|Bid||0.1700 x 4000|
|Ask||0.1800 x 800|
|Day's Range||0.1710 - 0.1809|
|52 Week Range||0.1500 - 1.4000|
|Beta (3Y Monthly)||1.62|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
On January 2nd Aevi (GNMX) announced that ASCEND, the phase II trial evaluating their non-stimulant glutamatergic neuromodulator in pediatric and adolescent subjects with ADHD, failed to meet its primary endpoint of a statistically significant reduction of ADHD-RS at 6 weeks in either Part A (mGluR+ subjects) or Part B (mutation free subjects). As we have consistently stated in our coverage, given the largely positive results of SAGA and enrichment of ASCEND with only patients with mutations to nine select genes in the mGluR network, along with a pediatric weighting, we had expected ASCEND would prove successful. As a reminder about SAGA’s results (see link to our report), it did meet statistical significance on the CGI-I secondary endpoint as well as on the ADHD-RS responder measure (prespecified as decrease of ADHD-RS score of 30% or more, which is considered a clinical response).
Bristol-Myers Squibb Co (NYSE: BMY) announced a deal to buy Celgene Corporation (NASDAQ: CELG) in a cash and stock transaction with an equity value of approximately $74 billion. Separately, the company announced FDA approval for an expanded indication for its Sprycel tablets to include the treatment of pediatric patients one year of age and older, with newly diagnosed Philadelphia chromosome-positive, or Ph+, acute lymphoblastic leukemia in combination with chemotherapy.
Aevi Genomic Medicine (GNMX) reported Q3 financial results and provided a business update. Just two months later, GNMX announced that part ‘B’ (i.e. Also noteworthy is that while the initial plan was for parts A and B to enroll and read-out sequentially, given the rapid enrollment of part B, the expectation is now that top-line data will be announced for both in January.
On a per-share basis, the Wayne, Pennsylvania-based company said it had a loss of 12 cents. The company's shares closed at $1.09. A year ago, they were trading at $1.66. _____ This story was generated ...
Despite the slight additional delay to ASCEND (as a result of the optioned increased enrollment), we continue to think there may be several pipeline-related events over the very near term that could potentially favorably influence equity valuation and related pricing of any near-term financings. GNMX hopes to swap out AEVI-001 (which is in phase 2 mGlur+ ADHD ASCEND study) with an improved version. AEVI-004 provides the benefits of intellectual property protection (out to 2039) and is designed to maintain substantially similar solubility, dissolution and pharmakokinetics of AEVI-001 but with (per GNMX's press release) "greater stability and a higher melting point".
On a per-share basis, the Wayne, Pennsylvania-based company said it had a loss of 14 cents. The company's shares closed at $1.10. A year ago, they were trading at $1.20. _____ This story was generated ...
Indicating that after an interim look at the placebo arm, the decision was made to continue to enroll to n=64 in order to “ensure sufficient power to detect a robust treatment effect”. In other words, in order to further reduce the risk of placebo effect. Importantly, this decision was based solely on a statistically-derived estimate of placebo response based solely on the placebo arm (i.e.