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ARAY

FXI

Accuray Incorporated has announced that its Tomo C Radiation Treatment Delivery System has been approved by China's National Medical Products Administration. This approval could potentially open up a new market for Accuray in China.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 8:23 pm

ICU

SeaStar Medical has announced that it has received a Humanitarian Device Exemption from the FDA for the use of its Selective Cytopheretic Device in pediatric acute kidney injury. The news was disclosed in a recent SEC 8K filing.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 8:14 pm

RGNX

REGENXBIO has presented interim clinical data from its Phase I/II AFFINITY DUCHENNE trial of RGX-202 at the 28th Annual International Congress of the World Muscle Society. The data is expected to have implications on the company's future developments.

Portfolio Pulse from Bill Haddad

October 03, 2023 | 8:08 pm

OCUL

Ocular Therapeutix has initiated its first pivotal clinical trial to evaluate OTX-TKI for the treatment of wet AMD. This marks a significant step in the company's development pipeline.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 8:03 pm

NFLX

VZ

Verizon has announced a new promotional offer, bundling Netflix Premium and NFL+ Premium together for $25 per month on +play. This offer could result in annual savings of up to $120. The deal is part of Verizon's ongoing partnership with the NFL, which includes exclusive deals, team sponsorships, and stadium network upgrades. The offer is available to all Verizon mobile, 5G Home, and LTE Home Internet customers, including current Netflix customers.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 7:48 pm

AMGN

The FDA has raised concerns over Amgen Inc's lung cancer drug, Lumakras, ahead of the Oncologic Drugs Advisory Committee meeting. The FDA staff reviewers suggested that the company's late-stage trial might not be considered 'adequate and well-controlled'. While Lumakras was approved by the FDA in May 2021, the recent findings imply the potential need for an additional confirmatory trial. Despite this, the commercial prospects for Lumakras might be mitigated by encouraging outcomes in colorectal cancer treatments and additional planned combination studies.

Portfolio Pulse from Vandana Singh

October 03, 2023 | 7:30 pm

NVAX

Novavax CEO has announced that the company's Covid-19 vaccine could be available in the U.S. as early as this week, and certainly by next week.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2023 | 7:30 pm

PM

Morgan Stanley analyst Pamela Kaufman reiterated an Overweight rating on Philip Morris International Inc (PM) with a price target of $113. The analyst sees significant growth opportunities for PM's IQOS in new and existing markets, and expects the expansion of smoke-free product portfolio to increase PM's addressable market. PM's new mid-term targets from 2024-2026 reflect stronger growth, and the company expects to generate $36 billion to 39 billion in total operating cash flow during this period. However, the analyst reduced 2023/24 EPS estimate due to unfavorable currency impacts.

Portfolio Pulse from Shivani Kumaresan

October 03, 2023 | 7:25 pm

ATAI

Clinical-stage biopharma company atai Life Sciences (NASDAQ:ATAI) has completed its Phase 1 study of proprietary oral transmucosal film (OTF) DMT formulation VLS-01 in 74 healthy participants. The study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of VLS-01. The results showed that the compound was well-tolerated with a favorable safety profile. The company now plans to test an optimized version of its OTF formulation in an upcoming Phase 1b trial before initiating a Phase 2 in Treatment-Resistant Depression patients.

Portfolio Pulse from Lara Goldstein

October 03, 2023 | 7:23 pm

FEMY

Femasys Inc. (NASDAQ:FEMY) shares traded lower on Tuesday, following a period of volatility since the company received FDA 510(k) clearance for FemaSeed, an infertility treatment, in late September. Despite a price target increase from HC Wainwright & Co. last Friday, Femasys shares fell by nearly 40% on Tuesday. The company also announced the successful completion of the annual Medical Device Single Audit Program (MDSAP) surveillance audit with no nonconformances and no findings.

Portfolio Pulse from Ryan Gustafson

October 03, 2023 | 6:56 pm