Baker Bros. Advisors is a ~5 BB small & micro-cap focused biotechnology fund run by Julian Baker and Felix Baker. The fund has generated exceptional returns this year ��largely due to a huge long position they started in ACADIA Pharmaceuticals (NASDAQ: ACAD) (YTD = +481%). While the fund is quite secretive, it is required file SEC Form 13F which allows the public to see which particular biotech stocks are being accumulated.
This allows investors the opportunity to invest alongside the fund in some of its high-risk / high-reward bets. Here are four stocks that have seen recent buying:
Prothena Corp. (PRTA)
Baker Bros. Advisors holds 369,630 shares of PRTA - equivalent to a $7.5 MM stake at time of writing. The company has been adding to PRTA, with the most recent transaction being in Q2 2013 with a net purchase of 177,954 shares.
Top 10 Financial Stocks To Watch Right Now: Celgene Corp (CELG)
Celgene Corporation is a global biopharmaceutical company primarily engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases. The Company is engaged in the research and development, which is designed to bring new therapies to market, and is engaged in research in several scientific areas that may deliver therapies, focusing areas, such as intracellular signaling pathways in cancer and immune cells, immunomodulation in cancer and autoimmune diseases, and therapeutic application of cell therapies. The Company�� primary commercial stage products include REVLIMID, VIDAZA, THALOMID, ABRAXANE and ISTODAX. Additional sources of revenue include a licensing agreement with Novartis, which entitles it to royalties on FOCALIN XR and the entire RITALIN family of drugs, the sale of services through its Cellular Therapeutics subsidiary and other miscellaneous licensing agreements. In March 2012, it acquired Avila Therapeutics.
The Company invests in research and development, and the drug candidates in its pipeline at various stages of preclinical and clinical development. These candidates include pomalidomide and apremilast, its oral anti-cancer and anti-inflammatory agents, PDA-001, its cellular therapy, oral azacitidine, CC-223 and CC-115 for hematological and solid tumor malignancies, CC-122, its anti-cancer pleiotropic pathway modifier, and ACE-011 and ACE-536 biological products for anemia in several clinical settings of unmet need. Celgene product candidates include Pomalidomide (CC-4047), Oral Anti-Inflammatory: Apremilast (CC-10004), CC-11050, Kinase Inhibitors:Tanzisertib (CC-930), Cellular Therapies: PDA-001, Activin Biology: Sotatercept (ACE-011) ACE-536, and Anti-tumor Agents: CC-22, CC-115, CC-122 and Oral Azacitidine. It owns and operates a manufacturing facility in Zofingen, Switzerland. The Company also owns and operates a drug product manufacturing facility in Boudry, Switzerland.
Commercial! Stage Products
REVLIMID (lenalidomide) is an oral immunomodulatory drug marketed in the United States and many international markets, in combination with dexamethasone, for treatment of patients with multiple myeloma who have received at least one prior therapy. It is also marketed in the United States and certain international markets for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is distributed in the United States through contracted pharmacies under the RevAssist program, which is a risk-management distribution program. Internationally, REVLIMID is distributed under mandatory risk-management distribution programs.
REVLIMID continues to be evaluated in numerous clinical trials worldwide either alone or in combination with one or more other therapies in the treatment of a range of hematological malignancies, including multiple myeloma (MDS) various lymphomas, chronic lymphocytic leukemia (CLL) other cancers and other diseases. VIDAZA (azacitidine for injection) is a pyrimidine nucleoside. VIDAZA is a Category 1 recommended treatment for patients with intermediate-2 and high-risk MDS and is marketed in the United States for the treatment of all subtypes of MDS. In Europe, VIDAZA is marketed for the treatment of intermediate-2 and high-risk MDS, as well as acute myeloid leukemia (AML) with 30% blasts and has been granted orphan drug designation for the treatment of MDS and AML.
