Ontvang nu dagelijks onze kooptips!
word abonnee
sluiten ✕
Terug naar discussie overzicht
Waar beleggen jullie nog meer in
Volgen
Derwing schreef op 7 maart 2024 10:51 :
Eindelijk loopt Aquestive wat op. Ik blijf het nog wel even aanhouden, teveel potentie in mijn ogen om nu al te verkopen. Baal er wel van dat ik niet flink heb ingeslagen toen het nog onder de $2 stond :(
Lang geleden, Derwing! Goed dat je er nog bent, ik heb je bijdragen gemist. Idem wat AQST betreft: Ik hou ze ook aan én heb ook verzaakt extra in te slaan. Heb m'n centen in AFMD gestopt en dat loopt vooralsnog totaal verkeerd...
Another setback of 3 months for Zevra (NASDAQ: ZVRA). For long time shareholders including myself, these couple of years this position has been a letdown. By the way the street thinks the FDA will likely approve Arimoclomol. Aquestive Therapeutics (AQST) is also finally seeing strong momentum, which will likely continue into 2024. Here is the latest analyst rating for ZVRA.Canaccord Genuity Biotechnology | Company Update Our glass is half-full on 3-month push-out of action date on acrimoclomol to 9/21; Reiterate BUY, $24 PT ZVRA-NASDAQ | Price US$6.22 | Market Cap US$216.0M BUY UnchangedPRICE TARGET US$24.00 Unchanged Weakness presents an opportunity to BUY into action date, other catalysts This morning, ZVRA announced that the FDA has extended the action date on its pending filing for arimoclomol for Niemann-Pick Type C (NPC) by three months to 9/21/24. Recall the company had resubmitted the filing on 12/27/23. We subsequently viewed the quick turnaround by the FDA on accepting the filing on 1/8/24 and issuing an action date with priority review of 6/21/24 as boding well for the filing. With the caveat that it is difficult to second guess what the FDA might eventually do, we are optimistic that the modest 3- month delay of the action date also bodes well for the pending filing. Specifically, we are encouraged by the fact pattern here. First, given this was a resubmission, FDA had ample chance to refuse to file or to not turn around as quickly as it did, or could issue a complete response letter (CRL) on its original timeline. Second, the company has responded to all requests for information in a highly timely manner so far. Third, the FDA has not requested any new clinical data in any of the interactions that ZVRA has had on the resubmission. We confirmed points two and three in our follow-up with management earlier today. Separately, while the circumstances in each case are likely to be very different, we note the FDA has issued several 3-month extensions that have led to timely approvals on/ around the new action dates especially when unmet need in the underlying indications is high. For these reasons, we view today's weakness on the 3-month push out of the action date on arimoclomol for NPC as an opportunity to BUY this significantly undervalued and under-followed stock. In addition to a potential Advisory Committee meeting (AdCom) and action on the NDA, we await Phase 2 data for KP1077 for idiopathic hypersomnia (IH) in 1H24, and a read on the ongoing launch of Olpruva for urea cycle disorders (see here). Reiterate BUY. Some interesting tidbits from government/FDA documents The Code of Federal Regulations (21 CFR Sec. 314.60 here) is clear that major amendments also apply to resubmissions of new drug application (NDA) filings. In addition, the FDA's CDER 21st Century Review Process Desk Reference Guide states the following on deciding whether to extend the review cycle by 3 months after a major amendment: "This decision should be based, in part, on whether the amendment has the potential of bringing the application into condition for approval. If there are deficiencies that cannot be addressed by the amendment, the division should generally defer review of the amendment until a subsequent review cycle without extending the review clock." see page 31 here for details. Prior FDA draft guidance, e.g., pg. 5 of the 2018 document and pg. 16 of the 2005 document is also consistent with this philosophy.Recent 3-month extensions have mostly led to timely approvals We performed a quick search of filings that were subject to 3-month action date extensions by the FDA. While our list of ~20 filings (mostly 2019+) is not comprehensive, we found most products were approved, while two had complete response letters (CRL); see Table 1 (pgs.2-3). We will be watching pending filings with action dates prior to 9/21/24 closely for any counterintuitive FDA rulings.No change to model; we still assume a 2025E arimoclomol launch We include arimoclomol for NPC at an unchanged 60% probability of approval with a potential launch in 2025E and peak unadjusted sales of $302mn in 2034E. We still believe our probability of approval assumption is conservative for a product with an issued action date. We also include KP1077 in idiopathic hypersomnia (IH) and narcolepsy at a 15% probability of approval each, with assumed launches in 2027 and 2028E, respectively. For Olpruva (UCD), which ZVRA is launching currently, we estimate peak sales of $174mn in 2034E, which we view as conservative. Our unchanged DCF-based price target of $24 represents ~285% potential upside from current levels.
