Phase 2 data establish proof-of-concept of efgartigimod SC in myositis Enrollment to continue in Phase 3 across all three subtypes (IMNM, ASyS, DM) under evaluation in ALKIVIA Potential for efgartigimod SC to be first targeted approach for myositis patients who have limited treatment options November 20, 2024, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company...Read more
Dapirolizumab pegol (DZP) met its primary endpoint, demonstrating statistically and clinically significant improvement across all organ systems as measured by BICLA, an endpoint measuring disease activity A greater response was observed across multiple clinical endpoints among participants treated with DZP including 50% less severe disease flares compared to participants on standard of care alone Systemic Lupus Erythematosus is a...Read more
Icotrokinra (JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, met its co-primary endpoints in patients with moderate to severe plaque psoriasis 74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24 Comprehensive results are being prepared for presentation at upcoming medical congresses SPRING HOUSE, Pa., Nov. 18, 2024 /PRNewswire/ -- Johnson &...Read more
Muvalaplin, an oral, once-daily treatment that inhibits lipoprotein(a) formation via a novel mechanism, achieved positive results in a 12-week Phase 2 study These data were published in the Journal of the American Medical Association (JAMA) and simultaneously presented today at the American Heart Association (AHA) Scientific Sessions 2024 INDIANAPOLIS, Nov. 18, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today...Read more
Ratio to receive upfront, and potential milestones and tiered royalty payments BOSTON, Nov. 18, 2024 /PRNewswire/ -- Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, entered today into an exclusive worldwide license and collaboration agreement with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS)....Read more
MINNEAPOLIS, Nov. 18, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced a strategic partnership with ALZpath, Inc to accelerate breakthroughs in neurodegenerative disease research and treatment, including Alzheimer's disease. The collaboration leverages Bio-Techne's Ella™ fully automated, multiplexing immunoassay platform and ALZpath's proprietary pTau217 antibody to provide the Simple Plex Human Phospho-Tau...Read more
OPUVIZ™ is one of the first wave aflibercept biosimilars in Europe OPUVIZ is the second European Commission (EC)-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership EC approval based on robust totality of evidence confirming biosimilarity to reference aflibercept in terms of quality, efficacy, and safety INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co.,...Read more
WILMINGTON, Del. / Nov 18, 2024 / Business Wire / Incyte (Nasdaq:INCY) today announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU). The decision was made following the observation of certain in vivo preclinical toxicology findings. These data have been shared with the U.S. Food and Drug Administration (FDA) and Incyte will work closely with the FDA to determine...Read more
ELAHERE is the first and only novel therapy approved in the European Union specifically for patients with folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer ELAHERE represents the first treatment to demonstrate an overall survival benefit in a Phase 3 trial in platinum-resistant ovarian cancer compared with chemotherapy VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the companion diagnostic to identify ovarian cancer...Read more
The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers. The test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE. This certification follows the unprecedented decision by regulators to grant an early exemption approval for the test in Germany and Austria earlier this year. TUCSON, Ariz., Nov. 18, 2024 /PRNewswire/...Read more
Single Dose of Nucresiran 300mg or Higher Led to Rapid Knockdown of Mean TTR Levels of Greater than 90% by Day 15 that was Sustained at Six Months At These Doses, Peak Reduction of Mean TTR Levels of Greater than 96% were Achieved by Day 29 Data Support Potential for Biannual or Annual Subcutaneous Dosing, Representing a New Paradigm in the Treatment of ATTR Amyloidosis Encouraging Safety and Tolerability Observed Alnylam Continues to...Read more
