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KRMD

KORU Medical Systems, Inc. (KRMD) has signed a Phase III clinical supply agreement for a novel enzyme replacement therapy aimed at treating a rare endocrinological disease. This marks a significant milestone in the collaboration announced in July 2023, with the KORU Medical Freedom System passing validation testing for subcutaneous infusion administration of the drug. The Phase III trial will evaluate bi-weekly infusions using the Freedom System. The drug has received Breakthrough Therapy, Rare Pediatric Disease, and Fast Track designations by the FDA, along with Orphan Drug designation in the US and Europe.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 8:22 pm

LUMO

Lumos Pharma has announced a successful end-of-Phase 2 meeting with the FDA regarding its ongoing drug development. The company expects to finalize the trial design details with the FDA in Q3 and aims to initiate the next trial phase before the end of the year.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 8:17 pm

BGNE

BeiGene, Ltd. announced it will present new data from its hematology portfolio and pipeline at EHA2024, including studies on BRUKINSA, sonrotoclax, and BGB-16673, showcasing promising results in treatment-naive CLL/SLL patients and BTK inhibitor resistant disease.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 8:17 pm

GOSS

Gossamer Bio, Inc. will present updated seralutinib TORREY open-label extension data for treating PAH and PH-ILD at the American Thoracic Society 2024 International Conference in San Diego, California, from May 17-22.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 8:15 pm

QGEN

Qiagen has announced that its clinical decision support software, QIAGEN Clinical Insight Interpret, has received the European IVDR certification. This certification allows the software to be used for NGS molecular profiling of hereditary and somatic diseases within the EU.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 8:09 pm

ZPTA

Zapata AI has announced a partnership with Tech Mahindra to use industrial generative AI for transforming network and customer operations for global telecom customers. This collaboration aims to leverage AI technologies to enhance operational efficiencies and customer experiences in the telecom sector.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 8:04 pm

CRIS

Curis, Inc. announced an update on its TakeAim Leukemia study, expanding the AML dataset from 5 to 30 patients. The update will be presented at the ASCO and EHA conferences, including data for 25 new patients treated with emavusertib.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 8:02 pm

BEAM

Beam Therapeutics Inc. announced it will present data on the manufacturing process for BEAM-101 at the EHA 2024 Hybrid Congress. The data highlights a robust, closed, and automated process used in the BEACON Phase 1/2 clinical trial for sickle cell disease treatment.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 8:00 pm

AMGN

Senator Dick Durbin has accused Amgen (AMGN) of prioritizing profits over patient care by recommending a higher-than-necessary dose for its cancer drug, Lumakras. Durbin's allegations suggest that Amgen's dosing recommendations are not in the best interest of patients, potentially leading to higher costs and increased side effects without additional benefits. This criticism comes amid broader concerns over drug pricing and pharmaceutical practices.

Portfolio Pulse from Benzinga Newsdesk

May 14, 2024 | 6:55 pm

QBTS

D-Wave Quantum Inc (QBTS) receives positive analyst coverage with a focus on its fast anneal technology, which accelerates quantum processing speeds. Needham, Benchmark, and Piper Sandler analysts reiterate Buy or Overweight ratings with price targets ranging from $2.50 to $4. Despite reporting lower-than-expected revenues for the quarter at $2.5 million, the company shows strong year-over-year bookings growth and technological advancements, including the development of a 4,800+ qubit processor for its upcoming Advantage2 system.

Portfolio Pulse from Anusuya Lahiri

May 14, 2024 | 6:54 pm