SNDX News

Shares of Syndax Pharmaceuticals soared to a record high Tuesday after the biotech company unveiled promising results for its early-stage blood cancer treatment in leukemia patients.

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, announced today that it will release its first quarter 2020 financial results on Thursday, May 7, after the close of the U.S. financial markets.

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today presents preclinical and initial clinical data for SNDX-5613, the Company's potent, highly selective oral menin inhibitor. The oral presentation will be featured during the New Drugs on the Horizon session at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I. The New Drugs on the Horizon session will take place today at 4:50 p.m. ET and features discussions of innovative small molecules and biologics that have recently entered Phase 1 clinical trials.

Syndax Pharmaceuticals stock tumbled to a month-low Friday after the biotech's breast cancer treatment failed in a Phase 3 test. Syndax says it won't be asking for FDA approval.

Shares of Kura Oncology (NASDAQ: KURA) -- a clinical-stage biopharmaceutical company that focuses on developing cancer treatments -- were up by 42.6% as of 1:49 p.m. EDT on Tuesday. The company did not report any news, but its stock is probably riding the wave of Syndax Pharmaceuticals (NASDAQ: SNDX), another clinical-stage drugmaker whose shares are up by more than 50% as a result of positive data from a phase 1 clinical trial. Syndax released data from a phase 1 clinical trial for SNDX-5613 on Monday, saying that the data provided "the first clinical evidence that disrupting the interaction between menin and MLL1 with our potent and selective inhibitor, SNDX-5613, can induce response in patients with genetically defined acute leukemias."

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, announced today that it plans to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Syndax also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold in the public offering. All of the shares in the proposed offering are to be sold by Syndax.

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, announced today the pricing of an underwritten public offering of 5,555,556 shares of its common stock at a price to the public of $18.00 per share. The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $100 million. The offering is expected to close on May 4, 2020, subject to customary closing conditions. Additionally, Syndax granted the underwriters a 30-day option to purchase up to 833,333 additional shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock in the offering will be sold by Syndax.

What happened This morning Syndax Pharmaceuticals (NASDAQ: SNDX) updated investors with initial data from a phase 1/2 trial evaluating its leukemia drug, and shares are soaring 55% at 12:05 pm EST on Tuesday.

Image source: The Motley Fool. Syndax Pharmaceuticals (NASDAQ: SNDX)Q1 2020 Earnings CallMay 07, 2020, 4:30 p.m. ETContents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: OperatorLadies and gentlemen, thank you for standing by, and welcome to the Syndax first quarter-2020 conference call.

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the first quarter ended March 31, 2020. In addition, the Company provided a clinical and business update.

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the closing of its previously announced underwritten public offering of 6,388,889 shares of its common stock at a price to the public of $18.00 per share. This includes the exercise in full by the underwriters of their option to purchase up to 833,333 additional shares of common stock. The aggregate gross proceeds to Syndax from this offering were approximately $115 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Syndax.

