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Besides Crsp/Vertex Sickle Cell indication, Bluebird has Pdufa date on 12/20…they are updating Data @ASH
Anybody follow ticker??
bluebird bio to Present New and Updated Data from Gene Therapy Programs in Sickle Cell Disease and Beta-Thalassemia at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition
Mentioned: BLUE
--Updated long-term efficacy, safety, quality of life data and iron management outcomes from adult and pediatric patients with transfusion-dependent beta-thalassemia (n=63) treated with beti-cel through 9 years of follow-up (n=1) will be delivered in two poster presentations
bluebird bio, Inc. (Nasdaq: BLUE) today announced that new long-term efficacy, safety and health-related quality of life (HRQoL) follow-up data from its lentiviral vector (LVV) gene therapy programs in patients with sickle cell disease who have a history of vaso-occlusive events and patients with beta-thalassemia who require regular red blood cell transfusions will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will take place December 9-12, 2023 at the San Diego Convention Center and online.
bluebird bio to Present New and Updated Data from Gene Therapy Programs in Sickle Cell Disease and Beta-Thalassemia at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition
Mentioned: BLUE
--Updated long-term efficacy, safety, quality of life data and iron management outcomes from adult and pediatric patients with transfusion-dependent beta-thalassemia (n=63) treated with beti-cel through 9 years of follow-up (n=1) will be delivered in two poster presentations
bluebird bio, Inc. (Nasdaq: BLUE) today announced that new long-term efficacy, safety and health-related quality of life (HRQoL) follow-up data from its lentiviral vector (LVV) gene therapy programs in patients with sickle cell disease who have a history of vaso-occlusive events and patients with beta-thalassemia who require regular red blood cell transfusions will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will take place December 9-12, 2023 at the San Diego Convention Center and online.
Same here, kinda wish I had some dry powder post CC regardless of Up/down action!! Picked some up Sub $9’s, as well as > $30’s, lol…and IN Between like many of US…As long as TEOX is a buyer down here, they are soaking up Tax-loss harvesters and shorties probably cover regardless outcome( we all guessing at this point until Guidance, but doubt Foley will give much color on that subject)! GLTA
Good guess , but history shows this company burns cash, and ~$103mm could help if approved…they will still come to market for raise, but hopefully at higher levels, especially if Sickle Cell approved..
FYI:
FDA panel greenlights approval of first human drug using CRISPR
Food and Drug Administration (FDA) advisers cleared the way for the first FDA approval of a human drug using CRISPR technology.
The news: FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee said exa-cel, the sickle cell gene therapy developed by BIO members Vertex Pharmaceuticals and CRISPR Therapeutics, is safe for clinical use.
Revance Therapeutics, Inc. (RVNC) today announced that the company will release third quarter 2023 financial results on Wednesday, November 8, 2023, after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on the same day to discuss the results and provide a corporate update.
Revance Therapeutics, Inc. (RVNC) today announced that the company will release third quarter 2023 financial results on Wednesday, November 8, 2023, after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on the same day to discuss the results and provide a corporate update.
Lmao,
Down ~17% with volume !! Hmmm/ ATM $$
Sweet, and more readouts on other P2/3 in pipeline
Think your phone is upside down, turn it around…lol
:)
Yes, I recall ID web and your message, thanks for refresher :)( this specifically was ‘operating’ I get it…*~$585mm updated high end
Let’s see SG&A from Q3 when released.
Q2** showed ~64% increase over Q2( 2022) and I realize they added (employees) sales/ Marketing, other but with roughly $315mm cash +$50mm note, burn in 2024* will no doubt cause need for raise***( as perhaps expected, but with share price 2/3 lower, major dilution unless we recover next year)!
** Selling, general and administrative
77,384 Q2-2023
47,847 Q2-2022
***excludes any potential collaboration with Therapeutic partner
Again, grasping at straws of frustration, it helps my anxiety by lashing out at Mgmt!!
Freakin’ Drunken sailors!!! Still plsses me off!!
