Author: Prohost

Soon, Many Treatments for Life-Threatening Diseases Will Become History. Time to Select Biotech Companies With Novel Advanced Technologies and Products

 What About GRAIL Inc? GRAIL Inc (GRAL) is a healthcare company on a mission to detect cancers early so they can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, state-of-the-art machine learning, software, and automation to detect and identify multiple deadly . . . This content is for paid subscribers. Please …

Boehringer Ingelheim Product Nerandomilast Meets Primary Endpoint in Phase III Study in Progressive Pulmonary Fibrosis 

Boehringer Ingelheim Today, Boehringer Ingelheim, a private Company announced that the FIBRONEER™-ILD trial met its primary endpoint, which was the absolute change from baseline in FVC (mL) at week 52 versus placebo. FVC is a measure of lung function.  Initial data readouts of the FIBRONEER™-trials support a generally consistent safety and tolerability profile when compared to the Phase II IPF study, with overall adverse events comparable to …

Eledon Pharmaceuticals Announces Use of Tegoprubart as Key Component of Immunosuppression Regimen in its Second Transplant of a Genetically Modified Pig Kidney into a Human

Eledon Pharmaceuticals The patient was treated in the procedure, conducted at Mass General Transplant Center and in collaboration with partner eGenesis, and was recently released from the hospital.  Today,  February 07, 2025, Eledon Pharmaceuticals (ELDN) announced that tegoprubart, its investigational anti-CD40L antibody, was used as a key component of the immunosuppression therapy regimen in a patient who recently received . . . This content is …

Supernus Pharmaceuticals Announced FDA Approval of product ONAPGO for the Treatment of Motor Fluctuations in Adults with Advanced Parkinson’s Disease

Supernus Pharmaceuticals Supernus Pharmaceuticals (SUPN) - a biopharmaceutical company focused on developing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) approved ONAPGO (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults . . . This content is for …

CHMP Issued Positive Opinion for Subcutaneous RYBREVANT® Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Halozyme Therapeutics Halozyme Therapeutics (HALO) announced that Janssen-Cilag International NV, a Johnson & Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorization for a subcutaneous (SC) formulation of RYBREVANT® (amivantamab) in combination with LAZCLUZE® (lazertinib) for . . . This content is for paid subscribers. Please click here …

Vertex Outstanding and Promising News

Vertex Pharmaceuticals Yesterday, January 30, 2025, Vertex Pharmaceuticals (VRTX) announced FDA approval of journavx™(suzetrigine), a First-in-Class treatment for adults with moderate-to-severe acute pain. Today, Vertex Announced the CASGEVY® Reimbursement Agreement for treating Sickle Cell Disease in England. We start with the Approval of the JOURNAVX™ News Yesterday, after the stock market closed, Vertex Pharmaceuticals announced that the  U . . . This content is for paid …

The U.S. FDA Approved Daiichi Sankyo and AstraZeneca’s Product ENHERTU® for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following Disease Progression After One or More Endocrine Therapies

AstraZeneca FDA Approval On January 27, 2025, Daiichi Sankyo (TSE: 4568) and AstraZeneca (AZN) product ENHERTU® (fam-trastuzumab deruxtecan-nxki) was approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low or HER2 ultralow breast cancer, as determined by an FDA-approved test, that has progressed on one . . . This content is for paid subscribers. Please click here …

Complete Preliminary Week 96 Results from Akero Therapeutics EFX Results

Akero Therapeutics Full Press Release Following our shortened report earlier today, this posting is from the Company’s information and its press release. The news demonstrated statistically significant compensated cirrhosis (F4) reversal due to MASH by Both Completer and ITT Analyses at Week 96 in Phase 2b SYMMETRY Study. Akero Therapeutics (AKRO), released preliminary topline week 96 results from SYMMETRY . . . This content is …

