biotechnology stock investor

Joined January 2025
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I aspire to identify stocks that can be purchased now and held for a year to achieve long term capital gains. I seek to identify stocks that will at least double in value. I encourage you to consider these stocks yet do your own research before investing.
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$KURA Today's Presentation Many responders are continuing Ziftomenib as maintenance therapy for long periods of time. (Ziftomenib in combination with intensive chemotherapy, 7 3, in newly diagnosed NPM1-m)
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$CRDF Lawsuit Status Cardiff filled more documents with the federal court yesterday supporting their case. The court permitted some of this content to be filled under seal presumably to protect trade secrets. It appears that there has been no response yet from Nerviano. Yet, on Monday June 8, there was a filing of a "Joint MOTION for Extension of Time to File Answer." Others report that this is an agreement for Nerviano to file by July 17. It will be particularly interesting to see how Nerviano responds to accusations about pressure to change the royalty agreement and Cardiff declaring that they pushed them to include false information in a patent. pacermonitor.com/public/case…

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$KURA Today's Results Oral presentation tomorrow at European Hematology Association on longer term outcome of ziftomenib used in combo with 7 3. Results like this will result in more physicians using ziftomenib in combo treatments well in advance of that being part of an FDA label. (To be more specific these are long-term results from the Phase 1/2 KOMET-007 single-arm trial (NCT05735184) evaluating ziftomenib in combination with intensive chemotherapy, 7 3, in newly diagnosed NPM1-m or KMT2A-r AML.) library.ehaweb.org/eha/2025/… ir.kuraoncology.com/news-rel…
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$ABEO Updated Presentation They put emphasis on the effectiveness of the treatment. It it compelling data. Yet, what is key right now is patient count, especially reaching the mark of receiving payments from treating 9 or 10 patients in a quarter. They need to show strong progress towards that achievement in the second quarter. They need to meet that mark in the third quarter and report a small profit. d1io3yog0oux5.cloudfront.net…

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$TGTX Two Most Important Upcoming Events 2027: In early 2027, we likely will have SubQ Briumvi Phase 3 results. If these results support the expected quarterly dosing, I expect a major move in stock price. 2028: In early 2028, SubQ Briumvi could receive FDA approval. There is certainly a good chance that approval comes in the last quarter of 2027. This is technically the same drug that is just being given in a new format. ------------------------------------------------ Today's move appears to anticipate these events and significant growth in IV Briumvi sales over the next year.
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$BCTX 10-Q Reflections The 10-Q Report was published today. For me, it was an opportunity to be reminded of a few compelling findings. Here is my top 3: 1) The fact that one participant received 35 cycles of BRIA-IMT over 27 months conveys that this treatment is highly tolerable. They report, "No Bria-IMT related discontinuations have been reported to date." One way for a treatment to show better efficacy is for patients to find it tolerable and continue treatment for long periods of time. 2) Two of the long-term survivors had 9 prior regimes of other treatments. That is a ton. Those in this situation must have significant issues from treatment alone including compromised immune systems. They must have tumor cells that are highly resistant to treatment at this point. 3) Given they have hundreds of cancer patients in clinical trials, their spending is really low. Yes, they are living on the edge financially. They regularly need to raise capital through stock sales. Yet, it is important to recognize that their spending is quite reasonable.
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$TGTX Today's Conference Single Day Initial Infusion -Expect single day initial infusion (remove 15 day dose) label change to occur in 2027. Sub Q -Initial study results: bioavalability data (when put in sub Q compartment, 60% makes it into the blood). Using 2ML injector. Will use autoinjector. -Goal to take injections from 12 per year (current standard) to 4 per year. Competitor is working on extending to every 2 months. TG seeks every 3 months. Myasthenia Gravis Treatment -MG phase 1: n=11 "Data looked great - as great it can look for 11 patients." -The ultimate goal is to have Sub Q treatment quarterly. -Upcoming Phase 2 is potentially registrational study depending on results.
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AscendingBio retweeted