Revised 2023 GAAP and Non-GAAP operating expense guidance to reflect the company's exit of the
OPUL® payments business:
• GAAP operating expenses updated from $460 million - $480 million to
$545 million - $585 million
Agreed, and having been around markets for 50+ years, seen this movie before unfortunately, but in long run it has worked out, and with decent Balance sheet and prospects, I believe this will have better days and continue to soak up ( albeit minuscule) shares that are On Sale..Also, having a very good Dr. Friend who runs the Largest aesthetics institute in South Florida and who has used Daxxi during Prevue( wasn’t pleased with duration or cost to his clients) ( nor did I share what I learned from his 2 injectors several mos. back, my bad, sorry All- which wouldn’t have mattered anyway) He is pleased with new strategy and is in the market adding ( north of $ seven figures ) .. if I learn more, will share this time around ;) GLTA
Any Number is possible at this juncture until they report Full ( or pre announce Revs as many co’s are doing currently)
True:
An earnings blackout period is when insiders are prohibited from trading company stock before and after quarterly or annual financial results are released. “This period typically lasts from the end of the fiscal quarter until one or two days after the company publicly announces its earnings”.
Still, they had opportunities in Sept., prior to Qtr close.. remain positive,
Just frustrated.. GLTA
Yes,
August/Sept several Form 4 sales of psa grants as well 10b’s Set up for auto sales..It doesn’t mean they must, they can pause if they felt the need to!! Very disappointing especially while we ‘supporters’ are buying their shares! Up to ~25k @ avg. $28 or so hurts ( hopefully temporary) until 2023 ends…and Q1 2024 will be almost 1yr since
Launch ( with refined pricing and marketing) so traction, or lack of, will determine the course of managements abilities to steer this Ship!
Launch of Therapeutic(s) in Q1 should be catalyst , but given their performance on Aesthetics, we shall see..will continue to buy seeing the overall Bio space is under pressure
Quite disappointing that we’re not seeing any insider purchases, perhaps somewhat telling of how management feels the quarter & the year closes out! Still buying shares here in the single digits, but almost tapped out!
This post doesn’t change anything, other than publicly expressing my frustration with Mgmt and BOD! Better days ahead I truly believe, so patience will need to be a virtue :)
FWIW:
Morgan Stanley analyst Terence Flynn maintains Revance Therapeutics (NASDAQ:RVNC) with a Equal-Weight and lowers the price target from $25 to $12.
Starter position down here, mid $15’s…don’t follow company, but sell side folks seem
To give them more time to develop
Readouts in q1/2024…also:
Akero's cash, cash equivalents and short-term and long-term marketable securities for the period ended June 30, 2023 were $658.9 million.
Akero believes that its current cash, cash equivalents, short-term and long-term marketable securities will be sufficient to fund its current operating plan into 2026.
Spot on Denn!! Actually spent more time ‘reading’ their faces( no pun) to sniff out BS when replies( especially from Sell side Analysts)!! Was prob best presentation by company , et Al….in it thru 2025 at minimum,
GLTA
Personally I would be very disappointed and surprised if Management doesn’t file form 4’s with open market purchases! Long term nothing really changed negatively, and in fact have improved..been buying in 11’s $12’s( not that my opinion matters, but my 2cents)
Key Corporate Updates
Real-world feedback reinforces DAXXIFY’s differentiated performance profile and continued opportunity for long-term, broad-based adoption.
New pricing program for DAXXIFY®, which became effective September 1, 2023, positions the product to be priced competitively to Botox® Cosmetic for the provider, to further accelerate market share expansion.
Expects long-term supply chain strategy to support U.S. DAXXIFY® adjusted gross margin of over 80%.
Continued confidence in blockbuster potential in U.S. aesthetics product portfolio.
Provides update on DAXXIFY® cervical dystonia PrevU program and commercial launch plans, early feedback from payers and market access dynamics.
Exiting OPUL® payments business by the end of Q1 2024 to prioritize capital allocation and streamline operations. Expects to free up approximately $20 million a year for reinvestment in DAXXIFY® aesthetics and therapeutic commercial launches.
The company provides additional updates to its 2023 financial guidance:
With current cash, cash equivalents, and short-term investments of $319.7 million as of June 30, 2023, and the additional $50 million in notes funded through Athyrium Capital in August 2023, the company is funded to breakeven and expects to be Adjusted EBITDA positive in 2025.
