Being good involves recognizing when youโre lucky & pounding the table w/conviction. 4 most dangerous words in investing are: this time itโs different. $NVCT
For my own tracking reference: as of July 14, 2024, here are the order of my position weight in my model portfolio:
1. $NVCT 2. $ZURA 3. $VYNE 4. $MNPR 5. $CORZ 5. $NTLA (tied) 5. $PRPH (tied) 6. $ETNB 7. $FULC 8. $SGMT 9. $GOSS 10. $OCUL 11. $HROW 12. $MREO 13. $STRO 14. $GLTO
@WabKinew
What about the antisemitism the Jewish community is experiencing? Do you have any words about that?? My family has removed the Mezuzah from our front door because we donโt feel safe having people know weโre Jewish. What can we do about that, Wab?
$VKTX has announced significant 52-week histologic data from the Phase 2b VOYAGE study, evaluating VK2809 in patients w/ biopsy-confirmed NASH. This marks a pivotal moment, as VK2809 continues to show significant efficacy in a disease w/ limited treatment options.
#NASH
#biotech
$TGTX I forgot one important thing in my thread: Over 2200 new prescriptions within 2.25 quarters, with an important clarification that this data only encompasses the fresh scripts recorded in their portal. Refills, a substantial component, are not reflected here.
$IOVA recently received a green light from the FDA for the trial design of IOV-LUN-202, which could fast-track the approval process for LN-145. This trial focuses on patients who have already undergone chemotherapy and anti-PD-1 therapy, showing a 26.1% ORR in preliminary results
$FULC The Phase 3 study for losmapimod in FSHD is reading out in 4Q24E. This event is one of the most significant remaining in biotech for 2024, with the potential for a 300%+ upside on positive data. Conversely, negative data could see the company trading around its cash value.
$AVRO long๐งต
โขOn May 22nd, $AVRO sold its Cystinosis Gene Therapy Program to Novartis for $87.5 million.
โขThis cash injection extended their runway into Q4 2024.
โขStrategic alternatives were announced, exploring options like sale, merger, or returning cash to shareholders.
$TGTX TG Therapeutics dropped key updates at the 42nd Annual J.P. Morgan Healthcare Conference. Let's unpack the highlights and milestones projected for 2024: thread ๐งต (Iโm long the stock)
$TGTX gotta think some bids coming in near future. I donโt see much (if any) risks & itโs historically been infested with shorts playing games & scare tactics
$NXGL is a leader in medical & OTC hydrogel products. Hydrogels are ultra-gentle, high-water-content materials designed for various applications. This technology is pivotal in products like wound dressings & cosmetic applications, providing exceptional comfort and effectiveness.
Very curiousโฆ can anyone in this $MREO cult go a single day without tweeting about the name? How many times can you repeat the same tweet with different wording? is it addictive to tweet the name? I get the signals are bullish but whatโs the point?
In an odd way, $TGTX CEO Weiss' decision to curtail script data is a nuanced move. While some argue it provides short-term ammo for stock suppression, the broader narrative envisions script numbers ascending meteorically, with the anticipation of 20 NRx and 20 TRx imminently.
An often overlooked legal idea: With BRIUMVI providing a breast-cancer risk-free alternative to Ocrevus, physicians may face potential legal ramifications for persisting with the latter. This dynamic warrants astute consideration in the evolving landscape of MS treatments. $TGTX
$HROW introducing pipeline w/ multiple shots on goal. Iheezi demonstrates impressive growth, boasting a 36% sales increase last quarter. Vevye holds promise for substantial mkt value, & Tresiecne, crucial in the current landscape, prepares for production. Mark Baum is a visionary
CEO Weiss' strategic shift away from Symphony is a shrewd move, likely to paint a clearer revenue picture. Analysts and retail may have underestimated the actual figures, which, once revealed, could propel $TGTX to new heights.
Intriguing dynamics at play today for $TGTX. A substantial short covering on ER day, but new shorts might find themselves in a precarious position. With 27% of the float short, there's potential for a strong squeeze.
