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The Daily Biotech Pulse: Sesen Rallies On Positive FDA Meeting, Supernus Flunks Late-Stage ADHD Trial, GW Pharma Earnings

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Nov. 5.)

  • Agile Therapeutics Inc (NASDAQ: AGRX) (follow-on rally following positive Adcom verdict for Twirla)
  • Avadel Pharmaceuticals PLC (NASDAQ: AVDL)
  • Bio-Rad Laboratories, Inc. (NYSE: BIO)
  • Constellation Pharmaceuticals Inc (NASDAQ: CNST)
  • Fulgent Genetics Inc (NASDAQ: FLGT) (reported forecast-beating third-quarter results) Karyopharm Therapeutics Inc (NASDAQ: KPTI)
  • NextCure Inc (NASDAQ: NXTC) (made a huge move ahead of SITC presentation of its investigational cancer drug NC318)
  • Phathom Pharmaceuticals Inc (NASDAQ: PHAT)
  • Rapt Therapeutics Inc (NASDAQ: RAPT) (went public Oct. 31)
  • Reata Pharmaceuticals Inc (NASDAQ: RETA)
  • Recro Pharma Inc (NASDAQ: REPH) (announced board approval for spin-off of Acute Care business and a special dividend)
  • Repro-Med Systems, Inc. (NASDAQ: KRMD)
  • TFF Pharmaceuticals Inc (NASDAQ: TFFP)

Down In The Dumps

(Biotech stocks that hit 52-week lows Nov. 5.)

  • Cyclerion Therapeutics Inc (NASDAQ: CYCN)
  • Helius Medical Technologies Inc (NASDAQ: HSDT)
  • Homology Medicines Inc (NASDAQ: FIXX)
  • Kezar Life Sciences Inc (NASDAQ: KZR)
  • Mirum Pharmaceuticals Inc (NASDAQ: MIRM)
  • Myriad Genetics, Inc. (NASDAQ: MYGN) (reported lower third-quarter earnings and revenue and lowered its full-year outlook)
  • Neuronetics Inc (NASDAQ: STIM) (reacted to third-quarter results)
  • Strongbridge Biopharma plc (NASDAQ: SBBP) (announced preliminary third-quarter results and the departure of its CEO)

Stocks In Focus Sesen Bio, FDA Agree On Post-Marketing Confirmatory Trial

Following a Type C meeting with the FDA, Sesen Bio Inc (NASDAQ: SESN) said it has reached an agreement with the FDA that the post-marketing confirmatory trial for Vicinium will enroll BCG-refractory patients who have received less-than-adequate BCG.

Apart from the initial indication for BCG-unresponsive patients who have received adequate BCG, labeling will be expanded to include the additional population of patients who have received less-than-adequate BCG, provided the confirmatory trial is successful.

Vicinium, a locally administered fusion protein, is Sesen Bio's lead product candidate being developed for the treatment of high-risk, non-muscle invasive bladder cancer.

"This was our third face-to-face meeting with the FDA in the past six months, and we continue to have very positive and constructive interactions, which help us advance Vicinium toward regulatory review and approval," Dr. Thomas Cannell, CEO of Sesen Bio, said in a statement. 

The stock advanced 20.91% to $1.33 in after-hours trading.

Supernus Flunks Late-Stage Study, Posts Disappointing Q3 Print 

The P301 trial of SPN-810 to treat impulsive aggression in attention deficit hyperactivity disorder in patients 6-11 did not meet the primary endpoint, according to Supernus Pharmaceuticals Inc (NASDAQ: SUPN).

The news came in an announcement of top-line data from the Phase 3 trial. 

Patients receiving SPN-810 36mg showed a median percent reduction of 58.6% in the average weekly frequency of impulsive aggression episodes from baseline that was not statistically significant compared to placebo.

Supernus also reported third-quarter results, showing a 0.9% drop in total revenue of $102.1 million and earnings per share, or EPS of 54 cents compared to 52 cents in the year-ago period. The results trailed estimates. The company lowered its net product sales guidance for 2019.

View more earnings on IBB

The stock fell 23.1% to $22.40 in after-hours trading.

See also: The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight

Puma's Breast Cancer Drug Receives Regulatory Nod In Hong Kong

Puma Biotechnology Inc (NASDAQ: PBYI) said its licensing partner in Greater China, CANbridge Pharma, has received registration approval from the Department of Health in Hong Kong to market Nerlynx for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who have completed adjuvant trastuzumab-based therapy less than a year ago.

