Insider Trading Fri 10/13/23

Notable purchases -- 10% owner adds to GLT; notable sales -- Director active in AIR

Buyers:

• FNKO 10% owner bought another 23,082 shares at ~$7.2253 worth ~$167K.
• GLT 10% owner bought 236,000 shares at ~$1.80 worth ~$425K.
• LXRX Director bought 1,000,000 shares at $1.02 - $1.19 worth ~$1.1 mln.

Sellers:

• AIR Director sold 5,561 shares at $58.42 - $59.93 worth ~$329K.
• FRHC Director / former VP of Compliance sold 3,000 shares at $85.12 worth ~$255K.

This week's biggest % winners & losers : Dec 2 - 6, 19 (wk 49)

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

This week's top % gainers

• Healthcare: BOLD (59.25 +104.1%), AUPH (15.44 +94.46%), THOR (25.03 +39.83%), LXRX (4.87 +37.96%), RUBY (10.62 +37.92%), RCKT (22.37 +27.15%), ALLK (117.36 +23.54%), PDCO (23.51 +20.81%)
• Consumer Discretionary: EXPR (5.49 +39.69%), GCO (48.82 +31.45%), LE (15.05 +27.76%), BIG (25.21 +20.62%)
• Information Technology: SCWX (15.11 +33.25%), GTT (11.3 +27.4%), DOMO (23.39 +24.41%), DQ (45.71 +20.04%)
• Financials: EZPW (6.19 +20.9%)
• Utilities: PCG (9.65 +29.36%)

This week's top % losers

• Healthcare: SAGE (64.46 -58.35%), CLVS (9.61 -35.63%), CARA (16.76 -35.51%), PBYI (7.88 -16.97%), TGTX (7.12 -13.06%), FATE (13.67 -12.48%)
• Industrials: BE (5.28 -19.02%), EAF (12.29 -12.78%)
• Consumer Discretionary: HOME (5.67 -33.92%), MIK (6.69 -18.22%), CHS (4.03 -15.51%)
• Information Technology: ESTC (63.84 -19.61%), PAGS (28.82 -15.09%), MDB (131.17 -11.79%)
• Utilities: JE (2.1 -22.79%)

Long trade : LXRX +40% (12/19)

• Dec. 2:  Vol. 3.1M; $3
• Dec. 3; #44; vol. 1.3M
• Dec. 4; #29, 30, 37, 76; vol. 1.9M  +29%

 

Lexicon Pharma (LXRX) : Sanofi's (SNY) termination of Zynquista collaboration

 

** LXRX daily and monthly **

Sanofi said the termination of the partnership comes after the results of three late-stage studies of the oral drug, Zynquista, which is being jointly developed by the two companies.

In a separate statement, Lexicon said it had not yet received the underlying data from the studies and that it expects to conduct its own review. The company also said it considers Sanofi to be in breach of contract and the termination invalid.

Received preliminary top-line results from Sanofi (SNY) for three Phase 3 trials of Zynquista (sotagliflozin) for type 2 diabetes from the InSynchrony clinical program -- co had granted Sanofi an exclusive worldwide license (excluding Japan) to develop, manufacture, and commercialize Zynquista, but following the results, Sanofi notified co that it is terminating the Zynquista collaboration in all ongoing global type 1 and type 2 diabetes programs. Co has notified Sanofi that it considers that notice invalid and that it considers Sanofi to be in breach of contract. At this time, the ongoing clinical trials will continue. Among those top-line results, Zynquista 400 mg demonstrated numerical improvement on A1C in the SOTA-CKD3 study but did not achieve a statistically significant reduction on A1C in the subpopulation of patients with stage 3B chronic kidney disease, and in SOTA-CKD4, it achieved a clinically meaningful effect but narrowly missed statistical significance on A1C reduction vs placebo in patients with stage 4 CKD at 26 weeks. Co expects to conduct its own analysis of results when it receives the underlying data. Downgraded to Hold from Buy at Stifel. At new lows.

Lexicon Pharma (LXRX) reported earnings on Wed 13 March 19 (b/o)

 

Lexicon Pharma beats by $0.12, beats on revs

• Reports Q4 (Dec) loss of $0.16 per share, $0.12 better than the S&P Capital IQ Consensus of ($0.28); revenues fell 49.7% year/year to $17.1 mln vs the $13.33 mln S&P Capital IQ Consensus.
• Anticipated Upcoming Milestones
  • Q1 2019 -- Manuscript publications for XERMELO in carcinoid syndrome diarrhea
  • Q1 2019 -- Initiation of a Phase 1b study for LX9211
  • March 22, 2019 -- PDUFA date for sotagliflozin in type 1 diabetes in the U.S.
  • Q2 2019 -- European Commission decision on marketing application for sotagliflozin in type 1 diabetes in the EU

Earnings this week : March 11 - 15, 2019 (wk 11)

Earnings confirmed for this week

Monday (March 11)

