After-Hours Stock Movers 01/03: (CBAY) (SHAK) (CC) Higher; (AGRX) (ACUR) (TSLA) Lower (more...)

January 3, 2017 5:50 PM EST

News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.

Today's After-Hours Movers

Agile Therapeutics, Inc. (Nasdaq: AGRX) 72.2% LOWER; announced positive top-line results from its Phase 3 SECURE clinical trial of Twirla®, its investigational low-dose combined hormonal contraceptive patch. SECURE was a multicenter, single-arm, open-label, 13-cycle trial that evaluated the safety, efficacy and tolerability of Twirla in 2032 healthy women, aged 18 and over, at 102 experienced investigative sites across the United States. The Company plans to resubmit its new drug application (NDA) for Twirla in the first half of 2017 on the basis of the SECURE results and other information relating to the manufacture of Twirla.

CymaBay Therapeutics (NASDAQ: CBAY) 42.6% HIGHER; Entered an exclusive license agreement with Kowa Pharmaceuticals America, Inc. for the development and commercialization of arhalofenate in the U.S. Under the terms of the agreement, CymaBay will receive up to $15 million in upfront and near-term milestone payments and is eligible to receive up to an additional $190 million in payments based upon the achievement of specific development, regulatory and sales milestones. CymaBay is also eligible to receive tiered, double digit royalties on future sales of arhalofenate products. Kowa will be responsible for all development and commercialization costs. CymaBay had earlier reached agreement with the Food and Drug Administration (FDA) on the size and scope of the Phase 3 program which is estimated to cost $100 million. CymaBay retains full development and commercialization rights for the rest of the world. Locust Walk served as a transaction advisor to CymaBay.

Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) 6% LOWER; announced that it is exploring a full range of financing and strategic alternatives, including a possible sale of the company. The Company has retained Roth Capital Partners to assist in this process. Alternatives to a sale of the company include a capital raising transaction, a licensing transaction and a sale of certain assets. There can be no assurance a transaction will result from this process and the company does not intend to disclose additional details unless and until it has entered into a specific transaction.

Shake Shack Inc. (NYSE: SHAK) 3.8% HIGHER; will replace Chemours in the S&P SmallCap 600

The Chemours Company (NYSE: CC) 2.7% HIGHER; will replace IDEXX in the S&P MidCap 400

Tesla (NASDAQ: TSLA) 2% LOWER; produced 24,882 vehicles in Q4, resulting in total 2016 production of 83,922 vehicles. This was an increase of 64% from 2015. Tesla delivered approximately 22,200 vehicles in Q4, of which 12,700 were Model S and 9,500 were Model X. When added to the rest of the year, total 2016 deliveries were approximately 76,230.Our Q4 delivery count should be viewed as slightly conservative, as we only count a car as delivered if it is transferred to the customer and all paperwork is correct.

The Priceline Group (NASDAQ: PCLN) 1% HIGHER; Needham & Company initiates coverage with a Buy rating and a price target of $1,800.

Amgen (Nasdaq: AMGN) 1% HIGHER; Sanofi (NYSE: SNY) Loses Bid to Overturn Amgen (Nasdaq: AMGN) PCSK9 Patent Verdict - Bloomberg

IDEXX Laboratories, Inc. (NASDAQ: IDXX) 0.8% HIGHER; will replace St. Jude Medical, Inc. (NYSE: STJ) in the S&P 500.



Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Special Reports

Related Entities

Needham & Company, Roth Capital, Standard & Poor's, After-Hours Movers, Tesla, FDA