In a first-of-its-kind study, tirzepatide also alleviated heart failure symptoms and physical limitations Patients on tirzepatide experienced improved exercise capacity, greater weight loss and reduced systemic inflammation Lilly has initiated submissions for tirzepatide for the treatment of HFpEF and obesity to global regulatory agencies INDIANAPOLIS, Nov. 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today...Read more
SAN RAFAEL, Calif., Nov. 16, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced positive and consistent results from multiple real-world evidence studies of VOXZOGO® (vosoritide) in children with achondroplasia. These results, as well as data from the investigational research program for VOXZOGO in hypochondroplasia, were presented at the 62nd Annual European Society for Paediatric Endocrinology...Read more
New Findings Demonstrate 81% of Participants Achieve Durable Biochemical Response by Month 30 with Livdelzi Nearly Half of Participants with Primary Biliary Cholangitis (PBC) Achieve Alkaline Phosphatase (ALP) Normalization with Livdelzi Livdelzi Reduced Pruritus Severity in PBC Participants and Led to Near Resolution of Itch in 27% of Participants with Moderate to Severe Itch FOSTER CITY, Calif. / Nov 15, 2024 / Business Wire /...Read more
Opinion based on results from the Phase 3 CheckMate -8HW trial, in which the dual immunotherapy combination of Opdivo and Yervoy demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to investigator’s choice of chemotherapy PRINCETON, N.J. / Nov 15, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use...Read more
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:...Read more
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial RAHWAY, N.J. / Nov 15, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in...Read more
Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity with repotrectinib in these patient populations If approved, repotrectinib has the potential to be a best-in-class treatment for patients with advanced ROS1-positive non-small cell lung cancer in the European Union PRINCETON, N.J. / Nov 15, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today...Read more
TOKYO and CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the...Read more
Adults with moderately-to-severely active Sjögren's disease who received investigational FcRn blocker nipocalimab had improvements in disease activity scores at 24 weeks with accompanying significant reductions in IgG and autoantibody levels Nipocalimab was granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease based on results from the Phase 2 DAHLIAS...Read more
RAHWAY, N.J. / Nov 14, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and LaNova Medicines Ltd. (LaNova), a privately held clinical-stage biotechnology company, today announced that Merck has entered into an exclusive global license to develop, manufacture and commercialize LM-299, a novel investigational PD-1/VEGF bispecific antibody from LaNova. “At Merck, we continue to assemble a strong...Read more
SURMOUNT-1 results show a 94% reduction in risk of progression to type 2 diabetes across all pooled doses of tirzepatide compared to placebo over three years Results suggest one new case of diabetes could be prevented for every nine patients treated with tirzepatide Participants treated with tirzepatide had an average weight reduction of 22.9% (15 mg dose) INDIANAPOLIS, Nov. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:...Read more
Newly Presented Results, to be Published in The New England Journal of Medicine, Include Adherence and Pharmacokinetics Data; Data Underscore High Efficacy and Safety Profile of Lenacapavir Among Broad and Geographically Diverse Range of Individuals FDA Recently Granted Breakthrough Therapy Designation for Lenacapavir for PrEP; Gilead to Begin Regulatory Filings by End of 2024 Gilead Spearheading Lenacapavir Access...Read more
Acquisition to support the global execution of BioNTech’s oncology strategy and provide full global rights to BNT327/PM8002, an investigational PD-L1 x VEGF-A bispecific antibody, with potential to replace current checkpoint inhibitor standard of care treatments for solid tumors With the acquisition of Biotheus, BioNTech aims to further strengthen its capabilities to develop, manufacture and commercialize next-generation bispecific...Read more
Collaboration will leverage Flare Therapeutics' proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecules aimed at transcription factor targets in oncology Flare Therapeutics to receive US$70 million upfront, and potential milestone payments exceeding US$1.8 billion, as well as royalties CAMBRIDGE, Mass., Nov. 12, 2024 /PRNewswire/...Read more
