ACST - acasti pharma inc

  • Ecco la 60° Edizione del settimanale "Le opportunità di Borsa" dedicato ai consulenti finanziari ed esperti di borsa.

    Questa settimana abbiamo assistito a nuovi record assoluti in Europa e a Wall Street. Il tutto, dopo una ottava che ha visto il susseguirsi di riunioni di banche centrali. Lunedì la Bank of Japan (BoJ) ha alzato i tassi per la prima volta dal 2007, mettendo fine all’era del costo del denaro negativo e al controllo della curva dei rendimenti. Mercoledì la Federal Reserve (Fed) ha confermato i tassi nel range 5,25%-5,50%, mentre i “dots”, le proiezioni dei funzionari sul costo del denaro, indicano sempre tre tagli nel corso del 2024. Il Fomc ha anche discusso in merito ad un possibile rallentamento del ritmo di riduzione del portafoglio titoli. Ieri la Bank of England (BoE) ha lasciato i tassi di interesse invariati al 5,25%. Per continuare a leggere visita il link

renna63

Nuovo Utente
Registrato
17/7/09
Messaggi
2.816
Punti reazioni
85

Allegati

  • acst.png
    acst.png
    32,6 KB · Visite: 432
io sono entrato un paio di settimane fa seguendo un trader usa dopo una discesa notevole il mercato recupera un 5% questa non ha nessuna reazione non sono riuscito ancora a riprendere le commissioni mha.....
 
solita me.r.da del listino quando tutto saliva questa ferma ma ora a scendere nn si fa desiderare
 
Si conferma anche oggi dopo che gli indici hanno recuperato tutto lo storno sta palla va sempre piu giu
 
sopra la mm50 con volumi....sempre dentro OK!
 

Allegati

  • acst.png
    acst.png
    57,7 KB · Visite: 341
ACST ha una forte area di resistenza tra 1.30 e 1.40 il 26 e 27 febbraio è andata a testare quell'area ma è stata respinta e si è presa ulteriore tempo x accumulare, ieri ci sono stati dei bei volumi e mi attendo a breve un nuovo tentativo, di buono c'è che gli insider hanno acquistato più o meno ai livelli attuali o poco più sotto quindi penso sia solo questione di tempo....e di una bella news.
 

Allegati

  • acst.png
    acst.png
    69,2 KB · Visite: 313
speriamo non chiuda sotto 1.24 questa settimana. Sarebbe un bruttissimo segnale.
 
800.000 pezzi scambiati nella prima ora e mezza, okkio che se buca.....
 

Allegati

  • acst.png
    acst.png
    31,5 KB · Visite: 268
Upcoming Catalysts to propel Neptune towards a kriller 2014 : Article

Acasti: Providing Exposure to Pharmaceutical Market

Neptune is the majority owner (roughly 50%) of its subsidiary Acasti. This pharmaceutical subsidiary develops a formulation of Neptune’s krill oil product named CaPre, currently in Phase II clinical trials for hypertriglyceridemia. Competitors that utilize fish oils to target the same indication are Amarin (AMRN) with Vascepa, Glaxosmithkline’s (GSK) Lovaza and AstraZeneca’s (AZN) Epanova. CaPre’s COLT trial showed best-in-class results in patients with high triglyceride levels. Results were:

Reduction in triglycerides

Decline in LDL (bad cholesterol)

Decrease in non-HDL cholesterol

Increase in HDL (good cholesterol)

None of the approved FDA fish oil products, Vascepa or Lovaza, had been able to achieve the same affects on all measurements as CaPre. Lovaza was proven to reduce triglyceride levels, however at the expense of increasing bad cholesterol, arguably a counterproductive move. Vascepa, on the other hand, lowered all levels of cholesterol, including good cholesterol. CaPre’s double blind controlled trial, TRIFECTA, is expected to release Phase II study results in 1H 2014. This date could serve as a catalyst for Neptune by demonstrating that CaPre could outperform competitors which would all but guarantee FDA approval in the future.

Conclusion

Investors of Neptune have some crucial upcoming events that will trigger movements in stock price. Within the next month, the completion of the Sherbrooke plant and settlement with Enzymotec should be two dealings that keep momentum progressing. Afterwards, the TRIFECTA trial results will be a huge catalyst that may have potential to distinguish Acasti from competing drugs. In any case, Neptune investors are in for some exciting months ahead.
 
a me sembra che ne stiano caricando a iosa a 1,24 o sbaglio:mmmm:
 
doppio minimo e sembra ripartire :specchio:

Acasti Pharma: An Undervalued Biotech With A Potential Best-In-Class Omega-3 Drug

Apr. 1, 2014 8:27 AM ET | 1 comment | About: ACST

Summary
•The omega-3 prescription drug market is expected to double by 2019.
•ACST's omega-3 prescription drug CaPre is a potential blockbuster.
•ACST's stock price could double in 2014 if its TRIFECTA results, due in June 2014, are positive.

