$SNSS Definitive Merger Agreement CASE STUDYSunesis Pharmaceuticals and Viracta Therapeutics Announce Definitive Merger Agreement
Merger to create Nasdaq-listed company focused on developing Viracta’s precision oncology pipeline targeting virus-associated malignancies
Leading institutional investors committed a total of $105 million in private financings with Viracta
Combined company expected to have approximately $120 million cash balance following the close of the merger
intends to be listed on the Nasdaq Global Market under the ticker symbol “VIRX.”
Viracta plans to initiate a registration trial for the treatment of EBV-positive lymphoma in the first half of 2021, and also plans to initiate a Phase 1b/2 trial in EBV-positive solid tumors in 2021.
The transaction is expected to close in the first quarter of 2021.
finance.yahoo.com
Biotech
$SLDB FDA Lifts Clinical Hold case studySolid Biosciences Announces FDA Lifts Clinical Hold on IGNITE DMD Phase I/II Clinical Trial
As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the Company’s response to these requests, the FDA acknowledged that the Company satisfactorily addressed all clinical hold questions.
“We are working diligently to complete all activities necessary to resume dosing, which we expect to occur in the first quarter of 2021.”
finance.yahoo.com
$CLSN received Fast Track designation from the FDA$CLSN today announced that it has received Fast Track designation from the U.S. FDA for GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer.
Fast Track designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need.
Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market,” said Michael H. Tardugno
Fast Track allows for more frequent communication with the FDA to discuss development plans and clinical trial design.
finance.yahoo.com
This penny stock $OBSV could skyrocket 100% in 2021The company’s lead drug candidate, linzagolix (branded as Yselty), is an orally administered GnRH receptor antagonist that has completed two Phase 3 studies, PRIMROSE 1 in the US and PRIMROSE 2 in both the US and Europe. The clinical trials enrolled 574 and 535 patients, respectively, and used doses of 100mg or 200mg to treat heavy menstrual bleeding associated with uterine fibroids. The results from both studies were positive, supporting Linzagolix's favorable safety and efficacy profile.
In an update announced last month, ObsEva reported that, pursuant to Phase 3 results, the European Medicines Agency (EMA) had validated for review the company's Marketing Authorization Application (MAA) for Yselty (100mg and 200mg). Potential MAA approval is anticipated in Q4:21. The drug is also slated to be the subject of a New Drug Application (NDA) that is due to be submitted to the FDA in Q2.
Wedbush analyst Liana Moussatos said that Linzagolix has the potential to achieve best-in class oral GnRH receptor antagonist status based on a flexible dosing regimen either with or without the add-back hormone therapy (ABT)—a key differentiator from other GnRH receptor antagonists… Based on the positive PRIMROSE 1 and PRIMROSE 2 primary endpoint results for YSELTY®/UF and additional follow-up data, we project annual sales of more than $750 million in 2027 for Linzagolix/UF,” Moussatos opined.
To this end, Moussatos rates OBSV a Buy along with a $28 price target.
finance.yahoo.com
SDDGR: Selling Shovels During Gold RushWe are in the midst of a biotech boom. SDGR sits to profit greatly, selling cost/time saving software. They sell drug/material discovery software to biotechs and pharma companies. They also fully or jointly own some early stage/preclinical drug programs as well. Here are the investment highlights I believe are key.
1- Their physics based software makes new drug/material discovery cheaper/faster than traditional ways. This first step is the most costly/lengthy part in creating new drugs/materials.
2- They are a biotech in the respect that they are owners/co-owners of certain compounds in ongoing development/trails, giving them enormous upside. Joint ventures are as far as phase 2.
3- Strong balance sheet behind a secondary offering in August. Roughly 3.5 years worth of operating expenses in cash on the books.
4- Strong partnerships with big pharma such as Bristol-Meyers. Ongoing focus on research and development, putting 65% of revenue towards it.
5- Smart money is in on this. Bill/Melinda Gates foundation, billionaire investor David Shaw and his old life science hedge fund Deerfield along with another MP from Deerfield are all 10% owners.
6- Technically, it is also in a nice set up. It had been trading in a pretty tight channel before yesterdays' nonlogical sell off (no news). It has had a nice rebound today and I am expecting it to make a push back to that $97 resistance level. If it can break that, I think a move to the $130s is in store within the next 6 months
ENZC Elliot Wave ProjectionWave 1 is the start of a bullish trend, it is SUPER hard to catch, usually everyone is pessimistic on the stock and nobody believes the move that its making.
