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Tuesday, December 3, 2019

Unexpected Psychological Benefits Of Aerobic Fitness

Longstanding research has found that exercise that increases our cardiovascular activity brings a number of health benefits, including lowered blood pressure; improved cardiovascular health; strengthening of the immune system; regulation of weight; and moderation of blood sugar. Interestingly, it appears that vigorous aerobic activity (maintaining more than 60% of aerobic capacity) brings greater cardiovascular health benefit than moderate activity. Exercise therapy has been found to improve a measure called heart rate variability, which is associated with greater levels of psychological well-being and resilience in the face of stress. One strand of research finds that aerobic exercise conducted in a mindful state (i.e., with enhanced self-awareness, such as yoga and Feldenkrais) brings greater mood benefits than routine vigorous or moderate cardio workouts. Many of the activities we associate with self-development, from counseling and psychotherapy to meditation, are pursued in a state of reduced physical activity and enhanced self-awareness. Might it be the case that vigorous aerobic activity is an equally promising path toward emotional well-being and a positive psychology?
According to the National Institutes of Health’s National Center for Complementary and Integrative Health, yoga, a discipline of “meditative movement” is associated with such benefits as stress relief, pain reduction, and emotional well-being. There is also evidence that yoga also improves the aforementioned heart rate variability and lessens symptoms of depression. In an excellent review article, Julia Belluz notes the limitations of much of the research on the benefits of yoga, but cites fascinating evidence that yoga may be uniquely helpful in reducing inflammation in the body. Similar amounts of time spent in yoga and general physical activity yield greater inflammation benefit for the yoga participants, presumably because of the added components of mindfulness.
In a review of brief approaches to psychotherapy that I conducted with two colleagues at SUNY Upstate Medical University in Syracuse, an important conclusion was that these methods are effective to the degree that they generate novel, constructive experiences for clients. Such “corrective emotional experiences” deal with maladaptive patterns of emotion and behavior by activating more constructive ones. Thus, for instance, when a client retreats from a therapist out of fear of rejection, the therapist may encourage engagement and provide an active experience of acceptance and understanding. Such emotional experiences are readily internalized, helping people build new modes of construing and doing. This is the basis for many behavioral and cognitive therapies, where we learn to face and challenge our patterns of anxiety, negative thinking, and depression in emotionally impactful ways.
The unexpected benefits of aerobic exercise, yoga, and similar disciplines may arise from their ability to provide similar corrective emotional experiences, albeit outside of a therapeutic relationship. Through vigorous exercise, we directly challenge our limits and experience ourselves as efficacious and achieving. Through mindful movement, we experience enhanced levels of self-control and mastery. A great example of this occurs among the money managers and traders I work with, who make active use of meditation to deal with the stresses of markets and their inherent risks and uncertainty. In the midst of threat, direct experiences of calm and focus promote a unique experience of the self as being “in control”, facilitating sound decision-making. Exercise, like coaching, counseling, and psychotherapy, is a vehicle for generating fresh experiences of the self, reinforcing and expanding our strengths.
In recent articles, I’ve explored the psychological benefits of living a purposeful life and the importance of emotionally connecting with a positive vision of our future selves. All of these can be paths toward emotional resilience, increased mindfulness, and an enhanced capacity to pursue life goals. In a recent interview, Steven Goldstein and Mark Randall explore the mindfulness associated with special forces operations, highlighting the idea of “mindfitness”. A well-constructed program of exercise, expanding our abilities to extend our limits and sustain self-control and efficacy, provides a uniquely effective form of self-development—a promising therapy for the mentally well and program for mindfitness.

Bristol, Acceleron : FDA Panel to Review Reblozyl in Myelodysplastic Syndromes

Bristol-Myers Squibb (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will hold a review of Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for the use of Reblozyl® (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) at its meeting on December 18, 2019. Bristol-Myers Squibb is seeking approval of Reblozyl, an erythroid maturation agent representing a new class of therapy, for the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions.
Reblozyl is currently being reviewed by the FDA for an indication in patients with MDS, and the agency has set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 4, 2020 for completion of the review. The agency recently granted approval of Reblozyl for the treatment of anemia in adult patients with beta thalassemia who require regular RBC transfusions. Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Reblozyl is not approved for the treatment of MDS in any country.