Profile

Acasti Pharma Inc. (ACST) is a biopharmaceutical company focused on developing and commercializing innovative pharmaceutical ingredients for applications in cardiometabolic disorders. The company has two main products. Onemia is their only product in the commercialization stage and is a medical food intended to be used in illnesses associated with omega-3 phospholipids deficiency related to cardiometabolic disorders. The product has been on the market since 2011 and has yet to gain significant traction.

CaPre is their prescription drug product and is in the clinical trial stage. ACST obtained CaPre from Neptune Technologies & Bioresources, Inc. (NEPT) through a licensing agreement and has already prepaid all the future royalties under the agreement through the issuance of Class A shares to NEPT. NEPT currently owns 49.95 percent of ACST. Best in class results from its Phase II, open label study (COLT) were released on August 13, 2013. The study was designed to assess the safety and efficacy of CaPre in the treatment of mild to severe hypertriglyceridemia, a condition in which triglyceride levels are elevated. Elevated triglyceride levels can lead to serious health issues, such as heart attack and stroke. An overview of the condition can be found here. Over 230 patients in the study received CaPre for 4 to 8 weeks. Daily doses of 2g and 4g were used and both were shown to be safe and effective. An increased benefit was found for an increase in dosage and duration. Patients treated with 4g for 4 weeks showed a mean triglyceride decrease of 15.5 percent from baseline while patients treated with 4g for 8 weeks showed a mean triglyceride decrease of 21.6 percent. Each group showed an absolute mean improvement of 18.1 percent and 14.3 percent respectively as compared to Standard of Care. Drilling down on the 4g for 8 weeks group shows a mean LDL (bad cholesterol) decrease of 8.3 percent and non-HDL decrease of 14.3 percent. The 4g for 4 weeks group showed an HDL (good cholesterol) increase of 11.1 percent over the Standard of Care. Another critical piece of the study is that 88 percent of the population had baseline triglycerides between 200 and 500 mg/dL (borderline to high). People with triglycerides ≥500 mg/dL fall into the very high group.

Market Size and Competition

Currently, there are no FDA approved omega-3 prescription drugs for the direct treatment of people with triglycerides between 200 mg/dL and 500 mg/dL. This is significant because this group makes up about 36 million people in the U.S. alone. Global sales of prescription omega 3 drugs exceeded $2 billion in 2012. Forecasts of prescriptions written for omega 3 drugs in 2013 are around 5 million and are expected to grow to 10.7 million by 2019.

The big players in the prescription grade omega-3 market with drugs in the commercialization stage are Lovaza, Vascepa, and Epanova. These drugs are produced by GlaxoSmithKline plc (GSK), Amarin Corporation plc (AMRN), and AstraZeneca plc (AZN), respectively. See the table below comparing each drug to CaPre. Green is good and red is bad. Midpoints were used when only a range was reported in the results. Keep in mind that the results below for the commercialized drugs are from Phase III while CaPre's is from an open label Phase II study. Regardless, I believe this provides a reasonable comparison for the drugs. Most of CaPre's results are from the 200 mg/dL to 500 mg/dL group while the other trials focused on the ≥500 mg/dL group. The length of the trials are fairly similar, ranging from 6 weeks to 24 weeks. From the comparison below, it is apparent that CaPre is on par with the current drugs on the market at the very least. No serious health complications were noted during the COLT trial.



