Category: Impacting News

The U.S. FDA Approved Novartis Product Fabhalta® for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

Novartis Approval Novartis (NVS) product Fabhalta (iptacopan) is a Factor B inhibitor that acts in the proximate alternative complement pathway of the immune system, It provides comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis.   Fabhalta treatment of paroxysmal nocturnal hemoglobinuria (PNH) increased hemoglobin levels (≥ 2 g . . . This content is for paid …

Treating Obesity: Altimmune Announces Positive Topline Results from the MOMENTUM 48-Week Phase 2 Obesity Trial of Pemvidutide

Altimmune Positive Topline Results Altimmune (ALT) announced positive results from the MOMENTUM 48-Week Phase 2 Obesity Trial of Pemvidutide.  Altimmune is a clinical-stage biopharmaceutical company focused on developing treatments for obesity and liver fibrosis. The Company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist developed for treating obesity and metabolic dysfunction-associated steatohepatitis (MASH

About the FDA Approval of Eli Lilly’s Product Zepbound for Obesity   

FDA Approval of Eli Lilly Product Zepbound for Obesity On Wednesday, Nov. 8, 2023,  the U.S. FDA approved Eli Lilly (LLY) product ZepboundTM (tirzepatide) injection for the treatment of obesity.  Zepbound is the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound is indicated for adults with obesity (with a BMI of …

Current News From Three Selected Biotech Firms

Three Biotech Firm in the NEWS Verona Pharma Verona Pharma plc (VRNA) announced that senior management will present a company overview at the following conferences in November 2023: Jefferies London Healthcare Conference Date: Wednesday, November 15, 2023 Time: 10:00 AM EST / 3:00 PM GMTLocation: London, UK Piper Sandler 35th Annual Healthcare . . . This content is for paid subscribers. Please click here to subscribe or …

More Good News for Neurocrine Biosciences

Neurocrine Biosciences’ Product INGREZZA Improved Chorea Associated with Huntington's Disease Through Week 50  Yesterday, November 2, 2023, Neurocrine Biosciences (NBIX) announced interim results from the KINECT®-HD2 study about INGREZZA® (valbenazine) capsules used for long-term treatment of adults with chorea associated with Huntington's disease (HD). The Interim data suggest that one-capsule, once-daily of INGREZZA improved . . . This content is for paid subscribers. Please click here …

Intellia Therapeutics Receives PRIME Designation from the EMA for NTLA-2002 – Investigational In Vivo CRISPR Genome Editing Treatment for Hereditary Angioedema

Intellia Therapeutics Receives PRIME Designation from EMA Intellia Therapeutics (NTLA) announced that the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to its product NTLA-2002.  As we already know, NTLA-2002 is an in vivo CRISPR-based investigational therapy designed to prevent potentially life-threatening swelling attacks in people with Hereditary Angioedema  (HAE). From Intellia Therapeutics . . . This content is for paid subscribers. Please …

INOVIO Receives FDA Feedback that Data from Completed Phase 1/2 Trial of INO-3107 Can be Used to Submit a BLA

Inovio Receives FDA Feedback for INO-3107 INOVIO (INO) - a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, announced that it received feedback from the U.S. FDA that data from its completed Phase 1/2 trial of INO-3107 for the treatment of Recurrent . . . This content is for paid subscribers. …
Please Don’t Miss Akero Therapeutics Investor Conference Tomorrow, October 10th at 8 AM

Please Don’t Miss Akero Therapeutics Investor Conference Tomorrow, October 10th at 8 AM

Akero Therapeutics to Present Results from Phase 2b SYMMETRY Study Investigating Efruxifermin in Patients with Compensated Cirrhosis Due to NASH Investor webcast on Tuesday, October 10th at 8:00 a.m. ET to present clinical data.   Akero Therapeutics (AKRO) will hold an investor conference . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Apellis Pharmaceuticals Announces Preliminary U.S. Net Revenues of Approximately $74 M for SYFOVRE® in the Q3 2023

