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 [...]
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 [...]
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 [...]
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 [...]
Co-written by Jake King and Rajesh Patel, Ph.D. Zogenix (ZGNX) currently awaits an approval decision from the FDA on Zohydro ER (extended release), a hydrocodone bitartate formulation that differs from existing hydrocodone products because it does not include acetaminophen (like Vicodin). But despite losing almost 60% of its dollar value since going public in 2010, we believe [...]
Synergy’s equity financing, which wrapped up last Tuesday, put the company in a strong position for a partnership (or M&A) negotiation regarding plecanatide. The stock continued to demonstrate weakness following the pricing of the offering as investors moved on to stories with more catalysts upcoming. But we think they’ve missed a few events, and this [...]
On April 9, Synergy Pharmaceuticals (SGYP) reached a new 52-week intra-day high of $7.44, driven by a Cantor Fitzgerald analyst report highlighting more detailed trial results (disclosed in a prior Form 8-K) for Synergy’s lead drug candidate plecanatide. A compelling dose-response curve and strong safety, efficacy, and tolerability data gave investors significantly more confidence in [...]
On May 2, 2013, AVEO Oncology (AVEO) is set to face the FDA’s Oncologic Drugs Advisory Committee (ODAC) for a review of the company’s New Drug Application (NDA) for tivozanib, the proposed indication being for treatment of patients with advanced renal cell carcinoma. The PDUFA goal date for the final decision is by July 28, [...]
Tekmira’s (TKMR) story over the last few years has largely been focused on its siRNA delivery technology, lipid nanoparticles (LNPs), and the ability of the platform to be used in broader RNAi applications. But the focus of investors is shifting as Tekmira brings a new therapy into the clinic this year and moves out of [...]
ICPT has a big problem, and could be headed back to its post-IPO prices, 50% lower than where they trade today. The company piqued our interest with the realization that pressure on the stock was a result of a lock-up expiration on the majority of ICPT’s outstanding shares. But the digging led us down a [...]
Intercept Pharmaceuticals’ (ICPT) shares immediately took off from their late October IPO price of $15 per share, soaring to a closing high of $41.70 on January 29th. However, in recent weeks the sellers have come out, with ICPT declining from $38 on March 25th to the current low-$30 range. Why the fallout? For one thing, [...]
Since our last report on Achillion Pharmaceuticals (ACHN) in November, shares have turned up a muted performance, losing around 7%. Through February, shares rose steadily, climbing from just below $8 in November to above $10. However, beginning in late February, shares of Achillion began to sell off, falling below $7.40 as a secondary offering and [...]
Keryx (KERX) has come back under the magnifying glass at PropThink. We hosted Dr. Scott Chambers, a patent attorney and former USPTO staff, on a conference call this week with our subscribers. The call cleared up a lot of unanswered questions about Zerenex’s IP protection, and our readers who were involved at the beginning of [...]
