NASDAQ 100 % ()
FTSE 100 % ()
DOLLAR INDEX % ()
BTC/USD % ()
EUR/USD % ()
GBP/USD % ()
GOLD % ()
SILVER % ()
CRUDE OIL % ()

LLY

Eli Lilly and Company New York Stock Exchange
$207.5
Open: $203 High: $206.54 Low: $198.01 Close: $206.45
Range: 2021-01-21 - 2021-01-22
Volume: 13,537,042
Market: Closed
Powered by Finage Stock APIDelayed data
LLY
Eli Lilly and Company Lilly Corporate Center Indianapolis IN, 46285 http://www.lilly.com
Eli Lilly and Co is a pharmaceutical company with a focus on neuroscience, endocrinology, oncology, and immunology. It discovers, develops, manufactures, and sells human pharmaceutical products and animal health products.
  • CEO: David A. Ricks
  • Employees: 40,655
  • Sector: Healthcare
  • Industry: Drug Manufacturers
LLY News
Latest news about the LLY
  • 3 Blockbuster Drug Launches to Watch This Year

    The coronavirus pandemic has impacted lots of industries but it didn't slow down the pace of new drug approvals. The FDA greenlighted 59 new drugs last year, and 2021 is shaping up to be a big year too. Read on to see why new drugs from GlaxoSmithKline (NYSE: GSK), Gilead Sciences (NASDAQ: GILD), and Eli Lilly (NYSE: LLY) made the list.

    View More →
  • 3 Top Healthcare Stocks That Can Make You Richer in 2021 (and Beyond)

    Investing in stocks remains one of the best ways to do that. With that in mind, here are three excellent stocks that should make you richer over the long-run if you buy today: Bristol Myers Squibb (NYSE: BMY), Veeva Systems (NYSE: VEEV), and Eli Lilly (NYSE: LLY). Pharma giant Bristol Myers has a strong lineup of medicines, a rich pipeline, and a juicy dividend, all of which can help drive revenue and earnings higher while rewarding investors with dividend increases.

    View More →
  • The Week Ahead In Biotech (Jan 24-30): J&J, Lilly to Kickstart Big Pharma Earnings, Amgen FDA Decision and More

