Vertex Pharmaceuticals announced that Health Canada has granted Market Authorization for ORKAMBI to include use in children ages 2 through 5 years with cystic fibrosis who have two copies of the F508del CFTR mutation.
Thursday, December 13, 2018
Adial Pharmaceuticals to expand ADO4 for potential use for opioid disorder
Adial Pharmaceuticals announced plans to expand activities around the company’s lead asset, AD04, beyond alcohol use disorder, or AUD, to now include its potential use in patients with opioid use disorder. According to the Centers for Disease control, in 2017 alone, more than 72,000 people in the U.S. died of drug overdoses, at least two-thirds of which were linked to opioids.
Adaptimmune price target lowered to $12 from $18 at SunTrust
SunTrust analyst Peter Lawson lowered his price target on Adaptimmune to $12 to reflect the pullback in the Biotech sector ahead of ASH. The analyst keeps his Buy rating on the shares however, claiming that the recent departure of the company CTO Gwen Binder, while a negative surprise, is not a “reflection of the company’s transition from preclinical to clinical execution”. Lawson further believes that Adaptimmune is insulated from any related to the departure disruption given that its CMO assumed the CTO functions in August.
https://thefly.com/landingPageNews.php?id=2836653
Credit Suisse downgrades Alkermes to Underperform from Outperform
Credit Suisse analyst Vamil Divan double downgraded Alkermes to Underperform from Outperform and lowered his price target for the shares to $31 from $47. The stock closed yesterday at $35.50. The analyst, who admits to being a long time bull of the company, sees “limited drivers” in 2019 to turn the story around following a “series of disappointing or underwhelming pipeline catalysts.” He removed sales of depression drug ALKS 5461 from his model and lowered expectations for schizophrenia drug ALKS 3831 after Phase 3 data indicated to him a “more limited commercial opportunity.”
https://thefly.com/landingPageNews.php?id=2836697
Magellan rallies after activist Starboard discloses nearly 10% stake
Jeff Smith’s Starboard Value disclosed this morning a 9.8% stake in Magellan Health, which represents over 24M shares. Starboard purchased the shares based on its belief that they “were undervalued and represented an attractive investment opportunity,” according to a filing with the SEC. The filing allows for activism. Shares of Magellan Health are up 5%, or $3.17, to $61.80 in early trading.
Wednesday, December 12, 2018
Zynerba: Improved Fragile X Symptoms Through 12 Months with ZYN002
Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, is reporting new 12-month open label clinical data describing the long term impact of ZYN002 on emotional and behavioral symptoms of Fragile X Syndrome (FXS) in a poster presentation at the 57th Annual Meeting of the American College of Neuropsychopharmacology. The presentation is taking place today from 5:30 to 7:30 PM EST in poster session III at the Diplomat Beach Resort in Hollywood, Florida. A copy of the presentation and poster are available on the Zynerba corporate website at http://zynerba.com/publications/.
In a poster entitled, “Transdermal Cannabidiol (CBD) Gel for the Treatment of Fragile X Syndrome (FXS),” Steven Siegel, M.D., Ph.D., Professor and Chair of the Department of Psychiatry and the Behavioral Sciences at the Keck School of Medicine, University of Southern California, is presenting new 12-month data from the open label Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) trial of ZYN002 in children and adolescents with FXS. The data demonstrate that treatment with ZYN002 improved core emotional and behavioral symptoms of FXS with statistical significance versus baseline across multiple measures of efficacy at month three, and that these improvements were sustained through 12 months of treatment. ZYN002 continues to be well tolerated; no serious adverse events were reported, and no clinically meaningful trends in vital signs, ECG, or clinical safety laboratories, including liver function tests, were observed.
In the Social Avoidance subscale of the Aberrant Behavior Checklist for Fragile X (ABC-CFXS), patients completing 12 months of treatment with ZYN002 experienced a 77.2% improvement in social avoidance behaviors versus baseline, compared to a 57.9% improvement at three months of treatment. Both results are statistically significant compared to baseline. The Social Avoidance subscale of the ABC-CFXS is the primary endpoint of the ongoing pivotal CONNECT-FX study of ZYN002.
“I am encouraged to see that improvements in FXS-associated emotional and behavioral symptoms after 12 months of treatment with ZYN002 are consistent with those seen at three and nine months; these data continue to suggest the potential for sustained responses that may be conserved over extended use of the drug,” said Dr. Steven Siegel of the Keck School of Medicine. “Improvements in these behaviors may enhance the child’s capacity for interaction and engagement with their peers, families, teachers and caregivers. These data are promising, and I am enthusiastic about the potential opportunity for ZYN002 in these patients. I look forward to the results of the double blind, placebo-controlled CONNECT-FX study next year.”
Bovie Medical to change name to Apyx Medical, to transition listing to Nasdaq
Bovie Medical Corporation announced a corporate rebranding and company name change to Apyx Medical Corporation effective January 1, 2019. The company also announced plans to move its stock exchange listing to the NASDAQ Global Select Market from the New York Stock Exchange. The company expects that its common stock will commence trading on the NASDAQ Global Select Market on January 2, 2019, under a new ticker symbol – “APYX”. “We are pleased to join the world’s most innovative and growth-oriented companies listed on NASDAQ and are excited to partner with NASDAQ to leverage trading liquidity, enhanced visibility for issuers, leading technology and cost efficiencies,” said Charlie Goodwin, President and Chief Executive Officer. “We also announced a corporate rebranding and Company name change to Apyx Medical Corporation which is the final milestone resulting from the previously announced divestiture and sale of the Core business segment and Bovie brand to Symmetry Surgical, Inc.”
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