 Scaling The Peaks Biotech Stocks Hitting 52-week Highs Aug. 10 Allovir Inc NASDAQ: ALVR BioLife Solutions Inc NASDAQ: BLFS BioSpecifics Technologies Corp. NASDAQ: BSTC reacted to second-quarter results CymaBay Therapeutics Inc NASDAQ: CBAY Eton Pharmaceuticals Inc NASDAQ: ETON Fennec Pharmaceuticals Inc NASDAQ: FENC Fulgent Genetics Inc NASDAQ: FLGT Harvard Bioscience, Inc. NASDAQ: HBIO Inari Medical Inc NASDAQ: NARI Kura Oncology Inc NASDAQ: KURA Omeros Corporation NASDAQ: OMER announced positive results for the study of its lead asset in COVID-19 Pacira Biosciences Inc NASDAQ: PCRX RedHill Biopharma Ltd NASDAQ: RDHL Rocket Pharmaceuticals Inc NASDAQ: RCKT Seres Therapeutics Inc NASDAQ: MCRB reacted to positive late-stage clinical readout Silk Road Medical Inc NASDAQ: SILK Sorrento Therapeutics Inc NASDAQ: SRNE Trevena Inc NASDAQ: TRVN announced FDA nod for pain drug Unity Biotechnology Inc NASDAQ: UBX Vaxcyte Inc NASDAQ: PCVXDown In The Dumps Biotech Stocks Hitting 52-week Lows Aug. 10 Checkmate Pharmaceuticals Inc NASDAQ: CMPI went public Friday Freeline Therapeutics Holdings plc ADS NASDAQ: FRLN went public Friday Lantern Pharma Inc. NASDAQ: LTRN Nkarta Inc NASDAQ: NKTX Recro Pharma Inc NASDAQ: REPH reacted to second-quarter resultsStocks In Focus Equillium Announces Positive Interim Data For Lead Drug, Requests Pre-IND Meeting For COVID-19 Study Equillium Inc NASDAQ: EQ announced positive interim data from the first two cohorts of the Phase 1b open label, dose escalation portion of the EQUATE study of itolizumab in acute graft-versus-host disease. Across the first two dose cohorts, itolizumab has been generally well-tolerated to date, and five of seven patients achieved a complete response by day 29, the company said.Additionally, Equillium said it has submitted a request to the FDA for a pre-IND meeting to review its proposal to initiate a global randomized controlled clinical trial to study itolizumab in hospitalized patients with COVID-19.The stock was trading 21.29 higher premarket Tuesday at 12.19. Clearsides IND Application Approved For Wet AMD Study Clearside Biomedical Inc NASDAQ: CLSD said the FDA has accepted its IND application for CLS-AX, enabling initiation of a Phase 12a clinical trial of CLS-AX in neovascular age-related macular degeneration patients by the end of 2020.The dose-escalation study will assess the safety and tolerability of single doses of CLS-AX administered through suprachoroidal injection following two or more prior treatments with an intravitreal anti-VEGF agent, according to the company. Separately, the company announced second-quarter results, reporting an increase in license revenue from 45,000 in 2019 to 354,000 in 2020. The net loss per share narrowed from 15 cents to 13 cents, but was wider than the 12-cent-per-share loss expected by analysts.The stock was up 7.26 at 1.92 premarket Tuesday.Innate Pharma Receives French Government Funding For COVID-19 Research Innate Pharma SA NASDAQ: IPHA said it has received 6.8 million euros 8 million in funding from the French government to support its COVID-19 RD activities.The company said it expects the funding to help cover the development of the COVID-19 activities it began in March 2020, including the EXPLORE COVID-19 translational research study and its two Phase 2 clinical trials, FORCE and ImmunONCOVID-20.Fennec Handed Complete Response Letter For Drug To Treat Chemotherapy-Induced Ototoxicity Fennec Pharma said it received a complete response letter Monday from the FDA regarding its NDA for Pedmark, a unique formulation of sodium thiosulfate, for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic solid tumors.The stock was plunging 28.42 premarket to 7.28.See also: The Week Ahead In Biotech: Bausch Health, Fennec Pharma FDA Decisions And Smid-cap Earning Catalysts Firdapse Flunks Late-Stage Study In Neuromuscular Disease Catalyst Pharmaceuticals Inc NASDAQ: CPRX said the top-line results from its Phase 3 study for Firdapse in anti-MuSK antibody positive myasthenia gravis patients did not replicate the robust positive results that were observed in the 2017 proof-of-concept study. The study did not meet the primary or secondary endpoints.The company also reported second-quarter results, showing a modest increase in revenue but a decline in EPS, which beat the consensus estimate by a penny.The stock was down 11.14 at 3.79 premarket. Ligand To Buy Pfenex For Up To 516M Ligand Pharmaceuticals Inc. NASDAQ: LGND and Pfenex Inc NYSE: PFNX announced the signing of a definitive agreement for Ligand to acquire all