Rite Aid Corporation announced that its board of directors has approved a reverse stock split of the company’s common stock at a ratio of 1-for-20. The reverse stock split was previously approved by stockholders at a Special Meeting of Stockholders held on March 21, 2019. Rite Aid’s common stock will begin trading on a split-adjusted basis on the New York Stock Exchange at the market open on April 22, 2019. Once effective, the reverse stock split will reduce the number of shares of common stock issued and outstanding from approximately 1.08B to approximately 54M.
Wednesday, April 10, 2019
Alcon initiated with an Outperform at Wells Fargo
Wells Fargo analyst Larry Biegelsen started coverage of Alcon (ALC) with an Outperform rating and $66 price target following the spinoff from Novartis (NVS). The analyst believes the shares will trade at a premium to Alcon’s large-cap medtech peers based on its leadership position in the $23B ophthalmology device market and an attractive financial profile with mid-single-digit sales growth, major margin expansion potential, and double-digit EPS growth beyond 2020. Biegelsen expects new products like PanOptix trifocal IOL, Dailies Total 1 toric, and Precision 1 to drive sales growth acceleration toward 2023.
Gilead upgraded to Buy from Neutral at UBS
UBS analyst Carter Gould upgraded Gilead Sciences to Buy from Neutral and raised his price target for the shares to $77 from $75. Following the failure of selonsertib in nonalcoholic steatohepatitis, Gilead announced “two important clinical wins” in the positive Descovy PrEP data and filgotinib Finch1/3 data, Gould tells investors in a research note. These unlock two $2B-plus revenue opportunities and go “far to de-risk” the company’s growth in 2021 and beyond, contends the analyst. Further, while the analyst expects a Q1 earnings miss, he believes 2019 estimates will move higher as NASH precommercialization spend likely comes out of guidance.
Syros Pharmaceuticals price target lowered to $24 from $28 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff lowered his price target for Syros Pharmaceuticals to $24 from $28 to account for dilution of the company’s recent $70M capital raise. The analyst, however, reiterates an Overweight rating on the name. Syros is developing potentially best-in-class CDK7 inhibitors, Tenthoff tells investors in a research note. He points out that data from the expansion cohorts in ovarian cancer are expected in Q4.
https://thefly.com/landingPageNews.php?id=2890531
https://thefly.com/landingPageNews.php?id=2890531
Evotec downgraded to Hold from Buy at Deutsche Bank
Deutsche Bank downgraded Evotec to Hold from Buy citing valuation.
Newly Approved Drug a ‘Revolution’ for Postpartum Depression
Women with postpartum depression (PPD) can achieve rapid remission with a 60-hour infusion of brexanolone (Zulresso, SageTherapeutics), and remission is sustained over 30 days, a pooled analysis from three randomized controlled trials shows.
Brexanolone is an intravenous formulation of allopregnanolone, an endogenous progesterone metabolite that is thought to modulate gamma-aminobutyric acid (GABA) receptors.
The US Food and Drug Administration (FDA) approved brexanolone injection on March 19 for the treatment of PPD in adult women, noting that “this is the first drug approved by the FDA specifically for PPD.”
In the current analysis, Robert Lasser, MD, a psychiatrist at Sage Therapeutics, Cambridge, Massachusetts, analyzed results from three randomized trials in which 140 women with PPD were treated with one of two doses of the drug and compared the results to those of more than 100 patients given placebo.
The findings, which were described by one expert as “a revolution” in the care of PPD, were presented here at the European Psychiatric Association (EPA) 2019 Congress.
Better Efficacy Than Oral Meds
Results showed not only that 75% of patients achieved a response and that 50% were in remission by the end of the 60-hour infusion but also that the response was sustained for 30 days, with 56% still responding and 36% in remission.
Moreover, Lasser said that the results “revealed brexanolone injection to be significantly better than placebo at reducing depressive symptoms” at rates that are “notably higher” than those “commonly expected with oral medications.
“Adverse events, as expected, included dry mouth and sedation, and those cases of excessive sedation resolved with simple dose interruption,” said Lasser.
Lasser began by noting that the underlying cause of PPD is unknown and is likely to involve multiple factors.
These may include a history of depression, alterations in inflammatory signaling, fluctuations in levels of gonadal hormones and neuroactive steroids, and dysregulation of stress pathways in the brain.
One potential mechanism that has been suggested for PPD, Lasser said, is the inability of the GABA system to regulate neural network activity, possibly through altered GABA receptor regulation.
Effective, Safe
To investigate the efficacy of brexanolone, the researchers conducted three randomized, double-blind trials in women with PPD.
The first trial involved patients with severe PPD, defined as the patient’s having a total Hamilton Rating Scale for Depression (HAM-D) score of ≥25. Patients were randomly assigned to receive brexanolone injection at 90 µg/kg/hr (BRX90; n = 10) or placebo (n = 11).
For the second study, women with severe PPD were randomly assigned to receive BRX90 (n = 41), brexanolone injection at 60 µg/kg/hr (BRX60; n = 38), or placebo (n = 43).
In the final trial, women with moderate PPD, defined as the patient’s having a total HAM-D score of 20–25, were randomly allocated to receive BRX90 (n = 51) or placebo (n = 53).
The investigators pooled the results of the three trials and conducted an efficacy analysis in 102 patients treated with BRX90 and 107 treated with placebo.
