Today GEN Edge sums up the week’s leaders and laggards among publicly traded biotech companies. Stay at the forefront of the week’s champions and runners-up among publicly traded biotech companies and the reasons behind the ups or downs of their stock price fluctuations.
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Biogen shares dipped 2% then bounced back 8% this week after the company on Wednesday presented long-term Phase III data of its controversial yet approved Alzheimer’s disease drug Aduhelm (aducanumab) at AD/PD 2022. After 128 weeks of treatment, patients in the long-term extension phase of two Phase III trials continued showing “significant” reductions in amyloid beta plaques and plasma p-tau181. Effective Monday, Biogen obtained sole decision-making authority over the development, commercialization and manufacturing of Aduhelm as Eisai gave up sharing global profits and losses in favor of a global royalty arrangement starting at 2% and reaching 8% when annual sales exceed $1 billion.
Blue Water Vaccines (BWV)
Blue Water shares dropped 38% on Wednesday, to $42.00, due to apparent profit-taking by investors, absent negative news or speculation, though shares remain more than quadruple their $9 IPO price. The Cincinnati-based company grossed just under $20 million through the IPO, launched last month. Blue Water is developing a universal flu vaccine designed to protect against all virulent strains, and a Streptococcus pneumoniae vaccine to prevent acute otitis media in children. The company has also licensed a norovirus shell and protrusion (S&P) nanoparticle versatile virus-like particle (VLP) platform from Cincinnati Children’s Hospital Medical Center toward vaccines for multiple infectious diseases.
Eiger BioPharmaceuticals (EIGR)
Investors eagerly snapped up shares of Eiger on Thursday, sending the stock soaring 40% after the company announced it will seek FDA Emergency Use Authorization for its Peginterferon Lambda “as soon as possible” based on positive data from the Phase III TOGETHER trial (NCT04727424). The first-in-class, type III interferon met the study’s primary endpoint by reducing the risk of COVID-19-related hospitalizations or emergency room visits greater than six hours by 50%. Lambda was also shown to cut the risk of COVID-19-related death by 60%, Eiger said. Lambda is one of 11 therapeutic agents for non-hospitalized COVID-19 patients evaluated in TOGETHER.
Nektar Therapeutics (NKTR)
Nektar’s shares plummeted 61% on Monday after the company warned of “substantial changes” to company operations following the failure of its lead candidate bempegaldesleukin (BEMPEG/NKTR-214) in the Phase III PIVOT IO-001 trial (NCT03635983) assessing the drug plus Bristol-Myers Squibb (BMS)’s Opdivo® (nivolumab) in first-line treatment for previously untreated unresectable or metastatic melanoma. The combo missed the study’s primary endpoints of progression-free survival and objective response rate—results that Nektar president and CEO Howard W. Robin called “obviously very upsetting to all of us at Nektar.” The companies unblinded the trial, and another trial of the combination (PIVOT-12, NCT04410445) in adjuvant melanoma.
Sonnet BioTherapeutics Holdings (SONN)
Microcap stock Sonnet shares nearly doubled on Wednesday, zooming 87% the day the FDA cleared the company’s IND application for SON-1010, a proprietary version of Interleukin 12 (IL-12) configured via the company’s Fully Human Albumin Binding (FHAB™) technology. Sonnet said it plans to begin a first-in-human Phase I trial in the second quarter that will evaluate SON-1010 in adult patients with advanced solid tumors. The primary endpoint will assess the drug’s safety and tolerability. The study aims to establish a maximum tolerated dose and recommended Phase II dose using monthly subcutaneous injections of SON-1010.