Pre-Open Stock Movers 11/14: (CRBP) (HAR) (DGII) (MENT) Higher; (DVAX) (HEAR) (ACM) Lower (more...)

November 14, 2016 9:24 AM EST

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Today's Pre-Open Stock Movers

Dynavax Technologies (Nasdaq: DVAX) 70.7% LOWER; announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years and older against hepatitis B infection. The FDA issues CRLs to communicate that the Agency has completed a review cycle of an application and to request additional information for review and approval. Dynavax expects a Class 2 designation for a resubmission of the BLA, which would result in a target review period of six months.

Corbus Pharmaceuticals Holdings, Inc. (Nasdaq: CRBP) 68.4% HIGHER; announced positive topline results from its Phase 2 study evaluating Resunab or the treatment of diffuse cutaneous systemic sclerosis. JBT-101 out-performed placebo in the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, reaching 33% at week 16, versus 0% for placebo. The higher the CRISS score the greater the improvement; a CRISS score 20% (CRISS20) can be considered a medically meaningful improvement. The difference in CRISS scores between JBT-101 and placebo groups over the trial period was significant (p = 0.044). Differences in categorical levels of CRISS responses and changes from baseline in the five individual domains of the CRISS score also supported clinical benefit of JBT-101.

Harman International (NYSE: HAR) 26.8% HIGHER; Samsung Electronics and Harman International Industries, Incorporated (NYSE: HAR) announced that they have entered into a definitive agreement under which Samsung will acquire HARMAN for $112.00 per share in cash, or total equity value of approximately $8.0 billion. Upon closing, the transaction will immediately give Samsung a significant presence in the large and rapidly growing market for connected technologies, particularly automotive electronics, which has been a strategic priority for Samsung, and is expected to grow to more than $100 billion by 20251. HARMAN is the market leader in connected car solutions, with more than 30 million vehicles currently equipped with its connected car and audio systems, including embedded infotainment, telematics, connected safety and security. Approximately 65% of HARMANs $7.0 billion of reported sales during the 12 months ended September 30, 2016 are automotive-related, and its order backlog for this market at June 30, 2016 was approximately $24 billion.

Digi International Inc. (Nasdaq: DGII) 19.8% HIGHER; confirmed that it received an unsolicited, conditional and non-binding proposal from Belden Inc. (NYSE: BDC) to acquire the Company for $13.82 per share in cash. After careful evaluation and in consultation with its independent financial and legal advisors, the Digi Board of Directors unanimously rejected the proposal on November 8 and again on November 11, 2016, determining that the proposal significantly undervalues Digi and its future growth prospects and is not in the best interest of the Company and its shareholders.

Mentor Graphics (Nasdaq: MENT) 18.5% HIGHER; Siemens is further building its Vision 2020 to shape Digital Industrial Enterprise by expanding its unique portfolio for industrial software. Siemens and Mentor Graphics (Nasdaq: MENT) today announced that they have entered into a merger agreement under which Siemens will acquire Mentor for $37.25 per share in cash, which represents an enterprise value of $4.5 billion. The offer price represents a 21% premium to Mentor's closing price on November 11, 2016, the last trading day prior to the announcement. Mentor's Board of Directors approved and declared advisable the merger agreement, and Mentor's Board of Directors recommends the approval and adoption of the merger agreement by the holders of shares of Mentor common stock. Mentor shareholder Elliott Management has committed to support the transaction. StreetInsider.com first reported Mentor hired a financial advisor to review as sale on October 13.

Turtle Beach Corporation (NASDAQ: HEAR) 14.5% LOWER; B. Riley downgraded from Buy to Neutral following Friday's surge higher

PTC Therapeutics (NASDAQ: PTCT) 8.4% HIGHER; Credit Suisse upgraded from Neutral to Outperform with a price target of $25.00

Ceragon Networks (NASDAQ: CRNT) 6.1% HIGHER; reported Q3 EPS of $0.04, in-line with the analyst estimate of $0.04. Revenue for the quarter came in at $79.1 million versus the consensus estimate of $77.57 million.

US Steel (NYSE: X) 5% HIGHER; Morgan Stanley upgraded from Equalweight to Overweight with a price target of $46.00.

AK Steel (NYSE: AKS) 4.5% HIGHER; Morgan Stanley upgraded from Equalweight to Overweight with a price target of $11.00.

Autohome (NYSE: ATHM) 4% HIGHER; reported Q3 EPS of $0.38, in-line with the analyst estimate of $0.38. Revenue for the quarter came in at $221.2 million versus the consensus estimate of $207.44 million.

The Medicines Company (Nasdaq: MDCO) 4% HIGHER; Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and The Medicines Company (Nasdaq: MDCO) announced that results from the Phase 1 study of inclisiran (in-CLEE-si-ran), the recommended International Nonproprietary Name (INN) for ALN-PCSsc, were published in The New England Journal of Medicine (NEJM). Inclisiran is an investigational RNAi therapeutic targeting PCSK9 a genetically validated protein regulator of LDL receptor metabolism being developed for the treatment of hypercholesterolemia. The paper can be found online here.

Cliffs Natural Resources (NYSE: CLF) 3.4% HIGHER; Morgan Stanley upgraded from Underweight to Equalweight with a price target of $9.00.

AECOM Technology (NYSE: ACM) 3.2% LOWER; reported Q4 EPS of $0.65, $0.06 worse than the analyst estimate of $0.71. Revenue for the quarter came in at $4.32 billion versus the consensus estimate of $4.66 billion. GUIDANCE: AECOM Technology sees FY2017 EPS of $2.70-$3.10, versus the consensus of $3.21. Guidance includes approximately $0.20 of anticipated gains related to AECOM Capital realizations.

Twitter (NYSE: TWTR) 1.6% HIGHER; activist investor JANA Partners discloses new, nearly 3M share stake.



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