    Biopharma stocks advanced yet again in the week ended Jan. 22, with the change of guard at the White House generating broader market strength.Eli Lilly And Co (NYSE: LLY) was the standout biopharma stock of the week, as it set fresh 52-week highs in all four sessions of the truncated week, the catalysts being an oncology licensing deal with Merus NV (NASDAQ: MRUS), an analyst upgrade and a positive readout for its COVID-19 antibody treatment candidate.News flow on licensing deals and follow-on offerings abounded.The Food and Drug Administration approved two key drugs during the week -- Merck & Co., Inc.'s (NYSE: MRK) heart failure drug and a long-acting, injectable combo treatment option for HIV from ViiV Healthcare, a venture established by GlaxoSmithKline plc (NYSE: GSK) and Pfizer Inc. (NYSE: PFE).Aurinia Pharmaceuticals Inc's (NASDAQ: AUPH) voclosporin in combination with a background immunosuppressive therapy regimen was also approved by the agency to treat adult patients with active lupus nephritis.Here are the key catalysts for the unfolding week:Conferences: The International Association for the study of Lung Cancer, or IASLC, World Conference on Lung Cancer (virtual event): Jan. 28-31PDUFA Dates: The FDA is scheduled to rule on Amgen, Inc.'s (NASDAQ: AMGN) sBLA for Nplate, a protein that raises and sustains platelet counts, as a treatment option for hematopoietic subsyndrome of acute radiation syndrome. The decision is due Thursday, Jan. 28.Related Link: The Gilead, Galapagos Pipeline Opportunities That Are Turning Morgan Stanley Bullish Regulatory Filings: Axsome Therapeutics Inc (NASDAQ: AXSM) expects to file this month a new drug application for its AXS-05 treatment of mild depressive disorder.Clinical Readouts: Rhythm Pharmaceuticals Inc (NASDAQ: RYTM) is scheduled to host a virtual event on Tuesday, Jan. 26, from 8 a.m. to 10 a.m. to provide an update on its ongoing exploratory Phase 2 study and genetic sequencing efforts. The company will present data for setmelanotide in individuals living with heterozygous obesity due to genetic variants in one of two alleles of the POMC, PCSK1 or LEPR gene, as well as SRC1 and SH2B1 deficiency obesities. It will also provide an update on data from its sequencing efforts, which now includes samples from about 37,500 people with severe obesity.Zymeworks Inc (NYSE: ZYME) is due to present a clinical progress update for ZW49, which is being evaluated in a Phase 1 clinical trial as a treatment for patients with locally advanced or metastatic HER2-expressing cancers. The presentation is scheduled for Wednesday, Jan. 27, at 4:30 p.m.January Readouts Johnson & Johnson (NYSE: JNJ): interim results of a Phase 3 clinical trial of its experimental COVID-19 vaccine, JNJ-78436735GlaxoSmithKline plc (NYSE: GSK)/Vir Biotechnology Inc (NASDAQ: VIR): initial results from the Phase 3 trial of COVID-19 antibody treatment candidate VIR-7831IASLC World Conference on Lung Cancer Presentations View more earnings on IBBAmgen: Phase 2 data from the CodeBreaK 100 clinical study, evaluating investigational sotorasib in patients with KRAS G12C-mutated advanced non-small cell lung cancer, or NSCLC, (Friday, Jan. 2), and an oral presentation of updated Phase 1 data from AMG 757 in small cell lung cancerEarnings: Tuesday Johnson & Johnson (NYSE: JNJ) (before the market open) Varian Medical Systems, Inc. (NYSE: VAR) (after the close)Wednesday Abbott Laboratories (NYSE: ABT) (before the market open) Edwards Lifesciences Corp (NYSE: EW)(after the close) Hologic, Inc. (NASDAQ: HOLX) (after the close) Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (after the close)Thursday ABIOMED, Inc. (NASDAQ: ABMD) (before the market open) ResMed Inc. (NYSE: RMD) (after the close)Friday Lilly (before the market open)IPOs Raritan, New Jersey-based Ortho Clinical Diagnostics Holdings plc has filed to offer 70 million shares in an initial public offering, expected to be priced between $20 and $23. The pure-play in vitro diagnostics company has applied for listing the shares on the Nasdaq under the ticker symbol OCDX.Related Link: Pfizer-BioNTech Vaccine Found Effective Against New Coronavirus Strain In Lab Study See more from Benzinga * Click here for options trades from Benzinga * The Daily Biotech Pulse: Fluidigm's Saliva-Based COVID Test Approved In Europe, China Backs Amarin's Vascepa * The Daily Biotech Pulse: Addex Jumps On Positive Data For Out-Licensed Drug, COVID-19 Vaccine Developer Inovio Announces 0M Follow-On Offering, Boston Scientific Goes Shopping(C) 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

    View More →
  • Lilly's (LLY) Bamlanivimab Lowers COVID-19 Risk in Nursing Homes

    Eli Lilly's (LLY) COVID-19 antibody drug bamlanivimab (LY-CoV555) reduces risk of contracting symptomatic COVID-19 infection by 80% at nursing homes in the United States.

    View More →
  • Lilly Completes Acquisition of Prevail Therapeutics

    Eli Lilly and Company (NYSE:LLY) today announced the successful completion of its acquisition of Prevail Therapeutics Inc. (NASDAQ: PRVL). The acquisition establishes a new modality for drug discovery and development at Lilly, extending Lilly's research efforts through the creation of a gene therapy program that will be anchored by Prevail's portfolio of clinical-stage and preclinical neuroscience assets.

    View More →
  • Pharma Stock Roundup: FDA Nod to MRK, AZN, JNJ, GSK Drugs, LLY's New Antibody Deal

    Merck (MRK), Glaxo (GSK), AstraZeneca (AZN) and J&J (JNJ) announce FDA approvals.

