Achieve Life Sciences is developing Cytisinicline for the treatment of smoking cessation. The drug has been available in Eastern Europe for years, but Achieve has taken the lead to bring this drug to market in developed countries. The safety profile is significantly better than both Chantix and Zyban and they are about to release data from the first of two Phase 3 clinical trials (ORCA-2 and ORCA-3). Given that there are 31M Americans who smoke and that e-cigarette usage is on the rise, there will be a large market of people who can benefit from Cytisinicline. Thanks to InfoPathways for being ..read more

Karyopharm is an oncology company that is commercializing XPOVIO (Selinexor) in Multiple Myeloma and DLBCL. Selinexor blocks nuclear export thereby hindering the ability of cancer cells to block tumor suppressor protein activity. In this episode, I break down the bear and bull narratives of Karyopharm and discuss how the company has transitioned since entry of the new CEO Richard Paulson. Thanks to InfoPathways for being a sponsor of the show! Check them out for all your biotech IT needs at infopathways.com or call 410-751-9929. Help out the show (or join the discord) by becoming a patron at ..read more

The NASH space has seen some setbacks in the last couple years, but a few players continue to make nice progress on their clinical trials. Madrigal Pharma announced positive topline data in their MAESTRO-NAFLD trial, which is an encouraging sign for their upcoming readout in NASH in Q3-2022. I discuss other players in the space including: ETNB, AKRO, VKTX, ICPT, IVA and NVO. Checkpoint Therapeutics announces positive topline data from their trial of Cosibelimab in metastatic cutaneous squamous cell carcinoma. I talk to about what we can look forward to in 2022 for this company as well. Thanks ..read more

CRISPR is an exciting space, with a number of companies finally sharing early clinical data in 2021. NTLA benefitted the most from this by doubling in valuation after data release, while the other CRISPR companies continue to trend lower in the XBI bear market. Caribou Biosciences is one of the smaller EV CRISPR companies with their first clinical readout coming up in 2022. In this episode, I go through a short primer on all the CRISPR companies and discuss why I think Caribou will have a great year. 2022 is on track for another exciting year in biotech - despite the early sell off in the XBI ..read more

ALXO announces new HR-MDS data that disappoints! I talk about the comparison to Magrolimab data and why I think ALXO is still a buy. LGVN pushes data updates but is still a risk for a short squeeze! I talk about some of the stock statistics and fundaments to determine whether I'm going to place that short trade. The neurodegeneration space had an exciting 2021 and I provide an update on all the companies I covered earlier in the year. 2022 might prove to be more exciting with some big Alzheimer's Disease readouts expected. The Breaking Biotech portfolio hit -17% YTD and I cover my best and wor ..read more

Curis is an oncology company trying to develop an inhibitor of IRAK-4. They have shown positive results in AML/MDS in spliceosome/FLT3 mutation patients as well as their non-target group. This will hopefully allow them to get accelerated approval with the FDA but they still have some hurdles to overcome. Longeveron is a cell therapy company looking to develop their Medicinal Signaling Cell therapy, Lomacel-B, in aging patients. They are focusing on Alzheimer's Disease, Aging Frailty as well as Hypoplastic Left Heart Syndrome, but there's something off that makes me question the therapy's poten ..read more

Two CD47 targeting companies announced data updates from their clinical programs: Shattuk Labs and ALX Oncology. Both have suffered major stock price declines and in this episode, I go through the updates and discuss the potential of their molecules moving forward. Biogen cannot catch a break with the latest news continuing to contribute to new stock price lows. However, Medicare is close to announcing their National Coverage Determination (NCD) decision on Aduhelm, which will be a big mover for the stock. Help out the show (or join the discord) by becoming a patron at: https://www.patreon.com ..read more

Arvinas' PROTAC technology has led to two exciting molecules that are in the clinic for the treatment of breast cancer and prostate cancer. The company has spent years optimizing their protein degraders to achieve specific and effective protein degradation. ARV-471 targets the Estrogen Receptor for degradation and is in clinical trials for patients with HR+/HER2- breast cancer. The early efficacy and safety data bode very well for the company and an upcoming update will be provided in December 2021. The company's Androgen Receptor targeting asset (ARV-110) has also shown exciting early data an ..read more

REGENXBIO ($RGNX) presents data using the Clearside Bio ($CLSD) SCS injector to treat wet AMD and diabetic retinopathy patients with RGX-314. Since existing treatments are on the market for these indications, it is very important that safety signals in these studies are reduced to a minimum. It is also critical that efficacy remains non-inferior to Eylea or Lucentis. In this video, I go through both readouts and discuss the potential for the therapy moving forward. 4D Molecular Therapeutics ($FDMT) announces positive early interim data in their intravitreal treatment of 4D-125 in patients with ..read more

Absci is a synthetic biology company focused on developing better, faster paths to new medicines. Starting with their bioengineered E. Coli strain named SoluPro, Absci is able to manufacture complex biologics in a prokaryotic system, something that had never been done before. More recently, they have made acquisitions that have added on drug discovery and AI capabilities to the platform to create an end-to-end solution that can help Pharma streamline their preclinical and clinical programs. In this video, I interview Sean McClain, Founder and CEO of Absci, to talk about all the exciting things ..read more