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Regulatory

RVPH

Reviva Pharmaceuticals Holdings, Inc. (RVPH) reported progress in its clinical program for brilaroxazine, a treatment for schizophrenia, with positive Phase 3 data and ongoing enrollment in a one-year OLE trial. The company expects to initiate a Phase 3 RECOVER-2 trial in Q1 2024 and release topline OLE trial data in Q4 2024. These developments are aimed at supporting an NDA submission to the FDA in 2025. Reviva also reported advancements in preclinical studies for brilaroxazine's potential in treating psoriasis and IPF, and raised $30 million in a registered direct offering.

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January 04, 2024 | 1:35 pm

ATXI

Avenue Therapeutics has finalized an agreement with the FDA on the Phase 3 safety study protocol for IV tramadol, aimed at treating acute post-operative pain. The study will compare the risk of opioid-induced respiratory depression between IV tramadol and IV morphine.

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January 04, 2024 | 1:33 pm

EIGR

Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR) announced a 1-for-30 reverse stock split to regain compliance with Nasdaq's minimum bid price requirement. The split will be effective on January 5, 2024, with post-split trading starting on January 8, 2024. The split was approved by stockholders and the Board on December 28, 2023, and will reduce outstanding shares from 44.4 million to approximately 1.5 million. Adjustments will be made to outstanding equity awards and the number of shares issuable under equity incentive plans.

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January 04, 2024 | 1:32 pm

FDMT

4D Molecular Therapeutics (4DMT) reported clinical pipeline progress, upcoming milestones, and organizational updates. The company remains well-capitalized with $300M in estimated cash, sufficient to fund operations into H1 2026. Key clinical advancements include progress in wet AMD, DME, and CF programs, with Phase 2 trial data for 4D-150 in wet AMD and DME expected in 2024. The company also announced a partnership with Arbor Biotechnologies for CNS diseases and appointed Noriyuki Kasahara as Chief Scientific Officer. Upcoming milestones include data presentations, trial updates, and IND filings across its ophthalmology, pulmonology, cardiology, and rare inherited retinal disorders portfolios.

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January 04, 2024 | 1:20 pm

CTMX

CytomX Therapeutics, Inc. (NASDAQ:CTMX) announced its 2024 priorities, including anticipated milestones for its pipeline. Key programs like CX-904, CX-2051, and CX-801 are expected to reach clinical proof of concept. CX-904, partnered with Amgen, will have Phase 1a data in H2 2024. IND applications for CX-2051 and CX-801 have been filed, with Phase 1 initiations expected in H1 2024. Bristol Myers Squibb is advancing BMS-986288 to Phase 2 studies. CytomX has partnerships with major companies and ended Q3 2023 with $194 million in cash, projecting a runway to H2 2025.

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January 04, 2024 | 1:16 pm

C

GS

JPM

MS

Citigroup Inc. (C) is planning to launch a fully-owned investment banking unit in China by the end of the year, aiming to hire about 30 people initially and potentially expanding to nearly 100. The Chinese securities regulator approved the U.S. bank's application last month. Citi's move follows similar expansions by Goldman Sachs (GS), JP Morgan (JPM), and Morgan Stanley (MS) in China. The expansion is seen as risky due to China's slowing economic growth and evolving policies.

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January 04, 2024 | 1:14 pm

INDP

The European Patent Office has approved a patent for Indaptus Therapeutics' Decoy technology platform, titled 'Methods of Treatment of Infections Using Bacteria'. This patent provides protections for the technology's application in preventing or treating viral infections, alone or in combination with standard care. It is the second patent granted to Indaptus outside the United States for this application.

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January 04, 2024 | 1:14 pm

RNAZ

Transcode Therapeutics (RNAZ) has published an open letter to shareholders, highlighting its progress in 2023 and objectives for 2024. The company has raised $18.5M in additional capital in 2023 despite a challenging environment. It has advanced its lead therapeutic candidate, TTX-MC138, and plans to submit an IND to the FDA in Q1 2024 for a Phase 1 clinical trial. Transcode is in partnership discussions for its preclinical programs and has streamlined operations, including reducing headcount and implementing temporary salary reductions for senior management. The company is proposing a reverse stock split to improve its ability to raise additional capital and comply with Nasdaq's stockholders' equity requirement.

Portfolio Pulse from Benzinga Newsdesk

January 04, 2024 | 1:08 pm

RLYB

Rallybio Corporation has announced progress in its portfolio and outlined key milestones for 2024, including the initiation of a Phase 2 study for RLYB212 in the second half of 2024. The company also plans to update on Phase 2 discussions with the European Medicines Agency for RLYB212 in the first half of 2024. Additionally, Rallybio has extended its cash runway into the third quarter of 2025.

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January 04, 2024 | 1:06 pm

VNRX

VolitionRx Limited (NYSE:VNRX), an epigenetics company, released its 2023 Business Review highlighting key achievements such as launching the Nu.Q® Vet Cancer Test in significant markets, expanding access to the test globally, advancing market access for Nu.Q® NETs, completing the Q-Sub process with the FDA, announcing a new early cancer detection method, strengthening its patent portfolio, and scaling up operations. The company aims to save lives with its blood tests for diseases in humans and animals.

Portfolio Pulse from Benzinga Newsdesk

January 04, 2024 | 1:05 pm