IsoRay (ISR +1.7%) inks an agreement with
MIM Software for, what it says, is a novel one-stop-provides-all
program to treat head and neck cancer. The new offering bundles MIM’s
software technology and Isoray’s Cesium Blu, also known as Cesium-131,
brachytherapy expanding treatment options and access for both doctors
and patients.
https://seekingalpha.com/news/3538596-isoray-to-offer-total-solution-in-head-and-neck-cancer
Wednesday, February 5, 2020
Nike shuts half its stores in China amid outbreak
Nike Inc. NKE, -0.97%
says it has temporarily closed about half of its stores in China
because of the coronavirus outbreak. The company said its remaining open
stores are operating with reduced hours and have experienced lower than
expected retail traffic. “In the short term, we expect the situation to
have a material impact on our operations in Greater China,” the company
said in a statement. “However, Nike brand and business momentum with
the Chinese consumer remains strong, as reflected in the continued
strength of our Nike digital commerce business.” Nike shares are up 22%
over the past year, while the broader S&P 500 SPX, +0.94% is up 20.5% the past 12 months. Nike shares were flat in after-hours trading.
Vivus up on FDA nod for improved formulation of Pancreaze
Thinly traded nano cap VIVUS (NASDAQ:VVUS) is up 25% premarket in reaction to FDA approval of a new formulation of Pancreaze (pancrelipase) with a 36-month shelf life across all dosages.
https://seekingalpha.com/news/3538466-vivus-up-25-premarket-on-fda-nod-for-improved-formulation-of-pancreaze
https://seekingalpha.com/news/3538466-vivus-up-25-premarket-on-fda-nod-for-improved-formulation-of-pancreaze
Moleculin Bio up on potential accelerated approval of Annamycin
Thinly traded nano cap Moleculin Biotech (NASDAQ:MBRX) jumps 41% premarket on robust volume in reaction to its plan to discuss accelerated approval
of Liposomal Annamycin with the FDA and EMA for the treatment of
relapsed/refractory acute myeloid leukemia, an Orphan Drug- and Fast
Track-tagged indication in the U.S.
It hopes to get sign-off on a single Phase 2 study to support the applications.
https://seekingalpha.com/news/3538481-moleculin-bio-up-41-premarket-on-potential-accelerated-approval-of-annamycinFDA signs off on BioXcel IND for study of BXCL501 for opioid withdrawal
Thinly traded micro cap BioXcel Therapeutics (NASDAQ:BTAI) perks up 4% premarket on light volume on the heels of the FDA’s sign-off
on a Phase 1b/2 clinical trial, RELEASE, evaluating BXCL501, a
sublingual thin film formulation of the sedative dexmedetomidine, for
the treatment of opioid withdrawal symptoms.
The candidate is also being developed to treat
agitation in schizophrenia and bipolar disorder patients and agitation
related to dementia.
https://seekingalpha.com/news/3538492-fda-signs-off-on-bioxcel-ind-for-study-of-bxcl501-for-opioid-withdrawalAimmune up 10% premarket on increased Nestlé stake
Aimmune Therapeutics (NASDAQ:AIMT) perks up 10% premarket on average volume in reaction to its announcement that Nestlé Health Science will invest an additional $200M in the company, raising its stake to $473M (25.6% stake).
Nestlé’s investment includes 1M common shares at
$31.97 and 525,634 shares of convertible stock (one for ten based on
certain conditions) at $319.675.
Closing date is February 7.
Separately, AIMT has in-licensed global rights to Xencor’s (NASDAQ:XNCR) humanized monoclonal antibody, XmAb7195, for the potential treatment of food allergies (renamed AIMab7195).
Under the terms of the agreement, it will pay XNCR
$5M upfront, up to $385M in milestones and high
single-digit-to-mid-teen royalties on net sales. It will also invest $5M
in XNCR stock.
https://seekingalpha.com/news/3538510-aimmune-up-10-premarket-on-increased-nestl-stakeAbbVie’s Rinvoq successful in second late-stage psoriatic arthritis study
AbbVie (NYSE:ABBV) announces positive results from a Phase 3 clinical trial, SELECT-PsA 1,
evaluating RINVOQ (upadacitinib) in adults with psoriatic arthritis
(PA) who failed to respond adequately to or were intolerant of DMARD
(disease modifying anti-rheumatic drug) therapy.
The study met the primary endpoint demonstrating a
statistically significant proportion of treated patients achieving
ACR20 (20% improvement in PA) at week 12 versus placebo. Specifically,
71% and 79% of participants receiving 15 mg and 30 mg, respectively, of
RINVOQ achieved ACR20 compared to 36% in the control arm (p<0.0001).
Both doses of RINVOQ demonstrated non-inferiority
to Humira (adalimumab) as measured by ACR20 at week 12 while the 30 mg
dose also showed superiority.
No new safety signals were observed.
A sister Phase 3, SELECT-PsA 2, was also successful.
Results will be submitted for presentation at a future medical conference and publication.
The FDA approved the JAK inhibitor in August 2019 for rheumatoid arthritis.
Shares up 1% premarket on light volume.
https://seekingalpha.com/news/3538534-abbvies-rinvoq-successful-in-second-late-stage-psoriatic-arthritis-study
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