THALOMID (thalidomide) is marketed for patients with newly diagnosed multiple myeloma and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) an inflammatory complication of leprosy and as maintenance therapy for prevention and suppression of the cutaneous manifestation of ENL recurrence. THALOMID is distributed in the United States under its System f! or Thalid! omide Education and Prescribing Safety (S.T.E.P.S.) program. Internationally, THALOMID is also distributed under mandatory risk-management distribution programs. ABRAXANE (paclitaxel albumin-bound particles for injectable suspension) is a solvent-free chemotherapy treatment option for metastatic breast cancer, which was developed using its nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. As of December 31, 2011, ABRAXANE was in various stages of investigation for the treatment of expanded applications for metastatic breast; non-small cell lung; malignant melanoma; pancreatic; bladder and ovarian.
ISTODAX (romidepsin) has received orphan drug designation for the treatment of non-Hodgkin's T-cell lymphomas, which includes CTCL and PTCL. The Company has licensed the worldwide rights (excluding Canada) regarding certain chirally pure forms of methylphenidate for FOCALIN and FOCALIN XR to Novartis. It also licensed to Novartis the rights related to long-acting formulations of methylphenidate and dex-methylphenidate products which are used in FOCALIN XR and RITALIN LA.
Preclinical and Clinical-Stage Pipeline
The product candidates in the Company�� pipeline are at various stages of preclinical and clinical development. Pomalidomide is a small molecule that is orally available and modulates the immune system and other biologically important targets. Pomalidomide is being evaluated in a phase III clinical trial for the treatment of myelofibrosis and a phase III clinical trial evaluating pomalidomide as a treatment for patients with relapsed/refractory multiple myeloma is accruing patients.
The Company is developing a product, ORAL ANTI-INFLAMMATORY AGENTS, which is orally available small molecules that target PDE4, an intracellular enzyme that modulates the production of multiple pro-inflammatory and anti-inflammatory mediators, including interleukin-2 (IL-2), IL-10, IL-12, IL-23, INF-gamma, TNF-a, leukotrienes,! and nitr! ic oxide synthase. Its investigational drug, apremilast (CC-10004), is used for the treatment of moderate to severe psoriasis and active psoriatic arthritis and is being evaluated in a phase II trial for rheumatoid arthritis and six phase III multi-center international clinical trials. In addition, it is investigating its oral PDE4 inhibitor, CC-11050, which is an anti-inflammatory compound that treat a variety of chronic inflammatory conditions, such as Cutaneous Lupus Erythematosus (CLE).
The Company�� oral kinase inhibitor platform includes inhibitors of the c-Jun N-terminal kinase (JNK) mTOR kinase, spleen tyrosine kinase (Syk) c-fms tyrosine kinase (c-FMS) and DNA-dependent protein kinase (DNAPK). Its oral Syk, c-FMS and DNAPK kinase inhibitors are being investigated in pre-clinical studies. The Company�� new second generation JNK inhibitor, tanzisertib (CC-930), is being evaluated in a phase II trial for the treatment of idiopathic pulmonary fibrosis and a phase II trial for the treatment of discoid lupus is accruing patients. Amrubicin is a third-generation fully synthetic anthracycline molecule with potent topoisomerase II inhibition.
At Celgene Cellular Therapeutics (CCT), it is researching stem cells derived from the human placenta, as well as from the umbilical cord. CCT is the Company�� research and development division. Stem cell based therapies provide disease-modifying outcomes for serious diseases, which lack adequate therapy. It has developed technology for collecting, processing and storing placental stem cells with broad therapeutic applications in cancer, auto-immune diseases, including Crohn's disease, multiple sclerosis, neurological disorders, including stroke and amyotrophic lateral sclerosis (ALS), graft-versus-host disease, and other immunological / anti-inflammatory, rheumatologic and bone disorders.
