The FDA lends a speedy nod to Deciphera's (DCPH) Qinlock for the treatment of fourth-line gastrointestinal stromal tumors. The approval comes three months ahead of schedule.
By Geoffrey Smith
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.
Biopharma’s shares up 40% year to date. It reports 1st-quarter results May 6 Continue reading...
Investors will focus on regular top and bottom-line numbers along with pipeline updates, when Incyte (INCY) reports first-quarter 2020 results.
Diagnostic testing, treatment, and a coronavirus vaccine could allow near-normal distancing and nonessential business recovery by mid-2021.
When Mac Holmes noticed a lump in the middle of his chest it took him a year to mention it to his physician. The 55-year-old, who flew packages for FedEx after a 28-year career with the US Air Force, appeared a picture of middle-aged vigour. Days later he was diagnosed with breast cancer, a disease that has spread to his bones.
Swiss drugmakers Roche and Novartis released data on Wednesday on treatments aimed at winning sales from each other in eye disease and multiple sclerosis, in a sign of rising rivalry. Facing each other across the Rhine in Basel, the drugmakers have clashed and cooperated over the years, but their latest products point to more direct competition. Roche
Any vaccine to fight the new coronavirus will not be ready for use for at least two years, the chief executive of Swiss pharmaceutical company Novartis, which no longer makes vaccines itself, told a German newspaper. Novartis sold its vaccine business in 2015 to GlaxoSmithKline, one of many companies around the world now racing to make a drug. "The results of the first clinical studies on the vaccine candidates should be available in autumn," Novartis CEO Vas Narasimhan told Frankfurter Allgemeine Zeitung (FAZ).
Top Analyst Reports for Apple, Berkshire Hathaway & Pfizer
NVS earnings call for the period ending March 31, 2020.
Telehealth companies enabling individuals to see physicians without stepping foot into a physical doctor’s office are having their moment, as the coronavirus pandemic confines individuals and would-be patients across the country largely to their homes.
Amgen stock is consolidating as it takes a two-pronged approach to coronavirus treatment, partnering with Adaptive Biotechnologies and testing Otezla in Covid-19. Is Amgen stock a buy?
A Relative Strength Rating upgrade for Novartis shows improving technical performance. Will it continue?
The hydroxychloroquine debate is far from over, as the drug gets qualified support from others deeply involved in the war against the coronavirus.
Global Blood Therapeutics (NASDAQ: GBT) plans to report its first quarter earnings on Wednesday, May 6. Importantly, investors will see the first full quarter of sales for Oxbryta, the company's recently approved drug for adults and children age 12 and older with sickle cell disease. The Food and Drug Administration (FDA) approved Oxbryta on Nov. 25., three months before the FDA's Priority Review action date for the decision.
Novo Nordisk (NVO) and Bristol-Myers (BMY) announce Q1 results. Pfizer (PFE), Roche (RHHBY) and Lilly (LLY) provide update on their coronavirus-related research efforts.
Coronavirus is probably the 1 concern in investors' minds right now. It should be. On February 27th we published an article with the title Recession is Imminent: We Need A Travel Ban NOW. We predicted that a US recession is imminent and US stocks will go down by at least 20% in the next 3-6 […]
Novartis' (NVS) gene therapy, Zolgensma, obtains EC approval for spinal muscular atrophy.
Clinical Professor of Epidemiology at NYU School of Global Public Health Dr. Robyn Gershon joins Yahoo Finance’s Seana Smith to discuss the latest coronavirus developments as more states gear up to implement reopening plans.