inhibition of radiographic progression at Week 24, which was sustained through Week 48, preserving joint health with a well-established safety profile More than half of TREMFYA®-treated patients across both dose groups achieved a 50% improvement in signs and symptoms of psoriatic arthritis by Week 48 in the Phase 3b APEX study NEW YORK, Nov. 17, 2025 /PRNewswire/...Read more
Acquisition provides highly differentiated clinical-stage treatment for prostate cancer, building on Johnson & Johnson’s nearly two decades of innovation in the disease area Lead asset shows potential to overcome common types of resistance to treatment in prostate cancer with a precision tumor cell-killing approach Includes novel technology platform capable of developing the next generation of highly targeted oral treatments for...Read more
LUPRON DEPOT (leuprolide acetate for extended-release injectable suspension) is a hormonal medication first approved by Health Canada in 1989 for advanced prostate cancer, and later for various conditions including endometriosis, uterine fibroids, and central precocious puberty.1 MONTREAL, Nov. 17, 2025 /CNW/ - AbbVie (NYSE: ABBV) announced today that a new 6-month 45mg LUPRON DEPOT® (leuprolide acetate for extended-release...Read more
Despite treatment with standard-of-care anti-seizure medicines, children with Dravet syndrome experienced high seizure burden and plateaued in neurodevelopment, resulting in a widening gap relative to children with typical development Findings underscore the urgent need for new medicines that target the underlying genetic cause of Dravet syndrome to improve long-term outcomes CAMBRIDGE, Mass. and BEDFORD, Mass., Nov. 17,...Read more
Positive CHMP opinion is based on data from the DEVOTE study which evaluated the high dose regimen of nusinersen in treatment-naive participants and those transitioning from the currently approved 12mg dose regimen1 Final European Commission decision expected in January 2026 SMA is a rare, genetic, neuromuscular disease that affects individuals of all ages2 CAMBRIDGE, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq:...Read more
SHANGHAI & JERSEY CITY, N.J. / Nov 17, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to PERJETA (pertuzumab), for all indications of the reference product.1 POHERDY is the...Read more
PARSIPPANY, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Embecta Corp. (“embecta”) (Nasdaq: EMBC), a global company that is advancing its 100-year legacy in insulin delivery to become a broad-based medical supplies company, today announced that David J. Albritton, a member of the Board of Directors (the “Board”) of embecta, has resigned from the Board due to personal reasons, effective immediately. In addition, LTG (Ret.) David F. Melcher,...Read more
LifeMD expands access to Wegovy and Ozempic at the lowest cash-pay pricing, reinforcing its commitment to patient affordability and high-quality care NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) -- LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care services and pharmacy, today announced a new, lower cash-pay price for GLP-1 medications, Wegovy® and Ozempic®, made possible through its ongoing collaboration with Novo...Read more
Total revenue increased 13% year-over-year to $60.2 million, and adjusted EBITDA rose 20% to $5.1 million. Telehealth revenue grew 18% to $47.3 million, while telehealth adjusted EBITDA increased 30% to $2.9 million. Paid off all outstanding debt during the quarter. Subsequent to quarter end, fully divested our majority stake in WorkSimpli, positioning LifeMD as a pure-play telehealth and pharmacy platform. Continued to diversify...Read more
Five-year grant of $7 million annually to the academic researchers is aimed at accelerating the development of new therapeutics to combat resistant fungal infections, including the Company’s next generation of triterpenoid antifungals (fungerps). Next-generation fungerps, in preclinical stages of development, are targeted to have enhanced pharmacological properties to treat fungal infections where current therapies are limited or not...Read more
CHICAGO, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today reported financial results for the third quarter and nine-month period ended September 30, 2025. Financial Highlights for the Three and Nine Months Ended September 30, 2025 Income Statement Cosmos Health delivered a record quarter, achieving the highest...Read more
CD388 is an investigational long-acting, strain-agnostic antiviral agent currently in Phase 3, designed to prevent influenza infection in individuals at higher risk of influenza complications Acquisition aligns with Merck’s science-led business development strategy, diversifying and expanding the company’s pipeline RAHWAY, N.J. & SAN DIEGO, Calif. / Nov 14, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the...Read more
CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Alcyone Therapeutics, a clinical-stage biotechnology company known for its innovative CNS therapy delivery solutions, such as the ThecaFlex DRx™ drug delivery system. ThecaFlex DRx™ is an investigational implantable device designed to provide an alternative to repeat lumbar punctures in chronic intrathecal administration of...Read more
Conference Call Scheduled for Monday, November 17 at 11:30 AM EST Northvale, New Jersey--(Newsfile Corp. - November 14, 2025) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, announced results for the second quarter of fiscal year 2026 ended September 30, 2025 ("Second Quarter"). Consolidated revenues for the three-month period ending...Read more
The Novel HIV Therapy has the Potential to Expand Options for Virologically Suppressed Adults Treated with Complex ART Regimens Phase 3 Results from ARTISTRY-1 and 2 Trials will Form the Basis of Regulatory Submissions FOSTER CITY, Calif. / Nov 13, 2025 / Business Wire / Gilead Sciences, Inc. (NASDAQ: GILD) today announced positive topline results from the Phase 3 ARTISTRY-1 trial. The open-label trial evaluated the...Read more
Acquisition brings highly differentiated clinical-stage obesity candidates with potential to reshape the treatment landscape Complements and transforms Pfizer’s Internal Medicine portfolio Positions Pfizer to lead in one of the most dynamic and high-growth therapeutic areas NEW YORK / Nov 13, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced the successful completion of its acquisition of Metsera, Inc. (NASDAQ: MTSR), a...Read more
Alloy Partners, Elanco and other corporate partners join forces to develop new venture studio INDIANAPOLIS, Nov. 13, 2025 /PRNewswire/ -- Alloy Partners today announced the launch of OneHealth Studio, a first-of-its-kind venture studio designed specifically to create and scale new companies at the convergence of animal, plant and human health in partnership withElanco Animal Health (NYSE: ELAN). Located in the OneHealth Innovation...Read more
First-to-market complex injectable with expected launch in Q1 2026 BRIDGEWATER, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque® (iohexol) injection. Amneal expects to launch the product in the...Read more
Adjusted EBITDA grew 19% in Q3 and 25% year-to-date Cash from operations grew 67% in Q3 and 121% year-to-date Announced new credit facility with lower rates, increased flexibility and reduced F/X risk Bempedoic acid approval expected in Q4 2025; preparations underway for Q2 2026 launch TORONTO, Nov. 13, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused...Read more
Once issued, this new U.S. patent covers the use of CardiolRx™ and CRD-38 for a broad range of cardiac disorders, including atherosclerosis and heart failure, significantly expanding intellectual property protection in the world's largest pharmaceutical market. This allowance fortifies Cardiol's global intellectual property portfolio, adding to granted and pending patent applications in Europe, Japan, Canada, Australia, and...Read more
Reports Significant Revenue Growth to $590K and Substantial Increase in Gross Profit to $575K Launched Sales of Arbli™, the First FDA-Approved Ready-To-Use Liquid Formulation of Losartan for Hypertension COMMACK, NY, Nov. 13, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and...Read more
Entered into an Agreement to be acquired by QOL Medical Net product sales for the third quarter of 2025 reached $4.3 million; up 61% year-over-year Gimoti patent life for Gimoti extended through November 2038 SOLANA BEACH, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI®...Read more
Conference call will be held today, Thursday, November 13 at 10:00 am ET Woburn, MA, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three and nine months ended September 30, 2025 and provided a business update. Financial...Read more
LONDON, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) today announced that management will present at the Jefferies Global Healthcare Conference in London on Monday, November 17, 2025 at 2:30 p.m. Greenwich Mean Time (9:30 a.m. Eastern Time). A live webcast of Kiniksa’s presentation will be accessible through the Investors section of the company’s website at www.kiniksa.com. A replay of...Read more
RANCHO CUCAMONGA, CA / ACCESS Newswire / November 12, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, and Jacob Liawatidewi, EVP of Corporate Administration, will be participating in an Analyst-Moderated fireside chat at the Jefferies Global Healthcare Conference on Wednesday, November 19th, 2025, at 3:30 pm GMT. For access, visit Amphastar's Pharmaceuticals website at http://ir.amphastar.com....Read more
