PCYC â Ibrutinib NDA Filed â Well Ahead of Expectations, in MCL and (surprise!) in CLL, Too â Expect Rapid FDA Turnaround And Street Numbers to Come Way Forward â Pharmacyclicsâ filing on July 10 is well ahead of the September 30 company forecast, which is also three months ahead of initial forecast (end 2013)[…]
ONXX â AMGN Bid Sets Biotechs On Fire and Sets A New Valuation on The New Blockbuster Drugs Fourth of July fireworks have come early for the Biotechs as the BTK and NBI are both up over 3% on ONXX takeover speculation. The spark was ONXX disclosed it rejected a takeover bid from Amgen for[…]
June 20, 2013 Below is a pdf for MTSL Issue #757 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/06/MTSL-757-June-20-2013.pdf” save=”1″]
June 6, 2013 Below is a pdf for MTSL Issue #756 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/06/MTSL-756-June-6-2013.pdf” save=”1″]
ISIS & ASCO APO & CRP: Blockbuster Alphabet Soup for ISIS? Among its broad and deep R&D pipeline, ISIS has two potential home run compounds with important Phase II clinical data due by mid-year â each addressing multiple blockbuster drug markets. In our view, a successful result from either candidate is likely to establish ISISâ[…]
INCY Knows JAK Incyte Pharmaceuticals (INCY) is an MTSL recommendation and one of the few stocks that trades below its BUY LIMIT. In our February 15 update (Issue #748), we suggested that the Q4:12 quarterly report was a pivotal turning point for the company; and the stock subsequently had begun to make its move and[…]
Pharmacyclics (5/2/13) â Ibrutinib On Market In 2013 Now Highly Likely; Synergy With Almost Every Hem/Onc Drug Around Leading To Widespread Combination Therapy â REITERATE BUY. The Pharmacyclicsâ first quarter conference call included more positive details that can be included in a short note. In a nutshell, the company will now be officially filing for approval[…]
PLENTIFUL PLATFORMS Several of the MTSL Portfolio Companies have business models based on proprietary platform technologies. Platform technologies are attractive for several reasons. Among the favorable investment characteristics, platforms provide the following: â¢Cutting edge technology â¢Multiple compounds, partners, therapeutic classes â¢Significant diversification/relatively lower risk â¢Initial drug candidates may be partnered earlier in development â¢Begins to[…]
NovaVax released positive Phase II data from their respiratory syncytial virus (RSV) vaccine development candidate, RSV-F. RSV-F exhibited a robust antibody response and clean safety profile in the trial that enrolled 330 women of childbearing age. The trial is a major step towards the commercial viability of the very first RSV vaccine candidate ever for use[…]
ORPHANS FIND A HOME Orphan drugs (OD) have been a part of the biotech industry almost from its inception. The pioneer in Orphan Drug development is Genzyme, which was acquired by Sanofi last year to take advantage of the OD business model. Orphan Drugs resulted from the Orphan Drug Act (ODA) of 1983. (Think of[…]
Pharmacyclics (4/5/13) â Ibrutinib â Expanding the Potential – Pancreatic Cancer, Combination Therapies and Recovery of Functional Immunity â Reiterate BUY UNDER 80 and TARGET PRICE OF 115. The AACR meeting begins this weekend in Washington, D.C. An overwhelming number of studies by every oncology company, both preclinical and human trials, are due to be[…]
Aastrom (3/27/13) – ASTM Restructures to Focus on Orphan Drug Indication, Lowering BUY and TARGET PRICE – Aastrom dropped a bomb premarket today when new CEO, Dominick Colangelo, announced that the company is shelving their Phase III CLI program and cutting half their workforce after completing a comprehensive strategic review. ASTM will now focus on[…]
March 15, 2013 Below is a pdf for Issue 750 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/03/MTSL-750-March-15-20131.pdf” save=”1″]
Pacira posts Phase 3 nerve block study; completes EXPAREL pilot hernia study. Pacira has posted the design and is about to begin a Phase III nerve block study with EXPAREL in patients undergoing thoracic surgery. The trial will enroll 180 patients and data collection is due by August. Nerve block is the next major market for[…]
Coronado announced the initiation of an investigator-sponsored pilot study to evaluate CNDO-201 (TSO) for the treatment of moderate-to-severe psoriasis. This is first new TSO study since Harlan Weisman joined the Company as CEO in early January. As a reminder, Weisman led the development of Remicade, JNJ’s best-selling product and approved for several of the same indications[…]
