The upcoming Phase II trial, which is expected to begin before the end of the H1 2013, should be watched closely since it will demonstrate to Neuralstem investors and the rest of the market whether or not the company can replicate the implied efficacy in the Phase I studies with NSI-566.
Particularly interesting with regards to Aegerion’s business model is its ability to keep its costs extremely low while targeting an extremely lucrative drug indication. The company’s SG&A expenses did rise to $13.2M for Q1 2013 relative to $5.1M reported in Q1 2012, although this more so reflected the costs of a market launch for Juxtapid rather than a trend that investors should be worried about. Aegerion can keep its costs relatively low due to the small size of the HoFH market, and should see extremely high profit margins.
Dendreon’s balance sheet has also seen some substantial deterioration. As of December 31st 2012, the company had $429.8M of cash and cash equivalents but has seen a decline to $337.3M reflecting their GAAP net loss of $72M for the quarter. The company has also seen expansion of their enormous pool of convertible debt due in 2016 to a new figure of $539.1M. The company has also went from a positive net worth (or stockholder’s equity) of $34.6M to a negative figure of $35.9M. Psychologically, this could be significant going forward as the company’s financial situation sees more scrutiny by potential investors.
Today, Dendreon (NASDAQ: DNDN) shareholders will brace for the company’s Q1 2013 earnings, which will be discussed in a conference call on Thursday at 9:00 AM EDT. Dendreon, which has been operating at steep losses years after the market launch of its flagship product PROVENGE® (sipuleucel-T), is still attempting to reduce manufacturing costs of their prostate cancer therapy while boosting sales.
Overall, STML looks like another interesting mid-stage play on cancer therapeutics. The company’s focus on cancer stem cell targeting with SL-701 and SL-401 makes sense in the context of cancer treatment as a whole. Safety and tolerability of the two therapeutics has also been generally established in early-stage trials, and each of the two therapies have established a niche indication that could significantly improve patient outcomes while generating significant revenue for Stemline shareholders.
Titan Pharmaceuticals just received a rejection letter, or CRL from the FDA regarding its application for the marketing of the subdermal implant probuphine in opioid addicted patients. As discussed in the adcom meeting in March 2013, the product has some issues with its dosing and quirky safety issues that should be explored further.
Good morning. Please sit, have a cup of coffee (or tea), and let's go over last week's action in the biotech & small pharma sector
Although the short interest in QCOR is incredibly high, the market’s sentiments will not be able to derail Questcor so long that it continues the performance it’s had in the first quarter of 2013. The first quarter earnings release, which is due after the bell on Tuesday (4/30/2013), is very likely to surprise to the upside. Whether or not this will cause QCOR to pop high enough to induced a short squeeze is uncertain, although the fundamentals support a significantly higher valuation for the equity.
We’ve been seeing a lot of new activity in BioCryst Pharmaceuticals (NASDAQ: BCRX), which we last covered on April 7th following a 42% run in the stock chasing the good news that the company received from the FDA about its antiviral agent peramivir. .
The PEGPH20 program can build Halozyme’s reach into oncology indications significantly in upcoming years, along with the Roche partnership which will combine “standard” rHuPH20 with Roche’s best oncology (and other) drugs.
