Farmas USA

je,je ... Hablando de chinos ... este Jueves 8, conference de CLSN ... a ver que nos cuentan ...

Como sea otro cuento chino....ya podemos vender y ponernos cortos.

Es que donde esté una buena copa, que se quiten los bastos.

AMPE o MSTX?

AMPE: Chicharro pero al menos NASDAQ, tiene 3 fase III en breve, la primera el 31/8. Ha tocado el suelo del canal a corto que esta dibujando y tiene pinta de rebote inminenete. Alto riesgo porque el medicamento que presenta no tiene buena pinta en cuanto a eficacia y los artículos que he leido acerca de la dirección no pueden ser peores. Especulación pura y dura a 15 días vista. De entrar en esta tiene que ser ya, buscar el run up previo a la FDA y salir por patas antes del 25 o 26 de Agosto.

MSTX: Chicharrazo AMEX. Ha hecho dilución reciente y está en mínimos históricos. Capitaliza 43'50M según yahoo y 20'82M según FINVIZ. No tiene deuda. Tiene en cash 30M contantes y sonantes. Cotiza a 0'45 y por cash vale en libros 0'79 con lo que está infravalorada un 40%!! Varios catalizadores pendientes en este Q3, entre ellos una designación de Orphan drug status.
http://finance.yahoo.com/news/mast-therapeutics-reports-results-clinical-120000550.html

2013 Activities

Event Timing

Initiate tQT/QTc Study Completed

Secure Orphan Designation for MST-188 for SCD in EU Completed

Activate First Site in Phase 3 Study Completed

File New Patent Applications Completed

Dose First Subject in Phase 3 Study Completed

Report data from tQT/QTc Study Q3

Submit Applications for U.S. Government Funding for Phase

2 Study in Resuscitation of Shock following Major Trauma Q3

Request Orphan Designation for MST-188 for ALI in U.S. Q3

Initiate Nonclinical Proof-of-Concept Study in Heart Failure Q3

Open First Ex-U.S. Clinical Site in Phase 3 Study Q4

Initiate Phase 2 Study in ALI Q4 ‘13/Q1 ‘14

El dedo "me se" mueve sólo....ainssss

http://invest.arenapharm.com/secfiling.cfm?filingid=1193125-13-317504

10Q

ARNA

ARNA

En principio todo parece en orden, pero no sé cuáles eran los números previstos, así que habrá que esperar a que salga algún artículo si ninguno los tenéis controlados.

Resumen

Las páginas 7 y 8 explican cómo se computan y cobran las ventas según el acuerdo con ESAI.

We believe our cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months.

We recognized revenues of $68.9 million for the three months ended June 30, 2013, compared to $22.0 million for the three months ended June 30, 2012.

We recognized revenues of $71.3 million for the six months ended June 30, 2013, compared to $24.2 million for the six months ended June 30, 2012.

Absent any new collaborations, we expect our 2013 revenues will primarily consist of the $66.0 million of milestone payments from Eisai earned to date in 2013 and net product revenues from sales of BELVIQ. We also expect to recognize revenues in 2013 from amortization of the upfront payments we received from Eisai, Ildong and CYB, as well as manufacturing services revenues from Siegfried.

Cost of manufacturing services increased by $0.3 million to $1.0 million for the three months ended June 30, 2013, from $0.7 million for the three months ended June 30, 2012. This increase was primarily related to our contract loss provision for these services, which is the result of providing the services at sales prices that are less than our costs.
Cost of manufacturing services increased by $1.3 million to $2.7 million for the six months ended June 30, 2013, from $1.4 million for the six months ended June 30, 2012.

Research and development expenses increased by $4.7 million to $18.8 million for the three months ended June 30, 2013, from $14.1 million for the three months ended June 30, 2012.

Research and development expenses increased by $4.3 million to $32.8 million for the six months ended June 30, 2013, from $28.5 million for the six months ended June 30, 2012

General and administrative expenses increased by $3.4 million to $8.6 million for the three months ended June 30, 2013, from $5.2 million for the three months ended June 30, 2012.