The Orphan Drugs Leader. With 2012 exceeding $500 million, BioMarin has vaulted itself into an elite group of the top-tier biotech companies. Naglazyme ($257 million, +14% Y/Y) and Kuvan ($143 million, +23%) each had solid years and royalties from Aldurazyme ($80 million, +6%) continue to deliver strong cash flow. With a truly impressive pipeline filled[…]
GSK Begins Pivotal Trial For ISIS-TTR. The company earned a $7.5 million milestone payment from their partner, GlaxoSmithKline (GSK), on the initiation of a Phase II/III trial for ISIS-TTR. ISIS-TTR is an antisense drug development candidate for the treatment of transthyretin (TTR) amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral[…]
Janssen (JNJ) Begins Ibrutinib Long-Term Extension Study. Pharmacyclicsâ partner Janssen has filed to begin a Phase 3b study, enrolling 200 patients who have participated in ibrutinib studies. This is a long-term follow-up study to give patients ibrutinib for up to 3 years, a logical trial to continue to monitor the long-term safety and efficacy of[…]
OGXI has started their fourth Phase II trial testing OGX-427 in cancer patients. Borealis-2 is being initiated as an investigator-sponsored, randomized, controlled Phase II trial of 427 in patients with advanced or metastatic bladder cancer (http://clinicaltrials.gov/ct2/show/NCT01454089?term=Oncogenex&rank=1). This trial will evaluate the potential of ‘427 to work synergistically with second- or third-line chemotherapy to overcome treatment[…]
February 1, 2013 GLORY DAYS The performance of biotechnology stocks since the start of 2013 has been no less than stellar. The BTK and NBI are up 9% and 8% respectively, and the MTSL Model (+21%) and Traderâs Portfolios (+37%) are up sharply as well (see below).  Two of BioInvestâs recommended stocks â CNDO (+63%)[…]
PCYC = Janssen (JNJ) To Begin Front-Line Phase III Mantle Cell Lymphoma and Phase II Refractory Follicular Lymphoma Studies. We have discovered that www.clinicaltrials.gov recently (1/29) posted two new ibrutinib studies. First, and most important in our view, is the Phase III trial of ibrutinib in front-line mantle cell lymphoma (MCL) in combination with bendamustine[…]
Anthera announced last week that they priced a public offering of 60 million shares at $0.66 per share, which will add $40 million to their balance sheet. Jefferies is acting as sole book-running manager in the offering and Leerink Swann is acting as co-manager. These are quality investment banks and it is an impressive accomplishment for[…]
On a positive note, Pacira pre-released some of their key Q4 financials. The company expects Q4:12 and FY12 revenues to come in above Wall Street consensus estimates, driven by higher net sales of Exparel. Q4 sales of the drug are targeted at $7.8 million, and total revenues are estimated at $10.5 million, compared to $4.2[…]
Incyte’s stock has had a nice move to start the year. The company presented at JP Morgan and did a good job of detailing how they will grow Jakafi sales. Importantly, some on Wall Street also believe that INCY has learned a lot from the launch over the last year and are positioned to grow[…]
With T-DM1 FDA approval nearing the goal line â the PDUFA date is February 26 â ImmunoGen will join the ranks of commercially successful biotech companies, a major achievement. While it is widely known that the royalty rate IMGN will receive from partner Roche (~3%) is unlikely to lead the company to major profitability, regulatory[…]
CONTINUED PROGRESS AND PIPELINE VISIBILITY. Nektar management continues to make progress across its lateâstage development pipeline, relieving some investor concern for the naloxegol (NKTR-118) program â NKTRâs lead compound â under development for the treatment of opioid-induced constipation (OIC). With renewed optimism on the â118 program and upcoming related catalysts, increasing appreciation of the breadth[…]
January 9, 2013 Top Picks for 2013 Written By Chloe Lutts Welcome to the super-sized Investment Digest Top Picks for 2013 issue. Inside this issue, you’ll find over 50 of our contributors’ very favorite investments to own this year. Plus, this year we’re bringing you an even wider selection of Top Picks through a collaboration with[…]
January 4, 2013 Below is a pdf for Issue 745 of the Medical Technology Stock Letter. [gview file=”http://50.87.166.114/wp-content/uploads/2013/03/MTSL-745-January-4-2013-2.pdf” save=”1″]
