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Turning Point Therapeutics, Inc. (TPTX)

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72.66-0.37 (-0.51%)
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Neutralpattern detected
Previous Close73.03
Open72.16
Bid60.00 x 1000
Ask76.00 x 1000
Day's Range71.54 - 74.28
52 Week Range43.16 - 141.30
Volume269,107
Avg. Volume312,105
Market Cap3.571B
Beta (5Y Monthly)1.09
PE Ratio (TTM)N/A
EPS (TTM)-3.85
Earnings DateMay 10, 2021 - May 14, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est160.10
  • Turning Point Therapeutics Initiates Global Phase 1/2 Forge-1 Clinical Study of TPX-0131, a Next-Generation ALK Inhibitor
    GlobeNewswire

    Turning Point Therapeutics Initiates Global Phase 1/2 Forge-1 Clinical Study of TPX-0131, a Next-Generation ALK Inhibitor

    Investigational New Drug Application Cleared Study Initiated in Australia, with U.S. Site Activations Now Planned SAN DIEGO, April 12, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced initiation of its Phase 1/2 FORGE-1 study of TPX-0131, a potent inhibitor of the anaplastic lymphoma kinase (ALK) and multiple resistant mutations of ALK. The investigational new drug (IND) application for TPX-0131 is Turning Point’s third IND to be cleared by the FDA in less than 2 years, and FORGE-1 is the company’s fourth clinical study to initiate during the same period of time. The study was initiated in Australia, with U.S. site activations now planned. “With a lack of available therapies to address a broad spectrum of ALK resistant mutations, we are encouraged by the preclinical potency for TPX-0131, particularly against the G1202R solvent front mutation which is reported to occur in more than 40% of biopsies with resistance mutations,” said Ben Solomon, M.D., principal investigator for the FORGE-1 study, a medical oncologist and group leader of the Molecular Therapeutics and Biomarkers Laboratory at the Peter MacCallum Cancer Centre in Melbourne, Australia. “In addition, TPX-0131 has been shown preclinically to penetrate the central nervous system, which is important in the treatment of patients with ALK-positive non-small cell lung cancer as the disease often progresses in the brain.” ALK alterations are estimated to be responsible for 3% to 5% of non-small cell lung cancer (NSCLC) cases annually in the U.S. and EU5 countries. In preclinical studies, TPX-0131 potently inhibits wildtype ALK and is more potent in comparison to approved ALK inhibitors against many clinically observed resistance mutations, including the G1202R solvent front mutation, L1196M gatekeeper mutation, and multiple compound mutations. In addition, TPX-0131 has shown brain tissue penetration after repeat oral dosing. “Our clinical study of TPX-0131 will begin with a Phase 1 dose finding portion in patients previously treated with up to 2 prior ALK tyrosine kinase inhibitors, a population we believe is underserved today by available therapies that are less potent against known resistant mutations of ALK,” said Mohammad Hirmand, M.D., chief medical officer of Turning Point Therapeutics. The Phase 1 dose finding portion of the FORGE-1 study will enroll patients with locally advanced or metastatic TKI-pretreated ALK-positive NSCLC. Patients with up to 2 prior ALK TKIs and 1 prior platinum-based chemotherapy will be enrolled. The study endpoints include safety and tolerability, determination of the maximum tolerated dose and/or the recommended Phase 2 dose, and objective response rate by RECIST 1.1. About Turning Point Therapeutics Inc.Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes TPX-0022, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer. Turning Point’s next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com. Forward Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics’ drug candidate TPX-0131, the results, conduct, progress and timing of Turning Point Therapeutics’ pre-clinical studies and clinical trials and plans regarding future clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point’s business and the other risks described in Turning Point Therapeutics’ filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contact: Jim Mazzolajim.mazzola@tptherapeutics.com858-342-8272

  • Turning Point Therapeutics Announces New Preclinical Data for Three Drug Candidates
    GlobeNewswire

    Turning Point Therapeutics Announces New Preclinical Data for Three Drug Candidates