• Morning: None
• Afternoon: ADT COUP KRO OXFD  PETQ SFIX

Tuesday (March 12)

• Morning: DKS IPI KEYW MOMO NOG 
• Afternoon: APEI CLNE COHU EVRI GH QHC NTRA  SENS SNCR SWCH  TEUM ZAGG ZTO  

Wednesday (March 13)

• Morning: DQ EXPR  LXRX  SGRY VRA
• Afternoon: APYX CLDR DOMO FSM GDS KINS MDB NNBR SFS SMTC TLRD

Thursday (March 14)

• Morning: BIOS CNNE DG ERJ GCO HUD INAP LX PPDF RDNT SND TEN UXIN
• Afternoon:  ADBE ASNA AVGO AVID DOCU HEAR HTHT JBL MRAM NDLS ORCL PVTL TERP TLYS TRQ TUSK ULTA VRAY WSC ZUMZ

Friday (March 15)

• Morning: BIOS BKE CTRN DPLO KIRK MDCA

-=Lexicon Pharma (LXRX) : FDA votes on type 1 diabetes mellitus treatment

• FDA AdCom votes 8-8 over whether to support sotagliflozin as an adjunct to insulin to improve glycemic control in adults with type 1 diabetes mellitus

Lexicon Pharma (LXRX) and Sanofi (SNY) confirm FDA Advisory Committee vote on Zynquista as treatment for adults with type 1 diabetes

• The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted eight to eight on the question of whether the overall benefits of Zynquista (sotagliflozin) outweighed the risks to support approval. Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor under regulatory review as an adjunct to insulin for the treatment of adults with type 1 diabetes (T1D). While the FDA is not required to follow the committee's vote, the agency considers the committee's recommendations when making its decision, which is anticipated by March 22, 2019. Sotagliflozin, developed by Sanofi and Lexicon, has the potential to be the first oral antidiabetic drug approved in the United States together with insulin therapy to improve glycemic (blood sugar) control in adults with T1D.
• Sanofi also submitted a regulatory application to the European Medicines Agency in 2018. An EMA approval decision is expected in the first half of 2019.

-=Lexicon Pharma (LXRX) reported earnings on Thur 22 Feb 2018 (b/o)

Lexicon Pharma beats by $0.14, beats on revs 

• Reports Q4 (Dec) loss of $0.27 per share, $0.14 better than the Capital IQ Consensus of ($0.41); revenues rose 43.7% year/year to $33.05 mln vs the $29.84 mln Capital IQ Consensus.
  • Revs increased, primarily due to milestone payments from the Ipsen alliance for the first commercial sale of XERMELO in the United Kingdom and Germany, and $5.4 million in net product revenues.
• Regulatory Filings for Sotagliflozin in Patients with Type 1 Diabetes Expected in First Quarter of 2018

=Lexicon Pharma (LXRX) reported earnings on Fri 3 March 17 (b/o)

Lexicon Pharma beats by $0.20, beats on revs:

• Reports Q4 (Dec) loss of $0.31 per share, $0.20 better than the Capital IQ Consensus of ($0.51); revenues fell 81.9% year/year to $23 mln vs the $15.56 mln Capital IQ Consensus. 
• Sotagliflozin: Results from this third Phase 3 clinical trial are expected in mid-2017. Lexicon also expects to report additional efficacy and safety data in 2017 from the inTandem1 and inTandem2 studies.
• In late 2016, Lexicon initiated a Phase 1 clinical trial of LX2761, an orally-delivered small molecule compound for the potential treatment of diabetes. LX2761 is an internally generated compound and is designed to inhibit SGLT1 locally in the gastrointestinal tract without any significant inhibition of SGLT2 in the kidney. Also in 2016, Lexicon obtained exclusive research, development and commercialization rights to LX9211, a development candidate for neuropathic pain that was jointly developed by Lexicon and Bristol-Myers Squibb Company as part of their neuroscience drug discovery alliance. Additional small molecule compounds acting through the same target as LX9211 are also included in the exclusive arrangement. LX9211 has completed IND-enabling studies, with Phase 1 clinical trials anticipated to commence during 2017.
• "With this week's FDA approval of XERMELOTM Lexicon has become one of a select few biopharmaceutical companies to bring to market on its own in the United States an innovation that was first discovered in its own labs."

Lexicon Pharma (LXRX) reports clinical trial results

Lexicon Pharma reports that the pivotal inTandem1 Phase 3 clinical trial of sotagliflozin met its primary endpoint :

Top-line results from the Phase 3 study showed that patients treated with sotagliflozin had a mean A1C reduction from baseline of 0.43% on 200mg once daily sotagliflozin dose (p

• Sanofi (SNY) stated, "These top-line results highlight potential benefits of sotagliflozin when treating adults with type 1 diabetes. We congratulate our partners on this positive outcome and look forward to further exploring this compound for the treatment of adults with type 2 diabetes when Sanofi begins the Phase 3 program later this year."