Medigene, Bluebird Bio Expand Cancer Collaboration to $1.5B

MediGene, based in Martinsfried and Munich, Germany, and bluebird bio, headquartered in Cambridge, Massachusetts, announced they are expanding a strategic research and development collaboration inked in September 2016.

Under the terms of the original deal, Medigene was responsible for creating and delivering T cell receptors (TCR) using its TCR isolation and characterization platform. After the collaborative preclinical development, bluebird handled the clinical development and commercialization of the TCR product candidates. Bluebird also received an exclusive license for the intellectual property that came out of the TCRs.

Medigene received an upfront payment of $15 million (U.S.), as well as possible preclinical, clinical, regulatory and commercial milestone payments. Together they had the potential to reach $1 billion for the four TCR products, or about $250 million for each TCR.

Under the new expansion, they have added two additional TCR candidates under the same terms, bringing the possible deal total up to $1.5 billion, in addition to royalties on sales if anything makes it to market. Bluebird is also paying Medigene $8 million upfront and additional research-and-development funding to cover the new programs.

Analysts at Baader Helvea confirmed their “buy” recommendation for Medigene, indicating the collaboration extension validated Medigene’s tech platform.

In February, Medigene announced that its first Phase I/II clinical trial of its TCR-modified T-cell therapy MDG1011 had been approved by German regulatory authorities. Its contract manufacturer had also received the necessary manufacturing license to create the study materials. This program is independent of the bluebird bio collaboration.

MDG1011 targets the tumor antigen PRAME (PReferentially expressed Antigen in MElanoma). In the trial, it will be tested in about 92 patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM).

“Attaining these approvals for MDG1011 is an important step towards the start of our clinical trial, and a further validation of our research and product development work,” said Kai Pinkernell, senior vice president clinical affairs and chief medical officer of Medigene, in a statement. “With our specific study design, we are able to evaluate our T-cell therapy simultaneously in various diseases and to generate data in three hematological indications in parallel.”

Under the new terms, Medigene is anticipating a milestone payment of $1 million based on the first project from the collaboration.

“We are delighted to broaden this outstanding collaboration for the joint research and discovery of TCR lead candidates designed for the treatment of multiple cancer indications,” said Dolores Schendel, Medigene’s chief executive officer and chief scientific officer, in a statement. “Medigene is contributing its unique TCR technology platform, which encompasses multiple innovative screening and assessment tools to identify and characterize specific, non-modified TCRs to selected target antigens in a highly competitive framework. The expansion of this alliance further validates the efficiency and quality of Medigene’s TCR platform technology.”

Medigene also updated their financials as a result of the deal, indicating that it “improves the Company’s cash burn guidance for 2018 and now anticipates a cash usage of EUR 16-19 million instead of EUR 21-25 million for the full year. Revenue, R&D expense and EBITDA guidance for 2018 will not change substantially as a result of this expansion of the agreement. Full financial guidance will be provided in Medigene’s six-months report 2018.”

https://bit.ly/2If1Coz

Rhythm Pharmaceuticals (RYTM) Misses Q1

Rhythm Pharmaceuticals (NASDAQ: RYTM) reported Q1 EPS of ($0.60), $0.15 worse than the analyst estimate of ($0.45).

“Our achievements year-to-date reflect our dual commitment to addressing the unmet medical needs of people living with rare genetic disorders of obesity and raising awareness and understanding of these conditions,” said Keith Gottesdiener, M.D., Chief Executive Officer of Rhythm. “In addition to advancing our ongoing clinical trials of setmelanotide across six melanocortin-4 receptor (MC4R) pathway deficiencies, we expanded our pipeline with the in-licensing of RM-853, a preclinical ghrelin o-acyltransferase (GOAT) inhibitor for the treatment of PWS that may have benefit both as a single agent or in combination with setmelanotide. We are on track to complete enrollment in our Phase 3 trial in POMC deficiency obesity by the end of the second quarter, and are particularly encouraged by the rate of enrollment in our Phase 3 trial in leptin receptor (LEPR) deficiency obesity, which we initiated earlier this year.

Dr. Gottesdiener continued, “We are also pleased that the FDA agreed that BBS and Alström Syndrome are included under our existing BTD for setmelanotide, underscoring the need for medicines that effectively address the excess hunger and weight gain associated with rare genetic disorders of obesity. We look forward to continuing our work with physicians and the broader community to improve the diagnosis of, and ultimately treat, people living with these conditions.”

https://bit.ly/2rHd2Gu

Tandem Diabetes Care upped to buy by Piper

Piper Jaffray upgraded Tandem Diabetes Care (NASDAQ: TNDM) from Neutral to Overweight with a price target of $13.00 (from $8.00).

https://bit.ly/2wKuxvA

Overcoming FOMO

Cognitive Behavioral Techniques for Changing Your Trading Psychology – Part Two: Overcoming FOMO

In the first post of this three part series, we looked at specific techniques traders can employ to overcome procrastination.  These methods, backed by significant research, can very much help traders approach their work in a more decisive, positive mind frame.

