Obalon Engages Cowen to Explore Financial and Strategic Alternatives

Obalon Therapeutics, Inc. (NASDAQ:OBLN), a vertically integrated medical technology company with the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity,announces that the Company has retained Cowen as an independent financial advisor to assist in exploring financial and strategic alternatives. As previously announced, Obalon recently undertook an organizational restructuring intended to refocus activities, streamline operations and make more efficient use of cash. With Cowens assistance, the Company plans to expand these efforts by exploring a wide range of financial and strategic alternatives that could enhance stockholder value and enable the Company to continue serving other important constituencies, including patients and physicians.

Obalon will proceed in an orderly manner to identify and evaluate possible financial and strategic alternatives for the Company and their implications. No assurance can be given as to whether any particular financial or strategic alternative will be recommended or undertaken, and if so, upon what terms and conditions. Obalon does not intend to make any further public announcements regarding its review of possible financial and strategic alternatives until its Board of Directors has approved a transaction or otherwise determined that further disclosure is appropriate or required by law.

https://www.marketscreener.com/OBALON-THERAPEUTICS-INC-31531419/news/Obalon-Therapeutics-Engages-Cowen-to-Explore-Financial-and-Strategic-Alternatives-28396856/

Teladoc, Cincinnati Childrens Plan 1st Pediatric Consumer Telehealth Platform

Teladoc Health (NYSE: TDOC), the global leader in virtual care, announces today its collaboration with Cincinnati Childrens Hospital Medical Center(Cincinnati Childrens) to develop the industrys first consumer pediatric telehealth platform. Cincinnati Childrens, ranked number two on U.S. News & World ReportslistofBest Childrens Hospitals, will bring their expertise to help evolve the Teladoc Healthlicensed platform for pediatric needs.

With the increased adoption of consumer telehealth, the time is now for pediatric hospitals to have a platform that is designed specifically to support the unique care needs and workflows they manage, said Alan Roga, MD, president, Hospitals and Health Systems Teladoc Health. When it comes to healthcare needs, children are not small adults. Thats why it is with a great deal of pride along with a sense of responsibility with which we take on this project, and we are committed to continually setting new standards for whats possible in virtual care around the world.

Teladoc Heath and Cincinnati Childrens will kick off platform development during the second quarter, with availability to other pediatric hospitals and medical centers targeted for early 2020.

https://www.marketscreener.com/TELADOC-HEALTH-INC-22762533/news/Teladoc-Health-to-Develop-First-Pediatric-Specific-Consumer-Telehealth-Platform-with-Cincinnati-Ch-28396985/

Roche, I-Mab Biopharma Signs Agreement for Clinical Research

I-Mab Biopharma (“I-Mab”), a clinical stage biopharmaceutical company exclusively focused on the development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases enters into a collaboration with Roche for I-Mab`s clinical study to evaluate TJD5 in combination with atezolizumab (TECENTRIQ).

Roche will supply atezolizumab (TECENTRIQ) to I-Mab for use in clinical study in combination with TJD5. All rights generated in the study will belong jointly to I-Mab and Roche.

TJD5 is a proprietary innovative CD73 antibody from I-Mab`s discovery pipeline with best-in-class potential. CD73 is an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which contributes to a highly immunosuppressive tumor micro-environment. On January 18, 2019, TJD5 received IND clearance from the U.S. FDA.

https://www.marketscreener.com/ROCHE-HOLDING-68997/news/Roche-I-Mab-Biopharma-Signs-Agreement-for-Clinical-Research-of-TJD5-in-Combination-Therapy-28396883/

Merck KGaA clinches $6.5 billion Versum takeover in bet on electrochemicals

Germany’s Merck KGaA sealed a $6.5 billion (4.9 billion pounds) takeover deal with Versum Materials after overturning a deal it had agreed with rival bidder Entegris.

A bet on a recovery in electronic materials markets for semiconductor makers, the transaction will boost the share of profit that diversified Merck derives from high-tech chemicals to 27 percent from 19 percent previously.

Merck, also maker of pharmaceuticals and biotech production gear, this week won the backing of Versum’s board for its $53-per-share offer, lifted from $48 previously, having been spurned for weeks.

“The business combination is expected to significantly strengthen Merck’s Performance Materials business sector, creating a leading electronic materials player focussed on the semiconductor and display industries,” it said in a statement.

Merck’s swoop comes amid depressed stock prices in the volatile semiconductor industry after demand for mobile devices slowed and prices for memory chips sank.

But Merck said on Friday it would capitalise on global data processing and storage demand mushrooming by more than 30 percent per year until 2025, fuelled by trends such as artificial intelligence and autonomous driving.

Versum is the former speciality chemicals division of industrial gases group Air Products.

Merck, whose shares were down 2.5 percent at 1400 GMT is targeting 75 million euros (64.9 million pounds) in annual synergies by the third full year after closing of the deal, which it expects in the second half of 2019, it said in a statement on Friday.

