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Tag: Verastem

  • Regulatory Milestone Sends Verastem (VSTM) Shares Soaring

    Regulatory Milestone Sends Verastem (VSTM) Shares Soaring

    After a significant regulatory notification, shares of Verastem, Inc. (NASDAQ: VSTM) are up 39.51% to $5.12 as of the recent check on the US stock charts. VSTM’s New Drug Application (NDA) for avutometinib in combination with defactinib has been approved by the US Food and Drug Administration (FDA) via the accelerated approval process.

    Innovative Therapy for Uncommon Ovarian Cancer

    The suggested treatment is intended for adult patients with recurrent low-grade serous ovarian cancer (LGSOC) who have KRAS mutations. It consists of the oral RAF/MEK clamp avutometinib and the oral FAK inhibitor defactinib. The Prescription Drug User Fee Act or PDUFA action date is planned for June 30, 2025, as a result of the NDA’s October 2024 submission being awarded Priority Review.

    For this study, the FDA does not presently have any plans to convene an advisory committee meeting. A major advancement in oncology, if approved, the medicine would be the first FDA-approved treatment especially for recurrent KRAS-mutant LGSOC. 

    Clinical Evidence Supporting the Filing

    The NDA builds on compelling evidence from the Phase 2 RAMP 201 trial, where the avutometinib-defactinib combination demonstrated a robust overall response rate, confirmed by an independent central review.

    These responses were often durable, with patients generally tolerating the treatment well. Supporting data from the FRAME Phase 1 trial further substantiates the efficacy and safety of this innovative approach.

    Pathway to Expanded Treatment Options

    In parallel with the FDA review process, Verastem is advancing its RAMP 301 Phase 3 trial, enrolling patients with recurrent LGSOC regardless of KRAS mutation status. This confirmatory trial aims to broaden the therapy’s indication, potentially addressing a wider spectrum of patients.

    With the FDA’s Priority Review designation, Verastem is positioned to deliver a groundbreaking treatment addressing a critical gap in cancer care. VSTM is actively preparing for a commercial launch anticipated in mid-2025, signaling hope for patients battling this rare disease.

  • Bullish Trend For Verastem (VSTM) Stock Following Orphan Drug Designation

    Bullish Trend For Verastem (VSTM) Stock Following Orphan Drug Designation

    Verastem, Inc. (NASDAQ: VSTM) experienced a notable increase in its share value following the receipt of a significant designation from regulatory authorities. The stock demonstrated a bullish trend on US stock charts, climbing by 6.57% to $2.92 during the after-market session on Monday. With this increase, the -7.43% loss during regular trading hours was recovered.

    FDA Approves Orphan Drug Status

    Verastem stated that, when combined with defactinib, a selective FAK inhibitor, avutometinib, an RAF/MEK clamp, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). This classification relates to pancreatic cancer therapy. The acknowledgement highlights the significant unfulfilled medical need for efficient therapies in this area.

    Positive Interim Results and Future Prospects for Verastem

    At the ASCO 2024 Annual Meeting, Verastem presented preliminary interim findings from the ongoing RAMP 205 trial. This trial is assessing the efficacy of the combination of avutometinib and defactinib alongside standard chemotherapy in first-line metastatic pancreatic cancer. The positive interim results highlight the potential of this therapeutic approach to offer a novel treatment strategy for this challenging disease.

    VSTM anticipates releasing updated data from various dose cohorts of the RAMP 205 trial in the first quarter of 2025. As of May 14, 2024, 41 patients had been administered treatment across four dose cohorts, with those in dose cohort 1 showing promising results. Specifically, 83% of patients in this cohort achieved a confirmed partial response with over six months of follow-up.

    Furthermore, one dose-limiting toxicity was noted in the dose level 1 cohort, which was subsequently resolved upon the inclusion of additional patients. Of the 26 patients in all groups who had their initial scans, 21 reported a reduction in the target lesions’ overall diameter.

    The FDA’s Orphan Drug Designation offers the possibility of a seven-year market exclusivity following approval for treatments addressing rare diseases affecting fewer than 200,000 people in the US, as well as tax credits for qualifying clinical trials and waivers of certain FDA user fees.

