The Daily Biotech Pulse: Novavax CFO Departs, Zai Lab Inks Cancer Drug Collaboration, FDA Nod For Gilead

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 April 13)

• Bio-Techne Corporation TECH
• Celcuity Inc. CELC
• Medpace Holdings, Inc. MEDP
• Medtronic plc MDT
• MiMedx Group, Inc. MDXG
• Natus Medical Incorporated NTUS
• NovoCure Limited NVCR (reacted to positive independent Data Monitoring Committee review of pivotal Phase 3 study data for lung cancer treatment candidate)
• Theratechnologies Inc. THTX
• Zymeworks Inc. ZYME

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 13)

• Acutus Medical, Inc. AFIB (announced FDA clearance for AcQCross family of universal transseptal crossing devices)
• Adverum Biotechnologies, Inc. ADVM
• Aprea Therapeutics, Inc. APRE
• Assembly Biosciences, Inc. ASMB
• Athenex, Inc. ATNX
• Atreca, Inc. BCEL
• Avidity Biosciences, Inc. RNA
• Axsome Therapeutics, Inc. AXSM
• Calithera Biosciences, Inc. CALA
• Celyad Oncology SA CYAD
• Checkmate Pharmaceuticals, Inc. CMPI
• Coherus BioSciences, Inc. CHRS
• ContraFect Corporation CFRX
• Decibel Therapeutics, Inc. DBTX
• Design Therapeutics, Inc. DSGN
• Evofem Biosciences, Inc. EVFM
• Homology Medicines, Inc. FIXX
• Idera Pharmaceuticals, Inc. IDRA
• IMARA Inc. IMRA
• Ionis Pharmaceuticals, Inc. IONS
• iRhythm Technologies, Inc. IRTC (announced revenue impact from recently published Medicare reimbursement rate by Novitas)
• Karyopharm Therapeutics Inc. KPTI
• Kronos Bio, Inc. KRON
• Lixte Biotechnology Holdings, Inc. LIXT
• MediciNova, Inc. MNOV
• Metacrine, Inc. MTCR
• Millendo Therapeutics, Inc. MLND
• Nabriva Therapeutics plc NBRV
• NeuBase Therapeutics, Inc. NBSE
• Osmotica Pharmaceuticals plc OSMT
• PainReform Ltd. PRFX
• Pulmatrix, Inc. PULM (reacted to termination of license agreement for Johnson & Johnson JNJ)
• Qualigen Therapeutics, Inc. QLGN
• Reata Pharmaceuticals, Inc. RETA
• Relay Therapeutics, Inc. RLAY
• Reneo Pharmaceuticals, Inc. RPHM (IPOed Friday)
• Repro Med Systems, Inc. KRMD
• Reviva Pharmaceuticals Holdings, Inc. RVPH
• Sarepta Therapeutics, Inc. SRPT
• Syros Pharmaceuticals, Inc. SYRS
• Titan Pharmaceuticals, Inc. TTNP
• VectivBio Holding AG VECT (IPOed Friday)
• Voyager Therapeutics, Inc. VYGR
• Y-mAbs Therapeutics, Inc. YMAB

Stocks In Focus

Novavax Announces Departure of CFO, Executive Appointments

Novavax, Inc. NASDAQ announced CFO Greg Covino will step down for personal reasons and will take on a new role as executive adviser to the company. John Trizzino, EVP, chief commercial officer and chief business officer, will assume the CFO role on an interim basis while a search is underway for a replacement.

The company also announced the promotion of Gale Smith to the role of SVP, Discovery and Pre-Clinical Research and chief scientist, and the appointment of biopharma industry veteran Troy Morgan as SVP, chief compliance officer.

The stock was down 1.37% to $192 in after-hours trading.

Flexion Expects Q1 Revenues to Be Roughly In Line With Estimates Despite COVID Impact

Flexion Therapeutics, Inc. FLXN announced preliminary first-quarter revenues, comprising solely Zilretta sales, of $24.6 million, roughly in line with the $25.23 million consensus estimate. Zilretta is an FDA-approved medication indicated to treat osteoarthritis of the knee. The company expects full-year revenues of $120 million to $130 million. Analysts, on average, estimate net sales of $137.42 million.

