Q2 2020 Applied DNA Sciences Inc Earnings Call

Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today it plans to release financial results for its fiscal 2020 second quarter ended March 31, 2020 after market close on Thursday, May 14, 2020. In conjunction with the release, the Company has scheduled a conference call at 4:30 p.m. Eastern Time that will also be broadcast live over the Internet.

Shares of Applied DNA Sciences Inc. [: apdn] soared 66.2% in premarket trading on Thursday after the company announced emergency use authorization from the Food and Drug Administration for its COVID-19 test. The machine that runs Applied's test can process 94 samples per hour and more than 2,000 tests per day, the company said. The FDA has issued emergency use authorizations to about 50 molecular tests that can detect COVID-19. Applied's stock is up 112.1% year-to-date, while the S&P 500 is down 12.7%.

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 See more from Benzinga * The Daily Biotech Pulse: Moderna Secures 3M In BARDA Funding, Gilead Remdesivir Data, Veracyte's Positive Pre-Announcement * The Daily Biotech Pulse: FDA Nod For UroGen, Novavax Coronavirus Vaccine To Enter Clinics, Soligenix Licenses Vaccine Adjuvant(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Applied DNA Sciences (APDN) is a tiny microcap healthcare stock with a 37-year history in business -- but no profits, and almost no (less than $5 million annual) revenues. Despite this somewhat mixed resume to recommend it, Applied DNA Sciences stock shot through the roof on Thursday, spiking 71% on news that the FDA has approved its new coronavirus detection test for emergency use.The test in question, a "patent-pending Linea COVID-19 RT-PCR test for COVID-19," is a "reverse transcription, Real Time Polymerase Chain Reaction" test to detect the presence of the SARS-CoV-2's "Spike (S) gene" in a person's bloodstream. It is designed to run on the FDA-approved Applied Biosystems QuantStudio Dx real-time PCR detection machine, "which allows for testing results for up to 94 samples within one hour, or more than 2,000 tests in 24 hours per device," explains Applied DNA Sciences.The Emergency Use Authorization (EUA) under which the test can be used is not equivalent to an actual FDA "approval" of the test. It does, however, permit the test to be used in the hope it will prove effective in diagnosing a "disease or condition" -- in this case the novel coronavirus SARS-CoV-2 -- during a public health emergency such as the present COVID-19 pandemic.Nor is this the only iron that Applied DNA Sciences has in the coronavirus fire.As Maxim analyst Anthony Vendetti explained, Applied DNA Sciences is also one of several biotech firms working on a vaccine to prevent infection with COVID-19. Specifically, on May 4, the company claimed success in generating antibodies to fight the SARS-CoV-19 coronavirus in response to a vaccine administered to mice in a preclinical trial.Applied DNA Sciences' vaccine focuses on the same spike gene that its test aims to detect, "a surface protein that plays a key role in viral entry into host cells," explains Vendetti. The analyst seems especially impressed with the fact that Applied DNA Sciences' vaccine, in contrast to others being worked on elsewhere, "is effective without insertion into the patient's genome" and "can be rapidly revised to accommodate mutational drift (in the virus)." This could indeed become important if the novel coronavirus mutates into even more novel forms over time.Additionally, Vendetti reminds investors that in April, Applied DNA Sciences was admitted to the FDA's "Emerging Technology Program (ETP) for the molecular tagging of Solid Oral Dosage Forms [which] serves to help promote the adoption of innovative approaches to pharmaceutical product design and manufacturing."Of these three coronavirus-related efforts on Applied DNA Sciences' part, Vendetti seems to place the most weight on the vaccine, albeit (a) it's not been admitted to any clinical trials yet and (b) the COVID-19 test news hadn't come out yet at the time the analyst made his recommendation to buy Applied DNA Sciences stock.Citing "outyear revenue estimates" (presumably 2022 and beyond) and best guesses at Applied DNA Sciences' "share of the COVID-19 vaccine market and share of revenue generated per vaccine," Vendetti thinks Applied DNA Sciences stock could be worth as much as $18 a share a year from now, and assigns the stock a "buy" rating.To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Applied DNA Sciences' coronavirus test kit is now cleared under the FDA's emergency-use authorization.

The latest analyst coverage could presage a bad day for Applied DNA Sciences, Inc. (NASDAQ:APDN), with the covering...

Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced consolidated financial results for the fiscal second quarter and the six months ended March 31, 2020.

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 May 13.) * AstraZeneca plc (NYSE: AZN) * AtriCure Inc. (NASDAQ: ATRC) * BioXcel Therapeutics Inc (NASDAQ: BTAI) * Catalent Inc (NYSE: CTLT) (announced a collaboration with Ennaid Therapeutics to develop an oral antiviral treatment targeted at COVID-19) * Co-Diagnostics Inc (NASDAQ: CODX) (reacted to disappointing sensitivity data reported by Abbott Laboratories (NYSE: ABT) for its rapid molecular testing for SARS-CoV-2) * CytomX Therapeutics Inc (NASDAQ: CTMX) * Forward Pharma A/S (NASDAQ: FWP) (announced extended timing for patent appeal) * Immunovant Inc (NASDAQ: IMVT) * Kala Pharmaceuticals Inc (NASDAQ: KALA) * Minerva Neurosciences Inc (NASDAQ: NERV) * Orgenesis Inc (NASDAQ: ORGS) (announced a cell-based vaccine platform targeting COVID-19 and other existing and emerging viral diseases) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN) * Translate Bio Inc (NASDAQ: TBIO) * Zai Lab Ltd (NASDAQ: ZLAB) (announced Chinese regulatory nod for its Optune in combination with temozolomide for the treatment of patients with newly diagnosed glioblastoma and Optune monotherapy for recurrent glioblastoma) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)Down In The Dumps (Biotech stocks that hit 52-week lows May 13.) * Genfit SA (NASDAQ: GNFT) * Recro Pharma Inc (NASDAQ: REPH) * Sensus Healthcare Inc (NASDAQ: SRTS) * Sonnet Biotherapeutics Holdings Inc (NASDAQ: SONN)Stocks In Focus ASCO Abstracts A slew of biotechs reacted to publication of online abstracts that are set to be presented at the 2020 American Society of Clinical Oncology Annual Virtual Meeting May 29-31.Updated safety and initial efficacy data for Arvinas Inc's (NASDAQ: ARVN) Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer showed two patients with ongoing confirmed prostate-specific antigen responses, including one with an unconfirmed partial tumor response.The stock was down 17.65% at $42 in Thursday's premarket session. Allogene Therapeutics Inc's (NASDAQ: ALLO) abstract consisted of first data from its Phase 1 dose escalation ALPHA study of CAR-T cell therapy ALLO-501 in relapsed/refractory non-Hodgkin lymphoma.Preliminary data on the first nine patients treated with escalating doses of ALLO-501 and a lower dose of ALLO-647 showed no dose limiting toxicities or graft-vs-host disease and a 78% overall response rate, with three complete responses and four partial responses.The stock was up 22.01% at $37.80 in the premarket session. ImmunoGen, Inc.'s (NASDAQ: IMGN) abstract consisted of initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin in patients with medium and high folate receptor alpha-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate.The company said the combination showed promising anti-tumor activity and favorable tolerability, with a confirmed overall response rate of more than 60%.The stock was trading 5.39% higher at $4.30 in the premarket session. MEI Pharma Inc (NASDAQ: MEIP) announced updated data from a Phase 1b study of ME-401 in clinical development for the treatment of B-cell malignancies that showed treatment was generally well-tolerated, with an 83% overall response rate in patients with relapsed or refractory follicular lymphoma.MEI shares were up 2.47% at $2.90 premarket Thursday.MacroGenics Inc (NASDAQ: MGNX) announced preliminary results from two of its studies.The Phase 1 dose escalation and expansion clinical trial of MGD013 -- in combination with margetuximab, its investigational Fc-engineered monoclonal antibody targeting HER-2 -- suggested a response in approximately 40% of late-stage HER-2-positive tumors that compares favorably to low response rates for HER-2-directed agents and checkpoint blockades.Separately, the company announced early results from an ongoing Phase 1 study of MGC018, an ADC directed against B7-H3, showing preliminary signals of anti-tumor effects, including prostate-specific antigen reductions of 50% or more in five of seven patients with late-stage prostate cancer.The stock slumped 19.81% to $21.25 in after-hours trading.See also: The Week Ahead In Biotech: Virtual Conference Presentations, Clovis PDUFA Date In The Spotlight CytomX announced further