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Regulatory

LTRN

Lantern Pharma published new data in Oncotarget supporting the clinical advancement of LP-284, a novel drug candidate for non-Hodgkin's lymphomas (NHL). The company plans to file an IND application with the FDA and initiate a Phase 1 trial for LP-284 in NHL during the second half of 2023.

Portfolio Pulse from Happy Mohamed

June 26, 2023 | 12:30 pm

BNTC

Benetic Biopharma received FDA clearance for the IND of BB-301, a treatment for Oculopharyngeal Muscular Dystrophy, leading to higher trading of its shares.

Portfolio Pulse from Benzinga Newsdesk

June 26, 2023 | 12:29 pm

ARGX

AZN

The European Union has recommended AstraZeneca's Soliris for marketing authorization for expanded use in refractory generalized myasthenia gravis (gMG) in children and adolescents. If approved, Soliris would be the first targeted therapy for pediatric patients with refractory gMG in the EU.

Portfolio Pulse from Vandana Singh

June 26, 2023 | 12:29 pm

FEMY

Femasys announced FDA approval of its IDE for the pivotal clinical trial of FemBloc permanent birth control, a non-surgical alternative for women, leading to higher trading of its shares.

Portfolio Pulse from Benzinga Newsdesk

June 26, 2023 | 12:25 pm

PFE

The FDA has approved Pfizer's Litfulo (ritlecitinib) as the first and only treatment for adolescents (12+) with severe alopecia areata. The approval is based on clinical trial results, including the ALLEGRO Phase 2b/3 trial. Litfulo will be available in the coming weeks.

Portfolio Pulse from Vandana Singh

June 26, 2023 | 12:20 pm

BIVI

BioVie Inc. presented baseline data from its Phase 3 study of NE3107, an anti-inflammatory insulin sensitizer, in patients with mild to moderate Alzheimer's Disease at the American Diabetes Association's 83rd Scientific Sessions. The study aims to evaluate the safety and efficacy of NE3107 in treating Alzheimer's Disease.

Portfolio Pulse from Happy Mohamed

June 26, 2023 | 12:18 pm

CLNN

Clene Inc. announces the publication of Phase 2 clinical data for CNM-Au8, a treatment for ALS, in The Lancet's eClinicalMedicine. The data includes results from the RESCUE-ALS trial and its open-label extension, showing a clear survival signal and delayed clinical worsening morbidity events. Clene plans to report long-term follow-up data and meet with the FDA in Q3.

Portfolio Pulse from Happy Mohamed

June 26, 2023 | 12:13 pm

SVRA

Savara has completed enrollment for its Phase 3 IMPALA-2 trial of Molgramostim nebulizer solution in autoimmune pulmonary alveolar proteinosis, with 164 patients enrolled. The company expects to report top line results by the end of Q2 2024.

Portfolio Pulse from Benzinga Newsdesk

June 26, 2023 | 12:07 pm

SLNH

Soluna Holdings (NASDAQ: SLNH), the parent company of Soluna Computing, has been granted a 180-day extension by Nasdaq to regain compliance with the minimum per share bid price requirement. The company now has until December 18, 2023, to meet the $1 minimum per share bid requirement.

Portfolio Pulse from Happy Mohamed

June 26, 2023 | 12:07 pm

OCEA

Ocean Biomedical has been granted a US patent for its bispecific cancer immunotherapy treatment, which has demonstrated the ability to kill tumor cells in lung cancer, brain cancer (glioblastoma), and metastatic melanoma.

Portfolio Pulse from Bill Haddad

June 26, 2023 | 12:06 pm