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PHRRF

PharmaTher Holdings (OTCQB:PHRRF) has submitted a priority-original Abbreviated New Drug Application (ANDA) for its proprietary racemic ketamine, KETARX, to the FDA. The company expects an expedited review and anticipates KETARX’s approval and commercial launch in the U.S. in Q2 2024. PharmaTher is also working on international approvals to meet the growing global demand for ketamine. The company is partnering with Vitruvias Therapeutics to commercialize KETARX in the U.S.

Portfolio Pulse from Lara Goldstein

September 06, 2023 | 9:21 pm

JNJ

Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has decided to halt the Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with Chronic Thromboembolic Pulmonary Hypertension due to futility. The decision was made following a recommendation by the study’s independent data monitoring committee after a pre-planned interim analysis. The interim results do not impact any of the company's commercialized pulmonary hypertension medicines.

Portfolio Pulse from Charles Gross

September 06, 2023 | 9:15 pm

AI

C3.ai Inc reported Q1 revenue of $72.4 million, beating the consensus estimate of $71.59 million. The company also reported a quarterly loss of 9 cents per share, which was less than the estimated loss of 17 cents per share. C3.ai expects Q2 revenue to be between $72 million and $76.5 million, and full-year revenue to be between $295 million and $320 million. The company also launched the C3 Generative AI Suite, which includes 28 domain-specific generative AI offerings. Despite the positive report, C3.ai shares were down 3.85% after hours.

Portfolio Pulse from Adam Eckert

September 06, 2023 | 8:51 pm

AZYO

Aziyo Biologics, Inc. (NASDAQ:AZYO) has rebranded to Elutia Inc. to reflect its strategic focus on drug-eluting biomatrix technology. The company's stock will begin trading under the new ticker symbol 'ELUT' on September 7, 2023. Elutia is developing new products for the pacemaker and implantable defibrillator markets, and is expected to expand into neurostimulator markets. The company also serves the market with its SimpliDerm® Acellular Dermal Matrix, used in breast reconstruction following mastectomy.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 8:39 pm

BNTX

MRNA

NVAX

PFE

UK regulators have approved an updated COVID-19 vaccine by Pfizer and BioNTech that targets the Omicron XBB.1.5 subvariant. Moderna and Novavax have also created versions of their shots that target this variant. The U.S. plans to deploy all three vaccines in the fall season. Pfizer's updated vaccine elicited a strong antibody response in a preclinical study in mice with the highly mutated BA.2.86 subvariant of the coronavirus. Moderna's updated vaccine is expected to be effective against the BA.2.86 subvariant and is expected to be available by early October.

Portfolio Pulse from Upwallstreet

September 06, 2023 | 8:39 pm

AI

C3 AI has launched the C3 Generative AI Suite, which includes 28 new domain-specific generative AI offerings. The suite combines C3 AI's enterprise domain and industry expertise with the latest innovations in generative AI. The offerings have been well received by the market with projects now in place at Georgia-Pacific, Flint Hills Resources, Nucor, Pantaleon, Con Edison, the U.S. Missile Defense Agency, and a U.S. intelligence agency. The solutions can operate on the cloud platform of the customer's choice including Google Cloud Platform, AWS, and Microsoft Azure.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 8:39 pm

VXRT

Vaxart, Inc. (NASDAQ:VXRT) has announced top-line data from the Phase 2 challenge study of its oral tablet monovalent norovirus vaccine candidate. The study met 5 of 6 primary endpoints, showing the vaccine to be safe and well tolerated with no serious adverse events. The vaccine led to a statistically significant reduction in infection rate and a substantial reduction in viral shedding. However, it did not achieve a statistically significant reduction in norovirus acute gastroenteritis.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 8:30 pm

CRVS

Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) has confirmed plans to initiate a Phase 3 clinical trial of soquelitinib, its ITK inhibitor product candidate, in relapsed peripheral T cell lymphoma (PTCL) in Q1 2024. The trial is designed to enroll 150 patients and will compare soquelitinib to standard of care chemotherapy. The company is recruiting U.S. and international investigators and anticipates participation from leading academic and private medical centers.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 8:29 pm

CHTR

DIS

The Walt Disney Company (NYSE:DIS) is offering a major discount on several Disney+ plans, reducing the price of its basic plan to $1.99 per month for a three-month period, a 70% discount from the usual $7.99 monthly rate. This promotion coincides with the release of new content on the platform and precedes a planned price increase for its Disney+ Premium plan and several bundle tiers. Disney is also in a dispute with Charter Communications (NASDAQ:CHTR) over carriage fees. Disney shares recently hit a nine-year low and are down 9% year-to-date in 2023.

Portfolio Pulse from Chris Katje

September 06, 2023 | 8:21 pm

PEPG

PepGen Inc. has received clearance from Health Canada to begin the FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in patients with Myotonic Dystrophy Type 1. This marks a significant step in the company's efforts to develop treatments for this rare genetic disorder.

Portfolio Pulse from Benzinga Newsdesk

September 06, 2023 | 8:10 pm