    Presentations Planned at Annual Meeting of American Association for Cancer Research, Held Virtually April 9-14SAN DIEGO, April 09, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced new preclinical data supporting the ongoing development of three of its drug candidates, repotrectinib, TPX-0022 and TPX-0131. The findings will be presented this weekend at the American Association for Cancer Research (AACR) annual meeting, which is convening virtually through April 14. For lead drug candidate, repotrectinib, poster presentations will highlight new preclinical combination data with MEK and MEK/Raf inhibitors, as well as repotrectinib’s potency against wildtype and mutant TRKA/B/C as compared to approved TRK inhibitors. The preclinical studies found that repotrectinib combinations with approved MEK inhibitor, trametinib, or investigational MEK/Raf inhibitor, VS-6766, were more effective than single-agent treatment in patient-derived KRAS mutant G12D/V lung and G12D/V/R pancreatic cancer models. Based on the findings and additional preclinical support presented previously, Turning Point anticipates the first cohort of its planned Phase 1/2 TRIDENT-2 study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS mutant G12D advanced solid tumors. “We are encouraged by the new preclinical data our research team has generated in support of our ongoing development of repotrectinib, TPX-0022 and TPX-0131,” said Athena Countouriotis, M.D., president and CEO. “In particular, our preclinical models continue to suggest that the combination of repotrectinib with MEK inhibitors can suppress mutant KRAS signaling to achieve more potent and durable anti-tumor activity. We look forward to studying this further in the first cohort of our planned TRIDENT-2 combination study. “In addition, preclinical studies show repotrectinib is highly potent against wild type TRK fusions and is less affected by NTRK resistance mutations than approved therapies, with strong potency in both in vitro and in vivo studies. We look forward to sharing additional clinical data from our TRIDENT-1 study of repotrectinib in the second half of the year.” TPX-0022, MET, SRC, CSF1R InhibitorFor MET/SRC/CSF1R inhibitor TPX-0022, the company will present preclinical data demonstrating potential utility in combination with immune checkpoint inhibitors. In a syngeneic xenograft tumor model, TPX-0022 treatment downregulated immunosuppressive cytokines, increased anti-tumor M1 macrophages, and enriched levels of CD8+ cytotoxic T cells. TPX-0022 had single agent in vivo efficacy and enhanced the efficacy of an anti-PD-1 inhibitor. With the new data, Turning Point is evaluating a potential additional combination study of TPX-0022 and an anti-PD-1 checkpoint inhibitor. In the second half of 2021, the company plans to provide a clinical data update from the Phase 1 dose finding portion of its ongoing SHIELD-1 study and initiate its planned Phase 1b/2 SHIELD-2 clinical study of TPX-0022 in combination with an EGFR targeted therapy. TPX-0131, ALK InhibitorFor its ALK-inhibitor, TPX-0131, Turning Point will present preclinical data showing its potential to cross the blood-brain barrier and its potency against wild type ALK and a broad spectrum of acquired ALK resistance mutations, including the G1202R solvent front mutation, L1196M gatekeeper mutation, and the G1202R/L1196M and /L1198F compound mutations. Turning Point plans to initiate a Phase 1/2 study in patients with ALK-positive TKI-pretreated advanced non-small cell lung cancer in the second quarter of 2021. AACR plans to make poster presentations available via its website on Saturday, April 10. The four posters to be presented are: Title: Repotrectinib increases effectiveness of MEK inhibitors in KRAS mutant cancer models Abstract Number: 1104 Title: Molecular characteristics of repotrectinib that enable potent inhibition of TRK fusion proteins and broad mutant selectivity Abstract Number: 1119 Title: TPX-0022, a potent MET/SRC/CSF1R inhibitor that modulates the tumor immune microenvironment in preclinical models Abstract Number: 1444 Title: TPX-0131, a potent inhibitor of wild type ALK and a broad spectrum of both single and compound ALK resistance mutations Abstract Number: 1469 About Turning Point Therapeutics Inc.Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes TPX-0022, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and TPX-0131, a next-generation ALK inhibitor. Turning Point’s next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com. Forward Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics’ drug candidates, the results, conduct, progress and timing of Turning Point Therapeutics’ pre-clinical studies and plans regarding future development activities. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point’s business and the other risks described in Turning Point Therapeutics’ filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contact: Jim Mazzolajim.mazzola@tptherapeutics.com858-342-8272

  • The Daily Biotech Pulse: Illumina Lights Up, Cara Soars On Index Inclusion, Novavax Starts Crossover Vaccine Study, Turning Point Data Readout
    Benzinga

