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Tag: Moleculin Biotech

  • Moleculin (MBRX) Stock Rallies On Positive Regulatory Developments

    Moleculin (MBRX) Stock Rallies On Positive Regulatory Developments

    Moleculin Biotech, Inc. (NASDAQ: MBRX) experienced a dramatic surge in its stock value following positive regulatory developments. As of the latest market check, MBRX shares had soared by 545.24%, reaching $2.71. This substantial increase comes after the company received pivotal feedback from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) amendment, which facilitates a reduction in the scale of its Phase 3 clinical trial protocol.

    Refined Clinical Trial Strategy for Annamycin

    Annamycin and Cytarabine, also known as “AnnAraC,” are being tested in the current Phase 3 “MIRACLE” project (Moleculin R/R AML AnnAraC Clinical Evaluation) to treat patients with acute myeloid leukemia (AML) who are resistant to or have relapsed following induction treatment (R/R AML). Clinical locations in the Middle East, Europe, and the United States will be part of this international investigation.

    Important FDA recommendations about Moleculin Biotech’s statistical analysis plan were granted, enabling a roughly 10% reduction in the trial’s Part B size. While the core elements of the study remain intact, these refinements will optimize efficiency without compromising scientific rigor. MBRX views this regulatory feedback as an encouraging milestone in advancing the development of Annamycin.

    Accelerated Timelines and Expanded Trial Sites

    With regulatory clarity in place, Moleculin Biotech is now poised to expedite site openings within the U.S., supplementing its planned expansions in Europe and the Middle East. This strategic acceleration aligns with MBRX’s broader objective of advancing the trial toward regulatory approval within an optimized timeline. The streamlined approach enhances the likelihood of expeditiously securing approval for Annamycin, a novel non-cardiotoxic anthracycline with transformative potential in oncology.

    Potential Breakthrough in AML Treatment

    Annamycin’s approval could mark a significant advancement in AML treatment, potentially saving thousands of lives annually. Beyond AML, its non-cardiotoxic properties hold the promise of broader oncology applications, with an estimated long-term impact up to 20 times greater. Moleculin Biotech anticipates reaching the first unblinding of 45 trial subjects in the second half of 2025, followed by a second unblinding in early 2026.

    This timeline acceleration is attributed to the enthusiastic response from potential investigators during recruitment discussions held in December. As the MIRACLE trial progresses, the collaborative momentum surrounding this groundbreaking therapy underscores the potential for a paradigm shift in cancer treatment.

  • Moleculin (MBRX) Stock Jumps On Accelerated Clinical Trial News

    Moleculin (MBRX) Stock Jumps On Accelerated Clinical Trial News

    During previous trading session, the stock price of Moleculin Biotech, Inc. (NASDAQ: MBRX) saw a notable uptick, rising 23.11% to close at $3.09. This encouraging development came after MBRX revealed a revised clinical trial design for its Phase 3 pivotal trial, which evaluates the use of Annamycin and Cytarabine to treat relapsed or refractory acute myeloid leukemia (AML).

    Strategic Amendments to the “MIRACLE” Trial

    The goal of Moleculin’s Phase 3 trial, appropriately called “MIRACLE,” is to determine if anamycin and cytarabine work well together for individuals who are not responding to induction treatment. The U.S. Food and Drug Administration (FDA) accepted the updated study protocol, which takes a more efficient approach and might speed up the trial’s duration.

    MBRX’s dedication to expanding AML treatment choices is demonstrated by the worldwide study, which will include locations both inside and outside of the United States. The new protocol allows Moleculin to unblind data from the first 45 subjects earlier than originally planned.

    This early analysis is expected to provide actionable insights into all three study arms, offering a clearer understanding of Annamycin’s potential and enabling strategic decisions, including accelerated regulatory pathways and advanced partnering discussions.

    Enhanced Trial Design Aligns with Regulatory Standards

    The trial’s second phase (Part B) will include 244 subjects, slightly increasing from the initial estimate of 240. This adjustment accommodates the statistical requirements of the interim unblinding process.

    Participants will be randomized to receive either HiDAC (high-dose Cytarabine) with a placebo or HiDAC with the optimal dose of Annamycin. Dose selection will adhere to FDA’s Project Optimus guidelines, emphasizing a balance of safety, efficacy, and pharmacokinetics.

    The updated protocol is under review by the Institutional Review Board (IRB) and will be filed with Moleculin’s amended Investigational New Drug (IND) application upon approval.

    Regulatory Designations and Market Potential

    The FDA has granted Annamycin Orphan Drug Designation and Fast Track Status for relapsed or refractory AML. It also has similar designations from the European Medicines Agency (EMA), extending its potential market reach. With these strategic developments, Moleculin (MBRX) is positioning itself as a significant contender in the fight against AML, supported by robust clinical and regulatory initiatives.