Wave 2. where we currently are and possibly just finished.... usually has lower volume than wave 1, The price usually does NOT go below 0.618 fib retracement line (which we haven't) :), however sometimes but rarely it does.... The price usually falls in an ABC type of wave, which we currently saw last week. Phase 2 is where the shorts try to take over, the bears eat away at the ones scared to hold onto profits as we attempt to retest phase 1 lows. If you follow charts we ALWAYS retrace and test an old resistance like where we fail and drop harder, or buyers come in and we make the previous resistance a new support.
wave 3 THE EXCITING WAVE!!!!!!!! Usually the most POWERFUL and largest wave in a trend. (some would argue wave 5 is, but not necessarily true... Wave 3 - the news is now POSITIVE and fundamental analysts start to raise earnings targets and estimates.... *prices rise quickly and corrections are short lived. Anyone looking to get in on a pullback will likely "miss the boat" Wave 3 OFTEN extends wave 1 by a target ratio of 1.618 aka the GOLDEN POCKET!
$EOLS skyrocketed after end of Intellectual Property LitigationAbbVie, Evolus, and Medytox Announce Resolution of Intellectual Property Litigation
AbbVie (NYSE: ABBV), Evolus (NASDAQ: EOLS) and Medytox announce settlement agreements to fully resolve all outstanding litigation, including the United States International Trade Commission (ITC) case regarding the sale of Jeuveau®, between the companies. A California court case filed by Medytox against Evolus will be dismissed.
Under the terms of the settlement agreements, AbbVie and Medytox will release all claims against Evolus related to the alleged misappropriation of Medytox's trade secrets and grant a license to Evolus to continue to commercialize Jeuveau® in the United States and Nuceiva™ in all other territories in which Evolus has licensing rights. AbbVie and Medytox will receive milestone and royalty payments from Evolus. In addition, Evolus will issue common stock to Medytox.
finance.yahoo.com
$VCNX skyrockets on Deals with Two Pharma CompaniesVaccinex Announces Signing of Two Multi-Project Deals with Leading Pharmaceutical Companies Focused on Leveraging Its ActivMAb® Platform
Partnerships will use Vaccinex’s ActivMAb® platform for viral display of complex antigens to enable antibody discovery
www.globenewswire.com
Jefferies $PRTA buy recommendation with price target of $6Why VistaGen Therapeutics Stock Soared yesterday
The big jump came after Jefferies analyst Andrew Tsai initiated coverage on the stock with a buy recommendation. Tsai also set a one-year price target of $6, nearly three times the price of VistaGen's shares at the market close on Wednesday.
Why bullish?
Tsai really likes the potential for VistaGen's lead pipeline candidate PH94B . It's a nasal spray that VistaGen is evaluating in phase 2 studies targeting multiple neurological disorders. The company has already reported positive data from one of those studies, with PH94B showing promise in treating acute social anxiety disorder .
There are still plenty of risks for PH94B and VistaGen's two other pipeline candidates.
www.fool.com
$ONTX Closing of $28.75 Million Public Offering of Common StockOnconova Therapeutics to Present Corporate Update at the 2021 BIO CEO & Investor Digital Conference-February 16-18, 2021
finance.yahoo.com
Onconova Therapeutics, Inc. Announces Closing of $28.75 Million Public Offering of Common Stock Including Full Exercise of the Over-Allotment Option.
A total of 28,750,000 shares of its common stock were sold, including 3,750,000 shares of common stock following the exercise by the underwriters of their over-allotment option, at a public offering price of $1.00 per share.
finance.yahoo.com
$NVCN Regains Compliance with Nasdaq Minimum Bid Price RuleNeovasc Regains Compliance with Nasdaq Minimum Bid Price Rule
Currently, the Company is still not in compliance with the minimum market value requirement set forth in Nasdaq Rules for continued listing on the Nasdaq. Nasdaq Listing Rule 5550(b)(2) requires companies to maintain a minimum market value of US$35 million; the Company has until June 8, 2021 to regain such compliance.
The Company is also listed on the Toronto Stock Exchange and regaining compliance on the Nasdaq does not affect the Company’s compliance status with such listing.
finance.yahoo.com
TRXC - Ready to jump in to the double digit's area TRXC robot surgery company, with unique laparoscopy technology called Senhance. You can see more on February 23. on a virtual conference. finance.yahoo.com
PT1: 6.5$ done
TOP: 6.95$
Between R1 (4.74) - MA20 (4.14) Moderated BUY, under 4.14 (blue arrow) Strong BUY and they also have some good news today.
finance.yahoo.com
PT2: 10.10$ /R4 - blue arrow/
SONN Technical Analysis 🧙Sonnet BioTherapeutics Holdings Inc is a clinical-stage biopharmaceutical company. The company has developed FHAB (Fully Human Albumin Binding) technology which is well suited for drug development across a range of human disease areas, including in oncology, autoimmune, pathogenic, inflammatory, and hematological conditions. The firm's pipeline products include SON-080 (low-dose IL-6), SON-1210 (IL15- FHAB-IL12), SON-1010 (IL12-FHAB), and others.
