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 March 25.) * Ra Pharmaceuticals Inc (NASDAQ: RARX)Down In The Dumps (Biotech stocks that hit 52-week lows March 25.) * Anixa Biosciences Inc (NASDAQ: ANIX) * IMMUTEP LTD/S ADR (NASDAQ: IMMP) (reacted to breast cancer trial readout) * PLx Pharma Inc (NASDAQ: PLXP) * Taro Pharmaceutical Industries Ltd. (NYSE: TARO)Stocks In Focus Quidel COVID-19 Detection Assay Obtains Expanded EUA, CE Mark Approval Quidel Corporation (NASDAQ: QDEL) said its Lyra SARS-CoV-2 Assay has received expanded Emergency Use Authorization from the FDA to allow testing with three additional thermocyclers, namely Applied Biosystems' 7500, Roche Holdings AG's (OTC: RHHBY) LightCycler 480 and Qiagen NV's (NYSE: QGEN) Rotor Gene Q.Quidel said the initial EUA awarded allowed qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19. The expanded authorization includes nasal and nasal turbinate swabs.Quidel also said it received the CE-Mark on March 25, which will allow it market and sell the Lyra SARS-CoV-2 Assay in Europe as well as other countries that accept CE Mark.Alector Out-Licenses China Rights of AL008 In Oncology To Innovent Biologics Alector Inc (NASDAQ: ALEC) and Hong Kong-listed biopharma Innovent Biologics said they have entered into a licensing agreement to develop and commercialize an anti-SIRP-alpha antibody AL008 for the treatment of oncology indications in China.The companies did not disclose the financial terms of the deal. The agreement gives Innovent the responsibility of leading development and commercialization of the investigational compound in China, while Alector is in charge of developmental activities outside of China.See also: The Week Ahead In Biotech: Bristol-Myers, Rockwell Medical Await FDA Decisions, COVID-19 Updates In Focus Bristol-Myers Squibb Receives FDA Nod For Celgene's Multiple Sclerosis Drug Bristol-Myers Squibb Co (NYSE: BMY) announced FDA approval for ozanimod 0.92 mg as a treatment option for patients with relapsing forms of multiple sclerosis.In premarket trading Thursday, Bristol-Myers Squibb shares were adding 1.52% to $50.10.Cerecor To Test Role Of Inflammatory Cytokinin In COVID-19-Induced Acute Respiratory Distress Cerecor Inc (NASDAQ: CERC) said it plans to explore the role of an inflammatory cytokine -- LIGHT -- in patients with COVID-19-induced acute respiratory distress. It said it will use its proprietary free LIGHT assay as well as multiple assay to determine if there are differences in LIGHT levels and other inflammatory markers, including IL-18 and IFN-g, in patients with mild-to-moderate vs. severe disease with Acute Lung Injury or Acute Respiratory Distress Syndrome.Grifols To Develop Hyperimmune Globulin For COVID-19 Grifols SA - ADR (NASDAQ: GRFS) said it has entered a formal collaboration agreement with the U.S. BARDA, the FDA and other federal public health agencies to collect plasma from convalescent COVID-19 patients and process this specific plasma into a hyperimmune globulin.The company also said it will support the necessary preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can be used to treat COVID-19 disease.In Spain, Grifols is working on a clinical trial with inactivated plasma from recovered patients through a collaboration with select donation centers and public hospitals.View more earnings on IBBThe company also said it has accelerated the development and validation of a proprietary technology transcription-mediated amplification-based diagnostic procedure to detect the virus, with a sensitivity equivalent or even superior to that of PCR test.The stock was rising 10.47% to $19.63 in premarket trading.Pfizer, Mylan Announce Delay In Merger Of Generic Businesses Pfizer Inc. (NYSE: PFE) and Mylan NV (NASDAQ: MYL) announced the proposed merger between Mylan and Pfizer's generic unit Upjohn will now close in the second half of 2020 due to the unprecedented circumstances surrounding the COVID-19 pandemic, including associated delays in the regulatory review process. The companies initially had a closing deadline of mid-2020.Biopharmx Gets Delisting Notice From NYSE American Specialty pharma company Biopharmx