TBRA
Tobira Therapeutics, Inc.NASDAQ
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  • Wed, Oct. 5, 11:21 AM
    • Slingshot Insights is hosting an exert interview today at 2:00 pm ET focused on non-alcoholic steatohepatitis (NASH), a sizable market opportunity for drug makers that many call the "next hepatitis C." The space has heated up recently stoked by Allergan's (NYSE:AGN) $1.7B takeout of Tobira Therapeutics (NASDAQ:TBRA) and $50M acquisition of privately held Akarna Therapeutics.
    • SA subscribers should use their 90-day coupon code SA_Sub16.
    • NASH-related tickers: (NYSE:PFE)(NASDAQ:GALT)(NASDAQ:BLRX)(NASDAQ:GLMD)(NASDAQ:CNAT)(NASDAQ:MNOV)(NASDAQ:RGLS)(NASDAQ:ICPT)(NASDAQ:SHPG)(NYSEMKT:CANF)(NASDAQ:VBLT)(OTCPK:ISLT)(OTCPK:GNFTF)(NASDAQ:GILD)
    | Wed, Oct. 5, 11:21 AM | 22 Comments
  • Fri, Sep. 23, 8:28 AM
    • Clovis Oncology (NASDAQ:CLVS) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $41 (7% upside) from $19.
    • Sarepta Therapeutics (NASDAQ:SRPT) upgraded to Outperform from Market Perform with a $64 (5% upside) price target by Cowen and Company. Upgraded to Hold from Underperform with a $50 (18% downside risk) price target by Jefferies. Upgraded to Outperform from Market Perform with an $88 (44% upside) price target by William Blair. Upgraded to Neutral from Reduce by SunTrust Banks. Price target raised to $48 (21% downside risk) from $4. Upgraded to Market Perform from Underperform with a $50 (18% downside risk) price target by Leerink Swann. Upgraded to Buy from Neutral by Janney Montgomery Scott. Price target raised to $65 (7% upside) from $30.
    • Molina Healthcare (NYSE:MOH) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $58 (2% downside risk) from $51.
    • Tobira Therapeutics (NASDAQ:TBRA) downgraded to Hold from Buy by Cantor Fitzgerald. Price target raised to $42 (6% upside) from $19.
    • OraSure Technologies (NASDAQ:OSUR) downgraded to Neutral from Buy by BTIG Research. $8 price target removed.
    | Fri, Sep. 23, 8:28 AM | 3 Comments
  • Thu, Sep. 22, 11:30 AM
    • Thinly traded nano cap Galmed Pharmaceuticals (GLMD +13.1%) enjoys the NASH rally stoked by Allergan's (AGN +1.7%) generous acquisition of Tobira Therapeutics (TBRA +0.9%). Shares have rallied over 46% in a week.
    • Today, the company announced that it inked an agreement with the UC-San Diego School of Medicine to conduct a Phase 1/2 study, ARTISAN, assessing Aramchol in a juvenile population with nonalcoholic fatty liver disease (NAFLD). The trial is expected to commence in H1 2017.
    • Aramchol, a conjugate of cholic acid and arachidic acid, is in Phase 2 development for the treatment of non-alcoholic steatohepatitis (NASH).
    • There is a first-to-market horse race among drug developers for a NASH treatment considering it affects ~5% of Americans. As many as 20% have a milder condition known as "fatty liver."
    | Thu, Sep. 22, 11:30 AM | 5 Comments
  • Thu, Sep. 22, 10:45 AM
    • Buoyed in large part by the FDA's approval of Sarepta Therapeutics' (SRPT +4.4%) Exondys 51 for Duchenne muscular dystrophy and Allergan's (AGN +1.9%) over-the-top acquisition of NASH player Tobira Therapeutics (TBRA +0.6%), money flow has turned decidedly bullish for biotechs. On a technical basis, the iShares Nasdaq Biotechnology ETF (IBB +0.6%) is poised for a breakout through 300, a healthy 25% turnaround from the low of ~240 in June.