If you understand the idea,🎯 press a thumb up! 👍 Have a question? Don't be shy to ask! 🤓 Interested to study how to analyze charts, follow me!
Topline data from the open-label, Phase 1b clinical trialDiffusion Pharmaceuticals Increases Previously Announced Bought Deal Offering of Common Stock to $30 Million, due to demand
announced today that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 29,268,294 shares of common stock of the Company at a price to the public of $1.025 per share, less underwriting discounts and commissions.
finance.yahoo.com
Diffusion Pharmaceuticals Completes Phase 1b Study of TSC in Hospitalized COVID-19 Patients
No Dose Limiting Toxicities or Serious Adverse Events Observed in Dosing Regimen Previously Untested in Clinical Trial Setting.
completion and topline data from the open-label, Phase 1b clinical trial of its novel.
finance.yahoo.com
Botanix Bullish Channel to Continue?Botanix Pharmaceuticals Ltd (ASX:BOT) is a clinical stage cannabinoid therapeutics company. The company focus is the development of safe and effective topical treatments for serious skin conditions. It has an exclusive license to use a proprietary drug delivery system - Permetrex for direct skin delivery of active pharmaceuticals in all skin diseases. The company's product pipeline includes BTX1503 - Moderate to Severe Acne, BTX1308 - Plaque Psoriasis, BTX1204 - Atopic Dermatitis, and BTX 1701 - Mild Acne.
Since posting my last idea on the 16th JAN, I thought since we are at another critical level to revisit the Idea and look at 3 posible forecasts.
1. Bullish
- Respect Upward Channel
- MACD weak and anticipating Bullish Cross
- RSI Trending Bullish towards the 50.00 Level
- TB Fib Extension level 1.618 aligning with upper band of Channel
NOTE: price will need to see some Strong Volume and Bullish movement to break through the Ichimoku Cloud internal of the channel (could we be so lucky to receive an announcement worthy?)
2. Bullish off Daily Support (EQ)
- If price is to break Uptrend Channel then a fall to Daily Equilibrium (Support) is likely. RSI is still below the Bullish 50.00 and MACD yet to cross Bullish. Price would also have to break through the Bearish ichimoku cloud that is identified. I think that lack of news and investment frustration could see price fall before a potential Double/Triple Bottom.
3. Bearish
- Break of Upward Channel
- Break of Daily Support
- TB Fib Extension Targets aligning with key levels of Support
- RSI would break uptrend
- MACD would spread and continue Bearish
NOTE: If price manages to fall below Daily Support then I would expect opportunistic buying at former levels of support before reversal.
The "boys" holding this down are getting weaker and starting to sweat IMO GLTAH
Disclosure: Held, Sentiment: Buy
"DISCLAIMER: NO ADVICE. The information presented here is general in nature and is for education purposes only. Nothing should be considered to be advice. You should consult with an appropriate professional for specific advice tailored to your situation."
BCRX may start an uptrendAfter a bit of correction and going down to sub $9 last week, buy side was more powerful Friday afternoon, and the SP climbed above $9.50... $10 is a first level resistance point, but once it is achieved, we can expect the SP to run towards $11.80... Support would be around $8.80 but considering the earnings was moved 2 weeks earlier (which may be a good sign), Factor D news, EU Orladeyo approval and upcoming Q1 earnings, the stock is believed to be in a positive momentum...
My analysis are not investment advice. Always do your own DD and take your own decisions.
Jefferies upgraded $PRTA to buy from neutral-100% upside1. Jefferies upgraded the stock to buy from neutral expecting a 100% upside to the stock.
Citing the ‘positive momentum and pipeline execution’ and rising investor attention, the analyst Michael Yee ups the price target to $30 from $15, nearly double its previous close.
Prothena’s pipeline has significantly expanded and improved.
The company’s early-stage candidates for Alzheimer’s disease ‘should start to garner more attention,’ Yee argues, projecting the three mid-to-late-stage assets to yield ‘a significant upside.’
Add more than $300M in cash and the partnerships with Bristol Myers and Roche, the stock ‘is primed to move up 100% towards $30+,’ concluded the analyst.
Out of Prothena's two candidates, PRX012 and multi-immunogen vaccine, targeting the Alzheimer’s disease, the former is on track for an IND filing in Q1 2022, the company disclosed in the recent R & D update.
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2. BTIG Research upgraded $PRTA from neutral to buy with price target $29.
seekingalpha.com