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CCXI is undervalued ahead of 4 catalystsTrade Summary Ticker: CCXI (Last: $8.84) Entry: $8.50-8.84 Price Target: $13-15.0+ Target Timeframe: 0-6 weeks Trade Thesis CCXI is an orphan/rare disease-focused company with a robust pipeline of clinical assets targeting autoimmune and inflammatory disorders as well as cancer. The company's lead asset CCX168 (Avacopan) is an orally administered small molecule being tested as a treatment for 3-indications. The most advanced of which is a pivotal phase 3 study in patients with ANCA associated vasculitis (AAV). Topline data is due this quarter. A key differentiator discussed by Nick Dinh, PharmD in this article between Avacopan and its failed peers is its ability to selectively inhibit parts of the complement system. In doing Avacopan avoids over-suppressing the patient's immune system. On June 5th, 2019 CCXI dropped -20% in response to the failure of its competitors InflaRx (Nasdaq: IFRX) lead asset (IFX-1) in phase 2. The market, in turn, failed to realize is that the mechanism of action of IFX-1 is distinctly different from Avacopan. Avacopan is a small molecule, unlike IFX-1 which is an antibody. The share price continued to decline and hit a new 52-week low of $6.16 in August following weak Q2 earnings. The stock price was resurrected after a J.P. Morgan analyst upgraded them to overweight and commented that CCXI's phase 3 ADVOCATE trial "has a high probability of success and the stock could rally +90-110% if successful, or fall -45-80% if it fails. To succeed Avacopan must prove non-inferior to the standard of care (SOC)(Rituximab or Cyclophosphamide and steroids). In phase 2 Avacopan hit its primary endpoint and demonstrated comparable efficacy (if not superior) to the SOC. Based on comments by the CEO, and the fact the management decided to withdraw its conditional marketing application in Europe so they could instead submit the phase 3 data due this quarter in support of full marketing authorization, and an NDA in the U.S, I bullish on the data readout. Of note, in May 2016 Vifor Pharma licensed Avacopan from CCXI gaining rights for areas outside the U.S. The deal was pretty sweet for CCXI and came with an upfront cash payment of $60 million, royalties, and milestone payments. Additionally, in 2016 CCXI was awarded PRIME designation by the EMA. On top of all this, there are 3 three more data catalysts coming in 2020 for a total of 4-shots on goal. CCXI is still down -22% since the IFRX data drag down. Consequently, positive data is not baked into the share price.CCXI's stock price should bounce into the second half of Q4. Heavy call option volume for Dec. 20th @$13 strike suggests the market is optimistic. Key Focus Phase 3 ADVOCATE top-line data due Q4 2019. Technicals RSI= 53 on the daily chart. Nearing a recent support level at $8.52 The next support level is $7.70 The 9-day EMA is holding above the 20-day and 200 day EMAs. (Assuming an $8.67 entry) Risk Assessment To mitigate the downside risk we can hedge by buying puts (Dec. 20th @$8.00 strike). I am looking to enter on any dips next week and am shooting for a cost basis below $8.84. Reward Potential and Price Targets: +14% ($9.90) +28% ($11.11) +49% ($13.00) +73% ($15.00) I (Sultan) have no position but intend to buy shares and/or call/put options next week. CCXI
CLong
by MS_Money_Moves
2
Buy The Dip In $MYOK$MYOK has caught our attention after selling off on key data and bouncing off a key support level. Also, key data reported yesterday was positive. Here are the highlights: A 59-subject Phase 2 clinical trial, MAVERICK-HCM, evaluating MyoKardia's (NASDAQ:MYOK) mavacamten in patients with non-obstructive hypertrophic cardiomyopathy (HCM) (the walls of the ventricles thicken compromising blood flow) met the primary endpoint of safety at week 16. Meaningful reductions in cardiac stress biomarkers were also noted. The results will be submitted for presentation at a future medical conference. The company intends to launch additional studies in patients with non-obstructive HCM (will provided a regulatory update in H1 2020) and heart failure with preserved ejection fraction (Phase 2 study should commence in Q2 2020). On another note, new data from its PIONEER open-label extension study of mavacemten in symptomatic obstructive HCM showed consistent results at week 48 (12 participants) compared to weeks 12, 