Update bij Seelos. Staat voorbeurs op min 45%. Vind persoonlijk de uitslag van het onderzoek zo slecht niet. While the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set (FAS)2, by showing a 13% improvement in Function and Mortality with an 88% success probability (versus the pre-specified 98%), it showed a potential signal of efficacy in a pre-specified subgroup (ERF)1.
Vaak wel schreef op 19 maart 2024 13:57 :
Update bij Seelos.
Staat voorbeurs op min 45%. Vind persoonlijk de uitslag van het onderzoek zo slecht niet.
While the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set (FAS)2, by showing a 13% improvement in Function and Mortality with an 88% success probability (versus the pre-specified 98%), it showed a potential signal of efficacy in a pre-specified subgroup (ERF)1.
Seelos is wel mooi gedachtenvoer voor iedereen die erover denkt om in BIO te gaan beleggen. Vorig jaar zomer nog 50 dollar, daar is nu 99% vanaf. Sterkte aan iedereen die hier inzit.
Hulskof schreef op 7 maart 2024 11:32 :
[...]
Lang geleden, Derwing! Goed dat je er nog bent, ik heb je bijdragen gemist.
Idem wat AQST betreft: Ik hou ze ook aan én heb ook verzaakt extra in te slaan. Heb m'n centen in AFMD gestopt en dat loopt vooralsnog totaal verkeerd...
Ha Hulskof, goed om te zien dat je er nog bent. Ik mis de discussies en gedachtewisselingen van enkele jaren geleden wel. Aqst heeft helaas door een aandeeluitgifte want ingeleverd, maar ik blijf er volop vertrouwen in hebben. Zie je Affimed nog goedkomen? Ik zal er eens induiken, wellicht iets voor een klein beetje spreiding. Zevra heeft me teleurgesteld maar ik blijf matig positief over de toekomst.
Derwing schreef op 22 maart 2024 09:36 :
[...]
Ha Hulskof, goed om te zien dat je er nog bent. Ik mis de discussies en gedachtewisselingen van enkele jaren geleden wel.
Aqst heeft helaas door een aandeeluitgifte want ingeleverd, maar ik blijf er volop vertrouwen in hebben. Zie je Affimed nog goedkomen? Ik zal er eens induiken, wellicht iets voor een klein beetje spreiding.
Zevra heeft me teleurgesteld maar ik blijf matig positief over de toekomst.
Tja, Affimed is intussen een grote gok geworden, maar ik zit daar met behoorlijk wat aandelen te kijken. Ik heb m'n positie op 50 en 60 cent nog zelfs verdubbeld omdat ik nog altijd geloof in hun product(en). De CEO heeft er lange tijd een potje van gemaakt, maar is intussen buitengezet samen met de helft van het personeel. Affimed zet m.i. in op een overname. Nu is het wachten op data van AFM13 met NK-cellen van Artiva (welke zeer waarschijnlijk goed zullen zijn, want AFM13 met NK's van MD Anderson hebben dat reeds aangetoond) en verdere rijping van AFM24 met PDL1. Het bedrijf noteert onder kaspositie, dus wie nu instapt lijkt goede zaken te kunnen doen. Mijn GAK zou ik nog wat verder naar beneden willen hebben, maar de positie is al onverantwoord groot voor mij, dus daar ben ik voorzichtig mee. Misschien als de shorts de koers tot de 3 weten te drukken, maar of het zover komt... ?
Vinden jullie Ionis pharmaceuticals interessant als belegging? Ze hebben een flinke pijplijn deels in eigen beheer en deel gepartnerd .
@Derwing / Phill / Hulskof / Altviolist / Chasse_Patate and others have you read the latest 10-K filing from Zevra (NASDAQ: ZVRA) ?Going Concern Company is able to restructure the amounts outstanding on its margin loan facility, we may be required to repay the loan and thereby deplete the cash available to fund our operations. If this occurs, our forecasts reflect a shortfall in cash available for operations as early as mid-2024. While the Company expects to obtain the necessary financing that is needed, there is no assurance that the Company will be successful in obtaining the necessary funding for future operations. These factors raise substantial doubt as to the Company’s ability to continue as a going concern for at least one year from the date these financial statements are being issued. The financial statements do not include any adjustments that might result from the outcome of these uncertainties.See Page 112 below investors.zevra.com/static-files/8856... Don't be surprised if there comes another dilution and share offering. Time will tell but even this new Board of Directors haven't been able to create shareholder value.
