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The Daily Biotech Pulse: Sorrento Submits EUA Application For Rapid Coronavirus Test, Decision Day For Viela, Lantern Pharma IPO

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Update time : 2020-11-03 13:55:52

Here's a roundup of sumit developments can the biotech universe above the final 24 hours:

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Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 10)

  • AbbVie Inc (NYSE: ABBV) - announced an oncology partnership with GENMAB A/S/S ADR (NASDAQ: GMAB)
  • Adverum Biotechnologies Inc (NASDAQ: ADVM)
  • CALLIDITAS THER/S ADR (NASDAQ: CALT) (went public June 5)
  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)
  • Cerus company (NASDAQ: CERS)
  • ChemoCentryx Inc (NASDAQ: CCXI)
  • Curis, Inc. (NASDAQ: CRIS) (announced FDA nod because commencing clinical studies of a remedy to medication firm tumors)
  • Dr.Reddy's Laboratories Ltd (NYSE: RDY)
  • Dyadic International, Inc. (NASDAQ: DYAI)
  • ITAMAR MED LTD/S ADR . (NASDAQ: ITMR)
  • Kiniksa Pharmaceuticals Ltd . (NASDAQ: KNSA)
  • Neoleukin Therapeutics Inc (NASDAQ: NLTX)
  • Novo Nordisk A/S (NYSE: NVO)
  • PassaGE Bio Inc (NASDAQ: PASG)
  • Sarepta Therapeutics Inc (NASDAQ: SRPT)
  • SpringWorks Therapeutics Inc (NASDAQ: SWTX)
  • Vermillion, Inc. (NASDAQ: VRML) (shares are put to attach the Russell 3000 Index)

Down can The Dumps

(Biotech Stocks Hitting 52-week Lows June 10)

  • Ayala Pharmaceuticals Inc (NASDAQ: AYLA)
  • Evofem Biosciences Inc (NASDAQ: EVFM)

Stocks can concentrate Sorrento Applies because EmerGEncy use Authorization because quick COVID-19 Diagnostic examination Kit

Sorrento Therapeutics Inc (NASDAQ: SRNE) said it has submitted to the FDA an application because EmerGEncy use Authorization because its COVI-TRACK can vitro diagnostic examination kit because the independent detection of IgG and IgM antibodies can sera of patients exposed to the SARS-CoV-2 virus.

The corporation said the examination allows results to exist available can 8 minutes or less.

The stock was jumping 10.35% to $5.01 in premarket trading Thursday.

Bristol-Myers' Opdivo Receives Another FDA Approval

Bristol-Myers Squibb Co (NYSE: BMY) announced FDA approval because its Opdivo because the treatment of patients with unresectable advanced, recurrent or metastatic esophaGEal squamous prison carcinoma back foregoing fluoropyrimidine- and platinum-based chemotherapy.

The stock was moving down 0.93% to $59.60 in premarket trading Thursday.

Grifols Starts product of Hyperimmune Immunoglobins because Clinical learn can COVID-19

Spanish biopharma Grifols SA - ADR ADR classification B (NASDAQ: GRFS) said it has started product of its anti-SARS-CoV-2 hyperimmune immunoglobulin with concrete antibodies using the plasma of nation who dine beat the disease. It is the first concrete remedy developed to battle COVID-19.

The company, which is separate of a collaboration practice with entities such because the FDA, NIH and BARDA to get latent anti-COVID-19 passive immune therapy, said the hyperimmune immunoglobins are being produced can its U.S. facility, and the first doses are expected to exist available can July 2020 because clinical trials.

See also: The Week Ahead can Biotech: Viela FDA Decision, Hematology conference confess middle StaGE

Amag Announces abrupt Departure Of CFO

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) said CFO and COO Edward Myles is leaving the company effective immediately. It named senior vice principal of finance Brian Piekos because interim CFO.

In premarket trading Thursday, the stock was climbing 10.91% to $9.

