BioPharma« Terug naar discussie overzicht

1. [verwijderd] 29 juni 2008 23:46

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   Ach Henks, het had niets met jou te maken, maar ik wilde symbolisch een nieuwe pagina beginnen.
   
   Nog even en de laatste insurgents zijn door de moderator opgeruimd.
   
   P.
2. [verwijderd] 7 oktober 2008 10:16

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   Staat ook erg laag deze.
3. Ortega 4 november 2014 15:43

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   finance.yahoo.com/q?s=AEZS
   
   Aeterna Zentaris' product, Macrilen™, for use in the evaluation of adult growth-hormone deficiency ("AGHD"). A New Drug Application ("NDA") for Macrilen is currently under review by the FDA, with a Prescription Drug User Fee Act ("PDUFA") date of November 5, 2014.
   
   ==>
   www.prnewswire.com/news-releases/aete...
   
   If AEZS had any doubts they wouldn't be launching a sales force Nov 17th. Smart move not wasting any time to get the drug to the market. PPS will only go up from here. Macrilen can be used to test all the retired football players to see if they are deficient in HGH from traumatic brain injuries also war veterans would be a large market as well as car crash victims and any accidents with head trauma. Since this would be the only oral test available Macrilen should get at least 90% of the market. AEZS has worldwide rights for Macrilen
   
   ==>
   
   About Macrilen™ (macimorelin)
   
   Macimorelin, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. The Company has completed a Phase 3 trial for use in evaluating AGHD, and a NDA in this indication for macimorelin, under the trade name Macrilen™, is currently under review by the FDA with a PDUFA date of November 5, 2014. Macrilen™ has been granted orphan drug designation by the FDA for use in AGHD. Furthermore, macimorelin is in a Phase 2 trial as a treatment for cancer-induced cachexia. Aeterna Zentaris owns the worldwide rights to this novel patented compound.
   
   MACRILEN: A niche product
   Aeterna filed a new drug application (NDA) in November 2013 for MACRILEN to be used in the evaluation of AGHD. The company reported that the FDA is conducting a substantive review of the NDA. If approved (PDUFA date 5 November 2014), Aeterna plans to launch the product into a $40-80m US market (our estimate is based on company data) with a c 20-person sales team in H115.
   
   ==>
   
   Valuation: Upside remains
   Aeterna’s EV (including shares from exercising stock options and warrants) of c $50m is relatively modest for a company with a product in NDA and another in Phase III development.
   
   Cash and cash equivalents totaled $39.6 million as at June 30, 201. Strong cash. Working capital only $20 million and FDA pending. Green light next week we should move $3-$5. Cheapest biotech stock
   
   ==>
   also Aeterna Zentaris' product
   
   About EstroGel® www.estrogel.com/what-is-estrogel
   
   EstroGel® 0.06% (estradiol gel) is an FDA-approved, estrogen therapy ("ET") gel and the only non-patch transdermal ET that provides relief for two major problems due to menopause: moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar/vaginal atrophy. EstroGel® is marketed in over 70 countries and is the most prescribed estrogen product in Europe, as well as the most prescribed transdermal estrogen product in Canada. Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). For full prescribing information and boxed warning, please see www.estrogel.com.
4. Ortega 5 november 2014 16:30

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   +17% nu op verhoogde outlook analyst. Approval vandaag (?) nog niet geheel duidelijk nu.
   
   Maxim Group analyst Jason Kolbert reiterated a Buy and bumped his price target on AEterna Zentaris (NASDAQ: AEZS) price target of $6.00 (from $5.00) as the company is ready for launch.
   
5. Ortega 6 november 2014 14:46

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   en weer een Biotec investering die je jaren moet aanhouden voor enigszins wat rendement.. pff :
   
   Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the “Company”) today announced that the Company has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application (“NDA”) for MacrilenTM (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (“AGHD”). Based on its review, the FDA has determined that the NDA cannot be approved in its present form.