  • What changed for these 49 stocks in Pre Market Session

    What changed for these 49 stocks in Pre Market Session

    Lizhi Inc. (LIZI) stock plunged -8.14% to $4.4 in the pre-market trading after reporting that it entered in-car audio collaboration with Xpeng Motors. The most recent rating by Citigroup, on February 18, 2020, is a Buy.
    American Airlines Group Inc. (NASDAQ: AAL) shares are trading up 4.72% at $16.85 at the time of writing. Company’s 52-week ranged between $8.25 to $30.78.
    FuelCell Energy Inc. (FCEL) is up more than 5.01% at $7.75 in pre-market hours Friday December 04, 2020. The firm recently declared the 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 stock had jumped over 1.93% to $7.38 in the last trading session.
    Before the trading started on December 04, 2020, AMC Entertainment Holdings Inc. (AMC) is up 5.51% to reach $3.83. It has been trading in a 52-week range of $1.95 to $8.78.
    Cinemark Holdings Inc. (CNK) stock soared 6.02% to $14.1 in the pre-market trading. The most recent rating by Loop Capital, on November 19, 2020, is a Hold.
    Iterum Therapeutics plc (ITRM), a Biotechnology company, dropped about -3.8% at $0.809 in pre-market trading Friday.
    Norwegian Cruise Line Holdings Ltd. (NYSE: NCLH) shares are trading up 3.7% at $26.36 at the time of writing following its announcement extension of suspension of voyages. Company’s 52-week ranged between $7.03 to $59.78. Analysts have a consensus price target of $26.
    Before the trading started on December 04, 2020, Jaguar Health Inc. (JAGX) is up 7.84% to reach $0.399. It has been trading in a 52-week range of $0.19 to $1.08.
    Transocean Ltd. (RIG), a Oil & Gas Drilling company, rose about 4.43% at $2.12 in pre-market trading Friday after declaring amendments to certain financing documents and internal reorganization transactions to resolve allegations contained in purported notices of default.
    Novan Inc. (NOVN) stock soared 19.92% to $0.67 in the pre-market trading. The most recent rating by Piper Jaffray, on January 06, 2020, is a Neutral.
    Li Auto Inc. (LI) lost over -2.48% at $31.51 in pre-market trading Friday December 04, 2020 following declaration its pricing of follow-on public offering of American depositary shares.
    Southwestern Energy Company (NYSE: SWN) shares are trading up 2.13% at $2.88 at the time of writing. Company’s 52-week ranged between $1.06 to $3.90. Analysts have a consensus price target of $2.40.
    Occidental Petroleum (OXY) is up more than 3.23% at $16.92 in pre-market hours Friday December 04, 2020. The company recently reported the release of its 2020 Climate Report, which provides a pathway detailing milestones to achieve its net-zero aspirations. The stock had jumped over 3.15% to $16.39 in the last trading session.
    Torchlight Energy Resources Inc. (TRCH) is up more than 6.9% at $0.48 in pre-market hours Friday December 04, 2020. The stock had jumped over 15.13% to $0.45 in the last trading session.
    TransGlobe Energy (TGA) grew over 2.82% at $0.659 in pre-market trading today following its agreement to merge, extend and modernize its eastern Desert concessions.
    Before the trading started on December 04, 2020, Catabasis Pharmaceuticals Inc. (CATB) is up 2.07% to reach $1.97. It has been trading in a 52-week range of $1.25 to $8.59.
    Inovio Pharmaceuticals Inc. (INO) stock moved up 8.07 percent to $13.53 in the pre-market trading after declaring the execution of an agreement with Kaneka Eurogentec S.A., for Eurogentec to manufacture INOVIO’s COVID-19 vaccine candidate INO-4800 at their industry-leading GMP plasmid production scales.
    Clovis Oncology Inc. (CLVS) is down more than -4.81% at $5.15 in pre-market hours Friday December 04, 2020. The stock had jumped over 11.09% to $5.41 in the last trading session.
    Cinedigm Corp. (CIDM) gained over 71.43% at $0.96 in pre-market trading Friday December 04, 2020 after reporting that its eight additional linear streaming channels are now Available on Rad’s fast-growing global streaming platform.
    Onconova Therapeutics Inc. (ONTX) stock plunged -1.9% to $0.3143 in the pre-market trading. The most recent rating by H.C. Wainwright, on March 01, 2018, is a Buy.
    Marvell Technology Group Ltd. (MRVL) stock plunged -5.1% to $43.2 in the pre-market trading after announcing a quarterly dividend of $0.06 per share of common stock payable on January 14, 2021 to shareholders of record as of December 23, 2020. The most recent rating by Craig Hallum, on October 30, 2020, is a Buy.
    QEP Resources Inc. (QEP) stock soared 5.0% to $2.1 in the pre-market trading. The most recent rating by JP Morgan, on July 20, 2020, is a Neutral.
    Arlo Technologies Inc. (NYSE: ARLO) shares are trading up 3.09% at $7.0 at the time of writing. The company recently revealed that Matthew McRae, CEO, and Gordon Mattingly, CFO, will present at the Raymond James Virtual Technology Investors Conference on Tuesday, December 8, 2020. Company’s 52-week ranged between $1.20 to $7.75. Analysts have a consensus price target of $6.