OncoGenex has announced the start of PACIFIC, an investigator-sponsored, randomized Phase II trial testing OGX-427 in 80 men with metastatic castrate-resistant prostate cancer (CRPC) who are experiencing a rising PSA while receiving JNJ’s Zytiga (abiraterone acetate). The aim of the study is to determine if adding 427 to Zytiga treatment can reverse or delay treatment[…]
Pharmacyclicsâ stock is on fire as the company has presented outstanding data for ibrutinib at the American Society of Hematology meeting. We know we sound biased but the bottom line is: ibrutinib really is an unbelievable drug and the data at ASH is overwhelmingly positive in so many ways. It’s doing everything one could dream[…]
Anthera’s CFO and Chief Medical Officer explained the detailed plans for the blisibimod (B-mod) Phase III program at the recent Piper Jaffray conference.  The Phase III development program was blessed by the FDA in September and the EU regulatory agency in April. The first Phase III – CHABLIS1 will start where PEARL was done – Asia/Pacific/S.[…]
Pacira had good news this morning and the stock is up modestly. The company announced results from the first IMPROVE study to complete its prospective Phase 4 clinical program. The IMPROVE studies compare the difference in opioid use, total hospital cost and length of stay (LOS) between patients receiving Exparel (bupivacaine liposome injectable suspension) as[…]
November 16, 2012 Below is a pdf for Issue 742 of the Medical Technology Stock Letter. [gview file=”http://50.87.166.114/wp-content/uploads/2013/03/MTSL-742-November-16-2012-1.pdf” save=”1″]
Alkermes reported financial results for its second quarter of fiscal 2013, which ended Sept. 30, 2012, and the company provided improved financial expectations for its fiscal year 2013. Total revenues for the second quarter of fiscal 2013 increased more than 72% to $124.0 million, compared to the same period in fiscal 2012, which was attributable[…]
NVAX – Novavax Announces Positive Results of RSV F Protein Vaccine in Elderly – Paving Way For The Ultimate INFLUENZA/RSV Combination Vaccine – Raising BUY LIMIT and TARGET PRICE – The successful trial exhibited evidence of a real vaccine across the board. In 220 patients, the F-Protein vaccine: a) was well-tolerated without any vaccine-related serious[…]
ISIS Delivers Powerful Phase II Data for APOCIII-Rx â Raising BUY LIMIT and PRICE TARGET â Isis has presented rather positive Phase II data for APOCIIIRx in patients with high triglycerides and Type 2 diabetes at the American Diabetes Association (ADA) meeting. In our view, this is a major unexpected surprise in the ISIS story[…]
DUNE â HANDICAPPING THE WORMSIGN CNDO â The Best and Worst Case Scenarios of TRUST I, Possible Stock Outcomes and Protection Strategies â Top-line results from the TRUST I clinical trial of Coronadoâs TSO in patients with Crohnâs disease (CD) will be released in the fourth quarter. Based upon the timing of the completion of[…]
May 27, 2013 Tiny Biotech Developing Drugs Akin To Biogen’s Rituxan Seen As Potential Buyout Bet Written By Gene Marcial, Contributor Welcome to the super-sized Tiny Biotech Developing Drugs Akin To Biogen’s Rituxan Seen As Potential Buyout Bet. Unfortunately for investors in the arcane world of biotechnology, biotech stocks haven’t fully participated in the market’s[…]
ASCO ABSTRACTS CONFIRM BULLISH STANCE ON PCYCÂ â Keeping it simple, two key abstracts were released online last night for the upcoming ASCO conference (5/31-6/4, Chicago) support our favorable thesis on PCYC and INCY (see INCY update). PCYCâs ibrutinib combination in NHL – Abstract #8502 is a study testing the combination of ibrutinib plus standard[…]
May 9, 2013 Below is a pdf for Issue 754 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/05/MTSL-754-May-9-2013.pdf” save=”1″]
April 25, 2013 Below is a pdf for Issue 753 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/05/MTSL-753-April-25-2013.pdf” save=”1″]
Pharmacyclics (4/24/13) â Completes Enrollment of RESONATE and SPARK Well Ahead of Schedule â Continue to Expect Ibrutib on Market This Year, Ahead of All Expectations. Completion of both trials, RESONATE (CLL) and SPARK (MCL), approximately 6-9 months ahead of forecasts supports our belief that ibrutinib is on track to be approved in the U.S. in[…]
Pharmacyclics (4/17/13) â JNJ Opens Ibrutinib Early Access Program (EAP) – Expect FDA Filing By Q3/Approval By Year-End – Raising BUY LIMIT to 90 and TARGET PRICE to 125 Last night, Janssen (in conjunction with Pharmacyclics) filed a Phase 4 Open Label Treatment Protocol for patients with relapsed/refractory mantle cell lymphoma (MCL) on www.clinicaltrials.gov. This early[…]
