Mon, Aug. 24, 2:13 PM
- The FDA has approved a label expansion for Novartis' (NYSE:NVS) Promacta (eltrombopag), a treatment for chronic immune thrombocytopenia (ITP) -- a rare blood disorder -- to include children 1 year or older who aren't responding sufficiently to other treatment.
- The product, which uses Captisol platform technology from Ligand Pharmaceuticals (NASDAQ:LGND), was approved in June for children 6 years and older, and in 2008 for adults.
- The new label includes an oral suspension formulation, better for younger children who might not be able to swallow tablets.
- Ligand is up 0.5%; Novartis is trading down 1.5%.
Mon, Aug. 17, 6:58 AM
- Nano cap AVEO Oncology (NASDAQ:AVEO) enters into an exclusive worldwide license agreement with Novartis (NYSE:NVS) for the development and commercialization of AV-380, AVEO's humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), and related antibodies.
- GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been associated with cachexia (weakness and wasting of the body) in cachectic cancer patients. Preclinical data show that inhibiting GDF15 may reverse the effects of cachexia by switching from catabolism (destructive metabolism) to anabolism (constructive metabolism).
- Under the terms of the agreement, AVEO will receive an upfront payment of $15M, potential milestones totaling $311M and tiered royalties from high single-digit to low double-digit. Novartis will be responsible for all clinical development, manufacturing and commercialization activities and costs.
- Cachexia, a serious complication in advanced cancers and other chronic diseases, affects ~5M Americans.
- Shares are up 126% premarket on robust volume.
Fri, Aug. 14, 12:00 PM
- Nano cap Prima BioMed (PBMD +42.5%) jumps on a 9x surge in volume in response to its announcement that it will receive an disclosed clinical milestone payment from Novartis (NVS) related to the Phase 1 study of its IMP701 LAG-3 antibody for the treatment of cancer.
- The license and collaboration agreement was signed in September 2012 between Immutep (acquired by Prima in December 2014) and CoStim Pharmaceuticals (acquired by Novartis in February 2014).
- Prima is eligible to receive additional development-related milestones and royalties on commercial sales.
- IMP701 binds to LAG-3 (Lymphocyte Activation Gene 3), an antibody that plays a key role in controlling the signaling pathways in both effector T cells and regulatory T cells. Binding to LAG-3 removes two brakes that prevent the immune system from responding to and killing cancer cells.
Mon, Jul. 20, 7:42 AM
- Top-line results from a Phase 3 clinical trial, called METEOR, show Exelixis' (NASDAQ:EXEL) Cometriq (cabozantinib) reduced the risk of disease progression or death by 42% compared to Novartis' (NYSE:NVS) Afinitor (everolimus). The late-stage study compared the two drugs in 658 patients with renal cell carcinoma (RCC) who had experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor.
- The trial met its primary endpoint of a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients (p<0.0001) as determined by an independent radiology committee.
- Data on Overall Survival (OS) in the population of 658 patients were immature at the data cutoff, although an interim analysis showed a trend in OS favoring cabozantinib. Final analysis of OS is expected around August 2016.
- Exelixis plans to complete regulatory filings in the U.S. and Europe early next year. The FDA designated cabozantinib for Fast Track review for RCC in April. It originally approved it in November 2012 for the treatment of progressive metastatic medullary thyroid cancer.
- The company will host a conference call this morning at 8:30 am ET to discuss the data.
- Shares are up 33% premarket on robust volume.
Thu, Jul. 16, 8:34 AM
- Small cap Radius Health (NASDAQ:RDUS) is up a modest 2% premarket on light volume in response to its announcement that its investigational drug RAD1901, in combination with CDK4/6 inhibitors [Pfizer's (NYSE:PFE) Ibrance (palbociclib)] and mTOR inhibitors [Novartis' (NYSE:NVS) Afinitor (everolimus)] showed anti-tumor activity in preclinical breast cancer models with either wild type or mutant ESR1 (estrogen receptor 1). Tumor shrinkage was much greater when exposed to the combination including RAD1901 compared to the other agents alone.
- RAD1901 is a selective estrogen receptor degrader (SERD) that crosses the blood-brain barrier. If approved, it will be the first ER-targeted therapy to have this capability thereby enabling the treatment of intracranial metastatic breast cancer tumors.
- The company is currently enrolling patients in a Phase 1 dose escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor-positive and HER2-negative breast cancer. The study will determine the recommended dose for a Phase 2 trial.
Thu, Apr. 23, 5:26 AM
Wed, Feb. 25, 1:43 PM
Thu, Feb. 12, 12:56 PM
- Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
- Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
Tue, Jan. 27, 6:09 AM
Thu, Jan. 15, 8:40 AM
- "Words fail me," says Swatch (OTCPK:SWGAY) CEO Nick Hayek. "Today's SNB action is a tsunami; for the export industry and for tourism, and finally for the entire country." Swatch is lower by 15.75% in European action.
- Previously: Swiss shares crater after SNB abandons cap on euro (Jan. 15)
- A sampling of others: Cement maker Holcim (OTCPK:HCMLY) is down 11.2%, Novartis (NYSE:NVS) is down 9%, Roche (OTCQX:RHHBY) is down 7.9%, Credit Suisse (NYSE:CS) is down 11.7%, and UBS (NYSE:OUBS) is down 10.8%.
- The good news for ADR players is that's all action in Switzerland. Thanks to the franc's now 13.5% gain, the ADRs trading in the U.S. are likely all to be higher.
Thu, Jan. 15, 8:35 AM
- Swiss-based Novartis (NYSE:NVS) jumps 5% premarket in response to the upsurge in the value of the Swiss franc versus the euro. The franc rose 30% after the Swiss National Bank announced that it would remove the three-year old cap of 1.20 francs/euro.
- Previously: Swiss shares crater after SNB abandons cap on euro (Jan. 15)
Wed, Jan. 14, 8:25 AM
- Ziopharm (NASDAQ:ZIOP) jumps 50% premarket on robust volume in response to its announcement of an exclusive license deal with partner Intrexon (NYSE:XON) (+12%) with The University of Texas MD Anderson Cancer Center covering technology and intellectual property related to non-viral adoptive cellular cancer immunotherapies. The technologies originate from two researchers who have pioneered the design and clinical investigation of chimeric antigen receptor (CAR) T cell therapies for the potential treatment of cancer using non-viral gene integration platforms.
- The two researchers are Laurence Cooper, M.D., Ph.D, professor of pediatrics at MD Anderson who has expertise in immunotherapies and Perry Hackett, Ph.D., professor within the College of Biological Sciences at Minnesota, who discovered and developed a system called Sleeping Beauty, a non-viral DNA plasmid-based gene transfer system.
- The deal brings the CAR-T technology together Intrexon's technology suite and Ziopharm's clinically tested RheoSwitch Therapeutic System interleukin-12 modules. Up to five CARs are expected to enter the clinic this year and off-the-shelf programming initiating in 2016.
- Under the terms of the agreement, MD Anderson will receive $100M from the companies in the form of $50M of common stock from each firm. In addition, the companies have committed $15M - 20M over each of the next three years for researching and developing the technologies.
- CAR-T therapies are the "next big thing" in cancer treatment.
- Related tickers: (NASDAQ:KITE) (NASDAQ:JUNO) (NASDAQ:AMGN) (NYSE:NVS) (NYSE:JNJ)
Dec. 3, 2014, 6:33 PM
- Array BioPharma (NASDAQ:ARRY) +24% AH says it reached a deal with Novartis (NYSE:NVS) to regain global rights to its binimetinib cancer treatment as well as an upfront payment of $85M.
- The agreement is subject to NVS and GlaxoSmithKline (NYSE:GSK) completing a series of transactions which were unveiled in April and remain subject to regulatory approval.
- ARRY says binimetinib is advancing in three phase 3 clinical trials and that it plans to file for its first regulatory approval in H1 2016.
Aug. 29, 2014, 11:52 AM
- Shares of United Therapeutics (UTHR +23.1%) jump on 5x surge in volume after a court rules that Sandoz (NVS +0.3%) failed to prove that United's '007 and '117 Remodulin (treprostinil) patents are invalid and that United proved that Sandoz's ANDA will infringe on patent '117.
- Remodulin accounted for almost 45% of United's 1H sales of $612.2M.
May 20, 2014, 8:15 AM
- Ophthotech (OPHT) could potentially receive over $1B in milestone and other payments - including the $200M upfront free - during the course of its collaboration with Novartis (NVS) for the commercialization of Forvista, as well as any royalties on sales.
- Fovista is in a Phase III program consisting of three trials.
- Ophthotech's shares were +24% premarket. (PR)
Feb. 25, 2014, 2:14 PM
- InterMune's (ITMN +162.8%) spectacular gains after reporting positive ASCEND data (I, II) may have further to go, Baird analyst Brian Skorney believes, viewing ITMN as an ideal acquisition target for a big pharma company.
- A substantial unmet need in idiopathic pulmonary fibrosis provides a blockbuster market opportunity, Baird says, with a number of companies with the capability to sell ITMN's drug with their current salesforce, most notably GlaxoSmithKline (GSK), Gilead (GILD) and Novartis (NVS); Skorney sees a potential acquisition price into the 60s.
- Even without an acquisition, Skorney thinks ITMN should reach $44, with clinical risk is now in the rear-view mirror and potential for greater penetration and higher pricing in the U.S.
NVS vs. ETF Alternatives
Other News & PR