UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT PURSUANT TO

SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report: November 26, 2018

(Date of earliest event reported)

 

LOXO ONCOLOGY, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

 

(203) 653-3880

(Registrant’s Telephone Number, Including Area Code)

 

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company o

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

 

 

 

Item 7.01 Regulation FD.

 

On November 26, 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/m2 orally twice daily with a maximum of 100 mg per dose). A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated herein by reference.

 

The information furnished with this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 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.

 

Exhibit Number		Description of Exhibit
99.1		Press release dated November 26, 2018.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	Loxo Oncology, Inc.
Date: November 27, 2018	By:	/s/ Jennifer Burstein
	Name:	Jennifer Burstein
	Title:	Senior Vice President of Finance and principal financial officer

 

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