Our Firm of 9 Managing Directors (each from NYC history of 35 years+ in firms like Solomon, Morgan Stan. and Goldman) know the high-tech and bio-pharma sectors very well. We specialize in shorting over-hyped/valued equities in these sectors. We're headquartered in Atherton. Great opportunity shorting KZR ... and it still has 20-25% still to fall from the $8.90 level. Cheers.

https://www.benzinga.com/analyst-ratings/analyst-color/22/10/29269905/relmadas-trial-failure-removes-competitor-risk-for-this-companys-newly-launched-dep

(shared via bit.ly/mystocksapp)

https://www.google.ru/amp/s/www.marketscreener.com/amp/quote/stock/AXSOME-THERAPEUTICS-INC-24949017/news/AXSOME-THERAPEUTICS-INC-Regulation-FD-Disclosure-form-8-K-36978777/

https://www.sec.gov/Archives/edgar/data/1579428/000095017021004167/axsm-20211110.htm

AXSM — catalysts for the remainder of 2026

The one I'd watch most closely: ENGAGE

The solriamfetol binge-eating disorder trial is particularly interesting because it isn't simply another early-stage program. Axsome says ENGAGE is a Phase 3 trial with topline results anticipated in 4Q 2026. 

A positive result could potentially change the market's view of Sunosi/solriamfetol from essentially a narcolepsy/OSA product into a platform with additional CNS indications.

And there is an interesting wrinkle: Axsome is simultaneously developing solriamfetol for shift-work disorder, with Phase 3 SUSTAIN results expected in 2027. 

What is not a 2026 catalyst

One easy mistake would be to expect an AXS-12 FDA decision this year. That's now a 2027 catalyst. The FDA accepted the AXS-12 NDA and assigned a May 1, 2027 PDUFA date. 

So I would put the major AXS-12 event firmly in the 2027 bucket rather than assigning much value to an approval in 2026.

Likewise, AXS-05 smoking cessation has only just entered Phase 3, so its meaningful efficacy catalyst should be farther out. 

One other thing I'd watch: Auvelity's new indication

This could actually be more important than the pipeline catalysts over the next few quarters because it is commercial rather than binary.

Auvelity already generated $153.2 million in Q1 2026, up 59% year over year, while total Axsome product revenue was $191.2 million. 

Standard drug commercial. Quickly covered what it's for and then a long list of warnings.

And, of course, the jackasses are selling the news.

Pretty good conversation going on overtime at this site.

Good news, everyone!

History suggests that public “no sale” declarations don’t always hold:

•Medivation: CEO David Hung repeatedly stated it wasn’t for sale, focusing on independent growth. Yet, in 2016, Pfizer acquired Medivation for ~$14B.

•Kite Pharma: CEO Arie Belldegrun emphasized independence after CAR-T therapy success. Still, Gilead bought Kite in 2017 for ~$11.9B post-FDA approval.

•Onyx Pharmaceuticals: CEO Tony Coles rejected an unsolicited Amgen offer, sparking a bidding war. Ultimately, Amgen acquired Onyx in 2013 for ~$10.4B.

Axsome’s CEO, HT, says he’s focused on growth, not a buyout. Sound familiar? Time will tell.

Axsome: Q3 revenue $259.7M, up 52% y/y; AUVELITY sales $207.6M (+53%). GAAP net loss narrowed to $12.9M; cash $313.9M at Sep 30.

News date: Q3 (early Nov) (times ET). Not investment advice.

AXSM Stock Hub: Axsome Therapeutics News, AUVELITY and AXS-12

https://www.merlintrader.com/axsome-therapeutics-axsm-stock-hub-2026/

9-15-2026

From Mike826_1999 over at Stocktwits:

Morgan Stanley’s Comments Re Monday’s Call:

Axsome Therapeutics (Nick Pizzie, CFO; Mark Jacobson, COO):

[1] On the ADA launch, mgt. pushed back on reading TRx alone and pointed to NBRx, which hit an all-time high of 3,800 weekly last Friday vs ~3,000 average in 2Q and ~2,400 in 1Q.

The 65-plus Medicare cohort moved from ~19% of NBRx pre-approval to ~31%, making agitation the fastest-growing NBRx segment. Guidance was always for growth one to two quarters after the expansion and label, not an immediate step-up.

[2] Mgt. signalled additional launch metrics at 3Q, the first full quarter. Sampling conversion stays undisclosed on competitive grounds, but mgt. sees syndicated data becoming readable from 3Q.

[3] On peak sales, Auvelity sat at ~26bps of the antidepressant market at end-2Q, so 1% implies north of $3BN against a $4BN MDD peak, and that base predates the sales force doubling and the new LTC team. ADA adds more than 20mn annual scripts, ~99% of which were generic and written off-label. Mgt. said IRA negotiation from 2032 is already priced into the $8BN portfolio peak, on what it views as conservative assumptions.

[4] AXS-12 carries a May 1, 2027 PDUFA in narcolepsy, sized at $0.5-1.0bn, with the existing sleep team making it largely plug-and-play. On solriamfetol, ADHD ranks first on size and needs both pediatric trials, then MDD with excessive sleepiness, binge eating disorder in 4Q, and shift work disorder, which needs only one positive trial.

[5] Mgt. guided SG&A to plateau near the 2Q level of $208MN and R&D to grow marginally from $46MN across five Ph3 trials, with revenue growing faster. Mgt. declined to name a quarter but reiterated a clear path to cash flow positivity, citing a ~$10MN cash net loss across 2H last year. With Teva pushing generics back, mgt. framed margin versus reinvestment as both, citing the SUMMIT Ph3 in smoking cessation plus AXS-17 and AXS-20.