The Every day Biotech Pulse: Novavax Vaccine Information, ContraFect Secures BARDA Funding, 2 IPOs
This is a roundup of prime developments within the biotech house over the past 24 hours. Scaling The Peaks (Biotech Shares Hitting 52-week Highs March 11) Affimed N.V. (NASDAQ: AFMD) AngioDynamics, Inc. (NASDAQ: ANGO) Apyx Medical Company (NASDAQ: APYX) AVEO Prescription drugs, Inc. (NASDAQ: AVEO) Axonics Modulation Applied sciences, Inc. (NASDAQ: AXNX) BioAtla, Inc. (NASDAQ: BCAB) BioCryst Prescription drugs, Inc. (NASDAQ: BCRX) Bolt Biotherapeutics, Inc. (NASDAQ: BOLT) Entera Bio Ltd. (NASDAQ: ENTX) ( introduced optimistic Section 2 biomarker knowledge for osteoarthritis drug) Harvard Bioscience, Inc. (NASDAQ: HBIO) IDEAYA Biosciences, Inc. (NASDAQ: IDYA) Inari Medical, Inc. (NASDAQ: NARI) Jounce Therapeutics, Inc. (NASDAQ: JNCE) Longeveron Inc. (NASDAQ: LGVN) (introduced FDA granting expanded entry approval for its investigational cell remedy Lomecel-B to a pediatric affected person with hypoplastic left coronary heart syndrome) Magenta Therapeutics, Inc. (NASDAQ: MGTA) Nuvation Bio Inc. (NASDAQ: NUVB)(introduced orphan drug designation for NUV-422 in treating malignant gliomas) Renalytix AI plc (NASDAQ: RNLX) Sol-Gel Applied sciences Ltd. (NASDAQ: SLGL) Surmodics, Inc. (NASDAQ: SRDX) Verrica Prescription drugs Inc. (NASDAQ: VRCA) Down In The Dumps Not one of the NYSE- and Nasdaq-listed biotech/diagnostic shares hit 52-week lows Thursday. Shares In Focus Novavax Confirms Efficacy Information Following Remaining Evaluation of U.Okay. Section 3 Information Novavax, Inc. (NASDAQ: NVAX) introduced closing knowledge from the U.Okay. leg of the Section 3 research of its coronavirus vaccine candidate NVX-CoV2373, exhibiting efficacy of 96.4% in opposition to the unique COVID-19 pressure. Remaining knowledge additionally confirmed that efficacy fell to 86.3% in opposition to the B.1.1.7 variant circulating within the U.Okay. Total efficacy was 89.7%, barely increased than the 89.3% reported based mostly on preliminary evaluation in late January. The corporate additionally introduced an entire evaluation of knowledge from the Section 2b research in South Africa, exhibiting a 55.4% efficacy amongst HIV-negative trial participant, the place the overwhelming majority of the strains have been of the B1.351 variants. The inventory climbed 23.11% to $231 in after-hours buying and selling. ContraFect Will get $86.8M In BARDA Funding For Section 3 Research of Investigational Asset to Deal with Bacterial An infection In Bloodstream ContraFect Company (NASDAQ: CFRX) mentioned it has been awarded a cost-share contract for supporting its ongoing pivotal Section 3 DISRUPT superiority research of exebacase in sufferers with Staph aureus bacteremia, together with right-sided endocarditis. The contract offers for ContraFect receiving $9.8 million in preliminary funding and as much as an extra $77 million. if supported by Section 3 knowledge, BARDA might present the corporate with further funding upon achievement of key milestones to proceed the development of exebacase by way of FDA product approval and completion of post-approval commitments. The corporate expects outcomes from the Section 3 research interim futility evaluation within the second half of 2021. The inventory jumped 37.17% to $8.17 in after-hours buying and selling. CareDx Pronounces Appointment of New CFO CareDx, Inc (NASDAQ: CDNA) introduced the appointment of Agilent Applied sciences, Inc. (NYSE: A) govt Ankur Dhingra as its new CFO, efficient March 25. As CFO, Ankur will lead CareDx’s world finance group together with treasury, tax, and different company capabilities, and report on to President and CEO Reg Seeto. Takeda Recordsdata Regulatory Utility For Approval of Drug to Forestall Hereditary Angioedema In Japan Takeda Pharmaceutical Firm Restricted (NYSE: TAK) mentioned it has submitted a brand new drug software to Japan’s Ministry of Well being, Labour and Welfare for lanadelumab subcutaneous injection, a monoclonal antibody remedy for prophylaxis in opposition to assaults of hereditary angioedema. Altimmune Expands Intranasal COVID-19 Vaccoine Manufacturing Collaboration With Lonza Altimmune, Inc. (NASDAQ: ALT) mentioned it has expanded its previously-announced AdCOVID manufacturing collaboration with Swiss CDMO Lonza. Below the expanded settlement, Lonza will fee a devoted manufacturing suite for medical and industrial manufacturing of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate for COVID-19, at its facility close to Houston, Texas. Altimmune shares have been rallying 19.67% to $20.20 in premarket buying and selling Friday. Sanofi-Translate Bio Begin Section 1/2 Research of COVID-19 Vaccine Candidate Sanofi (NASDAQ: SNY) and Translate Bio, Inc. (NASDAQ: TBIO) introduced the beginning of the Section 1/2 medical trial for MRT5500, an mRNA vaccine candidate in opposition to SARS-CoV-2. Translate Bio mentioned it can obtain a $25 million cost based mostly on achievement of this