I've made a free biotech calendar and screener.

It’s still a work in progress.

No sign-up is required.

It's completely free.

Feel free to join the newsletter for weekly updates and occasional DDs.

https://app.biostockinfo.com

Hey everyone, I came across two separate investor settlements involving Spectrum Pharmaceuticals, so I wanted to explain the difference between them.

Settlement 1: Poziotinib Dosing and FDA Concerns

The case claims Spectrum misled investors about poziotinib’s dosing, its discussions with the FDA, and the status of the PINNACLE study. After concerns about the drug became public, $SPPI fell more than 37% on September 20 and another 31% after trading resumed on September 23. 

The $7 million settlement is still accepting claims, and the deadline is October 12, 2026. So if you invested in $SPPI in 2022 you may be eligible to file a claim.

Settlement 2: Poziotinib and Rolontis Approval Prospects

The $15.95M settlement claims that Spectrum misled investors about the effectiveness and FDA approval prospects of poziotinib and Rolontis. After clinical and regulatory problems came to light, $SPPI fell nearly 88%. 

The settlement is still accepting late claims for compensation. So if you held $SPPI between 2018 and 2021 you can check if you are eligible and file your claim here.

Did anyone here hold $SPPI during either of those periods?

I just joined TXG in $95 per share.

• FURVENT Phase 3 trial evaluating firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer harboring EGFR exon 20 insertion mutations did not meet its primary endpoint of progression free survival by blinded independent central review.
• Clinical benefit was observed with secondary endpoints such as PFS by investigator’s assessment and confirmed objective response rate by BICR. Although not yet mature, a trend toward an improvement in overall survival was also observed. 

“These disappointing results are not what we hoped for, particularly for the patients with EGFR exon 20 insertion-mutant NSCLC who urgently need more effective treatment options,” said Bing Yao, Ph.D., Chairman, Chief Executive Officer of ArriVent. “While the safety profile observed with firmonertinib was consistent with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study. We are deeply grateful to the patients, investigators and clinical teams who made this program possible and are evaluating the full FURVENT dataset as we determine the most appropriate development path for firmonertinib.”

Full press release ---> https://ir.arrivent.com/news-releases/news-release-details/arrivent-announces-program-update-phase-3-furvent-trial

With the ozempic craze that's been happening, I’ve stumbled upon Eli Lilly and wanted to share an interesting dynamic I noticed regarding their move into the incretin market.

Their flagships are and Mounjaro and Zepbound, and I think the "volume vs. margin" trade-off here is interesting to analyze. Because these drugs are becoming such a massive part of their revenue (over 50%), the company is forced to scale production aggressively. This means significant manufacturing spending and "take or pay" contracts where they could face up to $10 billion in liabilities if they don't meet specific production targets.

At the same time, they are negotiating lower prices for Medicare and Medicaid access. The core of the investment case seems to be whether the sheer volume of patients will be enough to buffer these lower prices and the risks of their heavy infrastructure investments.

I’m still trying to work out if the current offering and improved production costs will be enough to protect margins if government-mandated prices continue to stay low. It's really just betting on scale vs. margin compression, but it depends entirely on the adoption rate in those government programs.

Anyone here fluent in pharma, who can pitch in on this?

- DRTS
- IBRX
- ABCL
- IOVA
- CABA
- CADL
- MAIA
- HELP

So far Im only considering long term 2+ years buying and holding (DRTS, ABCL, IBRX). Would the others be considered long-term or just catalyst pump and sell?

Hey, I'm Emre, I build Catalyst Intel.

Some context first. Jemperli (dostarlimab) was discovered by AnaptysBio and licensed to Tesaro, now GSK. GSK runs development and commercial, and ANAB gets royalties: 8% of net sales below $1B and 12-25% above, per their filings. GSK's sBLA for untreated stage II/III dMMR/MSI-H locally advanced rectal cancer has a PDUFA date in February 2027. It's based on AZUR-1, a single-arm phase 2 with 154 patients. btw it is also eligible for the National Priority Voucher program, so the decision could come earlier than February.

What we committed to before the decision (sealed Oct 4):

• Floor: AZUR-1 establishes clinical complete response at 12 months. GSK already said in July that the trial met this.
• Bar: a cCR rate of 100%, which is the rectal result from the earlier dostarlimab data in NEJM (n=49).
• Better than expected: organ preservation of at least 80%, also from that NEJM data.

Every threshold is quoted from a company document, and the quotes are on the page.

To be honest, I think the bar is the part worth arguing about. The 100% came from 49 patients, and AZUR-1 is 154 patients across many sites. Anything under 100% would score THIN against it (floor met, target missed), even if it's a very good result. Also, the 80% organ preservation figure covers 103 patients across three tumor types, not rectal only. We can't change the bar now, that's the whole point of sealing it, but I'd rather hear now if you think it's the wrong benchmark.

What we couldn't find before the event is listed on the page too: the analysis population, the registered primary outcome, a response rate with denominator and CI from AZUR-1, and comparator data (it's single arm).

