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

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 BHVN
• Celldex Therapeutics, Inc. CLDX (announced a positive readout for the Phase 1 study of KIT inhibitor CDX-0159)
• Enochian Biosciences Inc 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 FENC
• Kiniksa Pharmaceuticals Ltd KNSA
• Phathom Pharmaceuticals Inc PHAT
• Replimune Group Inc REPL
• Sarepta Therapeutics Inc 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 YMAB
• Zynex Inc. 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 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 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 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.

The company, however, said top-line results showed significant positive changes in two of the three key secondary points. It also said interim analysis of the ongoing extension study showed further reductions in hyperphagia of 48% after six months of DCCR treatment.

The stock was down 48.15% at $1.68 premarket Tuesday. 

See also: The Week Ahead In Biotech: Viela FDA Decision, Hematology Conference Take Center Stage

NanoViricides' Coronavirus Candidates Found Superior To Remdesivir In Animal Models

NanoViricides Inc NNVC said it has signed a memorandum of understanding with respect to antiviral treatments for coronavirus-derived human infections with TheraCour Pharma. The MoU specifically provides a limited, exclusive license to all R&D toward human clinical trials. NanoViricides said it intends to retain an independent consultant for the evaluation of the assets in order to develop the full license agreement. The company said the broad-spectrum anti-coronavirus drug candidates that it is developing showed strong effectiveness in an animal model of human coronavirus disease, potentially superior to remdesivir in this particular model.

The company cautioned that no conclusions to that effect can be drawn with the limited dataset. NanoViricides said prior to filing for human clinical trials, it plans on conducting studies to further determine the effectiveness against SARS-CoV-2, perform drug development studies for safety/toxicology and request a pre-IND Meeting with the FDA for regulatory guidance.

The stock was up 7.18% at $7.02 premarket. 

Agios Blood Disorder Drug Receives Orphan Desgination 

Agios Pharmaceuticals Inc AGIO said the FDA granted an orphan drug designation to its first-in-class pyruvate kinase-R activator mitapivat for the treatment of patients with thalassemia.

Mitapivat is an investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated PKR enzymes.

The stock advanced 1.68% to $53.11 in after-hours trading.

Global Blood To Seek Label Expansion For Sickle Cell Disease Drug

Global Blood Therapeutics Inc GBT said it plans to seek label expansion for the potential use of Oxbryta for the treatment of sickle cell disease in children ages 4-11 following a Type B meeting with the FDA.

It is currently approved in the U.S. to treat SCD in adults and adolescents 12 and older.

The stock gained 4.8% to $69 in after-hours trading.

Ardelyz Appoints Justin Renz As CFO

Ardelyx Inc ARDX announced the appointment of biopharma industry veteran Justin Renz to the position of CFO.

Erytech Pharma Reports Positive Preliminary Results For Leukemia Drug

In an update on the ongoing Phase 2 trial of eryaspase in second-line acute lymphoblastic leukemia patients, Erytech Pharma SA ERYP said the trial, which is being conducted at 22 clinical sites in the Nordic and Baltic countries of Europe, has reached its target enrollment of 50 patients. The company also said preliminary findings from the study suggest that eryaspase achieved the target level and duration of asparaginase activity in these patients.

Additionally, the addition of eryaspase to the combination chemotherapy was associated with an acceptable tolerability profile, enabling the majority of these patients to receive their fully intended courses of asparginase.

Enzo Biochem Posts Q3 Loss

Enzo Biochem, Inc.'s ENZ third-quarter revenues fell 14% year-over-year to $16.9 million, dragged by a 28% reduction in accession volume due to factors related to the COVID-19 pandemic. The company reversed from a profit of 47 cents per share to a loss of 21 cents per share.

The stock moved down 6.57% to $2.56 in after-hours trading.

Offerings

Cerecor Inc CERC said it intends to offer for sale shares of its common stock in an underwritten public offering. All the shares are being offered by Cerecor.

The stock retreated 9.94% to $2.90 in after-hours trading.

Replimune priced its upsized public offering of 2.826 million shares at $23 per share. The company also said it priced the public offering of pre-funded warrants to purchase 1.523 million of its common stock at $22.999 per pre-funded warrant. The company expects to raise $100 million in aggregate gross proceeds. All the securities earmarked for the offering are sold by the company. The company expects the offering to close June 11.

The stock was plunging 17.39% to $2.66 premarket. 

Retrophin Inc RTRX priced its underwritten public offering of 6.5 million shares of its common stock at $15.50 per share for gross proceeds of about $100.8 million. All of the shares are being sold by the company. The offering is expected to close June 11.

In after-hours trading, the stock fell 3.44% to $15.98.

Fate Therapeutics Inc FATE priced its underwritten public offering of 6.182 million shares of its common stock at $28.31 per share, before underwriting discounts, for an aggregate offering of approximately $175 million. All shares of common stock to be sold in the offering are being offered by the company. The offering is expected to close on or about June 11.

The stock rose 2.44% to $29 in after-hours trading.

On The Radar

Clinical Readouts, Presentations

Novavax, Inc. NVAX said its President of Research and Development Gregory Glenn will join other vaccine industry leaders for a panel discussion at 2020 BIO Digital, discussing COVID-19 vaccines. The panel discussion is scheduled for 11:30 am.

Related Link: Novavax Analyst Says DoD Funding Reflects Conviction In Platform, Ability To Deliver On Vaccine