The Company has collaborated with Acceleron Pharma, Inc. (Acceleron) to develop sotatercept. Two phase I clinical studies have been co! mpleted. ! An additional phase II clinical study has been initiated and is ongoing related to treatments for end-stage renal anemia and to evaluate effects on red blood cell mass and plasma volume.
The Company competes with Abbott Laboratories, Amgen Inc. (Amgen), AstraZeneca PLC., Biogen Idec Inc., Bristol-Myers Squibb Co., Eisai Co., Ltd., F. Hoffmann-LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Pfizer, Sanofi and Takeda Pharmaceutical Co. Ltd. (Takeda).
Advisors' Opinion:- [By Maxx Chatsko]
In the following video, Fool contributor Maxx Chatsko explains whether he thinks Celgene (NASDAQ: CELG ) or Biogen (NASDAQ: BIIB ) is the better buy. The companies have tracked one another in valuation, separated by as little as half of one percentage point. Additionally, both have promising pipelines that have kept investors' expectations high. Does one stand out? Is it too close to call? Watch the video below to find out. If you are eyeing either company -- or both -- then you may want to use the recent pullbacks as a buying opportunity.
- [By Ben Levisohn]
The S&P 500 is up 0.1% at 1,800.48 at 2:29 p.m., getting a boost from big gains in Precision Castparts (PCP), which has risen 3.6%, Jabil Circuit (JBL), which is up 2.5% to $20.32 and Celgene (CELG), which has jumped 2.5% to $154.86. Even Abercrombie & Fitch (ANF) is lending helping hand today–its shares are up 2.5%.
- [By Mani]
Shares of Celgene Corporation (NASDAQ:CELG) are down 13 percent year-to-date, and sentiment has been relatively weak ahead of the FDA's action date for Celgene's Otezla (apremilast).
- [By Ben Levisohn]
Yes, say the folks at Nomura, who recommend buying�Celgene (CELG), Receptos
(RCPT), Gilead Sciences (GILD), Neurocrine Biosciences (NBIX), and Alexion Pharmaceuticals (ALXN), in that order. Analyst M. Ian Somaiya and team explain why:October has historically been a weak month for biotech, with the Nasdaq Biotechnology Index underperforming the S&P 500 in 14 out the last 20 years. We believe the current biotech selloff is driven primarily by macro concerns rather than sector fundamentals. We would take advantage of the weakness by focusing on names with near-term catalysts to drive shares, as our quarterly IMS analysis point to no clear winners in the 3Q14 earnings season….
With the October selloff, we believe these catalyst-driven names have the best chance for upside. 1) Celgene ��rohn�� drug GED-0301 will have Phase II data at the UEGW conference (18-22 Oct), potentially supporting $2.2bn in WW peak sales. 2)�Receptos ��RPC1063 Phase II data (expected in 4Q14) in ulcerative colitis is a favorable risk/reward event, potentially adding $2.4bn in peak revenues. 3) Gilead Sciences ��weak 3Q points to upside in 4Q as warehoused patients initiate treatment. Confirmation of rational pricing by AbbVie (ABBV) should help ease HCV price war concerns. 4)�Neurocrine Biosciences ��We expect positive elagolix Phase III results in endometriosis (4Q14), and Phase II uterine fibroid data in 1Q15. 5) Alexion Pharmaceuticals ��no change in tax guidance and lack of meaningful currency exposure address two concerns heading into 3Q while continued strength of aHUS rollout could provide upside.
�Celgene has fallen 1.4% to $85.33 at $12:15 p.m., while Receptos dropped 2.1% to $60.74, Gilead Sciences has dipped 0.4% to $95.75, Neurocrine Biosciences has declined 1.2% to $16.39, and Alexion Pharmaceuticals is off 0.2% at $160.34.