Corp (NYSE: BPMX) said it received a notification from NYSE American LLC on March 24 regarding its determination to delist the company's shares from the exchange. The decision is due to the company's non-compliance with certain continued listing standards.Biopharmx said it will appeal the delisting notice. The shares, according to the company, will continue to trade on the exchange during the appeal period.The company also clarified that the delisting does not affect its business operations, its intention to merge with Timber Pharma announced Jan. 28 or its SEC reporting requirements,The stock was down 2.83% at 28 cents at the time of publication.Xencor, Vir Agree To License Technology To Extend Half-Life Of COVID-19 Treatment Candidates Xencor Inc (NASDAQ: XNCR) said it entered into a technology license agreement with Vir Biotechnology Inc (NASDAQ: VIR) that provides Vir non-exclusive access to Xencor's Xtend Fc technology to extend the half-life of novel antibodies Vir is investigating as a potential treatment for COVID-19."Xtend Fc technology has demonstrated, in multiple antibodies and through numerous human clinical trials, the ability to extend antibody drug half-life and reduce dosing frequency in patients, an important feature in anti-viral therapy for pandemic use," Xencor CEO Bassil Dahiyat said in a statement. The companies did not disclose the financial terms of the deal.Vir shares were trading 3.22% higher at $31.74 in Thursday's premarket session.Earnings Biocept Inc's (NASDAQ: BIOC) fourth-quarter revenue climbed 108% year-over-year to $1.8 million. The net loss narrowed significantly from $1.43 per share to 20 cents per share. Analysts estimated a loss of 10 cents per share.The stock was trading 8.57% higher at 38 cents at the time of publication. On The Radar PDUFA Dates IntelGenx Technologies Corp.'s (OTC: IGXT) NDA for rizaport versafilm for the treatment of acute migraine is pending before the FDA, with the target action day fixed for Thursday. The company had faced three rejections for the investigational drug in the past.Earnings * Celsion Corporation (NASDAQ: CLSN) (before the market open) * Entera Bio Ltd (NASDAQ: ENTX) (before the market open) * TFF Pharmaceuticals Inc (NASDAQ: TFFP) (before the market open) * IGM Biosciences Inc (NASDAQ: IGMS) (after the close) * NovaBay Pharmaceuticals, Inc. (NYSE: NBY) (after the close) * Vermillion, Inc. (NASDAQ: VRML) (after the close) * aTyr Pharma Inc (NASDAQ: LIFE) (after the close)Related Link: Hoth Therapeutics Shares Jump On COVID-19 Vaccine Development Plans See more from Benzinga * The Daily Biotech Pulse: Milestone Pharma Flunks Late-Stage Study, CytomX Strikes Cancer Drug Collaboration, BARDA Grant For GenMark's COVID-19 Test(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
By David Bautz, PhD NASDAQ:CERC READ THE FULL CERC RESEARCH REPORT Financial Update On March 11, 2020, Cerecor, Inc. (NASDAQ:CERC) announced financial results for the fourth quarter and full year 2019. The company reported net product revenue of $6.7 million for 2019 compared to $6.6 million for 2018. These revenues were derived from the sale of Millipred®, which is the company’s only remaining
-Company Transformed Into Orphan and Rare Disease Biotech-Clear Corporate Strategy with New Leadership-Significant Advancement in Pipeline and Regulatory Milestones ROCKVILLE,.
Although the masses and most of the financial media blame hedge funds for their exorbitant fee structure and disappointing performance, these investors have proved to have great stock picking abilities over the years (that's why their assets under management continue to swell). We believe hedge fund sentiment should serve as a crucial tool of an […]
Sale of Pediatric Portfolio in a Deal Valued in Excess of $43 MillionFirst Patient Enrolled in Diabetic OH Trial with CERC-301Completed Phase 1 Healthy Volunteer Study with.
The CEO of Wayne-based Aevi is taking over as CEO of the combined company focused on rare pediatric diseases.
Significantly Improved Cash Position and Balance SheetClosed Aevi Merger; Transformed into Orphan and Rare Disease Biotech ROCKVILLE, Md., May 07, 2020 -- Cerecor Inc..
