Piper Jaffray analyst Matt O’Brien raised his price target for OrthoPediatrics to $33 from $30 saying the company’s business momentum is “excellent” following its beat and raise Q2. OrthoPediatrics remains a unique name within orthopedics that investors should own, O’Brien tells investors in a research note. He keeps an Overweight rating on the name.
Thursday, August 9, 2018
Pieris should be bought on any weakness, says H.C. Wainwright
Pieris Pharmaceuticals (PIRS) announced this morning the termination of two early-stage partnerships with Roche (RHHBY) and Sanofi (SNY), H.C. Wainwright analyst Joseph Pantginis tells investors in a research note. He notes that the partnerships did not proceed beyond preclinical development. Any contribution to the weakness in the shares by this announcement and any negative perception is unwarranted as these were non-core relationships, Pantginis says. His investment case on Pieris remains unchanged with primary focus on its two lead assets, PRS-343 and PRS-060, as well as the company’s major partnerships with AstraZeneca (AZN) and Servier. The analyst reiterates a Buy rating on Pieris with a $12 price target.
Inducing labor at 39 weeks decreases need for cesarean section, study finds
Inducing labor in healthy women at 39 weeks into their pregnancy reduces the need for cesarean section and is at least as safe for mother and baby as waiting for spontaneous labor. Choosing to induce could also reduce the risk that mothers will develop preeclampsia and that newborns will need respiratory support after delivery, according to a study publishing online in the New England Journal of Medicine on August 8.
“This doesn’t mean that everyone should be induced at 39 weeks,” says the study’s co-author Robert Silver, M.D., chair of Obstetrics & Gynecology at University of Utah Health and a Maternal-Fetal Medicine physician at Intermountain Healthcare in Salt Lake City. Kim Hall, R.N., B.S.N., a research nurse coordinator at U of U Health and Intermountain Healthcare is also co-author on the study.
“Electing to induce labor is a reasonable option that may give the best chance for vaginal delivery and improve outcomes,” says Silver.
Results were from 6,106 first-time mothers enrolled into the randomized ARRIVE clinical trial carried out at 41 hospitals participating in the National Institutes of Health-supported Maternal Fetal Medicine Units Network. More than 1,200 women were at the Utah MFMUN, consisting of University Hospital and Intermountain Medical Center, the largest enrolling site in the trial.
A Rising C-Section Rate
Driving the study is a steadily increasing rate of babies being delivered by C-section in the U.S., a number that has been holding at 32 percent since 2016. Medically unnecessary cesarean deliveries in healthy first-time mothers account for 80 percent of those deliveries, a point of concern.
Although the procedure is generally safe, the major surgery increases risk for complications to both mother and baby, and to future pregnancies. Women who deliver by C-section once are more likely to continue delivering that way, increasing the likelihood of high-risk complications such as placenta accreta.
For years, health care providers had been taught to avoid inducing labor in healthy, first-time mothers based on the belief that inducing increases the chance for C-section births. However, recent results from small, observational studies indicated that this may not necessarily be the case.
ARRIVE was a prospective trial designed to test this premise by examining outcomes from two groups of healthy, first-time mothers. One group elected to induce labor at 39 weeks, when the baby is full term and it is considered safe for mothers to give birth. The other group took part in expectant management or “watchful waiting,” the routine practice of waiting for spontaneous labor but undergoing active intervention should a medical need arise.
Inducing Labor vs. Waiting
On average, women who chose to induce at 39 weeks delivered nearly one week earlier than women who waited for spontaneous labor. C-section delivery was significantly less likely after elective induction than after expectant management (18.6 vs. 22.2 percent).
Based on these data, the researchers estimate that inducing labor at 39 weeks could eliminate the need for 1 C-section for every 28 deliveries.
“We’re always trying to find the safest way to deliver babies and take care of our patients,” says M. Sean Esplin, M.D., an associate professor of Obstetrics and Gynecology at U of U Health and chief of Maternal-Fetal Medicine at Intermountain Healthcare. “If the primary goal is to keep rates of C-sections down, then elective induction is an option.”
Choosing to induce labor at 39 weeks is at least as safe as spontaneous labor, according to results from the study. A composite score measuring several health indicators in newborns — including death, seizures, hemorrhage and trauma — was not significantly different between the two groups.
Inducing labor was linked to significant improvement in two specific outcomes: women were less likely to develop preeclampsia (9 vs. 14 percent), and rates of respiratory distress decreased in newborns. Silver says that the placenta tends not to function as well later in pregnancy, possibly explaining why mothers and babies who deliver earlier may fare better.
The study’s findings held true regardless of the woman’s age, ethnicity and BMI. Currently, researchers are evaluating whether inducing delivery at 39 weeks is cost effective.
“These results open the door for pregnant women and their health care providers to talk about what the woman wants to do,” says Michael Varner, M.D., vice chair for research in Obstetrics and Gynecology at U of U Health and primary investigator of the Utah MFMUN.
“The opinions that matter most comes from the women we serve,” says Varner.
Story Source:
Materials provided by University of Utah Health. Note: Content may be edited for style and length.
Journal Reference:
- William A. Grobman, Madeline M. Rice, Uma M. Reddy, Alan T.N. Tita, Robert M. Silver, Gail Mallett, Kim Hill, Elizabeth A. Thom, Yasser Y. El-Sayed, Annette Perez-Delboy, Dwight J. Rouse, George R. Saade, Kim A. Boggess, Suneet P. Chauhan, Jay D. Iams, Edward K. Chien, Brian M. Casey, Ronald S. Gibbs, Sindhu K. Srinivas, Geeta K. Swamy, Hyagriv N. Simhan, George A. Macones. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. New England Journal of Medicine, 2018; 379 (6): 513 DOI: 10.1056/NEJMoa1800566
CVS rolls out virtual care offering in 9 states
- CVS Health on Wednesday launched MinuteClinic Video Visits, offering 24/7 access to virtual care services for minor illnesses, injuries and other wellness needs.