24 and 36. Shares closed down 7% after the 5% runup at the end of last week. MyoKardia, Inc., a clinical stage biopharmaceutical company, discovers, develops, and commercializes targeted therapies for the treatment of serious and neglected rare cardiovascular diseases. Its lead product candidate is mavacamten, an orally administered small molecule, which is in Phase III clinical trial that is designed to reduce left ventricular contractility to alleviate the functional consequences and symptoms of obstructive hypertrophic cardiomyopathy (HCM) and prevent or reverse HCM progression, as well as in Phase II clinical trial for non-obstructive HCM. The company also develops MYK-491, an orally-administered small molecule, which is in Phase IIa clinical trial that is designed to restore normal cardiac muscle contractility in the diseased dilated cardiomyopathy (DCM) heart. Its preclinical programs include MYK-224, a HCM-targeting candidate that is designed to reduce excess cardiac contractility and enhance diastolic function; LUS-1, which is used to counteract a muscle abnormality that results in impaired relaxation of the left ventricle; and ACT-1 targeting genetic DCM due to sarcomeric mutations and impaired calcium regulation. The company has a collaboration with 23andMe, Inc., a consumer genetics and research company. Myokardia, Inc. was founded in 2012 and is headquartered in South San Francisco, California. As always, trade with caution and use protective stops. Good luck to all!
MLong
by InsiderFinancial
$NXTC Still Has Potential$NXTC got hammered on Monday after reporting disappointing data over the weekend. While the stock closed down 52%, it could have been a lot worse and the stock did bounce on the day. This signals that buyers were stepping in. Here's what happened: Thinly traded NextCure (NASDAQ:NXTC) closed down 52% on modest volume on the heels of updated results from the first part of its Phase 1/2 clinical trial evaluating NC318, a Siglec-15 (S15)-targeting monoclonal antibody, in patients with solid tumors. The data were presented at the SITC Annual Meeting in Maryland. Seven dose cohorts (8 mg - 1,600 mg every two weeks) were assessed, predominantly in patients with non-small cell lung cancer (n=13), ovarian cancer (n=7), melanoma (n=7), breast cancer (n=4) and colorectal cancer (n=3). All NSCLC patients failed to respond to PD-1 inhibitor treatment (median of four prior lines of therapy). Durable responses were observed, including one complete response (ongoing at week 55), one partial response (ongoing at week 28), four NSCLC patients with stable cancer (ongoing at weeks 16 - 40) and 14 participants overall with stable cancer (ongoing at weeks 16 - 42). On the safety front, 15 patients remain on study implying a discontinuation rate as high as 44% (n=15/34). Most treatment-emergent adverse events (TEAEs) were mild/moderate. There were three serious TEAEs, one case of episcleritis/uveitis and two cases of pneumonitis. The company has initiated the Phase 2 portion which will evaluate 400 mg administered every two weeks in ~100 patients with NSCLC, ovarian, head and neck and triple-negative breast cancers. The primary endpoints are safety and tolerability. Secondary endpoints include efficacy measures. Preliminary data should be available by late Q4 2020. NextCure, Inc., a biopharmaceutical company, engages in discovering and developing immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. Its lead product candidate is NC318, which is in Phase I/II clinical trials for the treatment of advanced or metastatic solid tumors. The company is also developing NC410, is a novel immunomedicine designed to block immune suppression for the treatment of ovarian cancer, non-small cell lung cancer, and renal cancer. Its discovery and research programs include an antibody in preclinical evaluation of other potential novel immunomodulatory molecules that targets a novel member of the B7-family of immunomodulatory proteins; and an antibody in preclinical development targeting an immune modulator that is expressed in inflamed tissue and the tumor microenvironment in various tumor types. NextCure, Inc. has a license agreement with Yale University; and a research and development collaboration with Eli Lilly and Company. The company was founded in 2015 and is based in Beltsville, Maryland. As always, trade with caution and use protective stops. Good luck to all!
