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Today, 12:28 PM
- Intercept Pharmaceuticals (ICPT +21.9%) jumps on modest volume in apparent response to yet another rumor of a possible sale. In December, shares spiked on the rumor that Shire plc (SHPG +4.3%) was interested, but it took out Baxalta instead.
- Its lead product candidate is obeticholic acid (OCA), under development for the treatment of primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis and biliary atresia.
- The supposed allure for potential suitors is NASH, a blockbuster opportunity for the first mover. OCA flunked a Japan-based Phase 2 study in NASH, however. The FDA's action date for its review of the company's NDA for PBC is February 29.
- Previously: Intercept Pharma's NASH candidate flunks mid-stage study; shares off 15% premarket (Oct. 28, 2015)
- Previously: Intercept Pharma's obeticholic acid NDA for PBC gets Priority Review; PDUFA date is February 29 (Aug. 31, 2015)
Today, 7:38 AM
- Gilead Sciences (NASDAQ:GILD) initiated with Outperform rating and $120 (37% upside) price target by Oppenheimer.
- CareDx (NASDAQ:CDNA) initiated with Buy rating and $12 (137% upside) price target by Janney Capital.
- Shire plc (NASDAQ:SHPG) initiated with Neutral rating by Guggenheim.
- Ultragenyx Pharmaceutical (NASDAQ:RARE) initiated with Buy rating and $104 (95% upside) price target by H.C. Wainwright.
- Depomed (NASDAQ:DEPO) initiated with Buy rating and $22 (38% upside) price target by UBS.
- ACADIA Pharmaceuticals (NASDAQ:ACAD) initiated with Buy rating and $40 (128% upside) price target by Bank of America.
- Leerink restarts coverage on eight stocks: four Outperforms: Alexion Pharmaceuticals (NASDAQ:ALXN); Regeneron Pharmaceuticals (NASDAQ:REGN); Vertex Pharmaceuticals (NASDAQ:VRTX) and Gilead Sciences (GILD); four Market Performs: Celgene (NASDAQ:CELG); Biogen (NASDAQ:BIIB); Medivation (NASDAQ:MDVN) and Amgen (NASDAQ:AMGN).
- TESARO (NASDAQ:TSRO) initiated with Buy rating by Lake Street.
- AbbVie (NYSE:ABBV) initiated with Outperform rating by William Blair.
- Seattle Genetics (NASDAQ:SGEN) upgraded to Buy with $38 (41% upside) price target by Cantor Fitzgerald.
- Shire plc (SHPG) upgraded to Outperform with price target of $240 (59% upside) by RBC.
- Amedisys (NASDAQ:AMED) upgraded to Outperform with $40 (15% upside) price target by Oppenheimer.
- Smith & Nephew (NYSE:SNN) downgraded to Neutral from Buy by UBS. Price target lowered to 1,100p (4% upside) from 1,250p.
- Quidel (NASDAQ:QDEL) downgraded to Hold from Buy by Canaccord. Price target lowered to $18 (18% upside) from $22.
- BioCryst Pharmaceuticals (NASDAQ:BCRX) downgraded Neutral from Overweight by JP Morgan. Price target lowered to $5 (201% upside) from $16.
Yesterday, 9:18 AM
- Shire plc (NASDAQ:SHPG) Q4 results ($M): Total Revenues: 1,715.7 (+8.9%); Product Sales: 1,623.7 (+8.2%).
- Key Product Sales: Vyvanse: 453.3 (+18.2%); Lialda/Mezavant: 201.4 (+9.0%); Elaprase: 147.1 (+2.7%); Cinryze: 143.3 (+0.6%), Firazyr: 125.2 (+22.9%).
- Net Income: 280.6 (-87.1%); Non-GAAP Net Income: 587.6 (+13.2%); EPS: 0.473 (-87.1%); Earnings per ADS: 0.1419 (-87.1%); Non-GAAP Earnings per ADS: 0.2971 (+12.8%); CF Ops: 761.8 (-70.2%).
- 2016 Guidance: Product Sales Growth: 11 - 14%; Non-GAAP Earnings/ADS Growth: 7 - 10%.
