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Tag: Plus Therapeutics Stock

  • 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.

  • Why Plus Therapeutics Inc [NASDAQ: PSTV] Is a Good Buy at Current Prices

    Why Plus Therapeutics Inc [NASDAQ: PSTV] Is a Good Buy at Current Prices

    Plus Therapeutics Inc [NASDAQ: PSTV] has been trading in a bullish channel for months now. Yesterday, the stock gained some more upside momentum and closed the day with gains of 24%. Yesterday’s rally followed the company’s announcement that it had got fast track designation from the U.S FDA for its new Glioblastoma treatment.

    With the fast track designation, the company will now have access to a number of benefits. For starters, it will be in a position to hold more regular meetings with the FDA on issues touching on its drug development process.

    The company will also have regular communication from the FDA on many issues including the design of its upcoming clinical trials and the biomarkers that it will use in its process. On top of that, the company will be eligible for accelerated review and approval whenever it meets the laid down criteria.

    Most importantly, the company will be in a position to submit sections of its new drug application whenever they are completed rather than waiting for the entire application to be reviewed by the FDA. This puts the company in an advantageous position in its quest to develop and sell its new treatment for Glioblastoma.

    Commenting on the  fast track designation, the company CEO,  Dr,  Marc Hedrick stated that the award of a fast track designation was a validation of the company’s treatment’s potential for people suffering from recurring cases of glioblastoma, and do not have any viable treatment options at the moment. He added that now that the company had received the fast track designation, it planned on moving the trial to cohort, a major step toward making the new therapy a reality.

    From an investor perspective, the FDA fast track designation means that the company is close to unlocking a new revenue stream. This would have the effect of driving up the company’s value and the stock price. For this reason, buyers are likely to keep bidding up this stock in the near-term.

    The stock is also likely to be the uplifted by the increased optimism in the market. Stocks are on the rise on hopes of a potential COVID-19 vaccine in the near-term. In this environment, any stock that has good fundamentals stands to gain at a higher rate than the rest of the market.

    About Plus Therapeutics Inc

    Plus Therapeutics Inc is a pharmaceutical company that develops treatments for cancer and other ailments. It is based in Austin, Texas.