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The Daily Biotech Pulse: Novavax Vaccine Data, ContraFect Secures BARDA Funding, 2 IPOs
Here is a summary of the main developments in the biotechnology space in the past 24 hours. Scaling peaks (biotech stocks reaching 52 week highs on March 11) NV Affine (NASDAQ: AFMD) AngioDynamics, Inc. (NASDAQ: ANGO) Apyx Medical Corporation (NASDAQ: APYX) AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO ) Axon Modulation Technologies, Inc. (NASDAQ: AXNX) BioAtla, Inc. (NASDAQ: BCAB) BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) Bolt Biotherapeutics, Inc. (NASDAQ: BOLT) Entera Bio Ltd. (NASDAQ: ENTX) (announced as positive Phase 2 biomarker data for osteoarthritis medication) Harvard Bioscience, Inc. (NASDAQ: HBIO) IDEAYA Biosciences, Inc. (NASDAQ: IDYA) Inari Medical, Inc. (NASDAQ: NARI) Jounce Therapeutics, Inc. (NASDAQ: JNCE) Longeveron Inc. (NASDAQ: LGVN) (announced the FDA granting expanded access approval for its experimental cell therapy Lomecel-B for a pediatric patient with hypoplastic left heart syndrome) Magenta Therapeutics, Inc. (NASDAQ: MGTA) Nuvation Bio Inc. (NASDAQ: NUVB) (announced the orphan designation 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 biotech / diagnostic stocks listed on the NYSE and Nasdaq hit 52 -Week low Thursday. Stocks In Focus Novavax confirms efficacy data after final analysis of UK Phase 3 data Novavax, Inc. (NASDAQ: NVAX) announced final data for the UK Phase 3 study phase of its NVX coronavirus candidate vaccine -CoV2373, showing 96.4% effectiveness against the original COVID-19 strain. Final data also showed that the effectiveness dropped to 86.3% against variant B.1.1.7 circulating in the United Kingdom. The overall effectiveness 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 complete analysis of the data from the Phase 2b study in South Africa, showing an efficiency of 55.4% among participants in the HIV negative study, where the vast majority of strains were of the B1.351 variants. The shares rose 23.11%, to US $ 231 on the floor. ContraFect obtains $ 86.8 million in BARDA funding for the Phase 3 study of investigative assets to treat bacterial infection in the bloodstream ContraFect Corporation (NASDAQ: CFRX) said it received a cost-sharing contract to support its study of superiority of Phase 3 DISRUPT in progress of exebacase in patients with Staph aureus bacteremia, including endocarditis on the right side. The contract provides for ContraFect to receive $ 9.8 million in initial financing and up to an additional $ 77 million. if supported by Phase 3 data, BARDA can provide the company with additional funding by achieving important milestones to continue the advance of exebacase through FDA product approval and completion of post-approval commitments. The company expects results from the interim futility analysis of the Phase 3 study in the second half of 2021. The shares jumped 37.17%, to $ 8.17 in after-hours trading. CareDx announces appointment of new CFO CareDx, Inc (NASDAQ: CDNA) announced the appointment of Agilent Technologies, Inc. (NYSE: A) executive Ankur Dhingra as its new CFO, starting March 25. As CFO, Ankur will lead CareDx’s global financial organization including treasury, taxes 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 has submitted a new drug application to the Ministry of Health, Labor and Welfare of Japan for subcutaneous injection of lanadelumab, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema. Altimmune expands COVID-19 intranasal vaccine manufacturing collaboration with Lonza Altimmune, Inc. (NASDAQ: ALT) said it expanded its previously announced AdCOVID manufacturing collaboration with Swiss CDMO Lonza. Under the expanded agreement, Lonza will contract a dedicated manufacturing suite for the clinical and commercial production of AdCOVID, Altimmune’s candidate single-dose intranasal vaccine for COVID-19, at its facilities near Houston, Texas. Altimmune’s shares were up 19.67% to $ 20.20 in Friday’s pre-market. Sanofi-Translate Bio Start Phase 1/2 of the COVID-19 Vaccine Candidate Sanofi study (NASDAQ: SNY) and Translate Bio, Inc. (NASDAQ: TBIO) announced the start of the Phase 1/2 clinical trial for MRT5500, a vaccine candidate