Mon, May 16, 12:21 PM
- Novo Nordisk (NVO +1.1%) submits its Biologics License Application (BLA) to the FDA seeking approval of its long-acting factor IX, nonacog beta pegol, for the treatment of patients with hemophilia B. The glycopegylated recombinant factor IX has a 5x longer half-life than standard factor IX products which enables once-weekly dosing.
- Related tickers: (BIIB +1.3%)(DMTX +8%)(QURE +2.9%)(SGMO -3.3%)(BAX +0.4%)
Fri, May 13, 7:36 AM
- The European Commission approves Biogen (NASDAQ:BIIB) and collaboration partner Swedish Orphan Biovitrum AB's (OTC:BIOVF) Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein) for the treatment of hemophilia B. It is administered every 7-10 days so it provides prolonged protection against bleeding episodes as well as on-demand treatment.
- The data supporting the marketing application was generated in two Phase 3 trials, B-LONG, in adults and adolescents, and Kids B-LONG, in children under age 12.
- Swedish Orphan has final development and commercialization rights in Europe, North Africa, Russia and most of the Middle East. Biogen has commercialization rights in North America and the rest of the world ex-Swedish Orphan territory.
- Alprolix in now approved in the EU, U.S., Canada, Japan, Australia, New Zealand and certain other countries.
- Previously: Biogen's hemophilia B med successful in Phase 3 trial in children (Feb. 27, 2015)
- Related tickers: (NYSE:NVO)(NASDAQ:DMTX)(NASDAQ:QURE)(NASDAQ:SGMO)(NYSE:BAX)
Wed, May 11, 12:03 PM
- The European Commission approves CSL Behring's Orphan Drug-tagged IDELVION [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B (factor IX deficiency). The labeling includes routine prophylaxis to prevent/reduce the frequency of bleeding episodes, on-demand control and perioperative management of bleeding. Market launch will commence in the next few months. Orphan Drug status means that IDELVION has a 10-year period of market exclusivity in the EU for the indication.
- IDELVION's principal value proposition is 14-day dosing. This is achieved via the maintaining of high levels of factor IX activity, above 5% over 14 days at 75 IU/kg, via the fusion with recombinant albumin.
- The FDA approved IDELVION in early March.
- Related tickers: (BIIB -0.8%)(NVO -0.1%)(DMTX -0.8%)(QURE -1.2%)(SGMO -0.2%)(BAX +1.9%)
Mon, May 9, 5:30 PM
- At its investor conference, Baxter International (NYSE:BAX) announced that it expects top line growth of 4% per year through 2020 and 3 - 4% from 2016 through 2018. In 2018, it sees non-GAAP EPS of $2.10 - 2.25, non-GAAP operating margin of 14 - 15% and free cash flow of ~$1B.
- In 2020, it expects non-GAAP margin to widen to 17 - 18%, non-GAAP EPS of $2.75 - 3.00 and FCF of ~$1.75B.
- Consensus view for 2016 is EPS of $1.65 on revenues of $10.1B.
Fri, May 6, 10:32 AM
- Baxter International (BAX -1.1%) initiated with Buy rating and $51 (13% upside) price target by Evercore ISI.
- Intrexon (XON +2.3%) initiated with Market Outperform rating and $42 (62% upside) price target by JMP Securities.
- Heron Therapeutics (HRTX -8.8%) initiated with Buy rating and $41 (143% upside) price target by Cantor Fitzgerald.
- Dr. Reddy's Laboratories (RDY -2.5%) initiated with Neutral rating and Rs.3,334 price target (8% upside) by Goldman Sachs.
- Aeglea BioTherapeutics (AGLE +7.4%) initiated with Buy rating and $12 (33% upside) price target by UBS.
- Cardiome (CRME +34.9%) upgraded to Speculative Buy from Hold by Mackie Research. Price target raised to $8.60 (58% upside) from $5.20.
- Medivation (MDVN +1.2%) upgraded to Buy from Neutral by Citigroup. Price target raised to $73 (22% upside) from $37.
- Masimo (MASI -0.3%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $52 (13% upside) from $43.
- GlaxoSmithKline (GSK -1%) upgraded to Buy from Reduce by Oddo & Cie.
- Cogentix Medical (CGNT -1%) downgraded to Neutral from Buy with a price target of $1.15 (14% upside) by Roth Capital.
