Allergan plcNYSE
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  • Today, 10:53 AM
    • Allergan (AGN +0.3%) exercises its option to acquire Rhythm Holding Company, LLC subsidiary Motus Therapeutics for $200M plus a contingent payment related to the first commercial sale of relamorelin, a ghrelin agonist about to enter Phase 3 development for the treatment of diabetic gastroparesis (DG). Earlier, Allergan paid $47M for the option to buy the relamorelin developer.
    • Top-line results from a Phase 2b trial prompted Allergan's move. Type 1 and type 2 diabetics treated with relamorelin for 12 weeks showed improvements in DG symptoms of nausea, post-prandial (after eating) fullness, abdominal pain and bloating in addition to a positive effect on gastric motility. Patients experienced a 75% reduction in vomiting frequency across all doses versus baseline, the primary endpoint, but it fell short of statistical significance due to an unexpected high rate of vomiting in the placebo group. Nevertheless, Allergan intends to advance relamorelin to Phase 3 development.
    • Diabetic gastroparesis is a disorder in which the movement of food from the stomach is slowed or stopped. The most frequent cause is damage to the vagus nerve, which controls the movement of food (motility) through the digestive tract.
    • Relamorelin (formerly RM-131) stimulates a hormone called ghrelin which increases appetite. Aeterna Zentaris (AEZS -7.9%) is developing a ghrelin agonist called Macrilen (macromorelin) for the treatment of adult growth hormone deficiency. Aratana Therapeutics (PETX -1.7%) is developing another, capromorelin, as an appetite stimulator in dogs.
    | Today, 10:53 AM | 2 Comments
  • Yesterday, 4:57 PM
    • Allergan (NYSE:AGN) President & CEO Brent Saunders has been elected Chairman of the Board replacing Executive Chairman Paul Bisaro who will continue to serve as a board member. Mr. Saunders has served as President & CEO since July 2014.
    | Yesterday, 4:57 PM | 3 Comments
  • 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.
    | Wed, Oct. 5, 11:21 AM | 21 Comments
  • Mon, Oct. 3, 4:40 AM
    • AstraZeneca (NYSE:AZN) has signed a deal with Allergan (NYSE:AGN) where the latter will pay up to $1.52B for rights to an antibody for Crohn's disease.
    • Allergan pays $250M up front, but it might also make payments worth up to $1.27B over a period of up to 15 years, tied to potential sales of the antibody, MEDI2070 -- an anti-IL-23 monoclonal antibody, currently in Phase IIb clinical development.
    • That includes launch milestone payments of up to $435M and sales-based milestones of $725M along with tiered royalties. The deal comes via AstraZeneca's global biologics research and development unit.
    • AZN is up 0.5% premarket.
    | Mon, Oct. 3, 4:40 AM | 14 Comments
  • Fri, Sep. 30, 3:45 PM
    • Depomed (DEPO +4.5%) perks up on increased volume in response to the news that a court has issued an an injunction against potential competitor Allergan (AGN +0.1%) from selling a generic version of NUCYNTA (tapentadol). Actavis (TEVA -0.2%) and Roxane have also lost bids to invalidate NUCYNTA patents, which are valid until 2022 to 2028.
    • In the first half of 2016, NUCYNTA products accounted for almost 64% of the company's product sales ($141.3M/221.1M).
    | Fri, Sep. 30, 3:45 PM | 15 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 | 4 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 | 21 Comments
  • Wed, Sep. 21, 1:04 PM
    • As previously reported, Bayer (OTCPK:BAYRY) aims to jettison its dermatology business in order to help fund its Monsanto buy. Although discussions are in the early phase, there appears to be plenty of interested parties. In addition to skincare-focused players like Allergan (NYSE:AGN), Almirall (OTC:LBTSF) and Nestle (OTCPK:NSRGY)(OTCPK:NSRGF), Teva Pharmaceutical Industries (NASDAQ:TEVA), Perrigo (NASDAQ:PRGO) and Sun Pharma (OTC:SMPQY) are also reportedly in the mix.
    • On the institutional investor side, KKR (NYSE:KKR), Nordic Capital, Bain Capital, Blackstone Group (NYSE:BX) and Cinven may also be eyeing the unit which, analysts say, could fetch $1.1B.
    • Previously: Bloomberg: Bayer eyes sale of $1.1B dermatology business (Sept. 8)
    | Wed, Sep. 21, 1:04 PM | 7 Comments
  • Wed, Sep. 21, 11:20 AM
    | Wed, Sep. 21, 11:20 AM | 45 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
  • Wed, Sep. 14, 8:27 AM
    • Allergan plc (NYSE:AGN) inks a deal to acquire Vitae Pharmaceuticals (NASDAQ:VTAE) for ~$639M in cash or $21 a share, almost a 160% premium to yesterday's close of $8.10.
    • The transaction beefs up Allergan's dermatology pipeline with the addition of VTP-43742, a retinoic acid receptor-related orphan receptor gamma inhibitor for the treatment of psoriasis and other autoimmune disorders and VTP-38543, a topical Liver X receptor beta selective agonist for the treatment of atopic dermatitis.
    • The deal should close by year end.
    • Read now Vitae Pharmaceuticals: Go Long?
    | Wed, Sep. 14, 8:27 AM | 8 Comments
  • Thu, Sep. 8, 2:11 PM
    | Thu, Sep. 8, 2:11 PM | 7 Comments