Ruven27

L/S Equity
Bio/Rare Focus + Tactical

I read a filing or 2 ;)

This is not financial advice.

[dough @semodough]

$IDYA •2H26: Complete NDA filing for darovasertib in uveal melanoma
•2H26: Initiate combo IDE892 with RG6505 (panRAS)
•2H26: Clinical update for darovasertib in HLA-A2 positive patients at ESMO
•2H26: Clinical update for darovasertib in neoadjuvant primary UM (OptimUM-09 trial) at ESMO
•2H26: Hengrui update for IDE849 (DLL3 ADC) at ESMO
•4Q26: R&D day
•2H26: IDE849 Ph1/2 US clinical update
•2H26: IDE034 Ph1/2 clinical update

[Ruven27 @Ruven27]

$IDYA

Why oh why would you do this
$300M

[financebully @financebully]

$idya $tngx 🤔

[Ruven27 @Ruven27]

$IDYA

IDEAYA Biosciences and Servier Provide Complete Data from Phase 2/3 Registrational OptimUM-02 Trial of the Darovasertib Combination in First Line HLA*A2:01 Negative Metastatic Uveal Melanoma in a Late-Breaking Oral Presentation at #ASCO

https://t.co/IQqSQBb22R

[Ruven27 @Ruven27]

$XBI

[NOTRELOAD AI @notreload_ai]

BREAKING: Trump is planning to fire FDA Commissioner Marty Makary, according to the WSJ.

[dough @semodough]

$IDYA JP MORGAN Rama) are surprised that IDYA shares are not in the high-$30s post positive pivotal data for
darovasertib (+crizotinib) in metastatic uveal melanoma. Key debates post data include – 1) financing overhang (which we
disagree with, given the company has cash into 2030; hence, there is no urgency to finance) and 2) what is next for the
company – for which we see a “choose your own adventure scenario” with many interesting pipeline opportunities (DLL3,
MAT2A, PARG, PRMT5, KAT6/7). Frankly, adventure lies within the darovasertib neoadjuvant opportunity, for
which prior data remains underappreciated (now in pivotal stage). For reference, the value of darovasertib (mUM +
neoadjuvant) + cash in our model is mid-to-high $40s.

[dough @semodough]

$IDYA mizuho given a multitude of interim data updates for daro in treatment UM in various disease settings that we've seen in the past year, confidence in a positive mPFS result for daro in mUM remains very high.
bottom line. $IDYA has been under pressure following the daro readout delay (-6% vs. +8% for XBI since March 23); that said, given the strength of the data seen in daro (and our confidence in the readout), positive KOL feedbackreceived regarding daro during a recent Mizuho Biotech Expert Call, and current risk/reward (our PT implies 50% upside), recommend buying shares of IDYA.

[Ruven27 @Ruven27]

@Crussian17 Refilling the ink in the pens.

[Ruven27 @Ruven27]

@jeromeleonard5 @Bernardo_D1983 @MetallRain_ @monaco_biotech Precaution if anyone was expecting data tomorrow morning.

[quantumup @Quantumup1]

Cantor reiterated Top Pick $IDYA at an Overweight rating.
$IMCR $IMTX BMY REPL
Cantor said in its note—IDEAYA has guided to a progression-free survival (PFS) readout from the Ph2/3 OptimUM-02 trial of darovasertib (daro; PKC inhibitor) in 1L metastatic uveal melanoma (MUM) by the last week of March.
A positive outcome could support accelerated approval in HLA-A2-negative MUM patients, and de-risk daro's potential in uveal melanoma more broadly, including in neoadjuvant, adjuvant, and HLA-agnositic disease.

Based on our recent investor survey on the PFS topline, most are expecting a positive outcome. The strength of the PFS benefit will likely dictate the stock reaction.

We view PFS >7 months as an upside scenario for shares (+30%). We also expect investors to use the PFS readout as an early indicator for overall survival (OS) in OptimUM-02, which could support full approval. Our investor survey suggests expectations for OS are more mixed. As such, a strong PFS benefit could alleviate concerns ahead of the interim OS analysis in 2027.

[quantumup @Quantumup1]

Truist reiterated $IDYA Buy/$60
$RVMD TNGX IMRX BMY GSK $AMGN
Truist said—This morning, IDYA disclosed enrollment of the first patient into the ph.I study of IDE892, a PRMT5i in MTAP-deleted solid tumors e.g. NSCLC and pancreatic cancer. IDE892 represents IDYA's second wholly-owned MTAP asset to enter the clinic alongside IDE397 (MAT2Ai).
We view this development as incrementally positive as our thesis on IDYA's MTAP program has largely centered on the potential for synergistic rationale combinations e.g. IDE892/IDE397 to enable clinical differentiation from competitors - an approach the company plans to evaluate in mid-2026... Collectively, we view IDYA's refined strategy in MTAP as net positive, with the company prioritizing higher-potential targets and rationale combinations that we see as carrying a greater probability of success.

In our model, IDE397 accounts for $5 or ~8% of our $60 PT with IDE397's mUC opportunity contributing <$1 (with the remainder from NSCLC). At a broader level, we view the upcoming data for darovasertib in 1L metastatic uveal melanoma as the key catalyst and front and center for IDYA's potential near-term commercial transformation.

[Ruven27 @Ruven27]

Significant insider buy from Insider/director on $IDYA https://t.co/XQcKOAQxpz

[Ruven27 @Ruven27]

Slingshot Insights today at 230pm EST https://t.co/WD91PHtWz9 $IDYA // @Slingshot_Invst

[Ruven27 @Ruven27]

@unusual_whales

[Ruven27 @Ruven27]

@jeromeleonard5 Can't recall last time I've see that type of action on IDYA.

[Ruven27 @Ruven27]

$XBI

[FSMN @faststocknewss]

U.S. FDA and HHS Announce Overhaul of Biosimilar Approval Process;
New Draft Guidance Aims to Halve Review Times and Reduce Need for Large Human Trials — CMS Urges Insurers to Expand Access to Low-Cost Biosimilars;
FDA Also Plans Additional Reforms to Animal Drug Testing and Will Finalize Biosimilar Guidance Within Six Months $CRL

[Ruven27 @Ruven27]

@Bernardo_D1983 Abstract/data being released

[Ruven27 @Ruven27]

$IDYA

Big movement

[Ruven27 @Ruven27]

@jeromeleonard5 @17thfellow Someone has it and likes it

[Ruven27 @Ruven27]

$IDYA

Guggenheim initiates coverage on IDEAYA Biosciences w/ a Buy rating: $50PT