details of oral and poster presentations to be made at the month end's ASCO meeting.The stock was down 19.7% at $21.28 at the time of publication. Genocea Biosciences Inc (NASDAQ: GNCA) announced updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neo-antigen vaccine candidate, which showed that seven of the eight patients enrolled have continued without progression with a median follow-up of over one year.View more earnings on IBBThe stock was up 7.92% at $2.86 at the time of publication. Verona Pharma Receives Positive End-Of-Phase 2 Feedback From FDA VERONA PHARMA P/S' ADR (NASDAQ: VRNA) released details of the FDA's written response following the end-of-Phase 2 briefing package for nebulized ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease. The company said the response supported the continuation of its planned Phase 3 study. Verona expects to start the study in 2020.Verona shares were up 22.28% at $4.61 at the time of publication. Sanofi's Hemolysis Drug Accepted For Priority Review Sanofi SA (NASDAQ: SNY) said the FDA granted priority review of its BLA for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease, or CAD. Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. The PDUFA date has been set for Nov. 13.AIM ImmunoTech Gets FDA Nod For Starting Human Study of Combo Treatment In Cancer Patients With COVID-19 AIM ImmunoTech Inc (NYSE: AIM) said the FDA authorized the first human trial assessing the safety and effectiveness of its lead asset, Ampligen, in combination with interferon alfa-2b, in cancer patients with COVID-19.The stock was rallying by 36.17% to $3.20 in the premarket session. Illumima Marketing Chief To Depart Illumina, Inc.'s (NASDAQ: ILMN) global marketing head Omead Ostadan is leaving the company after more than a decade and is becoming president and COO of Seer Inc. effective June 29. Illumina shares were down 17.74% at $266.03 in the premarket session. Lilly, Innovent's Cancer Drug Aces Midphase Chinese Study In Esophageal Cancer Hong Kong biotech Innovent Biologics announced along with Eli Lilly And Co (NYSE: LLY) that the Phase 2 study of Tyvyt in China, dubbed ORIENT-2, met its primary endpoint of overall survival. The study evaluated Tyvyt monotherapy compared to chemotherapy as a second-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma.Biopharmx Shareholders Approve Reverse Merger With Timber Pharma Biopharmx Corp (NYSE: BPMX) announced that all proposals related to its proposed merger with Timber Pharmaceuticals were approved by stockholders at a special meeting held May 13. The company said it expects the deal to close on or about May 18,, contingent upon customary closing conditions and regulatory approvals.Upon closing of the transaction, the combined company will change its name to "Timber Pharmaceuticals, Inc." Its shares are expected to commence trading on the NYSE American market under the ticker symbol "TMBR."The stock was roaring higher by 40.46% to 66 cents in premarket trading Thursday. Applied DNA's COVID-19 Diagnostic Assay Kit Receives Emergency Use Authorization Applied DNA Sciences Inc (NASDAQ: APDN) said the FDA has issued Emergency Use Authorization, or EUA, for its Linea COVID-19 RT-PCR test to be performed in clinical labs in the U.S. certified under Clinical Laboratory Improvement Amendments to perform high complexity tests.Applied DNA shares were ripping 79.98% higher to $16 at the time of publication. Xeris Signs Distribution Deal Outside US For Low Blood Pressure Drug Xeris Pharmaceuticals Inc (NASDAQ: XERS) said it has signed an exclusive agreement with AIM-listed Clinigen Group to distribute its low blood pressure drug Gvoke outside of the U.S., where it is not currently licensed.Gvoke has not yet been approved in Europe.Immunic Gets Regulatory Nod For Phase 2 Study Of Coronavirus Drug Immunic Inc (NASDAQ: IMUX) said it has received the first regulatory approval from Germany's BfArM to initiate a Phase 2 study of its selective oral DHODH inhibitor, IMU-838, in COVID-19.The study is designed as a multicenter, randomized, placebo-controlled and double-blinded study, and it intends to study 230 patients with moderate COVID-19.The company said it expects to dose the first patient later this month and make top-line data from the study available later this year.In premarket trading Thursday, the stock was surging 19.84% to $12.20. Earnings RA Medical Systems Inc (NYSE: RMED) reported first-quarter revenue of $1.4 million, down from $1.7 million a year ago and lower than the $1.58-million consensus estimate.The loss widened from $1.16 per share to 56 cents per share, while analysts estimated a loss of 34 cents per share.The stock was declining 5.97% to 90 cents at the time of publication. Biocept Inc's (NASDAQ: BIOC) first-quarter revenue rose 41% year-over-year to $1.4 million. The loss per share narrowed from 61 cents to 11 cents.The stock was trading 4.83% higher to 46 cents in Thursday's premarket session. Offerings Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA) priced its 2.4-million-share common stock offering at $18.25 per share. The company expects to raise gross proceeds of $75 million from the offering. The offering would close May 18.The stock was down 1% at $18.80 at the time of publication. Axcella Health Inc (NASDAQ: AXLA) priced its underwritten public offering of 11 million shares of its common stock at $4.75 per share to raise gross proceeds of $52.3 million. The offering is expected to close May 18.Axcella shares were down 0.56% at $5.31 premarket Thursday. On The Radar * Earnings * Vascular Biogenics Ltd (NASDAQ: VBLT) (before the market open) * Kaleido Biosciences Inc (NASDAQ: KLDO) (before the market open) * Biomx Inc (NYSE: PHGE) (before the market open) * Soliton Inc (NASDAQ: SOLY) (before the market open) * ImmuCell Corporation (NASDAQ: ICCC) (before the market open) * Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open) * Transenterix Inc (NYSE: TRXC) (before the market open) * Adaptimmune Therapeutics PLC - ADR (NASDAQ: ADAP) (before the market open) * Aptinyx Inc (NASDAQ: APTX) (after the close) * Aytu Bioscience Inc (NASDAQ: AYTU) (after the close) * Applied DNA (after the close) * INmune Bio Inc (NASDAQ: INMB) (after the close) * Dare Bioscience Inc (NASDAQ: DARE) (after the close) * Navidea Biopharmaceuticals Inc (NYSE: NAVB) (after the close) * Thermogenesis Holdings Inc (NASDAQ: THMO) (after the close) * Eton Pharmaceuticals Inc (NASDAQ: ETON) (after the close) * Onconova Therapeutics Inc (NASDAQ: ONTX) (after the close) * TFF Pharmaceuticals Inc (NASDAQ: TFFP) (after the close) * Viveve Medical Inc (NASDAQ: VIVE) (after the close) * Salarius Pharmaceuticals Inc (NASDAQ: SLRX) (after the close) * Vermillion, Inc. (NASDAQ: VRML) (after the close) * Aptinyx Inc (NASDAQ: APTX) (after the close) * BioLife Solutions Inc (NASDAQ: BLFS) (after the close) * Co-Diagnostics (after the close) * Capricor Therapeutics Inc (NASDAQ: CAPR) (after the close) * Dyadic International, Inc. (NASDAQ: DYAI) (after the close) * Thermogenesis Holdings Inc (NASDAQ: THMO) (after the close) * TFF Pharmaceuticals Inc (NASDAQ: TFFP) (after the close)Clinical Readouts Caladrius Biosciences Inc (NASDAQ: CLBS) will present at the Society for Cardiovascular Angiography and Intervention Virtual Conference, Scientific Sessions full data from the ESCaPE-CMD study of CLBS16 for the treatment of coronary microvascular dysfunction.Constellation Pharmaceuticals Inc (NASDAQ: CNST) said abstracts of a presentation due at the June 11-14 European Hematology Association meeting will be made available. The abstract pertains to an interim update from the MANIFEST Phase 2 study that is evaluating CPI-0610 in myelofibrosis.Related Link: 5 Biopharmas Where BofA Would Put Its Money To Work See more from Benzinga * The Daily Biotech Pulse: Gilead Signs Manufacturing Deal For Remdesivir, Bristol-Myers Gets Refuse-To-File Letter * The Daily Biotech Pulse: NASH Disappointment For Genfit, Novavax Lands 4M CEPI Funding For Coronavirus Vaccine, GW Pharma Earnings(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company" or "we/our") today announced with its COVID-19 vaccine development partner Takis Biotech ("Takis") that the first injections of the DNA vaccine candidates against the Spike protein (product of the S gene) of the SARS-CoV-2 virus, cause of the COVID-19 disease, have produced neutralizing antibodies in test animals. The studies were completed at the renowned Lazzaro Spallanzani ("Spallanzani") National Institute for Infectious Diseases in Rome. These initial results were obtained using plasmids (the templates for LinearDNA™) to baseline results; Applied DNA’s linear DNA dose-response trials begin this week.

Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") today announced the signing of an Agreement with Stony Brook University Hospital (the "Hospital") to validate and implement the Company’s patent-pending nucleic acid diagnostic (LineaCOVID-19™) to detect and quantify in diagnostic samples the presence of SARS-CoV-2, the virus that causes the disease, COVID-19. Validation is expected to begin immediately with results to be used to support the Company’s application to the U.S. Food and Drug Administration (FDA) before the end of April 2020 for Emergency Use Authorization (EUA).

Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, has received approximately $5.3 million in net proceeds calendar year to date as a result of the exercise of equity warrants.

It is a pleasure to report that the Applied DNA Sciences, Inc. (NASDAQ:APDN) is up 337% in the last quarter. But will...

Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-Week Highs April 14) * Bio-Rad Laboratories, Inc. (NYSE: BIO) * Acceleron Pharma Inc (NASDAQ: XLRN) * Dr.Reddy's Laboratories Ltd (NYSE: RDY) * Kala Pharmaceuticals Inc (NASDAQ: KALA) * Keros Therapeutics Inc (NASDAQ: KROS) (IPOed April 8) * Masimo Corporation (NASDAQ: MASI) * MEI Pharma Inc (NASDAQ: MEIP)(announced a licensing agreement with Japan's Kyowa Kirin for developing its ME-401, which is being evaluated for B-cell malignancies) * Neoleukin Therapeutics Inc (NASDAQ: NLTX) * Neubase Therapeutics Inc (NASDAQ: NBSE) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN) * SUMMIT THERAPEU/S ADR (NASDAQ: SMMT)(announced appointment of controlling shareholder Robert Duggan as CEO)Down In The Dumps (Biotech Stocks Hitting 52-Week Lows April 14) * Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)(announced a 1-for-20 reverse stock split, effective close of trading Tuesday) * TherapeuticsMD Inc (NASDAQ: TXMD)See Also: Gilead Analysts Break Down Remdesivir Data Readout From Compassionate UseStocks In Focus Pfenex Says FDA Requests Additional Data For Establishing Bioequivalence Of Osteoporosis Drug To Forteo Pfenex Inc (NYSE: PFNX) said the FDA informed its commercialization partner Alvogen Malta Operations through a General Advice letter, additional comparative use human factors data, especially from Forteo experienced users, would be required before PF708 Therapeutic Equivalence could be determined.Forteo is Eli Lilly And Co's(NYSE: LLY) drug indicated to treat ostmenopausal women with osteoporosis at high risk for fracture."We intend to work closely with Alvogen and the FDA to expeditiously move toward a solution addressing the Agency's expressed views, so that we can submit additional data as soon as possible," said Eef Schimmelpennink, CEO of Pfenex.The company also said it will continue to support Alvogen with its commercial strategy planning in the U.S. while continuing to seek "A" therapeutic equivalence designation.Crinetics Announces 7.15M Common Stock Offering Crinetics Pharmaceuticals Inc (NASDAQ: CRNX) priced its underwritten public offering of 7.15 million shares at $14 per share. All the shares are being offered by the company. The company expects to raise gross proceeds of $100.1 million from the offering. The offering is expected to close on or about April 17.The company said it intends to use the net proceeds to fund the development of paltusotine and other R&D programs, and for working capital and general corporate purposes.Athersys Given Go Ahead To Initiate Midstage Study Of Stem Cell Therapy For Traumatic Injuries Athersys Inc (NASDAQ: ATHX) said the FDA has authorized an IND to initiate a Phase 2 study evaluating its MultiStem cell therapy for early treatment of traumatic injuries and the subsequent complications that result following severe trauma.Applied DNA Ships 5 Vaccine Constructs To Begin Animal Testing In Italy Applied DNA Sciences Inc (NASDAQ: APDN) said it has completed design, qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech to start preclinical testing immediately. The vaccine candidates, according to the company, were produced by its proprietary PCR-based Linear DNA manufacturing systems."Preliminary animal test results from the plasmid-based vaccine templates, from which Applied DNA's linear DNA-based vaccine constructs were manufactured at scale, were immunogenic and induced a strong production of antibodies across all five vaccine candidates," said Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech.In pre-market trading, shares were surging up 43.96% to $6.55.Merck Announces U.S. Launch Of Biosimilar For Roche's Popular Breast Cancer Drug Merck & Co., Inc. (NYSE: MRK) announced the U.S. launch of Ontruzant, a biosimilar of the reference biologic medicine Herceptin - Roche Holdings AG's (OTC: RHHBY) breast cancer drug.The company noted that the biosimilar will be available in both 150 mg single-dose vials, priced at WAC of $1,325, and 420mg multiple-dose vials, priced at $3,709. This represented a 15% discount to the current list price of Herceptin.Ontruzant is developed by Samsung Bioepis, with Merck assuming the responsibility of the commercialization of the biosimilar in the U.S.In pre-market trading, Merck shares were slipping 1.44% to $81.65.Mallinckrodt Announces Publication Of Positive Efficacy Data For Acthar Gel Mallinckrodt PLC (NYSE: MNK) announced the publication of findings from a Phase 4 study to assess the safety and efficacy of Acthar Gel in patients with persistently active rheumatoid arthritis, with Acthar Gel demonstrating the potential for effectiveness in achieving low disease activity as assessed by DAS28-ESR2 in patients with active RA despite current treatment with low-dose glucocorticoids and one or two DMARDs.The stock was gaining 1.53% to $3.99 in pre-market trading.Oragenics' Antibiotic Candidate Flunks Midstage Study In Treating Oral Mucositis Oragenics Inc (NYSE: OGEN) said early top-line results of the company's Phase 2 clinical trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients did not demonstrate statistical significance on the primary endpoint of severe oral mucositis duration when compared to placebo.The stock slumped 46.20% to 43 cents in premarket trading Wednesday.On The Radar Clinical Readouts Vir Biotechnology Inc (NASDAQ: VIR) will present at a Key Opinion leader call an update on its Phase 1/2 hepatitis B virus clinical trial with small interfering ribonucleic acid VIR-2218, Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY).See more from Benzinga * The Week Ahead In Biotech: Spotlight On Q1 Pre-Announcements As COVID-19 Continues To Disrupt Operations * The Daily Biotech Pulse: Milestone Pharma Flunks Late-Stage Study, CytomX Strikes Cancer Drug Collaboration, BARDA Grant For GenMark's COVID-19 Test * The Daily Biotech Pulse: Setback For DBV In Peanut Allergy Patch Review, Roche Starts Coronavirus Test Shipment, Regeneron Aims For 'Cocktail' COVID-19 Treatment(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

