Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today provided a program update on ADVM-022, a novel, single-administration gene therapy being evaluated in the OPTIC Phase 1 clinical trial in patients with wet age-related macular degeneration (wet AMD).
The Company has completed enrollment and dosing of patients (n=6) in the first cohort in the OPTIC trial. The independent data monitoring committee (DMC) determined that enrollment and dosing of patients in the second cohort could proceed. This was based on a review of the preliminary safety data from the first cohort of patients, which has shown no serious adverse events (SAEs) or dose-limiting toxicities (DLTs) following a single intravitreal injection of ADVM-022 at the initial trial dose of 6 x 10^11 vg/eye.
Adverum has received a notification from the U.S. Food and Drug Administration (FDA) in early April requesting additional CMC information and requirements on the ADVM-022 manufacturing process. The FDA has placed the Companys IND on clinical hold until the agency has reviewed Adverums response, which was submitted last week. The Company is working closely with the agency during its review. The Company expects to resume dosing of patients once the FDA review is completed and the clinical hold is lifted.
We are working with the FDA to resolve this matter as quickly as possible, said Leone Patterson, chief executive officer of Adverum Biotechnologies. We are deeply committed to the development of our novel gene therapy ADVM-022 for patients with wet AMD. In the OPTIC trial, the DMC reviewed the safety data and unanimously agreed that we could proceed to dosing the second cohort. No patient has experienced an SAE, with a follow up period of up to five months. We look forward to sharing 24-week primary and secondary outcomes from the first cohort of patients at a scientific meeting in the second half of this year.
https://www.marketscreener.com/ADVERUM-BIOTECHNOLOGIES-I-27535811/news/Adverum-Biotechnologies-Provides-Clinical-Program-Update-on-ADVM-022-Gene-Therapy-for-Wet-AMD-28434069/
Tuesday, April 16, 2019
UnitedHealth sees minimal impact from rebate system overhaul
UnitedHealth Group Inc said on Tuesday it expects minimal impact to its margins if the rebate system is overhauled but investors remained concerned about the impact of the Trump administration’s proposal to end discounts from drugmakers.
Shares of the company fell 4 percent and dragged down those of rivals Anthem Inc, Centene Corp, Humana Inc and Cigna Corp.
“It goes back to the political pressure on the managed care area,” Thomas Martin, senior portfolio manager at GLOBALT Investments in Atlanta said.
“It remains a wild card even though they are proving that their business model is good and are producing good results.”
The healthcare sector has come under pressure after the U.S. government in January proposed a rule that would overhaul the use of drug company rebates in government-run healthcare plans.
Adding to investor concerns, U.S. Senator Bernie Sanders recently unveiled the latest version of his “Medicare-for-All” plan that would eliminate private insurance and shift all Americans to a public healthcare plan.
UnitedHealth Chief Executive Officer David Wichmann said some proposals being discussed represent a “wholesale disruption of American healthcare” that would impact the economy and jobs without improving patient access.
On the potential impact from the proposed change to the rebate rule, the company said discounts they currently receive are mostly passed on to clients.
“Ninety percent of what we manage is generic (drugs) with no rebates,” said John Prince, a senior company executive.
“Within our total client base, 98 percent of our discounts are passed on to our clients.”
Analysts said that despite the recent slump in shares, fundamentals of the industry are still on track.
“But a negative sentiment around the sector is, in the short-term, more than offsetting what we see as a continued positive fundamental trajectory for UnitedHealth,” Stephens Inc analyst Scott Fidel said.
UnitedHealth on Tuesday raised its full-year adjusted earnings forecast to between $14.50 and $14.75 per share from its prior view of $14.40 to $14.70.
Optum, the company’s fastest-growing unit which houses its pharmacy benefits business, brought in sales of $26.36 billion in the quarter, a jump of nearly 12 percent from a year earlier due to higher prescription volumes.
The company reported adjusted earnings of $3.73 per share, beating estimates of $3.60 per share, according to IBES data from Refinitiv.
Total revenue rose 9.3 percent to $60.31 billion, ahead of estimates of $59.71 billion.
ReWalk Robotics Up As 1st Cigna Insured Gets Personal 6.0 Exoskeleton
Israel-based Rewalk Robotics Ltd RWLK 18.59%, which develops wearable exoskeletons for individuals with lower limb disabilities, is in the news for the right reasons Tuesday.
What Happened
ReWalk said a Cigna Corp CI 7.11% insurance beneficiary in New York became eligible to receive its ReWalk Personal 6.0 exoskeleton. The person had suffered a spinal cord injury in a motorcycle accident in 2016.
Cigna revised its policy regarding coverage of exoskeleton medical devices for persons with spinal cord injury in February after having a non-coverage policy previously.
Cigna is the first major U.S. private insurer to extend coverage for exoskeletons, following in the footsteps of U.S. Department of Veterans Affairs, which in December 2015 issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeletons for all qualifying Veterans across the United States.
Why It’s Important
The endorsement of exoskeletons by payors such as Cigna should bode well for ReWalk. This will make the device more affordable for the needy people.
ReWalk said it has several other Cigna cases in the pipeline that are being processed.
“We continue to actively engage insurers regarding exoskeleton policy provision for eligible beneficiaries and are pleased to see recent progress with Cigna and other providers worldwide,” said Larry Jasinski, ReWalk CEO. “As payors evaluate the benefits of exoskeleton technology we are confident more will follow Cigna’s lead and make this life changing technology available to its members.”
The company said since inception it has sold 500 exoskeletons.