    • There is a laundry list of leaders in the rally, including bluebird bio (BLUE -0.1%), Clovis Oncology (CLVS +5.4%), Puma Biotechnololgy (PBYI +3.8%), Aerie Pharmaceuticals (AERI -2.1%) and CoLucid Pharmaceuticals (CLCD -3.7%).
    | Thu, Sep. 22, 10:45 AM | 22 Comments
  • Tue, Sep. 20, 4:39 PM
    • Allergan (NYSE:AGN) reinforces its commitment to the NASH space with its second acquisition in a day. It has acquired privately held Akarna Therapeutics for $50M in upfront cash plus unspecified milestones.
    • Akarna develops small molecule drugs for the treatment of inflammatory and fibrotic diseases. Its lead product candidate is AKN-083, a preclinical-stage FXR agonist in development for the treatment of NASH. FXR (farnesoid X receptor) is a master regulator of carbohydrate and lipid metabolism, bile-acid homeostasis, inflammation and fibrosis. FXR agonists reduce the expression of certain genes that control the synthesis of triglycerides in liver cells. They reduce liver steatosis (infiltration of liver cells with fat), lower the release of free fatty acids from fat tissue and reduce their uptake by the liver and improve tissues' responsiveness to insulin.
    • Allergan announced its takeover of Tobira Therapeutics (NASDAQ:TBRA) this morning.
    | Tue, Sep. 20, 4:39 PM | 2 Comments
  • Tue, Sep. 20, 3:20 PM
    • H.C. Wainwright analyst Ed Arce is doing a bit of chest thumping today after his bullish call on Tobira Therapeutics (TBRA +722.8%) paid off in spades when Allergan (AGN -2.2%) announced its intent to acquire the company for up to $1.7B. He raised his price target on the tiny biotech to $31 last month based his confidence that NASH candidate cenicriviroc will be successful in late-stage studies. TBRA shares plummeted to a low of $3.76 on August 2 after the company released the results from a failed mid-stage trial that used an endpoint that the company said will not be necessary to support regulatory applications. The trial met the endpoint that will be used in Phase 3 studies.
    • In an interview with StreetInsider, Mr. Arce said he likes other players in the NASH space, specifically Galectin Therapeutics (GALT +13.8%), with top-line data from a mid-stage study of NASH candidate GR-MD-02 due this month, and Conatus Pharmaceuticals (CNAT +20.6%), with lead candidate emricasan about to enter a Phase 2 trial using Exalenz Biosciences' BreathID Methacetin Breath Test to monitor patients during the study.
    • GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis.
    • Emricasan inhibits a family of enzymes that modulate essential cellular functions called caspases. The functions include those involved in apoptosis and inflammation. Caspases 3 and 7 are major players in apoptosis. These enzymes cleave a key protein called CK18 (cytokeratin-18), part of which is the small fragment cCK18, which correlates to the magnitude of hepatocyte apoptosis. Emricasan inhibits apoptosis regardless of the stimuli that causes it.
    • Mr. Arce has an $8 (315% upside) price target on GALT and $15 (608% upside) on CNAT, both rated Buy.
    | Tue, Sep. 20, 3:20 PM | 5 Comments
  • Tue, Sep. 20, 8:52 AM
    • Once investors catch their collective breath over Allergan's (NYSE:AGN) wildly bullish takeout of Tobira Therapeutics (NASDAQ:TBRA), they may want to keep an eye on other NASH players. Some, of course, have more credibility than others.
    • Premarket movers: MediciNova (NASDAQ:MNOV+3.3%; Regulus Pharmaceuticals (NASDAQ:RGLS+3.1%; Intercept Pharmaceuticals (NASDAQ:ICPT+6.0%; Conatus Pharmaceuticals (NASDAQ:CNAT+38.3%; Galectin Therapeutics (NASDAQ:GALT+24.0%; Shire plc (NASDAQ:SHPG): +1.0%; Can-Fite BioPharma (NYSEMKT:CANF+23.1%.
    • Others: Galmed Pharmaceuticals (NASDAQ:GLMD); Vascular Biogenics (NASDAQ:VBLT); Islet Sciences (OTCPK:ISLT); Genfit (OTCPK:GNFTF).
    | Tue, Sep. 20, 8:52 AM | 25 Comments
  • Tue, Sep. 20, 8:23 AM
    • Allergan (NYSE:AGN) inks an agreement to acquire nano cap Tobira Therapeutics (NASDAQ:TBRA) for $28.35 in upfront cash, a whopping six-fold premium to yesterday's close of $4.74. The potential consideration paid to TBRA shareholders could rise to $1.695B based on the successful completion of certain milestones [up to $49.84 in Contingent Value Rights (CVRs)] related to Tobira's lead product candidate cenicriviroc, in development for the treatment of non-alcoholic steatohepatitis (NASH).
