Wed, Jun. 8, 4:23 PM
- Nano cap Orexigen Therapeutics (NASDAQ:OREX) was up 52% today on a 6x surge in volume in response to its announcement of a favorable Markman ruling related to the company and Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Contrave patent infringement litigation against Actavis (NYSE:AGN).
- A Markman or claims construction ruling, is a pretrial hearing in which a judge determines the meaning of the disputed patent claims in patent litigation. In this case, Judge Richard Andrews adopted Orexigen's proposed constructions for the majority of the disputed claims, a big win for the company and making it significantly more difficult for Actavis to prevail.
Thu, May 26, 7:19 PM
- Valeant Pharmaceuticals (NYSE:VRX) is up 7.1% after hours, following a report from The Wall Street Journal that Takeda (OTCPK:TKPYY) and private-equity firm TPG made a combined takeover approach in recent weeks that the company rejected.
- No talks are ongoing between the three, though.
- The approach came before Valeant hired Joseph Papa as its new CEO and didn't get to a firm price.
- Updated 7:28 p.m.: The board wants to give Papa time to chart a course for the company, sources told the WSJ.
Mon, Jan. 25, 6:50 AM
- Affimed N.V. (NASDAQ:AFMD) and a subsidiary of Merck (NYSE:MRK) establish a clinical trial collaboration whereby Merck will supply KEYTRUDA (pembrolizumab) to Affimed in a Phase 1b clinical trial assessing the combination of the PD-1 inhibitor and Affimed's lead product candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with Takeda (OTCPK:TKPHF)(OTCPK:TKPYY) and Seattle Genetics' (NASDAQ:SGEN) ADCETRIS (brentuximab vedotin). The objective of the study, to be conducted by Affimed and expected to commence in H1, is to establish a dosing regimen of the combo as well as its safety and efficacy.
- In preclinical patient derived xenograft models, the combination eradicated up to 90% of tumors. The collaboration may expand to include a Phase 3 trial if the Phase 1b is successful.
- AFM13 is a bispecific antibody that binds to a protein expressed in a range of T-cell and B-cell lymphomas called CD30 and to a protein expressed on the immune system's natural killer cells called CD16A, both of which play key roles in the activation of the immune system to detect and kill cancer cells.
- Shares are up 13% premarket on average volume.
Wed, Jan. 20, 8:41 AM
- Thinly traded nano cap CymaBay Therapeutics (NASDAQ:CBAY) is up 20% premarket on increased volume in response to its announcement that it has completed its end-of-Phase 2 discussions with the FDA related to its gout candidate, arhalofenate, clarifying the design of the Phase 3 program.
- Late-stage development will consist of two Phase 3 studies of arhalofenate, in combination with febuxostat [Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) ULORIC], in patients with chronic gout and a third Phase 3 in patients with more advanced disease called tophaceous gout. Total enrollment will be ~1,300. Each study will have a treatment period of at least 12 months. The co-primary endpoints will be responder rates and flare rates. The trials should commence later this year.
- Gout is a type of arthritis caused by too much uric acid in the blood. Arhalofenate lowers serum uric acid by blocking the reabsorption of uric acid in the proximal tubes of the kidney by inhibiting the renal uric acid transporter, URAT1.
- Previously: CymaBay gout drug successful in Phase 2b study (Feb. 24, 2015)
Nov. 20, 2015, 5:12 PM
- Takeda Pharmaceutical (OTCPK:TKPYY +1.8%) says the FDA has approved its drug Ninlaro (ixazomib) for use in patients with multiple myeloma who received at least one prior therapy.
- The approval is based on the TOURMALINE-MM1 Phase 3 trial. Ninlaro is the only oral proteasome inhibitor, delivered via a once-weekly pill.
- "With the approval of Ninlaro, we can now offer patients a once-weekly oral proteasome inhibitor as part of a highly active triplet therapy," said Takeda's Paul Richardson, investigator for the trial. "This opens the door for a fully oral proteasome inhibitor-based triplet combination therapy," said Dr. Brian Durie, chairman of the International Myeloma Foundation.
- Takeda ADRs were up 0.5% after hours earlier.
Sep. 18, 2015, 6:13 PM
- Mexico City-based generic drugmaker Representaciones e Investigaciones Medicas -- Rimsa -- is drawing interest from big pharma companies, particularly including Pfizer (PFE -1.9%), Sanofi (SNY -3%) and Abbott Laboratories (ABT -2.1%), Bloomberg reports.
- Rimsa could draw about $1B in a purchase by any of a list of suitors, which also could include Teva (TEVA -1.6%) and Takeda (OTCPK:TKPYY -1.9%).
- Healthcare spending rates in Mexico are expected to rise to be more in line with other emerging markets like Brazil and Chile. Spending is relatively low and the market is fragmented.
- Goldman Sachs is managing the sale.
Mar. 23, 2015, 7:47 AM
- Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY), through its Millennium Pharmaceuticals subsidiary, licenses exclusive rights to use ImmunoGen's (NASDAQ:IMGN) antibody-drug conjugate (ADC) technology to develop and commercialize targeted cancer therapeutics for up to two undisclosed targets, with an option for a third target for an additional upfront fee.
