INO Hits New High, APYX Expands Footprint, TBIO/SNY To Begin COVID-19 Vaccine Trial In Q4

Today’s Daily Dose brings you news about the expanding footprint of Apyx Medical’s Helium Plasma Technology products; Inovio securing a $71 million funding from the U.S. Department of Defense for its COVID-19 vaccine delivery systems; Myovant’s positive results from its second phase III trial of Relugolix combination therapy in women with pain associated with endometriosis and Translate Bio and Sanofi expanding their collaboration.

Read on…

1. Apyx Medical Expands Footprint

Apyx Medical Corp. (APYX), formerly Bovie Medical Corp, has received regulatory approval to market and sell its Helium Plasma Technology products in five new countries – Australia, Brazil, Israel, Taiwan, and Thailand.

The Company’s Helium Plasma Technology is marketed and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market in the U.S.

While the Renuvion offers surgeons and physicians a unique ability to provide controlled heat to the tissue to achieve their desired results, the J-Plasma system allows surgeons to operate with a high level of precision and virtually eliminating unintended tissue trauma.

The Company has already shipped an initial commercial order to its distributor in Brazil in late-June and is expected to ship its initial commercial orders to each of the other new countries over the second half of 2020.

APYX closed Tuesday’s trading at $5.83, up 21.97%.

2. Inovio Clinches $71Mln Contract From U.S. Defense Department

Shares of Inovio Pharmaceuticals Inc. (INO) touched a new 52-week high on Tuesday on news of the Company securing a $71 million funding from the U.S. Department of Defense for the large-scale manufacture of its CELLECTRA 3PSP smart device and the procurement of CELLECTRA 2000 devices, which are used to deliver the COVID-19 vaccine INO-4800 directly into the skin.

Inovio’s CELLECTRA 3PSP is a small, portable, hand-held, user-friendly device that runs on “AA” batteries. The Company noted that its San Diego device manufacturing facility has produced initial quantities of the device, while also showing that the design and scale-up of the manufacturing processes can be transferred to contract manufacturers in order to further increase supply.

The Company’s COVID-19 vaccine candidate INO-4800 is under a phase I study in the U.S., with interim results expected to be available later this month. A phase II/III efficacy trial is planned to begin this summer (July/August).

INO touched a new 52-week high of $22.68 in intraday trading on Tuesday, before closing at $21.57, up 40.98%.

3. Millendo Drops CAH Program

Shares of Millendo Therapeutics Inc. (MLND) took a beating on Tuesday, following the company’s decision to drop the development program of Nevanimibe in the treatment of classic congenital adrenal hyperplasia (CAH), a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses.

The decision not to invest further in the Nevanimibe program was taken based on the observed level of Nevanimibe activity in an open-label phase II study in CAH and the changing competitive environment.

The Company is expected to advance MLE-301, being developed for the treatment of vasomotor symptoms (VMS), also known as hot flashes and night sweats, in menopausal women, in the US. phase I clinical studies in next quarter (3Q20).

MLND closed Tuesday’s trading at $1.99, down 17.08%

4. Myovant Sciences Lifts Investors’ Spirits

Shares of Myovant Sciences Ltd. (MYOV) touched a new 52-week high on Tuesday, following positive top-line results from SPIRIT 1, the second of two phase III studies of once-daily Relugolix combination therapy in women with pain associated with endometriosis.

In the SPIRIT 1 study, Relugolix combination therapy achieved both co-primary endpoints by demonstrating clinically-meaningful pain reductions for 74.5% of women with dysmenorrhea (menstrual pain) and 58.5% of women with non-menstrual pelvic pain compared to 26.9% and 39.6% of women in the placebo group, respectively. The trial also achieved all seven key secondary endpoints, including dyspareunia (painful intercourse) and a greater proportion of women not using opioids, with a generally well-tolerated safety profile including minimal bone mineral density loss.

The SPIRIT 1 study is a replicate of the SPIRIT 2 trial, the results of which were announced in April of this year. SPIRIT 2 met its co-primary efficacy endpoints with a 75.2% response rate for dysmenorrhea (menstrual pain) and a 66.0% response rate for non-menstrual pelvic pain while achieving six key secondary endpoints and demonstrating minimal bone mineral density loss.

An extension study of Relugolix combination therapy is underway, with one -year results expected in the first quarter of 2021.

MYOV touched a 52-week high of $20 in intraday trading on Tuesday, before closing at $19.90, up 14.30%.

5. Translate Bio, Sanofi To Begin Clinical Trial Of COVID-19 Vaccine In Q4

Translate Bio (TBIO) and Sanofi Pasteur, the vaccines global business unit of Sanofi (SNY), have expanded their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases.

Under the expanded agreement, Translate Bio will receive a total upfront payment of $425 million, potential future milestones and other payments of up to $1.9 billion, including $450 million of milestones under the 2018 agreement, and tiered royalty payments based upon worldwide sales of the developed vaccines.

Translate Bio and Sanofi are currently evaluating multiple COVID-19 vaccine candidates in vivo for immunogenicity and neutralizing antibody activity to support lead candidate selection. The companies are planning to initiate a first-in-human clinical trial of a COVID-19 vaccine in the fourth quarter of 2020.

TBIO touched an all-time high of $27.24 in intraday trading on Tuesday before closing at $23.87, up 46.98%.

6. Stocks That Moved On No News

Cyclerion Therapeutics Inc. (CYCN) closed Tuesday’s trading at $7.14, up 36.78%.

KalVista Pharmaceuticals Inc. (KALV) closed Tuesday’s trading at $12.90, up 18.41%.

Allied Healthcare Products Inc. (AHPI) closed Tuesday’s trading at $11.78, up 15.26%.

Nemaura Medical Inc. (NMRD) closed Tuesday’s trading at $11.76, down 23.54%.

AdaptHealth Corp. (AHCO) closed Tuesday’s trading at $18.99, down 13.99%.

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