    • The extraordinary premium is even more surprising considering the failure of cenicriviroc in an earlier NASH study, although the company said the primary endpoint would not be required to support a marketing application. Allergan clearly agrees.
    • Cenicriviroc is a dual inhibitor of proteins called CCR2 and CCR5 that play key roles in inflammation and fibrosis.
    • Previously: Tobira's lead product candidate flunks mid-stage NASH study; shares plummet 54% premarket (July 25)
    • Update: Allergan will host a conference call tomorrow, September 21, at 8:30 am ET to discuss the transaction and other recent R&D acquisitions.
    | Tue, Sep. 20, 8:23 AM | 17 Comments
  • Tue, Sep. 20, 8:02 AM
    • NASDAQ has suspended trading in Tobira Therapeutics (NASDAQ:TBRA) pending the release of news.
    • Shares have yet to recover from a plunge in July after lead product candidate cenicriviroc failed a mid-stage study in NASH.
    • Update: Allergan (NYSE:AGN) to acquire for $28.35 a share.
    | Tue, Sep. 20, 8:02 AM | 5 Comments
  • Mon, Sep. 12, 12:43 PM
    • Tobira Therapeutics (TBRA -0.4%) initiates a Phase 1 study assessing the combination of cenicriviroc (CVC) and evogliptin (EVO) for the treatment of non-alcoholic steatohepatitis (NASH). The single-center, open-label trial will evaluate the safety, tolerability and pharmacokinetics of EVO with administered with and without CVC.
    • Cenicriviroc is a dual inhibitor of proteins called CCR2 and CCR5 that play key roles in inflammation and fibrosis.
    • In July, company reported that CVC flunked a Phase 2b NASH study but added that CVC performed well when measured by the two criteria that will support a marketing application.
    • Evogliptin is an antidiabetic drug, specifically a DPP-4 inhibitor, developed by South Korea's Dong-A ST. Tobira licensed it in April.
    • Previously: Tobira's lead product candidate flunks mid-stage NASH study; shares plummet 54% premarket (July 25)
    | Mon, Sep. 12, 12:43 PM
  • Tue, Aug. 9, 4:26 PM
    • Tobira (NASDAQ:TBRA): Q2 EPS of -$0.71 misses by $0.08.
    • Revenue of $1.1M beats by $1.05M.
    • Shares +1.3%.
    • Press Release
    | Tue, Aug. 9, 4:26 PM
  • Mon, Jul. 25, 12:49 PM
    | Mon, Jul. 25, 12:49 PM | 33 Comments
  • Mon, Jul. 25, 11:00 AM
    | Mon, Jul. 25, 11:00 AM | 2 Comments
  • Mon, Jul. 25, 9:17 AM
    | Mon, Jul. 25, 9:17 AM | 1 Comment
  • Mon, Jul. 25, 9:05 AM
    • Thinly traded micro cap Tobira Therapeutics (NASDAQ:TBRA) is down 54% premarket on increased volume in response to its announcement that lead product candidate cenicriviroc (CVC) failed to achieve its primary endpoint of a two-point reduction in NAFLD Activity Score in a Phase 2b clinical trial, CENTAUR, in patients with non-alcoholic steatohepatitis (NASH).
    • On a positive note, the study did show a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of NASH, a secondary endpoint, after one year of treatment (p=0.02).
    • According to the company, achieving a two-point reduction in NAFLD Activity Score is not required to support a marketing application. The two endpoints needed are an improvement in fibrosis by at least one stage without worsening of NASH and complete resolution of NASH without worsening of fibrosis. Management intends to meet with regulators later this year to discuss the design of a Phase 3 trial.
    • Complete results will be presented at an upcoming medical conference.
    • Cenicriviroc is a dual inhibitor of proteins called CCR2 and CCR5 that play key roles in inflammation and fibrosis. 
    | Mon, Jul. 25, 9:05 AM | 2 Comments
  • Mon, May 9, 4:14 PM
    • Tobira (NASDAQ:TBRA): Q1 EPS of -$0.65 misses by $0.12.
    | Mon, May 9, 4:14 PM