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GRTS—(-48%)—adds insult to injury with a warrant-laden financing immediately following yesterday’s clinical failure (#msg-174154327):
https://finance.yahoo.com/news/gritstone-bio-announces-pricing-32-030000199.html
This is something you don't see very often.
VERV—(-38%)—halts enrollment in phase-1b trial:
https://finance.yahoo.com/news/verve-therapeutics-announces-updates-pcsk9-110000434.html
TSLA has much further to fall, IMO. If the SEC, which is currently investigating TSLA's accounting, finds evidence of fraud, look out below. Moreover, it's inevitable that China is going to put the squeeze on when they decide they don't need TSLA anymore.
ONTX reverse-merges with—(private)—Trawsfynydd Therapeutics:
https://www.globenewswire.com/news-release/2024/04/02/2855799/0/en/Onconova-Therapeutics-Inc-and-Trawsfynydd-Therapeutics-Inc-Announce-Business-Combination-to-Form-Traws-Pharma-Inc-a-Best-in-Class-Virology-and-Oncology-Company.html
FDA approves ABT’s TriClip device for repair tricuspid heart valve:
https://finance.yahoo.com/news/abbott-receives-fda-approval-triclip-130000245.html
EW is the only other company with a similar device.
FDA approves ABT’s TriClip device for repair tricuspid heart valve:
https://finance.yahoo.com/news/abbott-receives-fda-approval-triclip-130000245.html
EW is the only other company with a similar device.
SHEL pulls back on—(unrealistic)—decarbonization goals:
https://finance.yahoo.com/news/shell-oil-revises-climate-goals-220000675.html
SHEL pulls back on—(unrealistic)—decarbonization goals:
https://finance.yahoo.com/news/shell-oil-revises-climate-goals-220000675.html
Recent Biotech Bankruptcies/Liquidations/Dissolutions
[Added ACOR and EIGR.]
*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
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
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
GMDA 3/24 #msg-174125313
GNCA 5/22 #msg-168957883
GNTA 8/12 #msg-78123007
GTOP 9/08 #msg-32249160
HEMA 4/12 #msg-74167597
HGEN 7/23 #msg-172432338
HSTO 9/23 #msg-172847239
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
SCLX 2/23 #msg-171193757
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
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
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
ACOR files for bankruptcy—drug portfolio bought by Merz (subject to approval by the bankruptcy court):
https://www.businesswire.com/news/home/20240401939079/en
GUTS—I’ll be astonished if this device works as advertised:
https://www.globenewswire.com/news-release/2024/04/01/2855050/0/en/Fractyl-Health-Receives-FDA-IDE-Approval-for-the-Revita-Remain-1-Pivotal-Study-of-Weight-Maintenance-in-Obesity-after-Discontinuation-of-GLP-1-Based-Drugs.html
STKH implements 1:10 reverse split, LOL:
https://www.prnewswire.com/news-releases/steakholder-foods-announces-ads-ratio-adjustment-302104528.html
GRTS—(-40%/AH)—reports purportedly-positive interim phase-2 data:
https://www.globenewswire.com/news-release/2024/04/01/2855416/0/en/Gritstone-bio-Announces-Positive-Preliminary-Progression-free-Survival-and-Long-term-Circulating-Tumor-DNA-ctDNA-Data-from-Phase-2-Portion-of-Ongoing-Phase-2-3-Study-of-its-Persona.html
GRTS—(-40%/AH)—reports purportedly-positive phase-2_data_for colorectal-cancer vaccine:
https://www.globenewswire.com/news-release/2024/04/01/2855416/0/en/Gritstone-bio-Announces-Positive-Preliminary-Progression-free-Survival-and-Long-term-Circulating-Tumor-DNA-ctDNA-Data-from-Phase-2-Portion-of-Ongoing-Phase-2-3-Study-of-its-Persona.html
Dilution from the redemption of warrants:
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001837607/000183760724000017/aeon-20240329x8k.htm
SOLV begins trading on NYSE following completion of spinoff from 3M:
https://finance.yahoo.com/news/solventum-begins-trading-york-stock-103000676.html
FDA clears ABT’s 15-minute test for TBI/concussion:
https://finance.yahoo.com/news/abbott-receives-fda-clearance-whole-130000849.html
Note: This is not the hand-held diagnostic ABT is developing to give TBI results from a simple finger prick (#msg-172397644).
FDA clears ABT’s 15-minute test for TBI/concussion:
https://finance.yahoo.com/news/abbott-receives-fda-clearance-whole-130000849.html
Note: This is not the hand-held diagnostic ABT is developing to give TBI results from a simple finger prick (#msg-172397644).
You could well be right. We'll know more when they go public.
FDA clears ABT’s 15-minute test for TBI/concussion:
https://finance.yahoo.com/news/abbott-receives-fda-clearance-whole-130000849.html
Note: This is not the hand-held diagnostic ABT is developing to give TBI results from a simple finger prick (#msg-172397644).
Actually, all but two of the insider buys in #msg-174141720 were from 2017 and later. But the earlier purchases were not irrelevant—they showed LG's confidence in turning the company around.
CLF—The initial several years of LG’s tenure was devoted to cleaning up the mess created by the old management team: terminating the chromite project, shutting down the money-losing Quebec mines, selling the Australian mines before they ran out of ore, and getting out of the coal business. If LG had not been hired in 2014, CLF would almost certainly have gone bankrupt in fairly short order.
In short, you can’t properly evaluate what LG has done to enhance shareholder value by using 2014 as a starting point.
The simple answer is that Dr. Kaiser was working for OCUL less than 50% of the time. Rather than be in violation of an employment covenant, he renegotiated the contract.
Thanks—good to know!
Contracting for 100% of a supplier’s API, rather than a specified quantity, is a dangerous thing to do. It almost begs for a lawsuit from a competitor, a consortium of buyers, or the FTC.
An FDA breakthrough designation does not entitle the manufacturer to a period of marketing exclusivity, as far as I know. Maybe you are thinking of an FDA Orphan Drug designation, which confers 7 years of marketing exclusivity.
Thanks. The word, "circuit" refers to the dialysis loop, right?
TEVA sues AMRN for_alleged cornering of Vascepa API:
https://www.fiercepharma.com/pharma/teva-follows-suit-after-hikmas-2023-complaint-arguing-amarin-locked-drug-ingredient-supply
Housekeeping reminder—A link to the latest version of Mufaso's compilation on oral weight-loss drugs resides in the shaded box at the bottom of the main screen for the Biotech Values message board. (The link is immediately below the one for Biotech Buyouts/Premiums.)
CLF—To fully grasp value proposition of this stock, you have to recognize how monomaniacal the CEO, Lourenco Goncalves is at generating value for shareholders. LG owns ~$120M of CLF stock, and he has regularly purchased shares on the open market or held shares after exercising options.*
The single sentence in #msg-174061258 (in reply to jbog’s post of a disparaging WSJ piece) encapsulates my view of LG’s leadership.
*Form-4 filings:
#msg-171786873
#msg-165544918
#msg-162362326
#msg-154279025
#msg-149308747
#msg-134694391
#msg-131068048
#msg-122513056
#msg-114015543
Questions about TLPH:
Is nafamostat intended only for ICU dialysis, or for dialysis in general?
How is nafamostat superior to other anticoagulants used in dialysis?
Why is the FDA treating TLPH's nafamostat as a device rather than a drug?
TIA
Aardvark Therapeutics—(private)—has_dual-acting_small-molecule weight-loss drug_in_phase-2:
https://www.ft.com/content/e3c4130d-494d-4f69-b5fe-81833f88caed