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$OCUL FDA Submission I hold that we have now entered the time when news of a submission to the FDA is possible. Yes, it could be many weeks away. Yet, it is possible that they are seeking to have the submission completed by Investor Day on June 17.
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$COYA ALSTARS Progress They announced on Dec 9 that the first patients had been dosed. Today's PR is a reminder that this group has now completed the initial 24-week phase of the study. My best guess is that they will complete enrollment in the study by August. It would not surprise me if that happened by mid-July. ir.coyatherapeutics.com/news…
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$AQST Maybe, This Week . . . It is possible that they issue a press release this week indicating that they have received the Type A meeting minutes from the FDA, the design for the human factors study is set, and they will start the study very soon. (I hold that they are under no obligation to issue PR for this event. Yet, I am expecting some kind of announcement about the status of the human factors study prior to the next quarterly in August.)
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$FATE Reminder of EULAR Abstract Text I went back and looked at the original EULAR abstact. In the dose 2 group, there is a participant who had a setback between months 6 and 9. This person stopped taking 2 medications at their own initiative. I suspect the person did not slowly titrate off the medication. This appears to have prompted issues. This is a reminder that interpreting these graphs accurately requires more information. distribution-congress.eular.…

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$CRDF Short Version of the Legal Issue NMS approaches Cardiff seeking to increase the royalties NMS will receive. NMS uses Cardiff's need to raise more funds by the first quarter 2027 to pressure them. They threaten to tell Cardiff’s investors and investment banks that they are going to revoke the licensing agreement. NMS says all will be good if Cardiff adds a NMS scientist to two patents. This would function to extend royalties. It is illegal to present false information for a patent and voids the patent. Rather than comply, Cardiff files in federal court asking for an order ending these actions by NMS and maintaining the licensing agreement. They also seek a jury trial to award damages. They do this at the point when NMS seeks to pressure them into illegal actions. If NMS is smart, they will settle this quickly. Their actions are damaging their own royalties and making them liable for huge damages. (Yes, this is similar to "You have nice company there - it would be a shame if something happened to it." Ok, NMS is an Italian company, but there are persons of every nationality capable of mafia-like activity.)
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$FATE Today's SLE FT-819 SLEDAI-2K Results Measure: The SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index – 2000) is a 24‑item, weighted disease‑activity index for systemic lupus erythematosus that scores only active manifestations present at the visit or within the prior 30 days. It includes 8-point, 4-point, and 2-point items that total to a maximum of 105 points. Mild disease: 1–5 Moderate disease: 6–11 High disease activity: ≥12, Very high activity: ≥20 Interpretation: Scores in the 10 to 20 range are common. This group started with a mean baseline of 13.6. Again, we have 1 or 2 persons beyond the 9 month mark. Generally, participants appear to have moved into the mild or moderate disease levels. It is difficult to interpret to later flair ups that are for two individuals. Could this be another short-term illness that is not related to Lupus? That seems likely with the Benda patient who returned to a score of 0 at 24 months.
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I initially did not notice that this graph uses cSLEDAI-2K not the SLEDAI-2K. That is the same instrument with blood test based data omitted. This is often done in research to aid interpretation. It is typically preferred to look at the blood test data separately.
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$CRDF Details about the Legal Issue. The content below is from the legal filing by Cardiff. They appear to have a very solid case. In fact, NMS is now facing significant financial risk. Given how the stock price dropped, they could face significant damages. (Again, I am not a lawyer.) (We will see how NMS responds. It is hard to see how they overcome what is asserted in this document.) Content: "Cardiff did not add Dr. Valsasina as a named inventor to the Cardiff Patents because she had no involvement in Drs. Ridinger and Erlander’s conception or reduction to practice of the claimed inventions of the Cardiff Patents. Rather, upon information and belief, Dr. Valsasina and NMS were not aware of Drs. Ridinger and Erlander’s inventions until after their innovative methods had been reduced to practice and Cardiff