    View More →
  • The Daily Biotech Pulse: Fluidigm's Saliva-Based COVID Test Approved In Europe, China Backs Amarin's Vascepa

    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 Jan. 21) * Acasti Pharma Inc (NASDAQ: ACST) * Alimera Sciences Inc(NASDAQ: ALIM) * argenx SE - ADR (NASDAQ: ARGX) * Axonics Modulation Technologies Inc (NASDAQ: AXNX) * AzurRx BioPharma Inc (NASDAQ: AZRX) * Chimerix Inc (NASDAQ: CMRX) * Edap Tms SA(NASDAQ: EDAP) * Eli Lilly And Co (NYSE: LLY) (announced positive results for its COVID-19 antibody treatment) * ESSA Pharma Inc (NASDAQ: EPIX) * Idera Pharmaceuticals Inc (NASDAQ: IDRA) * Inari Medical Inc (NASDAQ: NARI) * INmune Bio Inc (NASDAQ: INMB) (INSM) * Integra Lifesciences Holdings Corp (NASDAQ: IART) * Inventiva ADR Representing Ord Shs (NASDAQ: IVA) * Jounce Therapeutics Inc(NASDAQ: JNCE) * Krystal Biotech Inc(NASDAQ: KRYS) * Laboratory Corp. of America Holdings (NYSE: LH) * Merus NV (NASDAQ: MRUS) * Neuronetics Inc (NASDAQ: STIM) * OncoSec Medical Inc (NASDAQ: ONCS) (announced common stock offering) * PRA Health Sciences Inc (NASDAQ: PRAH) * Precision BioSciences Inc (NASDAQ: DTIL) * Profound Medical Corp(NASDAQ: PROF) * Renalytix AI PLC (NASDAQ: RNLX) * Rhythm Pharmaceuticals Inc(NASDAQ: RYTM) * Seelos Therapeutics Inc (NASDAQ: SEEL) * Surface Oncology Inc (NASDAQ: SURF) * Syneos Health Inc (NASDAQ: SYNH) * Synlogic Inc (NASDAQ: SYBX) * Twist Bioscience Corp (NASDAQ: TWST) * Vericel Corp (NASDAQ: VCEL) * Xencor Inc(NASDAQ: XNCR)Down In The Dumps None of the biotech/medical device/diagnostic stocks hit 52-week highs in the session.Stocks In Focus Fluidigm's Saliva-based COVID Diagnostic Test Gets CE Mark Certification Fluidigm Corporation (NASDAQ: FLDM) said it has received the CE-IVD mark for its Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus. The CE-IVD mark is in conformance with the European Union in ivitro diagnostic directive.The Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab, and the company's clinical studies for submission demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays.The stock rallied 26.62% to $7.80 in after-hours trading.Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA DatesExagen's Avise Testing For Autoimmune Disorders Offered By Tuft Medical Center Exagen Inc (NASDAQ: XGN) announced a partnership with Boston's Tufts Medical Center to offer its Avise testing as an in-network benefit for patients suffering from debilitating autoimmune diseases."Tufts Medical Center is recognized as one of the nation's leading centers for the treatment of arthritis and rheumatic disease. As one of Boston's premiere hospitals, the incorporation of AVISE testing will play an important part in enabling rheumatologists' ability to improve patient care through the differential diagnosis, prognosis, and monitoring of complex autoimmune diseases, including SLE," said Ron Rocca, CEO of Exagen.In after-hours trading, the stock was up 12.29% to $18.Amarin's Vascepa Recommended By China's Cardiology Society For Preventing Cardiovascular Disease Amarin Corporation plc (NASDAQ: AMRN) announced that the Chinese Society of Cardiology has included icosapent ethyl in its updated 'Guidelines for Primary Prevention of Cardiovascular Diseases for 2021' as published in the Chinese Journal of Cardiovascular Diseases.The guideline authors include icosapent ethyl 2 grams twice a day, as studied in Amarin's REDUCE-IT trial, as a treatment consideration to further lower atherosclerotic cardiovascular disease in the appropriate patient population.The stock rose 5.39% to $6.65 in after-hours trading.Viiv Healthcare's Long-acting, Injectable HIV Combo Therapy Approved by FDA ViiV healthcare, a venture established by GlaxoSmithKline plc (NYSE: GSK) and Pfizer Inc. (NYSE: PFE), said the FDA approved Cabenuva, the first long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines -- ViiV Healthcare's cabotegravir and Johnson & Johnson (NYSE: JNJ) unit Janssen's rilpivirine -- dosed once monthly.This is as an option to replace the current antiretroviral regimen in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.Immutep Falls On Licensing Partner GlaxoSmithKline Halting Mid-stage Ulcerative Colitis Study Immutep ADS Representing 10 Ord Shs (NASDAQ: IMMP) said its licensing partner GlaxoSmithKline has discontinued its Phase 2 clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody, GSK2831781, which is derived from Immutep's IMP731 antibody, in patients with active ulcerative colitis.The trial was stopped by GlaxoSmithKline based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial's Data Review Committee. The company is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.Under the terms of its ongoing collaboration agreement with GlaxoSmithKline, Immutep is eligible to receive up to a total of 54 million pounds ($74 million) in remaining developmental milestone payments as well as single-digit tiered royalties, if GSK2831781 is commercialized. Further milestone payments are subject to the continuation of the program, while GSK is responsible for all costs associated with the clinical development and commercialization of GSK2831781.BioCryst Gets Japanese Regulatory Nod For Hereditary Angioedema Treatment BioCryst Pharmaceuticals, Inc. (BCRX) said Japan's Ministry of Health, Labor and Welfare has granted marketing and manufacturing approval for oral, once-daily Orladeyo, 150 mg, for prophylactic treatment of hereditary angioedema in adults and pediatric patients 12 years and older.The stock was advancing 3.99% to $9.51 in premarket trading Friday.Offerings Precigen Inc (NASDAQ: PGEN) said it has commenced an underwritten public offering of shares of its common stock. In addition, Precigen intends to grant the underwriters a 30-day option to purchase additional shares of its common stock.In after-hours trading, the stock slid 9.19% to $8.30.On The Radar The FDA is scheduled to rule on Aurinia Pharmaceuticals Inc's (NASDAQ: AUPH) voclosporin as a treatment option for lupus nephritis.See more from Benzinga * Click here for options trades from Benzinga * The Daily Biotech Pulse: Addex Jumps On Positive Data For Out-Licensed Drug, COVID-19 Vaccine Developer Inovio Announces 0M Follow-On Offering, Boston Scientific Goes Shopping * The Daily Biotech Pulse: FDA Greenlights Merck's Heart Failure Drug, Histogen Hit With Clinical Hold, Aptorum Gets Nod For Commencing Human Study(C) 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