Expects to provide product revenue guidance in first half 2024.
Q3 2023 product revenue has the potential to be around Q2 2023 levels based on the recent roll out of the new pricing program and traditional seasonality in facial injectables.
Revised 2023 GAAP and Non-GAAP operating expense guidance to reflect the company’s exit of the OPUL® payments business:
GAAP operating expenses updated from $460 million – $480 million to $545 million – $585 million.
Non-GAAP operating expenses updated from $320 million – $340 million to $315 million – $335 million.
Non-GAAP research and development expenses updated from $80 million – $90 million to $75 million – $85 million.
Agreed, and the ‘Street’ must be reading this thread ( j/k, but somewhat serious)
Sold the Oct. 22.5 strike( $2 Puts), so I assume it’ll get exercised unless Sept. Inv. Day is ‘well received’ considering what everyone has been suggesting over last few days( IE- strategy change/‘failed launch’ bad news already in stock price)…
Regardless, been buying in small tranches high teens( some today as well)..in it for long haul, believe Foley will right the Shit( wooops, SHIP)!! :) GLTA
Fwiw: (10b5-1)
Check this box to indicate that a transaction was made pursuant to a contract, instruction or written plan for the purchase or sale of equity securities of the issuer that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c). See Instruction 10.
1. Name and Address of Reporting Person*
Moxie Dwight
(Last) (First)
C/O REVANCE THERAPEUTICS, INC
2. Issuer Name and Ticker or Trading Symbol
Revance Therapeutics, Inc. [ RVNC ] 5. Relationship of Reporting Person(s) to Issuer
(Check all applicable)
X Officer (give title below) (specify below)
SVP, GC & Secretary
3. Date of Earliest Transaction (Month/Day/Year)
09/05/2023
X Form filed by One Reporting Person
Form filed by More than One Reporting Person
3. Transaction Code (Disposed Of (D)
Amount/Price
Common Stock 09/05/2023 S(1) 23,853 D $17.8141(2) 55,066 D
Common Stock 09/06/2023 S(1) 11,000 D $17.064(3) 44,066 D
Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned
(e.g., puts, calls, warrants, options, convertible securities)
1. Title of Derivative Security (Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Transaction Date (Month/Day/Year) 3A. Deemed Execution Date, if any (Month/Day/Year) 4. Transaction Code (Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D)
Explanation of Responses:
1. The sales reported in this Form 4 were effected pursuant to a Rule 10b5-1 trading plan dated June 05, 2023 by Mr. Moxie.
2. The price reported in Table 1, Column 4 is a weighted average price. These shares were sold in multiple transactions at prices ranging from $17.44 to $18.20. Mr. Moxie undertakes to provide to the Issuer, any security holder of the Issuer, or the staff of the Securities and Exchange Commission, upon request, full information regarding the number of shares sold at each separate price within the range.
3. The price reported in Table 1, Column 4 is a weighted average price. These shares were sold in multiple transactions at prices ranging from $16.80 to $17.52. Mr. Moxie undertakes to provide to the Issuer, any security holder of the Issuer, or the staff of the Securities and Exchange Commission, upon request, full information regarding the number of shares sold at each separate price within the range.
Remarks:
U.S. FDA Approves First Therapeutic Indication for Revance's DAXXIFY(R) (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia
Mentioned: RVNC
--- Approval expands the DAXXIFY(R) label to include efficacy data over the 52-week ASPEN repeat dose clinical study.
--- DAXXIFY(R) for cervical dystonia is the first and only peptide-formulated, long-lasting neuromodulator, designed to meet the needs of patients seeking improved treatment outcomes.(2-5)
--- 88% of U.S. cervical dystonia patients experience symptom reemergence eight to 10 weeks after conventional neuromodulator treatment.(6)
Press Release: Revance to Release Second Quarter 2023 Financial Results on Tuesday, August 8, 2023
Revance Therapeutics, Inc. (RVNC), today announced that the company will release second quarter 2023 financial results on Tuesday, August 8, 2023, after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on the same day to discuss the results and provide a corporate update.
Individuals interested in listening to the conference call may do so by dialing (888) 330-3637 for U.S. and Canadian callers, and reference conference ID 5680588 or from the webcast link in the investor relations section of the company's website at: www.revance.com.
