Atossa gains patent for breast cancer therapy

 Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, today announces that the U.S. Patent and Trademark office has issued a new patent further strengthening Atossa’s intellectual property in its proprietary therapy Endoxifen, which is under development for breast cancer and other breast conditions.

U.S. Patent No. 11,261,151 (the ‘151 Patent) is titled “Methods for Making and Using Endoxifen” and is directed to compositions of storage-stable Endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable Endoxifen.

https://finance.yahoo.com/news/atossa-therapeutics-announces-issuance-key-141500494.html

Can-Fite BioPharma Flags Delay In Piclidenoson Data Readout From Psoriasis Study

 Citing unanticipated delay in the collection of study data, Can-Fite BioPharma Ltd (NYSE: CANF) said that the topline data from its Phase 3 Comfort study of Piclidenoson in severe plaque psoriasis would be released in Q2 2022.

• Earlier, the data were anticipated in Q1 of 2022.

• The study enrolled more than 400 patients across 30 sites in Europe, Israel, and Canada.

• Piclidenoson is an A3 adenosine receptor agonist (A3AR) small molecule that inhibits interleukin-17 and interleukin-23, both pivotal for the formation of skin lesions.

• Piclidenoson has also recently been shown to induce the death of pathological skin cells.

• The Comfort study's primary endpoint is the proportion of patients who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16. Secondary endpoints include non-inferiority to Amgen Inc's (NASDAQ: AMGN) Otezla (apremilast).

https://finance.yahoo.com/news/fite-biopharma-flags-delay-piclidenoson-133505014.html

Alector cut to Hold from Buy by Stifel

 Target to $18 from $32

https://finviz.com/quote.ashx?t=ALEC&ty=c&ta=1&p=d

Aldeyra Initiates Phase 2 Clinical Trial of ADX-2191 for Retinitis Pigmentosa

 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, today announced that it has initiated a Phase 2 clinical trial of ADX-2191 (intravitreal methotrexate 0.8%), an investigational new drug product, for the treatment of retinitis pigmentosa (RP). RP is a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision. There are no approved treatments for RP, which affects an estimated 82,000-110,000 individuals in the United States, and approximately 1 in 4,000 people worldwide.

https://finance.yahoo.com/news/aldeyra-therapeutics-initiates-phase-2-130000676.html

Guardant Health Receives Medicare Coverage for Guardant360 TissueNext™ Test

 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for Guardant360 TissueNext™ under the existing local coverage determination (LCD) (MolDX: Next-Generation Sequencing for Solid Tumors). Guardant360 TissueNext is the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.

The policy covers Guardant360 TissueNext for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service. "We are pleased that Medicare has taken this important step to make complete genomic profiling more widely available for patients with advanced cancers," said Helmy Eltoukhy, Guardant Health co-CEO.

Medicare’s policy decision adds to the coverage of Guardant Health tests for patients with advanced stage cancer. In December 2019, Palmetto GBA expanded LCD of the Guardant360® assay, making it the first liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumor cancers.

https://finance.yahoo.com/news/guardant-health-receives-medicare-coverage-130500266.html

PROCEPT BioRobotics Reports Fourth Quarter and Full Year 2021 Financial Results

 PROCEPT® BioRobotics (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today reported financial results for the fourth quarter and full year ended December 31, 2021.

Recent Highlights

• Revenue of $10.1 million for the fourth quarter of 2021 and $34.5 million for the full year of 2021, compared to $3.2 million and $7.7 million, respectively, from the same periods of 2020

• U.S. system and rental revenue of $5.0 million for the fourth quarter of 2021, compared to $1.2 million in the prior year period

• U.S. handpiece and consumables revenue of $3.4 million for the fourth quarter of 2021, compared to $0.8 million in the prior year period

• Announced positive 5-year WATER Study data on February 14, 2022

• Issued 2022 total revenue guidance range of $54.0 million to $58.0 million
  

“We are very pleased with the results we delivered in 2021 and continue to see positive momentum in the first quarter of 2022,” said Reza Zadno, Chief Executive Officer. “We also achieved a number of critical milestones over the last few months, including approximately doubling the size of our field-based sales force and announcing 5-year WATER Study data - which highlights the durability, safety and efficacy of Aquablation therapy and demonstrates IPSS superiority compared to TURP in prostates larger than 50 mL. We believe these catalysts will accelerate the adoption of our technology to become the standard of care for BPH.”

https://finance.yahoo.com/news/procept-biorobotics-reports-fourth-quarter-120000128.html

Voyager: License Pact with Novartis Targets Gene Therapy Programs

 Voyager receives $54 million upfront with potential option exercise fees and milestone payments of up to $1.7 billion plus product sales-based royalties

Novartis receives target-specific access to Voyager’s novel TRACER AAV capsids for potential use with three CNS targets plus options to access capsids for two additional targets

Agreement marks the second recent major transaction leveraging Voyager’s TRACER capsid discovery platform

Conference call and webcast today at 8:30 a.m. ET

Conference Call
The Voyager Therapeutics leadership team will host a conference call and webcast today at 8:30 a.m. ET to discuss the Novartis license option agreement, and provide and discuss fourth quarter and full year 2021 financial and operating results. To access the call, please dial (877) 851-3834 (domestic) or (631) 291-4595 (international) and ask for the Voyager Therapeutics earnings call. A live webcast of the call will also be available on the Investors section of the Voyager website at ir.voyagertherapeutics.com, and a replay will be available at the same link approximately two hours after its completion. The replay will be available for at least 30 days following the conclusion of the call.

https://finance.yahoo.com/news/voyager-therapeutics-announces-license-option-061500864.html