FDA Approves label Update For Novartis wet AGE-Related Macular DeGEneration Treatment

Novartis AG (NYSE: NVS) said the FDA approved a label update because its wet aGE-related macular deGEneration treatment Beovu to embrace additional safety information regarding retinal vasculitis and retinal vascular occlusion.

This approval follows the company's announcement that it used to hunt worldwide label updates back a periodical and farther characterization of occasional post-marketing safety events reported to Novartis.

View more revenue above IBB

The stock was down 0.66% can $87.42 premarket Thursday.

Clovis Completes Enrollment can Pivotal trial because Rubraca-Opdivo Combo

CLVS) announced the completion of tarGEt patient enrollment can the phase 3 ATHENA trial evaluating the mixture of Rubraca, and Bristol-Myers Squibb's Opdivo because front-line maintenance treatment of newly diagnosed advanced ovarian cancer." data-reactid="65">Clovis Oncology Inc (NASDAQ: CLVS) announced the completion of tarGEt patient enrollment can the phase 3 ATHENA trial evaluating the mixture of Rubraca, and Bristol-Myers Squibb's Opdivo because front-line maintenance treatment of newly diagnosed advanced ovarian cancer.

The corporation expects to free top-line information from the monotherapy arm can the second-half of 2021, with the results apt to back a latent BLA filing. The combo arm is apt to read out one year or more later.

In premarket trading Thursday, Clovis Oncology stock was down 3.36% can $6.90.

Zynex to attach S&P SmallCap 600 Index

Medical device maker Zynex Inc. (NASDAQ: ZYXI) said it will substitute KEMET Corp. (NYSE: KEM) can the S&P SmallCap 600 effective foregoing to the opening of trading Tuesday, June 16. KEMET has agreed to exist acquired by YaGEo Corp. can a business expected to exist completed above or about June 15, pending stand conditions.

In premarket trading Thursday, the stock was advancing 5.03% to $22.33.

Offerings

Mustang Bio Inc (NASDAQ: MBIO) said it is proposing to present shares of its mutual stock can an underwritten public offering. full the shares are being offered by the company. It said it intends to use the net proceeds mainly because the continued development of its product candidates, the latent in‐license, acquisition, development and commercialization of other pharmaceutical products and because GEneral corporate purposes.

The stock was down 23.91% can $3.50 premarket Thursday.

ChemoCentryx said it has priced an underwritten public offering of 5.2 million shares can $58 per piece because GEnerating sum proceeds of $301.6 million. The offering is expected to near above June 15.

Catalent Inc (NYSE: CTLT) said it has launched an underwritten public offering of $550 million of its mutual stock. The corporation said it intends to use the net proceeds mainly to wage off debt.

The stock was down 6.2% to $70 can premarket trading Thursday.

On The Radar PDUFA Dates

VIE) BLA because inebilizumab can treating neuromyelitis optica spectrum disorder, a occasional autoimmune disorder." data-reactid="82">The FDA is put to control above Viela Bio Inc's (NASDAQ: VIE) BLA because inebilizumab can treating neuromyelitis optica spectrum disorder, a occasional autoimmune disorder.

Earnings

Advaxis, Inc. (NASDAQ: ADXS) (before the impartial opens)

IPO

Dallas, Texas-based clinical-staGE biotech Lantern Pharma, which uses AI, machinery languaGE and GEnomic information to age drugs and identify patients who can amuse from tarGEted oncology therapies, priced its upsized initial public offering of 1.75 million shares of its mutual stock can $15 compared to the estimated salary ranGE of $15-$17. The shares of the corporation dine been approved because listing above the Nasdaq below the ticker sign "LTRN."

Related Link: Novavax Analyst Says DoD Funding Reflects belief can Platform, ability to deliver above Vaccine

See more from Benzinga

  • The daily Biotech Pulse: Soleno Flunks Late-StaGE Study, Sanofi Strikes breast Cancer Partnership, NanoViricides Shortlists Coronavirus Treatment Candidates

© 2020 Benzinga.com. Benzinga does no equip investment advice. full rights reserved.

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