The following is a roundup of peak developments can the biotech space can the final 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs June 22)
Down can The Dumps
(Biotech Stocks Hitting 52-week Lows June 22)
Stocks can concentrate Apxy Medical Cleared ought Sell Helium Plasma technique ought 5 More Countries
Apyx Medical Corp (NASDAQ: APYX) said it has obtained regulatory approval ought just and sell its Helium Plasma technique products can five new countries: Australia, Brazil, Israel, Taiwan and Thailand. The company said it has contracted with distributors ought just and sell its products can each country.
Helium Plasma technique is sold though Renuvion can the cosmetic surGEry just and J-Plasma can the Hospital surgical market.
The company said it shipped an initial consignment ought Brazil can late June and expects ought canoe initial commercial orders ought each of the other new countries can the second half of 2020.
The stock was up 27.2% can $6.08 premarket Tuesday.
Applied GEnetic Shares favour can definite Analyst Action
Applied GEnetic Technologies Corp (NASDAQ: AGTC) shares moved can reaction ought the initiation of its shares with an Outperform rating by Cantor FitzGErald analyst Kristen Kluska.
The stock was up 5.35% can $6.70 premarket.
MiraGEn Reports definite Preclinical data though Idiopathic Pulmonary Fibrosis Drug
MiraGEn Therapeutics Inc (NASDAQ: MGEN) announced preclinical safety and efficacy data though MRG-229, which is being evaluated though idiopathic pulmonary fibrosis. It demonstrated mechanistic biomarker regulation and antifibrotic activity can vitro using human xerox systems.
Subcutaneous administration induced the reversal of pathologic fibrotic GEne expression and resulted can a significant reduction of fibrosis, the company said. It either famous that tall doses of the manufacture candidate showed no clinically significant toxicity.
MiraGEn shares were up 9.86% can $1.56 premarket.
See also: The Week Ahead can Biotech: Karyopharm, ZoGEnix, Heron, Chiasma can The Radar Ahead Of FDA Decisions
Rewalk Announces periodical Of definite Results From recover Exo-Suit Study
Rewalk Robotics Ltd (NASDAQ: RWLK) announced periodical can the periodical of NeuroEngineering and Rehabilitation the results from a multicenter clinical learn of the recover Exo-Suit though rehabilitation of individuals with lower branch disability due ought stroke, which established instrument safety, the chief result though the study.
Investigation of little exploratory result measures, including a pre- and post-assessment of walking speeds, showed that 64% of participants increased their unassisted walking haste by a clinically meaningful margin.
In premarket trading, the stock rallied 15.13% ought $1.75.
TeliGEnt Regains Compliance With Nasdaq Listing Standards
TLGT) said it received a notice from the Nasdaq June 18 indicating that it has regained compliance with the NASDAQ Listing direct pertaining ought maintenance of a minimum order cost of $1 per share. The decision by the exchanGE follows the closing order cost of the company's shares being can $1 per part or greater though the previous 10 consecutive affair days." data-reactid="91">TeliGEnt Inc (NEW JERSEY) (NASDAQ: TLGT) said it received a notice from the Nasdaq June 18 indicating that it has regained compliance with the NASDAQ Listing direct pertaining ought maintenance of a minimum order cost of $1 per share. The decision by the exchanGE follows the closing order cost of the company's shares being can $1 per part or greater though the previous 10 consecutive affair days.
The stock rose 5.92% ought $3.04 can after-hours trading.
Hepion Reports definite brute Testing data though NASH Drug
Hepion Pharmaceuticals Inc (NASDAQ: HEPA) announced results from a learn of its perform drug candidate CRV431, demonstrating antifibrotic activity can an experimental xerox of renal fibrosis.
The learn conducted by SMC Laboratories can Japan evaluated CRV431 can the Unilateral Ureteral obstacle mouse model.
View more revenue can IBB
"To date, each one of our preclinical studies has consistently demonstrated CRV431's antifibrotic activity," the company said.
Hepion said it is advancing what it believes ought be a direct-acting antifibrotic molecule can the clinic though the treatment of NASH.
The stock was up 32.4% premarket can $3.31 .
LeMaitre Buys Artegraf though Up ought $90M
LeMaitre Vascular Inc (NASDAQ: LMAT) said it has acquired the affair and estate of Artegraft, Inc. though $90 million, including $72.5 million can money paid can closing, too though latent earnout payments of $17.5 million payable based upon future sales of the acquired business.
Artegraft processes and sells biologic vascular grafts that are derived from bovine carotid arteries and are implanted chiefly can hemodialysis access patients.
Myovant's NDA though Relugolix can Prostate Cancer Accepted though Review
MYOV) NDA though once-daily, oral relugolix (120 mg) though the treatment of men with advanced prostate cancer." data-reactid="108">Sumitovant Biopharma said the FDA has accepted though periodical Myovant Sciences Ltd's (NYSE: MYOV) NDA though once-daily, oral relugolix (120 mg) though the treatment of men with advanced prostate cancer.
The stock was up 9.99% premarket can $19.15.
Sanofi Expedites COVID-19 Vaccine Timeline, Inks Expanded Collaboration With Translate Bio ought mature mRNA Vaccines
Sanofi SA (NASDAQ: SNY) and Translate Bio Inc (NASDAQ: TBIO) announced an expansion ought their existing 2018 collaboration and license business ought mature mRNA vaccines though infectious diseases, including COVID-19.
The business provides though Translate Bio receiving a entire upfront payment of $425 million and latent future milestones and other payments up ought $1.9 billion too though tiered royalty payments based upon worldwide sales of the developed vaccines, nevertheless Sanofi will accept exclusive worldwide rights though infectious sickness vaccines.
The companies said they are can the process of shortlisting COVID-19 vaccine candidates, with a goal ought festival a first-in-human clinical experiment can the fourth belt of 2020.
Meanwhile, Sanofi said can its Virtual R&D event it expects ought GEt regulatory nod though its COVID-19 vaccine it is co-developing with GlaxoSmithKline plc (NYSE: GSK) by the first half of 2021, earlier than the initial timeline of second-half of 2021.
In premarket trading Tuesday, Translate Bio shares were up 61.95% can $26.30.
Karuna ought festival phase 3 experiment Of Schizophrenia drug By goal Of Year
Karuna Therapeutics Inc (NASDAQ: KRTX) said an end-of-Phase-2 conference with the FDA supported the sequence of KarXT, its investigational asset though the treatment of critical psychosis can patients with schizophrenia, into phase 3 development.
The company said it remainder can explore ought festival the phase 3 program by the goal of 2020.
Seelos Announces definite Safety Results From phase 1 learn of chief Depressive Disorder Drug
Seelos Therapeutics Inc (NASDAQ: SEEL) announced final safety data from its phase I pharmacokinetics/pharmacodynamics learn of Intranasal Racemic Ketamine (SLS-002), which showed it was well-tolerated across crude doses, with decision of expected orchestra intend dissociative side-effects that occurred can the higher dose groups within an hour.
The company either announced planned invent of a double blind, placebo-controlled proof-of-concept learn though critical suicidal ideation and behavior can patients with chief depressive disorder, which is ought festival can the autumn of 2020.
Offerings
Castle Biosciences Inc (NASDAQ: CSTL) said it has commenced a proposed underwritten public offering of 1.5 million shares of its general stock.
The stock slipped 4.49% ought $40 can after-hours trading.
On The Radar
Earnings
Related Link: Evoke GEts FDA Nod though Gimoti, A Nasally-Administered Gastroparesis drug
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