mRNA against SARS-CoV-2. Translate Bio said it will receive a payment of $ 25 million based on the achievement of this milestone. Companies expect interim results from this trial in the third quarter of 2021. Aveo will study Fotivda in combination with Opdivo for kidney cancer Aveo has announced a clinical trial collaboration with the Bristol-Myers Squibb Company (NYSE: BMY) to evaluate its recently approved Fotivda with the Opdivo of the latter in a main Phase 3 study of TiNivo-2 in patients with relapsed or advanced refractory renal cell carcinoma after previous exposure to immunotherapy. Bristol-Myers Squibb will supply Opdivo’s clinical drug supply for the study and AVEO will act as the study sponsor and will be responsible for the costs associated with running the study. Aveo shares advanced 10.78% to $ 13.15 in Friday’s pre-market, while Bristol-Myers Squibb was advancing 0.33% to $ 60.55. Earnings Champions Oncology, Inc. (NASDAQ: CSBR) said its third quarter revenue increased 10% year-over-year to $ 10.8 million. Earnings per share increased from 3 cents to 5 cents, while analysts estimated earnings of 1 cent per share. The shares rose 8.18%, to $ 11.90 in the trading session. Fourth-quarter revenue from Chembio Diagnostics, Inc. (NASDAQ: CEMI) increased 62% year-over-year to $ 10.2 million. Net loss per share, however, increased from 23 cents to 35 cents, while analysts had predicted a lesser loss of 28 cents per share. The shares plunged 10.12% to $ 4.44 in the trading session. See more profits 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 decrease in order fulfillment supply chain to AbbVie Inc. (NYSE: ABBV) Allergan. Net loss per share decreased from 70 cents to 26 cents. Analysts, on average, estimated a loss of 35 cents per share. In the after-hours market, the stock fell 7.75% to $ 1.31. Capricor Therapeutics, Inc. (NASDAQ: CAPR) reported a fourth-quarter loss of 21 cents per share, less than the previous year’s loss of 34 cents per share, but greater than the consensus estimate for a loss of 20 cents per share. The shares fell 7.94% to $ 5.10 on the floor. Geron Corporation’s fourth quarter loss for fiscal year 2020 (NASDAQ: GERN) fell by more than half to 7 cents per share. The loss, however, was greater than the consensus estimate that required a loss of 6 cents per share. In the after-hours market, the stock lost 5.29% to $ 1.79. Net sales for the fourth quarter of Evoke Pharma, Inc. (NASDAQ: EVOK) reached $ 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 estimated a greater loss of 13 cents per share. Shares plunged 29.03% to $ 2.20 on the floor. Offerings Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) has said it intends to offer common shares for sale in a subscription public offering. All shares in the proposed offering will be sold by Cyclacel. The stock fell 5.97% to $ 7.40 in the trading session. Marker Therapeutics, Inc. (NASDAQ: MRKR) announced that it has initiated a subscription public offering of common shares. Shares were plummeting 24.90% to $ 1.90 in Friday’s pre-market. On The Radar Earnings Iterum Therapeutics plc (NASDAQ: ITRM) PLx Pharma Inc. (NASDAQ: PLXP) IPOs Prometheus Biosciences, Inc. priced its increased initial public offering of 10 million common shares at $ 19.00 per share, above the price estimated range of $ 16- $ 18. All shares are being offered by the company. The shares will begin trading on Nasdaq under the symbol “RXDX”. Gross offer revenue is expected to be $ 190 million. Prometheus is a precision medicine company that develops therapeutic and complementary diagnostic products for inflammatory bowel diseases. Longboard Pharmaceuticals, Inc., a clinical biopharmaceutical company focused on developing drugs for neurological diseases, priced its IPO of 5 million shares at $ 16.00 per share, generating gross revenue of $ 80 million . The shares must begin trading on Nasdaq under the symbol “LBPH”. Related link: Attention to biotechnology investors: Mark your calendar for March PDUFA dates See more from BenzingaClick here for Benzinga options tradingThe Daily Biotech Pulse: Contrasting COVID-19 treatment readings from Roche, Vir, FDA review delay from Kadmon, 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.