Novan, Inc. (“the Company” or “Novan”) (NOVN) today announced that the Company has conducted its Type C meeting with the U.S. Food and Drug Administration (“FDA”) regarding SB206 for the treatment of molluscum. The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application (“NDA”).

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Top-line efficacy results from the B-SIMPLE program were announced in January 2020 with additional efficacy and safety analyses through Week 12 announced in February 2020. The B-SIMPLE program consisted of two multi-center, randomized, double-blind, vehicle-controlled pivotal trials (“B-SIMPLE1” and “B-SIMPLE2”) in 707 patients aged 6 months and older, with a 2:1 (active:vehicle) randomization.

There's a growing consensus that the Triangle is not only strapped for the venture capital needed to make innovative ideas coming out of local universities work, but it is also severely lacking in the kind of corporate leadership needed to guide innovation to successful commercial companies.

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 1.) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) * AstraZeneca plc (NYSE: AZN) (announced an agreement with the University of Oxford for the development of the latter's potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2) * BIO-TECHNE Corp (NASDAQ: TECH) (reacted to its quarterly results) * Biondvax Pharmaceuticals Ltd - ADR (NASDAQ: BVXV) * Bio-Rad Laboratories, Inc. Class A Common Stock(NYSE: BIO) * Catalent Inc (NYSE: CTLT) * ChemoCentryx Inc (NASDAQ: CCXI) * DexCom, Inc. (NASDAQ: DXCM) * Imara Inc (NASDAQ: IMRA) * Replimune Group Inc (NASDAQ: REPL)Down In The Dumps (Biotech stocks that hit 52-week lows May 1.) * Sonnet Biotherapeutics Holdings Inc (NASDAQ: SONN) * Vaccinex Inc (NASDAQ: VCNX)Stocks In Focus Bio-Rad's Serology Test Gets EUA From FDA For Novel Coronavirus Test Bio-Rad said the FDA granted Emergency Use Authorization for its SARS-CoV-2 Total Ab test, making it the first total antibody test to receive EUA from the FDA. The blood-based immunoassay test can help clinicians identify if an individual has developed antibodies against SARS-CoV-2. The test has also met the CE mark requirements for Europe.Moderna, Swiss CDMO Lonza Announce COVID-19 Vaccine Manufacturing Deal Moderna Inc (NASDAQ: MRNA) announced a 10-year strategic collaboration agreement with a Swiss contract development and manufacturing organization to manufacture the former's novel coronavirus vaccine mRNA-1273 on a larger scale, as well as additional products in the future.Under the agreement, manufacturing suites will be established at Lonza's facilities in the U.S. and Switzerland to manufacture mRNA-1273. The companies look ahead to the manufacture of the first batches of the vaccine candidate at Lonza U.S. in July.Co-Diagnostics' COVID-19 Molecular Diagnostics Test Shows 100% Sensitivity, Specificity Co-Diagnostics Inc (NASDAQ: CODX) said COVID-19 test performance data from independent evaluations, including from the India National Institute of Pathology, the Mexican Department of Epidemiology and the others from the U.S. and overseas, demonstrated 100% sensitivity and 100% specificity -- metrics used to define accuracy in molecular diagnostics testing.The stock was up 10.23% at $12.50 in Friday's premarket session.See also: The Week Ahead In Biotech (April 26-May 2): Cancer Conference, Earnings News Flow In The Spotlight Essa Pharma Given Approval To Start Clinical Trial Of Cancer Drug ESSA Pharma Inc (NASDAQ: EPIX) said the FDA has notified the company that its investigational asset EPI-7386 can enter the clinics for the treatment of metastatic castration-resistant prostate cancer. The company had submitted an IND with the FDA March 30.J&J's Janssen Unit Gets Positive EMA Committee Recommendation For Darzalex Subcutaneous Formulation Halozyme Therapeutics, Inc. (NASDAQ: HALO) said Johnson & Johnson's (NYSE: JNJ) Janssen unit has received positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency that recommends approval of a subcutaneous formulation of Darzalex for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings.The subcutaneous formulation uses Halozyme's proprietary enzyme rHuPH20 to facilitate the delivery of injected drugs and fluids.Puma Strikes Commercialization Agreement For Breast Cancer Drug In South Korea Puma Biotechnology Inc (NASDAQ: PBYI) and South Korea's Bixink Therapeutics announced an agreement under which the latter will commercialize the former's breast cancer drug Nerlynx in South Korea.The agreement provides for Puma receiving upfront and milestone payments of up to $6 million, as well as significant double-digit royalties on the sales of NERLYNX in South Korea.Puma shares were adding 