Aquestive: FDA Will Not Require an Advisory Committee Meeting for NDA for Anaphylm

 

• NDA remains on track for FDA PDUFA goal date of January 31, 2026
• Commercial planning continues enabling rapid launch following approval

Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that an advisory committee meeting is not required for Anaphylm™ (dibutepinephrine) Sublingual Film. The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm remains January 31, 2026.

Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue.

https://www.globenewswire.com/news-release/2025/09/04/3144314/0/en/Aquestive-Therapeutics-Announces-that-FDA-Will-Not-Require-an-Advisory-Committee-Meeting-to-Discuss-New-Drug-Application-for-Anaphylm.html

Protest Outside Catholic School In Defense Of Trans Shooter

 by Steve Watson via Modernity.news,

In the wake of the tragic mass shooting at Annunciation Catholic Church in Minneapolis, where two children were killed and 17 others injured by a deranged transgender identifying individual, a small group of lunatics have sparked widespread outrage by protesting, apparently in defense of trans ideology.

The group positioned themselves directly across the street from the school, where the children were attacked as they prayed,

They heckled Vice President JD Vance and his wife Usha as they arrived at the church Wednesday to meet with victims’ families and pay respects. The ‘protesters’ held signs reading “Hate Won’t Make America Great.”

Imagine protesting outside a church kids were murdered at because you want to defend the killer’s trans ideology.

Sick. Just sick. pic.twitter.com/MoZldJbHjM

— Bonchie (@bonchieredstate) September 3, 2025

Someone has also placed a Pride/transgender flag next to signs reading “PROTECT KIDS NOT GUNS.”

These lunatics are just sick.

If they intentionally wanted everyone to hate them, what would they do differently? https://t.co/lLn7JRTGb5

— J🌞e (@JerseyJoe74) September 4, 2025

The group shouted insults at Vance, including “You’re a coward” and “Do better.” Their apparent motives blended calls for gun reform with support for LGBTQ+ rights, seemingly in response to the backlash against the trans community following the shooting.

The display of the trans flag at the site of a tragedy perpetrated by a trans-identified individual was widely interpreted as a provocative statement in defense of transgender visibility amid criticism.

The trans flag is a giant middle finger to the Church and victims.

You stay classy, Democrats. https://t.co/4ROig5cuo9

— Amy Curtis (@RantyAmyCurtis) September 3, 2025

The attack was carried out by 23-year-old Robin Westman, who fired through the church’s stained-glass windows during a back-to-school Mass, using firearms inscribed with phrases like “kill Donald Trump.” The shooter, who had a documented fascination with mass killings and mental health struggles, died from a self-inflicted gunshot wound at the scene. The FBI is investigating the incident as an act of domestic terrorism and a hate crime targeting Catholics.

It is galling and shocking the number of people on the left who are so cavalier about violence against some religious people.
The assassination plot on Alito, etc, led to MSM anchors saying "quit whining that your rulings had consequences."
The trans murders at a Tennessee… https://t.co/O50z2Ya1Jl

— Tim Carney (@TPCarney) September 3, 2025

The shooting has reignited national debates on gun violence, mental health, and the role of transgender ideology in such events. Conservative commentators have pointed to a pattern of mass shootings involving individuals identifying as transgender or non-binary, including incidents in Nashville, Lakewood, and Colorado. Meanwhile, Democrats, including Minneapolis Mayor Jacob Frey, have urged against “villainizing” the trans community.

Trans Shooting: Gutfeld Blasts Democrats “Who Enabled This Hysteria Of Horror”

These ghoulish trans activists are akin to the Westboro Baptist Church protestors.

Remember all the outcries about them? All those same folks are silent here. It was never about decency. https://t.co/jNvxMGKnJp

— Tyler (@TM0s41) September 4, 2025

*  *  *

https://www.zerohedge.com/political/sick-freaks-protest-outside-catholic-school-defense-trans-shooter

Bonds Climb as Jobs Cracks Keep Fed Cuts in Play: Markets Wrap

 

Wall Street traders gearing up for Friday’s jobs report got a trio of data that only reinforced the view of a cooling labor market, keeping bets on Federal Reserve rate cuts alive and driving bond yields down.

The latest readings on hiring and jobless claims came ahead of what economists expect to mark the weakest stretch of US job growth since the pandemic. As Treasuries rose, money markets almost fully priced in a Fed move in September and a total of at least two reductions in 2025. Equities fluctuated.

https://www.bloomberg.com/news/articles/2025-09-03/stock-market-today-dow-s-p-live-updates

Mamdani means to ax NYPD’s gang database, boost crimes that hit minorities most

 NYPD boss Jessica Tisch and her rank and file keep scoring impressive wins against crime, thanks in no small part to the department’s gang database.

Yet Zohran Mamdani is vowing to scrap it.

Yet more grounds to pray he doesn’t become mayor.

Major crimes plunged 7% last month, vs. August 2024, the latest stats show — indeed it was overall New York’s safest August on record.

“In the first eight months of the year,” boasts Tisch, “the NYPD drove down shooting incidents and shooting victims to the lowest levels” in city history.

Subway crime has also hit “record lows, excluding the pandemic years.”

Tisch praises the gang database in particular: “Much of the violence” over the last few weeks in the Bronx “is gang-related. We know who the gang members are, thanks to a Criminal Group database. And know where they operate,” so “[we’re] going after them.” Bravo.

These gang-related records have long proven vital, especially when gang-on-gang attacks threaten to escalate.