Cerecor Inc. (CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, today announced that Jeff Wilkins, MD has joined the Company as its Chief Development Officer, with a specific focus on CERC-002, CERC-006 and CERC-007 clinical development programs. "We are delighted to welcome Dr. Wilkins to the organization," said Mike Cola, Chief Executive Officer.
Cerecor Inc. (CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, today announces that it will explore the role of an inflammatory cytokine, LIGHT, in patients with COVID-19 induced Acute Respiratory Distress. The Company will use its proprietary free LIGHT assay as well as a multiplex assay to determine whether there are differences in LIGHT levels and other inflammatory markers including IL-18 and IFN-g in patients with mild to moderate vs severe disease with Acute Lung Injury / Acute Respiratory Distress Syndrome (“ARDS”).
Cerecor Inc. (CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, today announced that Dr. Sol J. Barer has been appointed as the Chairman of the Board as Dr. Simon Pedder steps down as Executive Chairman. Additionally, Dr. Suzanne Bruhn and Mr. Joseph Miller have been appointed as Directors to the Company’s Board.
Punch Card Capital lifted its holding in the maker of motor homes and recreational vehicles to 2,385,740 shares, and it wants changes at Winnebago.
Cerecor Inc. (CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today it has completed the previously announced acquisition of Aevi Genomic Medicine (GNMX) in an all-stock transaction valued at approximately $15.6 million at close, plus contingent value rights (CVRs) for up to an additional $6.5 million in subsequent payments based on clinical and/or regulatory milestones. Cerecor’s pipeline now includes six clinical-stage assets, accelerating the Company’s transformation into a research and development organization focused on developing new medicines for unmet needs in rare diseases, particularly for pediatric patients.
By David Bautz, PhD NASDAQ:CERC READ THE FULL CERC RESEARCH REPORT Business Update Acquisition of Aevi Genomic Medicine Strengthens Rare and Orphan Disease Pipeline On December 5, 2019, Cerecor, Inc. (NASDAQ:CERC) announced the acquisition of Aevi Genomic Medicine (GNMX) in an all-stock transaction valued at approximately $16.1 million plus contingent value rights (CVRs) for up to an additional
Just because a business does not make any money, does not mean that the stock will go down. For example, although...
NEW YORK, NY / ACCESSWIRE / December 10, 2019 / The following statement is being issued by Levi & Korsinsky, LLP: To: All Persons or Entities who purchased Aevi Genomic Medicine, Inc. ("Aevi" ...
Cerecor Inc. (CERC) and Myriad Genetics Inc. (MYGN) today announced that levels of novel cytokine, LIGHT, were highly correlated with disease severity and mortality in a COVID-19 acute respiratory distress syndrome (ARDS) biomarker study. The biomarker study was conducted using the serum samples of 47 hospitalized COVID-19 patients and 30 healthy controls from Hackensack Meridian Health Network.
By David Bautz, PhD NASDAQ:CERC READ THE FULL CERC RESEARCH REPORT Business Update Examining LIGHT as Potential Biomarker for ARDS In March 2020, Cerecor, Inc. (NASDAQ:CERC) announced it will examine the role of LIGHT ( L ymphotoxin-like, exhibits I nducible expression, and competes with HSV G lycoprotein D for H VEM, a receptor expressed by T lymphocytes [part of the Tumor Necrosis Super Family
Purcell Julie & Lefkowitz LLP, a class action law firm dedicated to representing shareholders nationwide, is investigating a potential breach of fiduciary duty claim involving the board of directors of Cerecor Inc. (NASDAQ: CERC).
Cerecor Inc. (NASDAQ:CERC) missed earnings with its latest full-year results, disappointing overly-optimistic...
Cerecor Inc. (CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for orphan and rare diseases, as well as neurology announced today it has entered into a definitive merger agreement to acquire Aevi Genomic Medicine (GNMX) in an all-stock transaction valued at approximately $16.1 million at closing, plus contingent value rights, or CVRs, for up to an additional $6.5 million in subsequent milestone payments on clinical or regulatory successes, or both. Additionally, the Company is exploring strategic alternatives for its neurological assets as well as its one commercialized product Millipred®.