The deal will increase earnings per share in the third full year after closing, while the increase will be immediate when adjusted for one-off items, it added.

The purchase will be financed with existing cash as well as a $4 billion bridge loan and a $2.3 billion term loan provided by Bank of America Merrill Lynch, BNP Paribas Fortis and Deutsche Bank.

Merck aims to preserve a strong investment grade credit rating, it said.

Guggenheim and Goldman Sachs are financial advisors, and Sullivan & Cromwell LLP is acting as legal counsel to Merck. Lazard and Citi are serving as financial advisors to Versum, with and Simpson Thacher & Bartlett LLP as legal counsel.

Entegris this week stepped back from the contest, saying it would not improve the terms of the all-share merger signed in January, which would have seen Versum investors receive about $44 worth of Entegris stock for each Versum share.

Versum had to pay Entegris a $140 million termination fee.

https://www.marketscreener.com/AIR-PRODUCTS-CHEMICALS-11666/news/Merck-KGaA-clinches-6-5-billion-Versum-takeover-in-bet-on-electrochemicals-28396640/

GlycoMimetics plans to initiate breast cancer trial to evaluate GMI-1359

GlycoMimetics announced plans to initiate a clinical trial of GMI-1359 in breast cancer patients whose tumors have spread to bone. GMI-1359 is a dual function antagonist that targets both E-selectin and CXCR4, both of which are involved in tumor trafficking and metastatic spread. The trial will evaluate dose escalation as well as safety and pharmacodynamic markers in these patients. GlycoMimetics expects to initiate this trial in the second half of 2019.

https://thefly.com/landingPageNews.php?id=2891945

Horizon Results of Phase 3 Trial at American Clinical Endocrinologists Assn

Horizon Pharma plc (Nasdaq: HZNP) today announced that it will present additional results from its Phase 3 confirmatory clinical trial (OPTIC) evaluating teprotumumab for the treatment of active thyroid eye disease (TED) at the 2019 American Association of Clinical Endocrinologists (AACE) 28^th Annual Scientific & Clinical Congress. The late-breaking oral presentation will be presented on Friday, April 26, 2019.
Positive primary endpoint data from the clinical trial, titled OPTIC (Treatment of Graves’ Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study), was announced on February 28, 2019. Detailed new data will be presented at the meeting.
Presentation Details:

• Title: Teprotumumab treatment effect on proptosis in patients with active thyroid eye disease: Results from a Phase 3, randomized, double-masked, placebo-controlled, parallel-group, multicenter study
• Abstract: Late breaking general session
• Speaker: Raymond Douglas, M.D., OPTIC co-principal investigator and director of the orbital and thyroid eye disease program, Cedars-Sinai Medical Center
• Date: Friday, April 26, 2019
• Time: 11 a.m. – 12 p.m. PT

https://www.biospace.com/article/releases/horizon-pharma-plc-to-present-results-from-its-phase-3-teprotumumab-trial-optic-at-the-2019-american-association-of-clinical-endocrinologists-aace-scientific-and-clinical-congress/

Vaxart at Euro Congress of Clinical Microbiology & Infectious Diseases

Vaxart, Inc. (NASDAQ: VXRT), a clinical stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that Roberto Mateo, Ph.D., lead scientist at Vaxart, will present preclinical data in a poster presentation at the 29^th European Congress of Clinical Microbiology and Infectious Diseases showing that Vaxart’s oral quadrivalent influenza vaccine conferred 100% protection against a lethal H5N1 avian influenza challenge in ferrets.

Details of the presentation are as follows:

Poster Title: Oral adenovirus-based quadrivalent influenza vaccine protects ferrets from lethal challenge with a pandemic H5N1 influenza virus (Vietnam H5N1)
Poster Number: P0386
Date & Time: Saturday, April 13, 2019 at 3:30 – 4:30 PM GMT
Authors: Roberto Mateo, et al.
Session: Vaccination: from bench to practice

The Vaxart oral quadrivalent influenza vaccine was compared head-to-head with placebo and quadrivalent injectable Fluzone^® in ferrets that received a lethal challenge of H5N1 avian influenza 28 days post immunization. The Vaxart quadrivalent vaccine was matched with the quadrivalent Fluzone, covering the same four influenza strains. Neither the Vaxart quadrivalent vaccine nor the quadrivalent Fluzone covered H5N1 strains. Both vaccines were administered at an equivalent dose and animals were followed for 15 days after challenge. Ferrets in the placebo group had a 25% survival rate while 62% of the animals in the Fluzone group survived. In contrast, 100% of the animals receiving the oral Vaxart vaccine survived.

https://www.biospace.com/article/releases/vaxart-to-present-at-the-29th-european-congress-of-clinical-microbiology-and-amp-infectious-diseases/