Vifor, Evotech Stitch Up Nephrology Joint Venture

Vifor Pharma AG (OTC: GNHAF) and Evotec SE (OTC: EVTCY) announced a 50/50 joint venture focused on the development of novel nephrology therapeutics. Under the collaboration, Evotec will focus on applying its leading drug discovery and development capabilities and leverage Vifor's proven commercial platform to create a robust pipeline of nephrology programs.

Earnings

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH)'s third-quarter revenue came in at $91 million compared to $2.4 million in the year-ago period.

This exceeded the consensus estimate of $85.32 million. Epidiolex sales were $86.1 million, with over 15,000 patients receiving the CBD medication since its launch in the U.S.

The loss per share narrowed from 23 cents to 4 cents.

The stock fell 11.87% to $118.75 in after-hours trading.

Insulet Corporation (NASDAQ: PODD) reported 27% year-over-year third-quarter revenue growth to $192.1 million, but EPS fell from 3 cents to 1 cent. Analysts estimated EPS of 3 cents for the quarter.

The company raised its 2019 revenue guidance above the consensus estimate.

The stock added 3.28% to $149.56 in after-hours trading.

On The Radar Earnings

  • ANI Pharmaceuticals Inc (NASDAQ: ANIP) (before the market open)
  • Achieve Life Sciences Inc (NASDAQ: ACHV) (before the market open)
  • Aquestive Therapeutics Inc (NASDAQ: AQST) (before the market open)
  • Albireo Pharma Inc (NASDAQ: ALBO) (before the market open)
  • Amneal Pharmaceuticals Inc (NYSE: AMRX) (before the market open)
  • Acceleron Pharma Inc (NASDAQ: XLRN) (before the market open)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) (before the market open)
  • NewLink Genetics Corp (NASDAQ: NLNK) (before the market open)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open)
  • MannKind Corporation (NASDAQ: MNKD) (before the market open)
  • Elanco Animal Health Inc (NYSE: ELAN) (before the market open)
  • Ionis Pharmaceuticals Inc (NASDAQ: IONS) (before the market open)
  • Moderna Inc (NASDAQ: MRNA) (before the market open)
  • Mersana Therapeutics Inc (NASDAQ: MRSN) (before the market open)
  • Esperion Therapeutics Inc (NASDAQ: ESPR) (before the market open)
  • Voyager Therapeutics Inc (NASDAQ: VYGR) (before the market open)
  • Horizon Therapeutics PLC (NASDAQ: HZNP) (before the market open)
  • Aimmune Therapeutics Inc (NASDAQ: AIMT) (after the market close)
  • Sangamo Therapeutics Inc (NASDAQ: SGMO) (after the market close)
  • AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) (after the market close)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP) (after the market close)
  • Assertio Therapeutics Inc (NASDAQ: ASRT) (after the market close)
  • Athersys, Inc. (NASDAQ: ATHX) (after the market close)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI) (after the market close)
  • Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) (after the market close)
  • Emergent Biosolutions Inc (NYSE: EBS) (after the market close)
  • Puma Biotechnology (after the market close)
  • Cellular Biomedicine Group Inc (NASDAQ: CBMG) (after the market close)
  • Coherus Biosciences Inc (NASDAQ: CHRS) (after the market close)
  • Caladrius Biosciences Inc (NASDAQ: CLBS) (after the market close)
  • Unity Biotechnology Inc (NASDAQ: UBX) (after the market close)
  • PDL BioPharma Inc (NASDAQ: PDLI) (after the market close)
  • Nevro Corp (NYSE: NVRO) (after the market close)
  • Dynavax Technologies Corporation (NASDAQ: DVAX) (after the market close)
  • Geron Corporation (NASDAQ: GERN) (after the market close)
  • Glaukos Corp (NYSE: GKOS) (after the market close)
  • Collegium Pharmaceutical Inc (NASDAQ: COLL) (after the market close)
  • Hologic, Inc. (NASDAQ: HOLX) (after the market close)
  • Globus Medical Inc (NYSE: GMED) (after the market close)
  • MacroGenics Inc (NASDAQ: MGNX) (after the market close)
  • Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (after the market close)
  • Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) (after the market close)
  • Nektar Therapeutics (NASDAQ: NKTR) (after the market close)
  • Five Prime Therapeutics Inc (NASDAQ: FPRX) (after the market close)
  • Endologix, Inc. (NASDAQ: ELGX) (after the market close)
  • DexCom, Inc. (NASDAQ: DXCM) (after the market close)
  • OpGen Inc (NASDAQ: OPGN) (after the market close)
  • Natera Inc (NASDAQ: NTRA) (after the market close)
  • Clearside Biomedical Inc (NASDAQ: CLSD) (after the market close)

Related Link: Bausch Analyst Sees Challenging Setup For Next Leg Of Recovery Story

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