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Recent Biotech Bankruptcies/Liquidations/Dissolutions
[Added GHSI.]
*Emerged from bankruptcy as FCSC.
iHub
Company Date Reference
ACOR 4/24 #msg-174156166
ADLS 5/11 #msg-62813901
AFFY 6/14 #msg-103663749
AGIX 1/09 #msg-35019458
AKAO 4/19 #msg-148227772
ALNA 9/22 #msg-169875553
ALPIX.PA 11/23 #msg-173275218
ALTU 11/09 #msg-43509933
AMB.TO 8/09 #msg-40145970
AMPE 4/24 #msg-174111257
ANSV 1/10 #msg-45161615
ARAV 1/24 #msg-173646720
ARDM 2/19 #msg-146903332
ARLZ 8/18 #msg-142824112
ARNI 12/17 #msg-137120846
ARTE 12/08 #msg-33895436
ASLN 7/24 #msg-174767930
ASP.TO 1/23 #msg-171046860
ATHX 1/24 #msg-173589749
ATNX 5/23 #msg-171913749
AXLA 12/23 #msg-173374718
BAXS 11/14 #msg-108147336
BCART.BR 9/23 #msg-172903024
BIND 5/16 #msg-122328088
BIOA 5/18 #msg-140549553
Biolex 7/12 #msg-77324773
BPUR 7/09 #msg-39629524
BTTX 3/24 #msg-174037486
BVTI‡ 3/13 #msg-85440257
CALA 1/23 #msg-170898055
CBIO 6/22 #msg-169273606
CDAK 3/23 #msg-171544942
CJB.TO 7/10 #msg-52557510
CHKT 12/08 #msg-33949508
CLSC 8/09 #msg-40685152
CLVS 12/22 #msg-170599077
CRXT 9/22 #msg-170229149
CWBR 11/23 #msg-173138450
DCGN 11/09 #msg-43629379
DDXS 6/16 #msg-123229557
DMK 2/24 #msg-173773814
DMTK 6/24 #msg-174619409
DNDN 11/14 #msg-108004147
DXTR 12/17 #msg-136829445
Egenix 1/15 #msg-109921347
EIGR 4/24 #msg-174151841
ENDP 8/22 #msg-169707980
Epix† 7/09 #msg-39900524
EPRS 7/16 #msg-123687350
EYES 6/20 #msg-156388471
FRTX 9/23 #msg-172854853
GHSI 10/24 #msg-175165048
GMDA 3/24 #msg-174125313
GNCA 5/22 #msg-168957883
GNTA 8/12 #msg-78123007
GTOP 9/08 #msg-32249160
GTRX 8/24 #msg-174921040
HEMA 4/12 #msg-74167597
HGEN 7/23 #msg-172432338
HSTO 9/23 #msg-172847239
IGXT 5/24 #msg-174439828
ILIU 7/17 #msg-133264435
IMMG 8/17 #msg-134305213
IMNP 2/19 #msg-146936897
IMV 5/23 #msg-171814610
INFI 10/23 #msg-172941539
Inspiration 10/12 #msg-81024196
INSY 6/19 #msg-149302493
Introgen†† 12/08 #msg-33947783
Isolagen* 6/09 #msg-38746197
KBIO 12/15 #msg-119489701
KLDO 4/22 #msg-168491485
KV.A 8/12 #msg-78203130
LBPS 6/22 #msg-169255625
LHDX 2/22 #msg-171275021
LIAN 2/24 #msg-173835088
LMDX 12/23 #msg-173530663
MACK 2/24 #msg-173845049
MBRK 4/10 #msg-49658072
MBVX 3/19 #msg-151985211
MIIS 11/08 #msg-33720220
MIPI 12/10 #msg-57646943
MLNT 12/19 #msg-153074747
MNK 10/20 #msg-158843178
MRV.TO 3/23 PR link
NBSE 3/24 #msg-174119874
NEXI 11/23 #msg-173152495
NMTI 4/11 #msg-62251315
NMTR 7/23 SEC link
NOVN 7/23 #msg-172361873
NRGX 3/12 #msg-73415156
NRX 5/16 #msg-122331475
NSTG 2/24 #msg-173773766
NVDL 2/17 #msg-128923029
NVIV 2/24 #msg-173755991
NVLN 1/20 #msg-153111867
NVTA 2/24 #msg-173844970
OBSN.SW 2/24 #msg-173937364
ODT 3/21 #msg-162706983
ONCR 6/23 #msg-172037432
ONCS 6/23 #msg-172145325
OREX 3/18 #msg-139213097
ORPH 3/22 #msg-168169591
OSCI 7/09 #msg-39511719
OTIC 12/22 #msg-170737355
PEAR 4/23 #msg-171639648
PHAS 10/22 #msg-170272758
PLXP 4/23 #msg-171677346
PROMO.ST 10/23 #msg-173007859
PTX 2/19 #msg-146937356
PYMX 4/13 #msg-86313192
PZRX 12/17 #msg-136794351
QTNT 12/22 #msg-170676963
RCPI 8/16 #msg-127560117
REX 11/08 #msg-32189097
ROKA 8/17 #msg-133945967
ROSG 6/18 #msg-141797330
RUBY 2/22 #msg-171270235
RVALL 1/20 #msg-153358221
RVLP 10/23 #msg-173007859
RXPC 7/14 #msg-104103329
SGYP 12/18 #msg-145394802
SIEN 2/24 #msg-173834941
