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The daily Biotech pulse: Novavax vaccine data, ContraFect secures BARDA funding, 2 IPOs
Here is an overview of the best developments in the biotechnology space over the past 24 hours. Scaling The Peaks (Biotech shares hitting 52-week highs on March 11) Affimed NV (NASDAQ: AFMD) AngioDynamics, Inc. (NASDAQ: ANGO) Apyx Medical Corporation (NASDAQ: APYX) AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) BioAtla, Inc. (NASDAQ: BCAB) BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) Bolt Biotherapeutics, Inc. (NASDAQ: BOLT) Entera Bio Ltd. (NASDAQ: ENTX) (positively announced) Phase 2 Osteoarthritis Drug Biomarker Data) Harvard Bioscience, Inc. (NASDAQ: HBIO) IDEAYA Biosciences, Inc. (NASDAQ: IDYA) Inari Medical, Inc. (NASDAQ: NARI) Jounce Therapeutics, Inc. (NASDAQ: JNCE) Longeveron Inc (NASDAQ: LGVN) (FDA announces that they grant access to approval for its screening therapy Lomecel-B to a pediatric patient with hypoplastic left heart syndrome) Magenta Therapeutics, Inc. (NASDAQ: MGTA) Nuvation Bio Inc. (NASDAQ: NUVB) (announced orphan drug guideline for NUV-422 in the treatment of malignant gliomas) Renalytix AI plc (NASDAQ: RNLX) Sol-Gel Technologies Ltd. (NASDAQ: SLGL) Surmodics, Inc. (NASDAQ: SRDX) Verrica Pharmaceuticals Inc. (NASDAQ: VRCA) Down In The Dumps None of the NYSE- and Nasdaq-listed biotechnology / diagnostic stocks reached 52-week lows Thursday. Shares in focus Novavax confirms efficiency data after final analysis of UK Phase 3 data Novavax, Inc. (NASDAQ: NVAX) has announced the final data of the UK Phase 3 study of its coronavirus vaccine candidate NVX-CoV2373, which shows 96.4% efficacy. against the original COVID-19 strain. Final data also showed that the efficiency dropped to 86.3% compared to the B.1.1.7 variant circulating in the UK. Overall efficiency was 89.7%, slightly higher than the 89.3% reported based on the preliminary analysis at the end of January. The company also announced a full analysis of the data from the phase 2b study in South Africa, which shows an effectiveness of 55.4% among the participant in HIV-negative trials, where the vast majority of the strains of the B1.351 variants were. The stock climbed 23.11% to $ 231 in hourly trading. ContraFect receives $ 86.8 million in BARDA funding for Phase 3 study of research assets to treat bacterial infection in bloodstream ContraFect Corporation (NASDAQ: CFRX) said it has received a cost-sharing contract to support its continuous core phase 3 DISRUPT superiority study of exebacase in patients with Staph aureus bacteremia, including right endocarditis. The contract provides for ContraFect to receive initial financing of $ 9.8 million and up to an additional $ 77 million. if supported by Phase 3 data, BARDA can provide the company with additional funding after reaching key milestones to continue exebacase promotion through FDA approval and compliance with post-approval commitments. The company expects results from the Phase 3 study’s interim uselessness analysis in the second half of 2021. The stock rose 37.17% to $ 8.17 after hours. CareDx Announces Appointment of New Chief Financial Officer CareDx, Inc. (NASDAQ: CDNA) Announces the Appointment of Anil Dhingra, CEO of Agilent Technologies, Inc. (NYSE: A), announced as its new CFO, effective March 25th. As CFO, Ankur will lead CareDx’s global financial organization. including treasury, tax and other corporate functions, and report directly to President and CEO Reg Seeto. Takeda submits a regulatory application for drug approval to prevent hereditary angioedema in Japan. Takeda Pharmaceutical Company Limited (NYSE: TAK) said it had submitted a new drug application to the Japanese Ministry of Health, Labor and Welfare for subcutaneous injection of lanadelumab, a monoclonal antibody treatment prophylaxis against hereditary angioedema attacks. Altimmune expands the intranasal COVID-19 collaboration with the manufacture of Vaccoine with Lonza from Altimmune, Inc. (NASDAQ: ALT), has said it has expanded its previously announced AdCOVID manufacturing partnership with Swiss CDMO Lonza. Under the expanded agreement, Lonza will set up a dedicated production suite for clinical and commercial production of AdCOVID, Altimmune’s intranasal vaccine candidate for COVID-19, at its plant near Houston, Texas. Altimmune shares rose 19.67% to $ 20.20 on Friday. Sanofi-Translate Bio Launch Phase 1/2 study of COVID-19 vaccine candidate Sanofi (NASDAQ: SNY) and Translate Bio, Inc. (NASDAQ: TBIO) has announced the start of Phase 1/2 clinical trial for MRT5500, an mRNA