As you might know, Applied DNA Sciences, Inc. (NASDAQ:APDN) last week released its latest second-quarter, and things...

STONY BROOK, N.Y.--(BUSINESS WIRE)--Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) today announced that the Emerging Technology Team (ETT) of the U.S. Food and Drug Administration (FDA) has accepted the Company into its Emerging Technology Program (ETP) for the molecular tagging of Solid Oral Dosage Forms (SODF). The ETP serves to help promote the adoption of innovative approaches to pharmaceutical product design and manufacturing and offers technology companies and their pharmaceutical customers the opportunity to discuss, identify, and resolve potential technical and regulatory pathways early in the development and implementation of novel technology.

Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company," "our") announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the clinical use of the Company’s patent-pending Linea™ COVID-19 RT-PCR test for COVID-19. Clinical laboratories in the United States certified under Clinical Laboratory Improvement Amendments (CLIA) to perform hi complexity tests. CLIA labs can immediately begin ordering and using the Linea™ COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19.

Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced that it has completed design qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech ("Takis"), a developer of cancer vaccines and the Company’s COVID-19 vaccine development partner, to support preclinical animal testing that will begin immediately. The vaccine candidates were produced by the Company’s proprietary PCR-based LinearDNA™ manufacturing systems.

Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company," "our") today announced that it applied prior to the end of April for U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its Linea™ COVID-19 diagnostic candidate to detect SARS-CoV-2, the novel coronavirus that causes the disease COVID-19. Validation for the EUA was completed in collaboration with Stony Brook University Hospital; the company’s neighbor and collaborator on campus.

Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, announced that Dr. James Hayward, president & CEO, will participate on a panel titled ‘COVID-19 Testing and Monitoring’ at 12:15 p.m. ET on Wednesday, May 27, 2020 as part of Maxim Group’s COVID-19 Virtual Conference Series. The panel will be moderated by Jason McCarthy, Ph.D., Maxim Group Senior Managing Director, Biotechnology.