The Daily Biotech Pulse: Merck's Keytruda Gets Label Expansion In Europe, Pfizer To Sell Chinese Biologics Unit, Celcuity Spikes

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 March 16)

• Affimed N.V. AFMD
• BioAtla, Inc. BCAB
• Champions Oncology, Inc. CSBR
• Harvard Bioscience, Inc. HBIO
• Myriad Genetics, Inc. MYGN
• Omnicell, Inc. OMCL
• Savara Inc. SVRA (reacted to a positive analyst action and insider buying)
• Sierra Oncology, Inc. SRRA
• Sol-Gel Technologies Ltd. SLGL
• Vincerx Pharma, Inc. VINC

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 16)

• Galecto, Inc. GLTO
• Immunocore Holdings plc IMCR

Stocks In Focus

Pfizer to Sell Chinese Biologics Unit to WuXi

Pfizer Inc.'s PFE China unit and Hong Kong-listed WuXi Biologics announced an equity agreement under which the latter will acquire the former's state-of-the-art biologics manufacturing facilities as well as its labor force in Hangzhou, China. The transaction is expected to close in the first half of 2021, which will immediately boost the commercial drug substance and drug product capacities for WuXi Biologics to address surging manufacturing demands.

Sage Announces Departure of COO Mike Cloonan, Details Data From Phase 3 Depression Study

Sage Therapeutics, Inc. SAGE announced that Mike Cloonan, its chief operating officer, is leaving the company effective May 3, to pursue other opportunities.

Separately, the company announced complete 12-month data from the 30 mg cohort and interim data from the 50 mg cohort of the ongoing Phase 3 study of zuranolone in major depressive disorder, showing the investigational compound was generally well-tolerated in both the 30 mg and 50 mg dose cohorts.

In the 30mg cohort, about 70% of participants with positive response with an initial 2-week treatment needed at most one additional zuranolone treatment during the 12-month period. After the initial 2-week treatment, over 70% of patients in the 30mg cohort and 80% of patients in the 50mg cohort achieved positive response at Day 15.

The stock was up 2.89% to $78.69 in premarket trading Thursday.

Novartis' Sandoz Generic Unit Acquires Distribution Rights to Generic Respiratory Inhalation Medicine In U.S.

Novartis AG's NVS Sandoz generic unit andoz announced the in-licensing of commercial distribution rights to the brand and authorized generic of respiratory inhalation medicine Proventil HFA inhalation aerosol from Kindeva Drug Delivery, a global CDMO. The albuterol sulfate authorized generic is immediately available to patients in the US.

Albuterol sulfate is used to treat patients four years and older suffering from bronchospasm, a condition where the muscular coat of the bronchial tubes contracts, resulting in a narrowing of the breathing airways.

Celcuity to Work With MD Anderson, Novartis and Puma Biotech For Breast Cancer Study

Celcuity Inc. CELC announced a clinical trial collaboration with the MD Anderson Cancer Center, Novartis and Puma Biotechnology, Inc. PBYI to conduct a Phase 2 clinical trial to evaluate the efficacy and safety of two targeted therapies, Tabrecta and Nerlynx in patients with previously treated metastatic HER2-negative breast cancer selected with Celcuity's CELsignia Multi-Pathway Activity Test.

MD Anderson will serve as the study sponsor and Celcuity will provide its CELsignia Multi-Pathway Activity Test to select patients with HER2-negative metastatic breast cancer who have hyperactive HER2 and c-Met signaling pathways for the trial. Celcuity will also fund the patient-related trial costs.

Based on MD Anderson's estimate of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after the protocol is activated and final results 12 to 15 months later. Celcuity expects enrollment to begin in the second quarter of 2021.

Celcuity shares were up 6.33% to $14.62 in premarket trading Wednesday.

Verrica Out-licenses Japanese Rights to Dermatology Product Candidates

Verrica Pharmaceuticals Inc. VRCA, a dermatology therapeutics company, announced a license agreement with Torii Pharmaceutical, granting Torii an exclusive license to develop and commercialize Verrica's product candidates for the treatment of molluscum contagiosum and common warts in Japan, including its lead product candidate VP-102.

The stock was advancing 6% to $17.66 in premarket trading Wednesday.

Merck's Keytruda Gets Label Expansion In Europe to Treat Adult and Pancreatic Patients With Hodgkin's Lymphoma

Merck MRK announced that the European Commission has approved an expanded label for Keytruda, its anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma, who have failed autologous stem cell transplant or following at least two prior therapies when ASCT is not a treatment option.

In premarket trading Wednesday, the stock was up 0.14% to $76.92.

Tonix Reports Positive Data From Animal Challenge Study of Single-dose COVID-19 Vaccine Candidate

Tonix Pharmaceuticals Holding Corp. TNXP announced positive preliminary results following vaccination of non-human primates with TNX-180, a live attenuated COVID-19 vaccine candidate engineered to express the SARS-CoV-2 spike protein.

"We are pleased that all eight animals vaccinated with TNX-1800 had undetectable SARS-CoV-2 in their upper and lower airways 6 days after challenge with SARS-CoV-2," said Seth Lederman, CEO of Tonix Pharmaceuticals.

Immunogenicity and protective efficacy of single-dose TNX-1800 were assessed at two dose levels, and at Day 41 after the vaccination, animals were challenged with live SARS-CoV-2 through intra-nasal and intra-tracheal routes. Protection was assessed at Day 47, six days after challenge. The research is part of an ongoing collaboration between Southern Research, the University of Alberta and Tonix.

Tonix shares were rallying 12.60% to $1.43 in premarket trading Wednesday.

Roche Launches New Compact Analyzer For Labs With Limited Space and Resources

Roche Holding AG RHHBY, which announced earlier this week a deal to buy GenMark Diagnostics, Inc. GNMK, announced the launch of cobas pure integrated solutions in countries accepting the CE mark. This new compact analyzer combines three technologies on a single platform helping to simplify daily operations in labs with limited space and resources.

"With a footprint of just two square meters, this new analyser provides small to medium sized labs with access to more than 230 diagnostic tests2 across a wide-range of disease areas including infectious diseases, oncology and cardiology," the company said.

Vyne, Adamas, ShockWave Move On Insider Transactions

VYNE Therapeutics Inc. VYNE revealed in a filing its director Patrick Lepore bought 12,500 shares in the company at $7.405.

Adamas Pharmaceuticals, Inc. ADMS disclosed in a filing David Mahoney, a director of its board, purchased 48,000 shares at 66.5 cents per share. John MacPhee, another director, bought 192,000 shares at the same price.

ShockWave Medical, Inc. SWAV said in a filing its chief commercial officer Isaac Zacharias exercised the option to buy 219 shares at $6.71 per share, and sold cumulatively 4,000 shares in four transactions.

Vyne shares added 4.06% to $7.69 in after-hours trading and Adamas rose 3.90% to $5.60, while Shockwave shed 4.76% to $109.

Earnings

Aprea Therapeutics, Inc. APRE reported a wider loss of 73 cents per share for the fourth quarter of 2020 compared to a loss of 64 cents a year ago. Analysts expected a narrower loss of 64 cents per share for the quarter. The company's cash balanced dwindled from $130.1 million at the end of 2019 to $89 million at the end of 2020.

The stock fell 6.50% to $5.75 in after-hours trading.

On The Radar

Earnings

ThermoGenesis Holdings, Inc. THMO (after the close)
CTI BioPharma Corp. CTIC (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates