$KMPH Announces FDA Approval of AZSTARYS™KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD
Corium, Inc. will lead the commercialization of AZSTARYS per the definitive collaboration and license agreement.
Corium expects to make AZSTARYS commercially available in the U.S. as early as the second half of 2021.
Under the License Agreement, KemPharm may be eligible for up to $468 million in regulatory and sales milestone payments, as well as tiered royalty payments, on a product-by-product basis for net sales, with potential percentages up to the mid-twenties for U.S. net sales, and up to the mid-single digits of net sales in each country outside of the U.S.
finance.yahoo.com
Biotech
Strong pan-coronavirus effectiveness of clinical drug candidatesPan-coronavirus Clinical Drug Candidates for the Treatment of COVID-19 Are Highly Effective in Pre-clinical Cell Culture Studies Performed in Preparation of FDA Pre-IND Application
$NNVC reported yesterday on the strong pan-coronavirus effectiveness of its two COVID-19 clinical drug candidates for which the Company is preparing a pre-IND application.
NV-CoV-2 is the Company's broad-spectrum anti-coronavirus clinical lead drug candidate for the treatment of COVID-19 patients based on its nanoviricides® platform.
$NNVC is also developing NV-CoV-2-R, a drug treatment that combines the power of both NV-CoV-2 and remdesivir in a single drug that encapsulates and protects remdesivir inside NV-CoV-2.
Both NV-CoV-2 and NV-CoV-2-R are expected to work against most, if not all , coronaviruses and their variants, based on the Company's findings on their pre-clinical effectiveness discussed below.
NV-CoV-2 and NV-CoV-2-R were found to be highly effective in comparison to remdesivir against two distinctly different coronaviruses in our new cell culture studies leading towards a pre-IND application and thereafter an IND submission for these COVID-19 drug candidates.
The Company intends to report on the results of these studies in its pre-IND application to the US FDA to obtain guidance regarding human clinical trials for treatment of COVID-19 patients. Additionally, the Company is actively seeking opportunities to engage appropriate sites for human clinical trials. Further, the Company is engaged in the preparation of clinical trial protocols and other activities that would be necessary for submitting an IND application to the US FDA.
The Company has developed NV-CoV-2 based on its platform nanoviricides® technology. This approach enables rapid development of new drugs against a number of different viruses.
finance.yahoo.com
SONA NANOTECHDowntrend broken. Bullish flag on the 1 hour while trading tight with the 9 EMA. Above average volume past 2 days with no news? Leak ?
This play is known for it's volatility and leaky news, market is expecting good update about the company's new Covid-19 saliva test, along with sales, revenue projections, and regulatory approvals. Either one of those will increase the sp drastically.
If all goes well, I really see this play breaking it's previous ATH of $16, but for now remain cautiously optimistic. Short term goal is $8, can change depending on what the company releases.
Drop your targets below or what news you think we will hear next.
Long on SONA.CN
After six-week slide, I am buying MerckMerck is one of my favorite pharmaceutical companies. As far as I can tell, it a genuinely ethical and well-managed company with an above-average ESG rating. Merck has executed pretty consistently, with an average of 2% annual sales growth, 2.5% annual dividend growth, 3% annual earnings growth, and 4% annual free cash flow growth over the past several years.
Merck's valuation is quite attractive for a growing, large-cap company. I estimate its forward P/E at 10, forward P/S at 3.4, and PEG under 5. Merck's dividend yield is a juicy 3.76%, and they should have no problem sustaining that given their free cash flow growth. I estimate that Merck has about 16% upside to its median price multiple of the last four years.
Market sentiment is quite bullish on Merck. The average analyst summary score is a "buy" at 6.4/10. Merck has about 30% upside to its average analyst price target. Open interest from option traders is in highly bullish territory, with a put-call ratio of 0.56.
News lately has been a bit negative for Merck. Today they voluntarily withdrew their drug Keytruda for one of its (many) indications because it didn't meet FDA post-marketing requirements. That's not great, but it won't be devastating to Keytruda revenues. Merck's proposed purchase of Pandion Therapeutics is being investigated for procedural problems, which also isn't great. Plus, the FDA delayed approval of Merck's application for emergency approval for its Covid-19 drug until it produces more data.
On the other hand, Merck just submitted a New Drug Application for gefapixant and cut a billion-dollar commercialization deal for Xevinapant. Both those things are positives for the company. Plus, Merck got some positive attention recently due to a large purchase of its stock by Warren Buffett's investment fund.
In technical terms, Merck obviously has been in a downtrend, but it's approaching trend line support. I'm looking at buy tomorrow in the $71.50-71.75 range if Merck continues to dip toward support.
Tight Risk Reward, Good CompanyMersana Therapeutics, Inc., a clinical stage biopharmaceutical company focusing on the development of antibody drug conjugate (ADC) for cancer patients with unmet need.