These results showed reduction in tumor volume, building on the established safety and efficacy profile of KOSELUGO in certain children and has the potential to support expanded use in certain adults RAHWAY, N.J. / Nov 12, 2024 / Business Wire / Alexion, AstraZeneca Rare Disease and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 KOMET trial, which is...Read more
Upgrade to full year 2024 guidance underpinned by strong underlying growth momentum CAMBRIDGE, United Kingdom / Nov 12, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary 9M 2024 % Change Q3 2024 % Change $m Actual CER1 $m Actual CER - Product...Read more
Continued financial progress with $1 billion in quarterly total revenue, reduced GAAP loss and second consecutive quarter of positive non-GAAP operating income Strengthened franchise leadership in chronic lymphocytic leukemia (CLL) with foundational therapy BRUKINSA global revenue of $690 million, rapidly progressing pivotal programs for late-stage hematology pipeline Expanded oncology pipeline with four new molecular entities (NMEs)...Read more
The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren's disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study A greater than 70 percent relative improvement in systemic disease activity at Week 24 was demonstrated in study participants on average who received nipocalimab 15 mg/kg compared to participants who received...Read more
EMPOWER-1 and EMPOWER-2 Phase 2 clinical trials did not meet their primary endpoint Emraclidine was well-tolerated with an adverse event profile consistent with Phase 1b trial NORTH CHICAGO, Ill., Nov. 11, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute...Read more
First and only NMPA-approved treatment for patients with CIDP in China Second VYVGART Hytrulo indication approved in China November 11, 2024 – 7:30am ET - Amsterdam, the Netherlands - argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for...Read more
mRESVIA is Moderna's second approved product in Canada, the first mRNA vaccine against RSV, and the only one in single-dose pre-filled syringes Canada is the fourth jurisdiction to approve mRESVIA following approvals in the U.S., Europe, and Qatar CAMBRIDGE, MA / ACCESSWIRE / November 8, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced Health Canada has approved mRESVIA™ (Respiratory Syncytial Virus mRNA vaccine) for active...Read more
TEZSPIRE demonstrated a statistically significant and clinically meaningful reduction in nasal polyp size and reduced nasal congestion compared to placebo WILMINGTON, Del. / Nov 08, 2024 / Business Wire / Positive high-level results from the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) showed that AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab) demonstrated a statistically...Read more
If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage RARITAN, N.J., Nov. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the submission of regulatory applications to the U.S. Food and...Read more
KIRKLAND, QC, Nov. 8, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that Canada's Drug Agency (CDA) has recommended WINREVAIR® (sotatercept) for reimbursement in combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III. Sotatercept is the first activin...Read more
Statistically Significant Reduction in Nasal Polyp Size, Nasal Congestion Compared to Placebo THOUSAND OAKS, Calif., Nov. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]). The trial demonstrated patients treated with TEZSPIRE® (tezepelumab-ekko) had a statistically...Read more
RYTELO™ (imetelstat) is FDA approved for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia Transaction increases Royalty Pharma’s synthetic royalty funding to $925 million in 2024, highlighting the significant opportunity for this attractive funding modality NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it will acquire a...Read more
Total Revenues of $3.8 Billion and Operational Revenue Growth of ~3% on a Divestiture-Adjusted Basis Demonstrate Strength of Company's Base Business[1] Strong New Product Revenues of $133 Million Drove Growth Across Segments U.S. GAAP Net Earnings were $95 Million; Adjusted EBITDA Grew ~4% to $1.3 Billion on a Divestiture-Adjusted Basis; U.S. GAAP Diluted EPS was $0.08 per Share; Adjusted EPS Grew ~6% to $0.75 per Share on...Read more