Lovaza trials

Vascepa trials

Epanova trials

Product Differentiation

CaPre contains about 66 percent phospholipids and 30 percent EPA/DHA. Lovaza and Epanova contain both EPA and DHA while Vascepa is only contains EPA. Results of the ECLIPSE study showed that Epanova has a superior bioavailability compared to Lovaza. What differentiates CaPre from the other three drugs is that it has the potential to treat triglycerides, LDL, and HDL. CaPre may be superior to Lovaza due to its ability to lower LDL's while Lovaza increases LDL's. In addition, the results of the COLT study were mostly related to the 200 mg/dL to 500 mg/dL group while the commercialized drug results were mostly based on the ≥500 mg/dL group. It has been shown that triglycerides are reduced at a greater percentage using omega-3 drugs when at elevated levels as found in the very severe group. This means that CaPre's triglyceride reduction may have been even greater had their COLT trial included more patients in the very severe group. It's worth noting that Lovaza and the others can be prescribed for off label uses. Vascepa is in a Phase III study (REDUCE-IT) for use in the 200 mg/dL to 500 mg/dL group while on a statin and has an estimated completion date of November 2016. The primary endpoint is to determine the effect of 4g per day for preventing the occurrence of a first major cardiovascular event. Vascepa only has a 3 year market exclusivity but is suing the FDA to get the 5 year status that comes with NCE. A discussion of the issues at hand can be found here. This creates a risk for CaPre should the FDA reject NCE exclusivity. However, I do not feel this will happen since CaPre contains about 66 percent phospholipids and lower levels of EPA. ACST has filed a composition and use patent application with the USPTO and is still awaiting the allowance. If granted, the patent would be good through 2029.

CaPre is currently in another Phase II study (TRIFECTA). This one is a randomized, double-blind, placebo-controlled study. The purpose of this 12 week study is to determine whether daily doses of 1g or 2g of CaPre has an effect on fasting plasma triglycerides in patients with mild to high hypertriglyceridemia as compared to a placebo. Estimated enrollment for this study is 429 and the estimated completion date is June 2014.

On January 9, 2014, ACST announced that the FDA has granted it approval to initiate a pharmacokinetic trial of CaPre. The PK trial is expected to start in Q2 2014 and results are expected in Q3 2014. ACST is using Quintiles for its PK trial and this will ensure that a high-quality trial is conducted. ACST plans to seek FDA approval to initiate a pivotal Phase III study of CaPre in the U.S. I was unable to find an exact timeline for the initiation of Phase III. Assuming the TRIFECTA and PK trial results are positive, Phase III could be initiated by early 2015 based on my estimates.

Financials

For the nine-months ended November 30, 2013, ACST reported revenues of $301,000 versus $675,000 for the corresponding period ended November 30, 2012. Revenues for both years were generated from Onemia. As of November 30, 2013, ACST had about $3.6 million in cash and short-term investments and a current ratio of about 1.1. It has no long-term debt and most of its current liabilities are payable to NEPT. Its cash burn rate is about $865,021 per quarter but this will most likely increase due to its TRIFECTA and PK trials and other operating activities. On December 3, 2013, ACST issued 18.4 million Class A shares at $1.25 per share and 18.4 million warrants with an exercise price of $1.50. Total proceeds of about $23 million were received. Each warrant entitles the holder to purchase one Common Share. The company also has another .75 million warrants outstanding with an exercise price of $1.50. On February 7, 2014, ACST sold more shares and warrants with an issuance price of $1.19 and exercise price of $1.43. Total proceeds from this offering was about $2 million. As of November 30, 2013, ACST had about 84 million shares outstanding.

Valuation

Precedent Transaction Analysis

ACST has a market capitalization of about $120 million at the time of writing this article. In May 2013, AstraZeneca acquired Omthera Pharmaceuticals for $323 million and gained access to Epanova. Omthera shareholders also received Contingent Value Rights valued at about $120 million. This brings the total potential acquisition price to $443 million. Epanova had completed two Phase III studies with positive results prior to the acquisition. This comparison will become more important if positive results are reported from TRIFECTA and CaPre enters a pivotal Phase III.

Discounted Cash Flow Analysis

For 2013, Lovaza recognized sales of about $966 million while Vascepa recognized sales of about $26 million. Analyst estimates of Vascepa sales were based on the massive growth rate of Lovaza during its commercial launch back in 2005. A good discussion of this can be found here. Lovaza had first-mover advantage which was one of the keys to its explosive growth. Although CaPre has the potential to be a blockbuster drug if its trial results continue to show superior efficacy and safety, this does not guarantee its commercial success. CaPre still needs to make it through Phase III and obtain FDA approval. This has its risks which need to be factored into the discount rate. The company will most likely need to raise additional capital in the future for its clinical development and operations and this will cause further dilution to shareholders. Assuming CaPre does obtain FDA approval, commercialization will be a challenge due to the competition in the marketplace and the potential for the expected market growth to not occur. The growth could stall if doctors begin writing less omega-3 drug prescriptions due to doubts about its positive effect on the heart. A recent article on this can be found here. The REDUCE-IT study results will hopefully shed some light on this debate. Lastly, there are many over-the-counter omega-3 brands on the market and this could eat into CaPre's future market share. A partnership with a larger pharmaceutical company with sufficient financial resources and marketing expertise would be ideal for ACST but it's too early in the game to tell if this will happen.