Northvale, New Jersey--(Newsfile Corp. - November 12, 2025) - Elite Pharmaceuticals, Inc. (OTCBB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP), with strengths...Read more
Third quarter 2025 net revenues were $17.6 million Emrosi™ total prescriptions increased 146% over the second quarter of 2025 Emrosi net revenues were $4.9 million Company to hold conference call today at 4:30 p.m. ET to discuss the financial results and provide a business update SCOTTSDALE, Ariz., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical,” “the Company,” “we” or “our”), a...Read more
Management to host conference call at 8:00 AM Eastern time on Thursday, November 13, 2025 Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - November 12, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company's second fiscal quarter ended September 30, 2025 (the company's fiscal Q2 2026). All dollar amounts in this press...Read more
Closed $17 million first tranche financing led by a strategic investment from CorMedix, Inc. Cash and investments at September 30, 2025 were $21.3 million; combined with conditional future tranches of previous financings, expect sufficient cash through a potential PMA approval of Niyad in late 2026 5 of the 9 target profile clinical sites are now activated; completion of NEPHRO study expected in H1 2026 Conference call and webcast...Read more
Net sales for the third quarter 2025 were $15.9 million. Company reiterates 2025 guidance for net sales to be between $65 million and $70 million. Achieved profitability on an Adjusted EBITDA basis for the third quarter 2025. Increased cash position to $23.7 million at September 30, 2025. WIXOM, Mich. / Nov 12, 2025 / Business Wire / Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops,...Read more
BOCA RATON, Fla. / Nov 12, 2025 / Business Wire / TherapeuticsMD, Inc. (“TherapeuticsMD” or the “Company”) (NASDAQ: TXMD), a company that owns rights to pharmaceutical royalties, today reported financial results for the three months ended September 30, 2025. Third Quarter 2025 Financial Results Net Income (Loss) from Continuing Operations Net income from continuing operations was $50 thousand, or $0.00 per basic and diluted common...Read more
Positive FDA feedback confirms clear clinical pathway for BX011 targeting S. aureus in Diabetic Foot Infections, building on Company’s prior Phase 2 success BiomX expects FDA feedback on BX004 clinical hold imminently; Enrollment and dosing of patients outside the U.S. are continuing in accordance with protocol Positive FDA feedback received in October provided guidance for potential Phase 3 development pathways of BX004 BiomX...Read more
TEL AVIV, Israel, Nov. 12, 2025 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) today announced that DeepSolar, its solar energy business unit developing next-generation AI analytics, has advanced the development of its proprietary automated reporting engine, designed to transform how solar-asset performance is analyzed, understood, and communicated. The automated reporting engine reduces manual effort and produces tailored reports...Read more
PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference – London on Tuesday, November 18, at 3:00 p.m. GMT/10:00 a.m. ET. The live and archived fireside chat will be accessible from the Company’s website at www.anipharmaceuticals.com, under...Read more
WIXOM, Mich. / Nov 11, 2025 / Business Wire / Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that Rashad Brown has joined the Company as Vice President, Manufacturing and Supply Chain. Mr. Brown brings more than two decades of leadership experience in manufacturing...Read more
The first (FENhance 2) of two pivotal RMS studies met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses compared to teriflunomide In a pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as Ocrevus, the only approved therapy in PPMS Full data from both studies will be shared at upcoming medical meetings; once the second RMS study (FENhance...Read more
Third quarter 2025 revenue of $1.602 billion, up 1% as-reported and down 1% excluding the impact of foreign currency Third quarter 2025 diluted earnings per share of $0.61 and non-GAAP Adjusted diluted earnings per share of $1.01 Third quarter 2025 net income of $160 million and Adjusted EBITDA (non-GAAP) of $518 million, representing an Adjusted EBITDA margin of 32.3% Revenue guidance range for full year 2025 lowered to $6.200 billion...Read more
Third-Quarter 2025 and Recent Selected Highlights: Total revenues of $71.6 million, a 45% increase over $49.3 million recorded in the prior-year period GAAP net income of $1.0 million Adjusted EBITDA of $22.7 million Cash and cash equivalents of $74.3 million as of September 30, 2025 HROW 3Q25 Letter to Stockholders: 3Q25 Letter to Stockholders NASHVILLE, Tenn., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a...Read more
