Mon, Apr. 27, 4:38 PM
Tue, Mar. 10, 12:34 PM
- The FDA approves United Therapeutics' (UTHR +0.4%) Unituxin (dinutuximab) injection, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line therapy.
- Neuroblastoma is the most common extracranial solid cancer in children and the most common cancer in infancy, affecting ~700 patients each year. About half are diagnosed as high-risk.
- Unituxin, a maintenance therapy for neuroblastoma, is a chimeric biologic antibody that induces cell lysis (breakdown) of GD2-expressing cells. GD2 is an attractive target for cancer immunotherapies since it is strongly expressed in tumors of neuroectodermal origin while highly restricted on normal cells.
Mon, Mar. 9, 5:21 PM
- Rehovot, Israel-based SteadyMed (Pending:STDY) is set for its IPO of 4.25M shares of common stock at $12 - 14. Underwriters over-allotment is an additional 637.5K shares.
- The specialty pharmaceutical company focuses on the development and commercialization of therapeutics that address the limitations of market-leading products in certain orphan and other well-defined, high-margin specialty markets. Its lead product candidate is Trevyent, a small, pre-filled, single-use device that delivers parenteral treprostinil (Remodulin) at a pre-programmed rate to patients with pulmonary arterial hypertension. Its value proposition is a more convenient dosing regimen enabled by its PatchPump technology which delivers a steady flow of drug to the patient either intravenously or subcutaneously.
- The company intends to apply for Orphan Drug designation with the FDA by mid-year and submit an New Drug Application (NDA) by Q1 2016.
- Net losses for 2014, 2013 and 2012 were ($19.0M), ($7.9M) and ($4.1M), respectively. Operations consumed $13.4M in cash in 2014 and $7.5M in 2013.
- Related ticker: (NASDAQ:UTHR)
Thu, Mar. 5, 8:52 AM
- AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
- The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
- Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
- According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
Tue, Feb. 24, 1:37 PM| Tue, Feb. 24, 1:37 PM | Comment!
Tue, Feb. 24, 6:01 AM
Mon, Feb. 23, 5:30 PM
- AIXG, ALKS, AMT, BMO, CBRL, CEQP, CLDT, CLDX, CMCSA, CMLP, COT, CRNT, CRZO, CYRN, DAKT, DCI, DPZ, DRH, DYAX, ECL, EXAS, EXLS, EXPD, FDML, GLDD, GTLS, HD, IART, IPXL, M, MNKD, NEO, ODP, PCRX, PF, PLL, RLGY, SAFM, SAH, SHLX, SHOO, SPAR, SPWR, SUI, THRM, TOL, TREX, TRXC, UTHR, VAL, VSI, WEN, WIN, WLK, WPC, ZINC
Mon, Feb. 9, 12:21 PM
- The following are healthcare companies whose after-tax margins have expanded the past three quarters and trade at least 500K shares per day:
- (ACOR -0.7%)(BCR -1.5%)(BIIB -0.2%)(CAH -1.2%)(CPHD +1.3%)(EVHC -1.6%)(ILMN +0.7%)(JAZZ -1.7%)(LCI +7.3%)(MNK -0.5%)(SHPG -2.9%)(SYK -0.2%)(TMO -0.7%)(UTHR +1.4%)(VRX).
- This is not a list of "Buy" recommendations, but rather a targeted list of firms that may be suitable for more in-depth research.
Dec. 24, 2014, 12:13 PM
- United Therapeutics (UTHR +2.4%) submits a Pre-Market Approval (PMA) application to the FDA for the use of Medtronic's (MDT +0.7%) SynchroMed II implantable drug infusion system with Remodulin (treprostinil) to deliver the drug intravenously to patients with pulmonary arterial hypertension.
- The company plans to submit a supplemental New Drug Application (sNDA) in January to amend Remodulin's label to include the use of the drug with the device.
Dec. 17, 2014, 9:12 AM
- Effective January 1, United Therapeutics (NASDAQ:UTHR) President & COO Roger Jeffs, Ph.D., is promoted to President & Co-CEO. Chairman & CEO Martine Rothbaltt, Ph.D will also be Co-CEO and will continue as Chairman. Chief Manufacturing Officer and EVP, Pharmaceutical Development David Zaccardelli, Pharm.D, is promoted to EVP and COO.
Dec. 15, 2014, 7:54 AM
- The Q-50 Index houses those companies next-eligible for inclusion into the Nasdaq 100 (NASDAQ:QQQ). Amid the Nasdaq 100's annual changes which added and dropped three from the index, the Q-50's quarterly re-ranking adds and drops eleven.
- Added: Ainylam Pharma (NASDAQ:ALNY), Expedia (NASDAQ:EXPE), F5 Networks (NASDAQ:FFIV), JD.com (NASDAQ:JD), MercadoLibre (NASDAQ:MELI), Maxim Integrated (NASDAQ:MXIM), Old Dominion Freight Line (NASDAQ:ODFL), Shire (NASDAQ:SHPG), Splunk (NASDAQ:SPLK), Stratasys (NASDAQ:SSYS), United Therapeutics (NASDAQ:UTHR).
- Dropped: Avis Budget (NASDAQ:CAR), Cree (NASDAQ:CREE), First Solar (NASDAQ:FSLR), Golar LNG (NASDAQ:GLNG), Methanex (NASDAQ:MEOH), Melco Crown (NASDAQ:MPEL), Nuance (NASDAQ:NUAN), SolarCity (NASDAQ:SCTY). Also dropped are the three Nasdaq 100 additions: American Airlines, Lam Research, and Electronic Arts.
- Source: Press Release
- Previously: Who's in, who's out in annual change to Nasdaq 100 (Dec. 13, 2014)
Dec. 3, 2014, 3:36 PM
- Actelion Ltd (OTCPK:ALIOF) (OTC:ALIOY) submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Uptravi (selexipag) for the treatment of patients with pulmonary arterial hypertension (PAH).
- Selexipag is selective IP prostacyclin receptor agonist. Prostacyclin activates the IP receptor inducing vasodilation and inhibiting proliferation of vascular smooth muscle cells. If approved, it will be the first such drug cleared for use in PAH.
- In April 2008, the company signed a license agreement with Nippon Shinyaku under which Actelion has global development and commercialization rights to selexipag outside of Japan. The firms will be partners in Japan.
- Actelion plans to submit an NDA to the FDA shortly.
- PAH-related tickers: (GSK -0.8%)(GILD -1.9%)(MSTX -1.5%)(ARNA +1.7%)(OTCPK:BAYRY -1.8%)(UTHR -1.2%)
Oct. 28, 2014, 10:53 AM
- United Therapeutics (UTHR -6%) Q3 results: Revenues: $330M (+9.2%); Net Product Sales: $328.3M (+9.4%); R&D Expense: $118.9M (+63.5%); SG&A: $202.5M (+115.2%); Operating Loss: ($32.2M) (-130.8%); Net Loss: ($25.2M) (-140.2%); Loss Per Share: ($0.53) (-145.3%).
- Product Sales: Remodulin: $142.9M (+8.0%); Tyvaso: $119.7M (-0.5%); Adcirca: $51.2M (+8.0%); Orenitram: $14.5M (+100.0%).
- No guidance given.
Oct. 28, 2014, 6:18 AM
Oct. 21, 2014, 11:37 AM
Aug. 29, 2014, 12:45 PM
United Therapeutics Corp is a biotechnology company. The Company is engaged in the development and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening conditions.
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