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Thursday, December 5, 2019

Not All Negative Emotions Are Problems

I recently spoke with an experienced, insightful trader who was experiencing performance anxiety.  He was so concerned with losing money that he failed to follow his own rules regarding entering positions, taking profits, etc.  As a result, he chronically felt frustrated, because his ideas were good, but his trading was mediocre.
It turns out that this trader had a pretty small account and was trying to use his trading to support himself and his family.  As a result, he was taking positions that were quite large–quite leveraged–relative to his capital base.  This ensured that, if he had a normal and expectable run of losing trades, his account would draw down meaningfully.
He knew that he could not afford to draw down significantly, so he was caught between a rock and a hard place.  He had to take risk to make the money he needed; he could not lose much of the money at all.
In such a case, anxiety is a normal and healthy response.  It is information, not a problem.  It is telling us that the trader’s goals are not realistic and are placing too much pressure on him and his performance.  He either needs to find other ways to support his family while developing his trading or find a position as a funded trader.  Most important, he needs to trade without the fear of risk of ruin.
Many times, the negative emotions of rational people are themselves rational responses to irrational situations.  If a spouse experiences emotional abuse from a partner, reactions of fear and anger are normal and natural–and they are telling us something!  Negative emotions can become prods to get us to look at our circumstances and expectations and make constructive changes in those.  Too often, we look to rid ourselves of negativity rather than looking into it and learning from it.

Aptinyx launches mid-stage NYX-458 study

Aptinyx (NASDAQ:APTXinitiates a Phase 2 clinical study of its NMDA receptor modulator, NYX-458, for the treatment of mild cognitive impairment associated with Parkinson’s disease.
Top-line data from the 135-patient study are expected in H2 2021.
The study will evaluate daily oral dosing of NYX-458 – 10 mg, 30 mg, or 100 mg – compared to placebo over a 12-week period.
The effects of NYX-458 on cognitive performance will be evaluated across multiple endpoints related to attention, memory, executive function, visuospatial deficits, and patient quality of life.
Shares are up 3% premarket.

Analyst actions, Dec. 5

NextCure (NASDAQ:NXTC) initiated with Buy rating and $72 (41% upside) price target at Needham.
X4 Pharmaceuticals (NASDAQ:XFOR) initiated with Buy rating and $25 (146% upside) price target at B. Riley FBR.

Dynavax up 4% premarket on Albertsons’ deal in hepatitis B

Dynavax Technologies (NASDAQ:DVAX) and Albertsons Companies have partnered to provide HEPLISAV-B at latter’s more than 1,700 pharmacies nationwide, with a special focus on people living with diabetes.
Through this partnership, patients will have access to HEPLISAV-B, the only FDA-approved two-dose hepatitis B vaccine for adults that is completed in one month.
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
Shares are up 4% premarket.

EC OKs Astellas’ XOSPATA for Relapsed or Refractory Acute Myeloid Leukemia

For twenty-five years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. The LeukoStrat® CDx FLT3 Mutation Assay may now be used as an aid in the assessment of AML patients for treatment with XOSPATA® (gilteritinib) in Europe. FLT3 mutation must be confirmed with a validated test, such as the LeukoStrat CDx FLT3 Mutation Assay, which served as the companion diagnostic in the Phase 3 ADMIRAL trial resulting in approval of XOSPATA®.
Companion diagnostics play a key role in the development and approval of targeted drug therapies. The ability to screen for biomarkers in a patient population creates patient subsets which further enables drug developers in the design of novel therapeutics and management of clinical trials. Accordingly, the successful approval of a targeted therapy is highly dependent on the performance of the companion diagnostic.
EC approval of gilteritinib is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML. The ADMIRAL study demonstrated that gilteritinib resulted in a statistically significant improvement in median overall survival (9.3 months) compared to salvage chemotherapy (5.6 months) when patients were selected with the LeukoStrat CDx FLT3 Mutation Assay (Hazard FLT3 Ratio = 0.637 (95%CI 0.488, 0.830, P=0.0004). This approval highlights yet another solution in patient care.

ViiV submits New Drug Application for inhibitor for the treatment of HIV

ViiV Healthcare, the global specialist HIV company majority owned by GSK , with Pfizer, Inc. and Shionogi, Inc  as shareholders, today completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection. Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.
Antiretroviral medicines that can effectively suppress HIV have been instrumental in decreasing disease progression, HIV transmission, and AIDS-related deaths, but because of HIV’s ability to constantly change, some individuals can develop viral resistance to antiretroviral medicines, causing their treatment regimens to fail. Challenges with tolerability, safety, and drug-to-drug interactions may further decrease the number of acceptable antiretroviral therapies available to design effective treatment regimens. There remains an unmet need for these individuals who are considered heavily treatment-experienced and who are unable to successfully suppress their HIV.
Deborah Waterhouse, CEO of ViiV Healthcare, said: “Fostemsavir may provide an important treatment option for the group of people living with HIV who, for a variety of reasons, are not able to suppress their virus with other medicines and could be left with few or no treatments available to them. In keeping with our mission of leaving no person with HIV behind, we have overcome many barriers to bring this important new medicine to people living with HIV, including investing in what is a very complex manufacturing process. We look forward to working with the FDA to make fostemsavir available to the people in the US who need it.”
This submission is supported by the data from the pivotal phase III BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV. The 96-week results from the BRIGHTE study were most recently presented in July at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City.

Regeneron: Positive Topline Phase 2 Data in Rare Blood Disorder Antibody Study

Results from initial 6-patient cohort show pozelimab reduced lactate dehydrogenase (LDH) to normal levels at week 8 in patients with paroxysmal nocturnal hemoglobinuria (PNH), utilizing a weekly subcutaneous dosing regimen
Second part of Phase 2 trial initiated; plans for Phase 3 program underway
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced topline data from the pozelimab (REGN3918) Phase 2 clinical program in paroxysmal nocturnal hemoglobinuria (PNH), validating the weekly 800 mg subcutaneous (SC) dosing regimen, following an initial intravenous (IV) loading dose. Pozelimab reduced the abnormal destruction of red blood cells, otherwise known as “hemolysis,” with patients in the initial cohort achieving normal levels of a blood biomarker of elevated hemolysis called lactate dehydrogenase (LDH).
PNH is an ultra-rare, chronic, life-threatening disease where genetic mutations cause hemolysis, resulting in a range of symptoms including fatigue, shortness of breath and blood clots. Even with existing therapies, which require regular intravenous infusions administered at infusion centers or during a home visit by a health professional, approximately 50% of newly-treated patients do not achieve normal LDH levels.
“In our view, any new medicine for PNH must deliver real change for patients, such as more patients achieving normal LDH levels, or a reduced treatment burden that potentially allows for at-home self-administration,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. “We are encouraged by these early pozelimab results, with patients achieving normal levels of LDH by week 8 using the subcutaneous dosing regimen. We look forward to speaking with regulators about the next phase of our program for these patients.”