Stephen Simpson, CFA
Yesterday, 8:43 AM
- Thinly traded micro cap Tokai Pharmaceuticals (NASDAQ:TKAI) craters 70% premarket on higher-than-normal volume in response to its announcement that it will stop its Phase 3 clinical trial, ARMOR3-SV, assessing lead product candidate galeterone compared to enzalutamide (XTANDI) in treatment-naive men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the androgen receptor splice variant AR-V7. The company made its decision based on the recommendation from the independent Data Monitoring Committee that the trial was unlikely to meet its primary efficacy endpoint.
- Tokai intends to evaluate its ongoing ARMOR2 expansion in mCRPC patients with acquired resistance to enzalutamide and its planned study in patients who rapidly progress on either enzalutamide or abiraterone acetate (ZYTIGA).
- Galeterone is an orally available small molecule that disrupts the androgen receptor (NYSE:AR) signaling pathway by degrading AR, blocking the binding of testosterone or dihydrotestosterone with AR and inhibiting CYP17, an enzyme that plays a key role in the synthesis of testosterone. Prostate cancer is stoked by androgens acting through the androgen receptor.
- Related tickers: (NASDAQ:MDVN)(OTCPK:ALPMF)(OTCPK:ALPMY)(NYSE:JNJ)
Thu, Jun. 9, 1:04 PM
- Thinly traded nano cap SCYNEXIS (SCYX -23.8%) slumps on a 17x surge in volume, albeit on turnover of only 674K shares, in response to its announcement of results from a Phase 2 clinical trial assessing lead product candidate, Fast Track- and QIDP-tagged SCY-078, for the treatment of patients with acute vulvovaginal candidiasis (VVC), commonly known as vaginal yeast infection.
- The study randomized 96 women with moderate-to-severe VVC 1:1:1 to receive either of two dose regimens of SCY-078 or fluconazole, the standard-of-care prescription oral medication.
- Data from the Intent-to-Treat population all favored SCY-078, but the cure rate, defined by a negative culture, was only slightly better than fluconazole (70.3% versus 68.8%). The therapeutic cure rate, defined as a negative culture and the resolution of symptoms without further antifungal treatment (clinical cure), was identical (56.3%) for both.
- One significant negative was the "considerably higher rate of GI-related adverse events (diarrhea, nausea, vomiting, abdominal pain) in the SCY-078 arms compared to fluconazole. According to the company, they were "mild to moderate and transient in nature" with the majority lasting no more than one day after initiating SCY-078.
- SCY-078 inhibits an enzyme called glucan synthase. Its value proposition is comparable activity to echinocandins [e.g., Astellas' (OTCPK:ALPMF)(OTCPK:ALPMY) Mycamine (micafungin sodium) for injection] but available in an oral formulation and active against multi-drug-resistant pathogens, including those resistant to echinocandins.
Wed, Mar. 30, 8:22 AM
- The FDA designates Vical's (NASDAQ:VICL) VL-2397 for Fast Track review for the treatment of invasive aspergillosis, an infection caused by inhaling the ubiquitous Aspergillus fungus. It is inconsequential in people with a normally functioning immune system, but can be dangerous in those with weakened immunity such as those undergoing hematopoietic stem cell transplantation, chemotherapy for leukemia or with AIDS.
- VL-2397, based on an isolate from a leaf litter fungus Acremonium species collected in Malaysia, was initially developed by strategic partner Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY). A Phase 1 study was recently initiated.
- The FDA designated it a Qualified Infectious Disease Product in August 2015 and an Orphan Drug in January of this year.
- Shares are up 16% premarket on increased volume.
Tue, Feb. 16, 11:53 AM
- Data from a Phase 2 clinical trial assessing FibroGen's (FGEN +4.9%) oral agent roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) showed that patients on hemodialysis who were previously receiving epoetin alfa [Amgen's (AMGN +1.1%) EPOGEN or J&J's (JNJ +0.3%) PROCRIT] but switched to roxadustat maintained hemoglobin (Hb) levels regardless of iron deletion status, degree of inflammation or prior iron regimen over six or 19 weeks. The results were published in the American Journal of Kidney Disease.
- In the first part of the study, lasting six weeks, lowest dose roxadustat (1.0 mg/kg 3x/week) maintained hemoglobin levels on par with epoetin alfa. Some separation was seen at higher doses of at least 1.5 mg/kg with 79% of patients showing a hemoglobin response compared to 33% for epoetin alfa.
- In the second part of the study, 51% of the roxadustat cohort achieved a Hb level of at least 11.0 g/dL compared to 36% for epoetin alfa (normal range is 13.5 - 17.5 for men and 12.0 - 15.5 for women). In addition, maintenance dosing of roxadustat was not correlated with levels of the inflammatory biomarker C-reactive protein (CRP). Decreases in cholesterol and hepcidin (key regulator of iron) were also observed in the roxadustat group.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa.
- It is currently in Phase 3 development through collaborations with AstraZeneca (NYSE:AZN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- Previously: Data from mid-stage study show CKD patients with anemia respond to FibroGen's roxadustat in dose-related manner (Aug. 13, 2015)
Thu, Jan. 21, 4:03 PM
- Micro cap XenoPort (NASDAQ:XNPT) spiked at the close to finish up 9% for the day, albeit on below average volume, on a rumor that it is exploring a sale.
- Its markets one commercial product: HORIZANT (gabapentin enacarbil), for restless legs syndrome (RLS) and postherpetic neuralgia. It is branded as REGNITE in Japan, where Astellas Pharma (OTCPK:ALPMY)(OTCPK:ALPMF) exclusively markets it. It was cleared for the treatment of RLS there in January 2012.
