Gilead Sciences On February 20, 2025, Gilead Sciences (GILD) announced that the European Commission (EC) granted conditional marketing authorization to seladelpar in combination with ursodeoxycholic acid (UDCA) for the treatment of Primary Biliary Cholangitis (PBC) in adults who have inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Now approved, Seladelpar (an orphan-designated . . . This content is for …

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 …

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 …

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 …

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 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.

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. …

Johnson & Johnson On December 9, 2024, Johnson & Johnson (JNJ) announced new results from the Phase 3 CARTITUDE-4 study demonstrating that a single infusion of CARVYKTI®  has significantly increased minimal residual disease (MRD) negativity rates in patients with relapsed or refractory multiple myeloma (RRMM) patients who were lenalidomide-refractory and had received one to three prior lines . . . This content is for paid subscribers. …

Intra-Cellular Therapies in the NEWS On December 3, 2024, Intra-Cellular Therapies (ITCI) announced the submission of the supplemental New Drug Application (sNDA) to the United States FDA to approve CAPLYTA as adjunctive therapy to antidepressants for the treatment of Major Depressive Disorder (MDD) in adults. Intra-Cellular Therapies is . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Gilead Sciences and Tubulis Agreement Gilead Sciences (GILD) and Tubulis announced that they entered into an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against a solid tumor target. Gilead will gain access to Tubulis’ proprietary Tubutecan and Alco5 platforms. The companies will collaborate to . . . This content is for paid subscribers. Please click here to subscribe or here to …

AstraZeneca in the NEWS AstraZeneca (AZN) Phase III trial CAPItello-281, which combines Truqap (capivasertib), abiraterone, and androgen deprivation therapy (ADT), demonstrates statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) vs. abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer . . . This content is for paid subscribers. Please click here to subscribe or here to …

BridgeBio Pharma in the NEWS BridgeBio Pharma (BBIO) focused on genetic diseases, announced that the United States FDA approved Attruby™ (acoramidis), an orally administered near-complete stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM. The aim is to reduce cardiovascular death and cardiovascular-related hospitalization. The approval is based on positive results seen in the ATTRibute-CM Phase 3 . . . This content is …

Viking Therapeutics Announcement On Nov. 19, 2024, Viking Therapeutics, Inc. (VKTX) announced that the final results from the company's Phase 2b clinical trial of VK2809, the firm’s novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) referred to also as metabolic dysfunction associated steatohepatitis (MASH) were highlighted in an oral late . . . This content is for paid subscribers. …

Intellia Therapeutics Announcement On Nov. 16, 2024,  Intellia Therapeutics (NTLA), a clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, announced positive new clinical data from the ongoing Phase 1 trial of nexiguran ziclumeran (nex-z, also known as NTLA-2001) in patients with transthyretin (ATTR) amyloidosis. Nex-z is an investigational in vivo CRISPR-based . . . This content is for paid subscribers. Please click here to …

Altimmune Third Quarter Financial Results Yesterday, October 12, 2024, Altimmune (ALT) announced financial results for the third quarter ended September 30, 2024, and provided a business update. From Altimmune Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune said,  “In the third quarter, we reached several important milestones, most notably the completion of enrollment in the Phase . . . This content is for …

From Gilead Sciences  Gilead Sciences (GILD) Chairman and CEO Daniel O’Day, said, “Gilead’s third-quarter results are the strongest of the year to date, with 7% year-over-year revenue growth, including 13% year-over-year growth for Biktarvy. Based on this strong topline growth and disciplined operating expense management . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Anavex Life Sciences Anavex Life Sciences (AVXL) presented new data from the Phase IIb/III study showing that blarcamesine (ANAVEX®2-73), once daily orally, demonstrates pre-specified clinical efficacy through upstream SIGMAR1 activation. Anavex Life Sciences Corp. is a publicly traded biopharmaceutical company developing novel therapeutics to treat neurodegenerative, neurodevelopmental, and neuropsychiatric disorders. The company aims at treating pain, Alzheimer's . . . This content is for paid …

Vera Therapeutics Announcement Two days ago, Vera Therapeutics, Inc. (VERA) announced data from its ORIGIN Phase 2b trial of atacicept in immunoglobulin A nephropathy (IgAN). The trial demonstrated a stabilization of kidney function through 96 weeks of long-term follow-up. These data were presented in a late-breaking oral presentation at the American Society of Nephrology Kidney . . . This content is for paid subscribers. Please …

Aligos Therapeutics On September 20, 2024, we posted a press release stating that Aligos Therapeutics (ALGS) announced successful topline results from a phase 2A HERALD study of ALG-055009, a thyroid hormone receptor . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Intellia Therapeutics Announcement Intellia Therapeutics (NTLA) announced the initiation of HAELO, a pivotal Phase 3 study of NTLA-2002 for the treatment of hereditary angioedema (HAE). NTLA-2002 is a wholly owned investigational in vivo CRISPR-based gene editing therapy developed as a single-dose treatment for life-threatening diseases. Patient screening is active following Intellia’s successful end-of . . . This content is for paid subscribers. Please click here to …