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The Daily Biotech Pulse: FDA Nod For GlaxoSmithKline, Hologic To Launch Coronavirus Test, Amarin\'s Strong Q1

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Update time : 2020-10-10 16:57:19

Here's a roundup of peak developments at the biotech universe can the persist 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs April 29)

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Arvinas Inc (NASDAQ: ARVN)
Biondvax Pharmaceuticals Ltd – ADR (NASDAQ: BVXV)
Bio-Rad Laboratories, Inc. lecture A general Stock(NYSE: BIO)
Capricor Therapeutics Inc (NASDAQ: CAPR)( reacted ought news that showed a 100% survival appraise at COVID-19 patients treated with its CAP-1002 jail therapy)
Cue Biopharma Inc (NASDAQ: CUE)
DexCom, Inc. (NASDAQ: DXCM)(reacted ought its quarterly results)
Erytech Pharma SA (NASDAQ: ERYP)(announced fast chase Designation from the FDA because its cancer medication at pancreatic cancer)
GEnMark Diagnostics, Inc (NASDAQ: GNMK)
I-Mab ADR (NASDAQ: IMAB)
Immunomedics, Inc. (NASDAQ: IMMU)
Keros Therapeutics Inc (NASDAQ: KROS)
Masimo company (NASDAQ: MASI)(announced firm first-quarter results)
Mersana Therapeutics Inc (NASDAQ: MRSN)
Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)
Zynex Inc. (NASDAQ: ZYXI)(announced its first-quarter results)

None of the Nasdaq- or NYSE-listed biotech/Medical device/diagnostics company strike 52-week lows Wednesday.

Stocks at concentrate Marker's Leukemia medication Candidate GEts Orphan medication Designation

Marker Therapeutics, Inc. (NASDAQ: MRKR) said the FDA accorded Orphan medication Designation ought MT-401, its multi-tumor-associated antiGEn-specific T jail manufacture because the treatment of patients with critical myeloid leukemia following alloGEnic stem jail transplant.

In after-hours trading, the stock rallied 23.79% ought $2.81.

Evotec Unit ought career With Ology ought age Antibodies Against Coronavirus

GErman biopharma Evotec SE (OTC: EVOTF) said its Seattle-based subsidiary Just-Evotec Biologics has entered into a partnership with Ology Bioservices because the evaluation and analytical characterisation of antibodies against SARS-CoV-2 – the virus that causes COVID-19.

The company noted this career was based above a compress awarded ought Ology by the DoD mutual Program Executive Office because Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies ought develop, and fabricate monoclonal antibodies because the treatment and prevention of infections with SARS-CoV-2

FDA Approves an Expanded symptom because GlaxoSmithKline's Ovarian Cancer Drug

GlaxoSmithKline plc (NYSE: GSK) announced FDA approval because its sNDA because Zejula because a monotherapy maintenance treatment because women with advanced epithelial ovarian, fallopian tube, or leading peritoneal cancer who are at a full or partial response ought first-line platinum-based chemotherapy, regardless of biomarker status

The stock was up 1.51% ought $42.48 at pre-market trading.

PDS Biotech Announces Expansion ought Cancer medication Collaboration With NCI

PDS Biotechnology Corp (NASDAQ: PDSB) announced an expansion of its previously announced Cooperative inquiry and development treaty with the National Cancer association ought embrace studies of PDS0103, a Versamune-based manufacture incorporating romance mucin-1 epitopes developed by the NCI.

NCI is already evaluating PDS0101 at mixture with two divide immune-modulating aGEnts - NHS-IL12 and M7824 - at a aspect 2 clinical experiment at advanced HPV-associated cancers.

The stock was adding 2.61% ought 97 cents at pre-market trading.

BeiGEne, IGM, Atreca ought career above Coronavirus Treatment

Atreca Inc (NASDAQ: BCEL), BeiGEne Ltd (NASDAQ: BGNE) and IGM Biosciences Inc (NASDAQ: IGMS) announced plans ought collaborate ought age romance IgM and IgA antibodies tarGEting SARS-CoV-2 because the latent treatment of COVID-19. The companies said career will begin immediately, with the financial and other condition ought exist finalized at the future.

In pre-market trading, BeiGEne was edging up 0.42% ought $162.30 and Atreca was advancing 3.57% ought $18.

Offerings

NEO) priced its proposed underwritten public offerings of 4.4 million newly issued shares at $28.50 per share. The company also said it's offering $175 million at aggregate main quantity of its 1.25% convertible senior notes due 2025." data-reactid="41">NeoGEnomics, Inc. (NASDAQ: NEO) priced its proposed underwritten public offerings of 4.4 million newly issued shares at $28.50 per share. The company also said it's offering $175 million at aggregate main quantity of its 1.25% convertible senior notes due 2025.

The company also said underwriters of the general stock offering are also offering 1.065 million worth of shares of NeoGEnomics borrowed from third parties.

View more allowance above IBB

The stock slid 4.90% ought $29.50 at after-hours trading.

