Regeneron Covid-19 Trial Meets Primary Endpoint

 Regeneron Pharmaceutical Inc. said Thursday that a clinical trial of its REGN-COV candidate treatment for Covid-19 met the drug's primary endpoint of significantly reducing viral load within seven days in hospitalized patients.

Regeneron said that the drug, an antibody cocktail of casirivimab and imdevimab, reduced the risk of death by 36% about a month after treatment began in the study's patient population.

The Phase 2/3 trial included 1,197 patients hospitalized with Covid-19, including some using supplemental oxygen and some who weren't. Patients got either a placebo, or one of two dose levels of REGN-COV.

REGN-COV hasn't been approved by the Food and Drug Administration, but its use has been authorized in some high-risk patients for treatment and post-exposure prophylaxis. Regeneron shares climbed 2.2% in pre-market trading.

https://www.marketscreener.com/quote/stock/REGENERON-PHARMACEUTICALS-10649/news/Regeneron-Covid-19-Trial-Meets-Primary-Endpoint-36557162/

Merck to buy Acceleron for about $11.5 billion in rare disease drugs push

 

Merck & Co will buy drugmaker Acceleron Pharma Inc for about $11.5 billion, the companies said on Thursday, as the U.S. pharmaceutical giant looks to beef up its portfolio with drugs for rare diseases.

Merck will pay $180 per Acceleron share in cash, representing a premium of about 2.6% to the stock's closing price on Wednesday, according to Refinitiv data.

The deal gives Merck, which makes the blockbuster cancer drug Keytruda, access to a potentially lucrative rare disease drug candidate, sotatercept.

Cambridge, Massachusetts-based Acceleron focuses on therapeutics that treat cardiovascular and other blood-related disorders. Its sotatercept drug, which is currently in a late-stage study, is aimed at treating a rare cardiovascular disease called pulmonary arterial hypertension (PAH), a type of high blood pressure that affects the lungs.

The market for treatments targeting rare diseases has become lucrative, as drugmakers typically charge higher prices for drugs which serve small patient populations.

An estimated 25-30 million Americans are living with a rare disease, according to the U.S. National Institute Of Health, prompting a number of drugmakers to eye that slice of the market.

Along with sotatercept, Merck will gain access to Reblozyl, which is approved for the treatment of two blood-related disorders, including anemia in patients with beta thalassemia.

"Although the acquisition of Acceleron will not fully remove the overhang of generic competition for MRK's single largest drug Keytruda (we estimate 37% of 2021 sales), it does help diversify sales, which addresses a large shareholder concern," Cantor Fitzgerald analyst Louise Chen said in a client note.

The transaction is expected to close in the fourth quarter.

https://www.marketscreener.com/news/latest/Merck-to-buy-Acceleron-for-about-11-5-billion-in-rare-disease-drugs-push--36557138/

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