- Bruker (BRKR +0.8%) downgraded to Neutral from Outperform by BTIG Research.
- Relypsa (RLYP -4%) downgraded to Underperform from Neutral by Mizuho Securities. Price target cut to $31 (132% upside) from $34.
- Molina Healthcare (MOH -0.7%) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $45 (0% upside) from $75. Downgraded to Neutral from Buy by UBS. Price target lowered to $54 (20% upside) from $76.
- Sarepta Therapeutics (SRPT +1.8%) downgraded to Underperform from Market Perform by Leerink Swann. Price target lowered to $5 (71% downside risk) from $13.
- Sanofi (SNY -0.4%) downgraded to Hold from Buy with an €81 (15% upside) price target by HSBC.
Thu, May 5, 9:28 AM
Tue, May 3, 8:41 AM
Tue, Apr. 26, 8:43 AM
- Baxter International (BAX) Q1 results: Revenues: $2,375M (-1.2%); R&D Expense: $136M (-4.9%); SG&A: $641M (-18.2%); Operating Income: $188M (+104.3%); Net Income: $3,387M (+999%); EPS: $6.13 (+999%); Non-GAAP EPS: $0.36 (+5.9%).
- Q2 Guidance: EPS before special items: $0.38 - 0.40; GAAP EPS: $2.18 -2.21.
- 2016 Guidance: EPS before special items: $1.59 - 1.67 from $1.46 - 1.54; GAAP EPS: $8.94 - 9.06.
Tue, Apr. 26, 7:05 AM
Mon, Apr. 25, 5:30 PM
- ABG, ABX, AHGP, AIXG, AKS, ALLY, ARLP, ATI, AVX, AXE, BAX, BEAV, BLMN, BP, CNC, CNX, COH, CPLA, CRS, CTG, CYNO, DD, DFRG, DTE, ENTG, ETR, FBC, FCAU, FCH, FCX, FLIR, FLWS, FMER, GLPI, GLW, GPK, HSY, HUBB, HZO, ICLR, IIVI, IR, JBLU, JNS, LLY, LMT, LPT, MAS, MDXG, MHFI, MMM, NCI, ODP, PAG, PCAR, PCH, PG, PH, PNR, POL, R, RAI, SAH, SAVE, SCL, SIR, SPG, ST, SUI, SVU, TEN, TMUS, TRI, TROW, WAB, WAT, WDR, WHR, WYN
Thu, Apr. 21, 5:11 PM
- Baxter International (NYSE:BAX) commences an offer to exchange up to 12.8M shares of Baxalta (NYSE:BXLT), representing a 1.9% stake, that are currently owned by Baxter for common Baxter shares. Following the offer, Baxalta will be wholly independent.
- Baxter shareholders should receive ~$107.52 of Baxalta common stock for every $100 of Baxter stock tendered. The offer will expire at 11:59 pm ET on May 18, unless extended or terminated.
- Baxter currently holds a total of 30,506,097 shares of Baxalta (4.5% stake). It intends to make a contribution to its pension fund or distribute the shares as a special dividend to stockholders for all the shares not tendered, thereby reducing its stake in Baxalta to zero.
- If Shire's (NASDAQ:SHPG) takeover of Baxalta is finalized, each BXLT share will be converted to the right to receive both $18.00 in cash and 0.1482 of an American Depositary Share (ADS) of Shire. BXLT shareholders also have the option to convert each share into 0.4446 of a Shire ADS. The merger should be consummated in early June.
- BXLT closed today at $41.08, BAX at $43.01.
- Update: In a May 4 press release, Baxter announced that it increased the size of the exchange to 13,360,527 shares. All other terms and conditions remained unchanged.
- Update: The final exchange ratio was 1.1591, announced on May 17.
Fri, Apr. 15, 11:46 AM
- Celator Pharmaceuticals (CPXX +4.6%) initiated with Buy rating and $24 (63% upside) price target by Needham.
- Retrophin (RTRX -1.7%) initiated with Outperform rating and $25 (67%upside) price target by BMO Capital.
- Fate Therapeutics (FATE -3.2%) initiated with Outperform rating and $4 (85% upside) price target by BMO Capital.
- Tobira Therapeutics (TBRA +4.4%) initiated with Buy rating and $22 price target by H.C. Wainwright.