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March 29, 2013 Below is a pdf for Issue 751 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/03/MTSL-751-March-29-2013.pdf” save=”1″]
Pharmacyclics (3/25/13) â BEAR RAID GIVES US OPPORTUNITY, PCYC BACK UNDER BUY LIMIT â Last week, Pharmacyclics shares dropped precipitously on the heels of several items â none of which were directly related to ibrutinibâs clinical trials, approval timeline and, hence, commercial potential. First, both ARIAâs Iclusig and ONXXâ Krypolis â two of the most[…]
Janssen (JNJ) Begins Ibrutinib Long-Term Extension Study. Pharmacyclicsâ partner Janssen has filed to begin a Phase 3b study, enrolling 200 patients who have participated in ibrutinib studies. This is a long-term follow-up study to give patients ibrutinib for up to 3 years, a logical trial to continue to monitor the long-term safety and efficacy of[…]
March 1, 2013 Below is a pdf for Issue 749 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/03/MTSL-749-March-1-2013C.pdf” save=”1″]
Roche received FDA approval for IMGN’s T-DM1 (Kadcyla) for the treatment of late-stage metastatic breast cancer patients who fail to respond to Herceptin and taxol. While this was a widely expected approval, it represents a significant milestone for IMGN as this is their first drug approval. The company will receive a $10.5 million milestone payment[…]
Abbott To Develop Diagnostic for p17 del Gene in High-Risk CLL for PCYC/JNJ â Abbott Labs announced that it would collaborate with PCYC and JNJ to develop a companion diagnostic test using their FISH technology to identify patients with high-risk CLL patients that present with a deletion of the p17 chromosome. As a reminder, ibrutinib[…]
PCYC held its quarterly call this week, two days after announcing the receipt of a “Breakthrough Therapy Designation” from the FDA for ibrutinib in refractory MCL/WM. The plethora of positive data continues to build for ibrutinib, and management confirmed the NDA filing for relapsed/refractory MCL by year-end. No one knows exactly what the new designation[…]
February 15, 2013 Below is a pdf for Issue 748 of the Medical Technology Stock Letter. [gview file=”http://50.87.166.114/wp-content/uploads/2013/01/MTSL-748-February-15-2013.pdf” save=”1″]
FDA Grants Ibrutinib Breakthrough Therapy Designation – Could Be On The Market in Q1:14 – Raising BUY LIMIT and TARGET PRICE. The FDA has granted PCYC’s ibrutinib Breakthrough Therapy Designation for the treatment of relapsed/refractory mantle cell lymphoma (MCL) and Waldenstrom’s macroglubinemia (WM). This is a major positive for Pharmacyclics that could conceivably lead to[…]
February 01, 2013 Below is a pdf for Issue 747 of the Medical Technology Stock Letter. [gview file=”http://50.87.166.114/wp-content/uploads/2013/02/MTSL-747-February-1-2013.pdf” save=”1″]
Isisâ Kynamro was approved by the FDA for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The approval is the first for a systemic antisense drug (Vitravene for CMV of the eye was approved in 1998), and represents a major milestone for the Companyâs antisense technology. The FDA approval triggers a $25 million milestone payment[…]
We attended the Pharmacyclics‘ presentation and breakout session at JP Morgan. While the company repeated much of the powerful ASH data from a month earlier, we did learn some new and not unimportant pieces of information. Â First, the company is about to open RESONATE 17 – a likely fast-track registration trial of ibrutinib (the fourth[…]
Isis’Â stock has been strong, pre- and post-JP Morgan. Wall Street is beginning to warm up to the story, as we believe; the deep pipeline from late-stage to early-stage compounds is attracting more investors. Â The recent partnerships with Biogen and AstraZeneca for certain early-stage drug development candidates have convinced some that antisense has real potential. The[…]
Sangamo’s stock has risen sharply (~35%) since their presentation last week at the JP Morgan conference. The company broadly explained what their novel technology – In Vivo Protein Replacement – has the ability to accomplish. It has the ability to mechanistically, physically, and permanently change a single disease related gene (“monogenic”) and, therefore, has substantial[…]
