Unusual Options Activity Fri 1/12/24

The following options are exhibiting notable trading, potentially indicating changing sentiment toward the underlying stocks, and/or potentially representing positioning for increased volatility.

Bullish Call Activity:

• ALT Jan 11.5 calls are seeing interest with the underlying stock up 4% (volume: 2100, open int: 1000, implied vol: ~236%, prev day implied vol: 158%). Co is expected to report earnings mid-February.
• TSM Jan 103 calls (volume: 16.1K, open int: 500, implied vol: ~45%, prev day implied vol: 27%). 1200 contracts traded in a single transaction. Co is confirmed to report earnings January 18 before the open.
• WW Feb 6.5 calls are seeing interest with the underlying stock down 5% (volume: 8570, open int: 20, implied vol: ~107%, prev day implied vol: 96%). NY Times reported that there is no evidence that weight loss drugs cause suicidal thoughts. Co is expected to report earnings late February.
• ARDX Feb 11 calls (volume: 2960, open int: 10, implied vol: ~78%, prev day implied vol: 74%). Co is expected to report earnings early March.
  

Bearish Put Activity:

• QCOM Jan 141 puts (volume: 1620, open int: 10, implied vol: ~47%, prev day implied vol: 31%). Co is confirmed to report earnings January 31 after the close.
• IOT Feb 31 puts (volume: 3230, open int: 0, implied vol: ~54%, prev day implied vol: 50%). Co is expected to report earnings late February.
  

Sentiment: The CBOE Put/Call ratio is currently: 1.04, VIX: (12.70, +0.26, +2.1%).
January 19 is options expiration -- the last day to trade January equity options.

-=Ardelyx (ARDX) : FDA questions its kidney disorder treatment drug

•  Company receives letter from the FDA identifying deficiencies in the NDA for tenapanor

Ardelyx receives letter from the FDA identifying deficiencies in the NDA for tenapanor that preclude discussions of labeling and post-marketing requirements/commitments at this time  

• Ardelyx received a letter from the FDA on July 13 stating that, as part of its ongoing review of the company's New Drug Application (NDA) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter stated that the notification does not reflect a final decision on the information under review.
  • Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company submitted an NDA to the FDA in June 2020. In April 2021, the FDA extended the PDUFA date to July 29, 2021, following the submission of additional analyses determined to be a major amendment.
• The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied.
  • While the FDA has not provided specific details regarding the deficiencies, the FDA noted that a key issue is the size of the treatment effect and its clinical relevance.
  • The company plans to work with the FDA to learn more about the identified deficiencies and will seek to resolve them as quickly as possible.

This week's biggest % winners & losers : Oct. 9 - 13, 17 (wk 41)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: ARDX (7.28 +28.76%), AERI (61.7 +17.19%), FPRX (43.36 +11.62%), LCI (23.25 +10.45%)
• Materials: PVG (12.01 +22.93%), RFP (6.4 +20.75%), FBR (16.32 +11.4%), MERC (13.18 +10.25%)
• Consumer Discretionary: CETV (4.8 +10.34%)
• Information Technology: ICHR (32.55 +23.25%), GLUU (4.35 +15.69%), NTNX (26.6 +14.93%), SOHU (64.96 +13.05%), CEVA (47.55 +11.49%), UCTT (33.54 +10.33%), TYPE (22.15 +10.2%)
• Financials: NOAH (40.13 +13.59%)
• Energy: HLX (7.86 +18.55%), SM (19.04 +12.13%), CVRR (11.35 +11.27%)

This week's top 20 % losers

• Healthcare: ATRS (2.33 -40.23%), NSTG (11.08 -31.52%), ONVO (1.55 -24.02%), SGRY (8.95 -20.8%), ARA (12.49 -19%), CYH (5.77 -18.73%), ADMS (19.05 -17.57%), CBPO (79.98 -16.84%), THC (13.15 -15.97%)
• Industrials: HDSN (5.95 -21.61%)
• Consumer Discretionary: ASNA (1.79 -18.26%), FRED (5.41 -17.15%)
• Information Technology: CCRC (12.79 -20.26%), AAOI (47.18 -18.89%), HAWK (34.9 -18.74%), HIMX (9.33 -15.41%)
• Energy: SDRL (0.29 -22.89%), PKD (0.98 -18.48%), CIE (1.05 -17.32%)
• Utilities: PCG (57.72 -16.15%)

Ardelyx (ARDX) : positive results of Tenapanor

 

Ardelyx Pivotal Phase 3 study of Tenapanor for IBS-C hits primary and all secondary endpoints to support NDA submission in 2H18

• Co reported positive results from T3MPO-2, its second Phase 3 study of tenapanor for irritable bowel syndrome with constipation (IBS-C). The study hit statistical significance for the primary endpoint and all secondary endpoints evaluated for the topline results and demonstrated the ability to normalize bowel movements. The primary endpoint, the combined responder rate for six of 12 weeks, showed that a greater proportion of tenapanor-treated patients compared to placebo-treated patients had at least a 30% reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements (CSBM) in the same week for at least six of the 12 weeks of the treatment period. In addition, tenapanor achieved statistical significance for the CSBM and abdominal pain responder rates in the six of 12 and nine of 12-treatment weeks, with a consistent response across the 26 weeks of the study. Tenapanor was well-tolerated in treated patients. 
• Based on positive results from two positive Phase 3 trials, Ardelyx is on track to submit a New Drug Application (NDA) to the FDA for tenapanor for the treatment of IBS-C in the second half of 2018.