vaccine, candidate against SARS-CoV-2. Translate Bio has said it will receive a $ 25 million payment based on reaching this milestone. The companies expect interim results of this trial in the third quarter of 2021. Aveo will study Fotivda in combination with Opdivo for kidney cancer Aveo has announced a collaboration with clinical trials with Bristol-Myers Squibb Company (NYSE: BMY) to introduce the Fotovda recently approved, to evaluate. with the latter’s Opdivo in a crucial phase 3 TiNivo-2 study in patients with advanced relapse or refractory renal cell carcinoma after exposure to immunotherapy. Bristol-Myers Squibb will provide Opdivo clinical medicine providers for the study, and AVEO will serve as the study sponsor and be responsible for the costs of conducting the trial. Aveo shares rose 10.78% to $ 13.15 on Friday, while Bristol-Myers Squibb rose 0.33% to $ 60.55. Earnings Champions Oncology, Inc. (NASDAQ: CSBR) said its third-quarter revenue increased 10% year-on-year to $ 10.8 million. Earnings per share rose from 3 cents to 5 cents, while analysts estimated earnings of 1 cent per share. The stock rose 8.18% to $ 11.90 in after-hours trading. Chembio Diagnostics, Inc. (NASDAQ: CEMI) fourth-quarter revenue rose 62% year-on-year to $ 10.2 million. However, the net loss per share increased from 23 cents to 35 cents, while analysts predicted a smaller loss of 28 cents per share. The stock fell 10.12% to $ 4.44 in after-sales. See more earnings at IBB Histogen Inc. (NASDAQ: HSTO) said its fourth-quarter revenue fell from $ 1.6 million in 2019 to $ 0.5 million, with the decline mainly due to a decline in the fulfillment of CCM’s orders to AbbVie Inc. (NYSE: ABBV) Allergan. The net loss per share decreased from 70 cents to 26 cents. Analysts estimated an average loss of 35 cents per share. In the after-hours trade, the stock fell 7.75% to $ 1.31. Capricor Therapeutics, Inc. (NASDAQ: CAPR) reported a loss of 21 cents per share in the fourth quarter, smaller than a year ago loss of 34 cents per share, but wider than the consensus estimate for a loss of 20 cents per share. The stock fell 7.94% to $ 5.10 in trading after hours. Geron Corporation (NASDAQ: GERN)’s fourth-quarter loss in the 2020 financial year more than halved to 7 cents a share. However, the loss was wider than the consensus estimate which requires a loss of 6 cents per share. In the after-hours trading, the stock lost 5.29% to $ 1.79. The net sales of Evoke Pharma, Inc. (NASDAQ: EVOK)’s fourth quarter rose to $ 23,000 in 2020, when the company began marketing its gastroparesis drug Gimoti nasal spray, which was approved in late June 2020. The net loss per share increased from 6 cents to 9 cents, while the analyst estimates a larger loss of 13 cents per share. The stock fell 29.03% to $ 2.20 in the after-hours trade. Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC), said it intends to offer shares of its ordinary shares for sale in an endorsed public offering. All the shares in the proposed offering are sold by Cyclacel. The stock slipped 5.97% to $ 7.40 after hours. Marker Therapeutics, Inc. (NASDAQ: MRKR) has announced that it has launched an endorsed public offering of shares in its ordinary shares. The stock fell 24.90% on Friday to $ 1.90 in the pre-trade. On the radar earnings Iterum Therapeutics plc (NASDAQ: ITRM) PLx Pharma Inc. (NASDAQ: PLXP) IPOs Prometheus Biosciences, Inc. priced its large initial public offering of 10 million shares of its common stock at $ 19.00 per share, above the estimated price range of $ 16- $ 18. All shares are offered by the company. The shares will start trading on the Nasdaq under the symbol “RXDX”. The gross proceeds from the offer are expected to total $ 190 million. Prometheus is a precision medicine company that develops therapeutic and associated diagnostic products for inflammatory bowel disease. Longboard Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focusing on the development of drugs for neurological diseases, priced its 5 million shares IPO at $ 16.00 per share for a gross return of $ 80 million. The shares are expected to trade on the Nasdaq under the symbol “LBPH”. Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates See More From Benzinga Click Here For Options Trading On Benzinga The Daily Biotech Pulse: Contrasting COVID-19 Treatment Readings From Roche, For, Delay In Kadmon’s FDA Review, Alzheimer’s Data From ProthenaThe Daily Biotech Pulse: MediciNova Bags BARDA Contract, Lilly’s COVID-19 Antibody Cocktail Data, Bluebird Bio refutes blood cancer link © 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.