had filed its patent applications. A patent must accurately name the inventors of the claimed subject matter under an oath or declaration; failure to do so renders the patent invalid. NMS’s demand would have therefore required Cardiff to submit false oaths or declarations to the Patent Office that would invalidate the Cardiff Patents." "The License Agreement does not impose an obligation on Cardiff to add an NMS employee as a named inventor to patents conceived of and reduced to practice solely by Cardiff’s employees. To the contrary, the License Agreement specifically contemplates Cardiff filing, prosecuting, and owning its own patents for its own innovations." "NMS’s purported termination and related demands present a real and substantial risk to the cancer patients in the United States currently undergoing treatment pursuant to Cardiff’s ongoing clinical trials. NMS’s actions not only risk continuity of care for those patients undergoing clinical trials, but they jeopardize the health and safety of those patients too. The potential harm to Cardiff and these patients is immediate and urgent." Facts Asserted: "Drs. Erlander and Ridinger conceived of novel therapeutic methods of use for onvansertib in connection with their work for Cardiff. On September 11, 2022 and July 26, 2023, Cardiff filed provisional patent application Nos. 63/405,466 and 63/515,831, and subsequent U.S. Patent Application Nos. 18/750,971 and 18/751,014. After prosecution, the United States Patent and Trademark Office duly issued the ’813 and ’173 Patents to Cardiff on November 19, 2024 and April 1, 2025, respectively. No NMS employee contributed to the novel aspects of the inventions claimed in the Cardiff Patents." "Dr. Valsasina did not, however, communicate with or otherwise participate in the work of Cardiff employees Drs. Erlander and Ridinger during or in temporal proximity to their inventive efforts that led to the claimed inventions of the Cardiff Patents. Tellingly, the Cardiff Patents do not claim priority to Dr. Valsasina’s work or patents; the Cardiff Patents are instead directed to and were found to be patentable by the Patent Office for separate, novel inventions that were conceived in connection with Cardiff’s work. A patent must accurately name the inventors of the claimed subject matter under an oath or declaration; failure to do so renders the patent invalid." "On information and belief, NMS began a campaign to extract additional money or other value from Cardiff and the License Agreement in or around September 2024, including through demands that Cardiff agree to extend the royalty term of the License Agreement. NMS’s campaign later evolved to demand that an NMS employee (later identified to be Dr. Valsasina) be named as an inventor to the Cardiff Patents even though she did not jointly invent the claimed invention, to achieve a similar royalty-extending result. On information and belief, NMS’s attempts to renegotiate the License Agreement stem from NMS’s desire to negotiate more advantageous financial terms for the onvansertib drug product." "Unless a person contributes to the conception of the invention, he is not an inventor.” MPEP § 2109 (citations omitted) (emphasis added). Even if NMS’s claims that Dr. Valsasina had suggested areas to investigate prior to the License Agreement were true “one who suggests an idea of a result to be accomplished, rather than the means of accomplishing it, is not a[] coinventor.” Id. (quoting Ex parte Smernoff, 215 USPQ 545, 547 (Bd. App. 1982).)" Action Requested: "Cardiff therefore requests preliminary and permanent injunctive relief from the Court ensuring that NMS continues to perform under the License Agreement and declaratory judgments that Cardiff did not breach the License Agreement, that NMS’s purported termination is ineffective, and that Drs. Ridinger and Erlander are the correct inventors on the Cardiff Patents. Cardiff further requests all other available remedies in law and equity, including damages, resulting from NMS’s conduct and breaches of the License Agreement and the implied covenant of good faith and fair dealing."
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$FATE Today's SLE FT-819 FACIT Results Measure: Fatigue using the FACIT (Functional Assessment of Chronic Illness Therapy).   This has 13 items like: “I feel fatigued.”  “I need to sleep during the day,”  “I have no limit to my social activity because I am tired.”    It uses a scale of 0 to 4:  0 -Not at all   1 -A little bit     2- Somewhat    3- Quite a Bit     4- Very Much.   When this is scored, they reverse the values so that a score of 52 represents answering 0 to all the questions. Interpretation: Patients are beginning with baseline score which represents severe fatigue (mean 26.4). The increases in scores after treatment represent moving into the little or no fatigue level. (Note: After the six month mark, some of these values are based on a single patient. I ponder how this data is impacted by a short-term illness like the Flu.)
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