AVTX-007 data in multiple myeloma indicated the therapy is generally safe and well tolerated; no efficacy signal was seen at the high dose and the decision was made to discontinue the program
Thursday, January 6, 2022
Avalo ends multiple myeloma program
Aligos Halting Further Development of Drug Candidate
Phase 1 data at projected efficacious dose (400 mg) indicate insufficient activity against hepatitis B virus to justify further development
Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has halted further development of its STOPS™ drug candidate, ALG-010133, in development to address chronic hepatitis B (CHB). This decision is based on emerging data from the Phase 1 Study ALG-010133-101 that indicate that at the projected efficacious dose (400 mg, estimated to achieve liver exposures >3 x EC90 for HBsAg inhibition) there is no meaningful HBsAg reduction. Furthermore, higher doses levels (maximum feasible dose is 600 mg) that were planned to be evaluated in a subsequent cohort are very unlikely to reach the 1 log10 IU/mL HBsAg reduction level that Aligos had previously defined as necessary to advance the program. No dose-limiting safety findings have been identified in CHB subjects dosed at any dose level. Based on this information, Aligos management reviewed the data with members of the study’s Study Review Committee (SRC) and jointly concluded that these data were not sufficient to support further development of ALG-010133 and that dosing should be discontinued.
https://finance.yahoo.com/news/aligos-halting-further-development-stops-130000126.html
Eargo Launches Eargo 6 with Sound Adjust for Effortless Hearing
Eargo, Inc. (Nasdaq: EAR), a medical device company on a mission to improve the quality of life of people with hearing loss, today launched Eargo 6, its sixth-generation FDA Class II exempt hearing aid and most powerful device yet, at CES 2022.
Eargo 6’s new Sound Adjust technology is an example of better hearing, made effortless. Its proprietary algorithm identifies the user’s surroundings and instantly modifies the hearing device’s settings to ensure optimal benefit, without requiring manual input from the wearer. Eargo 6 also introduces a new environmental offset called “mask mode” to offset the communication challenges faced by individuals with hearing loss while conversing with someone wearing a face mask; a user can select “mask mode” through the app.
“The current hearing aid model is broken: the customer has not been at the heart of the experience, and innovation has lagged to the detriment of the user," said Christian Gormsen, Eargo’s President and CEO. “Millions of Americans who could benefit from a device have long been boxed out of the category by clunky, unaffordable, and inconvenient solutions. By completely transforming how the product looks, works, and is purchased, we are one step closer to our overarching goal of changing the way the world thinks about hearing loss, and eliminating the stigmas surrounding it.”
Eargo 6’s new core features include:
Hearing Made Effortless: Eargo 6's Sound Adjust feature identifies the environment users are in and automatically modifies the device settings to provide optimal benefit. No need for users to pull out their app or tap their ear to make a manual change, as Eargo 6 adjusts automatically.
Improved Performance in Noise: Eargo’s fast-acting noise reduction reduces loud background noise and noise between pauses in speech, while leaving the speech energy unaffected, enabling improved hearing in noisy environments such as restaurants.
Water-resistance: Eargo 6 has been tested to a water-resistance rating of IPX7, or water resistance of up to 30 minutes at a water depth of up to one meter.
Valneva Confirms Trial, Submission Timelines for Inactivated COVID-19 Vaccine
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirms the previously communicated timelines of its clinical trials and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
As announced in December 20211, the Company commenced rolling submissions for initial approval of VLA2001 with the European Medicines Agency, the UK MHRA and the Bahraini NHRA, and is continuing to work closely with those authorities to complete their review process following its positive Phase 3 trial results2. Valneva continues to expect potential regulatory approvals in the first quarter of 20221.
The Company also announced positive homologous booster results at the end of December 20213. The data showed an excellent immune response after a third dose of VLA2001 administered seven to eight months after the second dose of primary vaccination. Valneva is also evaluating the sera from the boosted participants for cross-neutralization against Variants of Concern, including Omicron. In parallel, the Company is preparing to launch a dedicated heterologous booster trial, which will evaluate a VLA2001 booster shot provided at least six months after primary vaccination with licensed COVID-19 vaccines or following natural COVID-19 infection.
VLA2001 is also being evaluated in elderly and adolescent volunteers. The Company expects to report topline data for the elderly trial in the coming weeks.
https://finance.yahoo.com/news/valneva-confirms-clinical-trial-regulatory-060000273.html
Lilly, Entos to collaborate on neurological therapies
Combination of Entos' Fusogenix nucleic acid delivery technology and Lilly's therapeutic cargo offers potential to overcome a key challenge in delivering nucleic acid therapies to the nervous system
Eli Lilly and Company (NYSE: LLY) has acquired exclusive rights to Entos Pharmaceuticals' Fusogenix nucleic acid delivery technology to research, develop and commercialize nucleic acid products targeting the central and peripheral nervous system, the companies announced today. This technology provides an opportunity for Lilly to access a novel delivery platform technology with the potential to solve a key delivery challenge for many nucleic acid therapeutic modalities.
Under the terms of the research and collaboration agreement, Lilly and Entos have agreed to multiple programs focused on the development of proteo-lipid vehicles (PLV) for delivery of therapeutic cargo supplied by Lilly to targets in the central and peripheral nervous systems. Entos will be responsible for the generation, development and optimization of PLVs using its proprietary Fusogenix platform technology. Lilly will be responsible for selecting PLVs for clinical development and commercialization. Entos will receive an initial payment of $50 million, which includes an equity investment by Lilly in Entos. For each of the programs under the collaboration, Entos is also eligible to receive up to $400 million in potential developmental and commercial milestone payments, as well as royalties upon the successful development and commercialization of products.
https://finance.yahoo.com/news/lilly-entos-pharmaceuticals-enter-research-114500980.html
Walgreens Beats Views for Q1, Raises Guidance for Fiscal Year
First quarter highlights
First quarter earnings per share (EPS*) from continuing operations was $4.13, compared with a loss of $0.45 in the year-ago quarter; continuing operations adjusted** EPS increased to $1.68, up 53.1 percent on a constant currency basis
First quarter sales from continuing operations increased 7.8 percent to $33.9 billion, up 7.6 percent on a constant currency basis
First quarter operating income from continuing operations increased to $1.3 billion, compared with a loss of $535 million in the year-ago quarter; adjusted operating income from continuing operations increased to $1.8 billion, up 48.5 percent on a constant currency basis
VillageMD and Shields majority investments closed on November 24th and October 29th, respectively
Strong operational performance
Results surpassed expectations across business segments, driven by COVID-19 vaccinations and testing, U.S. retail comparable sales up 10.6 percent, and Boots UK retail comparable sales up 16.3 percent
WBA continues to play a leading role in fighting the COVID-19 pandemic, with Walgreens administering over 56 million vaccines to date, including 15.6 million in the first quarter
Transformational Cost Management Program is on track to deliver $3.3 billion in annual cost savings by fiscal 2024
Fiscal 2022 outlook
Increasing full year adjusted EPS guidance to low-single digit growth, from flat previously, to reflect first quarter performance and continued positive momentum; now includes 2 percentage point impact from incremental investments in team members
Outlook continues to include 4 percentage point negative impact from previously planned healthcare investments
REGENXBIO Cleared for Trial of Gene Therapy Candidate for Duchenne
Potential one-time gene therapy for the treatment of Duchenne includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector
Innovative trial design, including comprehensive immunosuppressive regimen, to evaluate safety and optimal dose
cGMP process material made at commercial-scale to be used throughout clinical development of RGX-202
REGENXBIO expects to initiate trial in the first half of 2022
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