Biotech

NASDAQ:PBYI

Puma Biotech released it now has a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for it’s drug neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer.

A US Food and Drug Administration (FDA) drug approval may be one of the hardest to achieve, but there’s still more hurdles with international regulatory agencies for global expansion.

On Tuesday (June 26), Puma Biotech (NASDAQ:PBYI) released that it now has a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for it’s drug neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer.

This is in lieu of reexamination as requested by the Puma in February when it first received a negative opinion from the committee. The CHMP intends to hold a final vote at its next meeting in July.

Back in January, the company first announced after an oral explanation with the CHMP, there was a negative trend vote for neratinib’s marketing authorisation application for the said treatment.

At the official meeting in February, the CHMP confirmed the formal decision was a negative opinion, but Puma could request a reexamination of the opinion.

For drugs to be approved in the European Union (EU) the application must first go through the CHMP which give recommendations on whether the drug should be marketed or not. Then, once granted by the European Commission, the centralized marketing authorization is valid in every EU member state.

Nerlynx (neratinib) was approved by the FDA last year in July for the same indication, extended adjuvant treatment of early-stage, HER2-positive breast cancer. This was the first anti-HER2 treatment to be FDA-approved as an extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.

Neratinib is Puma’s only product in its pipeline and the approval with the FDA was the company’s first and only commercial product. In its most recent Q1 financial results, the company reported US$36 million up from US$20.1 million in the previous quarter, Q4 2017 as net product revenue for Nerlynx.

The drug is in development for other indications for HER2+ breast cancer including metastatic, metastatic with brain metastasis, and more. The company focuses on acquiring and developing novel therapeutics for cancer.

Investor Takeaway

Following the announcement, shares of Puma Biotech increased 24.36 percent to US$63.55 after market close Tuesday.

Kennen MacKay, managing director and co-head of biotechnology equity research at RBC Capital Markets issued a note to investors on Tuesday. The note was based on Nerlynx potentially entering the EU market in Q4 of this year.

“PBYI’s press release suggests a more restrictive label vs that of the USA which could limit this upside,” the note said. This potential EMA approval adds possibly more than $30 a share to MacKay’s model on the company.

For investors interested in Puma, keep following the company for news on other clinical trials and a possible EMA approval around Q4 2018.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.

Featured

MARKETS

Markets
TSX20083.22-538.17
TSXV811.00-45.62
DOW33545.73-719.64
S&P 5004281.52-116.42
NASD13343.68-425.24
ASX7175.80-166.60

COMMODITIES

Commodities
Gold1833.74-0.45
Silver23.65-0.62
Copper4.41-0.11
Palladium2148.00+51.00
Platinum1018.00-12.00
Oil82.57-2.57
Heating Oil2.58-0.06
Natural Gas4.01+0.01

DOWNLOAD FREE REPORTS

×