LOXO ONCOLOGY,INC. (NASDAQ:LOXO) Files An 8-K Regulation FD Disclosure

ME Staff 8-k
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LOXO ONCOLOGY,INC. (NASDAQ:LOXO) Files An 8-K Regulation FD Disclosure

LOXO ONCOLOGY,INC. (NASDAQ:LOXO) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD.

On November26, 2018, Loxo Oncology,Inc. (“Loxo Oncology”), and its partner Bayer, issued a press release announcing that the U.S. Food and Drug Administration granted marketing approval to Vitrakvi® (larotrectinib). Bayer, the lead commercial party, has final decision-making authority on all commercial matters, including pricing. Per Bayer, the wholesale acquisition cost (WAC) of Vitrakvi® (larotrectinib) is $32,800 for a 30-day supply. This price is based upon the standard dose of Vitrakvi® capsules (100 mg BID), and is equivalent to the price of the average anticipated dose of Vitrakvi liquid (100 mg/m2orally twice daily with a maximum of 100 mg per dose). A copy of the press release is furnished as Exhibit99.1 to this report and incorporated herein by reference.

The information furnished with this report, including Exhibit99.1, shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

(d)Exhibits.


Loxo Oncology, Inc. Exhibit
EX-99.1 2 a18-40386_2ex99d1.htm EX-99.1 Exhibit 99.1       News Release   FDA Approves Vitrakvi® (larotrectinib),…
To view the full exhibit click here

About LOXO ONCOLOGY,INC. (NASDAQ:LOXO)

Loxo Oncology, Inc. is a United States-based biopharmaceutical company. The Company is engaged in developing selective medicines for patients with genetically defined cancers. Its pipeline focuses on cancers that are dependent on single gene abnormalities, such that a single drug has the potential to treat the cancer. Its pipeline includes LOXO-101, LOXO-195, Rearranged During Transfection (RET) Program and Fibroblast Growth Factor Receptor (FGFR) program. LOXO-101 is a selective inhibitor of tropomyosin receptor kinases (TRK) for the treatment of patients with soft tissue sarcoma. LOXO-195 is a selective TRK inhibitor capable of addressing potential mechanisms of acquired resistance that may emerge in patients receiving LOXO-101 or multikinase inhibitors with anti-TRK activity. It has designed a series of RET inhibitors that optimize on-target potency for RET gene fusions, mutations and clinically-identified resistance mutations. It is designing FGFR1-sparing FGFR inhibitor.