Perhaps for people to follow the progress of the court case??

JAZZ PHARMACEUTICALS, INC. v. BECERRA et al

https://www.pacermonitor.com/public/case/49319737/JAZZ_PHARMACEUTICALS,_INC_v_BECERRA_et_al

I agree with that. RVNC likely has the manuals and policies written; but, again, they're deliberately taking it slow to ensure low rates of dysphagia and maximum clinical benefit. I would have expected a quicker roll out, though. They might utilize the same staff they have now in cosmetics for therapeutics, but I'm just guessing.

But I agree...a 2024 launch is painfully slow.

I don't think RVNC could have done the so-called "doctor training" prior to getting FDA approval for CD. They could start now, obviously. I wouldn't mind a partnership or buyout announcement, but I suspect they are going to roll it out slowly as they truly want to train providers on the proper technique to ensure maximum benefit and outcome.

Jazz Pharmaceuticals Files Complaint Against FDA for Decision on Avadel Pharmaceuticals' Lumryz

Source: Dow Jones News

By Denny Jacob

Jazz Pharmaceuticals on Thursday said its subsidiary filed a complaint alleging that the Food and Drug Administration's unlawfully approved Avadel Pharmaceuticals' new drug application for Lumryz.

The biopharmaceutical company said in a regulatory filing, which outlined their complaint, that the FDA acted outside of its authority under the Orphan Drug Act. Jazz Pharmaceuticals said its product Xywav had orphan drug exclusivity. It said that the FDA approved Lumryz's new drug application and granted it orphan drug exclusivity based on its own findings that it boosts patient care, and is therefore clinically superior to Xywav and another drug it produces, Xyrem. Both drugs treat cataplexy, or excessive daytime sleepiness, in adults with narcolepsy.

Jazz Pharmaceuticals described Lumryz as an extended-release reformulation of Xyrem.

The Ireland-based company said among the complaint's allegations are that the FDA acted without lawful basis when it determined that the dosing regimen for Lumryz makes a major contribution to patient care.

The complaint was filed in the United States District Court for the District of Columbia.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

June 22, 2023 18:44 ET (22:44 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.

They should call it quits; and I think they finally will.

$AVDL

Wanted to thank you @Biowatch for bringing this article to my attention. I read this article about $JAZZ and did some digging into $AVDL (who I never heard of) and established a position. Seemed like an undervalued company with a drug significantly better than JAZZ's drug for narcolepsy. It has done very well in the past 2+ months since you posted this and I took a position. They are entering a $3B market and should stand to take a sizeable share away from JAZZ in due course. I could see it getting bought out before that, though.

Re ENTA's patent suit against Pfizer.
Is there a timeline of when this will be heard or decided on?

I like VKTX's prospects, too, but the insiders keep up the relentless selling. Never seems to matter as the price tends to go up every day after insider sales,. It's almost a given that there will be a daily 4pm SEC filing for more insider sales.

Avadel Pharmaceuticals Announces FDA Authorization to Import Tentatively-Approved LUMRYZ™ Ahead of Anticipated Final Approval Decision

Source: GlobeNewswire Inc.?


Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its Pre-Launch Activities Importation Requests (PLAIR) for LUMRYZ.

Through its PLAIR, Avadel is authorized to import unapproved drug product into the U.S. ahead of anticipated final approval of the tentatively approved LUMRYZ NDA, to prepare for market launch. By importing LUMRYZ into the U.S. before anticipated final approval, Avadel is able to further shorten the time to product availability following a final approval decision by the FDA.

“The granting of our PLAIR request by the FDA followed the submission of our amendment requesting a final approval decision for LUMRYZ. The approval to import LUMRYZ comes at an important time for Avadel as the availability of commercial supply allows us to further shorten the timeline between a potential approval and being able to provide LUMRYZ to patients,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “We remain committed to working collaboratively with FDA to bring LUMRYZ to people living with narcolepsy.”

About LUMRYZ

LUMRYZ is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

In March 2020, Avadel completed the REST-ON study, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of LUMRYZ in patients with narcolepsy. Among the three co-primary endpoints, LUMRYZ demonstrated statistically significant and clinically meaningful results in EDS, the clinician’s overall assessment of the patient’s functioning, and reduction in cataplexy attacks, for all three evaluated doses when compared to placebo.