  • Moleculin Biotech, Inc. (MBRX) stock is popping high today. What’s going on?

    Moleculin Biotech, Inc. (MBRX) stock is popping high today. What’s going on?

    Moleculin Biotech, Inc. (MBRX) received the approval of Fast Track Designation for Annamycin by the FDA after which the MBRX stock happened to be green today. MBRX stock price saw an uptrend of 21.08% to reach $4.48 a share as of this writing. The MBRX stock was down with a 3.39 drop at the previous closing. Let’s have a look at current scenarios.

    A Brief look at Approval:

    Moleculin Biotech is mainly working on the treatment of tumors and viruses via the development of oncology drug products. Moleculin stock recently announced that it has got approval for fast-track designation for Annamycin, an anthracycline antibiotic, by the U.S. Food and Drug Administration. In connection with this approval, MBRX will now be able to review Annamycin results against the treatment of soft tissue sarcoma (STS) lung metastases. There are good chances for Moleculin to approve its product against STS lung metastases as well as acute myeloid leukemia.

    Why Annamycin is better?

    Approximately 130000 cases of Soft tissue sarcomas are reported annually around the globe and most of them are handled through the surgical procedure. Analysis shows that 20 to 50% of these cases metastasize to the lungs and once it happens, it then becomes more difficult to treat such cases. So far treatment is very limited for this condition due to severe cardiotoxicity effects by previously approved drugs. Annamycin on the other hand proved to be much effective so far as it does not cause severe cardiotoxicity in patients and hence better than the former drugs.

    Financial View  of MBRX stock

    Recently announced earnings results of RMBX stock show that Moleculin research and development surged to $12.8 million in 2020 as compared to $11.0 million in 2019 due to increased clinical trials that increased the operational costs. General and administrative costs were recorded at $6.8 million in 2020 while these were $6.3 million in 2019. An increase in these costs is mainly due to an increase in the staff but thanks to the COVID-19 that overall travel expenses were significantly reduced.

    Conclusion:

    MBRX stock is enjoying the bullish sentiment in the stock market in response to fast-track designation approval for Annamycin. Management is optimistic to receive early approval for its product in the future. Hence investors should do fundamental as well as technical analysis of MBRX stock before taking any decision.