    View More →
  • Coronavirus update: Biden signs more COVID-19 orders; Pfizer wants to expand sales to states

    Biden takes more executive action on COVID-19 response. Pfizer looks to sell to states.

    View More →
  • Eli Lilly's Antibody Reduces COVID-19 Risk by 80% in Nursing Homes

    Results of a clinical trial suggest pre-emptive treatment with bamlanivimab can prevent COVID-19 from spreading through nursing homes.

    View More →
  • Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 per cent for residents

    TORONTO, Jan. 21, 2021 /CNW/ - Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, Eli Lilly and Company (NYSE: LLY) announced.

    View More →
  • Jim Cramer on Amazon, Eli Lilly, FuelCell, Vaccines, Stock Market Thursday

    In Thursday's market breakdown, Jim Cramer talks the vaccine rollout, airlines, Amazon, Eli Lilly, FuelCell and more.

    View More →
  • Eli Lilly Says Covid-19 Treatment Reduces Risk for Nursing Home Residents

    Eli Lilly says nursing home residents have an 80% lower risk of contracting Covid-19 compared with those who received a placebo.

    View More →
  • Eli Lilly Says Its Antibody Prevented Covid-19 in Nursing Home Residents

    People who received the drug, called bamlanivimab, had 80% lower odds of getting Covid-19 than people in the same facility who received a placebo.