Akero Therapeutics Successful Results

Akero Therapeutics Waiting to hear the news from Akero Therapeutics in treating NASH, the company reported Preliminary Topline Results showing statistically significant reversal of compensated Cirrhosis (F4) due to Mash-by both completer and ITT analyses- at week 96 in Phase 2b SYMMETRY Study. Indeed, Akero Therapeutics (

Vera Therapeutics Acquires Global Rights to Novel, Next Generation Dual BAFF/APRIL Inhibitor

Vera Therapeutics in the Market Today Today, many investors in the biotechnology market caused a selloff of Vera Therapeutics (VERA) following its announcement of an exclusive license agreement with Stanford University to acquire a next generation fusion protein targeting BAFF and APRIL, known as VT-109. VT-109 has wide therapeutic potential across the spectrum of B cell mediated diseases. What Vera Therapeutics . . . This …

Compugen Announces First Patient Dosed in Phase 1 Clinical Trial to Evaluate COM503 as Monotherapy and in Combination with Zimberelimab in Advanced Solid Tumors.

Compugen  January 8, 2025, Compugen (CGEN), announced that the first patient was dosed in a Phase 1 clinical trial with COM503, a potential first-in-class antibody against IL-18 binding protein licensed by Compugen to Gilead. Compugen is responsible for running the Phase 1 trial. This Phase 1 multi-center dose escalation and dose expansion trial will evaluate the safety, tolerability . . . This content is for …

Halozyme Therapeutics Reiterates 2024 Financial Guidance and Raises 2025 and Multi-Year Financial Guidance

Halozyme Therapeutics Today, January 8, 2025 /PRNewswire/ - Halozyme Therapeutics, Inc. (HALO) provided a financial update, reiterating full year 2024 financial guidance and raising full year 2025 and multi-year financial guidance. The Company has also announced that. it has recently entered into . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prescribing Specialists Confirm Success of Verona Pharma Product Ohtuvayre in Maintaining COPD Treatment

Verona Pharma Today, January 7, 2024 Verona Pharma (VRNA) announced preliminary unaudited net product sales for the fourth quarter and full year ended December 31, 2024, and provides a corporate update. Let’s read what the Company’s President stated: David Zaccardelli, Pharm. D., President and Chief Executive Officer said,“2024 was another transformational year for Verona with the approval and US . . . This content is …

A Reminder: Verastem Oncology Announced FDA Acceptance and Priority Review of the NDA Avutometinib (in Combination with Defactinib) for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

Verastem Oncology in the NEWS On December 30, 2024, Verastem Oncology (VSTM) announced that the U.S. FDA has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib. The drug is in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC . . . This content is for paid …

Vertex Announces US FDA Approval of ALYFTREK™ Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis

Vertex Pharmaceuticals Vertex Pharmaceuticals (VRTX) announced a United States  FDA has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily triple combination Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Revisiting Bluebird Bio Inc

Bluebird Bio Inc For investors who thought that bluebird bio Inc (BLUE) stock price jumped up from less than $1, to over $7, we inform those who didn't know and remind those who knew that on December 13, bluebird bio stock started a 1-for-20 reverse stock split of its common stock. Every 20 shares of BLUE . . . This content is for paid subscribers. …

Broadcom Inc’s Greatest Day

Broadcom Inc Q4 Financial Results for Broadcom Inc (AVGO) reported financial results for its fourth quarter and fiscal year ended November 3, 2024, provided guidance for its first quarter of fiscal year 2025, and announced its quarterly dividend.  From Broadcom Hock Tan, President and CEO of Broadcom Inc. Said, "Broadcom's fiscal year 2024 revenue grew 44% year-over-year . . . This content is for paid subscribers. …

Novo Nordisk: European Regulatory Authority Adopts Positive Opinion for an Update of Ozempic® Label to Reflect Risk Reduction of Kidney Disease-Related Events

Novo Nordisk Bagsværd, Denmark, 12 December 2024 – Novo Nordisk (NVO) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial. The FLOW trial assessed the risk reduction . . . This content is for paid …