2.49% to $10.30 in premarket trading Friday.Novan Receives FDA Meeting Minutes For Skin Infection Drug Novan Inc (NASDAQ: NOVN) announced receipt of April 1 Type C meeting minutes from the FDA regarding SB206 for the treatment of molluscum contagiosum. Based on the guidance received during the meeting and contained in the meeting minutes, the company said it is preparing to conduct an additional pivotal trial.View more earnings on IBBThe proposed trial, if successful, could be used along with a previously completed trial for a future NDA filing, the company said. It also said the FDA provided guidance with respect to the study design for B-SIMPLE4 and expectations for a future NDA submission.The company expects enrollment to begin in September and top-line results from the study in the second quarter.In premarket trading Friday, Novan shares were losing 1.62% to 36 cents.Vertex Gets EMA Committee Positive Opinion For Label Expansion Of Cystic Fibrosis Drug Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) said EMA's CHMP adopted a positive opinion for the label extension of Kalydeco to include the treatment of children and adolescents with cystic fibrosis who are ages 6 months and older, weigh at least 5 kg and who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.Novartis Says EMA Committee Recommends Approval Of Asthma Drug Novartis AG (NYSE: NVS) said EMA's CHMP has adopted a positive opinion recommending the approval of Enerzair Breezhaler as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.Offerings Acer Therapeutics Inc (NASDAQ: ACER) said it has entered into a common stock purchase agreement for up to $15 million with Lincoln Park Capital Fund, LLC, a Chicago-based institutional investor.The stock was advancing 4.17% to $2.50 in premarket trading Friday.Second Sight Medical Products Inc (NASDAQ: EYES) priced its underwritten public offering of 7.5 million shares at $1 per for aggregate gross proceeds of $7.5 million. The offering is expected to close May 5.The stock was slipping 13.53% to $1.15 in premarket trading Friday.Earnings Gilead Sciences, Inc. (NASDAQ: GILD) reported first-quarter total revenue of $5.55 billion, up from $5.28 billion a year ago. HIV product sales, accounting for 78% of the total revenue, rose about 14%, while HCV product sales declined. The non-GAAP earnings per share came in at $1.68 compared to the year-ago's $1.67, while analysts estimated EPS of $1.57.The stock fell was down 4.51% at $80.21 in Friday's premarket session.On The Radar Earnings * AbbVie Inc (NYSE: ABBV) (before the market open) * GlycoMimetics Inc (NASDAQ: GLYC) (before the market open) * ImmunoGen, Inc. (NASDAQ: IMGN) (before the market open)IPO Lyra Therapeutics, a clinical-stage company developing medicines precisely designed to target ear, nose and throat diseases, priced its initial public offering of 3.5 million shares at $16, the upper end of the estimated price range of $14-$16. The shares will begin trading on the Nasdaq under the ticker symbol "LYRA."Related Link: A Deep Dive On Coronavirus Vaccine Plays Moderna, Inovio See more from Benzinga * The Daily Biotech Pulse: FDA Nod For GlaxoSmithKline, Hologic To Launch Coronavirus Test, Amarin's Strong Q1 * The Daily Biotech Pulse: Inovio's MERS Vaccine Data, Fast Track Designation For Erytech, FDA Approves Higher Dose Of Merck's Keytruda * Moderna Applies For Phase 2 Study Of Coronavirus Vaccine Candidate(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Novan, Inc. (“the Company" or "Novan") (NOVN) today announced the closing of the Company’s previously announced underwritten public offering of 18,333,334 shares of common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase an aggregate of up to 18,333,334 shares of common stock, at a combined effective public offering price of $0.30 per share of common stock (or pre-funded warrant) and accompanying common warrant. The common warrants have an exercise price of $0.30 per share, are exercisable immediately and expire five years from the date of issuance.

Novan, Inc. ("the Company" or "Novan") (NOVN) today announced the closing of the Company’s previously announced registered direct offering priced at-the-market under Nasdaq rules with several institutional and accredited investors of 18,604,652 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) at an effective purchase price of $0.43 per share (or pre-funded warrant). The gross proceeds to Novan from this offering are approximately $8.0 million, before deducting the placement agent's fees and other offering expenses payable by Novan. Novan intends to use the net proceeds from the offering to fund its research and development programs and for general working capital purposes and other operating expenses.