Reports third quarter revenues of $1.9 billion, GAAP net income of $13 million and GAAP EPS of $0.03 Achieves year-to-date product sales of $2.2 billion; reiterates 2024 expected product sales of $3.0 to $3.5 billion Initiated dosing in two pivotal Phase 3 trials to assess efficacy of investigational mRNA vaccines against norovirus and influenza Announces expansion of its Executive Committee CAMBRIDGE, MA / ACCESSWIRE / November...Read more
Bagsværd, 6 November 2024 - Financial report for the period 1 January 2024 to 30 September 2024 Operating profit increased by 21% in Danish kroner and by 22% at constant exchange rates (CER) to DKK 91.6 billion. Sales in North America Operations increased by 31% in Danish kroner (31% at CER). Sales growth in the US was positively impacted by gross-to-net sales adjustments related to prior years. Sales in International...Read more
Net product revenues for the third quarter 2024 totaled $429.8 million, a 39% increase over the same quarter of the prior year ELEVIDYS net product revenue for the quarter totaled $181.0 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $9.5 million Achieved GAAP and non-GAAP net income of $33.6 million and $67.0 million for the third quarter 2024, respectively CAMBRIDGE, Mass. / Nov 06, 2024 /...Read more
Product Sales Excluding Veklury Increased 7% Year-Over-Year to $6.8 billion Biktarvy Sales Increased 13% Year-Over-Year to $3.5 billion Oncology Sales Increased 6% Year-Over-Year to $816 million FOSTER CITY, Calif. / Nov 06, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) announced today its third quarter 2024 results of operations. “Gilead’s third quarter results are the strongest of the year to date, with 7%...Read more
Portfolio Receipts growth of 15% to $735 million; Royalty Receipts growth of 15% Net cash provided by operating activities of $704 million Capital Deployment of approximately $1.2 billion Raising full year 2024 guidance: Portfolio Receipts expected to be $2,750 to $2,800 million NEW YORK, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today reported financial results for the third quarter of 2024 and raised...Read more
For an accessible version of this Press Release, please visit www.tevapharm.com Q3 2024 revenues of $4.3 billion reflect an increase of 13% in U.S. dollars, or 15% in local currency terms, compared to Q3 2023. AUSTEDO® – shows continued growth, U.S. revenues of $435 million in Q3 2024, an increase of 28% compared to Q3 2023; reaffirming 2024 revenue outlook of ~$1.6 billion. AJOVY® – global revenues of $137 million in Q3 2024, an...Read more
Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to one year Dupixent is the first-ever medicine in the EU indicated to treat these young patients, who persistently struggle to eat at a critical stage in life where growth is crucial TARRYTOWN, N.Y. and PARIS, Nov. 06, 2024 (GLOBE NEWSWIRE)...Read more
Q1'25 net revenue of $1.02 billion increased 4% as reported and in constant currency(1), compared to Q1'24. Q1'25 net revenue, excluding COVID revenue of ~$30 million in Q1’25 and ~$100 million in Q1'24, increased 13% compared to Q1'24. Q1'25 net loss of $(129) million. Q1'25 Adjusted EBITDA(1) of $125 million increased 11% as reported, or 10% in constant currency, compared to Q1'24. (1) See "Non-GAAP Financial Measures" below and...Read more
Proceeds expected to support the upcoming planned launches and fund the continued development of Niktimvo and revumenib Expected to fund Syndax through profitability; proforma cash approaching $800 million as of June 30 NEW YORK and WALTHAM, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that Royalty Pharma has entered into a $350 million synthetic...Read more
Product revenue of $2.77 billion, a 12% increase compared to Q3 2023 Raising full-year product revenue guidance to $10.8 billion to $10.9 billion Preparing for two potential near-term launches: vanzacaftor triple in CF and suzetrigine (VX-548) for moderate-to-severe acute pain Pipeline progress continuing with three additional programs advancing to Phase 3: suzetrigine in DPN, povetacicept in IgAN and VX-880 in...Read more
Presented clinical data for multiple assets across modalities, including bispecific antibody candidate BNT327/PM8002 and mRNA cancer vaccine candidate BNT113 based on BioNTech’s FixVac platform Initiated two Phase 2 dose optimization trials with BNT327/PM8002 in small-cell lung cancer and in triple-negative breast cancer to inform planned pivotal Phase 3 trials Phase 2 clinical trial on track to evaluate mRNA-based individualized...Read more