Wall Street Trader schreef op 3 april 2024 13:46 :
@Derwing / Phill / Hulskof / Altviolist / Chasse_Patate and others have you read the latest 10-K filing from Zevra (NASDAQ: ZVRA) ?
Going Concern Company is able to restructure the amounts outstanding on its margin loan facility, we may be required to repay the loan and thereby deplete the cash available to fund our operations. If this occurs, our forecasts reflect a shortfall in cash available for operations as early as mid-2024. While the Company expects to obtain the necessary financing that is needed, there is no assurance that the Company will be successful in obtaining the necessary funding for future operations. These factors raise substantial doubt as to the Company’s ability to continue as a going concern for at least one year from the date these financial statements are being issued. The financial statements do not include any adjustments that might result from the outcome of these uncertainties.
See Page 112 below investors.zevra.com/static-files/8856... Don't be surprised if there comes another dilution and share offering.
Time will tell but even this new Board of Directors haven't been able to create shareholder value.
I've seen it. With this added uncertainty, the delay of Arimoclomol and the slow progress on Azstarys, I've decided to sell my shares for now. If it drops to about $3-4 I'll taoe another wager. I'm very disappointed in both the old and new BOD/CEO's.
Derwing schreef op 3 april 2024 15:21 :
[...]
I've seen it. With this added uncertainty, the delay of Arimoclomol and the slow progress on Azstarys, I've decided to sell my shares for now. If it drops to about $3-4 I'll taoe another wager. I'm very disappointed in both the old and new BOD/CEO's.
I'm also very disappointed to say the least. The new board doesn't seem to care and run the company as if it is their own ATM. Me and my team have reached out to them for a couple of times but it's pointless. I will not be adding any more shares, although even how the company is now managed, the stock weakness at this point is not justified. Let's hope the stock price will run-up towards the PDUFA date of Arimoclomol.
galaking schreef op 1 april 2024 19:31 :
Vinden jullie Ionis pharmaceuticals interessant als belegging? Ze hebben een flinke pijplijn deels in eigen beheer en deel gepartnerd .
Heb je hierover nog iets geleerd??? Serieuze pijplijn.
de tuinman schreef op 10 april 2024 16:47 :
[...]
Heb je hierover nog iets geleerd??? Serieuze pijplijn.
Wel al een hoge waardering, 6 miljard. Dan mag er ook wel een flinke pipeline tegenover staan.
"Don't be surprised if there comes another dilution and share offering. Time will tell but even this new Board of Directors haven't been able to create shareholder value." Yes I have seen it, basically the acquisition of Acer Therapeutics was a Hugh cashflow mistake driven by the former CEO... . I have confidence in current CEO, so certainly not selling all but expecting a dilution after Arimoclomol approval (which I consider to be at 70% to be approved). It will all come to this approval, if not approved severe dilution is required or they need to sell one of their assets (e.g. Asztarys) to sustain sufficient cash for supporting both their commercial operations as R&D expenses. I have slightly reduced my position and in general significantly reduced Biotech stock until FED starts decreasing interest rates.
Aantal posts per pagina:
20
50
100
Direct naar Forum
-- Selecteer een forum --
Koffiekamer
Belastingzaken
Beleggingsfondsen
Beursspel
BioPharma
Daytraders
Garantieproducten
Opties
Technische Analyse
Technische Analyse Software
Vastgoed
Warrants
10 van Tak
4Energy Invest
Aalberts
AB InBev
Abionyx Pharma
Ablynx
ABN AMRO
ABO-Group
Acacia Pharma
Accell Group
Accentis
Accsys Technologies
ACCSYS TECHNOLOGIES PLC
Ackermans & van Haaren
ADMA Biologics
Adomos
AdUX
Adyen
Aedifica
Aegon
AFC Ajax
Affimed NV
ageas
Agfa-Gevaert
Ahold
Air France - KLM
AIRBUS
Airspray
Akka Technologies
AkzoNobel
Alfen
Allfunds Group
Allfunds Group
Almunda Professionals (vh Novisource)
Alpha Pro Tech
Alphabet Inc.
