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The Daily Biotech Pulse: Gilead Kicks Off Coronavirus Drug Trials, Adcom Nod For Lily, FDA Approves Esperion's Lipid-Lowering Adjunctive Combo Therapy

Shanthi Rexaline

The following is a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Feb. 26.)

  • Co-Diagnostics Inc (NASDAQ: CODX)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • Gilead Sciences, Inc. (NASDAQ: GILD)
  • Inspire Medical Systems Inc (NYSE: INSP) (reacted to fourth-quarter results)
  • Mersana Therapeutics Inc (NASDAQ: MRSN)
  • Moderna Inc (NASDAQ: MRNA)
  • Nevro Corp (NYSE: NVRO) (announced fourth-quarter results)
  • Oyster Point Pharma Inc (NASDAQ: OYST)
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN)
  • Revolution Medicines Inc (NASDAQ: RVMD)
  • Vir Biotechnology Inc (NASDAQ: VIR) (announced a collaboration with WuXi Biologics for the development of antibodies to treat COVID-19)

Down In The Dumps

(Biotech stocks that hit 52-week lows Feb. 26.)

  • ABIOMED, Inc. (NASDAQ: ABMD)
  • Accelerate Diagnostics Inc (NASDAQ: AXDX)
  • AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)
  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • AngioDynamics, Inc. (NASDAQ: ANGO)
  • ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
  • Aptevo Therapeutics Inc (NASDAQ: APVO)
  • Auris Medical Holding Ltd (NASDAQ: EARS)(announced publication of results of a study showing anti-epileptic and anti-convulsive activity of betahistine in a mouse model)
  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX)
  • Curis, Inc. (NASDAQ: CRIS)
  • Enochian Biosciences Inc (NASDAQ: ENOB)
  • Galectin Therapeutics Inc. Common Stock (NASDAQ: GALT)
  • GenMark Diagnostics, Inc (NASDAQ: GNMK)
  • Genocea Biosciences Inc (NASDAQ: GNCA)
  • Heat Biologics Inc (NASDAQ: HTBX)
  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (reacted to fourth-quarter results)
  • Medigus Ltd. ADR (NASDAQ: MDGS)
  • Mediwound Ltd (NASDAQ: MDWD)
  • Meridian Bioscience, Inc. (NASDAQ: VIVO)
  • Merrimack Pharmaceuticals Inc (NASDAQ: MACK)
  • Misonix Inc (NASDAQ: MSON)
  • Myriad Genetics, Inc. (NASDAQ: MYGN)
  • Neuronetics Inc (NASDAQ: STIM)
  • NuCana PLC (NASDAQ: NCNA)
  • OncoSec Medical Inc (NASDAQ: ONCS)
  • Orthofix Medical Inc (NASDAQ: OFIX)
  • Pacific Biosciences of California (NASDAQ: PACB)
  • Portola Pharmaceuticals Inc (NASDAQ: PTLA)
  • Radius Health Inc (NASDAQ: RDUS)
  • REDHILL BIOPHAR/S ADR (NASDAQ: RDHL)
  • Sangamo Therapeutics Inc (NASDAQ: SGMO)
  • Stealth BioTherapeutics Corp (NASDAQ: MITO)
  • Stemline Therapeutics Inc (NASDAQ: STML)
  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN) (announced a failed late-stage trial of investigational drug to treat impulsive aggression in ADHD patients)
  • TherapeuticsMD Inc (NASDAQ: TXMD)
  • Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (reacted to fourth-quarter results)
  • VIVUS, Inc. (NASDAQ: VVUS)
  • Xeris Pharmaceuticals Inc (NASDAQ: XERS)
  • Zogenix, Inc. (NASDAQ: ZGNX)

See also: The Week Ahead In Biotech: Biopharma Earnings Pick Up Pace

Stocks In Focus Gilead Initiates 2 Late-Stage Studies Of Remdesivir For COVID-19

Gilead said it has initiated two Phase 3 studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19.

The multi-center studies will enroll 1,000 patients in medical centers, primarily across Asian countries, as well as other countries with high numbers of diagnosed cases, beginning in March, the company said.

The initiation of studies follows FDA rapidly reviewing and accepting Gilead's IND for remdesivir for the treatment of COVID-19.

Gilead shares were rising 6.81% to $79.79 in Thursday's premarket session. 

Adcom Rules In Favor of Eli Lilly's Drug For Treating Lung Cancer With Certain Mutation

FDA's Oncologic Drugs Advisory Committee, which reviewed Eli Lilly And Co's (NYSE: LLY) sNDA for Cyramza injection for intravenous use, voted 6-5 that Cyramza in combination with Roche Holdings AG Basel's (OTC: RHHBY) Tarceva showed a favorable benefit/risk profile for patients with untreated metastatic EGFR-positive non-small cell lung cancer.

Esperion Snags FDA Approval For Drug Combo As Adjunctive Cholesterol Therapy 

Esperion Therapeutics Inc (NASDAQ: ESPR) announced FDA approval for its Nexlizet, bempedoic acid and Merck & Co., Inc.'s (NYSE: MRK) Zetia, as an adjunctive to diet and maximally tolerated statin therapy for treating adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

The company said it expects to make Nexlizet commercially available for U.S. patients in July. Meanwhile, Nexletol, which was approved earlier this month, will be commercially available in the U.S. on March 30.