Findings Presented at the 2024 Psych Congress Include Data From More Than 300 Patients SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) presented data from more than 300 patients diagnosed with tardive dyskinesia and treated with INGREZZA® (valbenazine) capsules. These data showed significant improvements in functional, social, emotional and health-related quality of life measures in...Read more
SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) presented data from the long-term KINECT®-4 study demonstrating tardive dyskinesia remission in nearly 60% of participants at Week 48 with once-daily INGREZZA® (valbenazine) capsules treatment. This research, "Remission of Tardive Dyskinesia in Patients Receiving Long-Term Valbenazine Treatment" (Poster #98), was shared at the 2024 Psych Congress in...Read more
INDIANAPOLIS, Nov. 1, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from the Phase 3 trial (EMBER-3) for imlunestrant, an oral selective estrogen receptor degrader (SERD), will be reported for the first time in a late-breaking oral presentation at the San Antonio Breast Cancer Symposium (SABCS) taking place December 10-13 in San Antonio, TX. EMBER-3 is a study in estrogen receptor positive (ER+),...Read more
Bagsværd, Denmark, 1 November 2024 – Novo Nordisk today announced the headline results from part 1 of the ongoing ESSENCE trial, a pivotal phase 3, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3)1. Part 1 of the ESSENCE trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue (histology) compared to...Read more
Teva’s presentation of findings from six schizophrenia studies at Psych Congress 2024 highlights its commitment to finding new innovations in neuroscience Data show TEV-'749 drug delivery technology resulted in no occurrence of Post-Injection Delirium/Sedation Syndrome (PDSS) events to date Real-world analyses of UZEDY (risperidone) subcutaneous long-acting injectable reveal high adherence rates and utilization in adults with...Read more
Performance Reflects Continued Focus on Near-Term Execution and Building a Foundation for Long-Term Sustainable Growth Third Quarter Revenues were $11.9 Billion, increasing 8% (+10% Adjusting for Foreign Exchange) Growth Portfolio Revenues were $5.8 Billion, increasing 18% (+20% Adjusting for Foreign Exchange) GAAP EPS was $0.60 and Non-GAAP EPS was $1.80; Includes Net Impact of $(0.09) Per Share for GAAP EPS and Non-GAAP EPS Due to...Read more
Achieved Third Quarter 2024 Global Net Product Revenues of $420 Million, Representing 34% Year-Over-Year Growth Compared to Q3 2023, Driven by Continued Momentum from TTR Business Submitted Regulatory Applications in U.S. and EU for AMVUTTRA® (vutrisiran) for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy Reiterated 2024 Financial Guidance, Including Combined Net Product Revenues of $1,575 Million to $1,650...Read more
Partnership to Combine AbbVie's Oncology Expertise with EvolveImmune's Proprietary EVOLVE T-Cell Engager Platform to Develop Novel Multispecific Therapeutic Antibodies for Cancer NORTH CHICAGO, Ill. and BRANFORD, Conn., Oct. 31, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and EvolveImmune Therapeutics, an immuno-oncology company developing next-generation biotherapeutics to overcome the therapeutic challenges of cancer cell...Read more
ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $93.4 Million for the Third Quarter of 2024, Reflecting 18% Growth Over the Third Quarter of 2023 NDA Submission for Brensocatib in Bronchiectasis Remains on Track for the Fourth Quarter of 2024 with Potential U.S. Launch Still Expected in Mid-2025 Expanded U.S. Sales Force is Now Fully Deployed; Focusing on Bronchiectasis Disease-State Awareness and Supporting...Read more
Total Worldwide Sales Were $16.7 Billion, an Increase of 4% From Third Quarter 2023; Excluding the Impact of Foreign Exchange, Growth Was 7% KEYTRUDA Sales Grew 17% to $7.4 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 21% WINREVAIR Sales Were $149 Million; U.S. Launch of WINREVAIR Gaining Momentum; Received Approval in the EU Animal Health Sales Grew 6% to $1.5 Billion; Excluding the Impact of Foreign Exchange, Sales...Read more