    View More →
  • Lilly says antibody drug cuts COVID-19 risk for nursing home residents

    A trial of Eli Lilly and Co's antibody drug shows it can cut the risk of COVID-19 by 80% for nursing home residents, the company said on Thursday, although the need for such disease prevention tools has dwindled as vaccines become available. The drug, bamlanivimab, was given emergency use authorization (EUA) by the U.S. Food and Drug Administration last October at a dose of 700 mg for non-hospitalized COVID patients. The nursing home trial involved 965 participants - 299 residents and 666 staff - who tested negative for the coronavirus.

    View More →
  • Eli Lilly Stock Is Surging on Hope for Alzheimer’s Drug. Analyst Says It Won’t Last.

    The company has said it will provide detailed data on the treatment on March 13. The stock is up some 19% over the past week.

    View More →
  • Precision BioSciences' (DTIL) New Lymphoma Drug IND Gets FDA Nod

    The FDA accepts Precision BioSciences' (DTIL) regulatory application to initiate a clinical study on its next-generation CD19 product candidate, PBCAR19B.

    View More →
  • Lilly signs cancer drug deal worth up to $1.6 billion

    Shares of Eli Lilly & Co. gained 0.8% in premarket trading on Wednesday, the day after the drugmaker announced a deal worth up to $1.6 billion with Merus to develop three antibody therapies aimed at treating cancer. The Dutch company's stock was down 5.1% in premarket trading on Wednesday. The deal, which includes research and a licensing agreement, is designed to give Merus an upfront payment of $40 million, a $20 million equity investment, and up to $540 million in potential milestone payments. Over the last year, Lilly's stock has gained 42.2%, shares of Merus are up 45.5%, and the S&P 500 has rallied 14.5%.

    View More →
  • The Daily Biotech Pulse: FDA Greenlights Merck's Heart Failure Drug, Histogen Hit With Clinical Hold, Aptorum Gets Nod For Commencing Human Study