In January 2018, the U.S. Food and Drug Administration (FDA) granted LUMRYZ Orphan Drug Designation for the treatment of narcolepsy based on the plausible hypothesis that LUMRYZ may be safer than the twice-nightly formulation of sodium oxybate already approved by the FDA due to the ramifications associated with the dosing regimen of that product. LUMRYZ is currently under review by the FDA.

On July 18, 2022, the FDA tentatively approved the LUMRYZ NDA for the treatment of cataplexy or EDS in adults with narcolepsy. Avadel submitted a minor amendment to the FDA on March 1, 2023, requesting final approval of LUMRYZ. This minor amendment submission occurred shortly after the delisting of the REMS Patent from FDA’s Orange Book by Jazz Pharmaceuticals in response to the unanimous 3-0 panel decision by the United States Court of Appeals for the Federal Circuit on February 24, affirming the previous ruling from the United States District Court for the Federal District of Delaware, ordering Jazz to do so.

Avadel is currently evaluating the long-term safety and tolerability of LUMRYZ in the open-label RESTORE clinical study. For more information, visit: www.restore-narcolepsy-study.com.

About PLAIR

A PLAIR allows for applicants with a pending NDA, ANDA, or CDER-regulated BLA nearing an FDA application decision to request permission to import an unapproved finished dosage form drug product for reconditioning in the form of approval. FDA’s granting of a PLAIR does not represent an implicit or explicit statement of the approvability of the NDA, ANDA, or CDER-regulated BLA. Rather, PLAIR facilitates the process for importing unapproved finished dosage form products to prepare for market launch based on anticipated approval of the pending application.

About Avadel Pharmaceuticals plc

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, LUMRYZ, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of cataplexy or EDS in adults with narcolepsy. For more information, please visit www.avadel.com.

Cautionary Disclosure Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, expectations regarding the FDA’s potential final approval of LUMRYZ, including the timing of thereof; the anticipated time savings between a potential approval and commercial launch of LUMRYZ attributable to the FDA’s grant of the PLAIR; the Company’s preparation for launch of LUMRYZ (if approved); and the market acceptance of LUMRYZ (if approved). In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable).

The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, which was filed with the Securities and Exchange Commission (SEC) on March 16, 2022, and subsequent SEC filings.

Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Investor Contact:
Courtney Turiano
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
(212) 698-8687

Media Contact:
Gabriella Greig
Real Chemistry
ggreig@realchemistry.com
(203) 249-2688

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Any chance you could post the list? I am curious to see who is and isn't on the list. TIA if you can.

Correct

My assumption was that he was being sarcastic. Basically, he was throwing out a counter argument against those who would incorrectly say that Daxi was only effective for twice as long due to twice the dose, by saying if it was that simple as doubling the dose, then why wouldn't RVNC double their dose again and get a year's worth of no wrinkles.

100% agreed. It's annoying when they use it as a verb like you described as opposed to using it for financial definitions you listed above. No worries about being pedantic; that's my style, too!

Speaking of that, although more from biotech executives rather than sell-side analysts, I get so annoyed every time I hear "leverage..." In conference calls or read it in press releases. Don't know why it bothers me so much, but it's a pet peeve of mine. It's like the only verb they feel they are allowed to use in that context. Sorry, end rant.

Was it the boilerplate language they left in when they should have omitted some of the language about "departure of directors or certain officers" when there was no mention of any departure?

ITEM 5.02 DEPARTURE OF DIRECTORS OR CERTAIN OFFICERS; ELECTION OF DIRECTORS; APPOINTMENT OF CERTAIN OFFICERS; COMPENSATORY ARRANGEMENTS OF CERTAIN OFFICERS.

Re HBV injectable drugs

Definitely a bummer. I was really hoping ENTA would be able to have two-thirds of a possible functional cure for HBV. It is still early on and if they have other options in the pipeline they could hopefully get it going more quickly given this recent discontinuation. The safety issue must have been very obvious, consistent, and/or severe given the quick hook they gave it. Hopefully it isn't a class effect if they have another RNA destabilizer in the pipeline.

Interesting read on Moderna.

BTW, got your message. Can't reply until Happy Hour on Friday since I don't have paid subscription, but I'll try to reply privately on Friday or I'll post publicly on message board where you found me.