Third quarter 2024 revenues increased 11% to $3.72 billion versus third quarter 2023 Third quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 23% to $3.82 billion versus third quarter 2023 Third quarter 2024 U.S. net sales for EYLEA HD® and EYLEA® increased 3% versus third quarter 2023 to $1.54 billion, including $392 million from EYLEA HD Third quarter 2024 Libtayo® global net sales increased 24%...Read more
Expanded agreement includes development of additional transgenic mouse technologies and performance of additional therapeutic antibody research programs FOSTER CITY, CA / ACCESSWIRE / October 31, 2024 / AbTherx, a biotechnology company with innovative technologies that enable and accelerate therapeutic antibody discovery and development, today announced the expansion of a previous agreement with Gilead Sciences, Inc. (Nasdaq:GILD) to...Read more
Revenue Growth of +13.4% at Actual Exchange Rates (AER); +5.0% at Constant Exchange Rate (CER) Driven by Continued Advancement of Growth & Launch Products (+18.7% at CER) Core Operating Profit Increase of +12.9% at CER; Core Operating Profit Margin of 30.2% Double-Digit Revenue Growth of ENTYVIO® at CER Driven by Launch of ENTYVIO® Pen in the U.S. Geographical Expansion with Approvals of ADZYNMA® in EU and FRUZAQLA® in...Read more
$573 million in third quarter global net product sales CIDP global expansion on track, with decisions on approval under review in Japan, Europe, China, and Canada Management to host conference call today at 1:30 PM CET (8:30 AM ET) Regulated information - Inside information October 31, 2024 7:00AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the...Read more
ItovebiTM (inavolisib)-based regimen demonstrated a statistically significant and clinically meaningful benefit, reducing the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the INAVO120 study The U.S. FDA recently approved the Itovebi-based regimen as a first-line treatment for people with HR-positive, HER2-negative breast cancer with a PIK3CA mutation, one of the most commonly mutated...Read more
Revenue in Q3 2024 increased 20%, driven by volume growth from Mounjaro and Zepbound, partially offset by $1.42 billion of revenue in Q3 2023 from the sale of rights for the olanzapine portfolio (Zyprexa). Excluding revenue from the olanzapine portfolio, total revenue increased 42%, and non-incretin revenue increased 17%. Q3 2024 EPS increased to $1.07 on a reported basis and $1.18 on a non-GAAP basis, both inclusive of $3.08 of...Read more
THOUSAND OAKS, Calif., Oct. 30, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2024. "Strong growth in sales and earnings this quarter reflects the momentum we're building throughout our business. We continue to invest heavily in our rapidly advancing pipeline, with a focus on delivering innovative therapies across our core therapeutic areas," said Robert A. Bradway, chairman and chief...Read more
Reports Third-Quarter Diluted EPS of $0.88 on a GAAP Basis, a Decrease of 12.0 Percent; Adjusted Diluted EPS of $3.00, an Increase of 1.7 Percent; These Results Include an Unfavorable Impact of $0.04 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Third-Quarter Net Revenues of $14.460 Billion, an Increase of 3.8 Percent on a Reported Basis or 4.9 Percent on an Operational Basis Third-Quarter Global Net Revenues...Read more
INGREZZA® (valbenazine) Third Quarter Net Product Sales of $613 Million Representing 26% Year-Over-Year Growth INGREZZA® (valbenazine) 2024 Net Product Sales Guidance Raised to $2.30 - $2.32 Billion Board Authorizes $300 Million Share Repurchase Plan SAN DIEGO, Oct. 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the third quarter ended September 30, 2024 and...Read more
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Oct 30, 2024 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter ended September 30, 2024. Total revenues in the third quarter of 2024 grew 23 percent year-over-year to $748.9 million, compared to $609.4 million in the third quarter of 2023. "I’m proud of the close to 1,300 Unitherians...Read more
MINNEAPOLIS, Oct. 30, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today reported its financial results for the first quarter ended September 30, 2024. First Quarter FY2025 Highlights First quarter organic revenue increased by 4% (5% reported) to $289.5 million. GAAP earnings per share (EPS) was $0.21 versus $0.31 one year ago. Delivered adjusted EPS of $0.42 compared to $0.41 one year ago. Continued...Read more