NASDAQ:NXTCLong
by InsiderFinancial
Nektar should test 21.34 on earnings strength and might fill gapNektar Therapeutics got a big upside surprise on its earnings report for both earnings and revenue. With earnings and revenue trending up, $21-22 is a fair price for the stock given analyst estimates from before the earnings report. There's resistance at 21.34, so we may initially get rejected from that level. In the near-to-mid-term, however, the earnings beat should lead analysts to revise their forecasts upward. Depending on the size of the revisions, Nektar could attempt a gap fill up to 27.85. (Average analyst price target is over $29.)
NASDAQ:NKTRLong
by ChristopherCarrollSmith
NGM, The Little NASH Stock That CouldNGM I remain bullish on NGM's near-term price performance. Seventy-one percent of the outstanding shares are held by insiders and institutions. The largest shareholders being The Column Group L.P, David Goeddel (managing partner at The Column Group), and Peter Svennilson who are lauded in the biopharma industry. Goeddel's last company (Tularik) was sold to Amgen for $1.3 B in 2003. Merck also took a stake worth $450 M before NGM went public which included a 15% equity stake. The key point here is that these are not your everyday stakeholders. They are activists as well as investors. They are in for the long haul and will continue to buy as long as shorts try to bring NGM down as shorts have done to every other NASH stock. Since October 11th there have been eleven Form-4s. If you look back further you'll see many pages of insider buys since NGM's IPO earlier this year. Today (11/6/19) four more Form-4s came out showing that the insiders above collectively purchased ~$420K worth of stock this week. Buying support like this from the likes of this caliber of scientists and investors sends a strong message to short-sellers. Moreover, it will stoke the interest of investors on the sidelines. The fact that from 1Q19 to 2Q19 the number of hedge funds invested in NGM went from 0 to 10 supports this assumption. There are also multiple intermediate-term catalysts. In November of 2018 MRK reported positive phase 1b proof of concept data which showed that once-monthly NGM313 had an efficacious effect on insulin-resistant (i.e diabetic) NASH patients. This led to MRK exercising its option to license NGM313 (now MK-3655) from NGM in January 2019. The initiation of the phase 2 study for MK313 could happen at any time and could be catalytic for NGM. Finally, top-line data from NGM's phase 2 NASH study is expected in the first quarter of 2020. In my opinion, this data readout has the potential to propel NGM like Constellation Pharmaceuticals (CNST) which closed up 90% today (11/6/19) after announcing promising phase 2 data. To this point, CNST is another stock that The Column Group has a significant stake in (6.2 million shares, 18% ownership). Whereas in NGM they own 16.5 M shares (25% ownership stake). I don't know about you but I concentrate my capital on my top picks. A final aspect of my thesis is that shorts have not covered since there latest attacks. Based on data available on iborrow, the number of shares available to borrow went down to 20K this week from 100K last week. Assuming I am correct, and shorts can not successfully bring NGM down, the combination of shorts covering and longs buying will fuel the next leg up. As I discussed above the float is locked up and sits at 22 M. Under these conditions, we could see a strong move up.
NLong
by MS_Money_Moves
Potential Reversal Marker TherapeuticsMRKR Entered MRKR at $4.01 on Friday (11/1/19) and am monitoring for a sustained trend reversal. Watching for SP to bounce off $4.10, or if that does not hold, $4.01. If it does not reverse here I think it'll consolidate between $3.83 and $4.32. A reversal would coincide with a run-up into Q3 earnings which should be sometime this month and phase 2 data in Ovarian Cancer expected this quarter. Closing over $4.32 would be a good confirmation of a trend reversal. RSI and CCI on the daily support the stock is building momentum IMO.
NASDAQ:MRKRLong
by MS_Money_Moves