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 [...]
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 [...]
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 [...]
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 [...]
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, [...]
Cadence (CADX) was a compelling buy last year as the sales ramp for its IV acetaminophen formulation began to improve. A position since Mr. King first wrote on the name in December has returned more than 60%, but we believe it’s time to take profits. Early in the week, Mr. King took a retrospective look [...]
The EMA’s advisory body took investors by surprise on Friday and announced that they would be recommending Halozyme (HALO) and Baxter’s (BAX) HyQvia for approval in the European Union. The stock has fallen considerably since January, but our subscribers — who jumped in Friday morning when we called it a buy — are already up [...]
The CPAP (Continuous Positive Airway Pressure) equipment market is about to enter a pivotal time. The Centers for Medicare and Medicaid (CMS) instituted a round of “competitive bidding”, which effectively cuts reimbursement for CPAP treatment (products and services), late last year. It’s the second round of Medicare cuts, the first of which lowered average Medicare [...]
It’s been a great week for Medicinova (MNOV) shareholders, who saw their holdings climb as much as 80% with the announcement that the company’s lead candidate, MN-166 (ibudilast) for the treatment of methamphetamine dependence, had received fast-track status from the U.S. FDA. What investors aren’t necessarily aware of, however, is the dilution that may be [...]
The Home Health Services industry remains under pressure due to regulatory scrutiny and looming reimbursement cuts. As we have written in the past, Amedisys, Inc. (AMED) remains vulnerable on these issues, in addition to a contract change with major health insurer, Humana, hence we expect more investors to sell this stock as 2013 unfolds. Among [...]
On Friday, PropThink launched its database of Special Protocol Assessments, or SPAs. These trials are, in essence, a FDA-blessed measure to mitigate clinical efficacy risk (learn more by visiting PropThink’s SPA landing page) The database is a new and unique facet to PropThink, something that we’ve yet to see widely available elsewhere, and provides a [...]
The hope remains alive that Optimer (OPTR) will somehow power through a disappointing launch and increase prescription growth sufficiently to offset the 25% discount that the company had to recently offer hospitals to start prescribing Dificid. Dificid is OPTR’s only product and is a bactericidal agent for the treatment of Clostridium dificile (C. diff.) infection. [...]
Shares of ResMed Inc. (RMD) have finally found their top, peaking at $48.37 in late January before dropping to the $43 level. But the downslide isn’t over yet. RMD had a great run in the back half of 2012, with a cult, “do no wrong” following that pushed shares on a meteoric ride with little [...]
Shares of Ampio Pharmaceuticals (AMPE) were on a tear in the past four weeks, climbing from $3.39 at the end of December to a recent high of $5.00 at the beginning of last week. But on Tuesday the 22nd, shares began retracing (PropThink Premium Subscribers received an alert that morning), and we expect the correction [...]
The highlight of our week was Allergan’s ~$1B buyout of MAP Pharmaceuticals, a company that we recommended in early January. The acquisition came at a 60% premium to MAPP’s closing price, but all-in-all for AGN, the deal was a bargain if Levadex lives up to its potential. Mr. Napodano sat down with management from Zalicus [...]
Telik, Inc. (NASDAQ:TELK) announced last Friday that the FDA granted its lead candidate, ezatiostat HCL (Telintra), orphan drug designation for the treatment of myelodysplastic syndrome (MDS), sending the stock soaring. Shares climbed 100% to $3.00 over the course of the trading session, but on Monday have been in a partial reversal, down 20% to $2.40 [...]
Synageva (NASDAQ:GEVA) announced its third stock offering in twelve months on Thursday, which after a pricing update, should raise approximately $90M for pipeline development, particularly for its lead – and only – candidate in the clinic, SBC-102 (sebelipase alfa). The drug is intended for a minuscule and underserved patient population, a strategy that proved vastly [...]
A California Superior Court judge has ruled against Medivation, Inc. (NASDAQ:MDVN) in the case of Medivation, Inc. vs The Regents of The University of California (Case Number: CGC-11-510715). While the ruling occurred last Thursday, the news was just confirmed last night, and it is curious that Medivation has yet to comment on this important decision [...]
