Category: Today’s Highlights

BridgeBio Pharma to Present Cardiovascular Outcomes Data in Patients with Variant and Wild-Type Transthyretin Amyloid Cardiomyopathy at the ACC Annual Scientific Sessions

BridgeBio Pharma Today, March 24, 2025, BridgeBio Pharma, Inc. (BBIO) announced that cardiovascular outcomes data in patients with variant and wild-type ATTR-CM from the ATTRibute-CM, its Phase 3 study of acoramidis in ATTR-CM, will be shared in a flatboard poster presentation at the American College . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

FDA Approved Alnylam Pharmaceuticals sNDA for AMVUTTRA® – A Treatment for Cardiomyopathy of Wild-Type or Hereditary Transthyretin-Mediated Amyloidosis in Adults to Reduce Cardiovascular Mortality, Cardiovascular Hospitalizations and Urgent Heart Failure Visits

Alnylam Pharmaceuticals in the NEWS March 20, 2025, Alnylam Pharmaceuticals (ALNY) - the leading RNAi therapeutics company, today announced that the U.S. FDA has approved the supplemental New Drug Application (sNDA) for its RNAi therapeutic, AMVUTTRA® (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to . . . This content is for paid subscribers. Please click here to subscribe or …

Two Companies: Pyxis Oncology Financial Results and Sarepta Therapeutics Unwarranted Selloff

Pyxis Oncology in the NEWS Pyxis Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update On March 18, 2025, Pyxis Oncology (PYXS) - a clinical-stage firm developing next-generation therapeutics for difficult-to-treat cancers, reported financial results for the year and quarter ending December 31, 2024, and provided a business update. From Pyxis Oncology Lara . . . This content is for paid …

A Little About the Stock Market and Some News from Johnson & Johnson

With a bad market and a lot of talk about recession and shutting down the Government, with most stocks tanking, in the middle of this chaos some biotech companies, that we selected for investment, have beaten the bad news and moved up, instead of sinking to the bottom of an uneasy ocean. These stocks closed today at: Stock Symbol Price Change

AstraZeneca: Imfinzi-based Regimen Demonstrated Statistically Significant and Clinically Meaningful Improvement in Event-free Survival in Resectable Early-Stage Gastric and Gastroesophageal Junction Cancers

AstraZeneca AstraZeneca (AZN) has positive high-level results from the MATTERHORN Phase III trial, which showed perioperative treatment with AstraZeneca’s Imfinzi (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (

Alnylam Pharmaceuticals Press Release Highlights Significant Pipeline Progress and Platform Innovation at R&D Day

– Showcases multiple potentially transformative near- and mid-stage therapies in ATTR amyloidosis, cardiovascular disease, and Neuroscience, each representing a blockbuster opportunity – – Announces TRITON Phase 3 program for next-generation TTR silencer nucresiran in ATTR-CM and hATTR-PN, targeting durable franchise leadership – – Provides details about Phase 3 cardiovascular outcomes trial for zilebesiran, poised to transform the treatment of hypertension in patients with high CV risk – …

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 …

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 …

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 …

At ASH 2024, Gilead Sciences’ Kite’s Yescarta® Shows Its CAR T-Cell Therapy Uniquely Durable Response and Long-Term Survival After Five Years in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas

Gilead Sciences Kite Pharma, a Gilead Sciences Company (GILD) announced results from a five-year follow-up analysis of ZUMA-5, a Phase 2 study of Yescarta ® (axicabtagene ciloleucel) in patients with relapsed/refractory non-Hodgkin lymphomas (NHL), including follicular lymphoma (FL) or marginal zone . . . This content is for paid subscribers. Please click here to subscribe or here to log in.