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The Daily Biotech Pulse: Fulgent Nabs CDC Contract, Enzo Rallies, Solid Biosciences Publish Gene Therapy Data, Moderna Launches Pediatric Vaccine Trial
Here’s a rundown of the major developments in the biotech space over the past 24 hours: Scaling The Peaks (Biotech stocks hit 52 weeks high on March 15) Aclaris Therapeutics, Inc. (NASDAQ: ACRS) Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) Amneal Pharmaceuticals, Inc. (NYSE: AMRX) AngioDynamics, Inc. (NASDAQ: ANGO) Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) Champions Oncology, Inc. (NASDAQ: CSBR) Elanco Animal Health Incorporated (NYSE: ELAN) Gemini Therapeutics, Inc. (NASDAQ: GMTX) GenMark Diagnostics, Inc. (NASDAQ: GNMK) – announced a deal to be purchased by Roche Holding AG (OTC: RHHBY) for $ 1.8 billion to Harvard Bioscience, Inc. (NASDAQ: HBIO) IDEAYA Biosciences, Inc. (NASDAQ: IDYA) Omnicell, Inc. (NASDAQ: OMCL) Oncternal Therapeutics, Inc. (NASDAQ: ONCT) Organogenesis Holdings Inc. (NASDAQ: ORGO) Prometheus Biosciences, Inc. (NASDAQ: RXDX) (went public Friday) Renalytix AI plc (NASDAQ: RNLX) Rubius Therapeutics, Inc. (NASDAQ: RUBY) (Anno unprecedented positive initial Phase 1/2 data for investigational drug in advanced solid tumors) Silverback Therapeutics, Inc. (NASDAQ: SBTX) (Announced appointment of biopharmaceutical industry veteran Maria Koehler to the board of directors) Sol-Gel Technologies Ltd. (NASDAQ: SLGL) Sotera Health Company (NASDAQ: SHC) Vincerx Pharma, Inc. (NASDAQ: VINC) Down In The Dumps (Biotech shares hit 52-week lows on March 15) Galecto, Inc. (NASDAQ: GLTO) (An independent Data Safety Monitoring Board recommends discontinuation of certain parts of a phase 2b study of GB0139 for the treatment of idiopathic pulmonary fibrosis) Shares in focus Fulgent Genetics awarded CDC contract for genomic sequencing of COVID-19 samples Fulgent Genetics, Inc. (NASDAQ: FLGT) said the U.S. Centers for Disease Control and Prevention has awarded it a contract to provide continuous genomic sequencing of SARS-CoV-2 samples, leveraging next-generation sequencing capabilities. Under the agreement, Fulgent Genetics will sequence the genomes of random samples that have tested positive for SARS-CoV-2, the virus that causes COVID-19. Fulgent will leverage its NGS platform and provide sequence data to the CDC as part of the agency’s initiative to conduct a large-scale genomic study of the virus using random samples from across the US. Ultimately, the CDC believes this large-scale genomic study of the virus could provide important basic information for virus surveillance at the national and state levels, Fulgent said. The stock rose 6.67% for the market to $ 111.22. Solid Biosciences Issues Update on Phase 1/2 Gene Therapy Trial in Duchenne Muscular Dystrophy Solid Biosciences Inc. (NASDAQ: SLDB) announced interim functional and biomarker data, and patient-reported outcome measures of six patients treated with pivotal gene therapy candidate SGT-001 in a phase 1/2 study of Duchenne muscular dystrophy. The six patients showed no drug-related safety findings 17-37 months after dosing. The seventh patient, who was first dosed in the trial according to a previously reported change to the clinical protocol and who used SGT-001 manufactured using the company’s second-generation process, also received a safe dose, with transient and manageable side effects. The study was placed on clinical hold in November 2019, with a hold release in October 2020. “The aggregate data collected and dose restart support the continued enrollment of patients in the IGNITE DMD trial,” it said. company. . During out of hours trading, the stock fell 0.79% to $ 28.89. Anchiano receives shareholder responsibility for merger with Chemomab Anchiano Therapeutics Ltd. (NASDAQ: ANCN) said its shareholders have voted in favor of a merger with Chemomab and the issuance of Anchiano stock in connection with the upcoming merger. Shareholders also approved a reverse split of Anchiano’s common stock. The stock rose 27.96% premarket to $ 5.72. Enzo Announces CEO Departure, Strategic Alternatives Review Enzo Biochem, Inc. (NYSE: ENZ) announced that founder and CEO Elazar Rabbani has decided to step down and transfer to an academic position once a replacement is hired. The company also said it has appointed former CEO of Laboratory Corporation of America Holdings (NYSE: LH) Gary Hugg as its strategic advisor. Enzo said it has engaged Cain Brothers to assist with strategic initiatives to identify, evaluate and execute strategic and commercial opportunities. In addition, the company announced its second-quarter results, with sales up 62% year-over-year to $ 31.5 million and profit of 5 cents per share, as opposed to the 16 cents per share loss it recorded a year ago. reported. The stock was up 28.72% for the premarket at $ 3.81. Moderna begins testing COVID-19 vaccine in pediatric population Moderna Inc. (Nasdaq: MRNA) said the first participants were dosed in the Phase 2/3 KidCOVE study of mRNA-1273, the candidate vaccine against COVID-19, in children aged 6 years. months to less than 12 years. The research is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases. The stock rose 2.51% to $ 147.27 during premarket trading Tuesday. View more earnings on IBB Related Link: The Week Ahead In Biotech (March 14-20): Update on Fibrogen-AstraZeneca’s