Altice
Alumexx ((Voorheen Phelix (voorheen Inverko))
AM
Amarin Corporation
Amerikaanse aandelen
AMG
AMS
Amsterdam Commodities
AMT Holding
Anavex Life Sciences Corp
Antonov
Aperam
Apollo Alternative Assets
Apple
Arcadis
Arcelor Mittal
Archos
Arcona Property Fund
arGEN-X
Aroundtown SA
Arrowhead Research
Ascencio
ASIT biotech
ASMI
ASML
ASR Nederland
ATAI Life Sciences
Atenor Group
Athlon Group
Atrium European Real Estate
Auplata
Avantium
Axsome Therapeutics
Azelis Group
Azerion
B&S Group
Baan
Ballast Nedam
BALTA GROUP N.V.
BAM Groep
Banco de Sabadell
Banimmo A
Barco
Barrick Gold
BASF SE
Basic-Fit
Basilix
Batenburg Beheer
BE Semiconductor
Beaulieulaan
Befimmo
Bekaert
Belgische aandelen
Beluga
Beter Bed
Bever
Binck
Biocartis
Biophytis
Biosynex
Biotalys
Bitcoin en andere cryptocurrencies
bluebird bio
Blydenstijn-Willink
BMW
BNP Paribas S.A.
Boeing Company
Bols (Lucas Bols N.V.)
Bone Therapeutics
Borr Drilling
Boskalis
BP PLC
bpost
Brand Funding
Brederode
Brill
Bristol-Myers Squibb
Brunel
C/Tac
Campine
Canadese aandelen
Care Property Invest
Carmila
Carrefour
Cate, ten
CECONOMY
Celyad
CFD's
CFE
CGG
Chinese aandelen
Cibox Interactive
Citygroup
Claranova
CM.com
Co.Br.Ha.
Coca-Cola European Partners
Cofinimmo
Cognosec
Colruyt
Commerzbank
Compagnie des Alpes
Compagnie du Bois Sauvage
Connect Group
Continental AG
Corbion
Core Labs
Corporate Express
Corus
Crescent (voorheen Option)
Crown van Gelder
Crucell
CTP
Curetis
CV-meter
CVC Capital Partners
Cyber Security 1 AB
Cybergun
D'Ieteren
D.E Master Blenders 1753
Deceuninck
Delta Lloyd
DEME
Deutsche Cannabis
DEUTSCHE POST AG
Dexia
DGB Group
DIA
Diegem Kennedy
Distri-Land Certificate
DNC
Dockwise
DPA Flex Group
Draka Holding
DSC2
DSM
Duitse aandelen
Dutch Star Companies ONE
Duurzaam Beleggen
DVRG
Ease2pay
Ebusco
Eckert-Ziegler
Econocom Group
Econosto
Edelmetalen
Ekopak
Elastic N.V.
Elia
Endemol
Energie
Energiekontor
Engie
Envipco
Erasmus Beursspel
Eriks
Esperite (voorheen Cryo Save)
EUR/USD
Eurobio
Eurocastle
Eurocommercial Properties
Euronav
Euronext
Euronext
Euronext.liffe Optiecompetitie
Europcar Mobility Group
Europlasma
EVC
EVS Broadcast Equipment
Exact
Exmar
Exor
Facebook
Fagron
Fastned
Fingerprint Cards AB
First Solar Inc
FlatexDeGiro
Floridienne
Flow Traders
Fluxys Belgium D
FNG (voorheen DICO International)
Fondsmanager Gezocht
ForFarmers
Fountain
Frans Maas
Franse aandelen
FuelCell Energy
Fugro
Futures
FX, Forex, foreign exchange market, valutamarkt
Galapagos
Gamma
Gaussin
GBL
Gemalto
General Electric
Genfit
Genmab
GeoJunxion
Getronics
Gilead Sciences
Gimv
Global Graphics
Goud
GrandVision
Great Panther Mining
Greenyard
Grolsch
Grondstoffen
Grontmij
Guru
Hagemeyer
HAL
Hamon Groep
Hedge funds: Haaien of helden?
Heijmans
Heineken
Hello Fresh
HES Beheer
Hitt
Holland Colours
Homburg Invest
Home Invest Belgium
Hoop Effektenbank, v.d.