Assuming a commercial launch of CaPre in early 2019 with annual sales of $100 million, a year-over-year sales growth rate of 45 percent, a discount rate of 30 percent, and total free cash flow of about $4.5 billion for the period of 2015 to 2029, this puts ACST at $2.00 based on 84 million shares outstanding. It's worth noting that Euro Pacific Capital has a $4 price target on the stock and this could be due to a lower discount rate and/or a different free cash flow estimate.

Technical Analysis

The stock seems to have been forming a rectangle bottom since November 2013. This could be indicative of accumulation before the markup phase. The stock seems to be stuck between a range of about $1.08 to $1.56. The warrants with an exercise price of $1.50 may act as resistance until the TRIFECTA readout. However, a run-up prior to the results is not out of the question. The height of the potential rectangle bottom is about $0.50 and the measured move objective is $2.00, assuming the breakout level is $1.50.

Conclusion

The recent selloff in the biotechnology industry has created some great buying opportunities. I believe ACST has great potential due to its drug CaPre. The stock price could rise significantly if its TRIFECTA results are positive. If the results do not meet the primary endpoint, the stock price could drop significantly. Based on the COLT results, I think this scenario is not as likely. The omega-3 prescription drug market is very promising but has some risk. This is an important year for CaPre and other drugs in this market and it will be exciting to watch.
 

Allegati

  • ACST.png
    ACST.png
    32,2 KB · Visite: 260
dopo il doppio minimo di qualche seduta fa forse riparte....sempre dentro pmc 1.26 :wall:
 

Allegati

  • acst.png
    acst.png
    32,8 KB · Visite: 233
speriamo esca qualcosa di buono dai due forum,
timing non proprio azzeccato :wall::wall: resto in attesa del momento giusto x incrementare visto che ne avevo prese poche come assaggio.
discesa si ma con divergenze positive....per ora resto fiducioso.


The National Lipid Association Scientific Sessions 2014 to be held in Orlando, Florida from May 1-4, 2014. Acasti will present on Friday, May 2 from 11:30 to 12:30 and Saturday, May 3 from 12:00 to 1:00


The 82nd Congress of the European Atherosclerosis Society to be held in Madrid, Spain from May 31-June 3, 2014. Acasti will present on Sunday, June 1 from 12:30 to 3:00 and Monday, June 2 from 12:30 to 3:00
 

Allegati

  • acst.png
    acst.png
    31,8 KB · Visite: 214
se chiude cosi, sul settimanale va a disegnare un hammer di probabile inversione x settimana prossima....io ho comprato ancora qualcosina sotto il dollaro e abbassato il pmc
 

Allegati

  • acst.png
    acst.png
    37,8 KB · Visite: 183
le vendite del loro prodotto sul mercato non vanno cosi male, ci sono ovviamente le spese sulla ricerca in aumento ma d'altronde con un farmaco in fase 3 bisogna fare le cose per bene per ottenere dei buoni risultati....poi si sa che con l'fda è una questione di kiulo :eek:

Acasti Announces Fourth Quarter and Fiscal Year Results

Wed May 21, 2014 5:29 PM|GlobeNewswire | About: ACST

LAVAL, Quebec, May 21, 2014 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Corporation") (Nasdaq:ACST) (TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces its consolidated financial results for the fourth quarter and fiscal year ended February 28, 2014.

Financial Results: Fourth Quarter Ended February 28, 2014
• Revenues were $201,000 for the quarter ended February 28, 2014, versus $49,000 for the quarter ended February 28, 2013. Sales in both years were generated from the commercialization of Onemia®, the Corporation's medical food product
• Research and development (R&D) expenses were $714,000 for the quarter, down from $918,000 in the prior year
• Adjusted EBITDA was negative $(977,000) for the quarter, versus negative $(1,373,000) in the prior year
• Net loss was $(2,553,000) for the quarter, versus a net loss of $(1,952,000) in the prior year.

The year-over-year improvement in adjusted EBITDA is largely due to lower R&D expenses. As well, general & administrative expenses were down due to lower professional fees and royalties, with Acasti now being royalty free from Neptune.

The increase in the year-over-year net loss is largely due to higher depreciation and amortization expenses, following an increase in the Corporation's licensed asset, resulting from the royalty prepayment agreement with Neptune, and higher stock based compensation expenses.