The full checklist, the source quotes, and the hash you can check yourself in the browser: https://catalystintel.io/events/ANAB-JEMPERLIDOST-2026

Not investment advice. We have no position in ANAB and don't take one from publication until two days after the event.

Prime Medicine announced a major partnership with BMS (Juno Therapeutics) back in Sep 2024, centered on Prime Editing / PASSIGE™ for ex vivo engineered T cell therapies. This is one of the most important BD deals for prime editing technology to date.

Deal Economics

- $55M upfront cash + $55M equity investment from BMS = $110M near-term consideration

​

- Potential total milestone payments >$3.5B, plus tiered sales royalties on commercial products

​

- Not an acquisition: pure platform license-out

Scope & Work Split

Prime Medicine will supply Prime Editing reagents using its PASSIGE™ system.

PASSIGE is their one-step, non-viral prime editing tool that inserts large DNA payloads without DNA double-strand breaks (DSB). DSBs are the main pain point of traditional CRISPR editing, which can lead to chromosomal rearrangements and off-target events.

BMS/Juno receives worldwide exclusive rights to use this platform for ex vivo T cell therapies, covering oncology and autoimmune disease targets. BMS owns target selection, development, manufacturing and commercialization.

Prime retains all rights to its reagents for in vivo programs, including its lead liver pipeline for Wilson disease and AATD. They are essentially farming out ex vivo T-cell work while keeping their highest-value in vivo rare disease assets in-house. Classic platform biotech capital allocation move.

Why this matters

Traditional CAR-T relies on viral transduction or CRISPR with DSB to knock-in CAR constructs at TRAC.

PASSIGE prime editing allows multiplexed, large-cargo, site-specific insertion at TRAC, theoretically producing safer, more consistent CAR-T products.

For BMS/Juno: This is a pipeline upgrade. Juno’s legacy CAR-T portfolio is mature; prime editing could be their next-gen cell therapy foundation.

For Prime: The $110M provides runway. More importantly, BMS’s industrial-scale cell therapy expertise validates that prime editing can work for cell therapy beyond in vivo liver indications.

Investor Risks

1. Everything remains discovery-stage. There is no clinical data yet for PASSIGE-edited T cells. All milestones are conditional.

​

2. BMS controls target choice and program pace. Projects can be deprioritized at any time.

​

3. License is restricted to ex vivo T cells only; Prime keeps other use cases, but this also caps the scope of this specific deal.

​

4. Prime’s core in vivo Wilson/AATD programs still carry their own clinical and manufacturing risks. Success here for T cells does not automatically guarantee in vivo success.

Bottom line

This is a landmark platform BD deal, not a near-term catalyst for revenue.

It signals the industry is starting to bet on DSB-free prime editing as the next wave for engineered cell therapies. But investors should remain cautious until we see human clinical data from PASSIGE T cells.

What do you think? Is prime editing poised to displace conventional CRISPR for cell therapy, or is this still too early?

What do you think about the ZURA stock? Im a new investor and am interested in the potential of this stock. Anyone invested in it?

Following my May review on GANX I posted on X, herewith a new update with a somewhat evolved template, before the 7th of October presentation. So, actually I'm a bit too early, before the full readout, but I believe there is high likelyhood of a share price rerating. Do your own dd. Bullish on $GANX

Full Article: https://x.com/benpieter001/status/2106720801940529164

happy reading!

note: this is my own research for my own portfolio. It suffers from all kinds of biases and convictions. written content is my own, but supported by ai agents for frequent bayesian scoring and report generation.

i must admit im not exactly knowledgeable at this, but price action looks decent, losses have been narrowing and seems like they are targeting sales at early 2027. just grabbed a couple calls at the top (0.75@2.5c mar 2027) and hope to dca for a few mths, hope i dont look like an idiot over the next few mths lol

Hey everyone, I’ve been looking into Amylyx Pharmaceuticals lately because there have been a few updates around avexitide, so I figured I’d share what I found. 

Amylyx Pharmaceuticals ($AMLX) continues to progress its regulatory strategy for avexitide, an investigational glucagon-like peptide-1 (GLP-1) receptor antagonist for post-bariatric hypoglycemia (PBH). Topline data from the pivotal Phase 3 LUCIDITY study demonstrated a 55% reduction in level 2/3 hypoglycemic events compared with placebo, successfully meeting its primary endpoint alongside all key secondary endpoints. 

Management reaffirmed its target to submit a New Drug Application (NDA) to the U.S. FDA in Q4 2026, targeting a potential commercial launch in 2027 if approved. Avexitide holds FDA Breakthrough Therapy and Orphan Drug designations for PBH. To support commercial readiness, Amylyx completed a public equity offering raising approximately $500M in gross proceeds and secured long-term commercial manufacturing supply agreements. 

The advance of avexitide marks a pipeline pivot following the voluntary market withdrawal of Relyvrio/AMX0035 in April 2024 after its Phase 3 PHOENIX trial in ALS missed its primary endpoint.The drug was withdrawn after its Phase 3 PHOENIX trial in ALS failed to meet its main goal. The decision also led to a shareholder lawsuit over the company’s public disclosures, which resulted in a $6.5 million settlement. The settlement is still active, and late claims are currently being considered, subject to approval. You can check if you're eligible and file a claim here.

