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The Daily Biotech Pulse: Applied DNA Begins Validating COVID-19 Test, Cara's Positive Readout, Novan Explores Strategic Alternatives

The Daily Biotech Pulse: Applied DNA Begins Validating COVID-19 Test, Cara's Positive Readout, Novan Explores Strategic Alternatives

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs April 20)

  • Abbott Laboratories (NYSE: ABT)
  • Acceleron Pharma Inc (NASDAQ: XLRN)
  • Arvinas Inc (NASDAQ: ARVN)
  • Chembio Diagnostics Inc (NASDAQ: CEMI)
  • ChemoCentryx Inc (NASDAQ: CCXI)
  • Eli Lilly And Co (NYSE: LLY) (RBC Capital Markets upgraded the shares from Sector Perform to Outperform)
  • Exelixis, Inc. (NASDAQ: EXEL) (announced positive Phase 3 results for its kidney cancer combo drug)
  • GenMark Diagnostics, Inc (NASDAQ: GNMK)
  • Incyte Corporation (NASDAQ: INCY) (received FDA approval for its biliary tract cancer drug)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • Moderna Inc (NASDAQ: MRNA)
  • Novavax, Inc. (NASDAQ: NVAX)
  • Novo Nordisk A/S (NYSE: NVO)
  • OraSure Technologies, Inc. (NASDAQ: OSUR)
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN)
  • Repro-Med Systems, Inc. (NASDAQ: KRMD)
  • Seattle Genetics, Inc. (NASDAQ: SGEN) (received FDA approval for its breast cancer drug ahead of the scheduled PDUFA date)
  • Verastem Inc (NASDAQ: VSTM)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
  • Zai Lab Ltd (NASDAQ: ZLAB)

None of the NYSE- or Nasdaq-listed biotech/diagnostics stock hit 52-week lows Monday.

Stocks In Focus

Applied DNA COVID-19 Test Enters Validation Process, With Plans For EUA Application This Month

Applied DNA Sciences Inc (NASDAQ: APDN) said it has signed an agreement with the Stony Brook University Hospital to validate and implement its patent-pending nucleic acid diagnostic test to detect and quantify the presence of SARS-CoV-2 in diagnostic samples.

The company said the validation will start immediately, and the results of the validation will be used to support its Emergency Use Authorization application to be submitted to the FDA before the end of April.

The stock was rallying 22.47% to $6.65 in premarket trading Tuesday.

Vertex Announces Agreement For Coverage Of Its Cystic Fibrosis Drugs In Switzerland

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) said it has reached an agreement with the Swiss Federal Office of Public Health and the Swiss Federal Social Insurance Office for the reimbursement of Orkambi and Symdeko for eligible Swiss patients suffering from cystic fibrosis.

The company also said the agreement creates the possibility of rapid patient access for a future triple combo regimen once approved in Switzerland.

The stock was down 0.46% at $272 in Tuesday's premarket session. 

Lab Corp. COVID-19 Testing Kit Obtains EUA

Laboratory Corp. of America Holdings (NYSE: LH) said it has received an EUA from the FDA that permits nasal swab specimens to be collected at home using its Pixel COVID-19 test home collection kit, if recommended by a health care provider after completing a COVID-19 questionnaire.

The stock was rising 4.73% to $152.50 at the time of publication. 

See also: The Week Ahead In Biotech (April 19-25): Eli Lilly, Biogen Earnings On Tap, Sanofi Awaits FDA Decision

Cara Reports Positive Late-Stage Results For Korsuva In Itching Associated With Chronic Kidney Disease

Cara Therapeutics Inc (NASDAQ: CARA) and its licensing partner ViFor Fresenius Medical Care Renal Pharma announced positive top-line data from Cara's Phase 3 study of Korsuva injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus.

Cara also said the positive results put it on track to file an NDA with the FDA in the second half of 2020.

The stock was moving 13.7% higher to $16.85 in Tuesday's premarket session. 

VBL Awarded $900K Grant For Anti-Cancer Gene Therapy

Vascular Biogenics Ltd (NASDAQ: VBLT) said it has been awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels ($900,000) by the Israel Innovation Authority to support the continued development of its lead product candidate, VB-111, a first-in-class targeted anti-cancer gene-therapy agent, which is being evaluated in a Phase 3 study for platinum-resistant ovarian cancer.

Novartis Releases Positive Long-Term Data For Multiple Sclerosis Drug

Novartis AG (NYSE: NVS) announced publication of new data related to its multiple sclerosis drug Mayzent, which showed the data reinforces earlier findings that Mayzent slowed physical disability progression and provides cognitive benefits in people living with secondary progressive multiple sclerosis.

The data was from the five-year EXPAND open-label extension trial to assess the long-term efficacy and safety of Mayzent.

Mayzent was approved by the FDA in March 2019.

The stock was slipping 1.17% to $88.73 in premarket trading Tuesday.

Roche Announces FDA Nod For HPV Test To Detect Cervical Cancer

Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) announced FDA approval for the cobas HPV test for use on the fully automated, high-throughput cobas 6800/8800 Systems. The test identifies women at risk for cervical cancer by detecting the presence of high-risk HPV DNA in cervical samples.

Novan To Explore Strategic Alternatives

Novan Inc (NASDAQ: NOVN) said it has engaged H.C. Wainwright & Co to assist in exploring and evaluating a range of strategic and financial alternatives intended to maximize shareholder value.

The stock was moving down 3.73% to 39 cents in premarket trading Tuesday.

BeiGene's Label Expansion Filing For Cancer Drug Accepted For Regulatory Review In China

Beigene Ltd (NASDAQ: BGNE) said the Chinese Drug Regulatory Agency has accepted a sNDA for its anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens for first-line treatment of patients with advanced squamous non-small cell lung cancer.

Cerus Obtains $14M Incremental BARDA Funding For Developing Intercept Blood Systems

Cerus Corporation (NASDAQ: CERS) announced an amendment to its contract with the BARDA, which will provide an additional $14 million to fund the development of the INTERCEPT Blood System for red blood cells. This will increase the total potential value of the contract to $214 million.

The stock was rising 0.55% to $5.47 in premarket trading Tuesday.

Related Link: Moderna Gains More Than 40% This Week: What You Should Know


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