$VKTX portfolio and strategic position make it a standout in the biopharma landscape. Whether through partnerships or acquisition, its potential to redefine the obesity and NASH markets cannot be overstated. This is a stock to watch for both long-term growth & strategic M&A
Future Catalysts:
โขJuly: Oral data for 60mg dose cohort.
โขObesity Conference: Full data presentation for high-dose oral drug cohorts.
โขYear-End 2024: Start of either Phase 2B or Phase 3 for SubQ formulation, contingent on FDA feedback.
$VKTX
With oral GLP-1s alone estimated at a $50B total addressable market, $VKTXโs VK2735 presents a significant opportunity. Considering 20-30% of patients may not tolerate existing GLP-1s from $LLY and $NVO, thereโs a $30B+ market for alternatives. Could VK2735 capture this? $VKTX
I got a lot of beautiful gifts for Hanukah the past week. However, the best gift I couldโve wished for is scooping up a bunch of $NVCT under $8. Wish granted ๐
For a potential acquisition cost of $25B, an acquirer would gain access to:
โขLeading NASH treatments.
โขInnovative obesity solutions.
โขX-ALD treatments.
โขMuscle mass improvement therapies (VK2511).
โขAll of which have potential best-in-class (BIC) profiles.
$VKTX
The $TGTX narrative takes a captivating twist with a short interest of 36.6 million shares, equivalent to a substantial 30% of the float. This substantial short interest adds a layer of complexity and intrigue to the unfolding story IMO
$MREO JP Morgan and Cantor project a 60-65% success probability for Setrusumab in the U.S. and EU, with peak sales estimates of $1.5 billion and $1 billion, respectively. With FDA and EU approval, both $MREO and Ultragenyx could each collect around $1 billion annually.
Lower Relapse Rate: Briumvi sets a new standard by lowering the annualized relapse rate below 0.1, indicating fewer than one relapse per year. It's faster, cheaper, and just as effective as Ocrevus. $tgtx
Going to be doing some reading into $OCUL over the weekend & craft an in-depth thread on my take. Very impressive pipeline that I canโt overlook here
Impressively, 23 out of 24 patients remain in the trial, some for as long as 20 months, with no serious adverse events reported, including cardiovascular issues. This is notable given the cardiovascular risks seen with Amgen's romosozumab in osteoporosis trials. $MREO $AMGN
$ARDX With an estimated 550,000 CKD patients on dialysis in the U.S., 80% of whom seek to manage serum phosphorus levels, the demand for effective solutions is substantial. XPHOZAH's novel mechanism positions it as a game-changer in this critical landscape.
Beyond GLP-1/GIP, $VKTXโs NASH program (VK2809) shows potential. With 52-week biopsy data expected soon, there could be a value surge. Comparatively, VK2809 might outperform recent approvals on efficacy and safety, setting a new benchmark. $VKTX
Alvelestat, targeting alpha-1-antitrypsin deficiency-associated lung disease (AATD-LD), has the potential for full U.S. and EU approval based on a single trial. This reflects the robust efficacy and strategic positioning of Alvelestat in $MREOโs pipeline. $MREO
Adding $UNCY to the model portfolio at $0.23. Think itโs more of a 2025 story but still cannot ignore the data looks good so far and they have a pretty lengthy cash runway
For my own tracking reference: as of July 14, 2024, here are the order of my position weight in my model portfolio:
1. $NVCT 2. $ZURA 3. $VYNE 4. $MNPR 5. $CORZ 5. $NTLA (tied) 5. $PRPH (tied) 6. $ETNB 7. $FULC 8. $SGMT 9. $GOSS 10. $OCUL 11. $HROW 12. $MREO 13. $STRO 14. $GLTO
VK2735โs ph.1 SAD results stand out:
โขCompleted all planned cohorts (0.25mg to 7.5mg).
โขPK profile: Tยฝ 170-250 hrs, suitable for weekly dosing.
Tmax 75-90 hrs indicates gradual onset.
