Biopharma Catalyst (FDA Approvals & Data Read outs)

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.

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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.

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see first post

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Some other upcoming catalysts on my radar:

  • AADI: Nab-sirolimus initial data for Ph2 pivotal in TSC1/2 tumor in 1H23
  • AFMD: AFM24 combotx (+anti-PD-1 or +NK cells) and monotx dose escalation/expansion updates 2Q (&3Q) 2023
  • FGEN: Phase III data of pamrevlumab in non-ambulatory DMD patients in Q2:23
  • FGEN: Phase III US data of Roxadustat for treatment of anemia in MDS in Q2:23
  • FGEN: Phase III data for pamrevlumab in IPF in mid-2023
  • FUSN: FPI-1434 Phase 1 safety, PK and imaging efficacy data from multi-dose cohorts in 2Q23
  • MGN: ELAHERE/mirvetuximab topline data from Ph3 MIRASOL trial in early ’23
  • KNTE: KIN-2787 Ph1a initial data in BRAF Class II&III tumors in 1H23
  • MLTX: Sonelokimab (IL-17 nanobody) Ph2 data in hidradenitis suppurativa in mid ‘23
  • MORF: Phase IIA ulcerative colitis data in Early Q2:23
  • RARE: GTX-102 (Angelman) ‘substantial’ data+reg update in 2023 (est mid’23)
  • RETA: Ph.III AYAME data in diabetic CKD pts in JPN in 1H23
  • RLAY: RLY-2608 Initial Clinical Data (1H’23)
  • THRX: Interim '630 ph.I/II GIST data in 2Q23
  • TVTX: Sparsentan ph.III DUPLEX FSGS 2yr eGFR data in 2Q23
  • VERA: Ph.IIb ORIGIN full 36-wk IgAN data in 2Q23

https://twitter.com/ScorpionFund/status/1640461317642305539?t=0eeIsO3Wb2rNYiCILYSdqw&s=19$

Leave it here so i don’t forget to check it tomorrow morning.

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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

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thank you @EV1

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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.

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Thinking about playing these binary catalysts (+100% upside potential). The source is the biotech reddit.

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Posted it in TF but here is a better place. If you play the BBIO buyout rumor be aware about the following other catalyst that are high impact:

  • Encaleret (CALIBRATE) Phase 3 data due late 2023
  • BBP-631 Phase 1 data due YE 2023
  • Propionic Acidemia ¶ and Methylmalonic Acidemia (MMA) Phase 1 due mid-2023
  • Acoramidis (AG10) - (ATTRibute-CM) & Amyloid cardiomyopathy (ATTR-CM) Phase 3 data due mid-2023
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Please read Biopharma/tech Education before you play any of these.

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XFOR is up 13% today, catalyst date is may 16. in case you are in this play with calls it’s now a good time to cover CB as they are up 100%

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https://seekingalpha.com/article/4593604-x4-pharmaceuticals-chronic-neutropenia-meets-match?source=tweet

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https://www.globenewswire.com/news-release/2023/04/25/2653691/0/en/Morphic-Announces-Corporate-Highlights-and-Financial-Results-for-the-First-Quarter-2023.html

Very strong clinical results:

  • In EMERALD-1, MORF-057
    • 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.

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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

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ImmunoGen Reports Recent Progress and First Quarter 2023 Financial Results (yahoo.com)

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.
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ALDX PDUFA approval decision June 21. (Putting this here as a reminder to myself.)

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https://investor.immunogen.com/news-releases/news-release-details/elaherer-demonstrates-overall-survival-benefit-phase-3-mirasol

IMGN up approx. 100% pre-market on outstanding news, will take profit at market open on my position. Already covered CB the last days.

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