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Hulskof
0
quote:

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...
Wall Street Trader
0
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 Unchanged

PRICE 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.
Vaak wel
0
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.
Chasse_Patate
0
quote:

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.
Derwing
0
quote:

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.
Hulskof
1
quote:

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... ?
galaking
0
Vinden jullie Ionis pharmaceuticals interessant als belegging? Ze hebben een flinke pijplijn deels in eigen beheer en deel gepartnerd .
Wall Street Trader
0
@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.
Derwing
0
quote:

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.
Wall Street Trader
0
quote:

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.
de tuinman
0
quote:

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.
Derwing
1
quote:

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.
Phill
1
"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.
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