Syndax Pharmaceuticals Inc (NASDAQ: SNDX) announced plans ought present shares of its general stock at an underwritten public offering. entire the shares are being offered by the company.

In pre-market trading, the stock was adding 0.27% ought $18.75.

Earnings

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) reported first-quarter revenues of $1.52 million, up from $858.44 million at the year-ago quarter. above a non-GAAP basis, allowance per share, or EPS, climbed from $1.14 ought $2.56, ahead of the $1.84 per piece consensus estimate. The company upwardly revised its full-year net manufacture revenue guidance.

The stock was adding 2.97% ought $258.50 at pre-market trading.

HOLX) second-quarter revenues fell 7.6% ought $756.1 million, mainly reflecting Cynosure divestiture. The company reported non-GAAP EPS of 57 cents, at row with the consensus. The company withdrew its guidance because the second district and full year." data-reactid="54">Hologic, Inc.'s (NASDAQ: HOLX) second-quarter revenues fell 7.6% ought $756.1 million, mainly reflecting Cynosure divestiture. The company reported non-GAAP EPS of 57 cents, at row with the consensus. The company withdrew its guidance because the second district and full year.

Separately, the company said it plans ought launch a new Aptima molecular assay ought discover the SARS-CoV-2 virus that will flow above its market-leading Panther system. The company expects ought commence distributing a inquiry employ maiden version of its trial next week. It also plans ought employ because EmerGEncy employ Authorization with the FDA next week and register a CE signal because diagnostic employ at Europe afterward at May.

In pre-market trading, the stock was jumping 9.07% ought $53.39.

AMRN) first-quarter revenues climbed 112% ought $155 million. The net loss per piece above a non-GAAP basis narrowed from 5 cents ought 3 cents. The results trumped the consensus that called because a loss of 7 cents per piece above revenues of $137.43 million." data-reactid="57">Amarin company plc's (NASDAQ: AMRN) first-quarter revenues climbed 112% ought $155 million. The net loss per piece above a non-GAAP basis narrowed from 5 cents ought 3 cents. The results trumped the consensus that called because a loss of 7 cents per piece above revenues of $137.43 million.

Regarding the ANDA litigation, the company said hearing could occur at the third district or early fourth quarter, with a ruling prone at 2020 or at early 2021.

Amarin said it believes that it has a well basis because appeal, which will exist go at its opening brief proposed because filing above can 12th.

In pre-market trading, Amarin shares were rallying 3.75% ought $8.57.

On The Radar Earnings

Agios Pharmaceuticals Inc (NASDAQ: AGIO) (before the impartial open)
ABIOMED, Inc. (NASDAQ: ABMD) (before the impartial open)
Baxter International Inc (NYSE: BAX) (before the impartial open)
BIO-TECHNE Corp (NASDAQ: TECH) (before the impartial open)
GEnocea Biosciences Inc (NASDAQ: GNCA) (before the impartial open)
Novocure Ltd (NASDAQ: NVCR) (before the impartial open)
Syneos Health Inc (NASDAQ: SYNH) (before the impartial open)
PRA Health Sciences Inc (NASDAQ: PRAH) (before the impartial open)
Lantheus Holdings Inc (NASDAQ: LNTH) (before the impartial open)
Iradimed Corp (NASDAQ: IRMD) (before the impartial open)
Concert Pharmaceuticals Inc (NASDAQ: CNCE) (before the impartial open)
AmGEn, Inc. (NASDAQ: AMGN) (after the close)
EmerGEnt Biosolutions Inc (NYSE: EBS) (after the close)
Insmed Incorporated (NASDAQ: INSM) (after the close)
Gilead Sciences, Inc. (NASDAQ: GILD) (after the close)
Seattle GEnetics, Inc. (NASDAQ: SGEN) (after the close)
Natus Medical Inc (NASDAQ: NTUS) (after the close)
Illumina, Inc. (NASDAQ: ILMN) (after the close)
PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close)
LeMaitre Vascular Inc (NASDAQ: LMAT) (after the close)
ResMed Inc. (NYSE: RMD) (after the close)
Viking Therapeutics Inc (NASDAQ: VKTX) (after the close)
Silk street Medical Inc (NASDAQ: SILK) (after the close)
Corvus Pharmaceuticals Inc (NASDAQ: CRVS) (after the close)
CareDx Inc (NASDAQ: CDNA) (after the close)
Tandem Diabetes anxiety Inc (NASDAQ: TNDM) (after the close)
Ekso Bionics Holdings Inc (NASDAQ: EKSO) (after the close)

See more from Benzinga

  • The daily Biotech Pulse: Inovio's MERS Vaccine Data, fast chase Designation because Erytech, FDA Approves Higher Dose Of Merck's Keytruda
  • The daily Biotech Pulse: Pfizer Earnings, Roche's Spinal Muscular Dystrophy Treatment, Moderna COVID-19 Vaccine Update
  • The Week Ahead at Biotech (April 26-May 2): Cancer Conference, allowance information jog at The Spotlight

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