Third-Quarter Performance Driven by Focused Commercial Execution and Robust Double-Digit Revenue Growth Across Product Portfolio Raises Full-Year 2024 Revenue Guidance(1) to a Range of $61.0 to $64.0 Billion and Raises Adjusted(2) Diluted EPS Guidance to a Range of $2.75 to $2.95 Third-Quarter 2024 Revenues of $17.7 Billion, Representing 32% Year-over-Year Operational Growth Excluding Contributions from Paxlovid and Comirnaty(3),...Read more
Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC) therapies1-3 Patients on Scemblix also had fewer dose reductions and half the rate of adverse reactions leading to treatment discontinuation1-3 Nearly 50% of CML patients do not meet efficacy milestones (MMR) with current SoC and almost 25% discontinue...Read more
A change in the initiation of donanemab dosing, shifting one vial of donanemab from the first infusion to the third infusion, lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen used in the pivotal Phase 3 clinical trial Reduction of amyloid plaque and P-tau217 on this modified titration was comparable to patients receiving the standard dosing regimen Lilly intends to submit this data to global...Read more
Total revenues of $1,138 million in the third quarter (Q3'24) (+24% Y/Y) Jakafi® (ruxolitinib) net product revenues of $741 million in Q3'24 (+16% Y/Y); raising full year 2024 Jakafi guidance to a new range of $2,740 - $2,770 million Opzelura® (ruxolitinib) cream net product revenues of $139 million in Q3'24 (+52% Y/Y); launch momentum continues in the U.S. supported by reimbursement expansion in Europe Niktimvo™ (axatilimab-csfr)...Read more
Third Quarter 2024 Total Revenues of $746 million (+28% Y/Y and +32% at Constant Currency Y/Y); Year-to-date 2024 Total Revenues of $2.11 billion (+19% Y/Y and +23% at Constant Currency Y/Y) During the Quarter, Strong Demand Drove 54% Y/Y Revenue Growth for VOXZOGO® During the Quarter, Revenues from Enzyme Therapies Portfolio Increased 27% Y/Y Third Quarter 2024 GAAP Diluted Earnings Per Share (EPS) of $0.55 (+162% Y/Y); Year-to-date...Read more
The collaboration aims to discover and develop molecular glue degrader clinical candidates for priority targets to Biogen. Collaboration leverages Neomorph's leading molecular glue discovery platform and Biogen’s deep expertise in Alzheimer’s, rare, and immunological diseases. CAMBRIDGE, Mass. and SAN DIEGO, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Neomorph Inc. announced a research collaboration to...Read more
Aliada's lead compound, ALIA-1758, an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody, is a potential best-in-class therapy for Alzheimer's disease Acquisition also allows AbbVie to utilize Aliada's novel blood-brain barrier (BBB)-crossing technology to enhance discovery and development efforts across neuroscience NORTH CHICAGO, Ill. and BOSTON, Oct. 28, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Aliada Therapeutics today...Read more
A greater number of patients treated with subcutaneous TREMFYA® induction and maintenance achieved clinical and endoscopic remission at 48 weeks in the Phase 3 GRAVITI study versus placebo TREMFYA® could become the first IL-23 treatment to offer both a subcutaneous and intravenous (IV) induction regimen for patients living with Crohn's disease (CD), pending FDA approval PHILADELPHIA, Oct. 28, 2024 /PRNewswire/ -- Johnson &...Read more
At three years, over 80% of patients with moderately to severely active UC who were in remission with mirikizumab sustained long-term remission and relief from disruptive symptoms, including bowel urgency Mirikizumab also helped over 50% of patients with moderately to severely active Crohn's disease sustain long-term endoscopic remission for up to five years INDIANAPOLIS, Oct. 28, 2024 /PRNewswire/ -- Eli Lilly and Company...Read more
The INTerpath-009 clinical trial demonstrates continued expansion of the INTerpath clinical program, as the third Phase 3 trial for the investigational individualized neoantigen therapy, V940 (mRNA-4157), focused on earlier stages of cancer RAHWAY, N.J. & CAMBRIDGE, Mass. / Oct 28, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (Nasdaq: MRNA), today announced the...Read more
The detailed study results confirmed interim findings, showing stable kidney function and sustained treatment effect more than 18 months after the last dose of felzartamab Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development IgA Nephropathy (IgAN) is a leading cause of chronic...Read more