Y-mAbs Announces Positive Pre-BLA Meeting For Omburtamab

Y-mAbs Therapeutics, Inc (NASDAQ: YMAB) said it has completed a positive Type B pre-BLA meeting with the FDA regarding a potential pathway for FDA approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma.

The company said it reached alignment with the FDA on an Accelerated Approval Pathway along with a rolling BLA submission, with the rolling submission expected to be completed within about 10 weeks.

GlaxoSmithKline's European Regulatory Application For Ovarian Cancer Drug Accepted For Review

GlaxoSmithKline plc (NYSE: GSK) said the European Medicines Agency validated the company's Type II Variation for Zejula as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.

Earnings

Alimera Sciences Inc (NASDAQ: ALIM) said its fourth-quarter net revenues rose 15% year-over-year to $17.3 million. The company reversed to a profit of 8 cents per share from a loss of 27 cents per share. Analysts estimated a loss of 45 cents per share.

The stock gained 11.48% to $6.70 in after-hours trading.

View more earnings on IBB

Natera Inc's (NASDAQ: NTRA) fourth-quarter revenues climbed 24% to $67 million and the net loss per share narrowed from 51 cents to 46 cents. The loss was narrower than the consensus estimate of a loss of 55 cents per share. The company issued above-consensus revenue guidance for 2020.

The stock added 8.71% to $37.80 in after-hours trading.

Portola Pharmaceuticals said its fourth-quarter revenues were $29.2 million, up from $15.3 million last year. Andexxa/Ondexxya sales came in at $28.4 million. The net loss per share narrowed from $1.34 to $1.24.

The stock was down 10.54% at $11.20 in Thursday's premarket session.

Akorn, Inc. (NASDAQ: AKRX) reported fourth-quarter revenues of $162.3 million, up 5.8% year-over-year. The adjusted loss per share narrowed from 29 cents to 7 cents. Analysts expected a loss of 1 cent per share on revenues of $162.26 million.

The stock slipped 6.35% to $1.18 in after-hours trading.

Offerings

Oramed Pharmaceuticals, Inc. (NASDAQ: ORMP) said it intends to sell shares of its common stock in an underwritten public offering. All shares in the offering are to be sold by Oramed. It said it intends to use the net proceeds for its anticipated Phase 3 study of ORMD-0801, oral insulin, and for other clinical trials and R&D activities as well as for general corporate purposes.

The stock moved down 10.64% to $4.20 in after-hours trading.

On The Radar Earnings

  • Atara Biotherapeutics Inc (NASDAQ: ATRA) (before the market open)
  • ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP) (before the market open)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP) (before the market open)
  • Allogene Therapeutics Inc (NASDAQ: ALLO) (before the market open)
  • IVERIC bio Inc (NASDAQ: ISEE) (before the market open)
  • Concert Pharmaceuticals Inc (NASDAQ: CNCE) (before the market open)
  • Radius Health Inc (NASDAQ: RDUS) (before the market open)
  • SAGE Therapeutics Inc (NASDAQ: SAGE) (before the market open)
  • Intellia Therapeutics Inc (NASDAQ: NTLA) (before the market open)
  • Obalon Therapeutics Inc (NASDAQ: OBLN) (before the market open)
  • NeoGenomics, Inc. (NASDAQ: NEO) (before the market open)
  • Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) (before the market open)
  • Athenex Inc (NASDAQ: ATNX) (before the market open)
  • Aimmune Therapeutics Inc (NASDAQ: AIMT) (after the market close)
  • Acceleron Pharma Inc (NASDAQ: XLRN) (after the market close)
  • Coherus Biosciences Inc (NASDAQ: CHRS) (after the market close)
  • Cara Therapeutics Inc (NASDAQ: CARA) (after the market close)
  • Glaukos Corp (NYSE: GKOS) (after the market close)
  • CareDx Inc (NASDAQ: CDNA) (after the market close)
  • CytomX Therapeutics Inc (NASDAQ: CTMX) (after the market close)
  • Collegium Pharmaceutical Inc (NASDAQ: COLL) (after the market close)
  • Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) (after the market close)
  • Five Prime Therapeutics Inc (NASDAQ: FPRX) (after the market close)
  • Otonomy Inc (NASDAQ: OTIC) (after the market close)
  • Immunomedics, Inc. (NASDAQ: IMMU) (after the market close)
  • Zynex Inc. (NASDAQ: ZYXI) (after the market close)
  • Tricida Inc (NASDAQ: TCDA) (after the market close)
  • Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) (after the market close)
  • Myokardia Inc (NASDAQ: MYOK) (after the market close)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON) (after the market close)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the market close)
  • ICU Medical, Incorporated (NASDAQ: ICUI) (after the market close)
  • Mylan NV (NASDAQ: MYL) (after the market close)
  • Nektar Therapeutics (NASDAQ: NKTR) (after the market close)

Related Link: What Drove Merck's Keytruda Shortfall In Q4

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