    Before the trading started on December 04, 2020, Nxt-ID Inc. (NXTD) is down -3.91% to reach $0.41. It has been trading in a 52-week range of $0.21 to $0.89.
    Halliburton Company (HAL) gained over 3.66% at $18.68 in pre-market trading Friday December 04, 2020 following its deal with Accenture (ACN), to accelerate Halliburton’s digital supply chain transformation and support digitalization within the Company’s manufacturing function.
    United Microelectronics (UMC) stock soared 10.32% to $8.55 in the pre-market trading. The most recent rating by Credit Suisse, on October 12, 2020, is an Outperform.
    Before the trading started on December 04, 2020, Cloudera Inc. (CLDR) is up 14.85% to reach $13.3 after reporting results for its third quarter of fiscal 2021, ended October 31, 2020. It has been trading in a 52-week range of $4.76 to $14.20.
    Before the trading started on December 04, 2020, Isoray Inc. (ISR) is down -4.92% to reach $0.47. It has been trading in a 52-week range of $0.35 to $1.06.
    iBio Inc. (AMEX: IBIO) shares are trading down -0.66% at $1.51 at the time of writing. The firm recently reported an agreement with Belgium-based ATB Therapeutics to produce its bioengineered antibody-toxin fusion proteins using iBio’s FastPharming® System. Company’s 52-week ranged between $0.14 to $7.45. Analysts have a consensus price target of $2.55.
    Centennial Resource Development Inc. (CDEV) stock soared 3.13% to $1.32 in the pre-market trading. The most recent rating by MKM Partners, on November 30, 2020, is a Neutral.
    BioCryst Pharmaceuticals Inc. (BCRX) is up more than 24.44% at $6.39 in pre-market hours Friday December 04, 2020 following the FDA Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to prevent attacks in Hereditary Angioedema patients. The stock had jumped over 1.88% to $5.14 in the last trading session.
    Borr Drilling Limited (BORR) is up more than 6.86% at $0.854 in pre-market hours Friday December 04, 2020. The stock had dropped over -1.78% to $0.80 in the last trading session.
    Before the trading started on December 04, 2020, Blink Charging Co. (BLNK) is up 4.14% to reach $23.64 after declaring an agreement with JSC Management Group, a large Burger King franchisee, to deploy numerous EV charging stations at key Burger King locations across the Northeast. It has been trading in a 52-week range of $1.25 to $34.67.
    Banco Santander S.A. (SAN) grew over 3.74% at $3.33 in pre-market trading today.
    Kandi Technologies Group Inc. (NASDAQ: KNDI) shares are trading up 2.98% at $8.3 at the time of writing. Company’s 52-week ranged between $2.17 to $17.45.
    InVivo Therapeutics Holdings Corp. (NVIV) lost over -4.67% at $0.6101 in pre-market trading Friday December 04, 2020.
    Aehr Test Systems (AEHR), a Semiconductor Equipment & Materials company, dropped about -8.74% at $1.88 in pre-market trading Friday after receiving $4.3 million order for initial FOX-XP™ test cell for production test of mobile sensor devices.
    ICICI Bank Limited (IBN) grew over 4.48% at $13.75 in pre-market trading today.
    NanoVibronix Inc. (NAOV) stock moved down -7.96 percent to $1.04 in the pre-market trading following the announcement of $6.0 million private placement.
    DocuSign Inc. (DOCU), a Software – Application company, rose about 4.43% at $241.25 in pre-market trading Friday.
    Dada Nexus Limited (DADA) is up more than 4.4% at $47.2 in pre-market hours Friday December 04, 2020 after reporting that Dada Now has partnered with dozens of cake chain brands across China, doubling the number of cooperating stores year-over-year as of November 2020. The stock had dropped over -15.65% to $45.21 in the last trading session.
    Salarius Pharmaceuticals Inc. (SLRX) stock moved up 1.85 percent to $1.1 in the pre-market trading.
    Auris Medical Holding Ltd. (NASDAQ: EARS) shares are trading down -3.23% at $3.3 at the time of writing after it pricing $8,000,000 common shares offering priced at-the-market. Company’s 52-week ranged between $0.65 to $6.60. Analysts have a consensus price target of $2.50.
    Acasti Pharma Inc. (ACST) lost over -2.94% at $0.33 in pre-market trading Friday December 04, 2020.
    Micro Focus International plc (MFGP) is up more than 6.3% at $6.07 in pre-market hours Friday December 04, 2020. The firm recently declared the findings of its ‘Endless Modernization’ research with Standish Group. The stock had jumped over 14.66% to $5.71 in the last trading session.
    BP p.l.c. (BP), a Oil & Gas Integrated company, rose about 4.54% at $22.33 in pre-market trading Friday.
    Tantech Holdings Ltd (NASDAQ: TANH) shares are trading up 4.27% at $1.71 at the time of writing after announcing the launch by its subsidiary, Shangchi Automobile Co., Ltd. (“Shangchi Automobile”), of its newest highly innovative driverless and autonomous street sweeper. Company’s 52-week ranged between $0.81 to $3.65.
    Trine Acquisition Corp. (TRNE) gained over 7.05% at $15.49 in pre-market trading Friday December 04, 2020.
    Enlivex Therapeutics Ltd. (ENLV) grew over 5.26% at $12.0 in pre-market trading today after reporting positive interim results of an investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients.