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 ABT
- Acceleron Pharma Inc XLRN
- Arvinas Inc ARVN
- Chembio Diagnostics Inc CEMI
- ChemoCentryx Inc CCXI
- Eli Lilly And Co LLY (RBC Capital Markets upgraded the shares from Sector Perform to Outperform)
- Exelixis, Inc. EXEL (announced positive Phase 3 results for its kidney cancer combo drug)
- GenMark Diagnostics, Inc GNMK
- Incyte Corporation INCY (received FDA approval for its biliary tract cancer drug)
- Kala Pharmaceuticals Inc KALA
- Moderna Inc MRNA
- Novavax, Inc. NVAX
- Novo Nordisk A/S NVO
- OraSure Technologies, Inc. OSUR
- Regeneron Pharmaceuticals Inc REGN
- Repro-Med Systems, Inc. KRMD
- Seattle Genetics, Inc. SGEN (received FDA approval for its breast cancer drug ahead of the scheduled PDUFA date)
- Verastem Inc VSTM
- Vertex Pharmaceuticals Incorporated VRTX
- Zai Lab Ltd 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 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 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 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.
Cara Reports Positive Late-Stage Results For Korsuva In Itching Associated With Chronic Kidney Disease
Cara Therapeutics Inc 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 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 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 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 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 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 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
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