Re JNJ-3989 and JNJ-6379

JNJ-3989 is monthly subcutaneous injections with a lot longer dosing regimen (48 weeks) vs. ENTA's oral formulation, which will likely be much shorter than that. In mice, ENTA used EDP-514 for 12 weeks, achieving max 4 log reduction in HBV viral titers. In humans, EDP-514 was used for 28 days, achieving HBV RNA 2.3 log reduction in HBeAg- patients and HBV RNA 2.8 log reduction in HBeAg+ patients. I'm not sure how long ENTA will end up dosing patients with EDP-514 in the long run, though, but presumably much shorter than 48 weeks.

JNJ-3989 200mg showed a mean reduction of HBsAg of 2.6 log, whereas ENTA's small molecule HBV RNA destabilizer, EDP-721, showed a max reduction of HBsAg of 3 log. Granted, JNJ had a larger study. Notably, though, EDP-721 is ENTA's add-on drug, not even their main drug EDP-514; and EDP-721 might end up being as good or better than JNJ-3989.

Interestingly, JNJ-3989 200mg + JNJ-6379 combo didn't seem to do as well JNJ-3989 200mg. I found that odd.

Also, no patient in the active treatment arms achieved functional cure at follow-up Week 24.

I am really excited to see the data as it progresses for EDP-514 and EDP-721, especially when they are combined together with a nuc.

TRIL rose 2.7% after a Nasdaq delisting notice indicated that the sale to Pfizer (NYSE:PFE) was tentatively scheduled to close prior to market open tomorrow. The stock is expected to be halted this evening, according to the notice. In late August Pfizer agreed to buy Trillium, a clinical stage immuno-oncology company, in a $2.3B deal. Under the terms of the agreement, Pfizer agreed to buy Trillium for an implied $18.50/share, in cash. The delisting notices comes as Trillium's HSR deadline for the Pfizer deal was scheduled to expire. Trillium didn't immediately return Seeking Alpha request for comment on the status of HSR. Last week, Trillium Therapeutics (TRIL) receives final court order approving arrangement.

From Seeking Alpha

I think you're probably right, especially since ENTA will likely not be able to get EUA by the time their data (assuming it's good) has been revealed. That just adds to the timeline having to wait the full time for NDA. I guess we'll just have to see if Covid is endemic by then, how the world stands with vaccinations, and which variants might emerge and wreak havoc.

What do you think is a realistic timeline for advancing through Phase 1-3?

Pfizer seemed to get through them amazingly quickly. It helped that Pfizer could jump into Phase 1 right away given they had an existing drug, whereas Enanta had to come up with a new drug. Even counting for the time needed to come up with an IND (explaining why ENTA is behind Pfizer), Pfizer seemed to crush it through their trials.

I would love to see ENTA move that quickly -- might be difficult with the vaccinations and Pfizer's drug if the pandemic continues its current trajectory.

Side effects were mild, slightly lower than placebo. ENTA's drug is more potent, so theoretically has a chance to have even fewer side effects.

I guess, but I don't think the dataset was really ever an issue. Daxi looks safe and effective. When PDUFA was delayed last year, FDA said there was no issue with BLA and that they were only waiting to do inspection.

Then after all the extra time they got with changing vial size and the FDA's delay, RVNC still seems like they were caught completely unprepared when inspectors showed up.

RVNC gets CRL

https://investors.revance.com/news-releases/news-release-details/revance-provides-regulatory-update-daxibotulinumtoxina-injection

Revance Provides Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines
October 15, 2021

NASHVILLE, Tenn.--(BUSINESS WIRE)--Oct. 15, 2021-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug Administration (FDA) has issued a Complete Response Letter, or CRL, regarding the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, for the treatment of moderate to severe glabellar (frown) lines.

In a communication received on October 15, the FDA has determined it is unable to approve the BLA in its present form, and indicated that there are deficiencies related to the FDA’s onsite inspection at Revance’s manufacturing facility. Revance plans to request a Type A meeting with the FDA as soon as possible to address the deficiencies raised. No other deficiencies were identified in the CRL.

“We are very disappointed by this unanticipated response from the FDA and are seeking further clarity from the agency. We remain committed to bringing our next-generation neuromodulator product to market in both aesthetic and therapeutic indications,” said Mark Foley, President and Chief Executive Officer.

So that explains the long delay in approval. RVNC had to respond to the issues brought up and hopefully FDA will be happy with what they hear.

EOLS rising on RVNC's falling.

Scary, might be so. Probably why FDA's decision was taking so long. Maybe there was a deficiency that had to be fixed, and they're getting CRL.. or maybe they're getting approval but not with a label significantly different from Botox, despite whatever data they get from the K-M curve.

Might be. Stock is green on a down day and on higher than average trading volume.

