Puma Biotechnology Receives Results of CHMP Formal Decision for Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Puma Biotechnology Inc (PBYI)
Last puma biotechnology inc earnings: 2/20 04:07 pm
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Source: Business Wire
LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion, recommending the refusal of the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer. On January 23, 2018, Puma announced that the CHMP had communicated a negative trend vote after meeting with the Company to discuss the MAA and that a negative trend vote meant it was unlikely that CHMP would provide a positive opinion related to the Company’s MAA at the formal CHMP meeting. The CHMP has noted that Puma may request a re-examination of the opinion and that a letter of intent to seek re-examination should be submitted within 15 days of acknowledgement of receipt of the final opinion package. Puma plans to submit this request in
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PBYI
Earnings
- 2/29/24 - Miss
PBYI
Analyst Actions
- 2/13/24 - HC Wainwright
PBYI
Sec Filings
- 3/29/24 - Form SC
- 3/19/24 - Form 4
- 3/19/24 - Form 8-K
- PBYI's page on the SEC website