SIGA 9/14 #msg-106313111
SIOX 12/22 #msg-170699458
SNNA 9/19 #msg-151196707
SPHS 5/20 #msg-155712447
SRGA 6/23 #msg-172201878
SRNE 2/23 #msg-171193757
SVNT 10/13 #msg-92997648
TCON 7/24 #msg-174837632
TDLP 6/11 #msg-64744114
TLCV 12/09 #msg-44751578
TMBR 11/23 #msg-173254229
TOMDF 12/23 #msg-173490278
TPPH 2/08 #msg-26765260
VBIV 7/24 #msg-174836196
VION 12/09 #msg-44654555
VLRX 2/20 #msg-153741993
VRA 10/07 #msg-18053275
VRAY 7/23 #msg-172361873
VVUS 7/20 #msg-156752080
ZSAN 6/22 #msg-169035970
GHSI is dissolving—liquidating dividend ~$3.25/sh:
https://www.globenewswire.com/news-release/2024/10/01/2956250/0/en/Guardion-Health-Sciences-Announces-Adoption-of-Plan-of-Dissolution-and-Liquidation-Appointment-of-Interim-President-and-CEO.html
The cover article in Barron's also had some very interesting comments on the obesity market and specifically manufacturing costs. (or at least what they have been so far). In the next month or so, I will have a lot to say about manufacturing in this space and specifically what VKTX is or could be doing to reduce capital fixed cost AND variable ongoing manufacturing costs. Especially key comments is that no one saw this success coming and what the timing/costs of a new plant are (or were).
Of course if neutritional issues, genectic factors, and pharmacological side effects that cause obesity were handled by real science obesity would probably be a nonexistant issue....
... ignore this at your own risk.
Barron's has a cover article on pharma stocks - https://www.barrons.com/articles/healthcare-biotech-pharma-stocks-roundtable-dcb49100?mod=past_editions
Among the interesting quotes are:
Hopefully it's for a large sum to be paid to $ENTA.
CAPR - huge move on news of filing for DMD - https://finance.yahoo.com/news/capricor-therapeutics-announces-intent-file-120000203.html
Roche sees Carmot obesity drugs' potential peak sales at $3.6B+: report
Sep. 30, 2024 11:25 AM ET3 Comments
Roche (OTCQX:RHHBY) said Monday that three obesity and diabetes drug candidates acquired through its takeover of Carmot Therapeutics have the potential to generate over $3.6B in combined annual sales, according to a report.
The three candidates were identified as CT-388, CT-996 and CT-868. Roche said it sees the combined potential sales of the products at more than CHF 3B, or around $3.6B. It added that it sees at least seven of its drugs in development having potential peak sales of more than CHF 3B, according to Reuters.
Roche made the comments in connection with its 2024 Pharma Day. A presentation of its R&D activities was posted on its website early Monday.
The Swiss drugmaker acquired Carmot for $2.7B in January.
https://seekingalpha.com/news/4154563-roche-sees-carmot-obesity-drugs-potential-peak-sales-at-4b-report
Hmm... PFE is selling ~$3.6B of HLN stock—according_to Bloomberg:
https://finance.yahoo.com/news/pfizer-pare-back-haleon-stake-163608433.html
RVNC
SAVA loves to skew data
Their CUNY scientist, Wang, has been charged with several federal crimes
Enanta Pharmaceuticals Gains Buy Rating on Strong Clinical Results for EDP-323 - September 26, 2024
In a report released today, Roy Buchanan from JMP Securities reiterated a Buy rating on Enanta Pharmaceuticals (ENTA – Research Report), with a price target of $22.00.
