Jodi Sievers

Biotech and pharmaceutical industry professional specializing in corporate communication and investor relations. The opinions expressed on this feed are my own.

[Celcuity @celcuity]

Listen in tomorrow morning as Celcuity CEO and co-founder Brian Sullivan participates in a fireside chat presentation with equity research analyst Rich Law the at Goldman Sachs 47th Annual Global Healthcare Conference in Miami. Webcast link: https://t.co/pEDPpWb1I2
$CELC

[Susan G. Komen @SusanGKomen]

🧬 Sara Hurvitz, MD presents VIKTORIA-1 at #ASCO26: In HR+/HER2- PIK3CA-mutant breast cancer after CDK4/6i, gedatolisib + fulvestrant (with or without palbociclib) doubled progression-free survival vs standard of care (11.1 vs 5.6 months). 🎯 @ASCO

[Sara Tolaney @stolaney1]

VIKTORIA-1 Study 2 (PI3Km) by Sara Hurvitz
Fulv+palbo+ gedatolisib OR fulv + gedatolisib vs Fulv + alpelisib
Primary endpt: triplet vs fulv+ alpelisib
PFS 11.1 vs 5.6 HR 0.50
doublet vs control: 11.3 vs 5.6 mo HR 0.51

@OncoAlert #ASCO26

[Celcuity @celcuity]

Celcuity reported detailed results for the PIK3CA mutant cohort of the pivotal Phase 3 VIKTORIA-1 trial in patients with HR+/HER2- advanced breast cancer. Read our press release here: https://t.co/8c8yIR8p5R

[Jason A. Mouabbi MD @JAMouabbi]

VIKTORIA-1 PIK3CA-mutant cohort (LBA1008) dropped this morning at #ASCO26.

Gedatolisib roughly doubled PFS vs alpelisib + fulvestrant after CDK4/6i progression:

• Geda doublet: 11.3 mo
• Geda triplet: 11.1 mo
• Alpelisib + fulv: 5.6 mo

ORR 48.9% (triplet) / 35.7% (doublet)

IMO Three things worth sitting with:

1️⃣ This beat an active comparator: Piqray, not fulvestrant alone. That’s a harder bar than the WT cohort cleared, and it makes the win more meaningful.

2️⃣ The doublet matched the triplet on PFS (11.3 vs 11.1). Palbociclib deepened responses (ORR 48.9 vs 35.7) but didn’t extend PFS in this readout. Might be beneficial to start with the triplet to increase the likelihood of a response and then transition to a maintenance doublet

3️⃣ The quiet headline is tolerability: hyperglycemia reported lower than anything in this class to date. That’s been the Achilles’ heel of PAM inhibition since SOLAR-1.

This is the first PAM inhibitor positioned to deliver regardless of PIK3CA status. BIG WIN 👏🏼👏🏼👏🏼

#bcsm

[Celcuity @celcuity]

$CELC announces updates to our clinical development plan including expansion of our Phase 3 VIKTORIA-2 clinical trial to include a second study evaluating gedatolisib as 1L treatment in patients with endocrine-sensitive HR+/HER2- advanced breast cancer. https://t.co/FKpP3TCZ4U

[Celcuity @celcuity]

Today, we announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with HR+/HER2- PIK3CA mutant advanced breast cancer. https://t.co/9iBrTNsRQm

[Celcuity @celcuity]

We look forward to attending the upcoming investor conferences in March: TD Cowen 46th Annual Health Care Conference, Leerink Global Healthcare Conference, and the 2026 Jefferies Biotech on the Beach Summit. For more information: https://t.co/bZjMK4RbNB
$CELC

[Celcuity @celcuity]

$CELC is participating in a fireside chat and hosting investor meetings at the upcoming Guggenheim Emerging Outlook: Biotech Summit 2026. Read more here: https://t.co/4DJxhz2KKu

[Celcuity @celcuity]

$CELC is proud to announce the acceptance of our NDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. Read more here: https://t.co/shuqr45lBw

[Celcuity @celcuity]

At this year’s SABCS meeting, we will share new data for gedatolisib from the Phase 3 VICKTORIA -1 trial in patients with HR+/HER2-/PIK3CA-wild type advanced breast cancer in a rapid oral session.

Read our press release: https://t.co/tcNUR98h9Q

[Jodi Sievers @Jodi_Sievers]

@Coherus_Bio nice!

[Jodi Sievers @Jodi_Sievers]

@Baileymoon15 That’s me to Matt 😅

[Jodi Sievers @Jodi_Sievers]

@DanBudwick 20 as well… 🤦🏼‍♀️ It took a lot of work to set the stage these past two years, think 2025 will be a great year for us.

[Jodi Sievers @Jodi_Sievers]

@NWSBayArea Sunset with hail in Burlingame Hills

[Coherus Oncology @Coherus_Bio]

LOQTORZI™ (toripalimab-tpzi) is now available through select specialty distributors in the United States. Read more here: https://t.co/MQjrLXNUoA

[Coherus Oncology @Coherus_Bio]

Coherus Agrees to Acquire Exclusive U.S. Commercial Rights to Eylea® Biosimilar FYB203 from Klinge Biopharma $CHRS https://t.co/UuNtBqGmUV

[California Life Sciences (CLS) @CALifeSciences]

BREAKING: @Coherus_Bio wins the #Pantheon2022 Biopharma Award!

[Jodi Sievers @Jodi_Sievers]

@MikeHuckman Welcome to the Westin! 😅

[Jodi Sievers @Jodi_Sievers]

Very excited to share this great news from @RigelPharma and @FORMAInc!

[Rigel Pharmaceuticals @RigelPharma]

@RigelPharma is pleased to announce our licensing agreement with @FORMAInc to bring a potential new treatment to patients with relapsed or refractory AML. Read our full press release here: https://t.co/jB3up20WZ5