The stock rose 5.96% to $9.96 in after-hours trading.

Zai Labs Announces Cancer Collaboration Deal With Preclinical Biotech RubrYc

Zai Lab Limited ZLAB announced an R&D collaboration and license option agreement with preclinical biotherapeutics company RubrYc, under which both companies will collaborate to identify product candidates using RubrYc's Discovery Engine, which leverages machine learning and structural data to identify antibodies that bind to subdominant epitopes and exhibit differentiated activity for an undisclosed oncology target.

On exercising of the licensing option, Zai Lab will have exclusive global rights to develop and commercialize product(s) of the collaboration. RubrYc will receive an upfront payment and is eligible to receive future research, development and commercialization milestones on a per candidate basis, along with royalties on worldwide net sales of each product.

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

Longboard Spikes On No Major News

Longboard Pharmaceuticals, Inc. LBPH, which IPOed recently, was found rallying ahead of the closing of the offering.

The stock surged up 33.22% to $15.80 in after-hours trading.

Gilead's Antibody-drug Conjugate Approved For Urothelial Cancer

Gilead Sciences, Inc. GILD said the U.S. Food and Drug Administration has granted accelerated approval of Trodelvy, an antibody-drug conjugate, for use in adult patients with locally advanced or metastatic urothelial cancer, who have previously received a platinum-containing chemotherapy and immunotherapy. The Trodelvy U.S. prescribing Information has a boxed warning for severe or life-threatening neutropenia and severe diarrhea.

Merck, TILT to Collaborate For Phase 1 Study of Oncolytic Virus-Keytruda Combo For Ovarian Cancer

TILT Biotherapeutics, clinical-stage biotech developing cancer immunotherapeutics, announced a clinical trial collaboration agreement with Merck & Co., Inc. MRK to evaluate TILT's adenoviral cancer immunotherapy TILT-123, a dual cytokine armed oncolytic adenovirus, in combination with Keytruda, in a Phase I dose escalation trial in platinum-resistant or refractory ovarian cancer.

J&J to Delay COVID-19 Vaccine Rollout and Trials In Europe Following U.S. Regulatory Decision to Pause

In response to the pause recommendation for the use of its COVID-19 vaccine, J&J said it is reviewing the cases with European health authorities in a bid to proactively delay the rollout of its vaccine in Europe and pause vaccinations in all its COVID-19 vaccine clinical trials.

"We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public," the company added.

Moderna Announces Positive Preclinical Data For COVID-19 Variant-specific Vaccine Candidates

Moderna, Inc. MRNA announced new results from a preclinical study of the its COVID-19 variant-specific vaccine candidates showed that the variant-specific booster vaccine candidates - mRNA-1273.351 and mRNA-1273.211 - increase neutralizing titers against SARS-CoV-2 variants of concern.

The company also said it remains on track to deliver the second 100 million doses to the U.S. government by end of May 2021 followed by another 100 million additional doses by end of July 2021.

The stock was higher by 1.92% to $152.59 in the after-hours trading.

Lilly Out-licenses Rights to Parkinson's Disease Antibody Therapy In Greater China Region

SciNeuro Pharma announced an exclusive license agreement with Eli Lilly and Company LLY for the development and commercialization of alpha-synuclein targeted antibody therapies for the treatment of Parkinson's disease, in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan.

Under the terms of the agreement, SciNeuro has obtained an exclusive license to alpha-synuclein targeted antibodies developed by Lilly, within Greater China. Lilly will receive an upfront cash payment, in addition to downstream milestones and royalties on products developed and commercialized by SciNeuro. Lilly retains all rights outside Greater China.

The stock was up 0.37% to $183.20 in premarket trading Wednesday.

Offerings

Satsuma Pharmaceuticals, Inc. STSA said selling shareholders may offer and sell up to 14.085 million shares of our common stock from time to time in one or more offerings.

The stock slid 9.85% to $4.85 in after-hours trading.