Author: Mahrukh Rehan

Arbutus Biopharma Corporation (ABUS) has experienced an increase of 9.80% in the pre-market. However, the last trading session closed at $4.08, with a decline of 1.69%.

New Appointment of Vice President

On 21^st September 2021, ABUS reported that Lisa M. Caperelli is the new Vice President of Investor Relations. Ms. Caperelli has 20 years of experience directing the design and implementation of complete investor relations. She has also worked in corporate communications programs for a variety of publicly listed biotechnology businesses at various stages of development. Moreover, she most recently worked for Harmony Biosciences as an Associate Vice President.

Lisa is happy to join the ABUS team, which has extensive expertise in creating antivirals and is dedicated to finding treatments for chronic HBV infection and coronaviruses. She is also looking forward to working with the investing community as they continue to progress their pipeline.

ABUS announced Second Quarter 2021 Financial Results

ABUS announced second-quarter 2021 financial results on 5^th August 2021. According to the report, ABUS had $121.3 million in cash, cash equivalents, and investments, compared to $123.3 million at the end of the previous fiscal year. ABUS also spent $31.9 million on operational operations in the six months ended June 30, 2021. Moreover, the Company estimates that its $121.3 million in cash, cash equivalents, and investments will be enough to support operations through the third quarter of 2022. The research and development costs were $15.4 million, up from $10.5 million at the same time in 2020.

In addition, the general and administrative costs were $4.4 million, up from $3.6 million in the same period in 2020. Non-cash stock-based compensation costs and professional fees accounted for the majority of the increase. The Company also has outstanding shares of approximately 97.7 million. Lastly, ABUS has about 13.3 million stock options and 1.164 million convertible preferred shares outstanding.

Phase 2a Clinical Trial

ABUS announced that it has received authorization to Proceed with an Investigational New Drug Application (IND) for AB-729 on 7^th July 2021. Experts will assess the safety and effectiveness of AB-729 in a Phase 2a proof-of-concept clinical study in CHB patients. The approval of our IND application is a significant step forward for AB-729 and helps ABUS achieve its goal of establishing value as a cornerstone therapy for CHB patients.

The experts will also investigate the safety and antiviral efficacy of the AB-729 open-label, multicenter Phase 2a study. The experiment will enroll 40 stable NA-suppressed, HBeAg negative, non-cirrhotic CHB participants. Subjects will be randomized into one of four groups after receiving AB-729 for 24 weeks (60 mg SC every 8 weeks).

Revance Therapeutics, Inc. (RVNC) has experienced a decline of 33.25% in the aftermarket because the company provided a Regulatory Update on DaxibotulinumtoxinA. However, the last trading session concluded at $22.71 with an increase of 0.66%.

Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines

On 15^th October 2021, RVNC announced that FDA has granted a Complete Response Letter for DaxibotulinumtoxinA for Injection, for the treatment of mild to moderate glabellar (frown) lines. The FDA has concluded that it is unable to accept the BLA in its current form. Hence it has stated that there are issues relating to the FDA’s onsite inspection at Revance’s manufacturing plant.

RVNC intends to request an FDA Type A meeting as soon as feasible to address the issues presented. FDA’s unexpected reaction has disappointed RVNC and therefore the company is requesting further information from the agency. However, the firm is dedicated to bringing its next-generation neuromodulator to market for both aesthetic and therapeutic purposes.

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS: RVNC Investigation

RVNC announced on 15^th October that it intends to compete in the Botulinum Toxin (BOTOX) industry, which is currently controlled by Allegan. The business claims that its primary product candidate DAXI is the first long-lasting botulinum toxin. Moreover, it is pursuing FDA clearance for its usage in brow frown lines. RVNC’s claims on the FDA’s pre-approval inspection of the company’s DAXI manufacturing plant in Northern California, as well as the timeliness and likelihood of FDA approval, are the subject of the inquiry. However, RVNC management felt pleased that the FDA was carrying out the scheduled examination and that their commercialization preparations were moving well.

Launch of OPUL

On 11^th October 2021, RVNC announced the introduction of OPULTM, the first-of-its-kind Relational Commerce Platform for aesthetic practices in the United States. It combines seamless, easy, and smart payment options, practice data analytics, and better customer care. This will help encourage higher client loyalty and retention. It helps to improve patient experiences and business outcomes by cultivating strong client loyalty and connections. Moreover, OPUL is the first technology platform in the aesthetics industry to revolutionize the physician and customer experience. This launch demonstrates RVNC’s dedication to creating new benchmarks through our products and services.

RVNC announced Data from Phase 3 ASPEN-1 Clinical Trial

RVNC announced data from Phase 3 ASPEN-1 Clinical Trial Evaluating Efficacy, Duration of Effect, and Safety of DaxibotulinumtoxinA on 16^th September 2021. The sustained period of effect will encourage the safety profile of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia. However, the company is excited to submit a Supplemental Biologics License Application. This might assist patients with this severe illness to obtain long-term symptom alleviation.