Abeona’s ABO-102 shows encouraging action in Sanfilippo study

Abeona Therapeutics (NASDAQ:ABEO) is up 11% premarket on light volume on the heels of positive data from its Phase 1/2 clinical trial evaluating gene therapy ABO-102 in patients with Sanfilippo syndrome type A (MPS IIIA), a rare inherited lysosomal storage disorder in which sugar molecules build up in cells leading to development disabilities.

The youngest patients enrolled in cohort 3 showed preservation of neurocognitive development 12-18 months after treatment. There was also “robust and sustained” improvement in certain biomarkers of biological effect.

No new safety signals have been reported.

https://seekingalpha.com/news/3481667-abeonas-abominus-102-shows-encouraging-action-sanfilippo-study-shares-11-percent-premarket

Abeona on go with late-stage study of EB-101 in rare skin blistering disorder

Abeona Therapeutics (ABEO -2.2%) reports that it expects to initiate a Phase 3 clinical trial, VITAL, evaluating autologous collagen 7 gene-corrected cell therapy EB-101 in patients with recessive dystrophic epidermolysis bullosa in Q4.

It recently met with the FDA and, based on its feedback, is clarifying certain aspects of the study, including CMC information related to product transport and the protocol to assess comparability of certain clinical materials used in the trial.

Shares sold off in November 2018 after it announced a delay in the start of the study to allow time to address the above issues.

https://seekingalpha.com/news/3481678-abeona-go-late-stage-study-ebminus-101-rare-skin-blistering-disorder

Editas in first in-human study of CRISPR gene therapy for rare eye disorder

Recruitment is underway in an open-label ascending dose Phase 1 clinical trial evaluating Editas Medicine’s (EDIT +1.2%) CRISPR gene therapy AGN-15187 (EDIT-101) in patients with a rare inherited eye disorder called Leber congenital amaurosis type 10 (LCA10) characterized by severe visual impairment.

LCA10 is caused by mutation in a gene called CEP290. AGN-15187 is designed to eliminate this mutation.

The estimated completion date is March 2024.

Shares are up 1% premarket.

https://seekingalpha.com/news/3480914-editas-launches-first-human-study-crispr-gene-therapy-rare-eye-disorder

Nektar down 5% on postponement of Ad Com meeting on NKTR-181

Nektar Therapeutics (NASDAQ:NKTR) is down 5% premarket on light volume in response to its disclosure that it received a General Advice Letter from the FDA regarding its marketing application for mu-opioid pain med NKTR-181.

Citing its ongoing consideration of scientific and policy issues regarding opioids, the agency is postponing product-specific advisory committee meetings for the time being so its previously scheduled Ad Com review for August 21 has been canceled.

The letter stated that it will continue reviewing the marketing application according to the existing timeline and will request additional information as needed, but did not state whether its action date (PDUFA) of August 29 will change.

https://seekingalpha.com/news/3481608-nektar-5-percent-postponement-ad-com-meeting-nktrminus-181

Analysts bail as Align Tech plunges post-earnings

“We expect the stock to be under significant pressure on Thursday, perhaps retesting the lows of last fall,” says William Blair. The “lows of last fall” would be under $200.

Stephens cuts Align’s (NASDAQ:ALGN) price target to a Street-low $200, noting the beginning of a structural shift in the market from an effective duopoly to a contested marketplace.

Evercore’s Elizabeth Anderson downgrades to Inline from Outperform, and slashes her price target to $220 from $340.

Baird pulls Align from its Fresh Pick list.

Previous to today, the Sell-Side Rating on Align has been solidly bullish, with 13 of 18 analysts covering, giving a Buy (or equivalent) rating.

ALGN is down 21% premarket to $217.

https://seekingalpha.com/news/3481631-analysts-bail-align-tech-plunges-post-earnings

Merck Presents on Phase 2b for HIV-1 Therapy Islatravir at IAS 2019

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced the results from a Phase 2b clinical trial evaluating the efficacy, tolerability, and safety of islatravir (MK-8591), the company’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), for the treatment of HIV-1.

The trial evaluated three oral, once-daily doses of islatravir initially for 24 weeks in combination with Merck’s doravirine (a non-nucleoside reverse transcriptase inhibitor [NNRTI]) plus lamivudine (3TC, 300 mg), and then for a further 24 weeks in combination with doravirine, compared to DELSTRIGO (doravirine 100 mg/3TC 300 mg/tenofovir disoproxil fumarate 300 mg) in adults with HIV-1 infection who had not previously received antiretroviral treatment. At all dose levels, the combination of islatravir and doravirine maintained antiviral activity as measured by the number of study participants achieving HIV-1 RNA levels.

https://www.marketscreener.com/MERCK-AND-COMPANY-13611/news/Merck-and-Announces-Presentation-of-Phase-2b-Results-for-Investigational-HIV-1-Therapy-Islatravir-28957115/

Baxter International Falls Short of Analysts’ 2Q Earnings Estimates

Baxter International Inc. (BAX) reported that net income and revenue remained the same as last year’s second quarter as the company saw a 1% decrease in sales in U.S. sales.

The provider of dialysis products had $343 million in net income, or 66 cents a share, compared with 63 cents a share at this time last year. Analysts polled by FactSet estimated earnings of 75 cents a share.

Baxter reported $2.84 billion in sales, the same as last year’s quarter. Analysts polled by FactSet estimated sales of $2.79 billion.

The company guided sales growth of 3% to 4% for the third quarter and estimated earnings at 75 cents to 78 cents a share.

https://www.marketscreener.com/BAXTER-INTERNATIONAL-INC-11763/news/Baxter-International-Falls-Short-of-Analysts-2Q-Earnings-Estimates-28957485/