OUTLOOK 2013 â RAISING BUY LIMIT AND TARGET PRICE Over the past decade, Alkermes has evolved into a fully integrated company as they receive revenue from five ALKS-developed approved drugs and have established a real R&D pipeline. ALKS has emerged as a leader in the development of injectable antipsychotics that can be administered as infrequently[…]
OUTLOOK 2013 – THE OPEN-ENDED POTENTIAL OF ZFPS SGMO’s stock has exploded since their presentation last week at the JP Morgan conference. The company began the presentation by broadly explaining what their technology can accomplish. The ability to actually mechanistically, physically, and permanently change a single disease related gene (monogenic) has huge potential. SGMO’s technology[…]
Coronado Biosciences is poised for a big year in 2013. Every year we are asked to give our top pick for the year by various publications such as Dick Davis Digest. This year we chose CNDO as our Top Pick for 2013. The company has had two pieces of good news since the last Issue. The[…]
ImmunoGen has announced that Amgen has licensed the exclusive right to use the Company’s TAP technology to develop anticancer therapeutics to a third target, which is undisclosed. Amgen licensed rights for two other targets in 2009 and has two compounds in clinical testing under those licenses. “We’re pleased with the interest major healthcare companies are[…]
Conferences and Meetings 2019 ASCO Gastrointestinal Cancers Symposium 17-Jan-19 19-Jan-19 San Francisco, California February WORLD Symposium 4-Feb-19 8-Feb-19 Orlando, Florida ISC International Stroke Conference 6-Feb-19 8-Feb-19 Honolulu, Hawaii ASCO-GU ASCO Genitourinary Cancers Symposium 14-Feb-19 16-Feb-19 San Francisco, California AVF American Venous Forum 19-Feb-19 22-Feb-19 Rancho Mirage, CA AAAAI / WAO American Academy of Allergy, Asthma[…]
December 8, 2012 Don’t Be Surprised If Underpriced Small-Cap Biotechs Catch Investors’ Eye Once Again Written By Gene Marcial, Contributor Biotechnology stocks haven’t produced much excitement for investors this year, partly because the Presidential elections and national politics usurped much of the news headlines. So Wall Street and most investors have had little chance or inclination to focus[…]
November 30, 2012 Below is a pdf for Issue 743 of the Medical Technology Stock Letter. [gview file=”http://50.87.166.114/wp-content/uploads/2013/03/MTSL-743-November-30-2012.pdf” save=”1″]
BioMarin’s stock is up significantly since the last Issue. The trigger for the strong price move was positive data from their Phase III trial in patients with the rare genetic disorder known as Morquio A Syndrome. The patients treated with a weekly infusion of GALNS were able to walk an average of 22.5 meters further[…]
Nektarâs stock has had a horrible two weeks despite announcing positive top-line results from two Phase III trials and one safety extension trial in patients with non-cancer related pain and opioid-induced constipation (OIC). Last week, potential FDA concerns with CV risk associated with opioid withdrawal in chronic use of opioid antagonists became an investor issue[…]
CNDO – TRUST-1 Fully Enrolled (And Then Some) On Schedule, The Clock Is Set – CNDO Now Under BUY LIMIT. Coronado announced completion of enrollment of TRUST-I, its Phase II clinical trial with TSO (Trichuris suis ova or CNDO-201) in 250 Crohn’s disease patients. As expected, top-line data is expected in the fourth quarter –[…]
H2 OUTLOOK CNDO, OGXI, SGMO: MTSL Stock of the Year Recommendation Coronado BioSciences has pulled back from an intraday high of $12.70 (on 4/23) to $7.55. The stock is still up 67% YTD, however the pullback from the high is no doubt a meaningful one…
INCY – Abundance of Positive News – Solid Bari Long-Term Phase II Data, Jakafi Label Expansion, NVS Begins Hodgkin’s Lymphoma Study – Reiterate BUY – INCY and partner Eli Lilly released positive 52-week efficacy and safety data from the open-label, long-term extension of the Phase IIb JADA study of baricitinib (“bari”) in patients with active[…]
May 23, 2013 Below is a pdf for MTSL Issue #755 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/05/MTSL-755-May-23-2013.pdf” save=”1″]
ASCO ABSTRACTS CONFIRM BULLISH STANCE ON PCYC AND INCY â Â Keeping it simple, two key abstracts were released online last night for the upcoming ASCO conference (5/31-6/4, Chicago) support our favorable thesis on INCY and PCYC (). Incyteâs INCY’s Jakafi improves bone marrow fibrosis â Abstract #7030 is a study evaluating BM fibrosis in MF[…]