New data on povetacicept 80 mg SC Q4 weeks in IgA nephropathy shows mean UPCR reduction from baseline of 66% observed at 48 weeks, associated with stable renal function (eGFR) and 63% achieving clinical remission -- First proteinuria data on povetacicept in primary membranous nephropathy shows mean UPCR reduction from baseline of 62% at 24 weeks – - Global Phase 3 RAINIER trial of povetacicept in IgA nephropathy now underway – –...Read more
First-of-its-kind Phase 3b study shows TREMFYA® achieved statistical significance across all primary and secondary endpoints in low body surface area psoriasis with special site involvement Johnson & Johnson launches library of clinical images from Phase 3b VISIBLE study to enhance clinical decision making for people across all skin tones living with moderate to severe plaque psoriasis LAS VEGAS, Oct. 25, 2024 /PRNewswire/ --...Read more
In first dedicated study of a selective IL-13 inhibitor in patients previously treated with dupilumab, the majority of patients had a history of inadequate response to dupilumab EBGLYSS also provided meaningful improvements in difficult-to-treat face and hand dermatitis The safety profile of EBGLYSS was consistent with previous Phase 3 studies and of the patients who reported eye-related events, facial dermatitis or...Read more
Companies will discover and develop novel targets for the potential treatment of neuropsychiatric conditions New discovery program builds upon nearly two decades of partnership between AbbVie and Gedeon Richter NORTH CHICAGO, Ill. and BUDAPEST, Hungary, Oct. 24, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Gedeon Richter Plc. ('Richter') today announced a new discovery, co-development and license agreement to advance novel targets...Read more
Dupixent significantly reduced itch and hive activity from baseline; 41% of patients achieved well-controlled disease status Confirmatory data to support U.S. regulatory resubmission by year-end; if approved, Dupixent would be the first new targeted treatment for people living with chronic spontaneous urticaria in more than 10 years More than 300,000 people in the U.S. suffer from chronic spontaneous urticaria that is inadequately...Read more
First-of-its-Kind Research Collaboration for Takeda and Boston Medical Center with the Aim to Decarbonize the Health Care Value Chain Three-Year Collaboration to Tackle Carbon Emissions from Regulated Medical Waste, Including Pharmaceutical Packaging Learnings will be Shared to Scale Decarbonization Solutions Across the Health Care Value Chain CAMBRIDGE, Mass. & BOSTON / Oct 24, 2024 / Business Wire / Takeda (TOKYO:4502/NYSE:TAK)...Read more
Single dose of vaccine elicited robust immune response with acceptable safety profile in adults aged 18-49 at increased risk for RSV-LRTD Two doses of vaccine in immunocompromised adults aged 18 and older elicited immune responses similar to one dose in healthy adults aged 50+ and with an acceptable safety profile In the US alone, adults aged 18-49 with at least one risk factor for RSV disease could exceed 21 million1 PHILADELPHIA /...Read more
KEYTRUDA plus chemotherapy is the first approval in the EU for an anti-PD-1 therapy combined with chemotherapy only for patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status KEYTRUDA plus chemoradiotherapy is the first anti-PD-1-based regimen approved in the EU for patients with FIGO 2014 Stage III-IVA locally advanced cervical cancer RAHWAY, N.J. / Oct 24, 2024 / Business Wire / Merck...Read more
Age-based recommendations for adult pneumococcal vaccination lowered from 65 to 50 years of age and older National-level CDC surveillance data shows CAPVAXIVE covers the serotypes responsible for approximately 84% of invasive pneumococcal disease cases, compared to approximately 52% covered by PCV20 RAHWAY, N.J. / Oct 23, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today...Read more
| Company | Change | Last Trade |
|---|---|---|
| BioNTech | 6.09 5.96 | $108.23 |
| argenx | 4.74 0.80 | $596.56 |
| AbbVie | 3.97 2.37 | $171.73 |
| United Therapeutics | 3.03 0.83 | $367.36 |
| Merck | 2.42 2.48 | $99.86 |
| Johnson & Johnson | 2.39 1.56 | $155.50 |
| Bio-Techne | 2.33 3.39 | $71.05 |
| Amgen | 2.03 0.71 | $289.90 |
| Biogen | 2.01 1.29 | $158.01 |
| Neurocrine Biosciences | 1.71 1.39 | $125.00 |
| Moderna | 1.31 3.55 | $38.25 |
| Regeneron Pharmaceuticals | 1.15 0.15 | $744.50 |
| Insmed | 1.14 1.57 | $73.81 |
| Gilead Sciences | 1.13 1.27 | $89.76 |
| AstraZeneca | 1.06 1.68 | $64.26 |
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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