These are the questions that many are asking me these days regarding PSTI: * When will the interim Ph3 data be released? * What is taking them so long? * Is there a chance they are withholding the data because it is negative, and they will wait until full study data is available to provide […]
SRPT – The Street Will Get It – Study-103 Is the Fast Path to Full Approval
Last week, Sarepta Therapeutics ( SRPT) on the 3Q earnings call provided key updates on SRP-9001 gene therapy in Duchenne Muscular Dystrophy (DMD). Where they already met the FDA and resolved the FDA’s requests with regard to the potency assays for the commercial material to be used in the next studies, and they came with […]
Perimeter, OTIS – Optical Coherence Tomography and the Future of AI in Surgical Breast Cancer Treatment
Perimeter Medical Imaging AI (PINK.v) is a Toronto-based company with U.S. headquarters in Dallas, Texas developing advanced imaging tools that allow surgeons, radiologists, and pathologists to visualize microscopic tissue structures during cancer excision surgery. Perimeter has an innovative FDA 510(k) approved medical device, soon to launch commercially, that is ready to disrupt breast cancer surgery […]
October 15th Biotech (and MLP) Update
Not much to add as we gear up for earnings season and the sector basically following the broader market in its moves. It looks like we are switching from setting the new higher high level to establishing the higher low level. In other words, we are likely in the part of the uptrend where the […]
October 12 Biotech Update
We are not starting the week with new M&A but we are starting the week with strong momentum both with the sector and the broader market. Of course, very strong broader markets have not necessarily been great in recent weeks for the sector but there is certainly a chance that we break to new highs. […]
SRPT to Release 2-Years DMD and LGMD-2E GT Data at WMS-2020
It was a surprising and unexpected decision by Sarepta to release the long term data from the first clinical trial of DMD Gene-Therapy, a 2-years data to be presented at the World Muscle Society WMS25 Virtual Congress, despite the previous statements saying, we do not want to release data from an open label study while […]
September 24th Biotech Update
We are not quite in trouble with the sector despite the recent sell off and pain. Obviously the broader market is not helping but we have not broken below recent lows and still can reverse (needs to be soon) higher and make a higher high to start a new trend. Of course, nothing is guaranteed […]
September 14th Biotech Update
We are back baby! This is the M&A that the sector has been wanting. If this cannot break the sector out of the downtrend and push it back to highs (if not higher) then not much else could. The ideal scenario would be a push above the recent lower high today but we were pretty […]
Sarepta (SRPT) LGMD2E Data Readout and The Street Expectations
Sarepta will finally reveal the high dose LGMD2E data from the gene therapy SRP-9003 on Monday morning and put this highly underappreciated program on the big podium. In a surprising Friday post-market closing press release, Sarepta announced that on Monday, June 8, 2020 at 8:30 am ET, it will host a webcast and conference call […]
Cardiol Therapeutics – Pharmaceutical Cannabidiol (CBD) Long-Term Value Creation Will Lead the Way to Acute Myocarditis Clinical Trial
Cardiol Therapeutics (CRTPF) is a Canadian company that completed its initial public offering (IPO) on the Toronto Stock Exchange (the “TSX”) back in December 2018 and trades mainly on the TSX under the symbol CRDL while in the U.S. it trades on the OTCQX under the symbol CRTPF. Cardiol is focused on producing pharmaceutical cannabidiol […]
CHFS – Can The COVID-19 Pandemic Become the Inflection Point?
A Reported Shortage of Dialysis Machines Puts a Focus on Aquadex. Aquadex Smartflow System is being used to remove excess fluid from patients being treated with fluid resuscitation as part of the treatment for COVID-19, and in some cases is helping to relieve the shortage of dialysis machines at a growing number of hospitals. A […]
February 3 Biotech Update
The market is off to a good start this morning but I suspect we fade. The old saying goes that markets never bottom on Fridays and typically when you have a big selloffs on Friday and a bounce Monday morning, the bounce ultimately fades and fails. We will see. We still have some macro that […]
The PTI Bear Case
Proteostasis Therapeutics is a small biotech company focused on the development of treatments for cystic fibrosis. To their credit, they have 3 compounds, each of a different class in the clinic. This is crucial because the current standard of care for CF relies on combination therapy. Vertex laid out a blueprint for CF treatment through […]
January 16 Addendum
The link I sent sends you to the twitch front page. You can go to videos to see the replay or this link below should send you there. https://www.twitch.tv/chimeraresearch/videos
Another Look at TPTX
With the entrance of RET inhibitor TPX-0046 into P1/2 last November, fast moving Turning Point Therapeutics now has a full slate of 3 clinical candidates. Soon, another ALK inhibitor is expected to join the fray. Pipeline: The pivotal repotrectinib studies in ROS1 and TRK are ongoing with interim results from some registrational cohorts expected during […]
All Eyes On SAGE Ahead of JPM
SAGE has been a very volatile stock even since its early days. Hopes have been dashed only to be renewed by another promising aspirant. Only weeks ago, the subject of this affection was SAGE-217. It traded as high as $198 in July before falling to $56 on December 5 when it was announced the drug […]
Is APLS a Buy Ahead of Data?
Apellis Pharmaceuticals is developing treatments through targeting the human complement cascade. Its most advanced product is C3 inhibitor APL-2. Pivotal trials are ongoing in PNH and geographic atrophy in age-related macular degeneration, or GA, where C3 is known to be a primary disease driver. Results from a highly anticipated head-to-head study of APL-2 vs eculizumab […]
The CNST Bull Case in a Single Slide
Constellation Pharmaceuticals presented some compelling data at ASH. In early results from 15 JAKi naive Myelofibrosis patients treated with a combination of BET inhibitor CPI-0610 and ruxolitinib, 12 (80%) achieved a Spleen Volume Response of at least 35% (SVR35). The numbers indicate 8/11 (73%) of the newly added patients had a response. This is a […]
Taking a BET on CNST
Constellation Pharmaceuticals is focused on the development of cancer therapeutics by targeting the epigenetic pathway. It has EZH2 and BET inhibitors in mid-stage clinical studies. Excitement in the stock is driven by the BET inhibitor CPI-0610. There is substantial interest in this class of compounds. While small biotechs often lead the way with novel targets, […]
Initiating: Turning Point Therapeutics
San Diego based Turning Point Therapeutics is an oncology focused biotech that completed a successful IPO in April this year, raising about $190M with pricing at $18/sh. As the stock continued to climb, TPTX quickly filed for a secondary on September 3rd, adding another $200M to its cash hoard. The company is now very well […]