It certainly is taking quite a while. The drag on share price is very evident. It's unfortunate that we are almost a year from the PDUFA date and still have no idea when/if it'll get approved. Since the FDA didn't do any sight visits for such a long time, I would have thought they would have used the extra time to have the rest of their report all done and just wai for inspection part of their report to be written after their inspection in June. Seems like it should have just been a formality since RVNC had forever and a day to get their ducks in a row to prepare for inspection. I am certainly nervous the inspection didn't go as planned.

CBC-Led Consortium Buys Bain’s Hugel Stake For $1.5 Billion

https://www.bloomberg.com/news/articles/2021-08-25/cbc-led-consortium-buys-bain-s-hugel-stake-for-1-5-billion

Bloomberg News

August 24, 2021, 10:41 PM EDT
South Korean cosmetic pharmaceutical company Hugel Inc. said its largest investor, Bain Capital, has signed a deal to sell a 46.9% stake to a consortium led by private equity firm CBC Group.

The deal, one of the largest medical aesthetics transactions in Asia, is worth around 1.7 trillion won ($1.5 billion), including convertible bonds, Seoul-based Hugel said in a statement Wednesday. Abu Dhabi-based investment company Mubadala and South Korea’s IMM Investment Corp. and GS Holdings Corp. are also part of the bidding group, the filing shows, confirming an earlier report by Bloomberg News.

Hugel shares tumbled as much as 9% in early Seoul trading Wednesday after the announcement. GS Holdings rose 0.91% as of 11:04 a.m. local time.

The South Korean company mainly produces beauty goods including botulinum toxin, commonly known as botox, and hyaluronic acid filler, its website shows. It also makes cosmetics and medical devices.

Hugel’s Botox product ‘Letybo’ was approved by China’s drug regulator in October 2020 after it filed an application in 2019. It is the fourth Botox product approved by China, where the aesthetic-medicine market is set to reach 31.5 billion yuan ($4.9 billion) in revenue by 2023, according to a Deloitte report. Hong Kong-listed Sihuan Pharmaceutical Holdings is currently the sole agent for Letybo in China.

The acquisition is healthcare buyout fund CBC’s first move into the medical aesthetics sector. The Singapore-based firm invests across sectors including biopharmaceuticals, medtech and services, including Hong Kong-listed Everest Medicines Ltd. and Nasdaq-listed I-Mab.

“This marks the beginning of CBC’s journey into the global medical aesthetics sector, in addition to our current pharma, medtech and services exposure,” the firm’s Managing Director Michael Keyoung said in a statement.

— With assistance by Claire Che

Congrats, jbog! Glad that the huge chunk of your shares were over a year old so you can pay less taxes on the earnings!

Why were they booted from the index? Market cap too high or expected to be too high soon?

I do approximately 100 fluoroscopic-guided LPs per year, and probably about 2-3 of those patients per year get a spinal headache that requires us to perform an epidural blood patch to treat the headache. I'm sure there are others who may get mild spinal headache, but I don't hear back from them because mild spinal headache is generally relieved with analgesics, fluids, caffeine, and more lying flat.

When I consent patients for lumbar punctures, the complications I describe are bleeding, infection, and spinal headache. The headache is the most common, although still in the 2-3% range, I'd guess. I've been doing this for 14 years, and I've never seen bleeding or infection from an LP.

Finally!

Revance Provides Update on DaxibotulinumtoxinA for Injection Pre-Approval Inspection

May 26, 2021

NASHVILLE, Tenn.--(BUSINESS WIRE)--May 26, 2021-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the FDA plans to initiate its pre-approval inspection of the company’s manufacturing facility for DaxibotulinumtoxinA for Injection by the end of June 2021.

In November 2020, Revance received notification from the FDA that the Agency was deferring a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar (frown) lines because the required pre-approval inspection of the company’s manufacturing facility could not be completed due to travel restrictions associated with the COVID-19 pandemic.

Immediately after the delay, I never would have expected the approval to come later than Labor Day 2021. Crazy that the FDA seemingly didn't travel AT ALL in 2020. I can't believe this could literally spill over into 2022. ABBV must be loving this...

Wow, that's horrible it'll take till September for those key seven inspections to occur. Seems like RVNC will be delayed over a year from their original PDUFA at that rate.

Btw, careless error in their article re "insure," which should be "ensure."

Speculating, but maybe it's due to patients who are taking BCPs and smoke?