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. …

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 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 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 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. …

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 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 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 . . . …

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 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 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 . . …

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 …

Merck and Kintara in the NEWS Treating cancers that have no treatments should be a priority for researchers to create a treatment for them.  Patients who are afflicted with untreatable deadly diseases might not have a single drop of hope in survival  from these untreatable cancers. In yesterday's news, we fell on a treatment by Merck that demonstrated statistically significant and clinically meaningful improvement in …

BioMarin Pharmaceutical US FDA Approval for ROCTAVIAN On June 30, 2023, BioMarin Pharmaceutical (BMRN) announced that the U.S. FDA has approved ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) gene therapy for adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by . . . This content is for paid subscribers. Please click here to …

BioMarin Pharmaceutical US FDA Approved ROCTAVIAN BioMarin Pharmaceutical (BMRN) announced that the U.S. FDA approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for adults with severe hemophilia A without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. The one-time, single-dose infusion is the first approved gene therapy for severe hemophilia . . . This content is for paid subscribers. Please click here to subscribe …

Vera Therapeutics Vera Therapeutics (VERA) announced that Phase 2b ORIGIN clinical trial of atacicept for IgA nephropathy  met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR through week 36. The week 36 results of ORIGIN trial were presented at the 60th European Renal Association (ERA

Today at 2.30... Today at 2.30, the Federal Reserve Chairman Jerome Powell will speak to the United States and the rest of the world about the Fed’s decision with regard to interest rates. Financial analysts in five star financial journals expect Chairman Powell not to hike interest rates again, which will be taken as good news by investors.   It is important to watch and …

Inside the Revolution In the Treatments of Untreatable Diseases We are now living a great revolution in the treatment of diseases. We expect to discover novel treatments capable of defeating cancers’ resistance to therapeutics old and new. We are following on all the firms that are discovering the unknown about life-threatening diseases, including the genetically derived diseases or else. Yesterday, May 25, 2023, we studied …

Atea Pharmaceuticals Receives Fast Track Designation for Bemnifosbuvir Atea Pharmaceuticals (AVIR) announced that the U.S. FDA has granted Fast Track designation to its product bemnifosbuvir for the treatment of resistant COVID-19.   Bemnifosbuvir is an oral, direct acting antiviral drug candidate being evaluated in the global Phase 3 SUNRISE-3 registrational trial for the treatment of COVID . . . This content is for paid subscribers. …

News from Innoviva That We Consider Positively Impacting and Extremely Important Innoviva, Inc. (INVA) (Innoviva), announced that the FDA Antmicrobial Drugs Advisory Committee (AMDAC) has unanimously voted 12-0 in favor of approval of sulbactam-durlobactam based on a favorable benefit-risk assessment for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused . . . This content is for paid subscribers. Please click here …