Lo del combo del otro día:

In addition to commercializing BELVIQ as a monotherapy for chronic weight management, we intend to explore BELVIQ’s therapeutic potential in combination with other drugs and for other indications. We recently completed dosing in a study to evaluate the safety, tolerability and pharmacokinetic properties of the co-administration of BELVIQ and phentermine, and we are in the process of analyzing the results. In addition, we expect Eisai to initiate a pilot study to evaluate the safety of co-administration of BELVIQ and phentermine over 12 weeks. We expect that results from these combination studies will help us evaluate options for possible further development of BELVIQ in combination

Otro pipeline

We also intend to utilize our GPCR-focused discovery and development approach to selectively advance other of our internally discovered, oral drug candidates, which include (i) APD811, an agonist of the prostacyclin receptor intended for the treatment of pulmonary arterial hypertension, for which dosing has been completed in a Phase 1 trial; (ii) temanogrel, an inverse agonist of the serotonin 2A receptor intended for the treatment of thrombotic diseases, which has completed single- and multiple-ascending dose Phase 1 trials and is expected to complete an additional Phase 1 trial in healthy volunteers and potentially a Phase 2a proof-of-concept trial in patients under our Co-Development and License Agreement with Ildong; (iii) APD334, an agonist of the sphingosine 1-phosphate subtype 1, or S1P 1 , receptor intended for the treatment of a number of conditions related to autoimmune diseases, for which dosing has been completed in a Phase 1 trial; and (iv) APD371, an agonist of the cannabinoid receptor 2 intended for the treatment of pain, which is in preclinical development. Our research and development pipeline also includes GPR119 agonists intended for the treatment of type 2 diabetes. With respect to APD334, preliminary results show a reduction in blood lymphocyte count, the desired benefit, and a slowing of heart rate, an undesirable adverse event seen with other drugs targeting the S1P 1 receptor. Further evaluation of the data is ongoing.

We will use substantial cash to achieve our goals. To date, we have generated limited revenues from sales of BELVIQ, which is our first and only drug approved by any regulatory authority. Even though we recorded net income in the three and six months ended June 30, 2013, we may continue to incur substantial losses, and do not expect to generate consistent positive operating cash flows for at least the short term. Accordingly, we will need to receive additional funds under our existing collaborative agreements, under future collaborative agreements for BELVIQ or one or more of our drug candidates or programs, or by raising additional funds through equity, debt or other financing transactions.

Riesgos
Our development and commercialization of BELVIQ may be adversely impacted by cardiovascular side effects associated with drugs used for the treatment of obesity.

We developed BELVIQ to more selectively stimulate the serotonin 2C receptor than did fenfluramine or dexfenfluramine because we believe this may avoid the cardiovascular side effects associated with fenfluramine and dexfenfluramine (often used in combination with phentermine, the combination of which was commonly referred to as “fen-phen”). These two drugs were serotonin-releasing agents and non-selective serotonin receptor agonists, and were withdrawn from the market in 1997 after reported incidences of heart valve disease and pulmonary hypertension associated with their usage.

In in vitro studies examining affinity, activity and serotonin receptor subtype specificity, BELVIQ demonstrated affinity for, and activity at, serotonin 2A, 2B and 2C receptors, but demonstrated greater affinity, activity and selectivity for the serotonin 2C receptor than for the serotonin 2A and 2B receptors. Activation of the latter two receptors has been associated with undesirable effects. Activation of the 2A receptor has been associated with central nervous system, or CNS, effects, including altered perception, mood and abuse potential, and activation of the 2B receptor has been associated with cardiac valvulopathy. We may not be correct in our belief that more selectively stimulating the serotonin 2C receptor will avoid these undesired side effects, or BELVIQ’s selectivity profile may not be adequate to avoid these side effects.

*There are a substantial number of shares of our common stock that may become eligible for future sale in the public market, and the sale of our common stock could cause the market price of our common stock to fall.

As of July 30, 2013, we had outstanding a seven-year warrant issued in August 2008 to purchase 1,965,418 shares of our common stock at an exercise price of $4.34 per share.

Along with our outstanding warrant, as of July 30, 2013, there were (i) options to purchase 14,546,845 shares of our common stock outstanding under our equity incentive plans at a weighted-average exercise price of $4.89 per share, (ii) 296,096 restricted stock unit awards outstanding under our equity incentive plans, (iii) performance restricted stock unit awards outstanding under our 2012 Long-Term Incentive Plan, targeted at 780,000 shares (however, the actual number of shares that may be awarded ranges from 0% to 200% of such amount), (iv) 26,580,147 additional shares of common stock remaining issuable under our 2013 Long-Term Incentive Plan, (v) 1,038,990 shares of common stock remaining issuable under our 2009 Employee Stock Purchase Plan, as amended, and (vi) 79,169 shares of common stock remaining issuable under our Deferred Compensation Plan.

Fin de las mil ediciones.

RNN

Otra que ha tocado el nivel inferior del canal alcista en el que está metido.

CYTK

FDA 3Sept. y parece que ha detenido la caida.