Rexahn soars after finding Chinese partner for cancer drug RX-3117
Rexahn Pharmaceuticals and BioSense Global announced earlier today a collaboration and license agreement to advance the development and commercialization of RX-3117 for pancreatic cancer and other cancers in Greater China. Shares of Rexahn are up 28%, or $1.49, to $6.87 in afternoon trading. Under the agreement, Rexahn will grant BioSense an exclusive license to develop and commercialize RX-3117 in Greater China. Rexahn will receive an upfront payment and will be eligible to receive additional development, regulatory and commercial milestones up to a total of $226M contingent on achieving regulatory and commercial goals related to pancreatic cancer and additional indications. The upfront payment consists of an aggregate of $3M, $1.5M of which has been paid and the remaining $1.5M of which is due August 24. Rexahn will also be eligible to receive tiered royalties in the low double digits to mid-teens on annual net sales in the territory. The companies will collaborate to develop RX-3117 for pancreatic cancer and other indications. BioSense will fund all activities related to the development and commercialization of RX-3117 in Greater China and will initiate a Phase 2 study to evaluate the drug candidate in up to three additional indications not previously studied by Rexahn. “Rexahn is focused on developing novel therapies for people with difficult-to-treat cancers. This partnership will enable us to extend the development of RX-3117 to patients in Greater China and also to evaluate RX-3117 in additional indications in collaboration with BioSense,” said Douglas Swirsky, President and CEO of Rexahn.
Boston Scientific should be bought on surgical mesh selloff, says Piper Jaffray
Piper Jaffray analyst Matt O’Brien recommends using the selloff today in shares of Boston Scientific after the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair to stop selling and distributing their products immediately as a buying opportunity. Mesh products have been declining for several years at Boston Scientific and represented only ~1% of revenue in 2018, O’Brien tells investors in an intraday research note. The analyst estimates the company’s revenue will be negatively impacted by less than $50M in 2019. Further, Boston Scientific is currently working with the FDA on a resolution, adds the analyst. Boston Scientific still has a “plethora of high-growth product launches fully intact” including Lotus, Acurate neo, and Watchman in Japan, “which should help cushion any lost revenue,” says O’Brien. He has an Overweight rating on the shares with a $42 price target. The stock in afternoon trading is down 4% to $36.34.
UnitedHealth earnings beat fails to stop recent slide of health insurance stocks
CEO says Medicare for All would “destabilize” the nation’s health system
Shares of UnitedHealth (UNH) are under pressure on Tuesday despite reporting better than expected quarterly results, dragging other healthcare stocks into negative territory as well. Acknowledging the company’s “solid” first quarter earnings, JPMorgan analyst Gary Taylor questioned whether the beat and modest guidance raise will be enough to change the negative public sentiment that has pressured both the stock and the group year-to-date. Meanwhile, his peer at Credit Suisse added that the company is setting a positive tone with a clean “beat and raise quarter.”
QUARTERLY RESULTS: On Tuesday, UnitedHealth reported first quarter adjusted earnings per share of $3.73 and revenue of $60.3B, both above analysts’ consensus estimates of $3.59 and $59.71B, respectively. The company also raised its fiscal year 2019 adjusted earnings per share view to $14.50-$14.75 from $14.40-$14.70, and said it sees “sustained growth” this year, in fiscal year 2020 and “beyond.” “Our employees’ shared vision of improving the health of the people we serve and the performance of health systems for everyone is producing value for society and driving consistent growth for our businesses,” said UnitedHealth Chief Executive Officer David Wichmann.
The chief executive also criticized the “Medicare for All” proposals being debated by Democrats, making UnitedHealth the first major health insurer to openly discuss the proposal. On the company’s quarterly earnings conference call, Wichmann warned that Medicare for All would “destabilize” the nation’s health system and limit the ability of clinicians to practice medicine “at their best.” Moreover, he feels Medicare for All would have a “severe” impact on the economy and jobs, “all without fundamentally increasing access to care.” The CEO argued that the best path forward is to achieve universal coverage, which he said could be substantially reached through existing public and private platforms.
SETTING POSITIVE TONE: Commenting on the company’s earnings results, Credit Suisse analyst A.J. Rice said UnitedHealth is setting a positive tone with a clean “beat and raise quarter.” The analyst reiterated an Outperform rating and a $310 price target on the shares. Voicing a similar opinion, Raymond James analyst John Ransom also pointed out that the company started the earnings season off “right” with its beat and raise, and reiterated a Strong Buy rating on the shares.
Meanwhile, JPMorgan’s Taylor called UnitedHealth’s first quarter report “solid,” with a 3.6% earnings per share beat on 1% revenue upside versus consensus, but noted that the Medical Loss Ratio, or MLR, beat was “unexpected” given upward pressure from the 2019 HIF Holiday and nearly four times faster government vs. commercial premium growth. Taylor also questioned whether the beat and modest raise will be enough to change the negative public sentiment that has pressured both the stock and the group year-to-date.
Wave Life Sciences suvodirsen data with little efficacy read-through: SVB Leerink
Wave Life Sciences suvodirsen data with little read-through for efficacy, says SVB Leerink. Leerink analyst Mani Foroohar says that Wave Life Sciences’ first-in-human safety data from the Phase I trial of suvodirsen in exon 51 skipping-amenable Duchenne Muscular Dystrophy shows that it was generally sage and well-tolerated up to the 5mg/kg dose, and notes the company has selected the 3.0mg/kg and 4.5mg/kg doses to pivotal trials. While the stock is trading down and investors seem to see negative read-throughs for the potential efficacy of suvodirsen at 5mg/kg, given that drisapersen was dosed at 6mg/kg in clinical trials, the analyst believes that due to differences in chemistry between the compounds, comparison of doses between drugs is not appropriate proxy of potential efficacy. Foroohar maintains his 30% probability of success on the suvodirsen program and reiterates an Outperform rating on the shares.
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