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PBYI

Puma Biotechnology

$34.74

-1.08 (-3.02%)

08:34
04/04/19
04/04
08:34
04/04/19
08:34

Puma Biotechnology expands cohorts in Phase II SUMMIT trial of neratinib

Puma Biotechnology has expanded two additional cohorts from the Phase II SUMMIT clinical trial investigating its lead drug candidate neratinib in patients with solid tumors who have an activating EGFR or HER2 mutation. The cohorts that have been expanded are HER2 mutant patients with metastatic salivary gland cancer and patients with EGFR exon 18 mutation-positive lung cancer. The Phase II SUMMIT basket trial is an open-label, multi-center, multi-histology, international study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR, HER2 or HER4 mutations. The salivary gland cancer patients initially entered the study in the "other solid tumors with a HER2 mutation" cohort, and due to the preliminary activity seen in the trial, the Company has expanded a separate salivary gland cancer cohort pursuant to the protocol for the trial. The expanded HER2-mutant salivary gland cancer cohort and the expanded EGFR exon 18 mutant lung cancer cohort will each now enroll approximately 18 patients.

PBYI Puma Biotechnology
$34.74

-1.08 (-3.02%)

01/03/19
GUGG
01/03/19
DOWNGRADE
GUGG
Neutral
Puma Biotechnology downgraded to Neutral from Buy at Guggenheim
01/17/19
LEER
01/17/19
INITIATION
Target $21
LEER
Market Perform
Puma Biotechnology initiated with a Market Perform at Leerink
Leerink analyst Thomas Smith started Puma Biotechnology with a Market Perform rating and $21 price target. In the near-term, the analyst sees the shares trading based on the outlook for Nerlynx revenue in its currently approved indication, extended adjuvant therapy after adjuvant Herceptin, and prospects for uptake in a near-term expansion indication, metastatic breast cancer. Results in Q3 were disappointing, he notes, further deflating investor sentiment as sales growth slowed and the number of company-reported active patients on therapy was revised lower. However, shares are trading in-line with his below consensus estimates and at current levels he cannot rule out strategic interest, given the resurgence in oncology-focused M&A and scarcity of commercial-stage oncology assets.
03/01/19
SBSH
03/01/19
NO CHANGE
Target $70
SBSH
Buy
'Excuses' for not owning Puma Biotechnology 'rapidly shrinking,' says Citi
With Puma Biotechnology's U.S. Nerlynx sales shaping up at $300M in 2019, U.S. metastatic revenue coming in 2020, Europe launching in the first half of 2019 and rest-of-world territories with high royalties coming online in next 12-24 months, the Nerlynx brand is closing in on the $500M mark "faster than many investors may appreciate," Citi analyst Yigal Nochomovitz tells investors in a research note. The "list of excuses for not owning the launch now seems to be rapidly shrinking," adds the analyst after Puma reported Q4 results. He raised his price target for the shares to $70 from $67 and keeps a Buy rating on the shares.
04/02/19
CANT
04/02/19
NO CHANGE
Target $57
CANT
Overweight
Puma Biotechnology buyout chances 'about the same,' says Cantor Fitzgerald
Shares of Puma Biotechnology traded down yesterday after the announcement of its partnership with Pierre Fabre in Europe, most likely because investors may think that a takeover is now less likely, Cantor Fitzgerald analyst Alethia Young tells investors in a research note. The analyst says that while a buyout is not her thesis, she thinks the likelihood of a potential deal "remains about the same." Management noted other companies like Pharmacyclics and Medivation that did deals in Europe for royalties and then were acquired, Young writes after speaking to Puma Biotechnology's CEO. Further, the analyst thinks the royalty with Pierre Fabre is probably more attractive than what investors expect. She keeps an Overweight rating on Puma Biotechnology with a $57 price target.

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