Novan, Inc. ("the Company" or "Novan") (NOVN) today announced that it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of 18,604,652 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) at an effective purchase price of $0.43 per share (or pre-funded warrant) in a registered direct offering priced at-the-market under Nasdaq rules. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to Novan from this offering are expected to be approximately $8.0 million, before deducting the placement agent's fees and other offering expenses payable by Novan.

Over the first quarter of 2020, more than $31 billion in value disappeared from the books of local public companies that collectively employ more than a hundred thousand workers in the Triangle and across the U.S.

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Novartis said it will proceed with a Phase III clinical trial of hydroxychloroquine in hospitalized patients with COVID-19 disease. The trial will be of approximately 440 patients at more than a dozen sites in the United States, and Novartis said it will make its hydroxychloroquine intellectual property available to support broad access if medicine is approved for COVID-19. Novartis said it plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible. Novartis said it will donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts in the event the medicine is proven beneficial for treatment of COVID-19, and said its generics arm Sandoz has already donated 30 million tablets to the US Department of Health and Human Services.

Benzinga Pro's Stocks To Watch For Tuesday * Target (TGT) \- Shares were lower by about 1.5% following mixed Q4 results and inline Q1 guidance. * Beyond Meat (BYND) \- The stock was up more than 5% following an appearance by Founder and CEO Ethan Brown on Jim Cramer's "Mad Money" Monday evening. The exec reiterated the company's international expansion plans. On Tuesday morning, Beyond Meat competitor Impossible Foods issued a press release which highlighted an average 15% price cut for its products. Impossible Foods will also expand its product offerings to include quarter- and third-pound patties. * Uber (UBER) \- Needham said it's a buyer of Uber shares and added the stock to its Conviction list. The firm's Brad Erickson cut his price target on Uber shares from $56 to $54. * Novan (NOVN) \- This penny stock was one of Monday's largest gainers, up about 112%. While a notable hedge fund, Sabby Management, on Friday afternoon showed a 7.54% stake in the company, we didn't see any company-specific news to justify the move higher on Monday. After the close Monday, Novan filed for a 14 million share offering of common stock and warrants. Shares were down about 14% in pre-market trade. * Qorvo (QRVO) \- The company cut its Q4 sales guidance amid supply chain disruptions related to the coronavirus outbreak. Qorvo now sees Q4 sales around $770 million, down from a previously-issued range of $800 million to $840 million. Despite the guidance cut, shares were up about 1.5% ahead of the open. * Heat Biologics (HTBX) \- One of Monday's most-talked-about stocks, Heat Biologics shares closed up 140% as traders considered the stock another play on the coronavirus. The company received a provisional patent for its immune therapy/vaccine technology. An analyst at Maxim reiterated a Buy rating and $1 price target on the penny stock. See more from Benzinga * Benzinga Pro's Top 5 Stocks To Watch For Fri., Feb. 28, 2020: BYND, TLRY, W, LAKE, FL * Benzinga Pro's Top 5 Stocks To Watch For Wed., Feb. 26, 2020: DIS, SPCE, BYND, SDC, JCP * Benzinga Pro's Top 5 Stocks To Watch For Wed., Feb. 12, 2020: UBER, AKAM, WYNN, BBBY, TRIP(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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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.

Novan, Inc. (“the Company” or “Novan”) (NOVN) today announced that it has engaged H.C. Wainwright & Co., LLC (“H.C. Wainwright & Co.”) to assist the Company in exploring and evaluating a range of strategic and financial alternatives, intended to maximize shareholder value. The Company has advanced several late stage development programs in the field of dermatology, including the Company’s lead product candidate, SB206, that is in Phase 3 clinical trials for molluscum contagiosum (“molluscum”), a primarily pediatric contagious skin infection.

A Triangle company that's struggled to develop its lead asset has brought in $8 million through a new public offering as it unveils plans to explore potential applications of its platform in the fight against COVID-19.

Novan, Inc. (“the Company” or “Novan”) (NOVN) today announced that the Company has received meeting minutes from the April 1, 2020 Type C meeting with the U.S. Food and Drug Administration (“FDA”) regarding SB206 for the treatment of molluscum contagiosum (“molluscum”). Based on guidance the Company received during the meeting and subsequently contained within the meeting minutes, Novan is preparing to conduct one additional pivotal trial (“B-SIMPLE4”), which, if successful, could be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application (“NDA”).

Potential Novan, Inc. (NASDAQ:NOVN) shareholders may wish to note that insider Joseph Moglia recently bought US$430k...

Actinium (ATNM) treats first patient in the third and final cohort of the Actimab-A and CLAG-M combination phase I study to treat relapsed or refractory acute myeloid leukemia.