Bausch: Significant Top Line Results in 2nd Dry Eye Phase 3

 Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") and Novaliq GmbH ("Novaliq"), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced statistically significant topline data from the second Phase 3 (MOJAVE) trial evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). The companies announced statistically significant topline data from the first Phase 3 trial (GOBI trial) in April 2021.

"The findings from this second Phase 3 trial reinforce the results of the first Phase 3 trial and further supports the efficacy and safety profile of NOV03 as a potential important new treatment option for the millions of people living with dry eye disease associated with MGD," said Joseph C. Papa, chairman and CEO, Bausch Health. "These results mark another important milestone in bringing NOV03 to market as a potential first-in-class treatment, and we anticipate filing a New Drug Application to the U.S. Food and Drug Administration in 2022."

https://finance.yahoo.com/news/bausch-lomb-announces-statistically-significant-105900789.html

Trevena: Positive Results in Proof-of-Concept Study in COVID-19

 92% probability that TRV027 has a potential beneficial impact on primary endpoint of D-dimer levels, a biomarker associated with critical illness and mortality

~12 days lower average hospital length of stay in patients treated with TRV027 compared to placebo

TRV027 is currently being evaluated in a randomized controlled study (NIH ACTIV-4) and a global adaptive platform study (REMAP-CAP)

TRV027 is a novel AT1 receptor selective agonist with the potential to treat acute lung damage / abnormal blood clotting associated with COVID-19

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Company to host conference call today, September 30th, 2021, at 8:00 a.m. ET

Conference Call and Webcast Information

The Company will host a conference call and webcast with the investment community on September 30, 2021, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer and Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer.

Title:	TRV027 Proof-of-Concept Data Presentation
Date:	Thursday, September 30, 2021
Time:	8:00 a.m. ET
Conference Call Details:	Toll-Free: (855) 465-0180
	International: (484) 756-4313
	Conference ID: 6687853
Webcast:	https://edge.media-server.com/mmc/p/piusmnaa https://finance.yahoo.com/news/trevena-announces-results-trv027-proof-110000150.html

TG Therapeutics Files with FDA for MS Treatment

 TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, as a treatment for patients with relapsing forms of multiple sclerosis (RMS). The submission was based on the results of the ULTIMATE I & II trials, two identical Phase 3, randomized, global, multi-center, double-blinded, active-controlled trials evaluating ublituximab compared to teriflunomide in patients with RMS. The ULTIMATE I & II trials were conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

https://finance.yahoo.com/news/tg-therapeutics-submits-biologics-license-113000407.html

37% of COVID patients deal with at least 1 long-term symptom

 While many people recover from the initial infection of COVID-19, there has been growing fear of COVID-19 long haulers who have problems months after becoming infected. A new study now quantifies how many people are running into those problems.

The study from the University of Oxford, the National Institute for Health Research, and the Oxford Health Biomedical Research Centre found 37% of COVID-19 patients suffered from at least one long-COVID symptom in the three to six month period after infection.

Researchers said the study looked at more than 270,000 people recovering from COIVD-19 and looked at nine core long-COVID symptoms and how often they were diagnosed.

The long-COVID symptoms that occurred 90-180 days after COVID-19 was diagnosed, and their frequency, included:

• Abnormal breathing - (8%)
• Abdominal symptoms - (8%)
• Anxiety/depression - (15%)
• Chest/throat pain - (6%)
• Cognitive problems - (4%)
• Fatigue - (6%)
• Headache - (5%)
• Myalgia - (1.5%)
• Other pain - (7%)

The study's authors said if the entire 180 day period after COVID-19 infection was included, "higher rates of the symptoms were seen."

According to the study, the severity of infection, age, and sex also impacted the likelihood of long-COVID symptoms. Those who were hospitalized typically saw more frequent symptoms. Older patients and men had more breathing difficulties and cognitive problems, while young people and women had more headaches, abdominal symptoms, and anxiety/depression, the study found.

The researchers involved said the study showed that "a significant proportion of people, of all ages, can be affected by a range of symptoms and difficulties in the six months after COVID-19 infection." However, they also noted the study doesn't explain what causes the long-COVID symptoms or how long they will last.

https://www.abcactionnews.com/news/coronavirus/study-finds-37-of-covid-patients-deal-with-at-least-1-long-term-symptom

Revenue cycle management platform Ensemble Health Partners files for estimated $500M IPO

 Ensemble Health Partners, which provides a healthcare revenue cycle management platform, filed on Wednesday with the SEC to raise up to $100 million in an initial public offering. However, this is likely a placeholder for a deal we estimate could raise up to $500 million.

Ensemble states that it is a leading provider of technology-enabled revenue cycle management (RCM) solutions for health systems, including hospitals and affiliated physician groups. The company manages and optimizes health systems' RCM operations from patient intake through revenue collection by deploying a scalable operating model that leverages a combination of experienced operators, proven processes, and proprietary cloud-based technology. The company derives a majority of net revenue from long-term, end-to-end RCM contracts, which generally have an initial term of 5-10 years with automatic renewals thereafter.

The Cincinnati, OH-based company was founded in 2014 and booked $742 million in revenue for the 12 months ended June 30, 2021. It plans to list on the Nasdaq under the symbol ENSB. Ensemble Health Partners filed confidentially on June 11, 2021. Goldman Sachs, BofA Securities, Deutsche Bank, Guggenheim Securities, Credit Suisse, Evercore ISI, Wells Fargo Securities, SVB Leerink, Baird, and William Blair are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: ENSB

https://www.renaissancecapital.com/IPO-Center/News/86628/Revenue-cycle-management-platform-Ensemble-Health-Partners-files-for-an-est

Health and wellness SPAC Thrive Acquisition cuts deal size by 25% ahead of $150M IPO

 Thrive Acquisition, a blank check company targeting the global health and wellness industry, lowered the proposed deal size for its upcoming IPO on Wednesday.

The Newton, MA-based company now plans to raise $150 million by offering 15 million units at $10. The company had previously filed to offer 20 million units at the same price. Each unit still consists of one share of common stock and one-half of a warrant, exercisable at $11.50. At the revised deal size, Thrive Acquisition will raise -25% less in proceeds than previously anticipated.

The company is led by CEO and Director Charles Jobson, the founder and former Portfolio Manager of global equity hedge fund Delta Partners. The company plans to target the global health and wellness industry, focusing on branded food, beverage, and consumer products in the better-for-you or sustainability-focused market sectors, as well as companies supporting the consumer shift towards health and wellness through innovative platforms or technologies.

Thrive Acquisition was founded in 2021 and plans to list on the Nasdaq under the symbol THAC.U. BTIG is the sole bookrunner on the deal.

Relevant Profile: THAC.U

https://www.renaissancecapital.com/IPO-Center/News/86637/Health-and-wellness-SPAC-Thrive-Acquisition-lowers-deal-size-by-25-ahead-of

Inflammatory disease biotech Ventyx Biosciences files for a $100 million IPO

 Ventyx Biosciences, a Phase 1 biotech developing selective therapies for inflammatory and autoimmune diseases, filed on Wednesday with the SEC to raise up to $100 million in an initial public offering.

Ventyx is focused on advancing new therapies for patients living with inflammatory diseases and autoimmune disorders. Its lead candidate is VTX958, an oral, selective clinical-stage tyrosine kinase type 2 inhibitor that it believes has the potential to address a broad range of immune-mediated diseases, such as psoriasis, inflammatory bowel disease, psoriatic arthritis, and lupus. The company plans to develop VTX958 initially for psoriasis, psoriatic arthritis, and Crohn's disease. Ventyx has completed the single-ascending dose portion of its Phase 1 trial for VTX958 and expects to initiate the multiple-ascending dose part of this trial in the 4Q21.

The Encinitas, CA-based company was founded in 2018 and plans to list on the Nasdaq under the symbol VTYX. Ventyx Biosciences filed confidentially on August 20, 2021. Jefferies, Evercore ISI, and Piper Sandler are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: VTYX

https://www.renaissancecapital.com/IPO-Center/News/86643/Inflammatory-disease-biotech-Ventyx-Biosciences-files-for-a-$100-million-IP