May 9, 2013 The Life Sciences Report: Six Superstars for Your Biotech Portfolio by : Tracy Salcedo The Life Sciences Report: The consensus is that biotech is on the upswing and that it may be a safer bet for investors than gold or energy at this point in time. Do you agree? Can you tell[…]
NovaVax – Why VLPs are VIPs. The key to the NVAX vaccine platform technology is the use of virus-like particles (VLPs) to safely deliver key immune-identifying proteins to the body. Importantly, proof of concept is in place as VLPs are recombinant particles similar to currently marketed vaccines. Merck’s Recombivax HB and GSK’s Engerix B are recombinant[…]
Alkermes (4/17/13)â Positive MDD Data Supports Increased BUY LIMIT and TARGET PRICE Alkermes eleased rather positive Phase II data from ALKS 5461 for the treatment of major depressive disorder (MDD). â5461 is a non-addictive opioid modulator, a combination of ALKS-33 and buprenorphine. The Phase II trial was highly statistically significant across major depression endpoints. The[…]
April 12, 2013 Below is a pdf for Issue 752 of the Medical Technology Stock Letter. [gview file=”http://www.bioinvest.com/wp-content/uploads/2013/05/MTSL_752_April_12_2013.pdf” save=”1″]
Pharmacyclics (4/10/13) âMajor Ibrutinib Competitor – ABT-199 – Still Seeing Tumor Lysis Syndrome; Richter’s Transformation Issues Completely Overblown. At the AACR, Rod Humerickhouse, M.D., Ph.D. of AbbVie presented an update on ABT-199, a Bcl-2 inhibitor, under development for hematologic malignancies similar to PCYC ibrutinib. Recall back in January, AbbVie suspended trials as two patients died from tumor lysis syndrome due (TLS) to[…]
Biotech Risk Management – An Oxymoron? With the vast majority of companies in the development stage and/or whose success is dependent on one key drug, biotechnology stocks are inherently quite volatile. Although the sector’s sizable rewards have been well documented of late, the outsized risks frankly never disappear. With many stocks trading at 52-week and/or[…]
Incyte’s stock is down this morning after disclosing that a UK patient taking Jakafi has died from a rare brain infection, progressive multifocal leukoencephalopathy (PML). It is unclear whether Jakafi caused the infection and that it is the only reported case among nearly 10,000 patients who have taken the drug. A review of the clinical[…]
March 1, 2013 BEST IN CLASS OR BUY THE CLASS II After the last MTSL Issue (#748) titled âThe New Hot Classesâ â âsuper pillsâ for hepatitis C, and small molecule inhibitors of the novel targets BTK, Pi3K, JAK and PCSK9 â the ideal sequel to that subject is âBest In Class or Buy The[…]
ISIS Starts Phase II Study for ISIS-CRP. ISIS also initiated Phase II trials with ISIS-CRP, which targets C-reactive protein (CRP), which is elevated in many inflammatory diseases, in patients with atrial fibrillation (AF). The goal is to reduce the frequency of AF episodes and provide proof-of-principle for CRP as a drug development target. In addition, ISIS[…]
CNDO signed an R&D, joint ownership and exclusive license agreement with Freie Universität Berlin for the identification and evaluation of secretory proteins from Trichuris suis. By collaborating with Dr. Susanne Hartman, one of the world leaders in parasitology, the deal extends Coronadoâs research into TSO (Trichuris suis ova or CNDO-201). Preclinical models will further explore the[…]
“Celgene Announces Accelerated $600 Million Share Repurchase Program” In a clear sign of optimism about its corporate outlook, CELG today announced it would accelerated share repurchases of $600 million of the companyâs common stock, representing approximately 1.4% of shares outstanding. The long-awaited PFS data for the Revlimid MM-020 trial is due end-Q2/early Q3. With renewed growth[…]
Incyte’s Q4:12 results exceeded Wall Street’s expectations, driving the stock up 10%. Sales of Jakafi were strong, but more importantly, the Company’s guidance for 2013 was impressive and could prove conservative. It appears new COO Jim Daly, who joined INCY in October from Amgen, is having a very positive impact, effectively educating physicians of the[…]
QUARTERLY UPDATE – stock has been volatile since the release of their financials last week (2/7). However, given that the stock has had an incredible start to 2013 (still up >50% YTD), a pullback was not unexpected, and the shares have since made an impressive recovery. Pullbacks after very strong moves that back and fill[…]