- Patients initiate a video visit through the CVS Pharmacy app using their mobile device. The program uses Teladoc’s technology platform.
- The service is now available in nine states — Arizona, California, Florida, Idaho, Maine, Maryland, Mississippi, New Hampshire and Virginia — as well as the District of Columbia. Nationwide rollout is expected by the end of the year.
More care is moving to retail settings, and virtual offerings are increasingly becoming part and parcel of that experience. Last month, Rite Aid inked a letter of intent with InTouch Health to bring virtual care to remote areas. The companies also plan to offer the services at alternative care sites, such as Rite Aid pharmacies.
Walgreens is also offering telehealth services through a partnership with NewYork-Presybterian. The virtual care option — part of NYP’s OnDemand digital health services — is available at self-service kiosks at select Duane Reed drugstores in New York City and through the Walgreens website. The retail pharmacy chain also recently launched a digital marketplace with 17 big-name providers to connect its mobile and online visitors to its clinics and healthcare services, as well as providers in communities across the U.S.
Payers are getting in on the act as well. Last month, Anthem announced a collaboration with Samsung to bring members 24/7 telehealth services, including video chats with providers.
CVS said early tests of the telehealth service showed strong consumer support. It claimed 95% of patients who opted for a virtual visit were highly satisfied with the care they received, and an equal share were satisfied with the convenience and overall experience. While those numbers can be taken with a grain of salt, there is reason to believe patients want more telehealth options. An American Well survey from earlier this year found that nearly 80% of respondents were willing to see their doctor via video and 20% would switch primary care providers to get access to such services.
Patients currently pay the $59 fee for a MinuteClinic Video Visit out of pocket, but the company said insurance coverage will be added in coming months.
The move comes as CVS is attempting to acquire Aetna for $69 billion. Shareholders for both companies have approved the deal between the pharmacy chain and payer. If approved by regulators, the merger would create an entity with annual revenues of roughly $245 billion. The Department of Justice is still scrutinizing the proposed merger and earlier this year requested more information on the bid.
On Wednesday, the American Medical Association urged DOJ to reject the deal, citing an AMA analysis showing it could undermine competition in many healthcare markets, at the expense of patients.
Among other things, the analysis said the merger would increase market concentration in 30 of 34 Medicare Part D regional markets, most likely leading to higher premiums. The analysis pointed to impact on the highly concentrated pharmacy benefit management services market, where both firms already have a stake.
Biocept Sees $11.6M Gross Proceeds On Recently Expired $25M Rights Offering
Biocept said today that it expects to take in approximately $11.6 million in gross proceeds from a previously announced rights offering, which expired on Wednesday. The company had previously estimated that proceeds from the offering could be as high as $22.6 million if all the rights were exercised.
According to Biocept, closing of the offering will take place on or about Aug. 13, subject to satisfaction or waiver of all conditions. At that time, a subscription agent will distribute shares of the firm’s Series A convertible preferred stock and warrants to rights holders.
Each right entitles the holder to purchase one unit at a subscription price of $1,000 per unit. Each unit consists of one share of Series A convertible preferred stock with a face value of $1,000 — which is immediately convertible into 220 shares of common stock at a conversion price of $4.53 per share — and 220 warrants with an exercise price of $4.53, exercisable for five years after the date of issuance.
Maxim Group and Dawson James Securities were co-dealer-managers in the offering. Chardan and WestPark Capital acted as financial advisors.
Natera Q2 Revenues Climb 21 Percent
Natera reported after the close of the market on Wednesday that its second quarter 2018 revenues rose 21 percent year over year.
The San Carlos, California-based molecular diagnostics firm reported total Q2 2018 revenues of $63.1 million, compared to $52.3 million in Q2 2017, beating analysts’ average estimate of $61.2 million.
The firm processed 162,807 tests in Q2 2018, a 29 percent jump from 125,700 tests in the prior year period. Total tests included 113,300 of its noninvasive prenatal test Panorama, a 27 percent bump from the 89,400 it ran in Q2 2017, as well as 41,800 of its Horizon carrier screening test, a 36 percent increase from the 30,700 accessioned in Q2 2017.
During a conference call with investors CEO Matt Rabinowitz said that the drivers for future revenue growth would be “volume growth and stable pricing,” and that “both trends are playing out.”
Natera recognized a net loss of $33.8 million, or $.62 per share, in Q2 2018, up from $29.1 million, or $.55 per share, in Q2 2017. It missed Wall Street’s loss-per-share estimate of $.55.
After the close of Q2, Natera completed a secondary equity offering, raising $97.3 million in net proceeds. Rabinowitz said in a statement that the “completion of our follow-on equity offering gives us capital to pursue near term opportunities across prenatal health, transplant rejection, and oncology.”
As previously announced, Natera plans to launch a kidney transplantation rejection test based on collaborative research with the University of California, San Francisco.
The firm’s R&D expenses ticked up 1 percent to $11.9 million from $11.8 million, while SG&A expenses rose 9 percent to $37.4 million from $34.3 million.
Natera anticipates total 2018 revenues between $250 million and $275 million. Analysts on average are expecting 2018 revenues of $258.7 million. Natera COO Steve Chapman said that the firm expects its test volume to grow by 25 percent to 35 percent in 2018.
Natera ended the quarter with $12.3 million in cash and cash equivalents, $5.6 million in restricted cash, and $70.9 million in short-term investments.
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