While the prime focus is currently on coronavirus treatments and vaccines for the biotech sector, a few other updates were also out this week. A slew of biotechs is evaluating their pipeline drugs and vaccines for the treatment of COVID-19 and updates from these companies will drive their share prices.
Recap of the Week’s Most Important Stories:
Gilead's HCV Drug Epclusa Gets FDA Nod for Expanded Age Group: Gilead Sciences (GILD - Free Report) announced that the FDA has approved the supplemental new drug application (sNDA) to update its hepatitis C infection (HCV) drug, Epclusa’s label. The sNDA sought approval of Epclusa for the treatment of chronic HCV in pediatric patients aged six years and above or weighing at least 17 kg, regardless of HCV genotype or liver disease severity. The approval was based on data from the open-label phase II Study 1143 trial. The safety profile of Epclusa in the pediatric patient population was generally consistent with what was observed in adults.
Hoth Surges on Collaboration With Voltron: Shares of clinical-stage biopharmaceutical company, Hoth Therapeutics, Inc. (HOTH - Free Report) , surged after it announced that it has reached an agreement with Voltron Therapeutics, Inc. to form a joint venture for a Self-Assembling Vaccine (SAV) for the potential prevention from the coronavirus (COVID-19). The joint entity will be called HaloVax. Based on VaxCelerate, this SAV platform was exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH). Both companies will jointly explore and develop this SAV technology as a means to help patients at risk of being infected with COVID-19. The vaccine focuses on both DNA and internal/external mutated proteins, providing the immune system with more potential targets to attack.
Per the agreement, Hoth shall be granted the right to receive single-digit royalties from the sale of any products developed. It shall also have the right to acquire up to a 30% equity interest in HaloVax.
Hoth currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Milestone Plunges on Study Failure: Milestone Pharmaceuticals Inc. (MIST - Free Report) plunged after it announced the failure of its late-stage study on the investigational new drug, etripamil nasal spray, the company's novel short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia (PSVT). The phase III, multicenter, randomized, double-blind, placebo-controlled NODE-301 trial missed the primary endpoint of mean time to conversion of supraventricular tachycardia (SVT) to sinus rhythm (SR) over a five-hour period following dosing.
Novavax Surges on Successful Flu Study Results: Novavax (NVAX - Free Report) surged after it announced that NanoFlu achieved all primary endpoints in a phase III study. NanoFlu is the company’s recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M adjuvant, indicated for use in adults aged 65 years and older. The study evaluated the immunogenicity and safety of NanoFlu compared to FluzoneQuadrivalent, a U.S.-licensed quadrivalent influenza vaccine, using the FDA’s criteria for accelerated approval of seasonal influenza vaccines. The trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to Fluzone Quadrivalent using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. NanoFlu achieved the primary endpoints, GMT and SCR, for all four strains included in the vaccine.
IMV to Develop Vaccine Candidate Against COVID-19: IMV Inc. (IMV - Free Report) announced that it plans to start the clinical development of a DPX-based vaccine candidate for the treatment of the novel coronavirus disease. The DPX-COVID-19 vaccine will be made using its DPX technology platform. The company plans to develop this vaccine candidate and begin its phase I clinical study in collaboration with lead investigators. Per the company, the aim of this development program is to establish the clinical safety and immunogenicity of a vaccine candidate based on IMV’s lipid-based delivery platform, DPX technology, and incorporate peptides targeting novel epitopes from the coronavirus strain.
The Nasdaq Biotechnology index gained 2.06% in the last five trading sessions. Among the biotech giants, Vertex gained 6.03% during this period. Over the past six months, shares of Regeneron have gained 55.17%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA & REGN Gain on Coronavirus Treatment Updates & More)
What's Next in Biotech?
Stay tuned for more pipeline updates, with a focus on treatments for the novel COVID-19.
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