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 27) * AstraZeneca plc (NYSE: AZN) * Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) * Avadel Pharmaceuticals PLC (NASDAQ: AVDL) * BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) * Bio-Rad Laboratories, Inc. (NYSE: BIO) * BioSig Technologies Inc (NASDAQ: BSGM) * Black Diamond Therapeutics Inc (NASDAQ: BDTX) * Cytosorbents Corp (NASDAQ: CTSO) * DexCom, Inc. (NASDAQ: DXCM) * Erytech Pharma SA (NASDAQ: ERYP) * Exelixis, Inc. (NASDAQ: EXEL) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) * I-Mab ADR (NASDAQ: IMAB) * Imara Inc (NASDAQ: IMRA) * Incyte Corporation (NASDAQ: INCY) * Kala Pharmaceuticals Inc (NASDAQ: KALA) * Keros Therapeutics Inc (NASDAQ: KROS) * Masimo Corporation (NASDAQ: MASI) * Novo Nordisk A/S (NYSE: NVO) * OraSure Technologies, Inc. (NASDAQ: OSUR) * Quidel Corporation (NASDAQ: QDEL) * REDHILL BIOPHAR/S ADR (NASDAQ: RDHL) * Repligen Corporation (NASDAQ: RGEN) * Seattle Genetics, Inc. (NASDAQ: SGEN) * Translate Bio Inc (NASDAQ: TBIO) * Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) * Vaxart Inc (NASDAQ: VXRT) * Vermillion, Inc. (NASDAQ: VRML) * West Pharmaceutical Services Inc. (NYSE: WST) * Y-mAbs Therapeutics, Inc (NASDAQ: YMAB) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL) * Zynex Inc. (NASDAQ: ZYXI)None of the Nasdaq- or NYSE-listed biotech/medical device/diagnostics company hit 52-week lows Monday.Stocks In Focus Syndax Presents Positive Pre-clinical & Clinical Data For Blood Cancer Drug Syndax Pharmaceuticals Inc (NASDAQ: SNDX) presented positive preclinical and initial clinical data for SNDX-5613, its potent, highly selective oral menin inhibitor, with the data suggesting the investigational asset can induce response in patients with genetically-defined acute leukemias."Notably, clinical activity was achieved rapidly after a single, 28-day cycle, a highly encouraging sign in this population of patients who face a particularly poor prognosis with few effective treatment options," said Briggs Morrison, CEO of Syndax.The company said it will present additional findings from this trial in the fourth quarter.It also said SNDX-5613 was recently granted Orphan Drug Designation for the treatment of adult and pediatric acute myeloid leukemia.In after-hours trading, Syndax shares added 20.33% to $13.85.Moderna Files IND Application For Phase 2 Study of Coronavirus Vaccine Moderna Inc (NASDAQ: MRNA) said it has submitted an IND application to the FDA for its mRNA vaccine candidate mRNA-1273 against the novel coronavirus - SARS-CoV-2 - for evaluating it in a Phase and late-stage studies if supported by the Phase 1 study conducted by the National Institute of Allergy and Infectious Diseases.The company expects the study to begin in the second quarter.The stock gained 7.18% to $51.50 in after-hours trading.Related Link: A Deep Dive On Coronavirus Vaccine Plays Moderna, InovioRoche Reports Positive Results For Pivotal Study of its Spinal Muscular Dystrophy Treatment Roche Holdings AG's Basel (OTC: RHHBY) presented data from FIREFISH Part 2 - a pivotal global study that is evaluating its risdiplam in infants, ages 1-7 months, with symptomatic Type 1 spinal muscular atrophy, which showed the primary endpoint was met. The company noted that 29% of infants could sit without support for five seconds by month 12, as assessed by the Gross Motor Scale of Bayley Scales of Infant and Toddler Development Third Edition.View more earnings on PFEAdditionally, the company noted that 43.9% of infants were able to hold their head upright, 31.7% were able to roll to the side and 4.9% infants were able to stand with support.Risdiplam is an orally administered survival motor neuron-2 splicing modifier for SMA.Roche is leading the development of risdiplam and is working with the SMA Foundation and PTC Therapeutics, Inc. (NASDAQ: PTCT) on this.The regulatory application for the investigational asset was accepted with priority designation by the FDA, with an expected PDUFA date of Aug. 24.Separately, Roche also released new analyses of Phase 3 OPERA I and OPERA II studies as well as open-label extensions, of its Ocrevus, which showed the treatment reduced the risk of disease and disability progression in relapsing multiple sclerosis and primary progressive multiple sclerosis.Avadel to Offer $100M Worth of ADSs Avadel Pharmaceuticals PLC (NASDAQ: AVDL) said it commenced an underwritten public offering of $100 million shares, in the form of ADSs. All the ADSs are being offered by Avadel.The stock slipped 0.90% to $11.05 in after-hours trading.Earnings Novartis AG's (NYSE: NVS) first-quarter net sales from continuing operations rose 11% to $12.28 billion, EPS climbed 19% to 96 cents and core EPS increased 29% to $1.56, ahead of the $1.36 per share consensus estimate. The company expects 2020 sales to grow mid- to high-single digits and core operating income to increase in high-single to low-double digits.The stock added 0.90% to $90.40 in after-hours trading.On The Radar Clinical Readouts Iovance Biotherapeutics Inc (NASDAQ: IOVA) is scheduled to present at the American Association for Cancer Research, or AACR, 2020 Virtual Annual Meeting Phase 1 data for tumor-infiltrating lymphocytes in non-small cell lung cancer.Earnings Merck & Co., Inc. (NYSE: MRK) (Q1 Revenues of $12.1 billion, up 11%, and non-GAAP EPS $1.50 Vs. consensus of $11.46 billion and $1.34; lowered full-year guidance)Pfizer Inc. (NYSE: PFE) (Q1 Revenues of $12 billion, down 7%, and adjusted EPS of 80 cents Vs. consensus of $11.87 billion and 73 cents; reaffirmed 2020 guidance)See more from Benzinga * The Week Ahead In Biotech (April 26-May 2): Cancer Conference, Earnings News Flow In The Spotlight * BioNTech, Immunic Soar On COVID-19 Developmental Updates(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Q1 2020 Syndax Pharmaceuticals Inc Earnings Call

Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs April 28.) * AstraZeneca plc (NYSE: AZN) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) * Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO) * Black Diamond Therapeutics Inc (NASDAQ: BDTX) * Erytech Pharma SA (NASDAQ: ERYP) * GenMark Diagnostics, Inc (NASDAQ: GNMK) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) * I-Mab ADR (NASDAQ: IMAB) * Imara Inc (NASDAQ: IMRA) * Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA) (reacted to first-quarter results) * Novo Nordisk A/S (NYSE: NVO) * OraSure Technologies, Inc. (NASDAQ: OSUR) * Quest Diagnostics Inc (NYSE: DGX) (announced direct-to-consumer COVID-19 antibody test) * REDHILL BIOPHAR/S ADR (NASDAQ: RDHL) (announced addition of its Talicia, meant to treat H. pylori infection, to Prime Therapeutics NetResults A-Series National Formulary) * Syndax Pharmaceuticals Inc (NASDAQ: SNDX) (presented positive preclinical and initial clinical data for SNDX-5613 in treating genetically defined acute leukemias) * West Pharmaceutical Services Inc. (NYSE: WST) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL) * Zynex Inc. (NASDAQ: ZYXI)None of the Nasdaq- or NYSE-listed biotech/medical device/diagnostics company hit 52-week lows Tuesday.Stocks In Focus Erytech's Lead Drug Granted Fast Track Designation In Second-Line Pancreatic Cancer Erytech Pharma said the FDA has granted Fast Track designation for its lead product candidate eryaspace in treating second-line pancreatic cancer. The candidate is being evaluated in a late-stage study for the indication in 11 countries in Europe and the U.S.Separately, the company provided an update on the pivotal Phase 3 trial of eryaspace in combination with chemotherapy as a second-line therapy for advanced metastatic pancreatic cancer. The company said the third independent safety review has again confirmed the favorable safety profile and that the trial has surpassed 75% of the planned target enrollment.Due to the COVID-19 pandemic, the company said it now sees a limited delay of three to four months in completion of patient enrollment. The company said it now expects an interim superiority analysis around the end of the year and final results in the second half of 2021.The stock was trading 44.15% higher at $11.95 in Wednesday's premarket session. Inovio Announces Positive Interim Data From Midstage Trial Of MERS Coronavirus Vaccine Inovio Pharmaceuticals Inc (NASDAQ: INO) and GeneOne Life Science announced positive interim data from a Phase 1/2a trial of its DNA vaccine INO-4700 for MERS coronavirus. Through week 16, the vaccine recipients showed strong antibody and T cell immune responses after two or three doses with 0.6 mg of INO-4700, the company said.It added that the vaccination was also well-tolerated, with no vaccine-associated severe adverse events."As we have designed our COVID-19 vaccine INO-4800 using the same strategy as INO-4700, including the selection of full length Spike protein as the target and the use of intradermal CELLECTRA device, we are hopeful that the ongoing Phase 1 clinical trial with INO-4800 would generate similar clinical immune responses and safety data as we have just reported for INO-4700," CEO Dr. Joseph Kim said in a statement. Inovio shares were up 5.09% at $14.45 in Wednesday's premarket session.See also: The Week Ahead In Biotech (April 26-May 2): Cancer Conference, Earnings News Flow In The Spotlight Novartis' Cosentyx Approved In Europe For Spondyloarthritis Novartis AG (NYSE: NVS) said the European Commission has approved Cosentyx for the treatment of adult patients with active non-radiographic axial spondyloarthritis.In premarket trading Wednesday, the stock was down 1.16% at $87.02.Immunomedics Prices Common Stock Offering Immunomedics, Inc. (NASDAQ: IMMU) said it has priced an underwritten public offering of 14.74 million shares of its common stock at $28.50 per share to generate gross proceeds of $420 million. The company expects the offering to close on or about May 1.In premarket trading, Immunomedics shares were trading 5.3% higher at $30.60. Supernus to Buy WorldMed's CNS Portfolio For Up to $530M Supernus Pharmaceuticals Inc (NASDAQ: SUPN) announced a definitive agreement under which it will acquire the CNS portfolio of US WorldMeds, a privately held biopharmaceutical company, for an upfront payment of $300 million, plus cash milestone payments of up to $230 million.View more earnings on IBBThe proposed purchase will help strengthen the neurology portfolio by adding three marketed CNS products and a late-stage pipeline, Supernus