Ardelyx down 3% premarket on late-stage tenapanor data

Ardelyx (NASDAQ:ARDX) is down 3% premarket on modestly higher volume in response to results from the Phase 3 PHREEDOM study evaluating tenapanor for the treatment of hyperphosphatemia (excess levels of phosphate in the blood) in chronic kidney disease (CKD) patients on dialysis.
The trial met the primary endpoint of a statistically significant change in serum phosphate levels in the responder population during the placebo-controlled randomized withdrawal period (12 weeks) (-1.4 mg/dL, p<0.0001). Responders were defined as those with at least a 1.2 mg/dL decrease in serum phosphorus during the first 26 weeks of the study (open-label phase).
On the safety front, the most frequent treatment-related adverse event was loose stools/diarrhea (52.5%), most (90%) considered mild or moderate. The discontinuation rate due to diarrhea was 16% in the open-label portion, but dropped to 0.8% during the withdrawal period. 17.2% of treated patients in the open-label phase experienced a serious adverse event compared to 22.6% for Sanofi’s (NASDAQ:SNYRenvela (sevelamer carbonate).
The company plans to file a marketing application in the U.S. by mid-2020.

Premarket analyst action, Dec. 3

BeyondSpring (NASDAQ:BYSI) initiated with Market Perform rating at Oppenheimer.
Centogene (NASDAQ:CNTG) initiated with Outperform rating and $15 (22% upside) price target at Baird.
Curaleaf Holdings (CURA CN) (OTCPK:CURLF) initiated with Buy rating and C$9.64 (21% upside) price target at Needham.
Gossamer Bio (NASDAQ:GOSS) resumed with Buy rating and $32 (30% upside) price target at BofA Merrill Lynch.
Moderna (NASDAQ:MRNA) resumed with Buy rating and $29 (47% upside) price target at BofAML.
Seattle Genetics (NASDAQ:SGEN) resumed with Neutral rating and $125 (7% upside) price target at BofAML.
Tela Bio (NASDAQ:TELA) initiated with Buy rating and $19 (54% upside) price target at Canaccord Genuity, Buy rating and $23 target at Jefferies, Market Perform rating and $22 target at JMP Securities and Overweight rating and $17 at Piper Jaffray. Shares up 4% premarket.
UniQure N.V. (NASDAQ:QURE) initiated with Buy rating and $98 (79% upside) price target at Goldman Sachs, Outperform at Cowen and Company. Shares up 15% premarket.
United Therapeutics (NASDAQ:UTHR) resumed with Underperform rating and $80 (13% downside risk) price target at BofAML.

Biogen down 2% premarket despite positive mid-stage lupus study

A two-part Phase 2 clinical trial, LILAC, evaluating Biogen’s (NASDAQ:BIIB) BIIB059 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) met the primary endpoints demonstrating a statistically significant reduction in disease activity compared to placebo.
The CLE part met the primary objective showing a statistically significant dose response as measured by the change from baseline in a scale called CLASI-A at week 16 compared to control. Specifically, participants receiving 50 mg, 150 mg and 450 mg of BIIB059 experienced CLASI-A reductions of 40.9%, 48.0% and 42.5%, respectively, compared to a 14.5% reduction in the placebo arm.
The SLE part also met the primary endpoint, demonstrating a statistically valid reduction in disease activity as measured by the change from baseline in total active joint count at week 24 versus placebo (-3.4 for the 450 mg dose; p=0.037).
On the safety front, the company says BIIB059’s safety and tolerability profile “supports its continued development.”
Detailed results will be submitted for presentation at a future medical conference.
BIIB059 is fully humanized IgG1 monoclonal antibody that targets a molecule called blood dendritic cell antigen 2 (DDCA2) expressed on a rare type of immune cell called plasmacytoid dendritic cells.
Shares down 2% premarket on light volume.

KalVista Pharmaceticals EPS beats by $0.22, beats on revenue

KalVista Pharmaceticals (NASDAQ:KALV): Q2 GAAP EPS of -$0.33 beats by $0.22.
Revenue of $3.92M (-29.9% Y/Y) beats by $0.65M.

Heron’s HTX-011 nabs accelerated review in Canada for postoperative pain

Under Priority Review status, Health Canada has accepted Heron Therapeutics’ (NASDAQ:HRTX) New Drug Submission (NDS) for HTX-011 for the management of postoperative pain.
Priority Review status provides an accelerated 6-month review target for the NDS.
HTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.