Hot Biotech Stocks To Watch Right Now: FibroGen Inc (FGEN)
FibroGen, Inc. (FibroGen) is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat unmet medical needs. The Company focuses in the areas of fibrosis and hypoxia-inducible factor (HIF) biology. FibroGen�� products include Roxadustat (FG-4592), which is an oral small molecule inhibitor of HIF prolyl hydroxylases (HIF-PHs), in Phase III clinical development for the treatment of anemia in chronic kidney disease (CKD), and FG-3019, which is a monoclonal antibody in Phase II clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis. The Company�� subsidiaries include FibroGen Europe Oy (FibroGen Europe) and FibroGen China Anemia Holdings, Ltd. (FibroGen China).
Roxadustat is the HIF-PH inhibitor in Phase III clinical development, which acts by stimulating the body�� natural pathway of erythropoiesis, or red blood cell production. Roxadustat represents a new paradigm for the treatment of anemia in CKD patients and offers injectable erythropoiesis stimulating agents (ESAs). 1,449 subjects have participated in 26 completed Phase I and II clinical studies for roxadustat in North America, Europe and Asia. The Company, along with its collaboration partners, Astellas Pharma Inc., (Astellas) and AstraZeneca AB,(AstraZeneca), has designed a global Phase III program to support regulatory approval of roxadustat in both NDD-CKD and DD-CKD patients in multiple geographies.
FG-3019 is the Company�� fully-human monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), a critical common element in the progression of fibrosis and associated diseases. In Phase II IPF clinical studies, FG-3019 demonstrated the stabilization of disease and, in human studies, reversal of lung fibrosis in some patients. In an open-label Phase II pancreatic cancer study of FG-3019 plus gemcitabine and erlotinib, FG-3019 demonstrated a dose-depen! dent improvement in one year survival rate. In 10 Phase I and Phase II clinical studies of FG-3019 to date involving over 340 subjects, FG-3019 has been tolerated across a range of doses studied, and there have been no dose-limiting toxicities observed as of November 13, 2014.
The Company competes with Threshold Pharmaceuticals, Inc., Gilead Sciences, Inc., Halozyme Therapeutics, Inc., Gilead Sciences, Inc., Celgene Corporation, Janssen Biotech, Inc., Johnson & Johnson, Inc., Sanofi, Novartis and Biogen Idec.
Advisors' Opinion:- [By John Udovich]
Recent IPO�FibroGen Inc (NASDAQ: FGEN) surged 22.96% today, reportedly after the journal Hepatology published the results of a workshop between the FDA and the American Association for the Study of Liver Disease (AASLD) which laid out criteria for a phase three study of a treatment for non-alcoholic steatohepatitis (NASH)���meaning its worth taking a closer look at the stock along with the performance of potential small cap or mid cap liver disease stock peers like Conatus Pharmaceuticals Inc (NASDAQ: CNAT), Intercept Pharmaceuticals Inc (NASDAQ: ICPT) and Raptor Pharmaceutical Corp (NASDAQ: RPTP) which rose 24.35%, 10.98% and 2.02%, respectively. According to Investors Business Daily, NASH (the more serious version of fatty liver disease) is potentially an enormous market with about 6 million�US patients but the�lack of previous treatments had left it unclear how the FDA would measure success against the disease while FibroGen Inc doesn't yet have a NASH human trial in the works, it has said it hopes to start one for its lead candidate FG-3019 (its in mid-stage trials for pulmonary fibrosis and liver fibrosis due to hepatitis B infection).
Hot Biotech Stocks To Watch Right Now: Portola Pharmaceuticals Inc (PTLA)
Portola Pharmaceuticals, Inc. (Portola), incorporated on September 2, 2003, is a biopharmaceutical company developing product candidates that have the potential to represent advances in the fields of thrombosis and hematology. The Company is advancing its three wholly owned programs using biomarker and genetic approaches.
Betrixaban
Portola's compound, betrixaban, is an oral, once-daily Factor Xa inhibitor being evaluated in the only biomarker-based Phase-III study for hospital to home prophylaxis of venous thromboembolism (VTE) in acute medically ill patients. Betrixaban's properties particularly suited to potentially demonstrate efficacy without increasing bleeding in this patient population.