- Its two main pipeline candidates are XP23829 for psoriasis and multiple sclerosis and XP21279 for Parkinson's disease.
Nov. 10, 2015, 6:57 AM
- Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) acquires Ocata Therapeutics (NASDAQ:OCAT) for $8.50 per share in cash or ~$379M. The tender offer will commence no late than November 25 and will not extend beyond May 9, 2016. The transaction will enable Astellas to establish a presence in ophthalmology and a leading position in cell therapy.
- The deal is not expected to impact Astellas' fiscal year (ended March 31) financials to a significant degree.
- OCAT closed yesterday at $4.46.
Dec. 13, 2013, 11:06 AM
- Aveo Pharma (AVEO -15.1%) says its lead experimental drug tivozanib was unlikely to succeed in a mid-stage colon cancer study that was testing if the drug was superior to an approved treatment.
- Partner Astellas (ALPMF, ALPMY) was testing the drug in combination with standard chemotherapy against cancer drug bevacizumab with standard chemotherapy, for use in previously untreated patients with advanced colorectal cancer.
- Aveo has seen a string of failures associated with the drug; the FDA denied approval for the drug's use in renal cell carcinoma in June, citing inconsistent patient survival data.
Nov. 1, 2013, 3:29 PM
- Astellas Pharma (ALPMY) reports H1 consolidated net sales ( ¥ millions) of ¥556,702, up 16.7% Y/Y.
- Net income ( ¥ millions) for H1 falls 16% Y/Y to ¥48.195. (full results)
- Xtandi U.S. sales of ~$190M for April-September. (supplementary documents)
- Backing out FQ1 sales of $82M gets ~$108M in U.S. Xtandi sales for FQ2.
- These numbers are likely behind the rally in shares of Medivation (MDVN +10.1%), Astellas' Xtandi partner.
Aug. 1, 2013, 3:40 PM
- As reported here earlier, Astellas Pharma's (ALPMY.PK +1%) quarterly report showed Xtandi sales of $82M. That's short of consensus and bad news for partner Medivation (MDVN -1.3%).
- More color: William Blair's forecast was for sales of $85.2M (so a big miss there) — Astellas' full year Xtandi sales guidance of $400M is well below the firm's estimate of $459M.
Aug. 1, 2013, 1:49 PM
- Astellas Pharma (ALPMY.PK +1.2%) corrects a translation error in its FQ1 conference call earlier, confirming that interim analysis on its Prevail study of Xtandi will actually occur this year.
- The company became aware of an error in the English translation, which cited incorrect timing of the interim analysis.
- Guidance has not changed.
Jul. 31, 2013, 11:24 AM
- AstraZeneca (AZN +0.9%) inks a collaboration deal to develop an oral anemia drug with privately held U.S. biotechnology company FibroGen that could potentially be worth more than $815M.
- The collaboration includes the development and commercialization of FG-4592, a drug that mimics the body's response to being at high altitude, which stimulates production of red blood cells and would be used to treat anemia.
- AZN's is making an initial $350M payment to FibroGen, will could rise to as much as $815M if development milestones are reached, and possibly even exceed that with royalty payments on future sales in the low 20% range.
- AZN has made $2.8B worth of acquisition and collaboration deals in the last six months alone in a bid to counteract the revenue-sapping effect of generic competition.
- The deal is limited to the U.S., China and a few other markets, but excludes Europe, Japan and other markets where FibroGen already has an agreement with Astellas Pharma (ALPMY.PK).
Jun. 25, 2013, 8:18 AMCytokinetics (CYTK +9.8%) grants Astellas (ALPMF.PK) an exclusive license to co-develop and commercialize Cytokinetics' CK-2127107 treatment for muscle weakness, which is in Phase I trials. Cytokinetics will receive $16M up front and is eligible to receive over $24M in reimbursements during the first two years. Astellas could also pay $450M in R&D and sales milestones and royalties, as well as make other milestone payments. (8-K) | Jun. 25, 2013, 8:18 AM
May 23, 2013, 6:21 PMAVEO Pharmaceuticals (AVEO) has been informed by its partner, Astellas Pharma (ALPMY.PK), that it no longer intends to submit a Marketing Authorization Application to the European Medicines Agency for tivozanib, its treatment for advanced renal cell carcinoma, nor does not intend to fund any future trials under its strategic collaboration agreement. AVEO says it's evaluating the impact of the news and its options for the drug going forward. AVEO -14.7% AH. | May 23, 2013, 6:21 PM
May 13, 2013, 5:09 PMShares of Optimer Pharmaceutical (OPTR +14%) ramped up into the close on reports that AstraZeneca (AZN), Astellas Pharma (ALPMY.PK) and Cubist Pharmaceuticals (CBST) are among the first round bidders for the antibiotic manufacturer. OPTR disclosed almost three months ago that they were working with Centerview Partners and JPMorgan to explore its strategic options, including a potential sale. | May 13, 2013, 5:09 PM
Aug. 31, 2012, 2:22 PM
The FDA has given early approval to enzalutimide, a new prostate-cancer drug developed jointly by Medivation (MDVN +1.4%) and Astellas Pharma (ALPMY.PK). The drug - which was approved to treat men with prostate cancer that has spread or returned after prior treatment with another drug, docetaxel - will be sold under the brand name Xtandi. Dendreon (DNDN -0.6%), whose already struggling with lagging sales of its own prostrate drug, Provenge, trades down on the news.| Aug. 31, 2012, 2:22 PM
Jun. 28, 2012, 4:04 PM
Astellas Pharma (ALPMY.PK +1.5%) says the the FDA has approved Myrbetriq, a drug to treat adults with overactive bladder. The condition is one in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning. The drug relaxes the muscle and thereby relieves the symptoms.| Jun. 28, 2012, 4:04 PM