    The Daily Biotech Pulse: Illumina Lights Up, Cara Soars On Index Inclusion, Novavax Starts Crossover Vaccine Study, Turning Point Data Readout

    Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs April 5) Aclaris Therapeutics, Inc. (NASDAQ: ACRS) Cara Therapeutics, Inc. (NASDAQ: CARA) Gain Therapeutics, Inc. (NASDAQ: GANX) IDEAYA Biosciences, Inc. (NASDAQ: IDYA) Magenta Therapeutics, Inc. (NASDAQ: MGTA) MiMedx Group, Inc. (NASDAQ: MDXG) PPD, Inc. (NASDAQ: PPD) Surmodics, Inc. (NASDAQ: SRDX) Down In The Dumps (Biotech Stocks Hitting 52-week Lows April 5) ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) (received a complete response letter for dementia drug) Achilles Therapeutics plc (NASDAQ: ACHL) (went public Wednesday) Coherus BioSciences, Inc. (NASDAQ: CHRS) Gracell Biotechnologies Inc. (NASDAQ: GRCL) Landos Biopharma, Inc. (NASDAQ: LABP) Lucira Health, Inc. (NASDAQ: LHDX) Metacrine, Inc. (NASDAQ: MTCR) Stocks In Focus Illumina Issues Positive Preannouncement For Q1, Lifts FY21 Guidance Illumina, Inc. (NASDAQ: ILMN) announced preliminary first-quarter revenue and upwardly revised its revenue guidance for fiscal year 2021. The company expects revenue of $1.085 billion for the first quarter, representing 26% year-over-year growth. Analysts, on average, estimate revenue of $945.23 million for the quarter. The company attributed the strength to record orders of $1.4 billion, sequencing consumables growth of about 25% and sequencing instrument growth of 120%. Illumina raised its 2021 revenue growth guidance from 17%-20% to 25%-28%, ahead of the consensus forecast of 21.6% growth. The stock was up 9.22% premarket at $420. Cara To Join S&P SmallCap 600 Index Standard & Poor's announced that Cara Therapeutics, Inc. (NASDAQ: CARA) will replace MTS Systems Corp. (NASDAQ: MTSC) in the S&P SmallCap 600 effective prior to the opening of trading on Thursday. This follows MTS Systems being acquired by Amphenol Corp. (NYSE: APH) The stock was up 12.05% premarket at $26.69. Turning Point's Drug Shows Promise In Treating RET-Altered Cancers In Phase 1/2 Study Turning Point Therapeutics, Inc. (NASDAQ: TPTX) announced initial data from the Phase 1/2 dose-finding study of TPX-0046, which showed clinical activity, including objective responses and a generally well-tolerated safety profile. TPX-0046 is being evaluated for RET-altered non-small cell lung cancer or medullary thyroid cancer. Tumor regression was seen in four of the five patients who were not previously treated with a targeted theory known as tyrosine kinase inhibitors, while in TKI-pretreated patients, tumor regression was seen in three of the nine participants. The company said it continues to evaluate doses and schedules to determine a recommended Phase 2 dose. It also plans to revise the study protocol to include Phase 1 expansion cohorts at the recommended Phase 2 dose. The stock shed 6.17% to $84.40 in after-hours trading. Novavax Commences Crossover Study In Ongoing COVID-19 Trials In UK, South Africa Novavax, Inc. (NASDAQ: NVAX) announced the initiation of crossover arms in two clinical trials of NVX-CoV2373, its COVID-19 vaccine candidate. For those participating in the ongoing trials who elect to receive an additional round of injections, an additional two-dose regimen of either vaccine for those who were put on placebo or placebo for those who were given the vaccine will be administered. This will ensure all trial participants receive active vaccine. While the crossover study has begun for the South African and U.K. trial, the company is planning a crossover in the ongoing PREVENT-19 Phase 3 study in the U.S. and Mexico. The company expects an initial readout from the PREVENT-19 trial in the second quarter. The company is also planning to expand the PREVENT-19 trial to include pediatric and adolescent arms, which are also expected to begin in the second quarter. The stock was up 0.71% premarket at $178.54. View more earnings on IBB Related Link: The Week Ahead In Biotech: Regeneron, Supernus FDA Decisions, Cancer Conference Presentations In The Spotlight Biodesix Announces 2 Patent Awards For Blood-Based Immunotherapy, Pipeline Testing Biodesix, Inc. (NASDAQ: BDSX) announced two patent awards by the U.S. Patent and Trademark Office