This spring, Tisch credited it for helping cops nab Tren de Aragua gangbangers who attacked police.

Yet since 2022, Mamdani has pushed to have it dismantled, siding with critics who claim it amounts to racial profiling, since most people in it are black or Hispanic.

D’oh: Most gangs are black and Hispanic; of course a gang database will reflect that.

Thing is, the victims of gang violence are almost entirely minorities.

So scrapping this tool — denying cops critical info to ID potential witnesses and suspects — will hurt blacks and Hispanics most.

Crime victims are invisible men, women and children to Mamdani & Co.: Who are the real racists?

Nor will Mamdani’s pro-crime measures end there: He says he’ll eliminate the NYPD’s elite Strategic Response Group; he won’t add cops despite the force’s shortage, but instead shift resources away from policing to a new Department of Community Safety that would rely on near-useless “violence interruption.”

On Tuesday, Mayor Eric Adams boasted of the city’s recent crime-fighting successes, insisting, “Our public safety plan is working.”

But it’s guaranteed to stop if Mamdani takes City Hall.

https://nypost.com/2025/09/03/opinion/a-zohran-win-could-end-the-nypds-gang-database-and-crime-spikes-that-hit-minorities-most/

Intuitive Surgical drops amid tariff concerns

 Intuitive Surgical (NASDAQ:ISRG) was a notable decliner in the S&P 500 on Wednesday, falling ~7% in the afternoon trading as the maker of the da Vinci robotic surgical system flagged tariff-related concerns during an investor event.

At the Wells Fargo Healthcare Conference on Wednesday, CEO David Rosa and CFO Jamie Samath outlined the company’s strategic priorities for the next 5-10 years, and highlighted the impact of the Trump administration’s tariffs.

While the Sunnyvale, California-based MedTech said that its financial goals remain intact, it added that tariff headwinds for next year could exceed its Q2 projection for 2025, which stood at a 100 bps impact on revenue.

“So the 100 basis point guidance for the year is just as it continues to climb over the rest of the year as a function of how tariffs roll through inventory into COGS,” CFO Samath noted, adding that the company will wait until the situation stabilizes to come up with any mitigation strategies.

https://www.msn.com/en-us/money/markets/intuitive-surgical-drops-amid-tariff-concerns/ar-AA1LOBg7

Pfizer collaboration with Olema may spark future bidding war - analyst

 Olema Pharmaceutical's (NASDAQ:OLMA) announcement of a new clinical trial collaboration and supply agreement with Pfizer Inc. (PFE) in metastatic breast cancer may be a sign of a potential bidding war for Olema in the future, according to an Oppenheimer analyst. 

"Alongside the palazestrant + ribociclib combination (i.e., OPERA-02) with Novartis, Olema now has two of the big three players in HR-postive breast cancer with a seat at the data table - which under ideal circumstances may set the scene for a future bidding war," Oppenheimer analyst Matthew Biegler, who has an outperform rating and $22 price target on OLMA, wrote in a note on Wednesday. "We think that's a real possibility of Roche's PersevERA trial -- expected any day -- reads out positively."

Olema (NASDAQ:OLMA) surged 19% on Tuesday in the wake of the Pfizer (PFE) news. Shares of Olema fell 3.1% on Wednesday.

https://www.msn.com/en-us/money/companies/pfizer-collaboration-with-olema-may-spark-future-bidding-war-analyst/ar-AA1LOQTd

Neonode expects up to $20 million from Samsung patent settlement

 Neonode Inc. (NASDAQ:NEON), currently valued at $360 million and showing a remarkable 200% return over the past year, announced Wednesday it anticipates receiving between $15 million and $20 million in net proceeds from a settlement between Samsung Electronics and Aequitas Sub, a subsidiary of Aequitas Technologies LLC.

The settlement resolves a patent infringement lawsuit filed in June 2020 in the United States District Court for the Western District of Texas. While Neonode was not directly involved in the litigation, the company is entitled to 50% of net proceeds under a 2019 agreement when it assigned certain patents to Aequitas. 

The expected amount factors in deductions for brokerage fees, legal costs, taxes, and other expenses related to the original patent assignment. The company stated it continues to evaluate tax implications that may affect the final sum.

According to Neonode, the court dismissed the case on September 2 following the settlement between Aequitas Sub and Samsung. The company’s board has not yet determined how the proceeds will be used.

A separate patent infringement case brought by Aequitas Sub against Apple Inc. remains pending in the United States District Court for the Northern District of California.

The information was disclosed in a press release issued by Neonode.

In other recent news, Neonode Inc. is set to receive between $15 million and $20 million from a patent lawsuit settlement involving Samsung Electronics. This settlement resolves a lawsuit filed by Neonode Smartphone LLC, a subsidiary of Aequitas Technologies LLC, against Samsung for alleged patent infringement. In addition to this development, Neonode announced its inclusion in the Russell 2000 Index, effective after the U.S. market opens on June 30. This inclusion will also see the company automatically listed in the corresponding growth and value indexes.

Furthermore, at Neonode’s 2025 Annual Meeting of Stockholders, Ulf Rosberg and Peter Kruk were reelected to the Board of Directors for three-year terms. These developments mark significant milestones for the company, both in terms of financial settlements and market recognition. Neonode’s inclusion in the Russell 2000 Index is part of the broader Russell indexes reconstitution for 2025. This inclusion is contingent upon its presence in the Russell 3000® Index.

https://www.investing.com/news/company-news/neonode-expects-up-to-20-million-from-samsung-patent-settlement-93CH-4222956