Roy Buchanan has given his Buy rating due to a combination of factors surrounding Enanta Pharmaceuticals’ promising clinical trial results and the potential of their drug candidate, EDP-323. The Phase 2a challenge trial for EDP-323 showcased significant viral load reductions that are competitive with, if not superior to, other similar treatments, which were also reflected in substantial symptom improvements compared to placebo. Buchanan’s confidence is also bolstered by the safety profile of EDP-323, which displayed no serious adverse events, suggesting a favorable risk-reward balance for the drug.
Additionally, Buchanan’s optimism is fueled by the strategic decisions of Enanta Pharmaceuticals to continue with the current dosing strategy in upcoming trials, given the high drug levels achieved relative to the effective concentration. The anticipation for further clinical data from the pediatric trial of zelicapavir adds to the positive outlook, as it could further validate the company’s approach. Enanta’s development plans are robust and not dependent on a single study outcome, indicating a strong commitment to advancing their treatment options for respiratory syncytial virus (RSV).
https://markets.businessinsider.com/news/stocks/enanta-pharmaceuticals-gains-buy-rating-on-strong-clinical-results-for-edp-323-1033802172
VKTX catalyst watch- The first week in November should be very important as we will get additional phase 1 data on oral VK2735 at Obesity Week (doses of 60mg, 80mg and 100mg/day top line info plus info on lipids, etc. on the smaller dose to 40mg). Top line data for the higher doses should show more AEs and higher weight loss but pk data is more important in my view. Other competing compounds in the space will undoubtedly providing additional updates as well and that has moved the VKTX considerably. In the distant past , competitive updates have moved VKTX noticeably lower when big pharma and others just released top line weight loss data, however in the last month or so as competing compounds progress and release more AE data, Viking has moved up nicely.
In addition to Obesity Week in Nov., we will get 3rd Q Earnings after the close Oct 23rd approximately 2 weeks earlier. Lots of progress updates (maybe timing/design on ph3 for VK2735 or CDMO partner update or could hear positive VK2809 news with regard to ph3 trial design/partner interest.)
Some chance we will get data on VK0214 for the Ph1 trial on the rare disease X-ALD with earnings. This trial has taken an excessively long time to enroll which I consider to be a bad sign but there does not appear to be any expectations here so the downside is limited. (I'd be a buyer on any dip as the value in this stock is almost entirely VK2735 in obesity.) On the other hand, positive news on VK0214 could drive the valuation noticeably higher.
I'm expecting some increased volatility very near term. (Options premiums are very high on this stock.)
Yes thx for pointing that out . They also have the Kidney Act now in the Senate IIRC
BMEA—The stock has rebounded to 11% below its closing price on 6/6/24—before the announcement of the FDA clinical hold (#msg-174556998). I do not follow the stock closely, but it seems reasonable for a small deficit to persist relative to the 6/6/24 closing price insofar as the safety problem that caused the clinical hold could conceivably resurface at some point.
ARDX can thank the US Supreme Court for undoing the "Chevron" doctrine. Without that, ARDX would not have stood any chance of prevailing, IMO (#msg-174813047).
BMEA...any thoughts on the lifting of clinical hold on BMF-219 in Type 2 and Type 1 Diabetes Trials?
https://finance.yahoo.com/news/fda-lifts-clinical-hold-bmf-180000898.html
Global_market_for AMD drugs_expected_to_grow_from_$10.5B_(2024)_to $17.4B (2029), according to market-research firm:
https://www.prnewswire.com/news-releases/amd-drugs-market-to-hit-usd-17-37-billion-by-2029-with-10-7-cagr--marketsandmarkets-302260905.html
Mufaso,thanks for pointing out the details on BIOA in your prior posts. Very much appreciated, your indepth analysis on the obesity stocks has always been very helpful.
novicetrader- I've posted here on muscle loss prevention multiple times on this board including on Azelpag specifically. I'm not saying there is anything nefarious going on with BIOA. Everyone should come to their own conclusions and invest according to their own goals and risk tolerance.
