Intercept Pharmaceuticals Weighed Down By A Troubling Trifecta
Stephen Simpson, CFA
Stephen Simpson, CFA
NASH Drugs Update: Intercept's Phase 3 Details, Genfit's Diagnostic Tool And Raptor's Failure
Logribel Biostocks • 54 Comments
Logribel Biostocks • 54 Comments
Thu, Nov. 3, 10:05 AM| Thu, Nov. 3, 10:05 AM
Thu, Nov. 3, 7:14 AM
Wed, Nov. 2, 5:30 PM
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Fri, Oct. 14, 8:03 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Intercept Pharmaceuticals' (NASDAQ:ICPT) obeticholic acid (OCA), branded as Ocaliva, for the treatment of primary biliary cholangitis (PBC), a chronic liver disease formerly known as primary biliary cirrhosis that is characterized by the progressive destruction of the bile ducts.
- OCA, in combination with UDCA (ursodeoxycholic acid), was approved in the U.S. in May for the treatment of PBC. UDCA is the only approved treatment for PBC in Europe, but the company says that a large proportion of patients receiving UDCA continue to experience elevations in a liver enzyme called alkaline phosphatase (ALP), a biomarker of liver stress.
- UDCA (tablet formulation) is the property of privately held Asklepion Pharmaceuticals. Retrophin (NASDAQ:RTRX) acquired the rights to the liquid formulation in June.
- OCA is an agonist of the farnesoid X receptor, a nuclear receptor expressed in the liver and intestine that is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.
- A final decision from the European Commission usually takes ~60 days.
- ICPT is ahead 3% premarket but only on 685 shares.
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)
Tue, Sep. 20, 9:19 AM
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).
Thu, Aug. 4, 10:31 AM| Thu, Aug. 4, 10:31 AM
Thu, Aug. 4, 7:08 AM
Wed, Aug. 3, 5:30 PM
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Fri, Jul. 8, 12:25 PM
- Anthera Pharmaceuticals (NASDAQ:ANTH) initiated with Buy rating and $10 (180% upside) price target by H.C. Wainwright.
- Ultragenyx Pharmaceutical (NASDAQ:RARE) initiated with Overweight rating and $70 (31% upside) price target by Piper Jaffray.
- Eiger Biopharmaceuticals (NASDAQ:EIGR) initiated with Outperform rating and $34 (85% upside) price target by Oppenheimer.
- Intercept Pharmaceuticals (NASDAQ:ICPT) initiated with Sell rating and $58 (61% downside risk) price target by Cantor Fitzgerald.
- Juno Therapeutics (NASDAQ:JUNO) initiated with Equal Weight rating and $48 (73% upside) price target by Barclays.
- Kite Pharma (NASDAQ:KITE) initiated with Equal Weight rating and $58 (21% upside) price target by Barclays.
- Endologix (NASDAQ:ELGX) upgraded to Outperform from Market Perform by BMO Capital. Price target raised to $16 (14% upside) from $11.50.
- Achillion Pharmaceuticals (NASDAQ:ACHN) upgraded to Outperform from Market Perform with a $13 (42% upside) price target by JMP Securities.
- Humana (NYSE:HUM) downgraded to Neutral from Overweight by JPMorgan. Price target lowered to $150 (8% downside risk) from $196.
- Ilumina (NASDAQ:ILMN) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $110 (22% downside risk) from $130.
- T2 Biosystems (NASDAQ:TTOO) downgraded to Sell from Buy by BTIG Research. Price target lowered to $4 (26% downside risk) from $12.
- Juno Therapeutics (JUNO) downgraded to Neutral from Overweight by JPMorgan. Price target lowered to $39 (40% upside) from $63.
- Depomed (NASDAQ:DEPO) downgraded to Neutral from Buy with $20 (6% upside) price target by UBS.
- Esperion Therapeutics (NASDAQ:ESPR) downgraded to Hold from Buy by WallachBeth.
Thu, Jun. 30, 9:16 AM
Wed, Jun. 29, 5:38 PM
Mon, Jun. 20, 5:01 PM
- Retrophin (NASDAQ:RTRX) secures the rights to a liquid formulation of ursodeoxycholic acid (UDCA) from privately held Asklepion Pharmaceuticals for the potential treatment of primary biliary cholangitis (PBC).
- Under the terms of the license agreement, Asklepion will receive an upfront payment of $0.5M and and up to $23.5M in sales-based milestones. It is eligible to receive up to $35.0M in milestones related to additional indications. Retrophin will assume all future program costs and will pay Asklepion tiered royalties on net sales.
- Retrophin says it will file a New Drug Application (NDA) for the PBC indication in 2017.
- UDCA, or ursadiol, is a naturally occurring hydrophilic bile acid derived from cholesterol. A liquid formulation would provide an attractive dosing alternative to patients who have difficulty swallowing pills.
- In late May, the FDA approved Intercept Pharmaceuticals' (NASDAQ:ICPT) Ocaliva (obeticholic acid), in combination with UDCA, for the treatment of PBC. Both are orally administered in tablet form.
Fri, Jun. 10, 6:41 AM
Thu, Jun. 9, 6:21 PM
- Barbara Duncan, Intercept Pharma's (NASDAQ:ICPT) CFO since 2009, is stepping down. Sandip Kapadia, CFO of Novartis' Sandoz generic drug unit, will succeed her, effective July 1.
- CEO Mark Pruzanski: "Sandip has substantial international financial management experience in the pharmaceutical industry and I look forward to working closely with him as we expand our commercial presence across the world, while advancing our global development programs."