Good, now I started a small position, will avg. down on next pump, lol
Appreciate, and I also heard CNBC mention similar earlier..not playing it, almost did though premarket ( 7am it traded down to Low $50ish, was just going to D/T flip )
I read your thread on subject, TY!!
Perhaps the 10b5-1 sale last week, but must be something more..new Deck perhaps, but 8k is usually filed ( presentation not until e.o.m) …guess we shall see
Anybody following Apls…down ~$30+ pre-m?? Nothing on sec.gov
Apellis Announces Seven Abstracts Accepted for Oral Presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting
Mentioned: APLS
GlobeNewswireJuly 10, 2023
New 30-month data from the GALE long-term extension study of SYFOVRE(R) (pegcetacoplan injection) to be presented
WALTHAM, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that seven abstracts will be presented as oral presentations at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting to be held July 28 to August 1 in Seattle. The upcoming data further reinforces the efficacy and safety profile of SYFOVRE(R) (pegcetacoplan injection), the first and only treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Probably see more if this:
Recursion Gets $50 Million Investment From NVIDIA
Mentioned: RXRX
By Chris Wack
Recursion said Wednesday it received a $50 million investment by NVIDIA, which was executed as a private investment in public equity.
The company also said it plans to accelerate development of its AI foundation models for biology and chemistry, which, in collaboration with NVIDIA, it intends to optimize and distribute to biotechnology companies using NVIDIA cloud services.
Recursion said it plans to use its proprietary biological and chemical dataset, which exceeds 23 petabytes and 3 trillion searchable gene and compound relationships, to accelerate the training of foundation models. NVIDIA will also help optimize and scale Recursion foundation models using its full-stack computing expertise.
Recursion expects to use this software to support its internal pipeline as well as its current and future partners.
Recursion was up 31% to $8.90 in premarket trading.
Appreciate and 100% concur with scenario(s)!
Written naked a few times now, and all expired worthless..wouldn’t mind getting assigned, hold for a bit, and then sell covered calls if position gets to ‘over-weight’….mgmt been hiring at a pretty good pace over last 30days
(~14 varied positions — Relatively speaking) ~200-500 current employees* ….not sure if that means anything or not, but my LinkedIn alerts me when sponsored post …
*example*
Associate Director, Analytical Operations
Revance
RUNC
Newark, CA (On-site)
Reposted 1 week ago • 21 applicants
& $162,000/yr - $210,100/yr (from job description) • Full-time • Mid-Senior level
• 201-500 employees •
Biotechnology Research
:: See how you compare to 21
applicants.
E Skills: Hands-on Technical
Leadership, Regulatory Submissions, +8 more
GLTA
Went out a little further (Oct.$22.5) And got 50 puts sold @ $2…if exercised, owning shares at adjusted cost of ~$20.5 is quite palatable. IMHO
Interesting tidbits:
From AI to Obesity Drugs - Global Pharma Has $700B For M&A and Investments: Goldman Sachs
Benzinga 2023-07-07T13:18:00-04:00
Goldman Sachs compiled research suggesting the global pharmaceutical sector has approximately $700 billion available for M&A and investments.
This significant financial reserve will be crucial as patents for some of the industry's blockbuster drugs are on the expiration cliff.
The pharmaceutical industry is experiencing strong interest in M&A due to anticipated revenue erosion of approximately $200 billion by the end of the decade.
The latest examples include Astellas Pharma Inc (OTC:ALPMY) acquiring American firm Iveric Bio Inc (NASDAQ:ISEE) for $5.9 billion, Pfizer Inc (NYSE:PFE) proposing a $43 billion acquisition of Seagen Inc (NASDAQ:SGEN), GSK plc (NYSE:GSK) agreeing to acquire BELLUS Health Inc (NASDAQ:BLU) for $2 billion, and Merck & Co Inc (NYSE: announcing to acquire Prometheus Biosciences Inc (NASDAQ: RXDX) for $10.8 billion.
Obesity drugs are generating significant investor enthusiasm, with forecasts suggesting a total addressable market exceeding $100 billion.