said.In premarket trading Wednesday, the stock was gaining 2.67% to $20.01.Merck Gets FDA Nod For Higher Dosage Option For Keytruda In All Adult Indications Merck & Co., Inc. (NYSE: MRK) said the FDA has approved an additional recommended dosage of 400mg every six weeks for its anti-PD-1 therapy Keytruda across all adult indications, including monotherapy and combination therapy.This dosage is in addition to the current dose of 200mg every three weeks.FDA Clears Chimerix For Rolling NDA Submission For Antiviral Drug To Treat Smallpox Chimerix Inc (NASDAQ: CMRX) said it has received clearance from the FDA for a rolling submission of its NDA for brincidofovir as a medical countermeasure for smallpox. The company said it intends to begin the rolling NDA submission in May 2020, with completion targeted for mid-2020.Separately, the company also said it has initiated a Phase 2/3 study of dociparstat sodium in COVID-19 patients with acute lung injury.The stock was advancing 32.45% to $2 in premarket trading Wednesday.Pfizer, BioNTech Dose First Cohort of Participants In Phase 1/2 Coronavirus Vaccine Study Pfizer Inc. (NYSE: PFE) and BioNTech SE - ADR (NASDAQ: BNTX) said the first cohort consisting of 12 participants in the latter's Phase 1/2 clinical trial in Germany has been dosed. The companies said they plan to initiate trials for BNT162 in the U.S. upon regulatory approval, which is expected shortly. In premarket trading, Pfizer was rising 1.61% to $38.52 and BioNTech shares were advancing 6.85% to $48.97.reTORbio to Reverse Merge With Adicet resTORbio, Inc. (NASDAQ: TORC) announced a reverse merger with Adicet Bio, Inc., a privately held biopharma, with the focus on developing Adicet's off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications.Earnings AstraZeneca reported better-than-expected first-quarter results and maintained its full-year guidance.Masimo Corporation's (NASDAQ: MASI) first-quarter revenue climbed 16.4% to $269.6 million and non-GAAP net income came in at 97 cents per share, ahead of the 91-cent-per-share consensus estimate.The stock was trading 2.56% higher at $218 in Wednesday's premarket session.DexCom, Inc. (NASDAQ: DXCM) reported first-quarter revenue of $405.1 million, up 44.1%, and its non-GAAP net income per share increased from 5 cents to 44 cents. Analysts had estimated EPS of 14 cents per share.The company said it is suspending its 2020 guidance, citing the uncertainty associated with the COVID-19 pandemic.In premarket trading, the stock gained 7.57% to $337.27.On The Radar Earnings * Alkermes Plc (NASDAQ: ALKS) (before the market open) * Boston Scientific Corporation (NYSE: BSX) (before the market open) * United Therapeutics Corporation (NASDAQ: UTHR) (before the market open) * Laboratory Corp. of America Holdings (NYSE: LH) (before the market open) * Alimera Sciences Inc (NASDAQ: ALIM) (after the close) * AtriCure Inc. (NASDAQ: ATRC) (after the close) * BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after the close) * Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close) * SurModics, Inc. (NASDAQ: SRDX) (after the close) * Hologic, Inc. (NASDAQ: HOLX) (after the close)Related Link: A Deep Dive On Coronavirus Vaccine Plays Moderna, Inovio See more from Benzinga * The Daily Biotech Pulse: FDA Approves Sanofi's Meningococcal Vaccine, Pluristem Secures M In Funding For COVID-19 Treatment, Oric Pharma Prices IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced three presentations at the upcoming 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting being held April 27 - 28, 2020.

Anyone researching Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) might want to consider the historical volatility of the...

Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) today announced receipt of the final results of E2112, the Phase 3 clinical trial conducted by ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), that evaluated the investigational compound entinostat, Syndax's class I HDAC inhibitor, plus exemestane in patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer who have progressed on a non-steroidal aromatase inhibitor. The trial did not achieve the primary endpoint of demonstrating a statistically significant overall survival (OS) benefit over hormone therapy alone.

Syndax (SNDX) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Syndax (SNDX) delivered earnings and revenue surprises of -9.80% and -0.26%, respectively, for the quarter ended March 2020. Do the numbers hold clues to what lies ahead for the stock?

Q4 2019 Syndax Pharmaceuticals Inc Earnings Call