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Tag: Plus Therapeutics

  • 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.

  • Plus Therapeutics Inc. (PSTV) stock Recovers in the Premarket

    Plus Therapeutics Inc. (PSTV) stock Recovers in the Premarket

    Plus Therapeutics Inc. (PSTV) was up by 9.73% at $1.24 premarket at the last check on Tuesday.

    In the regular trading session, the stock opened at a price of $1.20 and ranged between $1.12 and $1.32 during the day. PSTV stock declined by 4.24% in the regular session at $1.13 but reversed its course in the premarket session today. While there is no news from the company driving the stock, the stock was bound to recover sooner or later.

    The US-based company focuses on the development of innovative radiotherapeutics geared towards rare cancers that are not easily treatable. Currently, the company has a market capitalization of $18.12 million.

    PSTV’s ReSPECTTM-GBM Phase 1 Data

    PSTV has been conducting the ReSPECTTM-GBM Phase 1 clinical trial of its investigational drug Rhenium-186 NanoLiposome for patients with recurrent glioblastoma (GBM).

    During the annual meeting of the Society for Neuro-Oncology, the firm announced positive interim results from the trial. The meeting was held in November 2021, in Boston, Massachusetts. The company revealed a positive correlation of higher absorbed radiation doses of the drug with the overall survival of patients.

    According to the principal investigator of the trial, Andrew J. Brenner, the drug has shown good tolerance without any dose-limiting toxicities so far. Hence, further clinical investigation of relative efficacy is warranted. Moreover, Dr. Brenner is the Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio.

    Employment Inducement Grants

    On November 12, PSTV announced granting option awards to its chief medical officer, Dr. Norman LaFrance. The equity awards were used to mark the induction of LaFrance as the CMO. Moreover, the awards are to be utilized for the purchase of 120,000 common shares of the company.

    PSTV’s Q3 Financial Highlights

    On October 21, PSTV declared its financial results for the third quarter of 2021. In the third quarter of 2021, the company incurred a net loss of $3.7 million. This compares to $1.7 million in the year-ago quarter. Subsequently, the net loss per share was $0.28 and $0.39 in the third quarter of 2021 and 2020, respectively.

    Moreover, PSTV ended the third quarter with a cash balance of $21.3 million against, $8.3 million on December 31, 2020.

    Further, the total operating expenses of the company were $3.5 million in the third quarter of 2021. This compares to $1.4 million in the third quarter of 2020.

  • 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.

  • Plus Therapeutics, Inc. (PSTV) stock is high today. What’s going on?

    Plus Therapeutics, Inc. (PSTV) stock is high today. What’s going on?

    Plus Therapeutics, Inc. (PSTV) entered into the Master Services Agreement(MSA) with Piramal Pharma Solutions(PPS) today after which the PSTV stock price saw an uptrend of  45.26% to reach $3.98 a share as of this writing. Plus Therapeutics gained 3.40% at the previous closing and its per-share price was $2.74. Let’s see what the agreement says.

    MSA with Piramal Pharma Solutions (PPS).

    Plus Therapeutics, Inc. (PSTV) is a clinical-stage pharmaceutical company mainly focused on the treatment of cancer diseases. PSTV today announced its Master Services agreement with Piramal Pharma Solutions (PPS), leading contract development and manufacturing firm, to develop, manufacture, and supply Rhenium NanoLiposome (RNL™) which is an intermediate drug product of PSTV. According to this agreement, PSTV will transfer and perform its analytical methods at PPS’s drug product facility in Lexington, Kentucky along with the development of microbiological methods, intermediate drug manufacturing, and stability studies.

    Future Impact of MSA

    Plus Therapeutics is focused on the advancement of Rhenium NanoLiposome to make it a novel treatment for patients who are suffering glioblastoma, aggressive cancer often occurs in the brain or spinal cord.Plus management thinks that agreement with PPS will fast the process of RNL development and its regulatory approval in the future.

    Financial Overview of PSTV

    On February 22, 2021, PSTV announced its fourth quarter and fiscal year 2020 results according to which PSTV had an $8.3 million amount on hand as of December 30, 2021, as compared to a $17.6 million cash balance in 2019.Operating expenses in 2020 surged to $8.4 million from $5.9 million in 2019.PSTV net loss dropped to $8.2 million in 2020 while it was $11.4 million in the prior year.

    Conclusion:

    Investors are responding to PSTV stock after its master services agreement with PPS for the speedy development of RNL.Plus is expected to complete many clinical trials of its pipeline products in the upcoming quarters.Increase in operating expenses in 2020 suggests that PSTV stock is growing with time.Hence investors having long-term prospects need to keep an eye on it.

  • 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.