anemia drug, earnings and presentations AC immune system to promote Down syndrome Vaccine Phase 2 trial candidate AC Immune SA (NASDAQ: ACIU) said it plans to pass its new anti-amyloid beta vaccine to mid-stage clinical trials to treat and prevent the progression of Down syndrome-related Alzheimer’s disease. Topline results showed that ACI-24 encouraged immunogenicity and safety in Phase 1b clinical trials in people with Down syndrome. The stock rose 7.55% to $ 8.69 during premarket trading Tuesday. Can-Fite signs license agreement with Ewopharma for distribution of psoriasis, liver disease medicines in Europe Can-Fite BioPharma Ltd. (NYSE: CANF) said it has signed an exclusive distribution agreement with Switzerland-based Ewopharma for piclidenoson in the treatment of psoriasis and namodenoson in the treatment of liver disease. Under the terms of the distribution agreement, Ewopharma will pay Can-Fite $ 2.25 million upfront, with a maximum of $ 40.45 million, payable upon meeting regulatory and sales milestones plus 17.5% royalties on net sales. In return, Ewopharma will be given the exclusive right to market and sell piclidenoson in Central Eastern European countries and Namodenoson in CEE countries and Switzerland. Can-Fite shares were up 74.02% to $ 3.55 during premarket trading Tuesday. J&J Unit Announces Positive Long-Term Data for Psoriatic Arthritis Drug Johnson & Johnson’s (NYSE: JNJ) Janssen Unit Announced Long-Term Positive Data from Phase 3 Study showing Tremfya’s skin removal, joint symptom relief and safety previously demonstrated by 24 weeks and one year in adults with active psoriatic arthritis for two years. Roche Launches COVID-19 Assay to Detect Coronavirus Variants Roche announced the launch of the Cobas SARS-CoV-2 Variant Set 1 Assay to detect and differentiate mutations found in variants originating from the UK, South Africa Africa and Brazil. This laboratory test is for research purposes only and can be used to help scientists track the prevalence of mutations and assess the potential impact on diagnostics, vaccines and therapies, providing critical insight to healthcare systems in taking appropriate action to prevent COVID -19, the company said. Savara’s profits on the purchase of insider stock Savara Inc. (NASDAQ: SVRA) shares rose higher after three filings revealed that the company’s CFO David Lowrance and directors David Ramsay and Joseph MacCracken bought a total of 157,723 shares at a price of $ 1.45 a share. The stock rose 21.53% on the premarket to $ 2.15. Inspire Gets FDA Approval for Improved Surgical Procedure Inspire Medical Systems, Inc. (NYSE: INSP) announced that the FDA has approved an improved surgical implant procedure that eliminates one incision through a revised pressure-sensitive lead placement. This recently approved procedure will reduce the average procedure time for Inspire therapy by about 20%, the company said. The stock rose 3.02% to $ 224.75 during out of hours trading. Revenue AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) reported a loss of 10 cents a share for the fourth quarter of 2020, smaller than the loss of 18 cents a share a year ago and in line with consensus estimate. In out-of-hours trading, the stock lost 5.96% to $ 2.05. Predictive Oncology (NASDAQ: POAI) said full-year 2020 sales fell from $ 1.41 million in 2019 to $ 1.25 million in 2020. Losses per share dropped from $ 6.86 to $ 2.21. The stock fell 6.42% for the market to $ 2.04. Offering Rubius Therapeutics, Inc. (NASDAQ: RUBY) has announced that it has begun an underwritten public offering of $ 150 million worth of common stock. All shares in the offering are sold by Rubius. The stock fell 3.24% before the market at $ 29.31. Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) said it priced its underwritten public offering of 2.686 million common shares at $ 76 per share. Gross proceeds from the offering are expected to be approximately $ 200 million. The offering is expected to close on March 17, subject to compliance with customary closing conditions. In premarket trading, the stock fell 6.45% to $ 76.25. Sotera Health announced the launch of a secondary offering of 25 million common shares. All shares are offered by selling shareholders, including certain Warburg Pincus and GTCR affiliates, as well as certain current and former members of the company’s management. The company said it will not receive any proceeds from the offering. On The Radar Earnings Calithera Biosciences, Inc. (NASDAQ: CALA) (after closing) Cue Biopharma, Inc. (NASDAQ: CUE) (after closing) Curis, Inc. (NASDAQ: CRIS) (post-closing) Kindred Biosciences, Inc. (NASDAQ: KIN) (after closing) Exagen Inc. (NASDAQ: XGN) (post-closing) OncoCyte Corporation (NYSE: OCX) (post-closing) Eton Pharmaceuticals, Inc. (NASDAQ: ETON) (to closing) Organogenesis Holdings Inc. (NASDAQ: ORGO) (post-closing) Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (post-closing) Ra Medical Systems, Inc. (NYSE: RMED) (Post Close) Related Link: Attention To Biotech Investors: Mark Your Calendar For March PDUFA Dates See More From Benzinga Click Here For Benzinga Options Trading Week Ahead In Biotech (March 14-20): Update about Fibrogen-AstraZeneca’s anemia drug, revenues and presentations The Daily Biotech Pulse: Novavax Vaccine Data, ContraFect secures BARDA funding, 2 IPOs © 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.