After an insider at Mersana Therapeutics bought shares following a May 2020 selloff triggered by an interim data release, the stock rallied over 400% during the next eight months.
Another bounce back may emerge again with an insider purchasing shares after a one-day plunge of nearly 30% on tepid but still encouraging data from its lead ADC asset.
A 180-patient single-arm registrational trial is set to be initiated for XMT-1536 in the treatment of platinum-resistant ovarian cancer this quarter.
With early-stage clinical data due from both its candidates in the treatment of NSCLC adenocarcinoma in 2H21, Mersana merited another look.
I like it long here as tight risk-reward play.
$MORF Reports Positive Interim Results from Phase 1Morphic Reports Positive Interim Results from Single Ascending Dose Phase 1 Clinical Trial of MORF-057
1. MORF-057 well tolerated in all dose cohorts.
2. MORF-057 achieved greater than 95% mean receptor occupancy of integrin at three highest dose levels; demonstrates ability to saturate receptor
3. Data provide early clinical proof of concept for MORF-057 as an oral, selective inhibitor.
4. Phase 1 multiple ascending dose and food effect trials ongoing
“We’re excited to present the totality of the Phase 1 trial data later this year and to leverage this emerging data set to inform the optimal study design for Phase 2 trials in ulcerative colitis and beyond.”
In the Phase 1 SAD trial, MORF-057 was well tolerated in all 5 cohorts receiving MORF-057 in single doses ranging from 25 mg to 400 mg with no serious adverse events (SAEs) and no significant lab abnormalities in any subject.
Morphic expects to present the full data set from the MORF-057 Phase 1 clinical trial at an appropriate medical meeting in mid-2021.
finance.yahoo.com
Meanwhile, the company's long-standing partnership with pharma giant AbbVie is moving forward. Under the collaboration agreement between these two entities, which started more than two years ago, AbbVie initially paid $100 million up front to Morphic to acquire exclusive license options for some of Morphic's candidates.
Morphic Holding would be responsible for conducting research and development for these products up to the completion of investigational new drug enabling studies. AbbVie would then be able to exercise its license option for a fee to take up the development of these programs. Today, Morphic Holding announced that AbbVie paid a $20 million fee to assume the responsibility to develop and commercialize a couple of Morphic's pipeline candidates.
Lastly, Morphic has a partnership with Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), which focuses on developing integrin therapeutics for conditions for which there are few adequate therapy options. Morphic announced that it has expanded this partnership with the pharma company.
For a drugmaker with no products on the market, lucrative deals with well-established pharmaceutical companies are important. Morphic Holding will be able to use the funds it received from AbbVie to fund the clinical development of some of its other candidates, while its partnership with Janssen could bear fruit in the form of promising clinical compounds. These factors explain why investors are bidding up shares of Morphic Holding today.
www.fool.com
Why Lixte Biotechnology Soared heavily on friday?Why Lixte Biotechnology Soared heavily on friday?
It seems as though retail investors are banding behind this ultra-low float stock, lifting demand and therefore, lifting its price. the company hasn’t issued any news.
Nonetheless, it seems as though the retail crowd on Wall Street is banding behind the stock.
there is quite a bit of discussion about the stock on Wall Street Bets, StockTwits, and Twitter, suggesting that the retail crowd is interested.
At the moment, LIXT trades with a public float of just 4.5 million shares. That’s an incredibly low share supply. As the law of supply and demand tells us, when supplies of anything are very low and a flood of demand comes in, the price must increase.
With retail investors diving into LIXT, and such a tiny public float, it only makes sense that the stock is experiencing dramatic gains.
cnafinance.com
$JAN to Sell its Legacy Recycling Business for $25 MillionJanOne Announces Definitive Agreement to Sell its Legacy Recycling Business for $25 Million
Successful disposition will facilitate continued strategic focus on high-value late-stage biopharma asset JAN101 for the treatment of peripheral artery disease (PAD)
The transaction is expected to close on or before August 18, 2021
JanOne recently completed production of JAN101 under Current Good Manufacturing Practices (cGMP) for the anticipated Phase 2b PAD trials.
The Company plans to submit the Phase 2b protocol and related documents to the FDA under its Investigational New Drug Application (IND) for PAD in March 2021 .
finance.yahoo.com
Viracta Therapeutics Announces Closing of Merger with $SNSSViracta Therapeutics Announces Closing of Merger with Sunesis Pharmaceuticals and $65M Private Placement
Shares of Viracta to commence trading on the Nasdaq Global Select Market on February 25, 2021 under ticker symbol 'VIRX'
Cash and cash equivalents of over $120 million as of merger close
Registration trial for the treatment of relapsed/refractory EBV-positive lymphoma expected to begin in 1H2021, and a Phase 1b/2 trial in EBV-positive solid tumors in 2021.