- Under the terms of the agreement, ImmunoGen will receive $20M upfront for each target, milestones up to $210M and royalties on net commercial sales of any resulting products.
- An antibody-drug conjugate is a cytotoxic agent attached to an antibody that binds to a target antigen found on cancer cells. This delivers the agent specifically to the cancer cells where it kills them.
- IMGN is up 23% premarket on robust volume.
Mar. 3, 2015, 1:03 PM
- Orexigen Therapeutics (OREX +53%) short sellers are licking their wounds today. Shares are up on a whopping 22x surge in volume in response to the news that patients taking its obesity med Contrave (naltrexone HCl/bupropion HCl) may reduce their risk of having a heart attack by almost 50%.
- The data behind the news comes from an interim analysis of the 9,000-patient LIGHT study which is being conducted to determine the heart-safety profile of the obesity med. The analysis showed patients receiving Contrave experienced 35 major adverse cardiac events (MACE) compared to 59 for those taking placebo. The benefit was statistically significant. A MACE is a heart attack, stroke or heart-related death.
- The company will conduct a second interim analysis of the data at 50% of events, which should happen in the next several weeks. Orexigen is also required to run a second heart-safety study as a condition of its clearance by the FDA in September 2014.
- Contrave is sold in the U.S. by Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY).
- According to Yahoo Finance, almost 42% of Orexigen's float (more than 38M shares) was sold short as of February 13.
- Related tickers: (VVUS +4.3%)(ARNA -5.5%)
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
Dec. 27, 2013, 7:51 AM
- "The company has reached the conclusion that, on balance, the benefits of treating patients with fasiglifam do not outweigh the potential risks,” Takeda (TKPHF) says, ending development of its late-stage GPR40 agonist TAK-875.
- The drug was tied to liver damage.
- The company had hoped the treatment would help offset revenue lost to generic Actos, the diabetes drug which at one time accounted for more than a quarter of Takeda's top-line.
- Shares fell 5%+ in Tokyo on the news.
Jun. 10, 2013, 7:37 AM
Via the European Decentralized Procedure (Netherlands is the Reference Member State), Apricus (APRI) gets its ED treatment Vitaros approved. The company believes it will "capture a significant share of the ~$1B PDE-5 inhibitor market." APRI says it will work with partners Sandoz, Takeda (TKPHF.PK), and Bracco to obtain national phase approvals. Shares +9.38% premarket. (PR)| Jun. 10, 2013, 7:37 AM
Jan. 7, 2013, 12:12 PM
Affymax (AFFY +5.4%) and Japanese drug maker Takeda Pharmaceuticals (TKPYY.PK) have entered into a supply agreement for sourcing and supply of Omontys Injection with DSI Renal. Financial terms weren't disclosed, but the agreement allows DSI Renal to purchase the drug for use within its organization, provide discounts and rebates on the product in its selected centers, and then, based on ongoing evaluation, potentially expand to additional facilities.| Jan. 7, 2013, 12:12 PM
Sep. 25, 2012, 4:42 PM
Sucampo Pharmaceuticals (SCMP) and Takeda Pharmaceuticals (TKPYY.PK) say the FDA,has granted priority review of their supplemental new drug application for an additional indication for Amitiza, a treatment for opioid-induced constipation in patients with chronic, non-cancer pain. A decision is expected by late January 2013. Shares +7% AH.| Sep. 25, 2012, 4:42 PM
Sep. 13, 2012, 9:22 AM
Apricus Biosciences (APRI) +12.5% premarket after announcing it has licensed Takeda Pharmaceuticals (TKPHF.PK, TKPYY.PK) to market Vitaros, its erectile dysfunction drug, in the U.K. Takeda will pay APRI an undisclosed upfront payment and milestone payments of up to 35M euros.| Sep. 13, 2012, 9:22 AM | 1 Comment
Jul. 27, 2012, 4:18 PM
Furiex Pharmaceuticals (FURX +5.5%) ramped higher into the close after confirming that Takeda Pharmaceutical (TKPYY.PK) has resubmitted New Drug Applications to the FDA for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone for treating adult type 2 diabetes. Under it's agreement with Takeda, FURX is eligible to receive a $25M milestone payment for the approval of the first of these two NDAs, as well as additonal royalties and sales-based milestones.| Jul. 27, 2012, 4:18 PM
Jul. 2, 2012, 2:38 PMPiper Jaffray looks at other potential takeout candidates in the biotech space post-Amylin, highlighting BioMarin (BMRN +3.8%), Affymax (AFFY +1%), Theravance (THRX +8.3%), and Rigel Pharmaceuticals (RIGL +2.3%) all as potential candidates. Piper notes that BioMarin could fetch as much as $79 per share, and notes that Japanese drug heavyweight Takeda Pharmaceuticals (TKPYY.PK) could be the most likely suitor for Affymax. | Jul. 2, 2012, 2:38 PM