Pomalyst (“Pom”) was approved by the FDA for the treatment of multiple myeloma (MM) patients who have failed two prior therapies, providing the beginning of another growth driver for CELG. The Fast Track approval was based on response rates. Despite being the third “imid,” Pom’s label has a black box warning (just like Revlimid &[…]
January 31, 2013 The Life Sciences Report: Watchlist 2013 by George S. Mack Which biotech companies will take off in 2013? To zero in on possible winners, The Life Sciences Report teamed up with Sagient Research to crunch the numbers for companies with potential catalysts on the calendar. The results were sent to experts who, based on their[…]
NVAX has cleared an important hurdle tied to the government funding for their seasonal and pandemic flu vaccine program. The U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) has completed an In-Process Review of the company’s contract. Subsequently, BARDA has notified NVAX that a milestone decision has been made to[…]
Anthera has switched gears as they recently disclosed that development program testing blisibimod in lupus is on hold as the company searches for a partner that will fund further development. This is a disappointment as ANTH had previously planned to start Phase III development for lupus this year. ANTH now says that that they are[…]
January 18, 2013 Below is a pdf for Issue 746 of the Medical Technology Stock Letter. [gview file=”http://50.87.166.114/wp-content/uploads/2013/03/MTSL-746-January-18-2013-3.pdf” save=”1″]
OUTLOOK 2013, RAISING BUY LIMIT AND TARGET PRICE As recently as the summer of 2012, Celgene had a stable but slowing core business led by Revlimid but no apparent pipeline. Questions arose about the companyâs long-term growth. In a remarkable turn of events, the company and stock have been revived by not one but three[…]
Our #1 pick for 2013 We met with Coronado Biosciences’ new CEO Harlan Weisman during JP Morgan. We have known Dr. Weisman since our days as a Centocor analyst in the 1990s where he was Chief Medical Officer and subsequently became Senior management at Johnson & Johnson (JNJ) after its acquisition of CNTO. With his[…]
January 17, 2013 Top Picks for 2013 Written By John McCamant Pacira Pharmaceuticals (PCRX) is our top conservative stock recommendation for 2013. The specialty pharmaceutical company develops, commercializes, and manufactures pharmaceutical products for use in hospitals and ambulatory surgery centers. The company’s drugs are based on its proprietary DepoFoam drug delivery technology. Its lead drug, Exparel, is a[…]
Aastrom has announced that the company’s board of directors has named Dan Orlando interim CEO of Aastrom. Mr. Orlando, who joined the company as Chief Commercial Officer in August has the experience and skills to handle the additional responsibility. Aastrom’s president and CEO Tim Mayleben is retiring but will remain an active member of the[…]
December 21, 2012 Below is a pdf for Issue 744 of the Medical Technology Stock Letter. [gview file=”http://50.87.166.114/wp-content/uploads/2013/03/MTSL-744-December-21-2012-1.pdf” save=”1″]
Isis had bad news this morning and the stock is actually up. The company and its partner Genzyme announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for its marketing authorization application (MAA) for Kynamro for the treatment of patients with Homozygous[…]
John McCamant recommends in this year’s Top Stock picks from The Stock Advisors. Subscribers can read his full report on Pacira (see page 52) as well as learn more about all 70 stock recommendations in the PDF report below.
November 27, 2012 Isis Pharmaceuticals: Antisense Value by John McCamant, editor The Medical Technology Stock Letter Isis Pharmaceuticals (ISIS) has had a lots of news. The first was the announcement that the company will receive $1.1 million from Alnylam as its portion of the upfront fees from a collaboration with Genzyme. The company also announced that[…]
Anthera’s stock is down sharply since the last Issue. It appears that the company had been out trying to put together a private financing but could not execute the transaction. Hurricane Sandy made it almost impossible to conduct business normally and ANTH was not able to close a transaction. Alternatively, ANTH entered into an At Market[…]
Celgene’s stock is up since the last Issue on good news. The company announced that Abraxane has achieved overall survival (OS) is Phase III trial treating metastatic pancreatic cancer patients. CELG did not provide any exact results as they plan to present the data at an upcoming scientific meeting. We do know that the company designed[…]