    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 Jan. 19) * 4D Molecular Therapeutics Inc (NASDAQ: FDMT) * ABIOMED, Inc. (NASDAQ: ABMD) * AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) * Aclaris Therapeutics Inc (NASDAQ: ACRS) ( reacted to a positive mid-stage readout) * Adaptive Biotechnologies Corp (NASDAQ: ADPT) * Akari Therapeutics PLC (NASDAQ: AKTX) * Aldeyra Therapeutics Inc (NASDAQ: ALDX) * Alkermes Plc (NASDAQ: ALKS) * Apyx Medical Corp (NASDAQ: APYX) * Arvinas Inc (NASDAQ: ARVN) * Beigene Ltd (NASDAQ: BGNE) * Bicycle Therapeutics PLC (NASDAQ: BCYC) * BIO-TECHNE Corp (NASDAQ: TECH) * BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) * Biodesix Inc (NASDAQ: BDSX) * BioNano Genomics Inc (NASDAQ: BNGO) * BioVie Inc (NASDAQ: BIVI) * Burning Rock Biotech Ltd (NASDAQ: BNR) * Cara Therapeutics Inc (NASDAQ: CARA) * CareDx Inc (NASDAQ: CDNA) * CASI Pharmaceuticals Inc (NASDAQ: CASI) * Cassava Sciences Inc (NASDAQ: SAVA) * Castle Biosciences Inc (NASDAQ: CSTL) * Cellectis SA (NASDAQ: CLLS) * Celsius Holdings, Inc. (NASDAQ: CELH) * Clearside Biomedical Inc (NASDAQ: CLSD) * Clearpoint Neuro Inc (NASDAQ: CLPT) * Corcept Therapeutics Incorporated (NASDAQ: CORT) * Curis, Inc. (NASDAQ: CRIS) * Dare Bioscience Inc (NASDAQ: DARE) * DiaMedica Therapeutics Inc (NASDAQ: DMAC) * Eli Lilly And Co (NYSE: LLY) (announced an oncology licensing deal and received a ratings upgrade from Mizuho) * ESSA Pharma Inc (NASDAQ: EPIX) * Eton Pharmaceuticals Inc (NASDAQ: ETON) * Evelo Biosciences Inc (NASDAQ: EVLO) * Evogene Ltd (NASDAQ: EVGN) * Fulgent Genetics Inc (NASDAQ: FLGT) * Genetron Holdings Ltd - ADR (NASDAQ: GTH) * Glaukos Corp (NYSE: GKOS) * Gritstone Oncology Inc (NASDAQ: GRTS) (announced plans to commence clinical study of COVID-19 vaccine candidate) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) (reacted to FDA approval for partner Janssen's drug to treat newly diagnosed light chain amyloidosis) * Harpoon Therapeutics Inc (NASDAQ: HARP) * Idera Pharmaceuticals Inc (NASDAQ: IDRA) * ImmunoGen, Inc. (NASDAQ: IMGN) * Inari Medical Inc (NASDAQ: NARI) * Infinity Pharmaceuticals Inc. (NASDAQ: INFI) * INmune Bio Inc (NASDAQ: INMB) * Insulet Corporation (NASDAQ: PODD) * Integra Lifesciences Holdings Corp (NASDAQ: IART) * Inventiva ADR Representing Ord Shs (NASDAQ: IVA) * iTeos Therapeutics Inc (NASDAQ: ITOS) * Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) * Johnson & Johnson (NYSE: JNJ) * Kaleido Biosciences Inc (NASDAQ: KLDO) * LeMaitre Vascular Inc (NASDAQ: LMAT) * Ligand Pharmaceuticals Inc. (NASDAQ: LGND) * Merus NV (NASDAQ: MRUS) (announced an oncology licensing deal with Lilly) * Natera Inc (NASDAQ: NTRA) * Neuronetics Inc (NASDAQ: STIM) * Orphazyme A S ADR N(ASDAQ: ORPH) * PRA Health Sciences Inc (NASDAQ: PRAH) * Precision BioSciences Inc (NASDAQ: DTIL) (announced FDA acceptance of IND for commencing blood cancer study) * Pulse Biosciences Inc (NASDAQ: PLSE) * Purple Biotech ADR (NASDAQ: PPBT) * Repligen Corporation (NASDAQ: RGEN) * Shockwave Medical Inc (NASDAQ: SWAV) * Stoke Therapeutics Inc (NASDAQ: STOK) * Supernus Pharmaceuticals Inc (NASDAQ: SUPN) * Surface Oncology Inc (NASDAQ: SURF) * Sutro Biopharma Inc (NASDAQ: STRO) * Syneos Health Inc (NASDAQ: SYNH) * Taysha Gene Therapies Inc (NASDAQ: TSHA) (announced receipt of pediatric disease and orphan drug designations for TSHA-105, an AAV9-based gene for SLC13A5-related epilepsy) * TFF Pharmaceuticals Inc (NASDAQ: TFFP) * Twist Bioscience Corp (NASDAQ: TWST) (announced signing of two licensing agreements) * United Therapeutics Corporation (NASDAQ: UTHR) * Vericel Corp (NASDAQ: VCEL) * Vistagen Therapeutics Inc (NASDAQ: VTGN) * Zai Lab Ltd - ADR (NASDAQ: ZLAB)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Jan. 19) * Gracell Biotechnologies Inc (NASDAQ: GRCL) (declined despite the Chinese regulatory nod for commencement of a blood cancer study) * Stocks In Focus Calliditas to Present Clinical Pipeline Update at R&D Day Calliditas Therapeutics Adr Rep 2 Ord Shs (NASDAQ: CALT) said it will reveal near-term clinical development plans for setanaxib in primary biliary cholangitis and oncology at the R&D day to be held Wednesday morning. The company said it plans to initiate a pivotal Phase 2/3 study in PBC in the second half of 2021 and a Phase 2 proof-of-concept study in head and neck cancer this year.The company said it will also present select data from the recently concluded Part A of the Phase 3 study NeflgArd with lead candidate drug Nefecon for the treatment of immunoglobin A nephropathy, showing a 9.5% rate of discontinuation of study treatment and 3.5% rate of discontinuation from the study. No adverse clinical effects were seen with regards to weight gain, blood pressure or HbA1c, reflecting a safety profile.FDA Imposes Clinical Hold On Histogen's Knee Cartilage Regeneration Therapy Study Histogen Inc (NASDAQ: HSTO) said the FDA has verbally notified the company it has additional questions about its investigational new drug application package for the planned Phase 1/2 clinical trial of HST-003, which is intended to evaluate the safety and efficacy of human extracellular matrix, implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure.Based