Hunter Douglas
Hydratec Industries (v/h Nyloplast)
HyGear (NPEX effectenbeurs)
HYLORIS
Hypotheken
IBA
ICT Automatisering
Iep Invest (voorheen Punch International)
Ierse aandelen
IEX Group
IEX.nl Sparen
IMCD
Immo Moury
Immobel
Imtech
ING Groep
Innoconcepts
InPost
Insmed Incorporated (INSM)
IntegraGen
Intel
Intertrust
Intervest Offices & Warehouses
Intrasense
InVivo Therapeutics Holdings Corp (NVIV)
Isotis
JDE PEET'S
Jensen-Group
Jetix Europe
Johnson & Johnson
Just Eat Takeaway
Kardan
Kas Bank
KBC Ancora
KBC Groep
Kendrion
Keyware Technologies
Kiadis Pharma
Kinepolis Group
KKO International
Klépierre
KPN
KPNQwest
KUKA AG
La Jolla Pharmaceutical
Lavide Holding (voorheen Qurius)
LBC
LBI International
Leasinvest
Logica
Lotus Bakeries
Macintosh Retail Group
Majorel
Marel
Mastrad
Materialise NV
McGregor
MDxHealth
Mediq
Melexis
Merus Labs International
Merus NV
Microsoft
Miko
Mithra Pharmaceuticals
Montea
Moolen, van der
Mopoli
Morefield Group
Mota-Engil Africa
MotorK
Moury Construct
MTY Holdings (voorheen Alanheri)
Nationale Bank van België
Nationale Nederlanden
NBZ
Nedap
Nedfield
Nedschroef
Nedsense Enterpr
Nel ASA
Neoen SA
Neopost
Neovacs
NEPI Rockcastle
Netflix
New Sources Energy
Neways Electronics
NewTree
NexTech AR Solutions
NIBC
Nieuwe Steen Investments
Nintendo
Nokia
Nokia Oyj
Nokia OYJ
Novacyt
NOVO-NORDISK AS
NPEX
NR21
Numico
Nutreco
Nvidia
NWE Nederlandse AM Hypotheek Bank
NX Filtration
NXP Semiconductors NV
Nyrstar
Nyxoah
Océ
OCI
Octoplus
Oil States International
Onconova Therapeutics
Ontex
Onward Medical
Onxeo SA
OpenTV
OpGen
Opinies - Tilburg Trading Club
Opportunty Investment Management
Orange Belgium
Oranjewoud
Ordina Beheer
Oud ForFarmers
Oxurion (vh ThromboGenics)
P&O Nedlloyd
PAVmed
Payton Planar Magnetics
Perpetuals, Steepeners
Pershing Square Holdings Ltd
Personalized Nursing Services
Pfizer
Pharco
Pharming
Pharnext
Philips
Picanol
Pieris Pharmaceuticals
Plug Power
Politiek
Porceleyne Fles
Portugese aandelen
PostNL
Priority Telecom
Prologis Euro Prop
ProQR Therapeutics
PROSIEBENSAT.1 MEDIA SE
Prosus
Proximus
Qrf
Qualcomm
Quest For Growth
Rabobank Certificaat
Randstad
Range Beleggen
Recticel
Reed Elsevier
Reesink
Refresco Gerber
Reibel
Relief therapeutics
Renewi
Rente en valuta
Resilux
Retail Estates
RoodMicrotec
Roularta Media
Royal Bank Of Scotland
Royal Dutch Shell
RTL Group
RTL Group
S&P 500
Samas Groep
Sapec
SBM Offshore
Scandinavische (Noorse, Zweedse, Deense, Finse) aandelen
Schuitema
Seagull
Sequana Medical
Shurgard
Siemens Gamesa
Sif Holding
Signify
Simac
Sioen Industries
Sipef
Sligro Food Group
SMA Solar technology
Smartphoto Group
Smit Internationale
Snowworld
SNS Fundcoach Beleggingsfondsen Competitie
SNS Reaal
SNS Small & Midcap Competitie
Sofina
Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
Sparen voor later
Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
Sucraf A en B
Sunrun
Super de Boer
SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
Tele Atlas
Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
USG People
Vallourec
Value8
Value8 Cum Pref
Van de Velde
Van Lanschot
Vastned
Vastned Retail Belgium
Vedior
VendexKBB
VEON
Vermogensbeheer
Versatel
VESTAS WIND SYSTEMS
VGP
Via Net.Works
Viohalco
Vivendi
Vivoryon Therapeutics
VNU
VolkerWessels
Volkswagen
Volta Finance
Vonovia
Vopak
Warehouses
Wave Life Sciences Ltd
Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
Wessanen
What's Cooking
Wolters Kluwer
X-FAB
Xebec
Xeikon
Xior
Yatra Capital Limited
Zalando
Zenitel
Zénobe Gramme
Ziggo
Zilver - Silver World Spot (USD)