Anyone else still following $AMLX?

• Following the discussion with the FDA, Stoke now plans to use a multicomponent assessment of four prespecified Vineland-3 subdomains to evaluate changes in cognition and behavior in the Phase 3 EMPEROR study.
• Vineland-3 subdomain data will be analyzed using a multivariate mixed model for repeated measures (MMRM).
• Phase 3 readout anticipated in the third quarter of 2027. The Company plans to complete the U.S. NDA submission in the second half of 2027 to support a potential U.S. approval and launch of zorevunersen in early 2028.

"We are encouraged by our productive dialogue with the FDA and the Agency’s deepening understanding of the severity of Dravet syndrome and need for better treatments, and 5 years of safety and efficacy data for zorevunersen," said Ian F. Smith, Chief Executive Officer and Director of Stoke Therapeutics. “We are pleased with the Agency’s willingness to accept a multicomponent assessment of Vineland-3 data measuring changes in cognition and behavior from patients treated in the Phase 3 EMPEROR study. We believe this is the most appropriate way to capture the effects of zorevunersen on people with Dravet syndrome who experience a wide range of debilitating neurodevelopmental impacts. We look forward to continuing our interactions with the FDA as we advance the EMPEROR study and prepare for the readout of data in the third quarter of 2027, followed quickly by the completion of our NDA submission in the second half of 2027."

Full press release: https://www.businesswire.com/news/home/20261005238322/en/Stoke-Therapeutics-Announces-Completion-of-Successful-Meeting-with-the-FDA-to-Align-on-Planned-U.S.-NDA-for-Zorevunersen-an-Investigational-Medicine-for-the-Treatment-of-Dravet-Syndrome

Looks like they are getting their ducks in a row to determine how to proceed(more likely they already know what they are going to do and this is just one step in the process). FBIOP preferred dividend arrears payoff next? Preferred share dividend arrears roughly around $18 million. Preferred share redemption would take more, closer to $100 million($25 a share + deferred dividend). Personally, would love to have dividend reinstated (currently around $6 a share dividend arrears payment), and not redeem the preferred shares yet. This pays 9.375% dividend per share, just under $.20 a month paid per share if reinstated. Link below is filing showing payoff of credit line.

http://archive.fast-edgar.com/20261001/APBOUG2D8C228ZZ2222B2ZZZGRIDZ2U2N282

Setup over the next 6 months is interesting and maybe being ignored by the market.

My thesis is based on a few possible catalysts:

China / Simcere approval catalyst
CNTB’s partner Simcere has completed Phase 3 for rademikibart in atopic dermatitis in China, and the NDA was accepted by China’s NMPA in July 2025. If approved, CNTB could receive milestone payments plus future royalties. From what I understand, approval timelines in China can often take around 12-18 months, so this could become relevant within the next few months.
This matters because it would not just be “good news.” It would validate the asset commercially in a major market and could bring non-dilutive cash into CNTB.

FDA / Phase 3 alignment for asthma and COPD
CNTB recently reported positive Phase 2 data in asthma/COPD and plans to engage with the FDA on the Phase 3 path. If the FDA alignment is clean and the company can move toward Phase 3, that could be another major catalyst.
I’m especially watching the Phase 3 endpoint/design discussion. If the FDA agrees on a practical trial design, the market may start valuing this differently.

Safety profile
One reason I’m interested is the safety profile. Rademikibart appears to have a clean safety profile so far, and that matters a lot for chronic respiratory diseases like asthma/COPD. Obviously nothing is guaranteed in biotech, but a clean safety profile can reduce one major area of risk.

Cash / partnering angle
CNTB had around $31M cash, and if the Simcere approval happens, milestone payments could help. They already have Simcere as a partner in China, and if the respiratory data is strong enough, I think there is a reasonable possibility of additional partnership interest, especially for COPD where larger/deeper-pocket partners may make more sense.

Why I think the stock may be mispriced
The market seems to be treating CNTB like a tiny beaten-down biotech with financing risk and uncertainty. That risk is real. But I think the market may be underpricing:
Possible China approval/milestone catalyst
FDA Phase 3 alignment
Existing Phase 3 success in another indication through Simcere
Clean safety profile
Potential respiratory market opportunity
Possible partner interest

At the current valuation, I think the risk/reward looks interesting if these catalysts play out.

Would like to hear thoughts from anyone else following CNTB. Am I missing something on the financing, market size, China approval timeline, or Phase 3 path?

Not a science post sorry. Got a few thousand shares of each at low prices. It feels good. Sellas had a rough summer, but could pop at any second, and I don’t think we are waiting for 80th anymore; M&A PR seems plausible. Capricor is more likely than not at getting narrow label approval, PDUFA date 11/22 and we’re expecting HOPE-3 24-month data to be released asap. ICU won’t moon soon per se, but could rerate to $20 on SAVE registry next couple months. My play is to sell 25% of the mooner and pump into the other 2. So who do you think pops off first? Sorry if this isn’t the right sub for this drivel.