upon the verbal communication with FDA, the company said the agency indicated that the clinical hold is due to pending chemical, manufacturing and control information that is required to complete their review.The stock fell 16.11% to 99 cents in after-hours trading.Aptorum Gets Clearance In Canada to Commence First-ever Clinical Study Aptorum Group Ltd (NASDAQ: APM) said its subsidiary has received clearance from the Health Canada regarding the clinical trial application to commence a Phase 1 study of ALS-4, an orally administered small molecule drug intended to treat infections caused by Staphylococcus aureus including MRSA."This milestone supports the transition of Aptorum Group to a clinical-stage company and reflects the potential of our scientific rigor and novel approach of our products," said Clark Cheng, chief medical officer, of the company.The stock was rallying 19.50% to $3.80 in premarket trading Wednesday.Related Link: The Week Ahead In Biotech: FDA To Issue Decisions On Merck And Aurinia Drug Applications Merck's Heart Failure Drug Approved by the FDA Merck & Co., Inc.'s (NYSE: MRK) said the FDA has approved Verquo, a soluble guanylate cyclase stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.Verquo, 2.5 mg, 5 mg, and 10 mg tablets, is being jointly developed with Bayer AG (OTC: BAYRY).Bristol-Myers Squibb's Regulatory Application Seeking Label Expansion For Opdivo Accepted For Priority Review Bristol-Myers Squibb Co (NYSE: BMY) said the FDA has accepted its supplemental Biologics License Application sBLA for Opdivo for the treatment of patients with resected esophageal or gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy. The FDA granted the application priority review and assigned a PDUFA goal date of May 20.Offerings Syros Pharmaceuticals Inc (NASDAQ: SYRS) said it has priced an underwritten public offering of 5.4 million shares of common stock at $14 per share, resulting in gross proceeds of about $75.6 million. The proceeds of the offering are expected to be used to fund the development of Syros' ongoing clinical and preclinical programs, and for working capital and other general corporate purposes. All shares are being offered by the company.The stock was down 4.68% to $14.25 in after-hours trading.Merus announced the launch of a proposed underwritten public offering of up to $60 million of its common shares. All of the common shares are being offered by the company.The stock fell 6.11% to $23.20 in after-hours trading.CytomX Therapeutics Inc (NASDAQ: CTMX) said it has commenced an underwritten public offering of $75 million shares of its common stock. All of the shares are to be offered by CytomX.In after-hours trading, the stock moved down 6.84% to $7.90.AcelRx Pharma announced an underwritten public offering of its common stock. All shares to be sold in the offering will be sold by AcelRx, subject to customary closing conditions.The stock lost 11.49% to $2.08 in after-hours trading.BioLineRx ADR Representing 15 Ord Shs (NASDAQ: BLRX) said it has increased the size of the previously announced offering of 12.5 million ADSs of the company at a price to the public of $2.40 per ADS. The offering is expected to fetch the company $30 million in gross proceeds.The stock slumped 17.67% to $2.61 in after-hours trading.BioNano announced that it plans to sell, subject to market and other conditions, shares of its common stock in an underwritten public offering.The stock plunged 10.83% to $8.15 in after-hours trading.Chimerix Inc (NASDAQ: CMRX) said it intends to sell, subject to market and other conditions, up to $75 million worth of shares of its common stock in an underwritten public offering.In after-hours trading, the stock slid 0.62% to $8.05.CareDxi said it intends to sell, subject to market and other conditions, up to $175 million of shares of its common stock in an underwritten public offering. All of the shares will be offered and sold by CareDx.The stock edged down 0.41% to $92.95 in after-hours trading.Passage Bio Inc (NASDAQ: PASG) said it has commenced an underwritten public offering of 7 million shares of its common stock. All shares of common stock to be sold in the offering will be sold by the company.The stock fell 1.89% to $28.50 in after-hours trading.Editas Medicine Inc (NASDAQ: EDIT) announced its intention to sell 3.5 million shares of its common stock in an underwritten public offering. All of the shares in the offering are to be sold by the company.In after-hours trading, the stock was down 0.83% to $71.51.On The Radar Clinical Readouts: Seres Therapeutics Inc (NASDAQ: MCRB) will present at the Keystone Symposium Harnessing the Microbiome for Disease Prevention and Therapy, new data from its SER-109 Phase 3 study in recurrent C. difficile infection.Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates See more from Benzinga * Click here for options trades from Benzinga * The Week Ahead In Biotech: FDA To Issue Decisions On Merck And Aurinia Drug Applications * The Daily Biotech Pulse: Alexion Pauses COVID-19 Study, NantKwest Readout, Organogenesis Jumps On Guidance, Trial Updates(C) 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

