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Regulatory

CNTA

Centessa Pharmaceuticals has announced the dosing of the first subject in its PRESent-3 study of SerpinPC for the treatment of hemophilia B with inhibitors. The dosing phase follows a 12-week observation period during which baseline data of the subject's disease status under their current therapy are collected. The company began dosing subjects in the PRESent-2 study for the treatment of hemophilia B without inhibitors in July 2023. The FDA has granted Fast Track designation to SerpinPC for the treatment of hemophilia B, with or without inhibitors.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:06 pm

LIFE

aTyr Pharma has announced the dosing of the first patient in its Phase 2 EFZO-CONNECT study. The study will evaluate the efficacy, safety, and tolerability of efzofitimod, a first-in-class biologic immunomodulator, in patients with systemic sclerosis-related interstitial lung disease. The drug has been granted U.S. FDA and EU orphan drug and U.S. FDA Fast Track designations for systemic sclerosis. The study is a 28-week study with three parallel cohorts randomized to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses.

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October 31, 2023 | 12:05 pm

COCP

Cocrystal Pharma, Inc. (NASDAQ:COCP) has received authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human challenge trial for its oral PB2 inhibitor CC-42344, a potential treatment for pandemic and seasonal influenza A. The trial is expected to begin in Q4 2023. The company reported favorable safety and tolerability results from a Phase 1 trial in late 2022.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:04 pm

XFOR

X4 Pharmaceuticals has announced that the FDA has accepted with priority review its US New Drug Application (NDA) for Mavorixafor in WHIM Syndrome. This could potentially expedite the approval process for the drug.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:03 pm

INMB

INmune Bio, Inc. (NASDAQ:INMB) has received a favorable patentability opinion from the International Search Authority for its proprietary cell line, INB16, and the INKmune™ therapeutic composition. The company is exploring several potential commercial applications of the INB16 cell line, including uses in cancer research and therapeutic uses. INmune Bio intends to leverage the favorable written opinion to accelerate patent issuance for its inventions. The company has also opened an IND for a US trial of INKmune™ in metastatic castration-resistant prostate cancer.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:03 pm

ZIMV

ZimVie Inc. (NASDAQ:ZIMV) announced the first U.S. surgery using the 4.5mm Mobi-C Cervical Disc. The smaller 4.5mm height Mobi-C implants were approved by the FDA in August 2023. The first implantation was performed by Gregory D. Lopez, M.D., at Midwest Orthopaedics at Rush in Chicago. ZimVie is also enrolling patients in the first ever cervical arthroplasty-fusion study in the U.S.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 12:02 pm

SPRC

SciSparc Ltd. (NASDAQ:SPRC) has been granted a patent by IP Australia for its technology that reduces opioid use in pain management. The patent is for a combination of opioids and N-Acylethanolamines for pain treatment. The global opioid market, valued at $22.8 billion in 2022, is expected to grow at a CAGR of 1.4% from 2023 to 2030. The company's technology allows for effective pain treatment with significantly lower opioid concentrations.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 11:57 am

CYBN

Cybin has announced that its Phase 2 interim data for CYB003 in Major Depressive Disorder has met its primary efficacy endpoint. The data shows improvements in depression symptoms after a single dose.

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 11:48 am

QQQ

SPY

U.S. stocks are expected to extend gains as the Federal Reserve's two-day monetary policy meeting begins. Smid-cap earnings have been better than expected, triggering a strong upward move in premarket trading. However, sentiment towards mega-caps remains muted. The Dow Industrials posted its biggest one-day advance since early June, with the S&P 500 moving out of correction territory. Analysts from LPL Financial expect a strong job market, cooling inflation, the end of Fed rate hikes, stable interest rates, and growing corporate profits to keep the bull market going. In premarket trading, the SPDR S&P 500 ETF Trust (NYSE:SPY) rose 0.24% and the Invesco QQQ ETF (NASDAQ:QQQ) edged up 0.08%.

Portfolio Pulse from Shanthi Rexaline

October 31, 2023 | 11:44 am

XOMA

XOMA Corporation has earned a $5 million milestone payment following the FDA's acceptance of Day One Biopharmaceuticals' New Drug Application (NDA) for Tovorafenib, a treatment for relapsed or progressive pediatric low-grade glioma (pLGG).

Portfolio Pulse from Benzinga Newsdesk

October 31, 2023 | 11:34 am