For reference please see #msg-174123601 where I commented at length on muscle loss prevention from multiple companies. As a specific comment on Bioage I said in that message:
Maybe the data does make some think it would means more cash burn as they will now need to push 323 trials as well
But if that’s the reason, it’s just silly IMO
More options should make the program more valuable not less
That should be a criminal matter not just a civil complaint.
The Securities and Exchange Commission or SEC, announced Cassava Sciences its founder and former CEO, Remi Barbier, and its former Senior Vice President of Neuroscience, Dr. Lindsay Burns, will pay more than $40M to settle charges related to misleading statements made in September 2020 about the results of a Phase 2 clinical trial for the company's purported therapeutic for the treatment of Alzheimer's disease...According to the SEC's order, Wang received information that unblinded him to some aspects of the Phase 2 clinical data, which he used to identify about a third of the patients enrolled in the trial. In a blinded clinical trial, to avoid bias in the results, no one involved in the trial knows the treatment assignment of individual patients, including whether the patient received a placebo or an active dose of the therapeutic. Using information that unblinded him to aspects of the trial data, Wang was able to manipulate the data to create the appearance that the drug had caused dramatic improvements in biomarkers associated with Alzheimer's disease, such as total tau and phosphorylated tau, which are common indicators of neurodegeneration in Alzheimer's patients. The order also finds that Wang knew Cassava would disclose the manipulated data when announcing the results of its Phase 2 clinical trial, and Cassava did in fact publicize the data in a press release and investor deck issued on September 14, 2020. The SEC's related civil complaint alleges that Cassava and Burns misled investors with claims that the Phase 2 trial was conducted in blinded conditions, even though Wang had been unblinded.
Read more at:
https://thefly.com/n.php?id=3989496
I got some BIOA in A/H in the 18.60s. Your sarcasm might be warranted 😀, they did indeed smartly word their release with all the right verbiage!They seem legit though, they are partners with Eli Lilly & their management credentials look good. So thought I'd dip my toes for a few.Will see how it goes.
Thanks for the detailed rather informative information. It wasn’t what I expected.
…. it was much more.
Again, thanks,
Ian
Dewophile,
Thanks for the correction. I thought that 938 showed symptom relief but not at statistically significant levels. I think I got mixed up with the 938 trial on healthy adults.
Big implications tho for FULC ...enrollment in their P1 sickle cell trial likely to increase with results mid 2025
RA Capital now owns close to 20% of the Co
In all seriousness yes. There is a competitor with a similar MOA that is reporting results one quarter behind. Good results here may mean ENTA's lead compound may come under competitive pressure and force ENTA's hand to advance this compound as well, adding to the cash burn
Of course the worst outcome would have been for these challenge results to not look good and the competitor's to look better - that is pretty much off the table. VL dropped about as fast as it could, and symptoms in healthy patients were about what they were for ENTA's lead compound which seems to have a ceiling effect in healthy patients despite better virology
The problem with the market reaction is that ENTA's lead drug is over a year ahead of any real competitor, there may be no added benefit of somewhat better virologic effects for most patients in the clinic, and they can always move this latest compound forward alone and or in combination to always keep pace
This is a long answer to say the added cash burn if they advance this compound could easily explain the market reaction
Does that explain why ENTA traded below $10.50 this morning?
Better than EDP-938!
ENTA—CC slides_for EDP-323 phase-2 challenge study:
https://ir.enanta.com/static-files/dff51245-4767-47ff-a0b2-0eab26135627
The Bioage (BIOA) press release is remarkable. They managed to mention(key buzzwords bolded) that they had:
-an upsized offering that raised $227 million if you do the math
-had multiple product candidates including one for obesity
-Works by "targeting the biology of human aging"
-their drug was "well tolerated" for 265 individuals in EIGHT Phase 1 trials
-going to phase 2 with tirzepatide
-"improve weight loss"
-had a 10 day trial where muscle quality and improved metabolism were observed
Wow. They can address aging (really like this idea!!!), weight loss, muscle quality, have conducted eight trials already, works with tirzepatide, are really safe cause management said so and you know the drug is successful because over a whopping 10 days they observed good results. Was this trial was double blind placebo controlled?). I'm sure everyone in the 10 day study looked better or maybe younger hence they could claim to work by targeting aging. I can only imagine what they would have raised had they used been using generative AI in some way to discover new drugs or enhance their effectiveness.
