It doesn’t get much better than this, and Synergy Pharmaceuticals (SGYP) remains a favorite PropThink idea. The company’s lead drug candidate, plecanatide, has demonstrated strong safety and efficacy results in a 951-patient clinical trial, there’s a path to FDA approval, and the company is trading at a fraction of the value of its closest competitor, [...]
Things are looking up for Cubist Pharmaceuticals (CBST). As we speculated last week, a key piece of Cubist’s ongoing litigation with Hospira has gone in favor of the antibiotic developer, with Judge Sleet of the U.S. District Court in Delaware ruling in favor of Cubist in a Markman hearing on Monday. We previously laid out [...]
Cell therapy developers Athersys and Cytomedix target the immense stroke treatment market. Mr. Napodano laid out the theses for these two stem cell developers, although he’s more bullish on CMXI for the time being. News this week that Trius had patented a tidezolid/daptomycin combination has an interesting read-through for Trius and Cubist. Mr. King called TSRX a buy when [...]
This Tuesday, Synergy Pharmaceuticals (SGYP) will release the full data set from its recently completed trial for lead candidate plecanatide at the annual Digestive Disease Week (DDW) medical conference in Orlando, Florida. The study evaluated the compound in patients with Chronic Idiopathic Constipation (CIC), and after initial top-line results were reported and the company strengthened [...]
On May 16, 2013, Titan Pharmaceuticals (TTNP) reported financial results and provided a brief update on the recent complete response letter (CRL) issued by the U.S. FDA on April 30, 2013 for Probuphine, the company’s investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients. We remind investors, the CRL stated that the FDA [...]
With a capital raise recently out of the way and a pivotal trial enrolling towards a regulatory filing in the U.S., Sunshine Heart’s (SSH) $60M market capitalization drastically discounts the long-term potential of the company’s experimental heart assist device. The C-Pulse Heart Assist System is an implantable device being developed for the treatment of moderate [...]
On May 13, 2013, Trius Therapeutics (TSRX) announced that it had received a notice of allowance from the USPTO for a patent application relating to the use of its tedizolid phosphate antibiotic in combination with Cubist Pharmaceutical’s (CBST) antibiotic Cubicin (daptomycin). The application claims the use of sub-therapeutic doses of tedizolid for preventing bacterial resistance development when daptomycin is used long-term [...]
Since our original March 1 report highlighting Immunomedics (IMMU) as an inexpensive biotech with a novel platform and deep pipeline, shares have risen by 28.82%, outpacing the 24.52% rise in the NASDAQ Biotechnology Index. And over the next several months, there will be several catalysts that have the potential to lead to further outperformance as investors [...]
Shares of Cubist Pharmaceuticals (CBST) have not significantly participated in the market rally, and relative to biotech peers, CBST has lagged on performance as well; the stock is up just 14% since last May compared to the AMEX Biotechnology index (BTK), up 33% in the same period. The key to CBST’s stagnation is an ongoing [...]
This article is about cerebrovascular accident (CVA), or as it is more commonly referred, stroke. There are two small biotech companies targeting treatment of stroke with cell therapy that we discuss below: Cytomedix (CMXI) and Athersys (ATHX). The goal of this article is to introduce investors to the core technologies at each firm, outline each of their clinical [...]
For those that missed it last week, Dr. Chaudhry offered an educational, retrospective look at both AVEO and DCTH’s advisory panel votes. In addition, we listed a few reasons that investors might find AVEO interesting over the next few months. It’s a wildcard, but bottom-fishers might take a peek. While we were optimistic about the [...]
Since our original report on Onyx Pharmaceuticals (ONXX) in March, shares of the oncology drug developer have risen 14.8%, versus a 13.05% rise for the NASDAQ Biotechnology Index (IBB). After a solid first quarter, and with multiple sets of clinical data to be released in the next 12 months, as well as further proof that [...]
On May 8, 2013, Pozen (POZN) reported financial results for the first quarter 2013. Pozen reported revenues in the quarter of $1.415 million, driven entirely by royalties on $19.7 million in worldwide sales of Vimovo at AstraZeneca (AZN). Vimovo sales were dead-on with our forecast, only Pozen dropped a mini-bombshell in its earnings release on Vimovo, noting [...]
Since our original report on Regeneron Pharmaceuticals (REGN) in mid-December, shares of the company have rallied over 47%, versus a rise of over 27% for the NASDAQ Biotechnology Index, as a confluence of positive developments, both internal and external, have served to create a more favorable environment for Regeneron. And while REGN may be at [...]
This week was dominated by a number of binary events (which we outlined on Monday), two of which played out against us; Dr. Chaudhry expected that the FDA’s oncologic advisory panel would vote in favor of AVEO and DCTH. Here’s where AVEO went awry, and next week she’ll recap the DCTH panel outcome. (P.S. the AVEO [...]
Although shares of Aveo Oncology (AVEO) were crushed this week by a negative vote from the FDA’s Oncologic Drugs Advisory Committee regarding tizozanib (see Dr. Chaudhry’s follow-up), there’s reason to believe that picking up AVEO on the cheap might net investors some profit. AVEO tumbled from $7.50 at the beginning of the week to $2.62, [...]
Shares of ViroPharma fell 6.9% on May 1 with the release of mixed first quarter results, also amidst a weak day for the biotechnology sector driven in-part by market rumors that a relatively large biotechnology focused fund is liquidating, prompting a sell-off across the sector. However, ViroPharma’s commercial & pipeline progress is on track, with [...]
Vical Incorporated (VICL) expects to announce top-line data mid-2013 from the pivotal Phase III trial (NCT00395070) of Allovectin in metastatic melanoma, some two years later than first predicted. The uncertainty created by the delay, complexity of melanoma immunotherapy trials, and focus on the cancer trial has weighed heavily on Vical’s share price and caused investors [...]
Investors are well aware, the single biggest catalyst for shares of DURECT Corp. (DRRX) remains the filing of the Remoxy NDA by Pfizer (PFE). As such, DURECT shares popped on Tuesday, April 30th at around 10:35 AM based on comments made on Pfizer’s first quarter conference call. John Young, Pfizer’s President and General Manager of the Primary Care [...]
Shares of Trius Therapeutics (TSRX) took a 7% dive on Wednesday, creating an entrance opportunity for those not yet involved, as the unsubstantiated rumors that caused the sell-off haven’t changed the fundamentals at Trius. Sources have indicated to PropThink that the weakness is a result of an institutional investor, Ayer Capital, closing its doors and [...]