outstanding shares of Pfenex for 12 per share in cash or 438 million in equity value on a fully diluted basis.View more earnings on IBBAdditionally, Ligand will pay 2 per share or 78 million as a contingent value right in the event a predefined regulatory milestone is achieved by Dec. 31, 2021, for a total transaction value of up to 516 million. The transaction is expected to close in the fourth quarter.In premarket trading, Pfenex shares were jumping 63.45 to 12.52.Mesoblast Slumps As FDA Raises Questions Over Stem Cell Efficacy In Graft-Versus-Host Disease Shares of stem cell therapy company Mesoblast limited NASDAQ: MESO moved to the downside after FDA staffers expressed doubts over the adequacy of evidence for the efficacy of the companys remestemcel-L for treating acute graft-versus-host disease in children.The comments came in a briefing document released ahead of an Adcom meeting. The FDAs Oncologic Drugs Advisory Committee is scheduled to meet Thursday to discuss the BLA submitted by the company.The stock was down 25.66 at 12.95 premarket Tuesday.Inovio To Commence Late-Stage Coronavirus Vaccine Study In September, Q2 Results Trail Estimates Inovio Pharmaceuticals Inc NASDAQ: INO said it looks forward to starting a Phase 23 coronavirus vaccine study in the U.S. in September.The company reported second-quarter revenue of 267,187 in 2020 compared to 135,673 in 2019. The loss per share widened from 30 cents to 83 cents. Analysts estimated a loss of 17 cents per share on revenue of 2.61 million.The stock was down 11.01 at 16.90 premarket Tuesday. Earnings ICU Medical Incs NASDAQ: ICUI second-quarter revenue fell from 312.3 million in 2019 to 303.4 million, and adjusted EPS fell from 1.99 to 1.65. The results, however, exceeded expectations.Separately, the company announced a long-term agreement with Grifols SA - ADR ADR Class B NASDAQ: GRFS to distribute a full line of non-PVCnon-DEHP IV containers for 0.9 sodium chloride injections in the U.S. Omeros said its second-quarter revenue fell from 26.8 million in 2019 to 13.5 million in 2020, with the downside blamed on the postponement of cataract procedures by ASCs and hospitals due to COVID-19.The net loss per share narrowed from 61 cents to 29 cents. The revenue missed estimates and the net loss per share was wider than the consensus estimate.Separately, the company said it has commenced concurrent underwritten public offerings of 125 million shares of its common stock and 200 million in an aggregate principal amount of convertible senior notes due 2026.The stock was down 7.83 at 19.65 premarket Tuesday.Offerings PDS Biotechnology Corp NASDAQ: PDSB said it intends to offer shares of its common stock in an underwritten public offering. All of the shares in the offering are to be sold by the company.The stock was down 20.92 at 3.10 premarket Tuesday.On The Radar PDUFA Dates The FDAs decision on label expansion for Roche Holdings AGs Basel ADR Common Stock OTC: RHHBY Xolair for the treatment of nasal polyps could arrive, as the company is 10 months out from the submission of the sBLA.Earnings BioNTech SE - ADR NASDAQ: BNTX before the market open STRATA Skin Sciences Inc NASDAQ: SSKN before the market open Surface Oncology Inc NASDAQ: SURF before the market open Prevail Therapeutics Inc NASDAQ: PRVL before the market open Generation Bio Co NASDAQ: GBIO before the market open Fulcrum Therapeutics Inc NASDAQ: FULC before the market open Affimed NV NASDAQ: AFMD before the market open Burning Rock Biotech Ltd NASDAQ: BNR before the market open Gamida Cell Ltd NASDAQ: GMDA before the market open 10X Genomics Inc NASDAQ: TXG after the market close Agile Therapeutics Inc NASDAQ: AGRX after the market close Aethlon Medical, Inc. NASDAQ: AEMD after the market close T2 Biosystems Inc NASDAQ: TTOO after the market close Cumberland Pharmaceuticals, Inc. NASDAQ: CPIX after the market close DiaMedica Therapeutics Inc NASDAQ: DMAC after the market close HTG Molecular Diagnostics Inc NASDAQ: HTGM after the market close Sunesis Pharmaceuticals, Inc. NASDAQ: SNSS after the market close Shockwave Medical Inc NASDAQ: SWAV after the market close RA Medical Systems Inc NYSE: RMED after the market close Inari Medical after the market closeRelated Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates See more from Benzinga The Daily Biotech Pulse: Novavax Vaccine Deals, Trevena Awaits FDA Decision, 2 IPOs The Daily Biotech Pulse: FDA Nod For GlaxoSmithKline, Bristol-Myers Squibb Earnings, Acutus Medical IPOC 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved. 