Lilly to Develop Two Targets Identified and Validated Using Verge Genomics’ AI-Enabled, All-in-Human CONVERGE® Platform Demonstration of the Robust Predictive Power of CONVERGE® - 83% of Prioritized Targets were Validated in Disease-Relevant Models, a Rate Significantly Higher than Industry Standards SOUTH SAN FRANCISCO, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Verge Genomics, a clinical-stage biotechnology company pioneering the use of artificial intelligence... Read more
In the EU, HYMPAVZI is the first once-weekly subcutaneous treatment approved for eligible people living with severe hemophilia B and the first to be administered via a pre-filled pen or syringe for people living with severe hemophilia A or B HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors NEW YORK / Nov 20, 2024 / Business... Read more
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 committed to improving the lives of... 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 chronic, debilitating autoimmune disease... 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 & Johnson (NYSE: JNJ) today announced positive... 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 announced positive Phase 2 results... 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). The collaboration leverages Ratio's... 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 (T217) ALZpath Assay. The ALZpath... 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., Ltd. and Biogen Inc. (Nasdaq:... 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 next steps. Enrollment in the other... 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 patients eligible for ELAHERE,... 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/ -- Roche (SIX: RO, ROG; OTCQX:... 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 Expect to Share Phase 3 Development... 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 announced detailed results from the... 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 (ESPE) Meeting in Liverpool,... 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 / Gilead Sciences, Inc. (Nasdaq: GILD)... 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 (CHMP) of the European Medicines... 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: REGN) and Sanofi today announced that... 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 combination with pemetrexed and platinum... 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 announced that the Committee for Medicinal... 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 amyloid-beta (Aβ) monoclonal antibody... 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 study WASHINGTON, Nov. 14, 2024... 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 and diversified oncology pipeline... 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: LLY) announced today detailed results... 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 Strategies to Ensure Scientific Innovation... 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 antibodies and novel treatment c... 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/ -- Flare Therapeutics Inc., a... 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 the largest, global randomized double-blind... 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 Sales 37,576 16 19 12,947 18 20 - Alliance... 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) entering the clinic this quarter (eight... 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 placebo Nipocalimab was granted BTD in... 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 exacerbation of psychotic symptoms, did... 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 VYVGART Hytrulo 1,000mg (5.6ml)/vial... 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 immunization for the prevention of lower... 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 significant and clinically meaningful... 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 Drug Administration (FDA) and European... 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 signaling inhibitor therapy for PAH... 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 significant and clinically meaningful... 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 synthetic royalty on U.S. sales of... 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 a Divestiture-Adjusted Basis[2... 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 7, 2024 / Moderna, Inc. (NASDAQ:MRNA)... 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 Operations increased by 13% in Danish... 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 / Business Wire / Sarepta Therapeutics,... 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% year-over-year revenue growth, including... 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 full year 2024 guidance for Portfolio... 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 increase of 21% in local currency... 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) -- Regeneron Pharmaceuticals, Inc.... 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 the GAAP to non-GAAP reconciliation... 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 royalty funding agreement with... 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 T1D BOSTON / Nov 04, 2024 / Business... Read more
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