The Daily Biotech Pulse: Catabasis Halts Duchenne Muscular Dystrophy Study, Lilly's COVID-19 Trial Disappointment, Merck, Pfizer Earnings
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 Oct. 26) * Amicus Therapeutics, Inc. (NASDAQ: FOLD) * Beam Therapeutics Inc (NASDAQ: BEAM) * Blueprint Medicines Corp (NASDAQ: BPMC) * EXACT Sciences Corporation (NASDAQ: EXAS) * Kodiak Sciences Inc (NASDAQ: KOD) * Mirati Therapeutics Inc (NASDAQ: MRTX) (reacted to a positive clinical data readout) * Repligen Corporation (NASDAQ: RGEN) * Spruce Biosciences Inc (NASDAQ: SPRB)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Oct. 26) * Avenue Therapeutics Inc (NASDAQ: ATXI) * Baudax Bio Inc (NASDAQ: BXRX) * Biogen Inc (NASDAQ: BIIB) * DBV Technologies ADR Representing 0.5 Ord Shs (NASDAQ: DBVT) * Entasis Therapeutics Holdings Inc (NASDAQ: ETTX) * Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) * Gilead Sciences, Inc. (NASDAQ: GILD) * Jaguar Health Inc (NASDAQ: JAGX) * Kiromic Biopharma Inc (NASDAQ: KRBP) * Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) * Oncternal Therapeutics Inc (NASDAQ: ONCT) * Opiant Pharmaceuticals Inc (NASDAQ: OPNT) * Psychemedics Corp. (NASDAQ: PMD) * Recro Pharma Inc (NASDAQ: REPH) * Rockwell Medical Inc (NASDAQ: RMTI) * Teligent Inc (NEW JERSEY) (NASDAQ: TLGT) * Tricida Inc (NASDAQ: TCDA)Stocks In Focus Catabasis Ends Duchenne Muscular Dystrophy Trials After Failed Late-Stage Study Catabasis Pharmaceuticals Inc (NASDAQ: CATB) said the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy did not meet the primary endpoint, which was a change from baseline in the North Star Ambulatory Assessment over one year.The secondary endpoint of timed function tests such as time to stand; 10-meter walk/run; and four-stair climb also did not show statistically significant improvements, the company said.Consequently, the company said it is stopping activities related to the development of edasalonexent, including the ongoing GalaxyDMD open-label extension trial. Catabasis also said it plans to work with external advisors to explore and evaluate strategic options going forward.The stock was down 64.18% at $1.92 premarket Tuesday.Dexcom Pre-Announces Q3 Revenue, Announces Retirement Of Chief Commercial Officer DexCom, Inc. (NASDAQ: DXCM) preannounced third-quarter revenues of $500.9 million, representing 26% year-over-year growth. Analysts, on average, estimate revenues of $476.75 million.The company also announced that longtime executive Rick Doubleday, who is serving as chief commercial officer, will retire at the end of 2020.The stock was down 5.26% at $396 premarket. Lilly's Antibody Monotherapy Candidate Found Ineffective In Advanced COVID-19 Eli Lilly And Co's (NYSE: LLY) updated data from the NIAID-sponsored ACTIV-3 clinical trial evaluating the efficacy of its bamlanivimab in hospitalized COVID-19 patients suggests the antibody treatment candidate is unlikely to help them recover from this advanced stage of their disease, the company said in a statement. No additional COVID-19 patients in this hospitalized setting will receive bamlanivimab, Lilly said. All other studies are ongoing, including the NIH-sponsored ACTIV-2 trial testing bamlanivimab in recently diagnosed mild to moderate COVID-19 patients; the BLAZE-1 Phase 2 trial that is evaluating bamlanivimab monotherapy and in combination with etesevimab in recently-diagnosed COVID-19 patients in a non-hospitalized setting; and the BLAZE-2 Phase 3 trial that is evaluating bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities. View more earnings on IBBLilly shares were down 4.57% premarket at $135.23. Related Link: The Week Ahead In Biotech: Kala FDA Decision, Merck & Pfizer Earnings, Vaccine Updates And IPOs Novartis Q3 Beats Estimate, Company Raises FY20 Core Operating Income Guidance Novartis AG's (NYSE: NVS) third-quarter net sales from continuing operations rose 1% to $12.26 billion, and its core operating income climbed 9% due to lower spending and improved gross margin. Core EPS came in at $1.52, ahead of the $1.45 consensus estimate.The company raised its 2020 core operating income guidance from low double-digit growth to low double-digits-to-mid-teens percentage growth. The company expects net sales to grow by mid-single digits.Exelixis Says Japanese Partner Files For Label Expansion For Combo Drug To Treat Renal Cancer Exelixis, Inc. (NASDAQ: EXEL) said its Japanese partner Takeda Pharmaceutical Co Ltd (NYSE: TAK) and Ono Pharma have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare for manufacturing and marketing approval of Cabometyx in combination with Bristol-Myers Squibb Co's (NYSE: BMY) Opdivo for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma.NantKwest Appoints Veteran Health Care Exec Richard Adcock As CEO Nantkwest Inc (NASDAQ: NK) announced the appointment of Richard Adcock as its CEO effective immediately. Adcock will replace Patrick Soon-Shiong, who will become executive chairman of the board.The stock was up 0.89% at $9.11 premarket Tuesday.Aerpio Begins Midstage Study Of Razuprotafib In Moderate-To-Severe COVID-19 Patients Aerpio Pharmaceuticals Inc (NASDAQ: ARPO) said it has begun dosing of the first patient with razuprotafib in the military-sponsored Phase 2 trial targeting the prevention and treatment of acute respiratory distress syndrome in patients with moderate-to severe COVID-19.The stock was down 0.78% premarket at $1.27. FDA OKs Vanda To Initiate Midstage Allergic Conjunctivitis Study Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) said the FDA has approved an investigational new drug application to evaluate the cystic fibrosis transmembrane conductance regulator activator VSJ-110 for the treatment of allergic conjunctivitis.Vanda said it plans to initiate enrollment in the Phase 2 study by the end of 2020 and anticipates results of this study in 2021.The stock rose 2.59% to $10.70 in after-hours trading.Offerings Mirati, which announced positive early-stage results for its KRAS G12C inhibitor MRTX849 in non-small cell lung cancer, said it intends to offer $700 million in shares of common stock in an underwritten public offering, and a selling stockholder intends to offer 375,000 shares in the offering.The stock slid 2.89% to $191 in after-hours trading.On The Radar Clinical Readouts Galera Therapeutics Inc (NASDAQ: GRTX) is due to present at the ASTRO annual meeting data from its Phase 1b/2a clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy for locally advanced pancreatic cancer. The presentation is scheduled between 3 p.m. and 4:15 p.m.Earnings * Laboratory Corp. of America Holdings (NYSE: LH) (before the market open) * Merck & Co., Inc. (NYSE: MRK) (before the market open) * Pfizer Inc. (NYSE: PFE) (before the market open) * NeoGenomics, Inc. (NASDAQ: NEO) (before the market open) * Masimo Corporation (NASDAQ: MASI) (after the close) * DexCom (after the close) * Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) (after the close) * Omnicell, Inc. (NASDAQ: OMCL) (after the close) * Zynex Inc. (NASDAQ: ZYXI) (after the close)Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates See more from Benzinga * Click here for options trades from Benzinga * The Week Ahead In Biotech: Kala FDA Decision, Merck & Pfizer Earnings, Vaccine Updates And IPOs * The Daily Biotech Pulse: Gilead Gets Full Approval For Remdesivir, Akebia's Positive Readout, Foghorn IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga · 2020/10/27 13:24