milestone. The businesses count on interim outcomes from this trial within the third quarter of 2021. Aveo to Research Fotivda In Mixture With Opdivo For Kidney Most cancers Aveo introduced a medical trial collaboration with Bristol-Myers Squibb Firm (NYSE: BMY) to guage its recently-approved Fotivda with the latter’s Opdivo in a pivotal Section 3 TiNivo-2 trial in sufferers with superior relapsed or refractory renal cell carcinoma following prior immunotherapy publicity. Bristol-Myers Squibb will present Opdivo medical drug provide for the research and AVEO will function the research sponsor and will probably be answerable for prices related to the trial execution. Aveo shares have been advancing 10.78% to $13.15 in premarket buying and selling Friday, whereas Bristol-Myers Squibb was edging 0.33% to $60.55. Earnings Champions Oncology, Inc. (NASDAQ: CSBR) mentioned its third-quarter revenues elevated 10% year-over-year to $10.8 million. The earnings per share elevated from 3 cents to five cents, whereas analysts had estimated a revenue of 1 cent per share. The inventory rose 8.18% to $11.90 in after-hours buying and selling. Chembio Diagnostics, Inc.’s (NASDAQ: CEMI) fourth-quarter revenues climbed 62% year-over-year to $10.2 million. The web loss per share, nonetheless, widened from 23 cents to 35 cents, whereas analysts had forecast a narrower lack of 28 cents per share. The inventory slumped 10.12% to $4.44 in after-hours buying and selling. View extra earnings on IBB Histogen Inc. (NASDAQ: HSTO) mentioned its fourth-quarter revenues fell from $1.6 million in 2019 to $0.5 million, with the decline primarily as a consequence of a lower in success of provide orders of CCM to AbbVie Inc.’s (NYSE: ABBV) Allergan. The web loss per share narrowed from 70 cents to 26 cents. Analysts, on common, had estimated a lack of 35 cents per share. In after-hours buying and selling, the inventory was down 7.75% to $1.31. Capricor Therapeutics, Inc. (NASDAQ: CAPR) reported a fourth-quarter lack of 21 cents per share, narrower than the year-ago lack of 34 cents per share however wider than the consensus estimate for a lack of 20 cents per share. The inventory fell 7.94% to $5.10 in after-hours buying and selling. Geron Company’s (NASDAQ: GERN) fiscal-year 2020 fourth-quarter loss greater than halved to 7 cents per share. The loss, nonetheless, was wider than the consensus estimate that referred to as for a lack of 6 cents per share. In after-hours buying and selling, the inventory misplaced 5.29% to $1.79. Evoke Pharma, Inc.’s (NASDAQ: EVOK) fourth-quarter web gross sales got here in at $23,000 in 2020, as the corporate started advertising its gastroparesis drug Gimoti nasal spray, which was accredited in late June 2020. The web loss per share widened from 6 cents to 9 cents, whereas analyst estimated a wider lack of 13 cents per share. The inventory plunged 29.03% to $2.20 in after-hours buying and selling. Choices Cyclacel Prescription drugs, Inc. (NASDAQ: CYCC) mentioned it intends to supply shares of its widespread inventory on the market in an underwritten public providing. All the shares within the proposed providing are to be offered by Cyclacel. The inventory slid 5.97% to $7.40 in after-hours buying and selling. Marker Therapeutics, Inc. (NASDAQ: MRKR) introduced that it has commenced an underwritten public providing of shares of its widespread inventory. The inventory was plunging 24.90% to $1.90 in premarket buying and selling Friday. On The Radar Earnings Iterum Therapeutics plc (NASDAQ: ITRM) PLx Pharma Inc. (NASDAQ: PLXP) IPOs Prometheus Biosciences, Inc. priced its upsized preliminary public providing of 10 million shares of its widespread inventory at $19.00 per share, above the estimated value vary of $16-$18. All the shares are being supplied by the corporate. The shares will start buying and selling on the Nasdaq underneath the ticker image “RXDX.” The gross proceeds from the providing, are anticipated to be $190 million. Prometheus is a precision drugs firm creating therapeutics and companion diagnostic merchandise for inflammatory bowel illness. Longboard Prescription drugs, Inc., a clinical-stage biopharmaceutical firm targeted on creating medicines for neurological ailments, priced its IPO of 5 million shares at $16.00 per share, for producing gross proceeds of $80 million. The shares are anticipated to start buying and selling on the Nasdaq underneath the image “LBPH.” Associated Hyperlink: Consideration Biotech Buyers: Mark Your Calendar For March PDUFA Dates See extra from BenzingaClick right here for choices trades from BenzingaThe Every day Biotech Pulse: Contrasting COVID-19 Therapy Readouts From Roche, Vir, Delay In Kadmon’s FDA Overview, Alzheimer’s Information From ProthenaThe Every day Biotech Pulse: MediciNova Baggage BARDA Contract, Lilly’s COVID-19 Antibody Cocktail Information, Bluebird Bio Refutes Blood Most cancers Hyperlink© 2021 Benzinga.com. Benzinga doesn’t present funding recommendation. All rights reserved.