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Lol, Please keep enthusiasm low , still trying to sell some naked Puts and for a minute $2 was offered out by PHLX trader but pulled it as the ticker breached $25( after breaking to $24.90) ..haha
Lmaooooo
There will be 50 Oct. $22.5 Puts offered out @ $2 if the ticker hits sub $26 if anybody would like to buy them?? Long term bullish, but it’s become a Mmkr / hedge play until substance*
Still haven’t had the ‘chill’ barbecue with 2
injectors due to crappy PB County weather But still will try( more info than most care , lol) … irrespective of recent weakness, continue to believe Daxx is superior to competitor’s and bought more @ $26.5 this a.m
*>$…..fill in the blanks ;)
2 approved Drugs, Priority review and Pdufa date in Q4 on Sickle Cell, and this pig can’t move out of the sloppp!! Wtf
Prob sold off bcuz Auth. shares doubling and near term Capital raise again!! Dilution should be in its corporate name!! Certainly in its DNA
bluebird bio Announces FDA Priority Review of the Biologics License Application for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events
Mentioned: BLUE
--PDUFA date set for December 20, 2023
bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review. Lovo-cel is a potentially transformative one-time gene therapy for individuals living with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events (VOEs). It is specifically designed to treat the underlying cause of SCD through the addition of a functional gene that enables production of anti-sickling adult hemoglobin and is the most deeply studied gene therapy in development for this disease. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.
Dice Therapeutics Rallies As It Agrees To Be Bought By Lilly -- MarketWatch
Mentioned: DICE LLY
Dice Therapeutics Inc. (DICE) stock is up by 40% in premarket trades Tuesday after it agreed to be purchased by Eli Lilly & Co. (LLY) for $48 a share in a deal that values the immunology company at about $2.4 billion. The price values Dice at a 40% premium over the 30-day, volume-weighted average trading price of its stock as of June 16. "We're eager to see our pipeline, including our oral IL-17 inhibitors, DC-806 and DC-853, benefit from Lilly's resources and global reach and I'm excited by the prospect of watching these two talented teams in a united quest for scientific innovation," said Dice CEO Kevin Judice. Lilly stock is down 0.2% in premarket trades.
About to take a starter position, any input from board ( either way) appreciated:)
Great Refresher link, TY :) …keep eyes on BLUE—bla was sub’d 4/24 or so, expect over next week to hear yay or nay on Acceptance and/ or fast track ( 6mos. For pdufa date) or 10mos. If not ( key being accepted) … if denied, delay of prob 6mos-1yr!!! They burn crap load of cash, so an equity raise a certain… downside $2, upside could go parabolic to Double digits (24% shorties)
For sure, climbing steps and with a deep pipe bench/ late stage(s), readouts in Q3/4 could propel to the $5 target (Needham) GLTA
You guys are entertaining, please don’t stop til the ticker hits $1.00 :)
Excellent summation, thanks for print !! :)
One of the better( if not best) Conference calls with GS analyst and Mark/ Dustin..encourage all to listen for own analysis, but it flowed nicely, and uplifting relative to recent performance of share price..GLTA
Vin,
This was to be a New Post, not reply to your last commentary :)
LMAO! Oops
Let’s see how Foley spins next week:
Goldman Sachs 44th Annual Global Healthcare Conference
Chief Executive Officer Mark J. Foley and President Dustin S. Sjuts are scheduled to participate in a fireside chat on Monday, June 12, 2023, at 8:40 A.M. PDT, in Dana Point, California.
Same! Of the 2 injectors, one Is the ‘paid trainer’, so need to decipher facts from $alary..
For sure! Mainly I’ll be listening for how many peeps served, Units administered, location on face, duration (avg.)/side affects/outcome….I am aware the owner of Institute also got injected and is pleased to date.. but the purchasing Mgr. Is the one that makes the final decision I’ve been ‘told’( as to whether to promote other toxins) …pricing will also be of interest.. if anybody has other Q&A, please share before next week..
Will do my friend..
Should be a relaxed environment as my girlfriend and I have our barbecue and cocktail party and hopefully ‘loose lips’ will reveal real-time data :) ….you’re more than welcome to join , lol
Morning! Without going into detail at this point( don’t have enough direct info from 2 injectors, just 2nd hand )…I will ‘grill’ them next week, but the jest of it is that clients that been injected since December/Jan( PrevU), are not pleased with results to date…can’t mention practice, but prob largest* in Palm Beach County..
*Aesthetics, both fillers and Botox, etc.
*HHr- abbreviation for Happy Hour :)
Regardless, I continue to build position prior to Q2 release.. will reassess after Pdufa & ramp progress/traction
Evidently the Palm Beach snobs are not so happy with results to date ( part of prevue)..so after 5mos., will update after Hhr with 2 Injectors next week :(
Good luck today, prosperous trading!
TY! And I sorta made this reply on Forza thread( by mistake), so here it is on this one:
And good luck with this play, hopefully J.Visconti delivers for y’all ! :) ….somebody I know :)
Take a look at TARA( bio- low float, $90m in cash..under $3 … 3 or so drugs in pipe
And good luck with this play, hopefully J.Vis delivers for y’all ! :)
Saw that, and bought AH @ $1.15 and bought more this a.m @ 1.14….I think anything under $1.5 gets you a double to 3x….also, if other firms cover like:
Mereo BioPharma Group Price Target Maintained With a $5.00/Share by Needham
Perhaps 5x???
Bear Raid!