Promising developments in Alzheimer's, gene therapy, and other therapeutic modalities were discussed at the conference, indicating substantial innovation and scientific progress in these areas.
The healthcare sector had a challenging start to 2023, recording one of the worst first-half performances in three decades. Factors contributing to this include regulatory & growth concerns, macroeconomic rotations, and investor preference for large-cap technology stocks. Sentiment within the sector remains cautious.
The application of AI and machine learning in healthcare remains an area of interest. Companies are witnessing the positive impact of these technologies on their businesses.
Despite the general caution, there are pockets of optimism. Management teams across various healthcare verticals reported strong Q2 procedure volumes, and in the investor survey, medical devices were identified as the most likely area to outperform.
Consumer-facing healthcare segments also demonstrated positivity, with robust demand and continued patient traffic recovery. The biopharma sector shows promise with promising innovation trends.
Policy and regulatory uncertainties emerged as a key concern in several presentations. The Inflation Reduction Act and its impact on drug pricing created various uncertain outcomes.
Post-pandemic normalization trends continue to pose challenges for life sciences, tools, and managed care companies, which were beneficiaries during the pandemic.
Photo by Sharon McCutcheon on Unsplash
Thanks Dew, was just throwing darts at a few beaten down Big Pharma’s ( $ cost avg.) except for Lilly which has been almost ‘parabolic’(~40%) last several weeks …
AstraZeneca (ticker: AZN) said in a news release Monday that its drug, datopotamab deruxtecan, compared well to a competitor, docetaxel, in terms of its ability to slow down the progression of lung cancer. However, "for the dual primary endpoint of overall survival (OS), the data were not mature," the company said.
(like your highlight states, ‘not mature data’) but leaves door open for opportunity after ~10% hit today…
However, the company remained optimistic. Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, said the results provide powerful evidence of the role the drug can play in treating lung-cancer patients.
AstraZeneca Lung Cancer Treatment Meets Dual Primary Endpoint in First Phase 3 Trial Results
AstraZeneca said its treatment for lung cancer met one of its dual primary endpoints in the first batch of results for a Phase 3 trial.
The Wilmington, Del.-based pharmaceutical company said patients with locally advanced or metastatic non-small cell lung cancer in its Tropion-Lung01 Phase 3 trial showed a statistically significant improvement in progression-free survival when treated with the drug datopotamab deruxtecan, compared with the current standard of care chemotherapy.
AstraZeneca said the drug's safety profile was consistent with previous trials, and no new safety signals were identified. The company could not yet evaluate whether the trial would continue and whether the trial met its other primary endpoint of overall survival.
Datopotamab deruxtecan, an antibody therapy, was developed by AstraZeneca and Japanese healthcare company Daiichi Sankyo.
AstraZeneca shares fell 5.8% to $67.40 pre-market trading Monday.
Can someone take
My $22.50’s , only 50 @ $2?? :)
At least Siox ceo takes my call, and listens to my ‘pitch’ on R/M with private Bio….$~45 cash
Post liquidation !
Safe to assume UnInvestable until ( if at all) investigation is complete:
“The timing of the Company’s marketing application and prospects for regulatory approval of BXCL501 for the acute treatment of agitation associated with dementia in patients with probable Alzheimer’s disease may be adversely impacted by these developments. For example, even if the Company’s investigation and the independent audit conclude that data from the TRANQUILITY II trial have not been affected or compromised by the principal investigator’s actions or other deficiencies at the trial site, the FDA may not accept or agree with the Company’s conclusions or analyses, or may interpret or weigh their importance differently. Further, if the Company or the FDA determines that there are issues with data integrity and/or compliance with good clinical practice requirements at the trial site, the Company may be unable to use some or all of the subject data generated at this clinical site to support a marketing application. If all or a substantial portion of such data were discarded, the TRANQUILITY II trial may no longer be adequately powered for statistical significance and the Company may need to conduct a new clinical trial. If the Company conducts a new Phase 3 trial, such trial may have different safety or efficacy results from the topline data the Company is announcing today”…
To bad, results looked promising
Maybe 1 more breach of $25
Could do it, but OI only 11 contracts so might be difficult unless…. Also , chose October
( post Pdufa/Q2 #’s) ..IV pretty decent @ ~ 60
GLTA