No SAEs, with nausea increasing at higher doses. No vomiting until top dose (7.5mg) $VKTX
Game-Changing Drug Approval: In Dec 2022, the FDA approved Briumvi, a game-changer in the treatment of relapsing MS. It's a win for patients, requiring significantly fewer injections than competitors. $TGTX
Why I chose $NVCT for the
#biopick2024
contest. A new perspective I gained from reading
#Joelgreenblatt
โs โThe Little Book that Beats the Marketโ. Read till end:
$AUPH The landscape of Lupus patients in the U.S. is staggering, with 1.5 million affected individuals and an estimated 16,000 new cases annually. Yet, the stark reality persists: only 1939 active LUPKYNIS users two years post-approval.
$TGTX In the expansive landscape of MS, where 80K patients annually embark on new therapies, anti-CD20s claim their dominance. W/ BRIUMVI at the forefront, challenging Ocrevus, the scenario points toward anti-CD20s becoming the go-to treatment, capturing the lion's share of this
The optimism surrounding $TGTX intensifies as it gains traction with Ocrevus switches, attributed in part to the "efficacy gap". Furthermore, the involvement of esteemed Academic centers, now equipped with the J-Code, bolsters this positive momentum.
The valuation of $TGTX is poised to match, if not exceed, its peak sales potential. W/ influential MS opinion leaders expressing high intent for transitioning patients to Briumvi, there is substantial potential yet untapped, making any premature valuation seem unduly conservative
Brought my average in $NVCT down to $9.83. Thinking this name will be a 10-20x in 2024. Lots of positive updates in the JPM conference call today. See my tweets for all DD purposes; have posted many threads
Female-Focused Market: With 2/3 of MS patients being women and Ocrevus carrying a breast cancer warning, Briumvi becomes an attractive and safer option for many
Upcoming catalysts include VENTURE data in Q2, a Type C meeting with FDA mid-year, & ongoing ph.1 study for oral formulation. If VK2735 maintains its safety profile, it could redefine mkt. Imagine a well-tolerated pill sustaining lifelong weight lossโappealing to billions. $VKTX
$NVCT think the only reason weโre still sitting sub $10 is bc some inexperienced investors think that they will force the company into an offering, and expect further dilution. Highly doubt they will be successful with trying to force an offering w/ such high inside ownership
$ZURA pipeline is set to capture significant market share in the autoimmune and inflammatory disease space. Key opportunities lie in the treatment of Systemic Sclerosis (SSc), Hidradenitis Suppurativa (HS), and Alopecia Areata (AA).
Global Expansion Deal: Neuraxpharm agreed to pay $645 million (plus royalties) for the rights to sell Briumvi outside North America. This signals global potential and a significant revenue stream for $TGTX
$NXGL is a leader in medical & OTC hydrogel products. Hydrogels are ultra-gentle, high-water-content materials designed for various applications. This technology is pivotal in products like wound dressings & cosmetic applications, providing exceptional comfort and effectiveness.
Billing and Reimbursement Ease: The permanent J-Code issuance by CMS streamlines billing and reimbursement, aligning interests among insurers, infusion centers, doctors, and patients $TGTX
$VKTX While early data is promising, the sample size is small, and scaling peptide manufacturing is costly. The competitive landscape is vast, with many molecules vying for attention. Larger sample data could attract potential partners or acquirers, reducing the perceived risk.
Alvelestatโs mechanism of action, targeting neutrophil elastase, has shown promise in various lung diseases. Recent positive data from SINSM in bronchiectasis supports Alvelestatโs potential efficacy across multiple indications, further bolstering its market prospects. $MREO
Upcoming Data Release: The ORBIT Phase 2 study data is expected in the second half of the year, with a 14-month update anticipated around mid-year. This follows the October '23 update, which showed promising results after six to nine months of treatment. $MREO
Enter Ocrevus, where patients experience a wearing-off phenomenon before their next infusion. A compelling 61% of patients reported this phenomenon during ocrelizumab treatment. In this narrative, $TGTX's BRIUMVI emerges with advantages, providing a label with flexibility.
