Trading FDA Decisions: Cypress Bioscience Soars, A Trio of Buys

After the market close yesterday, Cypress Bioscience (CYPB) and Forest Labs (FRX) received FDA approval for Savella (milnacipran) in the treatment of fibromyalgia, almost exactly three months after the original PDUFA date of 10/18/08. Shares of CYPB soared into the double digits (up over 50%) while FRX is up 10% in after hours trading at just after 6 pm ET.

Meanwhile, Schering Plough (SGP) was not as fortunate, as the company received a complete response letter for schizophrenia drug Saphris (asenapine). However, no new clinical trials are required by the agency and SGP expects to file a re-submission with the requested data during 1Q09.

The accompanying tables below [click to enlarge] include an updated calendar of expected FDA new product decisions, clinical trial result estimates, and pending FDA re-submissions with over 140 entries. Click here for a link to my previous FDA calendars and the companies listed below are my favorite buys on the potential for approvals this year with similar upside potential as CYPB is experiencing today.

BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company recently raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement + a $3M advance of the $30M milestone payment upon FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents nearly half of the Company's current market cap, in addition to royalties that will be received on product sales once the breakthrough cancer pain drug is on the market.

Momenta Pharma (MNTA) – MNTA represents a pure play on the future of bio-generics and is developing a mix of proprietary compounds, follow-on-biologics, and complex generic drug products in partnership with the Sandoz division of Novartis (NVS). The pending ANDA for M-Enoxaparin as the generic equivalent for Lovenox does not have a decision date deadline, but MNTA has an inside track over competitors such as Teva Pharma (TEVA) and Amphastar/Watson Pharma (WPI) after working with the FDA during the heparin contamination crisis.

AMAG Pharma (AMAG) – AMAG received a second complete response late last year for Feraheme, but it appears that no new issues were raised by the FDA and the Company may not need to submit another response to the agency. The rate-limiting step to attaining FDA approval for Feraheme is having the agency review the Company's response to the manufacturing issues raised in the original complete response and conducting a re-inspection of the facilities, if deemed necessary – resulting in likely approval during 2Q09 at the latest.

Comments

[Dan Jacome:]

who else has drugs in pipe for fibromyalgia?????????

Jan 15 08:24 AM

[Mike Havrilla:]

Jazz Pharma (JAZZ) is starting a 2nd Phase 3 trial for JZP-6 (sodium oxybate) Expected NDA Filing by EOY-09 + Phase 3 Results Expected Mid-09

Jan 15 09:05 AM

[VFC's Stock...:]

was watching CYPB! Missed out on that one...will be waiting for BDSI.
vfcsstockhouse.blogspo...

Jan 15 09:06 AM

[Mike Havrilla:]

K-Fine's strategy is to invest in biotech ETFs such as IBB + XBI in addition to companies such as DNA rather than trying to pick riskier small/micro-cap stocks, which is a reasonable strategy since she manages other people's money and has to invest a lot more capital than you & me trading online

Below is a link to my blog for the new healthcare indexes that I follow for investing/trading ideas:
www.etfinnovators.com/...

Also, I track the cos. with pending FDA or clinical trial decisions, including over 140 such ideas at the link below:
www.etfinnovators.com/...

Jan 16 01:39 PM