In addition, they conducted a safety analysis in 140 patients treated with BRX90 or BRX60 and 107 patients who received placebo. Both analyses were preplanned.
Patients treated with BRX90 and those given placebo both experienced substantial reductions in the least squares mean total HAM-D scores over baseline by the end of the 60-hour infusion period.
However, the mean reduction from baseline to hour 60 was significantly greater with BRX90 than placebo, with a reduction in total HAM-D scores of -17.0 vs -12.8 (P < .001).
BRX90 was also associated with significant improvements in response rates, defined as a reduction in total HAM-D scores over baseline of ≥50%, and in rates of remission, defined as a total HAM-D score of ≤7.
Specifically, the team found that 75% of patients treated with BRX90 experienced a response at hour 60, vs 56% of those given placebo (P < .0001); 50% and 26%, respectively, achieved remission (P = .0003).
The significant difference in response was sustained over the 30-day follow-up period, with 56% of BRX90 patients and 45% of those in the placebo group showing a response at the final assessment (P < .0001).
A similar pattern was seen for those who achieved remission, with 36% of BRX90 patients and 22% of those given placebo in remission at 30 days (P < .0001).
Lasser pointed out that patients who achieved a response or remission at hour 60 were likely to continue experiencing response or remission over 30 days. Of those given BRX90, 83% demonstrated a response, and 85% were in remission; of those given placebo, 81% showed a response, and 75% were in remission.
In the safety analysis, it was found that cardiac disorders, such as tachycardia; gastrointestinal disorders, including diarrhea, dry mouth, and dyspepsia; and vascular disorders, such as flushing, typically occurred in 2% to 3% of patients treated with brexanolone.
However, of greater interest were rates of sedation, particularly because this adverse event was singled out by the FDA in its approval announcement for the drug.
The FDA stated that, because “of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring.”
In the current analysis, 13% of patients given BRX90 and 21% of those treated with BRX60 experienced sedation or somnolence; 3% and 5%, respectively, had loss of consciousness; and 12% and 13%, respectively, experienced dizziness, presyncope, or vertigo.
By comparison, among placebo patients, 6% experienced sedation or somnolence, and 7% experienced dizziness, presyncope, or vertigo.
Lasser said that the overall rates of sedation seen with brexanolone were “very similar to what we see with available antidepressants.
“In these cases, and with the oral medication that we’re testing, it comes exactly when you need it to, which is about 10 o’clock at night, when patients are ready to go to bed,” he said.
Depression Treatment Boon
Session chair Marcin Wojnar, MD, PhD, University of Michigan, Ann Arbor, told Medscape Medical News that brexanolone is “a kind of revolution in treating depression, especially postpartum depression.”
He noted that this “can be a very dangerous, threatening condition, both for the mother and the child, so the faster and more effectively we could help such people, the happier we would be.”
In the post-presentation discussion, Wojnar noted that in addition to the drug’s “ultra-rapid action, there was also a very high level of response to placebo, which is not surprising, because most of pharmaceutical studies have such high responses, but it was really maintained afterwards.”
Lasser agreed, noting that “overcoming the placebo effect is a bigger and bigger issue in trials.”
He pointed out that the studies were conducted in hospital inpatients, so there was “even more potential for bias” in the placebo group.
Asked by a member of the audience whether the drug would cause any problems during breastfeeding, Lasser said that women stopped breastfeeding during the trial.
However, he added that a previous lactation study indicated that the amount of drug expressed in breast milk “is quite low; it’s around 1%, and only 5% of that is available to the child. So even if you were to breastfeed for over that 60 hours [of drug infusion], we don’t think it would cause an issue,” Lasser said.
The study was funded by Sage Therapeutics. Lasser is an employee of and owns stock in Sage Therapeutics. Wojnar has disclosed no relevant financial relationships.
European Psychiatric Association (EPA) 2019 Congress: Abstract OC-0052. Presented April 8, 2019.
Silk Road Medical IPO Surges On First Day Of Trading
Shares of Silk Road Medical (SILK) popped more than 80% on Thursday with an initial public offering that drew heavy interest from investors. The Silk Road Medical IPO raised $120 million.
Shares priced at 20, the high end of its estimated range, and opened at 33.15. The stock climbed further, closing at 36.18, up 80.9% on the stock market today. Silk Road initially set a price range of 15 to 17, later revised to a range of 19 to 20.
Silk Road also hiked the number of shares for the offering by 28% to 6 million.
The Silk Road IPO garnered lots of attention from investors, with one IPO research firm giving the company its highest rating.
Research firm IPOboutique.com, which rates IPOs on a scale of 1 to 5, gave Silk Road a rare rating of 5, or “strongest buy,” at the IPO price. The last IPO that received a 5 rating was Facebook (FB) in 2012. Glitches marred the Facebook IPO, though.
Silk Road Medical focuses on preventing strokes. It uses minimally invasive technology “to safely and effectively treat carotid artery disease, one of the leading causes of stroke,” the company said in its IPO filing. “We have pioneered a new approach for the treatment of carotid artery disease called transcarotid artery revascularization, or TCAR, which we seek to establish as the standard of care.”
The company reported revenue of $34.5 million in 2018, up 143% from the prior year. It showed a loss of $39 million.
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