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 …

AstraZeneca Agreement with CSPC Pharmaceutical Group Yesterday, October 7, 2024, AstraZeneca (AZN) announced it entered into an exclusive license agreement with CSPC Pharmaceutical Group Ltd (CSPC) to advance . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Johnson & Johnson New TECNIS Odyssey On September 30, 2024, Johnson & Johnson (JNJ) announced expanding the roll-out of its latest advancement in presbyopia-correcting intraocular lenses (PC - IOL), TECNIS Odyssey, in the U.S. TECNIS Odyssey IOL is built on the TECNIS platform, providing two . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Aligos Therapeutics in the NEWS Yesterday, Sept. 19, 2024, Aligos Therapeutics (ALGS) - a small clinical-stage company, announced positive topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. Aligos Therapeutics is a clinical-stage biopharmaceutical company founded with the mission to improve patient outcomes by . . . This content is for …

AstaZeneca Fasenra Approval AstraZeneca (AZN) product Fasenra (bevacizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) - a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The approval in the United States FDA was based on positive results from the MANDARA Phase III trial published in . …

Novartis FDA Approval Yesterday, September 17, 2024, Novartis (NVS) announced that the United States FDA has approved Kisqali®(ribociclib) in combination with an aromatase inhibitor (AI) for adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those . . . This content is for paid subscribers. Please click here …

AstraZeneca Imfinzi + Imjudo Updated results from the HIMALAYA Phase III trial have demonstrated that AstraZeneca (AZN) Imfinzi (durvalumab) plus Imjudo (tremelimumab) showed a sustained clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment. The results from HIMALAYA were presented at . . . …

Halozyme Therapeutics in the NEWS Halozyme Therapeutics, Inc. (HALO) announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) infusion of . . . This content is for paid subscribers. Please click here to subscribe …

Johnson & Johnson FDA Approval Yesterday, September 11, 2024,  Johnson & Johnson (JNJ) announced that the FDA has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) - a chronic disease of the large intestine in which the lining of the colon becomes inflamed.  About Ulcerative Colitis Ulcerative colitis is a form of inflammatory bowel . . . This …