Added another $10K worth of shares to my core $NVCT pos. W/ the recent insider buys, and the hopes of a Japan partnership agreement + data in August-September, I am feeling optimistic. Best of luck to the other fellow $NVCT investors Iโve had the privilege of getting to know :)
colossal market. Amidst the speculative air, $MRK looms as a potential suitor for $TGTX. The prospect of a bidding war adds a layer of intrigue. As BRIUMVI charts its course, Symphony Trx data becomes the navigational tool, offering insights into the mkt dynamics & the potential
What does everyone think has better upside from current levels:
1. $MREO
2. $TGTX
3. $NTBL
4. $PRQR
I have my prediction of what will get the majority votes, but Iโm very curious to see which one wins the pollsโฆ
Time to put some of the clear winners from the previous polls up against each other. At current levels, which name has the most upside โ๏ธ
1. $PDSB
2. $MREO
3. $XFOR
4. $LPTX
I have my predictions set, but let the polls talk ๐ค
Cheers ๐ป
Alvelestat, licensed from $AZN, showed significant improvements in FEV1 and close to significant results on SVC in a small four-week trial for bronchiectasis. This positive data is supported by its mechanism of action targeting neutrophil elastase. $MREO
In the symphony of MS treatments, $TGTX's BRIUMVI is taking center stage with anecdotes hinting at a revolutionary redosing interval. Unlike Ocrevus, BRIUMVI offers flexibilityโredosable at 5 months to 24 weeks, combating the wearing-off effect observed in Ocrevus patients.
The partnership between $TGTX and Neuraxpharm brings forth a significant financial influx, paving the way for a bright future. The agreement's intricate structure ensures a substantial upfront payment along with potential royalties, marking a pivotal milestone for $TGTX.
The 2020 collaboration with Ultragenyx involves $254 million in milestone payments and double-digit royalties for $MREO, which retains EU rights. Ultragenyx CEO has emphasized Setrusumab as their highest value program with the strongest data and highest success probability.
The acquisition scenario for $MREO assumes even greater significance as Rubric Capital continues its buying spree. The strategic moves of this activist investor, as reflected in successive purchases, illuminate their confidence in $MREO's potential.
$NXGL also announced a pivotal IRB study in partnership with Innovative Optics US (
@InnovativeOptics
), targeting the application of hydrogels during laser hair removal.
$NVCT when you look at Charlesโ track record from 5-10 years ago, itโs impeccable. He touted $AXSM @ $2; itโs high was $110, was very right about $KERX, was right about $TGTX for a long time (until two days ago). & now heโs taking the most concentrated pos of his career in $NVCT
Big pharmaโs interest is keen, considering the efficacy and tolerability of VK2735. $PFE $AZN and others may find it more prudent to acquire $VKTX rather than develop lagging internal candidates.
$VKTXโs market cap (~$6B) with ~$1B in cash indicates undervaluation. Their assets in obesity and NASH, both with high success probabilities, suggest substantial upside. Obesity market PYS alone could generate massive revenues. $VKTX
$JANX with some very subpar preliminary data could be used as a barometer for upcoming $NVCT data. Think 400-500% is a reasonably conservative estimate for small cohort on prelim. But it will definitely create an aura affect for market anticipating future readouts. Expect 30%+ RR
An absolute game-changer for $GRVY - the approval for the Chinese market. This marks the inception of a fresh revenue stream, fortifying brand allegiance while intensifying global recognition.
With treatment. The ORBIT Phase 3 study is powered to demonstrate a 50% reduction in AFR. Even conservative assumptions for the placebo group's AFR suggest that Setrusumab could achieve statistically significant results with less than a 50% reduction $MREO
Unlike romosozumab, which has cardiovascular risks and is limited to one year of treatment in osteoporosis, Setrusumab has not shown similar risks and continues to be effective with ongoing treatment, suggesting it is suitable for chronic dosing in OI patients. $MREO
$TGTX so itโs obvious shareholders wanted a BO, not a partnership, they didnโt beat revenue or earningsโฆ sure maybe an overreaction, but this is why I try to stay away from overcrowded names because then it mitigates risk of massive reactions like this
The strategy focuses on capturing the new-to-market segment, a pivotal move in the evolving MS narrative. The Symphony Trx data becomes a key symphony in this narrative. As $TGTX eyes a top guidance of $37M, the intricate dance of Symphony Trx total reveals the trajectory.
$RCAT At the heart of their offerings is the Teal 2 drone. Designed to "Dominate the Nightโข", it boasts the highest-resolution thermal imaging in its class.