Please excuse the above sarcasm, as the drug may actually work. I have no idea but apparently some bought in. However, I don’t find their press release to provide a compelling case.
https://share.newsbreak.com/8ymt2atg?s=i16
Gilead product recall
Enanta's EDP-323 meets Phase 2a endpoints in respiratory syncytial virus
Enanta Pharmaceuticals announced positive topline results from a Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus - RSV -. These data demonstrated that EDP-323 was generally safe and well-tolerated and achieved an 85-87% reduction in viral load area under the curve - AUC - by qRT-PCR, a 97-98% reduction in infectious viral load AUC by viral culture, and a 66-78% reduction of total clinical symptoms score AUC vs. placebo. EDP-323, which received Fast Track designation from the FDA, is a novel L-protein inhibitor in development as a once-daily oral treatment for RSV. EDP-323 demonstrated a rapid and sustained antiviral effect. EDP-323 demonstrated favorable pharmacokinetics, supportive of once-daily dosing. Overall, EDP-323 demonstrated a favorable safety profile over a 5-day dosing period and through 28 days of follow-up. Adverse events were similar between EDP-323 dosing groups and placebo. There were no serious adverse events, no severe adverse events, and no adverse events leading to treatment discontinuation or study withdrawal.
Read more at:
https://thefly.com/n.php?id=3988864
JNJ
https://endpts.com/jj-folds-cardiovascular-and-metabolic-drug-unit/
BIOA IPOs 12.65M* shares @$18.00:
https://www.globenewswire.com/news-release/2024/09/26/2953430/0/en/BioAge-Labs-Announces-Pricing-of-Upsized-Initial-Public-Offering.html
Fortunately, PFE’s acquisition of GBT is not a total bust. PFE still has GBT-601 (a/k/a Osivelotor), which is in a phase-2/3 trial (https://www.clinicaltrials.gov/study/NCT05431088).
PFE- Withdrawing OXBRYTA from the market. Pfizer acquired Oxbryta as part of its $5.4 billion takeover of Global Blood Therapeutics (GBT), which closed in October 2022. The drug had $328 million in 2023 full year sales and was one of the places PFE was looking to for growth. (Original Peak sales estimates were for $2B)
Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease Treatment OXBRYTA® (voxelotor) From Worldwide Markets
Thanks so obviously some patients have still not seen resolution off drug (yet?)
Nothing here is a deal breaker to get to market IMO, but certainly could have implications commercially. It's possible intermittent dosing could alleviate some of these AEs without much drop off in efficacy if the AEs reverse faster than mast cells replenish
CLDX says, “Most events were grade-1, mechanism-related, and expected to be reversible” [emphasis added; from slide #14 from slide set linked in #msg-175137124]. So, it sounds like reversibility is in question to some degree.
was it reversible? if so not as big a deal IMO
It's odd that THRD is not tanking, but the ability to fine tune the dose with an oral drug must be off setting the on target tox here
The hair-color changes tell us that skin hypopigmentation, which is harder to mask cosmetically, is apt to be an issue for this drug.
The devil is going to be in the details. If things like hair color are mild and reversible and not a primary cause of dropout then perahps not a big deal
PBO adjusted dropout rate was 9%. I view this as disappointing because with such good efficacy you would think patients would want to stay on study through some AEs. Of course if you are in a CR for many months already and drop out towards the end then that is somewhat mitigating
looks like the Q4 week regimen had less AEs than Q8 weeks so if this is indeed the regimen that emerges as best then a negative for CLDX
*I do think this opens the door for oral drugs because of the fast on off to manage AEs in general so mildly bullish for THRD, BPMC and ENTA despite the AE concerns related to the target (so perhaps why THRD etc are relatively flat and not down along w CLDX now)
I will have to listen to the cc at some point
CLDX—(-20%)—reports phase-2 CSU data_for barzolvolimab—25%_dropout_rate_and hair-color changes _in_6_patients:
https://finance.yahoo.com/news/celldex-therapeutics-presents-landmark-52-144500144.html
CC slides (slide #6 contains AE info):
https://ir.celldex.com/static-files/104cb8ec-550b-42d3-aef6-3c9d9c9d9fdb
p.s. ENTA is pursuing small-molecule treatments for CSU.
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