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

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 CODX
• Fate Therapeutics Inc FATE
• Gilead Sciences, Inc. GILD
• Inspire Medical Systems Inc INSP (reacted to fourth-quarter results)
• Mersana Therapeutics Inc MRSN
• Moderna Inc MRNA
• Nevro Corp NVRO (announced fourth-quarter results)
• Oyster Point Pharma Inc OYST
• Regeneron Pharmaceuticals Inc REGN
• Revolution Medicines Inc RVMD
• Vir Biotechnology Inc 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. ABMD
• Accelerate Diagnostics Inc AXDX
• AcelRx Pharmaceuticals Inc ACRX
• Acorda Therapeutics Inc ACOR
• AngioDynamics, Inc. ANGO
• ANCHIANO THERAP/S ADR ANCN
• Aptevo Therapeutics Inc APVO
• Auris Medical Holding Ltd EARS(announced publication of results of a study showing anti-epileptic and anti-convulsive activity of betahistine in a mouse model)
• Blueprint Medicines Corp BPMC
• Cumberland Pharmaceuticals, Inc. CPIX
• Curis, Inc. CRIS
• Enochian Biosciences Inc ENOB
• Galectin Therapeutics Inc. Common Stock GALT
• GenMark Diagnostics, Inc GNMK
• Genocea Biosciences Inc GNCA
• Heat Biologics Inc HTBX
• Jazz Pharmaceuticals PLC JAZZ (reacted to fourth-quarter results)
• Medigus Ltd. ADR MDGS
• Mediwound Ltd MDWD
• Meridian Bioscience, Inc. VIVO
• Merrimack Pharmaceuticals Inc MACK
• Misonix Inc MSON
• Myriad Genetics, Inc. MYGN
• Neuronetics Inc STIM
• NuCana PLC NCNA
• OncoSec Medical Inc ONCS
• Orthofix Medical Inc OFIX
• Pacific Biosciences of California PACB
• Portola Pharmaceuticals Inc PTLA
• Radius Health Inc RDUS
• REDHILL BIOPHAR/S ADR RDHL
• Sangamo Therapeutics Inc SGMO
• Stealth BioTherapeutics Corp MITO
• Stemline Therapeutics Inc STML
• Supernus Pharmaceuticals Inc SUPN (announced a failed late-stage trial of investigational drug to treat impulsive aggression in ADHD patients)
• TherapeuticsMD Inc TXMD
• Vanda Pharmaceuticals Inc. VNDA (reacted to fourth-quarter results)
• VIVUS, Inc. VVUS
• Xeris Pharmaceuticals Inc XERS
• Zogenix, Inc. 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 LLY sNDA for Cyramza injection for intravenous use, voted 6-5 that Cyramza in combination with Roche Holdings AG Basel's 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 ESPR announced FDA approval for its Nexlizet, bempedoic acid and Merck & Co., Inc.'s 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 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 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 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.

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

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