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CELC

Celcuity

$26.90

0.4 (1.51%)

, PBYI

Puma Biotechnology

$42.22

1.17 (2.85%)

17:57
10/16/18
10/16
17:57
10/16/18
17:57

Celcuity, Puma Biotechnology and West Cancer Center to conduct Phase 2 trial

Celcuity (CELC) announced a clinical trial agreement with Puma Biotechnology (PBYI) and West Cancer Center, to conduct a Phase II clinical trial. This open-label Phase II trial will evaluate the efficacy and safety of Puma's drug, Nerlynx, and chemotherapy in up to 27 early stage triple-negative breast cancer patients selected with Celcuity's CELx HER2 signaling function, or CELx HSF, test. Under this agreement, West Cancer Center will serve as the sponsor and principal investigator of the trial and is responsible for enrolling patients and managing clinical data. Puma will supply Nerlynx, its pan-HER inhibitor currently approved by the FDA for extended adjuvant treatment of early-stage HER2-positive breast cancer. Celcuity will provide its CELx HSF test to select triple-negative breast cancer patients who have hyperactive HER2-driven signaling pathways for the trial and will initially fund the patient-related trial costs. Based on its estimates of patient enrollment rates, Celcuity expects to obtain interim results in 10-12 months after the first patient is enrolled and final results within 18-24 months. Celcuity expects enrollment to begin in early 2019. The most common adverse reactions for Nerlynx were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight decreased and urinary tract infection. The goal of the trial is to demonstrate that triple-negative breast cancer patients who have a hyperactive HER2 signaling tumor, as identified by the CELx HSF test, respond to treatment with Nerlynx, a matching HER2 therapy. Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for triple-negative breast cancer patients because fewer drug treatment options are available to them relative to other breast cancer sub-types. Celcuity submitted an investigational device exemption, or IDE, application to the FDA to use its CELx HSF Test for this clinical trial and received approval in mid-2018.

CELC

Celcuity

$26.90

0.4 (1.51%)

PBYI

Puma Biotechnology

$42.22

1.17 (2.85%)

  • 19

    Oct

  • 15

    Nov

CELC Celcuity
$26.90

0.4 (1.51%)

PBYI Puma Biotechnology
$42.22

1.17 (2.85%)

09/17/18
GUGG
09/17/18
INITIATION
Target $85
GUGG
Buy
Puma Biotechnology initiated with a Buy at Guggenheim
Target $85.
09/18/18
09/18/18
NO CHANGE
Target $151

Buy
Physician survey supports Puma's Nerlynx hitting $1B in sales, says Citi
Citi analyst Yigal Nochomovitz says his 100-physician survey of U.S. oncologists supports his "long-standing bull thesis" that Puma Biotechnology's Nerlynx is positioned to be a billion-dollar drug. Continued fundamental upside to the launch should limit investor concerns around a "stalled" launch that has been pressuring the stock, Nochomovitz tells investors in a research note. The survey indicates that one-in-four adjuvant Herceptin patients are expected to receive Nerlynx. This provides "substantive validation" that 20%-25% of Herceptin completers are high-risk and thus likely Nerlynx patients, Nochomovitz contends. The analyst lowered his price target for Puma shares to $151 from $164 and keeps a Buy rating on the name.
10/01/18
CANT
10/01/18
INITIATION
Target $75
CANT
Overweight
Puma Biotechnology initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young started Puma Biotechnology with an Overweight rating and $75 price target.
10/15/18
RBCM
10/15/18
NO CHANGE
RBCM
Sector Perform
Roche breast cancer data could pressure Puma shares, says RBC Capital
RBC Capital analyst Kennen MacKay thinks the data presented this morning by Roche's (RHHBY) Genentech could pressure shares of Puma Biotechnology (PBYI) today. Genentech announced the Phase III Katherine study met its primary endpoint, showing Kadcyla as a single agent reduced the risk of disease recurrence or death compared to Herceptin as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease present following neoadjuvant treatment. Kadcyla's ultimate entry into the HER2-positive adjuvant setting could complicate the positioning of Puma's Nerlynx, MacKay tells investors in a research note. He keeps a Sector Perform rating on shares of Puma, which are down 4%, or $1.55, to $41.14 in morning trading.

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