    View More →
  • Lilly (LLY) Inks Deal With Merus to Discover Cancer Antibodies

    Eli Lilly (LLY) signs a deal with Merus to develop novel T-cell re-directing bispecific antibodies. While Merus will lead early-stage development, Loxo Oncology will take care of further development and commercialization.

    View More →
  • Lilly Awash In Catalysts, Pipeline Updates, Mizuho Says In Upgrade

    Eli Lilly And Co (NYSE: LLY) received an upgrade from a Mizuho Securities analyst ahead of a key data readout in March.The Lilly Analyst: Vamil Divan upgraded Lilly shares from Neutral to Buy and increased the price target from $164 to $222.The Lilly Thesis: Lilly has navigated through a catalyst-heavy period and macroeconomic uncertainties that were mainly related to the U.S. presidential election, Divan said in a note.Added to that, the company impressed with the initial top-line data from its Alzheimer's antibody donanemab, which was released last week, the analyst said.Mizuho sees the potential for the drug to add significant upside to the Lilly story. Lilly has not only potentially found an effective drug, but also understood how to properly design its clinical trials to demonstrate that effect in the right patient population, Divan said. The fact that Lilly was able to generate statistically significant results on the primary endpoint in a relatively small trial bodes well for the absolute differences when the full data is released, as well as the clinical meaningfulness of those results, the analyst said.The full data is set to be released March 13 at the 2021 International Congress on Alzheimer's and Parkinson's Disease, he said.Related Link: The Week Ahead In Biotech: FDA To Issue Decisions On Merck And Aurinia Drug Applications The Lilly story is already robust with multiple recent positive developments in the areas of diabetes and oncology, Divan said.Additionally, there are a number of additional pipeline data releases this year, including pivotal data from lebrikizumab and mirikizumab and additional clinical data from tirzepatide and Jardiance, the analyst said.Since expectations from these data releases, especially lebrikizumab and mirikizumab, aren't too high, Divan sees the possibility for further upside.Lilly is also expected to release additional Phase 2 Alzheimer's data from its tau antibody zagotenemab, the analyst said.LLY Price Action: At last check, Lilly shares were rallying 3.99% to $198.43.Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates Latest Ratings for LLY DateFirmActionFromTo Jan 2021MizuhoUpgradesNeutralBuy Dec 2020Wolfe ResearchUpgradesPeer PerformOutperform Nov 2020MizuhoMaintainsNeutral View More Analyst Ratings for LLY View the Latest Analyst RatingsSee more from Benzinga * Click here for options trades from Benzinga * Why Aclaris, Tenax, Gritstone, Merus, Minerva And Celyad Are Rallying Today * The Daily Biotech Pulse: GSK, Vir To Start COVID-19 Antibody Study, Novartis In-Licenses BeiGene's Cancer Drug, Earnings Preannouncements Continue(C) 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

    View More →