Streetbeat News

Regulatory

TOVX

Theriva Biologics has been granted Orphan Drug Designation by the US FDA for VCN-01, a treatment for pancreatic cancer. The designation will provide various benefits including tax credits, market exclusivity, and FDA assistance for clinical studies.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2023 | 8:10 pm

RZLT

Rezolute, Inc. (NASDAQ:RZLT) plans to initiate a pivotal Phase 3 clinical study of RZ358, its product candidate for congenital hyperinsulinism, in Europe and other geographies outside the US in Q4 2023, with topline results expected in 1H 2025. The study follows the successful Phase 2b RIZE study which demonstrated that RZ358 was safe, well-tolerated, and effective. However, due to FDA restrictions, it is infeasible to include the US in the study at this time.

Portfolio Pulse from Happy Mohamed

June 27, 2023 | 8:07 pm

PRTA

Prothena Corporation has announced the publication of its Phase 3 VITAL clinical trial results in the Blood Journal. The results of this trial could have significant implications for the company's future drug development and market position.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2023 | 8:07 pm

INCY

The Therapeutic Goods Administration (TGA) in Australia has provisionally approved MINJUVI (tafasitamab), a therapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The therapy is marketed by Specialised Therapeutics (ST) under an exclusive distribution arrangement with Incyte (NASDAQ:INCY). The approval is a significant regulatory milestone for ST and is expected to address unmet needs in rare patient populations.

Portfolio Pulse from Happy Mohamed

June 27, 2023 | 8:02 pm

LFLY

Leafly has been granted U.S. Patent #11687994 for 'Systems For Selection Of Cannabis-Related Products And Visualization Of Chemical Data'. The patent involves the use of artificial intelligence in the decision engine.

Portfolio Pulse from Happy Mohamed

June 27, 2023 | 8:00 pm

MSSTF

Mindset Pharma (OTCQB:MSSTF) has received approval from the UK's Medicines and Healthcare Products Regulatory Authority to begin a Phase 2 clinical study on its novel psilocin prodrug, MSP-1014, for the treatment of Major Depressive Disorder. The study will assess the safety and efficacy of MSP-1014 and is expected to provide a strong efficacy signal for the drug. The company's CEO sees this as a significant step towards becoming a clinical-stage biotech company focused on novel and patentable psychedelic-inspired therapeutics.

Portfolio Pulse from Lara Goldstein

June 27, 2023 | 7:54 pm

REGN

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) shares fell after the FDA issued a Complete Response Letter (CRL) for aflibercept 8 mg Biologics License application due to an ongoing review of inspection findings at a third-party filler. No issues were identified with the drug's clinical efficacy or safety, and no additional clinical data or trials have been requested. The company is committed to working with the FDA and the third-party filler to bring the drug to patients as quickly as possible.

Portfolio Pulse from Ryan Gustafson

June 27, 2023 | 7:53 pm

MNMD

MindMed (NASDAQ:MNMD) announced that shareholders elected all six of its nominees at the annual meeting, indicating support for the company's current R&D strategy. The new board of directors includes CEO Robert Barrow, Dr. Suzanne Bruhn, Dr. Roger Crystal, David Gryska, Andreas Krebs, and Carol A. Vallone. The company is looking forward to two key clinical readouts expected later this year.

Portfolio Pulse from Lara Goldstein

June 27, 2023 | 7:36 pm

REGN

Regeneron Pharmaceuticals' shares are trading lower after the FDA declined to approve a higher-dose version of EYLEA.

Portfolio Pulse from Benzinga Newsdesk

June 27, 2023 | 7:34 pm

REGN

The FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8 mg, a drug being jointly developed by Regeneron Pharmaceuticals and Bayer AG. The CRL is due to an ongoing review of inspection findings at a third-party filler and does not identify any issues with the drug's clinical efficacy or safety. No additional clinical data or trials have been requested. Regulatory filings for aflibercept 8 mg are under review in Europe and Japan.

Portfolio Pulse from Happy Mohamed

June 27, 2023 | 6:57 pm