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BPMC

Blueprint Medicines has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, recommending the approval of Ayvakyt (Avapritinib) for Indolent Systemic Mastocytosis.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 1:30 pm

TAK

Takeda Pharmaceutical Co Ltd (NYSE:TAK) has received FDA approval for Adzynma, a therapy for congenital thrombotic thrombocytopenic purpura (cTTP), a rare blood clotting disorder. The approval was supported by data from a Phase 3 trial and a continuation trial. This comes after the FDA's recent approval of Takeda's Fruzaqla for metastatic colorectal cancer. TAK shares are up 1.32% premarket.

Portfolio Pulse from Vandana Singh

November 10, 2023 | 1:19 pm

ALGS

Aligos Therapeutics has presented data at the AASLD Liver Meeting 2023 showing that treatment with ALG-000184 results in significant reductions in Hepatitis B antigens. The data suggests that ALG-000184 may lower cccDNA levels via both mechanisms of action for CAM-E drugs and has a well-tolerated safety profile.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 1:10 pm

AQST

Aquestive Therapeutics, Inc. (NASDAQ:AQST) will present two posters at the American College of Allergy Asthma and Immunology (ACAAI) annual meeting, showcasing positive data from pharmacokinetic and pharmacodynamic studies of Anaphylm™ (epinephrine) Sublingual Film. The company's CEO, Dan Barber, expressed excitement about the results and the potential of Anaphylm for the treatment of acute allergic reactions, pending FDA approval.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 1:07 pm

VIR

Vir Biotechnology (NASDAQ:VIR) will present new data from its Phase 2 trials evaluating VIR-3434 and VIR-2218 for chronic hepatitis B and delta at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in November 2023. The company will host an investor conference call to discuss the data on November 13th. VIR-3434 and VIR-2218 are investigational treatments designed to block entry of hepatitis B and delta viruses into hepatocytes and reduce the level of virions and subviral particles in the blood.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 1:06 pm

BHC

Bausch Health Companies Inc. (NYSE:BHC) and its gastroenterology business, Salix Pharmaceuticals, have announced findings from a descriptive analysis of a hospital database showing that the absence of an overt hepatic encephalopathy-specific diagnosis code may have resulted in increased length of stay and hospitalization-related costs. The analysis showed that hospitalizations identified using in-hospital Xifaxan or lactulose use combined with a diagnosis for altered mental status, unspecified encephalopathy, or cirrhosis, had a mean hospital billing charge 2.5 times higher and mean length of stay 2.0 times longer than solely relying on OHE as a primary diagnosis.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 1:05 pm

NVCR

Novocure (NASDAQ:NVCR) will present research on Tumor Treating Fields (TTFields) therapy at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting. The presentations will include new data from the phase 2 2-THE-TOP trial and real-world evidence from patients diagnosed with glioblastoma and other central nervous system tumors. The company will also debut its new Optune Gio™ brand at the meeting.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 1:04 pm

MOTS

Motus GI has announced the successful completion of the first upper gastrointestinal (GI) patient procedure using its FDA-cleared Pure-Vu EVS system. This marks a significant milestone for the company in its efforts to improve patient outcomes in the GI field.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 1:03 pm

LIPO

Lipella Pharmaceuticals Inc. (NASDAQ:LIPO) has been granted 'Orphan Drug Designation' by the U.S. Food and Drug Administration (FDA) for its drug candidate, LP-310, designed for the treatment of oral Graft-versus-Host Disease (GvHD). LP-310 is Lipella's clinical stage pipeline asset intended for inflammatory diseases of the oral cavity. The FDA's 'Orphan Drug Designation' program provides orphan status to drugs and biologics for the treatment, prevention or diagnosis of a rare disease or condition that affects fewer than 200,000 people in the U.S.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 1:03 pm

ATXS

Astria Therapeutics, Inc. (NASDAQ:ATXS) is presenting new data on STAR-0215, a potential preventative therapy for Hereditary Angioedema (HAE), at the American College of Allergy, Asthma, and Immunology. The data supports the potential for STAR-0215 to be dosed once every three or six months. The company's Phase 1b/2 ALPHA-STAR trial is on track, with initial proof-of-concept data expected in Q1 2024.

Portfolio Pulse from Benzinga Newsdesk

November 10, 2023 | 1:03 pm