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Tag: Plus Therapeutics Inc

  • Pre-Hour Momentum Drives Plus Therapeutics (PSTV) Stock Higher On FDA Designation

    Pre-Hour Momentum Drives Plus Therapeutics (PSTV) Stock Higher On FDA Designation

    Plus Therapeutics, Inc. (NASDAQ: PSTV) stock is seeing a sharp increase today, building on the previous session’s enthusiasm. According to the most recent premarket check, PSTV shares were trading at $2.25 rising 56.25%. This comes after a significant regulatory change caused an incredible 300% spike in the prior trading day.

    Rhenium Classified as an Orphan Drug

    Plus Therapeutics has reached a significant milestone with the U.S. Food and Drug Administration’s (FDA) designation of Rhenium (186Re) Obisbemeda as an Orphan Drug Designation (ODD). The drug is intended to treat patients with leptomeningeal metastases (LM) from lung cancer. This difference highlights the pressing need for novel therapies for this rare and aggressive disease.

    A Brain Cancer Therapy

    Rhenium (186Re) Obisbemeda is a cutting-edge injectable radiotherapy designed to specifically target cancers in the central nervous system (CNS) with high radiation dosages. In comparison to current medicines, its novel formulation seeks to provide a safer and more efficient treatment choice. Because of the shortcomings of existing therapies, the drug’s potential to lower risks and improve outcomes for patients with CNS cancer is very noteworthy.

    Enhanced Innovation Pathway

    Together with Plus Therapeutics’ previously awarded Fast Track status, the Orphan Drug Designation greatly enhances the company’s approach to creating novel radiotherapeutic solutions for this underprivileged patient population. Given the rising frequency of LM in lung cancer and the pressing need for additional potent treatments, the designation comes at a particularly good time.

    The FDA offers significant advantages to drug companies in addition to its ODD, including prolonged market exclusivity, clinical trial tax incentives, and exemptions from high regulatory costs. This development follows the successful completion of the ReSPECT-LM Phase 1 study, which set the stage for more clinical research. Plus Therapeutics is now conducting Phase 2 and Phase 1 investigations while collaborating with the FDA to decide on the best course of action.

  • What Drove Plus Therapeutics (PSTV) Stock Up In Pre-hours Trading?

    The shares of Plus Therapeutics Inc. (PSTV) were up 10.09% at $2.4 during pre-market trading. Last session, PSTV stock closed at $2.18, an increase of 1.87% or $0.04. During the session, PSTV stock fluctuated between $2.11 and $2.28. PSTV traded 0.43 million shares on the day, up from 0.35 million on its 50-day average and below its 0.96 million volume year to date.

    PSTV stock has retreated -13.15% over the past 12 months, and over the last week, the stock has dropped -0.91%. In the last six months, PSTV stock has lost -29.45%, and in the last three months, it has lost -6.84%. So far this year, PSTV stock is up 7.92%. An exclusivity agreement has helped PSTV stock rise.

    With whom did PSTV Stock sign the contract?

    Plus Radionuclides encapsulated in nanoliposomes are a key feature of Plus Therapeutics’ radiotherapeutic portfolio for a variety of cancer targets. Creating and releasing drugs targeting various diseases is an essential part of PSTV’s drug development. The program’s unique nanotechnologies platform enables the company to reformulate, deliver and commercialize its drugs. PSTV’s platform facilitates new delivery approaches and/or formulations of safe and effective injectable drugs, potentially improving patient and healthcare provider safety, efficacy, and convenience.

    A new exclusivity agreement has been signed between Plus Therapeutics and ABX Advanced Biochemical Compounds GmbH (ABX), announced PSTV in a press release today.

    • This agreement outlines a key component required for the manufacture of the radiotherapeutic drug substance known as Rhenium-186 NanoLiposome (186RNL) by PSTV.
    • PSTV is strengthening its commercial RNL supply chain in tandem with its clinical progress.
    • The exclusive partnership provides with an additional layer of protection for the RNL portfolio of PSTV, as ABX has extensive experience manufacturing and supplying chemical components for the radiopharmaceutical industry.
    • A key part of the agreement is for ABX to produce a high purity precursor that meets all relevant Good Manufacturing Practices (cGMP) and the US Food and Drug Administration (FDA) as well as other global regulatory agencies.
    • PSTV will have exclusive access to the cGMP precursor for up to 10 years.
    • PSTV is securing the commercial supply chain for 186RNL and future products under the RNL platform as a result of this strategic partnership.

    PSTV’s further plans:

    In addition to recurrent glioblastoma, there are also several other difficult-to-treat cancers that may benefit from PSTV’s 186RNL. Plus Therapeutics (PSTV) is enrolling patients with recurrent glioblastoma in the US multicenter ReSPECT-GBM Phase 1 dose-finding clinical trial, which is intended to deliver high doses of radiation directly to brain tumors safely, effectively, and conveniently.