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

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

Down In The Dumps

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

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

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

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