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Regulatory

BTCY

Biotricity has announced the filing of a patent application for its Biotres device. The device is designed to provide real-time, continuous remote patient monitoring.

Portfolio Pulse from Bill Haddad

October 03, 2023 | 12:43 pm

ALXO

ODD

SPRC

ALX Oncology reported positive interim results from its Phase 2 ASPEN-06 clinical trial for the treatment of advanced HER2-Positive Gastric Cancer. SciSparc was granted a European patent for its core technology. ODDITY Tech reported solid preliminary Q3 results, projecting a net revenue growth of at least 58% in the first three quarters of 2023.

Portfolio Pulse from ryanfaloona@benzinga.com

October 03, 2023 | 12:40 pm

TAK

Takeda Pharmaceutical Co Ltd (NYSE:TAK) has decided to voluntarily withdraw its lung cancer drug, Exkivity, from the US market following a failed confirmatory trial. The company is also planning to initiate a global withdrawal where the drug is approved. The decision was based on the outcome of the Phase 3 EXCLAIM-2 confirmatory trial, which did not meet its primary endpoint. Takeda will continue to assess the impact of the withdrawal and update the full-year, consolidated forecast for the fiscal year ending March 31, 2024.

Portfolio Pulse from Vandana Singh

October 03, 2023 | 12:38 pm

ANIX

Anixa Biosciences, Inc. (NASDAQ:ANIX) has been granted an additional U.S. patent for its novel ovarian cancer vaccine technology. The patent covers nucleic acid-based delivery of the vaccine, which targets the extracellular domain of anti-Müllerian hormone receptor 2 (AMHR2-ED). Anixa is developing the technology in partnership with Cleveland Clinic and with support from the National Cancer Institute's PREVENT Program.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 12:34 pm

GILD

Gilead Sciences is set to present its latest innovative virology data on current and potentially transformative therapies for HIV and Covid-19 at IDweek 2023. The research reinforces the efficacy of Biktarvy in a broad range of people with HIV and highlights the potential impact of twice-yearly Lenacapavir on the future of HIV clinical care. The data also reinforces Veklury's strong safety profile and continued in vitro activity against new variants. Studies are also evaluating the utility of Obeldesivir as a potential treatment for COVID-19.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 12:32 pm

NVO

VTRS

Novo Nordisk A/S (NYSE:NVO) has successfully defended two pivotal patent claims related to the main ingredient in its weight-loss and diabetes drugs, Wegovy and Ozempic, against Viatris Inc (NASDAQ:VTRS). Viatris, through its subsidiary Mylan Pharmaceuticals, had challenged the patents in an attempt to produce generic versions of these drugs. However, the U.S. Patent Office tribunal ruled in favor of Novo Nordisk.

Portfolio Pulse from Vandana Singh

October 03, 2023 | 12:32 pm

ACRX

AcelRx Pharmaceuticals has received Investigational Device Exemption (IDE) approval from the FDA for its product Niyad, allowing it to advance to a single registration study.

Portfolio Pulse from Bill Haddad

October 03, 2023 | 12:31 pm

BDRX

Biodexa Pharmaceuticals PLC (NASDAQ:BDRX) has completed recruitment for cohort A of its Phase 1 study of MTX110 in patients with recurrent glioblastoma. The study is designed to assess the feasibility and safety of intermittent infusions of MTX110. The company plans to commence enrolment for cohort B upon approval by the study's Data Safety Monitoring Board, expected by the end of October 2023. Biodexa also plans to add two more investigational centres into the study by January 2024.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 12:31 pm

KA

Kineta has announced safety and biomarker data from its ongoing Phase 1/2 VISTA-101 clinical trial for KVA12123 monotherapy. The trial has cleared the first three monotherapy cohorts with no dose limiting toxicity and no consistent pattern of adverse events at any dose level. The clinical trial is advancing to higher monotherapy dose levels and in combination with Pembrolizumab. Initial monotherapy clinical efficacy data is anticipated in Q4 2023.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 12:31 pm

CCLD

CareCloud has announced that it expects an improvement of about $10M in annualized free cash flow, representing about 14% of total payroll cost, following a reduction. The information was disclosed in an SEC 8k filing.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 12:19 pm