There is a little more news today but still relatively quiet. The market seems to be looking for a direction but the sector seems to be outperforming to the upside. Yesterday was certainly better than expected but it also did not end in an exceptionally bullish manner. That is why I still think the market […]
Recent Option Activity (7/29 ~ 8/1)
The following stocks had recent and notable activity in their options: $EXAS (7/29): 8,000 OCT 20.0 Strike Calls were sold (stock at $15.78) for 0.50 or total proceeds of $400,000 against a 800,000 share position (this was a covered Call). Trade provides $0.50 of protection to the downside (and takes position out above $20). $DEPO […]
DEPO – Making sense of the AdCom Noise
Summary of our recent coverage/positions: October 26, 2011: We reiterated a BUY, see report April 21, 2012: We reiterated a BUY, see report October 17, 2012: We reiterated a BUY, see report January 31, 2012: I tweeted that I sold my shares, see tweet Respective Outcomes: Gains from coverage initiation in October 2011: +52% Gains from […]
DEPO – Action Ahead Of The AdCom
DepoMed Inc. (DEPO) -Nasdaq Serada is an investigational formulation of gabapentin, an FDA-approved immediate release pharmaceutical for the treatment of partial epilepsy and management of postherpetic neuralgia (PHN). Recently published studies suggest the potential application of gabapentin for the treatment of menopausal hot flashes. Based on these findings, Depomed has secured exclusive rights to develop […]
An October full of data and decisions
With October underway, we felt the need to highlight some of the most important upcoming data readouts and regulatory decisions. This month is particularly busy on the regulatory side of things with 5 PDUFAs, 4 Advisory Committees, 6 FDA actions, and multiple potential European Medicines Agency(EMA) decisions. The events are listed in chronological order. Eli […]
DEPO – Quick Update on Depomed
With Depomed’s recent PPS drop to below $5, many long-term investors have found themselves questioning their investment thesis. Although this past quarter has seen some interesting news releases, none have been able to move the stock price. Furthermore, the endless staring and tracking of weekly Gralise data has left investors, who lack patience, without a […]
DEPO, SNTS, XNPT, PFE – Update on Q1 Earnings
DEPO – Reaffirming Buy Yesterday, Depomed reported better-than-expected earnings for the first quarter. Gralise revenue was $1.75 million, Glumetza revenue was $9.2 million, Janumet XR was $0.2 million. We are reaffirming our BUY recommendation for this company. We feel that increases in total sales for Glumetza, price increases, and an increase in the percentage revenue […]
DEPO – Quick Update on Depomed’s plan to file NDA for Serada
On Tuesday, Depomed announced that they intend to file an NDA for Serada. At one point, in after hours trading the stock peaked up almost 7%, at which point we cautioned investors, here, to consider selling into this strength. Since then, it seems that the stock price had settled back down pre-news levels until […]
DEPO – Quick Update – Paragraph IV – DM1992 Phase 2
Depomed released a statement that Actavis Group, a generic drug manufacturer filed a paragraph IV challenge against Gralise, Depomed’s once-daily gabapentin formulation. NEUTRAL on Paragraph IV We view this event as having no net impact. Patent challenges are not unexpected in this pharmaceutical environment, especially in the drug delivery space. The current generic drug legislation rewards early […]
DEPO, XNPT, PFE – Managed-care to stunt Lyrica, Horizant and Gralise with step-edits
The Neurology and Pain sectors have been very interesting for biotech investors focused over the past year. Xenoport (NASDAQ:XNPT), Depomed (NASDAQ:DEPO), GlaxoSmithKline (NYSE:GSK) and Pfizer (NYSE:PFE) have all had regulatory successes over the past several months. The problem is the regulatory successes haven’t necessarily resulted in financial success for companies and their shareholders. At a […]
DEPO – Buying Opportunity after Serada failure
Earlier in October, Depomed (DEPO), announced results from it’s Phase 3 trial, called BREEZE 3, testing Serada, an extended release gabapentin formulation for the use in post menopausal hot flashes. The trial failed to meet 1 of 4 primary endpoints, and failed to meet its key secondary endpoints. Below is an excerpt from Depomed’s press […]
DEPO – Trading BREEZE-3 Results
Overview In the next several weeks Depomed (DEPO) is expected to announce top-line results from it’s large Phase 3 clinical trial for Serada, an investigational non-hormonal treatment for post-menopausal hot flashes. Our analysis suggests a 35-40% probability of positive outcome for all endpoints with an expected share price move from $1.00 to $3.00(1) from current […]
DEPO – Initiating Coverage on Depomed & Examining BREEZE-3
Initiating Coverage: Depomed is a commercial-stage specialty pharmaceutical company with three FDA approved products; ProQuin for infection, Glumetza for Adult Onset Diabetes Mellitus & Gralise for Post Herpetic Neuralgia. Within the next several weeks Depomed will launch Gralise in the USA with a detailing focus to high prescribing neurologists and pain specialists. Also, within the […]
Platform and Specialty Pharmaceutical Companies can bolster Big Pharma
The pharmaceutical industry is in a weak state, with an impending “patent cliff” that is forcing Big Pharma to reorganize and refocus. In 2011, roughly $20 billion in branded US sales dollars are “at risk” to patent expiry and generic competition. The pinnacle will be reached in 2013 and will subside after 2015. Fiscal Year […]
Neurogesx and Depomed seek to persuade pain specialists
I attended a recent medical conference where pain specialists outlined the history and direction of the pain industry, covering both nociceptive and neuropathic pain. After the conference, I had a chance to talk one-on-one with several pain specialists. I asked for their input on the industry and several products that I found particularly promising. […]
Depomed’s research posters and presentations from recent medical conferences
Depomed, Inc. (NASDAQ:DEPO) presented two analyses of phase 3 clinical data of Gralise™, a once-daily formulation of gabapentin for management of postherpetic neuralgia, at the 63rd Annual Meeting of the American Academy of Neurology (AAN). Below is a poster, presented at AAN, that concludes that there was no effect of previous treatment with gabapentin and […]
Despite Abbott Parting With Gralise, Depomed’s Future Looks Bright
During the past week, Depomed (DEPO) announced two significant business development updates. On March 15th, Depomed granted non-exclusive rights for its proprietary extended-release metformin patents, this time, to Boehringer Ingelheim. On March 16th, Depomed announced that they and Abbott (ABT) have reached an agreement over Gralise. Moving Forward From Abbott The details of the agreement […]
Depomed: Attractive and Under-Appreciated Potential
It almost seems counterintuitive that majority shareholders of Depomed (DEPO) have been adding shares after the FDA approval of Gralise, a once-daily treatment for post-herpetic neuralgia. One might expect that large funds would look to the high volume created with an FDA decision as an opportune exit strategy. Yet that hasn’t happened, several funds have […]
Depomed’s Stock Price Is a Gift Following FDA Approval of Pain Drug
Now that Depomed’s (DEPO) GRALISE has been approved by the FDA, making a bull case for Depomed becomes easy. GRALISE is an extended release gabapentin formulation, formerly DM-1796, that is prescribed once-daily for the treatment of post-herpetic-neuralgia (“PHN”), which is pain associated with shingles. Approval of GRALISE triggers a milestone payment of $48 million from […]
