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 [...]
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 [...]
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 [...]
MAKO Surgical’s (MAKO) first quarter results did little to inspire our confidence in this battered and bruised story, but for those that truly believe in the growth prospects, MAKO looks cheap relative to expectations. The main question that needs to be answered in order to justify ownership is: Are expectations (and guidance) achievable? MAKO, which [...]
Within biotechnology and the broader healthcare sector, investor sentiment often reaches extremes. A company might be heralded as a revolution in medicine and see its stock price soar, only to have it fall as reality fails to match lofty expectations; sentiment swings to the other extreme. That’s exactly what occurred with MAKO Surgical (MAKO). After [...]
In part 2 of the ODAC postmortem (see Part 1 on Aveo Oncology [AVEO] here), I will share my thoughts on the outcome of the afternoon session which reviewed Delcath’s (DCTH) Melblez Kit for the treatment of unresectable, hepatic dominant metastatic ocular melanoma Unlike the tone of the morning’s discussion, I really felt that both [...]
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, [...]
Yesterday was a dark day for those holding Aveo Oncology (AVEO) or Delcath Systems (DCTH) through the FDA’s Oncologic Drugs Advisory Committee meeting. I was personally very bullish on the prospects for both of these agents to receive a positive vote, and wanted to share my perspectives on the proceedings. AVEO’s Tivozinib for the treatment [...]
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 [...]
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 [...]
Zalicus (ZLCS) is starting to look very interesting at this level. Traders are no doubt waiting for the big phase 2 data on potential blockbuster drug Z160 coming in the fourth quarter 2013. But now might be the time value biotech investors take a look at the stock. The currently market capitalization is only $75 million. [...]
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 [...]
On April 30, 2013, Titan Pharmaceuticals (TTNP) announced that the U.S. FDA had issued a complete response letter (CRL) to its new drug application (NDA) for Probuphine, the company’s investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients. The CRL states that the FDA cannot approve the application in its present form. The CRL notes [...]
Shares of Auxilium Pharmaceuticals (AUXL) fell nearly 13% on April 29 after the company released weak Q1 earnings, and are down around 12% since our original report on the company. While the timing of our report may have been early, several elements to this story have played out as we predicted, including the assertion that [...]
As most biotech enthusiasts will be well-aware of, biotech is rife with binary events this week, many of which fall on Tuesday April 30. While PropThink has not opined on all of these events, below, we list those that PropThink has covered, as well as our latest commentary and outlook. Tuesday, April 30 FDA briefing [...]
Since our last report on Alexion Pharmaceuticals (ALXN) on April 5, shares have remained flat as continued concerns about the company’s manufacturing facilities and Soliris’ market expansion have weighed down the company’s stock price. However, Alexion’s Q1 2013 results, released last week, should put to rest some of the ongoing concerns. Shares rallied nearly 11% [...]
On April 22, after the close of trading, Illumina (ILMN) released its Q1 2013 earnings, delivering another solid quarter in the face of perceived uncertainty. Illumina’s Q1 results highlight the company’s resilience in facing funding challenges within the academic sector, as well as the large opportunities that lie ahead. And although the stock has rallied [...]
Since pricing its latest public offering at $5.50 two weeks ago, shares of Synergy Pharmaceuticals (SGYP) have failed to hold that print and are trading under $5.00 as of Monday morning. Nevertheless, existing clinical data for Synergy’s lead candidate plecanatide suggest that the drug will be competitive with Ironwood’s (IRWD) Linzess (linaclotide), a fellow guanylate [...]
Exact Sciences (EXAS) on Thursday released the long-awaited results of its DeeP-C trial examining the use of its Cologuard test in the detection of CRC and precancerous polyps. The release initially caused a sharp sell-off in shares of Exact Sciences as the results weren’t as good as investors expected, but the stock rebounded significantly by [...]