Apellis Pharmaceuticals Launch Update of SYFOVRE® On October 5, 2023, Apellis Pharmaceuticals (APLS) provided an update on the launch of its product SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). About Geographic Atrophy GA is an advanced form of age-related macular degeneration and a leading cause of blindness, impacting more than one million Americans . . . This content is for …

Akero Therapeutics Announced Publication in the Lancet Gastroenterology & Hepatology of HARMONY Phase 2b Trial Results for NASH

Akero Therapeutics Akero Therapeutics (AKRO) announced publication in The Lancet Gastroenterology & Hepatology of results from the HARMONY Phase 2b trial in nonalcoholic steatohepatitis (NASH). The paper, which is available online, provides data on the safety, tolerability, and efficacy of once-weekly subcutaneous injections . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Soleno Therapeutics Announces Positive Top-Line Results of Its Product DCCR for the Treatment of Prader-Willi Syndrome

Soleno Therapeutics Soleno Therapeutics (SLNO) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), recently completed its Phase 3 development program to support a planned NDA submission.  For more information, please . . . This content is for paid subscribers. …

Publication of Two Cases for Treatment of Metastatic Pancreatic Cancer by CARsgen Therapeutics Holdings Limited

CARsgen Therapeutics Holdings Limited Today, September 21, 2023, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK) - a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced the publication of two cases of metastatic pancreatic cancer treated with CARsgen’s CT041- an innovative Claudin (CLDN) 18.2 CAR T-cell Therapy in Journal of Hematology & Oncology . . . This content …

Alpine Immune Sciences Treating IgA Nephropathy Among Other Diseases

Alpine Immune Sciences Treating IgA nephropathy Alpine Immune Sciences (ALPN) announced a successful initiation of the second IgA nephropathy (IgAN) dose cohort in RUBY-3, a phase 1b/2a study in autoimmune glomerulonephritis. The safety Monitoring Committee (SMC) determined that repeat . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Exelixis Positive Results in Phase 3 CABINET Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors

Exelixis in the NEWS Exelixis CABOMETYX is approved for the treatment of many cancers. The product has been game changer in the treatment of various difficult to treat cancers before the products that target PD-L1 and approved for several various  cancers were developed by MRK and BMY.     Exelixis (EXEL) announced that the Alliance for Clinical Trials in Oncology independent Data . . . …

The Biotechnology Revolution: News from Nuvectis Pharma and Revolution Medicines Publication

Nuvectis Pharma Nuvectis Pharma (NVCT) is a biopharmaceutical company focused on developing innovative precision targeted drugs capable of treating cancers that have yet to find treatments. The Company’s pipeline comprises two drug candidates, NXP800 and NXP900. NXP800  is an oral small molecule in Phase 1b clinical investigating the product activity and potential treatment of platinum resistant ARID1a-mutated ovarian carcinoma . . . This content is …

Xenon Pharmaceuticals Reports 2Q 2023 Financial Results and Provides Corporate Update

Xenon Pharmaceuticals Q2 Financial Results On  August 09, 2023 , Xenon Pharmaceuticals (XENE) reported financial results for the second quarter ended June 30, 2023, and provided a corporate update. Xenon report started with Mr. Ian Mortimer, the firm’s President and Chief Executive Officer, stating, “We are pleased to announce that patient enrollment is complete in our XEN1101 Phase 2 “X . . . This content is for paid …

TG Therapeutics Will Have An Important Conference Call at 8:30 AM Tomorrow, August 1st

TG Therapeutics Conference Call TG Therapeutics (TGTX) announced that, tomorrow, Tuesday, August 1, 2023, a conference call will be held at 8.30 AM ET, to discuss the results of the second quarter 2023 and provide a business outlook for the remainder of the year.    Michael S. Weiss, Chairman and Chief Executive Officer will host the call. To participate in this conference please . . …

Halozyme Therapeutics’ Positive Results for Patients with Chronic Inflammatory Demyelinating Polyneuropathy

The way drugs are being delivered into patients’ bodies have become more than ever considered important with regard to the safety and efficacy of the treatments. We consider Halozyme Biopharmaceutical is a leader in bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used …