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Regulatory

JAGX

An independent study conducted at Boston Children's Hospital and Harvard Medical School has shown potential utility of Jaguar Health's drug, Crofelemer, for the treatment of MVID, a rare childhood disease. Currently, there are no approved drug treatments for MVID. Crofelemer has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for MVID, and Jaguar Health's Investigational New Drug application for crofelemer for treatment of MVID is now activated by the FDA.

Portfolio Pulse from Benzinga Newsdesk

October 19, 2023 | 12:34 pm

MULN

Mullen Automotive Inc. (MULN) has filed a preliminary proxy statement with the SEC for a special stockholders' meeting on Dec 15, 2023, to authorize a reverse stock split of the company's common stock at an exchange ratio between 1-for-2 to 1-for-100. The primary focus will be to maintain a continued price of at least $1.00 per share on The Nasdaq Capital Market. The reverse stock split will only be implemented if necessary to regain compliance with Nasdaq Listing Rule 5550(a)(2).

Portfolio Pulse from Benzinga Newsdesk

October 19, 2023 | 12:33 pm

PCVX

Vaxcyte has announced that the FDA has cleared its Investigational New Drug application for VAX-31, a drug aimed at preventing invasive pneumococcal disease in adults.

Portfolio Pulse from Benzinga Newsdesk

October 19, 2023 | 12:32 pm

NNDM

Nano Dimension has received approval from an Israeli court for its $200 million repurchase plan. This move could potentially increase the company's stock value.

Portfolio Pulse from Benzinga Newsdesk

October 19, 2023 | 12:31 pm

SPY

The Philadelphia Fed Manufacturing Index for October came in at -9.0, worse than the estimated -6.4 and the prior figure of -13.5.

Portfolio Pulse from Benzinga Newsdesk

October 19, 2023 | 12:30 pm

SRRK

Scholar Rock (NASDAQ:SRRK), a Phase 3 clinical-stage biopharmaceutical company, announced it will present clinical and biomarker data from the Phase 1 DRAGON trial at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting. The trial involves patients with advanced solid tumors treated with SRK-181, a selective latent TGFβ1 inhibitor. The company aims to establish the proof of mechanism of SRK-181, which has the potential to transform cancer immunotherapy by overcoming resistance to checkpoint inhibitor therapy.

Portfolio Pulse from Benzinga Newsdesk

October 19, 2023 | 12:18 pm

KIDS

OrthoPediatrics has launched its Pediatric Nailing Platform, TIBIA, which received FDA clearance in September 2023.

Portfolio Pulse from Benzinga Newsdesk

October 19, 2023 | 12:10 pm

MDAI

Spectral AI has announced that its DeepView SnapShot Wound Imaging System has achieved UKCA Mark and FDA Class 1 Medical Device Classification. This could potentially increase the company's market reach and boost sales.

Portfolio Pulse from Benzinga Newsdesk

October 19, 2023 | 12:03 pm

CYTK

Cytokinetics has provided an update on its cardiac myosin inhibitor programs, revealing new long-term data from its FOREST-HCM open-label extension study of Aficamten. The data shows sustained improvements in clinical efficacy endpoints.

Portfolio Pulse from Benzinga Newsdesk

October 19, 2023 | 11:34 am

BIIB

Biogen is set to present new data at the Clinical Trials on Alzheimer's Disease (CTAD) 2023 meeting on October 27-28. The data could potentially impact the company's standing in the Alzheimer's treatment market.

Portfolio Pulse from Bill Haddad

October 19, 2023 | 11:31 am