Financial Results: Fiscal Year ended February 28, 2014
• Revenues were $501,000 for the fiscal year ended February 28, 2014, versus $724,000 for the year ended February 28, 2013. Sales in both years were generated from the commercialization of Onemia®, the Corporation's medical food product
• Research and development expenses were $4,297,000 for the year, up from $3,009,000 in the prior year
• Adjusted EBITDA was negative $(5,584,000) for the year, versus negative $(4,397,000) in the prior year
• A net loss of $(11,612,000) or $(0.14) per share was recorded for the year, versus a net loss of $(6,892,000) or $(0.09) per share in the prior year.

Research and development expenses were up over the prior year due to an increase in contract expenses related to Acasti's clinical trials.

The year-over-year decline in adjusted EBITDA was driven by the higher R&D expenses described above.

The higher net loss over the prior year was largely due to expense increases related to depreciation and amortization, stock based compensation and R&D.

"Over the past year, we continued to strengthen our business, and focus our efforts on moving closer to securing regulatory approval for our investigational new drug candidate, CaPre®," said Pierre Lemieux, Acasti's Chief Operating Officer. "We actively advanced our research and clinical development program, secured a manufacturing agreement for CaPre® clinical material, successfully completed a major financing and defended and strengthened our intellectual property. These successes are a testimony to our commitment to lay the groundwork for future growth and create sustained shareholder value by further positioning Acasti as a leader in pharmaceutical grade omega-3 phospholipids. There remain a number of important milestones ahead. However, with the encouraging results seen to date, a strong team, a solid balance sheet and a firm drive to succeed, we are well positioned to seize the opportunities before us."

Clinical Trials

Phase II TRIFECTA Trial

The number of targeted patients evaluable as per protocol has been reached. Acasti is currently evaluating the efficacy and safety of CaPre® for the treatment of patients with mild to severe hypertriglyceridemia, which is the primary objective of the study. The secondary objective of evaluating if statistically significant efficacy was reached in patient populations with mild to moderate (triglyceride levels ranging from 200 to 499 mg/dL) and severe hypertriglyceridemia (triglyceride levels over 500 mg/dL) will also be assessed separately. Based on patient information currently available, the Corporation does not believe the sample size is large enough to conclude the efficacy of CaPre in treating severe hypertriglyceridemia as part of the TRIFECTA trial. Based on literature, Acasti does not expect the FDA to request efficacy data on patients with severe hypertriglyceridemia before granting permission to conduct a Phase III trial. Acasti is targeting trial completion by the end of the second quarter of calendar 2014 and results will be available at a future date yet to be determined.

Pharmacokinetic (PK) Trial

As previously announced the US Food and Drug Administration (FDA) gave Acasti clearance to initiate a PK trial in the US. The trial is underway and is expected to be completed by the end of the second quarter of calendar 2014, with results being announced in the following quarter.

Phase 3 Trial

Concurrently with the PK trial, the Corporation is corresponding with the FDA and has responded to their recommendations regarding Acasti's upcoming Investigational New Drug (IND) filing for a pivotal Phase III clinical trial of CaPre® in the US. The FDA has invited Acasti to formally request an end of Phase II/pre Phase III meeting to allow them to provide feedback on the submission and to address specific questions for which Acasti is seeking a buy-in and final response from the FDA. Acasti intends to do this as soon as TRIFECTA trial results are available.

With the FDA's recent decision to not grant authorization to commercialize Acasti competitors' drugs in the mild to moderate patient population before the demonstration of clinical outcome benefits, Acasti is reassessing its clinical strategy and may put a primary and first focus on the severe hypertriglyceridemia population.
 
da seguire la chiusura....buona sopra 0.91
 

Allegati

  • acst.png
    acst.png
    30,7 KB · Visite: 154
voglia di scendere esaurita, ha consolidato sopra le sma 10 e 20 e i volumi di ieri in deciso aumento lasciano presagire un prossimo strappo....okkio
 

Allegati

  • acst.png
    acst.png
    72,3 KB · Visite: 146
okkio al rimbalzone....la discesa è stata notevole e il rimbalzo potrebbe essere l'opposto....0.96 livello cruciale da superare in chiusura.
 
700mila pezzi scambiati, a 1.13 sono in pari :wall:
spero se qualcuno mi ha seguito che sia riuscito ad entrare sui minimi,
cmq se gli insider sono entrati tra 1.16/1.18 resto fiducioso, deve bucare la cloud per puntare come primo target la sma200
 

Allegati

  • acst.png
    acst.png
    75 KB · Visite: 112
Indietro