- Wright Medical Group (WMGI +2.4%) initiated with Buy rating and $23 (21% upside) price target by Bank of America.
- Cleveland Research rates UnitedHealth Group (UNH -0.9%) a Buy with a $155 (22% upside) price target; Anthem (ANTM -0.5%) a Buy with a $170 (20% upside) price target and Aetna (AET -0.4%) Neutral with a $120 (10% upside) price target.
- Glaukos (GKOS +0.3%) initiated with Hold rating by Stifel.
- Baxter International (BAX -0.3%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $58 (36% upside) from $39.
- Baird upgrades Exactech (EXAC +0.7%) to Outperform from Neutral and raises the price target to $26 (18% upside) from $21. Stryker (SYK -0.9%) downgraded to Neutral from Outperform and raises the price target to $116 (6% upside) from $111.
- Tenet Healthcare (THC -2.5%) upgraded to Positive from Neutral by Susquehanna.
- Clovis Oncology (CLVS -1.5%) downgraded to Neutral from Overweight by JP Morgan. Price target lowered to $15 (7% upside) from $42.
- AstraZeneca (AZN +0.3%) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to 3,700p (11% downside risk) from 4,400p.
- Intercept Pharmaceuticals (ICPT +0.2%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $80 (48% downside risk) from $100.
Thu, Mar. 17, 6:27 AM
- The FDA approves Bayer's (OTCPK:BAYRY) KOVALTRY Antihemophilic Factor (Recombinant), an unmodified full-length factor VIII compound for the treatment of children and adults with hemophilia A. KOVALTRY can be used two to three times per week in adolescents and adults and up to every other day in children.
- Hemophilia A, or factor VIII deficiency, affects 16,000 Americans.
- KOVALTRY was cleared in the EU and Canada in February.
- Related tickers: (NYSE:BXLT)(NYSE:BAX)(OTCQX:RHHBY)(NASDAQ:DMTX)(NYSE:SNY)(NASDAQ:ALNY)(NASDAQ:BIIB)(NYSE:OPK)(NASDAQ:SGMO)
Wed, Mar. 16, 6:54 PM
- Baxalta (NYSE:BXLT) prices the secondary offering of 63,823,582 common shares currently held by Baxter (NYSE:BAX) at $37.75. As previously announced, the equity will be exchanged for debt currently held by institutional investors, reducing Baxter's stake in Baxalta to 4.5% from 13.8%.
- Today's close was $38.05.
- Previously: Baxalta files to sell $2.3B worth of shares owned by Baxter (March 11)
Fri, Mar. 11, 6:32 PM
- Baxalta (NYSE:BXLT) has filed to offer $2.34B worth of shares owned by former parent Baxter (NYSE:BAX). As part of the offering, Baxter will exchange some of the 94.3M Baxalta shares it still owns (13.8% stake) for debt owned by the offering underwriters.
- In September, Baxalta filed to sell $1.45B worth of shares owned by Baxter. Baxter has said it plans to fully unload its Baxalta stake via debt-for-equity exchanges.
- Update: Baxalta commences a $2.34B debt-for-equity exchange for shares owned by Baxter that will reduce Baxter's stake in Baxalta to 5.1% from 13.8%. Baxalta will take ownership of Baxter debt currently held by institutional investors.
Mon, Mar. 7, 7:05 AM
- The FDA approves CSL Behring's IDELVION [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] for the routine prophylaxis of hemophilia B in children and adults to prevent or reduce the frequency of bleeding episodes, on-demand control and prevention of bleeding episodes and the perioperative (around the time of surgery) management of bleeding.
- IDELVION's principal value proposition is 14-day dosing. This is achieved via the maintaining of high levels of factor activity, above 5% over 14 days at 75 IU/kg.
- IDELVION will be available later this month.
- Related tickers: (NASDAQ:BIIB)(NYSE:NVO)(NASDAQ:DMTX)(NASDAQ:QURE)(NASDAQ:SGMO)(NYSE:BAX)
Baxter International, Inc. produces and supplies specialized medical products, including biopharmaceuticals and medical equipment. It operates through two segments: Hospital Products and Renal. The Hospital Products segment manufactures products used in the delivery of fluids and drugs to... More
Industry: Medical Instruments & Supplies
Country: United States
Other News & PR