RETA play was an absolute rollercoaster. Congrats to all who played it.
Saying this for people on the sidelines watching these percentages, this is arguably the highest risk you can take on a play, even greater than crypto shenanigans if you play options.
Also, please be careful when shorting this. With 98% institutional ownership it’s not likely to come crashing down like your average meme stock.
Be smart and manage your risk. On to the next one.
I strongly recommend to not enter any positions on the open plays until the overall market found its direction. In a more bearish market we will not see any run up towards the catalyst, so hence no opportunity to take profit / cover cost basis before the catalyst.
Announced a position couple of weeks ago in the position teams. ITCI up in pre-market on the positive top-line results. Results demonstrated statistically significant in the primary endpoint and the key secondary endpoint. Safety and tolerability profile aligned with previous results and seen as favorable. Will decide on my position after the investor call at 8:30 EST
After reading the full short report i am out of HRMY. The report is full of (fair) assumptions but actually doesn’t include much of a proof. So it’s basically just indicative. It requires a governance body (FDA, prosecutor) to do a independent investigations, so possible we are talking here months/years.
Achieved primary endpoint with statistical significance, demonstrating a reduction of 6.4 points (p=0.002) from baseline at week 12 in the Robarts Histopathology Index (RHI) Score
Achieved a 25.7% remission rate according to Modified Mayo Clinic Score (mMCS)
Was generally well tolerated and with no safety signal observed
Achieved saturation of α4β7 receptor and demonstrated changes in α4β7 lymphocyte subsets that are consistent with Phase 1 MORF-057 data
Took profit on this initial 40% pop but kept a small position to see if there is another pop at market open.
XFOR very busy MAY upcoming 3 MAY events. Starting with earnings on the 4th, May 16 Virtual investor event, followed by CIS oral presentation on May 21
expect to announce top-line data from our confirmatory MIRASOL trial in early May;
advanced our broader development program to move into platinum-sensitive disease and position ELAHERE as the combination agent of choice in ovarian cancer;
expect to complete enrollment in our pivotal CADENZA trial in frontline BPDCN by the end of the year;
anticipate reporting data from our expansion cohorts with the PVEK/VEN/AZA triplet in frontline AML at ASH in December;
advanced dose escalation with IMGN151, our second-generation ADC targeting FRα, and expect to report data for IMGC936 following an interim analysis.
Lots going on!
Generated $29.5 million in ELAHERE® (mirvetuximab soravtansine-gynx) net sales for the quarter ended March 31, 2023, the first full quarter of launch following approval in November of 2022.
Reached requisite number of progression-free survival (PFS) events in the confirmatory MIRASOL trial.
Presented final overall survival and additional efficacy data from the SORAYA trial at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting.
Advanced dose escalation with IMGN151 and enrollment in the non-small cell lung cancer (NSCLC) expansion cohort for IMGC936.
Announced non-dilutive credit facility with Pharmakon Advisors, LP for up to $175 million; $75 million received upon execution.
Appointed Isabel Kalofonos as Senior Vice President and Chief Commercial Officer.