LINZESS® (linaclotide) U.S. net sales of $315 million in Q3 2025, an increase of 40% year-over-year; EUTRx demand growth increased 12% year-over-year GAAP net income of $40 million and adjusted EBITDA of $82 million in Q3 2025; ended Q3 2025 with $140 million in cash and cash equivalents Raises full-year 2025 LINZESS U.S. net sales guidance to $860 - $890 million; total revenue guidance to $290 - $310 million and adjusted...Read more
Third Quarter Revenues of $47.0 Million, up 13% Year-over-Year, and Adjusted EBITDA of $11.7 Million, up 34% Year-Over Year Nine Month Revenue of $135.8 Million, up 11% Year-over-Year; Adjusted EBITDA of $34.2 Million, up 35% Year-over-Year Positive Outlook for Remainder of 2025 Based on the Company's Diverse Product Portfolio Supports Full-Year Revenue Guidance of $178 Million-$182 Million and Adjusted EBITDA of $40 Million-$44...Read more
Advanced Integration Efforts to Consolidate Subsidiaries and Pulled Forward Two Quarters of Rolvedon Demand Promotes Paul Schwichtenberg to President and COO Narrows FY2025 Net Product Sales Guidance Range to $110 to $112 Million and Adjusted EBITDA Range to $14 to $16 Million LAKE FOREST, Ill. / Nov 10, 2025 / Business Wire / Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with...Read more
Baxdrostat demonstrated a statistically significant placebo-adjusted reduction of 13.9 mmHg in night-time ambulatory systolic blood pressure at 12 weeks with a safety profile consistent with the BaxHTN trial Full results presented at the American Heart Association Scientific Sessions 2025 WILMINGTON, Del. / Nov 09, 2025 / Business Wire / Positive full results from the Bax24 Phase III trial showed baxdrostat demonstrated a...Read more
Enlicitide has the potential to be the first approved oral PCSK9 inhibitor designed to deliver antibody-like efficacy and help address critical unmet needs for patients with HeFH to help combat the ongoing CV epidemic Results were presented today at AHA Scientific Sessions 2025 and simultaneously published in the Journal of the American Medical Association RAHWAY, N.J. / Nov 09, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD...Read more
Enlicitide, designed to deliver antibody-like efficacy, has the potential to be the first approved oral PCSK9 inhibitor to lower LDL-C with a safety profile comparable to placebo Enlicitide may help address unmet needs in ASCVD, a key driver of the ongoing cardiovascular (CV) epidemic RAHWAY, N.J. / Nov 08, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first...Read more
Study Also Shows 36% Reduction in Risk of Heart Attack Repatha is the First and Only PCSK9 Inhibitor to Significantly Reduce the Risk of First Heart Attack and Stroke THOUSAND OAKS, Calif., Nov. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced detailed results from the Phase 3 VESALIUS-CV clinical trial, which showed that Repatha® (evolocumab) achieved statistically significant and clinically meaningful reductions...Read more
Sub-analysis of children with atopic dermatitis aged 2-17 in pivotal Phase 3 trials revealed early and clinically meaningful improvements in vIGA-AD™ and EASI-75 (skin clearance and severity), POEM (patient-reported outcomes) and PP-NRS (itch), regardless of comorbidity status, at week 8 JERSEY CITY, N.J. / Nov 08, 2025 / Business Wire / Organon (NYSE: OGN), a global independent healthcare company with a focus on women’s health, will...Read more
FASENRA also demonstrated a greater improvement in fatigue symptom relief in a single monthly dose compared to placebo WILMINGTON, Del. / Nov 07, 2025 / Business Wire / Positive full results from the NATRON Phase III trial showed AstraZeneca’s FASENRA (benralizumab) demonstrated a statistically significant delay in the time to first worsening or flare in hypereosinophilic syndrome (HES),1 a rare disease driven by elevated eosinophils.2...Read more
FOSTER CITY, Calif. / Nov 07, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced the Phase 3 ASCENT-07 study investigating Trodelvy® (sacituzumab govitecan-hziy) versus chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did not meet the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR)...Read more
New Data Exclusive to Livdelzi Highlights its Potential as an Effective and Well-Tolerated Option for PBC Patients Switching from Obeticholic Acid Analysis of Phase 3 ASSURE Study Finds Livdelzi Shows Promising Data on Liver Stiffness in PBC Patients After 3 Years Livdelzi Data in PBC Participants Provide Outcomes for Long-Term Biochemical Response, which Slows Disease Progression and Sustained Reductions in Chronic Itch, which Impacts...Read more
Phase 1b, Open-Label Study Follow Up Shows Stable Kidney Function (eGFR) in Patients Treated with Investigational Mezagitamab Through Week 96 – 18 Months After Last Dose1 Rapid Reductions in Proteinuria and Serum Gd-IgA1 Levels Were Sustained Through Week 961 No Serious Adverse Events or Opportunistic Infections Were Observed Through Week 961 Takeda Initiated Pivotal Phase 3 Clinical Trials Evaluating Mezagitamab in Primary IgA...Read more
In a new cohort of 27 adults from the IMPACT-TD Registry, up to 77% of participants reported improvements in aspects of their lives impacted by tardive dyskinesia (TD) while taking AUSTEDO or AUSTEDO XR Most (85%) participants taking AUSTEDO or AUSTEDO XR in conjunction with their mental health medications reported that their mental health condition remained stable or improved Teva is committed to truly understanding and empowering...Read more
Net proceeds will be applied to debt reduction, advancing Organon’s ongoing deleveraging efforts Positions Organon for future investment in growth opportunities with a focus on women’s health biopharma and other strategic priorities Laborie’s capabilities in medical technology will facilitate broader access to JADA for more mothers JERSEY CITY, N.J. / Nov 07, 2025 / Business Wire / Organon (NYSE: OGN), (“Organon” or “the Company”) a...Read more
Record quarterly net revenues of $227.8 million, an increase of 53.6% year-over-year Purified Cortrophin® Gel net revenues of $101.9 million, an increase of 93.8% year-over-year Record quarterly adjusted non-GAAP EBITDA of $59.6 million, an increase of 69.8% year-over-year Diluted GAAP income per share of $1.13 and record adjusted non-GAAP diluted earnings per share of $2.04 Raised 2025 total net revenue guidance to $854.0 million...Read more
Calgary, AB – November 7, 2025 – TheNewswire - Voyageur Pharmaceuticals Ltd. (TSXV: VM) (OTC: VYYRF) (the “Company” or “Voyageur”), a Canadian developer of pharmaceutical-grade barium and iodine for medical imaging contrast media, is pleased to announce, subject to regulatory approval, the appointment of Virginia Alling as an independent director. This addition builds on the Company’s recent board enhancements with Wall Street veterans...Read more
Proceeds of up to $10 million, consisting of $3 million at closing, $1 million upon availability of commercial product, and up to $6 million in sales-related milestone payments. Transaction further bolsters our cash position, which is expected to fund Biofrontera to profitability. Proceeds will support the growth of Biofrontera’s commercial photodynamic therapy (PDT) platform, and expansion of Ameluz® into additional...Read more
INDIANAPOLIS, Nov. 6, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the appointment of two new Executive Committee members and the expansion of other senior leaders' roles designed to accelerate one of the industry's most ambitious pipelines, generate new portfolio opportunities, and strengthen patient access to its medicines. Carole Ho, M.D., will join Lilly as executive vice president and president, Lilly...Read more
Medicare beneficiaries with obesity or overweight will have access to Zepbound and orforglipron, if approved, at $50 a month INDIANAPOLIS, Nov. 6, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced an agreement with the U.S. government to expand access to its obesity medicines and reduce patient costs. The agreement builds on Lilly's longstanding commitment to finding solutions with policymakers that...Read more
Based on these trial results, Lilly will begin enrolling Phase 3 clinical studies for the treatment of obesity next month INDIANAPOLIS, Nov. 6, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive results from a Phase 2 trial evaluating the safety and efficacy of eloralintide, an investigational once-weekly, selective amylin receptor agonist, in 263 adults with obesity or overweight with at least one...Read more
CAPLYTA®, in combination with an oral antidepressant, demonstrated superior efficacy with a favorable safety and tolerability profile consistent with established indications1,2 In pivotal trials, CAPLYTA® did not increase mean weight gain, metabolic changes, or reported sexual side effects1,2 In a six-month open-label extension safety study, safety profile was consistent with pivotal studies and 80% of MDD patients taking...Read more
Phase 3 AQUILA study showed DARZALEX FASPRO® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring Landmark approval supports earlier intervention and disease interception of multiple myeloma for the first time HORSHAM, Pa., Nov. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA)...Read more
Continued strong commercial performance and unprecedented pipeline delivery in the year to date CAMBRIDGE, England / Nov 06, 2025 / Business Wire / AstraZeneca: Revenue and EPS summary 9M 2025 % Change Q3 2025 % Change $m Actual CER1 $m Actual CER - Product...Read more
A post hoc analysis of REDEFINE 1 demonstrated a 10.9 mmHg reduction in systolic blood pressure with investigational CagriSema (2.4 mg/2.4 mg), allowing 40% of people on blood pressure medications to reduce or stop their medication1 CagriSema treatment demonstrated a nearly 70% reduction in a key inflammatory marker associated with increased cardiovascular risk2 Data showed that fewer people on CagriSema were at intermediate-to-high...Read more
The investigational FINE-ONE trial met its primary endpoint, demonstrating that finerenone led to a significant reduction in urine albumin-to-creatinine ratio (UACR), an important marker of cardiovascular risk and kidney disease progression, from start of trial through six months, for people living with type 1 diabetes (T1D) and chronic kidney disease (CKD) versus those receiving standard of care plus placebo1 These data were presented...Read more
Delivers Total Revenues in Line With Expectations, Reflecting Strong Execution of its Global Business Makes Late-Stage Pipeline Progress Including NDA Submission for Low-Dose Estrogen Weekly Patch Acquires Aculys Pharma Including Rights to Pitolisant in Japan and Spydia® in Japan and Certain Other Markets in the Asia-Pacific Region Returns More Than $920 Million of Capital to Shareholders Year-to-Date, Including $500 Million in...Read more
Generated Record Quarterly Net Revenue of $209.4 Million, Up 31% Year-over-Year Generated Record Quarterly Jornay PM® Net Revenue of $41.8 Million; Grew Prescriptions by 20% Year-over-Year Generated Record Quarterly Pain Portfolio Net Revenue of $167.6 Million, Up 11% Year-over-Year, with All Three Core Products Growing Year-over-Year Raised Full-Year 2025 Net Revenue Guidance to be in the Range of $775 to...Read more
Reports Net Revenues of $191.8 million for the Three Months Ended September 30, 2025 GAAP net income of $17.4 million, or $0.37 per share, for the third quarter Adjusted non-GAAP net income of $44.7 million, or $0.93 per share, for the third quarter Company to hold a conference call today at 2:00 p.m. Pacific Time RANCHO CUCAMONGA, CA / ACCESS Newswire / November 6, 2025 / Amphastar Pharmaceuticals, Inc....Read more
Third quarter revenues up 6% driven by EXPAREL volume growth of 9% Several key milestones advance 5x30 path to growth and value creation Conference call today at 4:30 p.m. ET BRISBANE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today reported financial...Read more
CANTON, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the third quarter ended September 30, 2025. Third Quarter 2025 Financial Results Summary: Net product...Read more
Achieved record-high quarterly revenues, Adjusted EBITDA1 and Adjusted EBITDA per share1 since inception Increased 2025 financial guidance MONTREAL, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight" or “the Company”), a pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its third quarter ended September 30, 2025. All currency amounts are in thousands except for...Read more
(All figures are presented in U.S. Dollars) Adjusted EBITDA1 in Q3 2025 was $7.3 million, an increase of 79% over Q3 2024 NatrobaTM sales were $8.1 million during the quarter, a sequential increase of 4% over Q2 2025 Strong cash generation with $10.8 million cash from operations in Q3 2025 $12.0 million debt repayments and share repurchases of $1.6 million during Q3 2025 Further de-levering with $5.0 million debt repayments post...Read more
Recorded $31.1 Million in Revenue During the Three Months Ended September 30, 2025, Representing a 26% Increase From Comparable Period of 2024 Multiple New Programs Signed with New Customers Continued Improvements in Efficiency and Productivity Across the Organization Conference Call Today at 4:30pm ET CHASKA, Minn., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully...Read more
| Company | Change | Last Trade |
|---|---|---|
| PTC Therapeutics | 0.86 1.14 | $76.46 |
| Johnson & Johnson | 0.56 0.28 | $203.07 |
| TherapeuticsMD | 0.27 16.36 | $1.92 |
| Biogen | 0.25 0.15 | $168.18 |
| Astellas Pharma | 0.25 2.05 | $12.47 |
| Bristol-Myers Squibb | 0.15 0.33 | $45.94 |
| Scynexis | 0.06 10.17 | $0.65 |
| China Pharma | 0.02 1.30 | $1.56 |
| Zomedica | 0.01 13.40 | $0.11 |
| Evoke Pharma | 0.01 0.09 | $10.69 |
| BiomX | 0.007 2.61 | $0.28 |
| China SXT Pharmaceuticals | 0.005 0.37 | $1.35 |
| Teknova | 0.005 0.11 | $4.43 |
| Petros Pharmaceuticals | 0.0004 2.94 | $0.01 |
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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