Dew,
Having followed Kevin( Tang Cap,
Et al) and been in a few takeouts, he’s been very active lately filing 13g’s, 4, etc..he’s a former banker/ sell side over
The years and expect he see’s opportunities especially with market caps under $500mm..I’m definitively not trying to pump BLUE, but he took ~4.7% postion recently and with BLA submitted for Sickle Cell( and 2 other drugs approved), wouldn’t be surprised to see 13g/a’s…
Dew, more consolidation:
Gastrointestinal drug maker Ironwood Pharmaceuticals said Monday it was acquiring Swiss biotech company VectivBio, adding to the increasing line of biopharma acquisitions this year.
The all-cash transaction for $17 a share totals an estimated $1 billion, net of VectivBio's (ticker: VECT) cash and debt. Ironwood (IRWD) tumbled 1% in premarket trading, while VectivBio was up 40% at $16.68.
The deal helps Ironwood expand its pipeline of drugs that can advance the treatment of gastrointestinal diseases, the companies said.
FYI:
Hepion Pharmaceuticals' Phase 2 'ALTITUDE-NASH' Trial Achieves Primary and Secondary Endpoints, Including Improvement in Liver Function and Multiple NASH Biomarkers
Mentioned: HEPA
GlobeNewswireMay 22, 2023
- Improvements in physiologic liver function and key NASH biomarkers including ALT, ProC3, PIIINP and ELF -
- Results reinforce rencofilstat's direct antifibrotic mode of action; increases confidence for reductions in fibrosis in ongoing Phase 2b 'ASCEND-NASH' paired biopsy trial -
If we can get this PR , should move high single digits.. then sell off on Capital raise, then double digits!! Otherwise, down she goes to $2-3ish!
• The Company anticipates BLA acceptance of lovo-cel for SCD in Q2 2023.
8K filing couple days ago showing $350mm shelf dinging ticker
JM, thought long and hard about reply and almost posted $position$, but better senses kicked in!!! Of course would like to see ramp in q1, but ok with Q2/3 … if no traction, bye bye to ~15k in shares @ avg. cost of $26.45…oops, my bad :)
GLTA
Ditto! Q2/3 more meaningful, so Q1 may offer an opportunity to Continue to build :)
In it , to win it in 2024/25+
Thanks, and appreciated :)
We’ll find out soon
Revance to Release First Quarter 2023 Financial Results on Tuesday, May 9, 2023
Conference Call Scheduled for Tuesday, May 9, 2023 at 4:30 p.m. ET.
Diabetes and Eli Lilly reports booming 1Q sales of its diabetes drug Mounjaro, and discloses new clinical data that could pave the way for Lilly to market the drug for obesity. Quarterly sales were $568.5M, while some analysts had predicted less than $400M. The new study showed Mounjaro helped Type 2 diabetes patients who were also overweight or obese lose up to 15.7% of body weight. The new data could lead to US regulatory approval of Mounjaro's use in weight loss by the end of the year, which would help Mounjaro's competitive position against Novo Nordisk's diabetes/obesity franchise that includes Ozempic and Wegovy.
Between affirming buy rating (Mereo BioPharma Group Price Target Maintained With a $5.00/Share by Needham) and interim data soon( Orbit study), Mkt makers keeping It above $1 ( we need 20consec days to stay on Nasdaq I think) .. also, company said in recent release —- ‘In line with previous guidance by the Company, Mereo is exploring potential partnerships to fund the Phase 3 study’…
We shall see, GLTA
We’ve done movements today! :)
FYI
bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events.
The severity of sickle cell disease, and its impact on patients and caregivers, has been underappreciated and overlooked for far too long. Transformative therapies for this community are long overdue," said Andrew Obenshain, chief executive officer, bluebird bio. "We are pleased to have satisfied the Agency's questions about comparability to enable our BLA submission, and to take this important step toward making lovo-cel available for individuals living with SCD."
Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease. The BLA submission is based on efficacy results from 36 patients in the HGB-206 Group C cohort with a median 32 months of follow-up and two patients in the HGB-210 study with 18 months of follow-up each. The BLA submission also includes safety data from 50 patients treated across the entire lovo-cel program, including six patients with six or more years of follow-up.
The FDA previously granted lovo-cel orphan drug designation, fast track designation, regenerative medicine advanced therapy (RMAT) designation, and rare pediatric disease designation for the treatment of SCD.
Plus a new 13g filing last week :)
FYI
bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events.
The severity of sickle cell disease, and its impact on patients and caregivers, has been underappreciated and overlooked for far too long. Transformative therapies for this community are long overdue," said Andrew Obenshain, chief executive officer, bluebird bio. "We are pleased to have satisfied the Agency's questions about comparability to enable our BLA submission, and to take this important step toward making lovo-cel available for individuals living with SCD."
Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease. The BLA submission is based on efficacy results from 36 patients in the HGB-206 Group C cohort with a median 32 months of follow-up and two patients in the HGB-210 study with 18 months of follow-up each. The BLA submission also includes safety data from 50 patients treated across the entire lovo-cel program, including six patients with six or more years of follow-up.
The FDA previously granted lovo-cel orphan drug designation, fast track designation, regenerative medicine advanced therapy (RMAT) designation, and rare pediatric disease designation for the treatment of SCD.
Thanks for the info Bio, and NO to the private comment asked :)
Simply trying to help a friend that possibly is having trouble conceiving, and more to the point, an Investor and knows I’m usually placing funds in biotechs and this IHUB is a great source of knowledge
(Appreciated by everyone’s Input)..
Thx for heads up on Medcity newsletter!
‘Top women’s fertility companies
Women’s fertility services have experienced a recent influx of investment, culminating in Progyny’s 2019 IPO’
. Read more about the STARTUP’s that are likely to make waves in 2020..
Appreciated, Thank you! Will do some research today and learn more about Progyny( ~3b Mkt cap)…encouraging!
its a fertility benefits management company. ‘The Company specializes in fertility’ and family-building benefits solutions in the United States’. Pretty sure this fits the bill for friend..TIA