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 September 30, 2025, were $36.3 million,... 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 medicines, which could ease both... 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 United States and Canada, and Cidara... 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 first quarter of... 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 clinical-stage biopharmaceutical... 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 treatment responses of adults with HIV... 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 District at Elanco's new global... 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 China. Toronto, Ontario--(Newsfile... 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 on addressing unmet needs in the... 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 caregivers through the development,... 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® (metoclopramide) nasal spray, today reported... 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 highlights Revenues for the first nine months... 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 release are in United States dollars... 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 commercial-stage... 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 the event will also be available... 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 according to the customers’ need... 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 will host a conference call and... 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 of 2 mg, 4 mg, 6 mg, 8 mg, and... 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. This webcast will be available for... 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 to be held Wednesday, November 12,... 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, manufactures, commercializes, and distributes... 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 share, compared to a net loss... 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 the Investors section 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 operations, procurement, warehouse... 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 comprehensive commercial capabilities... 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 leading provider of ophthalmic disease... 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 to $6.250 billion; Adjusted EBITDA... 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 EBITDA guidance to greater than $135... 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 Million
Generated $17.9 Million... 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 1) has read out, which is expected... 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 outside of the United States and... 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 statistically significant and highly clinically... 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 presentation of results from the pivotal... 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 in major adverse cardiovascular... 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 present results from a sub-analysis... 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 individuals living with TD to help... 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 Jeffrey J. Kraws and... 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 Nephropathy and Immune Thrombocytopenia... 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 These data will be presented... 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) according to RECIST v1.1 criteria.
Overall... 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 Patient Wellbeing and Quality of... 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 indications. WOBURN, Mass., Nov. 07,... 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 global healthcare... 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 to $873.0 million, adjusted non-GAAP... 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) approved DARZALEX FASPRO® (daratumumab... 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 quarter end MISSISSAUGA, ON, Nov.... 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. (NASDAQ:AMPH) ("Amphastar" or the "Company"),... 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 revenue of $150.5 million for the third... 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 integrated contract development... 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 Neuroscience, and will serve on the Executive... Read more