that will enhance its ability to develop blood-based immunotherapy and pipeline testing strategies. Dynavax Says COVID-19 Vaccine Using Its Adjuvant Aces Phase 1/2 Study Dynavax Technologies Corporation (NASDAQ: DVAX) said the French biopharma Valneva reported positive initial results for Part A of the Phase 1/2 clinical trial of Valneva's inactivated COVID-19 vaccine candidate VLA2001 using Dynavax's CpG 1018 adjuvant in 153 healthy adults ages 18-55. Valneva plans to commence a pivotal Phase 3 clinical trial by the end of April 2021, subject to regulatory approval. The stock was up 2.74% to $10.11 in premarket trading Tuesday. Opiant Commences Head-To-Head Comparison Study To Evaluate Opioid Overdose Drug Opiant Pharmaceuticals, Inc. (NASDAQ: OPNT) said the first subjects were dosed in a head-to-head clinical study comparing the effectiveness of its investigational opioid antagonist OPNT003, nasal nalmefene, with nasal naloxone. The study in heathy volunteers will evaluate the effectiveness of 3mg nasal nalmefene in comparison to 4 mg nasal naloxone to reverse the respiratory depression produced by the synthetic opioid remifentanil. Top-line data from the trial is expected in the fourth quarter of 2021. The stock was up 0.89% premarket at $11.30. Nkarta Rises On Fund Buying Nkarta, Inc. (NASDAQ: NKTX) gained ground after a filing revealed that RA Capital Management, which is a 10% stake owner in the biopharma, bought 568,033 shares in the company priced at $32.90 each. In after-hours trading, the stock added 4.42% to $35. HTG Molecular Expects Q1 Revenue To Miss Consensus On COVID-19 Resurgence HTG Molecular Diagnostics, Inc. (NASDAQ: HTGM) said it expects its 2021 revenue to increase by 30%-40% year-over-year. The resurgence of COVID-19 has impacted first-quarter results, with the impact expected to continue at least through the first half of 2021, the company said. For the first quarter, the company expects revenue of about $1.4 million, below the $2.39-million consensus estimate. Cash, cash equivalents and short-tern marketable securities are expected at about $30.8 million as of March 31. The stock fell 7.21% to $5.28 in after-hours trading. Aptinyx Resumes Suspended Midstage Parkinson's Disease Study Aptinyx Inc. (NASDAQ: APTX) said patient screening has resumed in a Phase 2 study of NYX-458 in patients with mild cognitive impairment and mild dementia associated with Parkinson's disease and dementia with Lewy bodies. The study was temporarily suspended due to the escalation of the COVID-19 pandemic. The company expects data readout from the study in the second half of 2022. The stock was adding 6.52% to $3.43 in premarket trading Tuesday. Landos Receives Approval To Commence Clinical Study Of Omilancor In Esophageal Inflammation Landos said the FDA has cleared its investigational new drug application for omilancor in development for the treatment of eosinophilic esophagitis. The company expects to initiate patient dosing in the first half of 2022. Offerings Maravai LifeSciences Holdings, Inc. (NASDAQ: MRVI) announced the commencement of a public offering of its Class A common stock by certain selling stockholders. The selling stockholders are offering 15 million shares of the company's Class A common stock. The company said it will not receive any proceeds from the offering. The stock was down 1.62% premarket at $34.02. XOMA Corporation (NASDAQ: XOMA) said it has commenced an underwritten registered public offering of depositary shares, each representing 1/1000th fractional interest in a share of its Series B cumulative perpetual preferred stock. The company said it expects to use the net proceeds of this offering to fund the segregated dividend account and the remaining net proceeds for general corporate purposes, including funding future acquisitions of milestone and royalty rights associated with drug development programs with third-party funding. Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates See more from BenzingaClick here for options trades from BenzingaThe Week Ahead In Biotech: Regeneron, Supernus FDA Decisions, Cancer Conference Presentations In The SpotlightAttention Biotech Investors: Mark Your Calendar For April PDUFA Dates© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.