Andexanet Alfa
Portola's second development candidate, andexanet alfa (PRT4445), has the potential to be a reversal agent to directly reverse the effects of Factor Xa inhibitors in patients who suffer a bleeding episode or who require emergency surgery. Portola has entered into clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors, including Bristol-Myers Squibb and Pfizer (Eliquis [apixaban]), Bayer HealthCare and Janssen Pharmaceuticals (XARELTO [rivaroxaban]), and Daiichi Sankyo (Savaysa [edoxaban]), while retaining all decision-making and commercial rights to the program.
Cerdulatinib (PRT2070) and PRT2607
Portola's third wholly owned product candidate, cerdulatinib (PRT2070), is an orally available kinase inhibitor that uniquely inhibits two validated tumor proliferation pathways - spleen tyrosine kinase (Syk) and janus kinase (JAK). It is being studied in patients with leukemias or lymphomas with a focus on genetically-defined subtypes, as well as in patients who have failed therapy due to relapse or acquired mutations. Portola's fourth program is partnered with Biogen Idec and is focused on the development of PRT2607, a selective Syk inhibitor.
Advisors' Opinion:- [By Todd Campbell]
That leads me to Medivation (NASDAQ: MDVN ) , Ophthotech (NASDAQ: OPHT ) , and Portola (NASDAQ: PTLA ) , three companies with important therapies that may very well be destined to become top sellers.
Hot Biotech Stocks To Watch Right Now: Cytomedix Inc (CMXI)
Cytomedix, Inc. (Cytomedix), incorporated in April 29, 1998, is a regenerative therapies company marketing and developing products within the United States and internationally .The Company commercializes cell-based technologies that harness the regenerative capacity of the human body to trigger natural healing. The Company is a commercial operation, and a robust clinical pipeline representing a logical extension of its commercial technologies in the evolving field of regenerative medicine. Cytomedix primarily operates in the United States. Its commercial offerings are centered on its point of care platform technologies for the safe and efficient separation of blood and bone marrow to produce platelet based therapies or cell concentrates.
The Company markets and selsl two distinct platelet rich plasma (PRP) technologies, the AutoloGel System for wound care and the Angel concentrated Platelet Rich Plasma (cPRP) Sytem in orthopedic and cardiovascular markets. Its clinical pipeline includes the ALDH, which are cell-based therapies (Bright Cells). In February 2012, the Company acquired Aldagen, Inc.
The AutoloGel System
The AutoloGel System is a point of care device for the production of a platelet based bioactive therapy derived from a small sample of the patient�� own blood. Using the patient�� own platelets as a therapeutic agent, AutoloGel harnesses the body�� natural healing processes to deliver growth factors, chemokines and cytokines known to promote angiogenesis and to regulate cell growth and the formation of new tissue.
Angel Product Line
The Angel concentrated Platelet Rich Plasma (cPRP) System is a multi-functional cell separation device which produces concentrated platelet rich plasma for use in the operating room and clinic and is used in a range of orthopedic and cardiovascular indications. Similar to the AutoloGel System, the Angel System is a point of care device for the production of a concentrated, aseptic platelet! -based bioactive therapy derived from a small sample of the patient�� own blood. The resulting cPRP is applied at the site of injury to promote healing. The Angel product line also includes ancillary products such as phlebotomy and applicator supplies and activAT. activAT is designed to produce autologous thrombin serum from platelet poor plasma and is sold exclusively in Europe and Canada, where it provides a safe alternative to bovine-derived products.
ALDHbr Cell Technology and Development Pipeline
The ALDHbr (Bright Cell) technology is an approach to cell-based regenerative medicine and a logical extension of its commercial technologies in the evolving regenerative medicine market, with potential clinical indications in markets with unmet medical needs such as peripheral arterial disease and ischemic stroke. The Bright Cell technology is in that it utilizes an intracellular enzyme marker to facilitate fractionation of essential regenerative cells from a patient�� bone marrow. The bone marrow fractionation process identifies and isolates active stem and progenitor cells expressing high levels of the enzyme aldehyde dehydrogenase, or ALDH, which is a key enzyme involved in the regulation of gene activities associated with cell proliferation and differentiation.
