Daily Brief United States: Abeona Therapeutics , Edesa Biotech , Essa Pharma , Guess? Inc, NeuroBo Pharmaceuticals , NOW Inc, Royce Micro-Cap Trust and more

• On May 15, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the first quarter of 2024 and provided a business update.
• The company is planning to resubmit the Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB) in the second half of 2024 following the receipt of a Complete Response Letter (CRL) in April 2024.
• The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data but did request additional CMC information.

• On May 10, 2024, Edesa Biotech, Inc. (EDSA) announced financial results for the second quarter of fiscal year 2024 that ended March 31, 2024 and provided a business update.
• Edesa is planning to seek regulatory approval for a Phase 2 trial of its anti-CXCL10 mAb in patients with moderate-to-severe nonsegmental vitiligo.
• For EB05, the company has expanded site selection activities for the Phase 3 study in acute respiratory distress syndrome (ARDS) caused by COVID-19 and has begun transitioning the day-to-day management of the trial to a new clinical research organization (CRO).

• On May 14, 2024, ESSA Pharma Inc. (EPIX) announced financial results for the second quarter of fiscal year 2024 that ended March 31, 2024 and provided a business update.
• ESSA is currently studying its lead compound, masofaniten (EPI-7386), in two clinical trials: EPI-7386-CS-001 and EPI-7386-CS-010.
• The -001 trial consists of Part A monotherapy treatment and Part B combination therapy of masofaniten plus abiraterone acetate/prednisone (Cohort 1 mHSPC or mCRPC) or with apalutamide following 12 weeks of monotherapy therapy (Cohort 2 nmCRPC).

• We are reiterating our Buy rating, $37 price target and projections for Guess?
• with the company announcing 1QFY25 (April) results after the close on Thursday.
• We believe 1Q, which included material upgrades in the domestic retail store base, the acquisition of contemporary leader rag & bone, continued European expansion and what we believe were cautious buys from the domestic wholesale segment, will set the stage for a strong back-half and FY26, but will result, beyond further share repurchases, in limited top and bottom line upside for 1Q.

• On May 22, 2024, NeuroBo Pharmaceuticals, Inc. (NRBO) announced that preclinical data of DA-1241 in combination with semaglutide in mouse models of metabolic dysfunction-associated steatohepatitis (MASH) will be presented at the EASL Congress 2024 on Thursday, June 6, 2024.
• Two abstracts will be presented: one using the GAN diet-induced obese and biopsy-confirmed mouse model of MASH and one using the CCl4 induced liver fibrosis model.
• The company shared some of the results that showed an additive effect on different parameters of liver health in both models, with the posters being available following the presentations.

• The 1Q24 Whitco Supply acquisition diversified DNOW’s customer base and added new revenue opportunities in the midstream markets.
• Management now expects FY24 revenue to increase in the mid- to high single digits range from FY23 and for adjusted EBITDA margin to be in line with FY23.
• Management lifted its FY24 free cash flow outlook to ~$200 million from ~$150 million.

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This content is sourced through publicly available sources and has been machine generated. Information displayed is for general informational purposes only. This article was originally published 3 months ago on Value Investors Club.