  • 49 Stocks Making Sharp Moves in Pre Market Session

    49 Stocks Making Sharp Moves in Pre Market Session

    BlackBerry Limited (BB) stock soared 21.29% to $8.49 in the pre-market trading following the announcement of its multi-year, global agreement with Amazon Web Services, Inc. (AWS). The most recent rating by TD Securities, on April 01, 2020, is a Hold.
    Gores Metropoulos Inc. (GMHI), a Shell Companies company, dropped about -3.71% at $16.37 in pre-market trading Wednesday.
    Carnival Corporation & Plc (NYSE: CCL) shares are trading up 2.48% at $20.65 at the time of writing. The firm recently reported Peter C. Anderson as a Section 16 Named Executive Officer. Company’s 52-week ranged between $7.80 to $51.94. Analysts have a consensus price target of $31.
    Guardion Health Sciences Inc. (GHSI) is up more than 2.11% at $0.3 in pre-market hours Wednesday December 02, 2020. The stock had jumped over 11.71% to $0.29 in the last trading session.
    Advaxis Inc. (ADXS) grew over 0.85% at $0.32 in pre-market trading today. The healthcare company recently announced closing of $9.2 million public offering.
    Before the trading started on December 02, 2020, RiceBran Technologies (RIBT) is down -5.56% to reach $0.68. It has been trading in a 52-week range of $0.37 to $2.43.
    Sundial Growers Inc. (SNDL) stock moved up 5.75 percent to $0.69 in the pre-market trading and the company recently announced elimination of senior secured second lien convertible notes.
    Kaixin Auto Holdings (KXIN) is up more than 4.55% at $7.35 in pre-market hours Wednesday December 02, 2020. The stock had jumped over 8.32% to $7.03 in the last trading session.
    Moleculin Biotech Inc. (MBRX) lost over -7.83% at $0.9125 in pre-market trading Wednesday December 02, 2020 after declaring that the US Food and Drug Administration (FDA) has approved its request for a “Rare Pediatric Disease” designation for its drug candidate WP1066.
    Jaguar Health Inc. (JAGX) stock plunged -5.83% to $0.4313 in the pre-market trading. The most recent rating by Rodman & Renshaw, on July 11, 2017, is a Buy.
    Auris Medical Holding Ltd. (EARS) stock plunged -17.97% to $4.29 in the pre-market trading after reporting positive efficacy data from testing AM-301 in vitro. The most recent rating by Euro Pacific Capital, on October 08, 2018, is a Buy.
    Before the trading started on December 02, 2020, Sunworks Inc. (SUNW) is up 9.88% to reach $4.67. It has been trading in a 52-week range of $0.29 to $8.50.
    China Automotive Systems Inc. (NASDAQ: CAAS) shares are trading down -4.95% at $8.25 at the time of writing after the firm declared that its shipped approximately 120,000 units from its portfolio of electric power steering products for use in Chinese electric vehicles during 2020. Company’s 52-week ranged between $1.42 to $10.50.
    Tilray Inc. (NASDAQ: TLRY) shares are trading up 1.61% at $8.2 at the time of writing. Company’s 52-week ranged between $2.43 to $22.95. Analysts have a consensus price target of $4.77.
    Ocugen Inc. (OCGN) lost over -8.87% at $0.3101 in pre-market trading Wednesday December 02, 2020. The company recently reported that leading independent proxy firms ISS and Glass Lewis recommended Ocugen stockholders vote “FOR” reverse stock split and authorized shares amendment proposals.
    AMC Entertainment Holdings Inc. (AMC) is up more than 2.41% at $4.25 in pre-market hours Wednesday December 02, 2020. The stock had dropped over -2.81% to $4.15 in the last trading session.
    Before the trading started on December 02, 2020, JetBlue Airways Corporation (JBLU) is down -4.67% to reach $14.7 following the declaration of its pricing of common stock offering. It has been trading in a 52-week range of $6.61 to $21.65.
    Before the trading started on December 02, 2020, Uxin Limited (UXIN) is down -3.65% to reach $1.32. It has been trading in a 52-week range of $0.72 to $3.10.
    Li Auto Inc. (NASDAQ: LI) shares are trading up 1.78% at $35.48 at the time of writing after announcing that the Company delivered 4,646 Li ONEs in November 2020. Company’s 52-week ranged between $14.31 to $47.70. Analysts have a consensus price target of $45.60.
    Aurora Cannabis Inc. (ACB) stock soared 3.59% to $10.1 in the pre-market trading. The most recent rating by Jefferies, on November 16, 2020, is an Underperform.
    Tantech Holdings Ltd (TANH), a Household & Personal Products company, dropped about -3.24% at $1.79 in pre-market trading Wednesday after reporting the launch by its subsidiary, Shangchi Automobile Co., Ltd., of its newest highly innovative driverless and autonomous street sweeper.
    Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP) shares are trading down -5.52% at $1.37 at the time of writing. Company’s 52-week ranged between $0.91 to $9.78. Analysts have a consensus price target of $3.
    iBio Inc. (IBIO) is up more than 19.31% at $1.73 in pre-market hours Wednesday December 02, 2020 after revealing that it has entered into its first Statement of Work (“SoW”) under a Master Services Agreement with ATB Therapeutics to produce its bioengineered antibody-toxin fusion proteins using iBio’s FastPharming® System. The stock had dropped over -2.68% to $1.45 in the last trading session.
    Norwegian Cruise Line Holdings Ltd. (NYSE: NCLH) shares are trading up 2.09% at $23.42 at the time of writing. Company’s 52-week ranged between $7.03 to $59.78. Analysts have a consensus price target of $26.
    Moderna Inc. (MRNA) stock soared 6.09% to $149.6 in the pre-market trading. The biotechnology firm reported recently, that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The most recent rating by Wells Fargo, on November 23, 2020, is an Equal weight.
    Switchback Energy Acquisition Corporation (SBE) is down more than -4.16% at $28.13 in pre-market hours Wednesday December 02, 2020. The stock had dropped over -12.67% to $29.35 in the last trading session.