The combined, publicly traded company will focus on the advancement and expansion of Viracta's clinical stage pipeline, including Viracta's lead program for the treatment of Epstein-Barr virus (EBV)-positive lymphoma.
Immediately prior to the closing of the merger, Viracta also closed the previously announced $65 million private placement of its common stock.
On February 24, 2021, and in connection with the closing of the merger, Sunesis effected a 1-for-3.5 reverse stock split . All issued and outstanding shares of common stock of Sunesis were subject to the reverse stock split.
Viracta has approximately 37.0 million shares of common stock outstanding , with pre-merger Viracta shareholders collectively owning approximately 86.05% of the combined company and pre-merger Sunesis shareholders collectively owning approximately 13.95% of the combined company.
finance.yahoo.com
ASLAN Pharmaceuticals Announces $18 Million Private PlacementASLAN Pharmaceuticals Announces $18 Million Private Placement
ASLAN today announced that it has entered into a securities purchase agreement to raise gross proceeds of approximately $18 million resulting from the sale of its ordinary shares through a private placement to new institutional investors, Vivo Capital and Surveyor Capital (a Citadel company).
the Company will issue an aggregate of 25,568,180 ordinary shares (equivalent to 5,113,636 American Depositary Shares (“ADSs”)) at an equivalent price of $3.52 per ADS, equal to the last closing price of the Company’s ADSs. The Company intends to use the net proceeds from the private placement primarily to advance clinical development of ASLAN004, as well as for general corporate purposes.
“These additional resources position us well as we look forward to unblinding the interim data from our ongoing study of ASLAN004 in atopic dermatitis in early March and look towards initiating our phase 2b program later in 2021.”
finance.yahoo.com
Covid vaccine play 🚀🚀🚀VBIV CEO Baxter said on a feb 5 2021 podcast that human trials were to begin in the next couple of weeks for their single dose monovalent covid vaccine vbi-2902, which received $56 Million from Canada to produce a vaccine. Today moderna announced forecasted sales of ~$18 Billion just from covid vaccine sales. Once VBi announces initiation of human trials for the ph1/2 study planned in Canada, I’m expecting a sizeable move to the upside.
Cup and handle - handle retraced to FIBO 618 retrace net which is a nice area to see bounce. I see potential to test The previous high of $6.98 as perceptive advisors did not sell any shares after loading bigly sub-$1 prior to that run which was over 1000% incl trade for them. This shows they expect SP to move significantly higher or fhey would have sold a percentage to re add on dips after that massive run.
With all the catalysts in 2021, GBM treatment with eVLP , SCI-b-vac and hepB therapeutic, pan-corona vaccine and this single dose vaccine, I see no reason why this can’t be double digits by year end.
Please like and follow! 🚀🚀🚀🚀
Disclosure: not investment advice as I am not a financial advisor. This information is to be used for educational purposes only.
HGEN: log chart of a COVID-related tradeHumanigen is due to present major data from Phase III trials at three conferences in mid-March. The stock is in multiple wedges, and a breakout or breakdown seems highly likely.
Shares are currently trending sideways --- in my opinion, as investors await the outcomes of these events.
When it comes, the move is likely to be explosive. Thus, implied volatility is presently quite high. Normally, I would be tempted to sell a straddle. But I think that realized volatility may exceed implied volatility in this case. Just a guess!
I am buying long ATM straddles here with the April 16 expiration. I am also buying shares of the stock on this week's pullback.
DOCT.C -- Cup & Handle breakout!Under the radar biotech play. Confirmed Cup & Handle breakout. Bullish MACD cross is a technical buy signal. Technical price target .30+.
$SNSS In at 5.45 -----> target 6.23 for 13.31Double position at 4.67
If this doesn't hit in two days 4hr chart plan will be initiated.
Reversal Setup #stocksPotential reversal to the upside off of range lows
Reward/Risk: 3.68/1
Entry: 81.94 or at a lower price
Stop: 76.00
Target: 102.00
Options Play: April 16 85/90 Call Vertical
SRNE - Beginning of third wave, maybe..As long as the company continues to provide decent news and progress, I believe this pattern will prove itself.
The market went down hard at yesterday's session and recovered strongly, I believe that SRNE weak hands were washed out in that move and now it will be easier for it to move towards the highs.
If the volume goes down and the price will move sideways/down for more than a week than consider the plan cancelled.
$ONCY initiated with a Buy at H.C. Wainwright -302.14% potentialOncolytics initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Patrick Trucchio initiated coverage of Oncolytics Biotech with a Buy rating and $15 price target. The company is "on the cusp of demonstrating potential to upend the treatment paradigms of several cancers," Trucchio tells investors in a research note. He believes Oncolytics is well positioned for the "oncolytic virus trend."
The price target was set to $ 15.00. At a current price of $ 3.73 there is upside potential of 302.14%.
$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
$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!