- Shares are up 3% premarket on increased volume.
Yesterday, 8:31 AM
Wed, Feb. 10, 5:30 PM
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Thu, Feb. 4, 4:33 PM| Thu, Feb. 4, 4:33 PM
Tue, Feb. 2, 8:02 AM
- The FDA designates privately held Cambridge, MA-based Nimbus Therapeutics' NDI-010976 for Fast Track review for the treatment of nonalcoholic steatohepatitis (NASH).
- NDI-010976 inhibits an enzyme called aceyl-COa carboxylase that plays a key role in the metabolism of fatty acids. A Phase 2 clinical trial is expected to commence in H1.
- NASH-related tickers: (NASDAQ:ICPT)(NASDAQ:TBRA)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:DRRX)(NASDAQ:CNAT)(NASDAQ:VBLT)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)(OTCPK:GNFTF)(NYSEMKT:CANF)
Mon, Jan. 25, 7:57 AM
- Shire plc (NASDAQ:SHPG) resubmits its New Drug Application (NDA) to the FDA seeking clearance of lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. It received a Complete Response Letter (CRL) in October 2015 after it filed the original NDA. Among the issues cited by the agency was the requirement for an additional trial.
- The new filing includes data from the Phase 3 OPUS-3 study as well as additional information related to product quality.
- Lifitegrast binds to a cell surface protein on white blood cells called integrin lymphocyte function-associated antigen-1 (LFA-1) which blocks its interaction with ICAM-1, an adhesion molecule that is over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction leads to the secretion of pro-inflammatory cytokines associated with dry eye disease.
- Previously: Mixed results for Shire in late stage lifitegrast trial (Dec. 6, 2013)
- Previously: Shire to refile lifitegrast NDA in Q1 (Oct. 19, 2015)
Fri, Jan. 22, 9:47 AM
- Shire plc (SHPG +3.1%) completes its $5.9B acquisition of (DYAX), whose shareholders will receive $37.30 per share in cash plus potentially $4 more via a non-tradable contingent value right (CVR) related to the regulatory clearance of DX-2930 for the treatment of hereditary angioedema (HAE). A Phase 3 study should be completed in December.
- Previously: Shire buys Dyax for $5.9B in cash (Nov. 2, 2015)
Wed, Jan. 20, 3:46 PM
Fri, Jan. 15, 12:10 PM
- Varian Medical Systems (VAR -1.4%) assumed (analyst transition) with Outperform rating and $91 (21% upside) price target by Barrington Research.
- Sucampo Pharmaceuticals (SCMP -6.5%) initiated with Sell rating and $7 (45% downside risk) price target by Empire.
- Shire plc (SHPG -1.1%) upgraded to Outperform from Neutral by Credit Suisse. Price target reduced to ₤50 from ₤54.
- Mead Johnson Nutrition (MJN -1.3%) downgraded to Neutral from Overweight by JP Morgan. Price target lowered to $77 (13% upside) from $85.
Thu, Jan. 14, 5:40 PM
Tue, Jan. 12, 5:37 PM
Tue, Jan. 12, 9:15 AM
Mon, Jan. 11, 7:36 AM
- It's official. Shire plc (NASDAQ:SHPG) acquires Baxalta (NYSE:BXLT) for $45.57 per share ($32B). Under the terms of the deal, Baxalta shareholders will receive $18 per share in cash plus 0.1482 Shire ADS. The deal represents a 13.9% premium to Baxalta's closing price on Friday. The transaction should close by mid-year.
- BXLT is up 4% premarket while SHPG is up 1%.
- SA Contributor Chris DeMuth, whose Rangeley Capital has a significant stake in Baxalta, says, "We support the transaction and think it will be a successful deal for both companies." Rangeley's Andrew Walker adds, "I think the deal makes plenty of sense. [It] is full and fair and there are substantial synergies to be had from cost cutting and tax improvement. Both sets of shareholders should be very happy."
- Previously: Shire to announce Baxalta deal as early as Monday (Jan. 7)
- Previously: Shire sweetens Baxalta bid, deal imminent (Dec. 22, 2015)
Thu, Jan. 7, 3:35 PM
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