    Novavax Inc. (NVAX) grew over 4.84% at $129.44 in pre-market trading today after declaring COVID-19 vaccine clinical development progress.
    Before the trading started on December 02, 2020, Eastman Kodak Company (KODK) is up 3.88% to reach $7.5. It has been trading in a 52-week range of $1.50 to $60.00.
    ReneSola Ltd (SOL), a Solar company, dropped about -11.66% at $6.97 in pre-market trading Wednesday after releasing its third quarter 2020 financial results.
    Acasti Pharma Inc. (ACST) stock plunged -9.56% to $0.3301 in the pre-market trading. The most recent rating by Oppenheimer, on September 01, 2020, is a Perform.
    Pfizer Inc. (PFE) stock moved up 3.73 percent to $40.88 in the pre-market trading after the firm and BioNTech SE reporting that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19.
    Gevo Inc. (NASDAQ: GEVO) shares are trading down -3.17% at $1.83 at the time of writing. Company’s 52-week ranged between $0.46 to $2.91.
    Fisker Inc. (FSR) is down more than -3.41% at $17.55 in pre-market hours Wednesday December 02, 2020. The company recently reported that that Henrik Fisker, chairman and chief executive officer of Fisker, will participate in the Credit Suisse Eighth Annual Virtual Industrials Conference. The stock had dropped over -6.24% to $18.17 in the last trading session.
    Nxt-ID Inc. (NXTD) grew over 43.17% at $0.587 in pre-market trading today.
    Before the trading started on December 02, 2020, Bloom Energy Corporation (BE) is down -6.58% to reach $23.0 and the company will host virtual analyst day on December 16, 2020. It has been trading in a 52-week range of $3.00 to $28.24.
    Ocean Power Technologies Inc. (OPTT), a Electrical Equipment & Parts company, dropped about -3.54% at $2.45 in pre-market trading Wednesday.
    Nikola Corporation (NKLA) stock soared 4.38% to $18.13 in the pre-market trading after signing MOU with General Motors. The most recent rating by Loop Capital, on November 20, 2020, is a Buy.
    Vaxart Inc. (VXRT) gained over 3.92% at $7.95 in pre-market trading Wednesday December 02, 2020.
    salesforce.com inc. (CRM) lost over -4.16% at $231.3 in pre-market trading Wednesday December 02, 2020 after introducing service cloud workforce engagement to help contact centers thrive in an all-digital, work-from-anywhere world.
    InVivo Therapeutics Holdings Corp. (NVIV), a Biotechnology company, rose about 2.42% at $0.635 in pre-market trading Wednesday.
    FuelCell Energy Inc. (FCEL) stock plunged -20.11% to $7.23 in the pre-market trading following the publication pricing of its underwritten public offering of 34,518,539 shares of its common stock, at a public offering price of $6.50 per share. The most recent rating by JP Morgan, on November 19, 2020, is a Neutral.
    Pershing Square Tontine Holdings Ltd. (PSTH), a Shell Companies company, rose about 2.34% at $26.25 in pre-market trading Wednesday.
    Virgin Galactic Holdings Inc. (NYSE: SPCE) shares are trading up 4.37% at $29.59 at the time of writing after reporting its new flight window since it paused the spaceflight preparations in response to state guidelines from the New Mexico Department of Health to reduce the spread of COVID-19. Company’s 52-week ranged between $7.14 to $42.49. Analysts have a consensus price target of $19.
    Second Sight Medical Products Inc. (EYES) stock moved down -8.0 percent to $1.38 in the pre-market trading.
    BioNTech SE (BNTX) grew over 7.36% at $122.4 in pre-market trading today after declaring that it will hold a press conference including a video webcast on Wednesday, December 2, 2020, to provide an update on the status of the COVID-19 vaccine development program of its lead vaccine candidate BNT162b2.
    Sogou Inc. (SOGO), a Internet Content & Information company, rose about 3.09% at $8.68 in pre-market trading Wednesday.
    Tellurian Inc. (TELL) is down more than -4.29% at $1.56 in pre-market hours Wednesday December 02, 2020 and the firm recently declared the appointment veteran CEO and adds industry experts to board of directors. The stock had jumped over 9.40% to $1.63 in the last trading session.
    Arlo Technologies Inc. (ARLO) lost over -3.48% at $6.66 in pre-market trading Wednesday December 02, 2020.
    Before the trading started on December 02, 2020, ZoomInfo Technologies Inc. (ZI) is down -3.57% to reach $46.22 as the firm announced pricing of secondary offering of shares of class a common stock. It has been trading in a 52-week range of $30.83 to $64.40.

  • Moleculin Biotech, (MBRX) shares skyrocketed early in the morning

    Moleculin Biotech, (MBRX) shares skyrocketed early in the morning

    Moleculin Biotech, Inc., (Nasdaq: MBRX) surged 43.59% in the pre-market session after, a clinical-stage pharmaceutical corporation with a wide pipeline of drug candidates targeting highly resistant tumors and viruses, recently confirmed that its drug candidate WP1066 has been licensed by the US Food and Drug Administration (FDA) to qualify for a ‘Rare Pediatric Disorder’ designation.

    The classification authorises Moleculin to obtain a New Drug Approval (NDA) transferable Priority Review Voucher (PRV) for any of the three indications, including diffuse intrinsic pontine glioma (DIPG), medulloblastoma, and atypical rhabdoid teratoid tumor.

    The company also revealed on November 19 2020 that recent animal results demonstrated a strongly improved performance against acute myeloid leukaemia (‘AML’) when used in conjunction with the widely used antileukemic agent Ara-C against the single agent. The results will be discussed under the title: “High Efficacy of Liposomal Annamycin in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model.” at the 62nd Annual Meeting & Exhibition of the American Society for Hematology.