The Company�� lead product candidate, ALD-401, is an autologous preparation of Bright Cells for the post-acute treatment of ischemic stroke. ALD-401 is being evaluated in the RECOVER-Stroke clinical study, an ongoing 100-patient, double-blind, placebo-controlled Phase 2 study in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of less than 22. An additional product candidate, ALD-301, is in clinical development for peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles in the leg. It has completed a Phase 1/2 study of autologous ALD-301 in critical limb ischemia (CLI), a late stage condition caused by PAD. The Phase 2 PACE! (Patient! s with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC.
The Company competes with Harvest Technologies (a subsidiary of Terumo), Biomet, Arteriocyte, and Arthrex.
Advisors' Opinion:- [By James E. Brumley]
To give credit where it's due, Cytomedix, Inc. (OTCBB:CMXI) and Baxter International Inc. (NYSE:BAX) have both helped shape the landscape of the hemostasis (bleeding control) market with their products, AutoloGel and TISSELL, respectively. Arch Therapeutics Inc. (OTCBB:ARTH) has proverbially taken their concepts "up a notch", however, and its direct solution to a problem that CMXI and BAX can't quite solve may make ARTH the hottest trading candidate in the hemostasis space.
Hot Biotech Stocks To Watch Right Now: Savient Pharmaceuticals Inc(SVNT)
Savient Pharmaceuticals, Inc., a specialty biopharmaceutical company, focuses on developing KRYSTEXXA, a biologic PEGylated uricase in the United States. The KRYSTEXXA is being developed as a treatment for chronic gout in patients refractory to conventional therapy. The company also sells and distributes branded and generic versions of oxandrolone, a drug used to promote weight gain following involuntary weight loss. It sells its products directly to drug wholesalers. The company, formerly known as Bio-Technology General Corp. and changed its name to Savient Pharmaceuticals, Inc. in June 2003. Savient Pharmaceuticals, Inc. was founded in 1980 and is headquartered in East Brunswick, New Jersey.
Advisors' Opinion:- [By James E. Brumley]
Since 2008's implosion from the stock, the interest in Savient Pharmaceuticals Inc. (NASDAQ:SVNT) has been waning. There was a brief burst of bullishness in September of last year, which stirred the bullish pot a little. But, when SVNT started to fade in October of that year - just as quickly as it had perked up - what lingering hopes there were for the stock finally started to melt away. By the middle of this year, pretty much everyone had written Savient Pharmaceuticals off as a lost cause. Big mistake. Over the last few days, SVNT has almost wiggled its way buck into a bullish zone.
Hot Biotech Stocks To Watch Right Now: AMAG Pharmaceuticals Inc.(AMAG)
AMAG Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia (IDA). Its principal product includes Feraheme (ferumoxytol) injection for intravenous (IV) use, which was approved for marketing in the United States in June 2009 by the U.S. Food and Drug Administration, for use as an IV iron replacement therapy for the treatment of IDA in adult patients with chronic kidney disease (CKD). The company is pursuing marketing applications in the European Union, Canada, and Switzerland for Feraheme for the treatment of IDA in CKD patients. AMAG Pharmaceuticals was founded in 1981 and is based in Lexington, Massachusetts.
Advisors' Opinion:- [By John Udovich]
The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns�plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many�� planned biotech IPOs that have recently been announced publicly:
- [By Monica Gerson]
AMAG Pharmaceuticals (NASDAQ: AMAG) shares fell 16% to $18.38 in the pre-market trading after the company received a CRL from the FDA for the supplemental NDA for Feraheme for broader IDA indication.
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