The Daily Biotech Pulse: Soleno Flunks Late-Stage Study, Sanofi Strikes Breast Cancer Partnership, NanoViricides Shortlists Coronavirus Treatment Candidates

The Daily Biotech Pulse: Soleno Flunks Late-Stage Study, Sanofi Strikes Breast Cancer Partnership, NanoViricides Shortlists Coronavirus Treatment Candidates

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 8)

  • Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN)

  • Celldex Therapeutics, Inc. (NASDAQ: CLDX) (announced a positive readout for the Phase 1 study of KIT inhibitor CDX-0159)

  • Enochian Biosciences Inc (NASDAQ: ENOB) (moved on positive outcome from a preliminary FDA meeting regarding its HIV treatment candidate that could lead to pre-IND filing)

  • Fennec Pharmaceuticals Inc (NASDAQ: FENC)

  • Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA)

  • Phathom Pharmaceuticals Inc (NASDAQ: PHAT)

  • Replimune Group Inc (NASDAQ: REPL)

  • Sarepta Therapeutics Inc (NASDAQ: SRPT) (announced positive results from a study of SRP-9003, its investigational gene therapy for limb-girdle muscular dystrophy Type 2E)

  • Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)

  • Zynex Inc. (NASDAQ: ZYXI)

None of the NYSE- or Nasdaq-listed biopharma/medical diagnostics stocks hit 52-week lows Monday.

Stocks In Focus Shockwave's IVL Procedure Gets CMS Code For Medicare Reimbursement

Shockwave Medical Inc (NASDAQ: SWAV) said the Centers for Medicare & Medicaid Services issued new codes for intravascular lithotripsy, or IVL, procedures performed in peripheral arteries in both the hospital outpatient and inpatient settings.

These outpatient and inpatient codes will go into effect July 1 and Oct. 1, respectively. Shockwave develops and markets IVL to treat complex calcified cardiovascular disease.

Under these new codes, Medicare payment rates for IVL procedures performed in the hospital outpatient and inpatient settings are consistent with payment levels for other similar peripheral artery interventional procedures, Shockwave said.

The stock added 9.13% to $49.11 in after-hours trading.

Sanofi Announces Breast Cancer Combo Therapy Collaboration With Hong Kong's Alphamab

Sanofi SA (NASDAQ: SNY) announced an agreement with Hong Kong-based biopharma Alphamab Oncology to establish a strategic collaboration to investigate the latter's KN026 in combination with Taxotere in HER2+ breast cancer. Sanofi is also granted an exclusivity period to negotiate the in-licensing of KN026, subject to the achievement of certain clinical milestones.

KN026 is an anti-HER2 bispecific antibody that has shown promising preliminary efficacy and excellent safety profile in late-stage breast cancer patients who have failed multiple treatments in China.

Soleno Says Late-Stage Study Of Genetic Disorder Drug Fails To Meet Primary Goal

Soleno Therapeutics Inc (NASDAQ: SLNO) said its Phase 3 trial evaluating once-daily Diazoxide Choline Controlled Release, or DCCR, tablets for patients with Prader-Willi Syndrome did not meet its primary endpoint of change from baseline in hyperphagia.