One of the most commonly recognized trading psychology challenges, especially for developing traders, is a fear of missing out on possible opportunity.  That FOMO leads to overtrading, as the fear of missing leads to the taking of marginal trades.  In the work I’m doing with Mike Bellafiore at SMB, combining mentoring and psychological coaching, we have the traders enter all of their trades into a platform that automatically calculates a wealth of statistics:  number of long and short trades taken; number of winning and losing trades; average sizes of winning and losing trades; winning percentage and P/L as a function of time of day; as a function of relative volume; etc.  A common pattern is that win percentage goes down when the number of trades placed increases.  This is often because the additional trades are made from a FOMO mindset.

In the previous post, we looked at Dr. Seth Gillihan’s recent self-help book on cognitive behavioral techniques and how those can help with patterns of thought and behavior.  The FOMO mindset is grounded in that F word:  fear.  Techniques that help people with fear and anxiety can be tremendously helpful in overcoming the overtrading that arises from concern over missing trade opportunities.  Here are three especially useful techniques traders can employ on their own:

1)  Mindfulness – Dr. Gillihan points out that our breathing tends to mirror our anxiety when we’re getting worked up.  By becoming aware of our breathing, slowing it down, and deepening it, we can place ourselves in a much more calm and focused mindset.  He recommends doing an exercise in which we a) breathe in gently for a count of two; b) breathe out slowly for a count of five; c) pause after exhaling for a count of three; and d) repeat this process for 5-10 minutes.  Notice how this creates a rhythm for your mind and body that counteracts the chaos of anxiety.  What I have found is that if you practice such an exercise daily, you can become proficient in the method and then can just take a few even breaths during trading to re-center yourself.  The focus on breathing keeps you grounded in the present and builds your self-awareness, so that you’re less likely to act on impulse.

2)  Reassess the Severity of the Threat – Many times, we get worked up about something that we tell ourselves is a threat, but that actually can do us little harm.  One way of reassessing that I have found to be very helpful is actively telling myself that *of course* I’m going to miss opportunity.  I miss opportunity in every market I don’t trade and in every time period (such as overnight) that I don’t trade.  No matter how many opportunities I miss, ones always end up appearing later in the day or the next day.  The goal is not to trade every possible opportunity, but to identify the best opportunities and trade those as well as possible.  By reframing the opportunity set and taking the threat out of missing something, I can eliminate FOMO as a motivation.

3)  Directing Attention Outward – Dr. Gillihan observes that, when we become fearful, we tend to dwell on worries.  By directing our attention outward, we can break the vicious cycle of worrying, getting anxious, leading to further worrying.  In trading, the outward focus can be a doubling down on one’s trading process and rules.  When we have our trading laid out in “playbook” form, with explicit rules, we can ground our decision making in what we do best.  This helps us reframe the fear of missing a move into a fear of trading poorly.  Notice how this approach helps to transform fear into actual opportunity.  Very often, the outward focus leads us to hold off on placing the FOMO trade, helping us find better opportunities to enter and exit.

My experience in trading is that, if I’m feeling FOMO, the odds are good that others are experiencing it as well.  The trade that seems obvious is often not the high percentage trade.  Using FOMO as information that actually makes the trade *less* attractive is a great example of how we can use emotional awareness as a tool for superior decision-making.

https://bit.ly/2rGqgnX

Allergan aesthetics chief David Moatazedi becomes CEO of Evolus

Allergan aesthetics chief David Moatazedi is leaving to take the helm of Evolus, a much smaller biotech developing a rival to Botox. Evolus’ new drug DWP-450 (PrabotulinumtoxinA) is under review. Moatazedi noted: “The team at Evolus has done a fantastic job in bringing forward what I believe will be the most exciting new product in aesthetics. I look forward to working with this talented group of professionals and completing the build out of a best in class leadership team.”

https://bit.ly/2wEUdtv

Lilly to buy cancer drug developer AurKa Pharma

Drugmaker Eli Lilly and Co said on Monday it would buy AurKa Pharma Inc to get access to the privately-held company’s experimental cancer treatment for solid tumors.

AurKa Pharma shareholders will get an upfront payment of $110 million and will be eligible to receive up to $465 million in regulatory and sales milestones, Eli Lilly said in a statement.

https://reut.rs/2KkWHip

Baxter pullback would warrant a potential upgrade: Argus

Argus analyst John Eade kept his Hold rating on Baxter after the company’s Q1 earnings beat and raised FY18 outlook, saying he would consider an upgrade if the stock price pulled back to the mid-$60’s range. The analyst notes that Baxter has “substantially improved profitability in recent quarters” even as it continues to rely on M&A as a source of revenue and margin growth. Eade adds that while the company’s Renal and Hospital Products segments are mature businesses, the company’s balance sheet is clean, and the management’s recent dividend raise is indicative of its confidence in Baxter’s prospects.

https://bit.ly/2rG4CQv